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| 1.
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成橋, 和正 ; 松下, 良 ; 清水, 栄 ; 山田, 清文 ; 宮本, 謙一 ; 木村, 和子 ; Naruhashi, Kazumasa ; Matsushita, Ryo ; Shimizu, Sakae ; Yamada, Kiyofumi ; Miyamoto, Ken-ichi ; Kimura, Kazuko
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医薬保健研究域薬学系<br />We conducted a prospective investigation using the visual analog scale (VAS) method to evaluate the phar
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macy experience and lectures of the Division of Pharmacy and Health Sciences, Graduate School of Natural Science and Technology, Kanazawa University. The students were instructed to evaluate their understanding and attainment of the pharmacy experience and lectures. The preceptors then evaluated the students in their charge based on their understanding and attainment of the pharmacy experience. Comparisons before and after the pharmacy experience and for each student-preceptor pair were performed with the aim of solving problems encountered, if any, for improvement. For most of the cases, scores of, self-evaluation by the students for after the pharmacy experience were higher than those for before, indicating that the pharmacy practice had been effective. The student-preceptor comparison showed that the students gave themselves higher scores for understanding and the preceptors gave their students higher scores for skills. This shows that the students felt that they had gained much knowledge of pharmacy but thought that they needed further training to improve their practical skills. In the self-evaluations after the course of lectures but prior to the pharmacy practice, the overall degree of understanding was 60%, however, this decreased after the pharmacy experience. Thus, the students were not able to retain the knowledge gained during the lectures until the end of the pharmacy experience, suggesting a need to review the content of the lectures and to rearrange schedules.
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金谷, 圭子 ; 古川, 裕之 ; 山嵜, 威志 ; 石崎, 純子 ; 木村, 和子 ; 宮本, 謙一 ; Kanaya, Keiko ; Furukawa, Hiroyuki ; Yamazaki, Takeshi ; Ishizaki, Junko ; Kimura, Kazuko ; Miyamoto, Ken-ichi
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医薬保健研究域薬学系<br />出版者照会後に全文公開
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Naruhashi, Kazumasa ; Asahi, Mariko ; Higuchi, Yasuko ; Matsushita, Ryo ; Shimizu, Sakae ; Kimura, Kazuko ; Suzuki, Nagao ; Yokogawa, Koichi ; Fujita, Shin-ichi ; Miyamoto, Ken-ichi ; 成橋, 和正 ; 松下, 良 ; 清水, 栄 ; 木村, 和子 ; 鈴木, 永雄 ; 横川, 弘一 ; 宮本, 謙一
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医薬保健研究域薬学系<br />To explore appropriate antimicrobial usage in Kanazawa University Hospital, the surveillance of antimicr
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obial use on an individual patient basis was conducted and analyses of outstanding cases were made in detail. All data of inpatients between August 1st and November 30th 1999, who were prescribed at least one of the 11 antimicrobial injections that are frequently used at our hospital were collected by utilizing a computer database support system of the hospital. The overall usage seemed appropriate in terms of the period of use based on an antimicrobial analysis. However, an analysis on an individual-patient basis suggested some inappropriate usage/misuse in certain cases. Imipenem was prescribed from the ophthalmology ward in more than 50% of all cases. This was found to be used as a postoperative prophylactic antibiotic. Since no antibiotic was prescribed to these patients thereafter, this usage cannot be defined as inappropriate although alternative antibiotics may be considered. Vancomycin was prescribed to some methicillin-resistant Staphylococcus aureus-negative patients. We also found some extensively prolonged usage of antimicrobials. All of these were considered to be inappropriate in regard to usage specified for insurance. After investigations of medical charts and consultations with attending physicians, these antimicorobials had been empirically prescribed. In one case, imipenem was prescribed to an imipenem-insensitive patient. A different effective antimicrobial drug should have been prescribed. In conclusion, we were able to uncover some inappropriate usage of antimicrobials in a patient-by-patient investigation. Our findings suggest that further surveillance and on-time suggestions to prescribers should result in a more appropriate administration of antimicrobials.
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Takizawa, Yukiho ; Mizuhara, Yasuharu ; Morita, Toshimi ; Kase, Yoshihiro ; Takeda, Shuichi ; Aburada, Masaki ; Miyamoto, Ken-ichi ; 宮本, 謙一
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Aims: Unpito, an herbal medicine extracted from a mixture of five crude medicines (Rhei Rhizoma, Glycyrrhizae Radix, Gin
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seng Radix, Zingiberis Rhizoma and Aconiti Tuber), has been developed as a drug for chronic renal failure. In general, it is difficult to estimate the absorption and excretion of herbal medicines due to the presence of a wide variety of components. The purpose of the current study was to examine the systemic pharmacokinetics and elimination of Unpito in healthy volunteers as part of the clinical study of the medicine. Methods: Three compounds, (-)epicatechin 3-O-gallate (ECG), glycyrrhetic acid (GA) and rhein (RH) were selected as markers, to examine the clinical pharmacokinetics of Unpito based on their levels in this medicine. The disposition of each compound was evaluated in 32 healthy volunteers receiving single oral doses (2, 4, 8, and 12 capsules). Results: After a single oral administration, ECG and RH exhibited linear pharmacokinetics in AUC and C max, while GA did not exhibit linear pharmacokinetics. A cross-over study was conducted to evaluate the effect of food at a single dose of 4 capsules. The effect of food was observed for the plasma concentrations of ECG and RH, while not for GA. The potential accumulations of δ-(3,4- dihydroxyphenyl)-γ-valerolactone (VL-2), a metabolite of ECG and RH were not observed. GA was not detected in urine. Conclusions: This is the first study presenting pharmacokinetics of ECG, GA and RH derived from Unpito, an herbal medicine, in healthy volunteers after single dose administration.<br />出版者照会後に全文公開
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宮本, 謙一
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[Reviews][学会開催報告]
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宮本, 謙一
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[巻頭言]
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宮本, 謙一
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[学会開催報告 / Reviews]
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石崎, 純子 ; 神田, 哲雄 ; 古川, 裕之 ; 松田, 静枝 ; 中川, 清治 ; 宮本, 謙一
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金沢大学大学院自然科学研究科分子作用学<br />金沢大学薬学部
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石崎, 純子 ; 松嶋, 由紀子 ; 長田, 幸恵 ; 松田, 静枝 ; 中川, 清治 ; 古川, 裕之 ; 宮本, 謙一
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金沢大学大学院自然科学研究科分子作用学<br />金沢大学薬学部
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石崎, 純子 ; 下村, 祥子 ; 福和, 千恵 ; 嶋田, 努 ; 横川, 弘一 ; 宮本, 謙一
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金沢大学大学院自然科学研究科分子作用学<br />金沢大学医学部附属病院薬剤部<br />金沢大学大学院医学系研究科<br />We examined the influence of basic drugs and protein var
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iants on the binding disposition of ropivacaine to α_1-acid glycoprotein (AGP). On doing this, we found the values of the competitive inhibition constant (K_i) for dipyridamole, verapamil, lidocaine and disopyramide with respect to the binding of ropivacaine to commercial AGP (70mg/dL) to be 2.1, 5.2, 6.0 and 11.0μM, respectively. Also, there was a strong correlation between the f_u value and the AGP concentration when ropivacaine was added to plasma samples from ten healthy volunteers (r=0.861). Among the volunteers, eight showed F_1S variants and two showed F_1 variants without the S variant of AGP. There was no difference in the f_u value of ropivacaine between these two groups. However, when ropivacaine was added together with dipyridamole, the f_u values of ropivacaine in plasma from volunteers with F_1S variants were clearly higher than those from volunteers without the S variant. When ropivacaine was added together with disopyramide or lidocaine, however, there was no difference in f_u values between these variants. Our results indicate that variability in the effectiveness and/or adverse effects of ropivacaine are caused by changes in f_u as a consequence of changes in AGP concentration. They also suggest that in combination therapy, it is also important to consider the AGP variant-dependence of the inhibitory effect of concomitantly administered drugs
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松田, 静枝 ; 石崎, 純子 ; 松嶋, 由紀子 ; 長田, 幸恵 ; 横山, 英子 ; 越野, みつ子 ; 片田, 真理子 ; 古川, 裕之 ; 分校, 久志 ; 宮本, 謙一 ; 和田出, 静子
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金沢大学大学院自然科学研究科分子作用学<br />金沢大学薬学部
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小川, 智美 ; 古川, 裕之 ; 内潟, 将宏 ; 畠, 真理子 ; 宮本, 謙一
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The Systematic education is needed now, because more expectations are placed on clinical research coordinator (CRC) whose duties range from clinical trials for drug development to clinical research. The purpose of this study was to grasp
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the present conditions of the education opportunity for CRC and to examine the education content in order to build a better education system. The number of survey respondents was 187 (32.9%) among the total of 568 surveys distribution. Half of person was hard to take education, and time and distance were outstanding as the cause. They answered that the fundamentals of "GCP" are very important as a learning item. The need to raise understanding of fundamentals such as "ethical problem", "compensation", and "data management" was suggested. As well as substantiality of the training on the national scale, it was thought that teaching materials for self-learning, such as e-learning, we will be necessary for the improvement of knowledge and professional ability of CRC.
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伊藤, さつき ; 石崎, 純子 ; 小柴, 美紀恵 ; 五十嵐, 康郎 ; 長田, 直人 ; 菅, 幸生 ; 西村, 良成 ; 前馬, 秀明 ; 小泉, 晶一 ; 中尾, 眞二 ; 横川, 弘一 ; 崔, 吉道 ; 宮本, 謙一
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The purpose of this study was to investigate whether the trough plasma concentration of voriconazole (VRCZ) in the stead
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y-state (Cmin) influences efficacy and safety in adult and pediatric patients. Treatment was successful in 75% of pediatric patients and 56% of adult patients,and there was no association between Cmin and efficacy.However,liver dysfunction occurred more frequently in the case that Cmin was over 4μg/mL in both adult and pediatric patients.Also,pediatric patients,especially those younger than 2 years,required a higher dose of VRCZ than adults to achieve a similar Cmin. We concluded that the use of VRCZ at a constant dose over a long period may lead to an increase in Cmin.Therefore,careful,continuous monitoring of the Cmin of VRCZ is necessary for pediatric patients,particularly recipients of hematopoietic stem cell transplantation.
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石崎, 純子 ; 松嶋, 由紀子 ; 長田, 幸恵 ; 松田, 静枝 ; 中川, 清治 ; 古川, 裕之 ; 宮本, 謙一
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成橋, 和正 ; 野村, 政明 ; 亀井, 浩行 ; 小野, 俊介 ; 松下, 良 ; 清水, 栄 ; 横川, 弘一 ; 山田, 清文 ; 鈴木, 永雄 ; 宮本, 謙一 ; 木村, 和子
概要:
金沢大学医薬保健研究域薬学系<br />従来の薬学教育における臨床教育の不足から,多くの薬学系大学院博士前期課程(修士課程)に薬剤師免許取得後の大学院生を対象とした臨床系の専攻やコースが設立されてきている.金沢大学でも,薬学研究科(現:自然
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科学研究科)に臨床薬学教育を主眼に置いた医療薬学専攻が平成8年に設立され,国立大学としては早期であった.本学医療薬学専攻では,薬剤師免許取得者を対象とし,臨床現場で指導的役割を果たす高度な薬剤師の養成および次世代の医療薬学教育研究に携わる人材の育成を教育理念としている.このため,医療薬学専攻の学生に対して医療現場の実習を通じて医療を担うものとしての自覚を深めさせるとともに,自然科学の素養を身に付けることを求めている.具体的な教育目標は,医療人としての倫理観の醸成,医療の専門家として健康と疾病に関する知識獲得,薬物治療に起因する問題の同定・評価・解決,ならびに,コミュニケーションに関する知識・技術の習得,さらには,関連分野における高い研究・開発能力を発展させることである.このため,発足当初は,入学初期の集中講義,1か月の市内保険薬局での薬局実習,6か月の本学医学部附属病院薬剤部での実務実習を行い,1年間を課題研究期間としていた.講義は学部教育に引き続き,基礎自然科学系科目が大半であり,臨床現場での実習との非関連性が学生からも指摘されていた.また,半年間の実習後に修士の学位論文の一部として病院実務実習篇の作成や口頭発表が要求されていたために,実質的な実務実習は,時間的に極めて限られていた.実務実習を終えたあとの課題研究は,医療薬学専攻ならびに生命薬学専攻に属する各研究室で行っていたことから,必ずしも臨床に近いものではなかった.さらに,学生が就職するのは実習終了後1年を経過した後であり,就職直前の学生から実務に対する不安がでたり,就職直後に修了生や雇用者から実習経験が薬剤師として十分に活かせていないとの声が聞かれた.このような問題点を踏まえて,平成13年度に医療薬学専攻のカリキュラムの改善を図った.医療薬学に対する幅広い知識を深めさせるため,臨床系講義科目を充実させた.この変更では,薬物治療の科学的基礎とともに,看護,倫理,心理,国際など,医療に関連する人文・社会系分野も開講し,受講する学生の講義科目数が増加した.また,実習に関しては,継続性や充実性を考慮し,実務実習期間を1年に延長した.最初の2か月間は薬剤師業務全般の集中的な導入実習として,6人ずつ4グループに分かれ,調剤部門(一般調剤・注射薬調剤,2週間),製剤部門(一般製剤・無菌調剤,1週間),薬剤管理指導部門(医薬品情報・医薬品管理・TDM,1週間:病棟業務,4週間)を行う.その後は学生1人に対し指導薬剤師1人というマンツーマン形式の個別指導とし,薬剤師職能の病棟の薬剤管理指導を中心の実習としている.これに対し,医療薬学専攻の各教官も3名程度の学生を担当し,面接などにより実習の進捗状況を把握するとともに,専門分野に応じた指導も担当している.しかしながら,実習(実務)の大部分は指導薬剤師により行われており,個別指導であるため学生全体としての質の評価や,問題点の抽出は行いにくい.そこで,この新カリキュラムによる講義の理解度や実習の達成度について,visual analog scale(VAS)を用いて,学生と指導薬剤師による評価を試みた.また,この評価結果から,新カリキュラムの問題点などについて考察することとした. We conducted an investigation to determine whether the visual analogue scale (VAS) method could be utilized in evaluating the lectures and pharmacy experience of the Division of Pharmacy and Health Sciences, Graduate School of Natural Science and Technology, Kanazawa University. Graduate students who had finished the 1-year pharmacy experience at the Kanazawa University Hospital were asked to make a self-evaluation of the understanding/attainment of lectures and experience in the course. Since the experience was carried out as a one-student-to-one-pharmacist system, the preceptors (pharmacists) were also asked to evaluate their corresponding students. When evaluating the necessity of the lectures, students tended to feel that the medical science- or pharmacotherapy-related subjects were important and those of social sciences were less important. These results suggest the need to review the contents of the lectures to enhance the interests of the students in the latter. By comparing the extent of understanding of each lecture before and after pharmacy experience, it was found that students had a better understanding of the lectures through their experience. In most results from the answers in pharmacy experience, students also scored themselves higher than their preceptors. Therefore comparisons of evaluation may provide more objective results in pharmacy experience. It was demonstrated that utilization of the VAS method and comparing the data are very useful in evaluating not only students' understanding/attainment but also the importance and usefulness of lectures and pharmacy experience in an objective way.
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成橋, 和正 ; 松下, 良 ; 清水, 栄 ; 山田, 清文 ; 宮本, 謙一 ; 木村, 和子
概要:
We conducted a prospective investigation using the visual analog scale (VAS) method to evaluate the pharmacy experience and lectures of the Division of Pharmacy and Health Sciences, Graduate School of Natural Science and Technology,
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Kanazawa University. The students were instructed to evaluate their understanding and attainment of the pharmacy experience and lectures. The preceptors then evaluated the students in their charge based on their understanding and attainment of the pharmacy experience. Comparisons before and after the pharmacy experience and for each student-preceptor pair were performed with the aim of solving problems encountered, if any, for improvement. For most of the cases, scores of, self-evaluation by the students for after the pharmacy experience were higher than those for before, indicating that the pharmacy practice had been effective. The student-preceptor comparison showed that the students gave themselves higher scores for understanding and the preceptors gave their students higher scores for skills. This shows that the students felt that they had gained much knowledge of pharmacy but thought that they needed further training to improve their practical skills. In the self-evaluations after the course of lectures but prior to the pharmacy practice, the overall degree of understanding was 60%, however, this decreased after the pharmacy experience. Thus, the students were not able to retain the knowledge gained during the lectures until the end of the pharmacy experience, suggesting a need to review the content of the lectures and to rearrange schedules.
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古川, 裕之 ; 内潟, 将宏 ; 松嶋, 由紀子 ; 長田, 幸恵 ; 横山, 英子 ; 石崎, 純子 ; 清水, 栄 ; 神谷, 晃 ; 宮本, 謙一
概要:
The major problem in the management of information on adverse events is found in both the clinical trial sponsor and the trial institution. The primary cause is inconsistency in the sponsors and trial institutions due to the use of original
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management methods which differ among sponsors or among trial institutions. In order to solve this problem, it is proposed to classify adverse events into three groups: "Case Report A", "Case Report B" and "Accumulated Information" based on the detected place (Japan or foreign country), the detected phase (clinical trial or post-marketing), unknown or known event, and the degree of severity. "Case Report A" and "Case Report B" will be evaluated individually, and "Accumulated Information" will be evaluated collectively in the institutional review board. Electronic list data is provided to the trial institution as the standard version only, and individual alteration request to the list data from institutions should not be accepted. Therefore, each institution should arrange the list data for creating its own database, if needed. The list data is presently provided by electronic media which are currently used widely such as the floppy disk or CD-R etc, but it might be necessary to plan for use by electronic mail. By classifying the adverse events and using electronic data for providing information about adverse events, more efficient information management is expected in both sponsors and trial institutions.
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吉冨, 克則 ; 古川, 裕之 ; 宮本, 謙一
概要:
Protocols and case report forms are different among clinical trials, however adverse events (AEs) occur in every trial and need to be assessed in the same way. Therefore, we conducted a survey to examine the actual condition of the
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information of AEs. We surveyed choices and criterions of items for AEs of 59 trials which were performed in Kanazawa University Hospital. As a result of the survey, it became clear that choices currently used for each item were varied and different in each trial. Criteria of severity and outcome were also varied ; there were even contradicting criteria among trials. There were also contradictory judgments of adverse drug reactions (ADRs), and the definition of "Probably not" expressed as an ADR differed. Moreover, in these trials, the criteria for "Probably not" was not markedly different. From these results, it was suggested that current the collection and assessment of the information of AEs were different in each trial and thereby assessments could also be different. Pharmaceutical companies, regulatory agenceis, and medical institutions should be in discussion to determine standardization of the expression of choices and criterions of AEs.
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古川, 裕之 ; 陶山, 和明 ; 河原, 昌美 ; 石崎, 純子 ; 松嶋, 由紀子 ; 長田, 幸恵 ; 松田, 静枝 ; 清水, 栄 ; 宮本, 謙一
概要:
To attain good medication compliance is the major premise in well-controlled clinical trials. We conducted a questionnaire survey on 40 clinical investigators, 25 sponsors and 20 trial subjects during Oct.-Dec. 1998 to
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investigate the correlation among actual circumstances of medication compliance in trial subjects and the evaluation of medication compliance by clinical investigators and sponsors, and to determine effective measures to improve medication compliance. Whereas almost all clinical investigators and sponsors evaluated or expected over 70% of medication compliance, the trial subjects answered over 90%. The clinical investigators (95%) and the sponsors (96%) thought in actuality that the primary means to maintain good compliance was for the clinical investigator to individually interview the trial subjects. The sponsors proposed possible adoption of clinical research coordinator's (CRC) support, a specific dispenser device or container, the use of medication diary, etc. However, only a few beneficial medication devices and medication diaries have been provided by the sponsors to date. This survey suggests that the medicine dispenser device and the interview by CRC are very effective to attain good medication compliance.
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古川, 裕之 ; 内潟, 将宏 ; 松嶋, 由紀子 ; 長田, 幸恵 ; 横山, 英子 ; 松田, 静枝 ; 石崎, 純子 ; 清水, 栄 ; 分校, 久志 ; 宮本, 謙一
概要:
In order to examine the efficient management method of the vast amount of information on adverse events, a questionnaire survey on the evaluation organization of adverse events in a clinical trial and the implementation of
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information technology for information management was given to 50 clinical trial sponsors. Of the sponsors, 64% has a evaluation criteria for the causal relationship of an investigational drug and adverse events, but the 84% is "internal original standard". With 56% of sponsors, a doctor permanently resides to perform causal relationship evaluation, and 44% of sponsors rely on "outsourcing". All sponsors with no permanent residence doctor and no evaluation criteria are Japanese companies. A delay in maintenance in information management organization, including the holding frequency of the evaluation committee, was observed in Japanese sponsor. Among sponsors, 88% replied that it would be useful to create a database of adverse events, presuming that sponsors can correspond with front electric formal data. However, the sponsors do not wish to meet the request from each individual institution, rather they want to offer by standard format; both the sponsor and the institution need to agree on standard data items.
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高月, 公博 ; 古川, 裕之 ; 宮本, 謙一
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The purpose of this study was to determine the items necessary for causality assessment in order to improve the usefulness of the individual case safety report (ICSR) from medical institutions as adverse drug reaction (ADR)
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information. Thus, we evaluated the standard items for causality assessment by surveying the items used in pharmaceutical manufacturers of generic drugs. The number of respondents was 35, which was 89.7% of the member companies of Japan Generic Pharmaceutical Manufacturers Association. The use of algorithms for causality assessment, terms for causal relation, and criteria for assessing whether or not ADR were varied among the companies. These findings were similar to the previous results in a survey of pharmaceutical companies of original drug. The variety of assessment criteria is inconvenient for reporters to judge and also lowers the validity of judgment. Additionally, it will be inappropriate to assess ADR information all together. And these variations may cause wide differences in the frequency measurement of ADR. Therefore, it is crucial to immediately derive consensus on international assessment criteria for causality assessment.
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古川, 裕之 ; 金谷, 圭子 ; 山崎, 威志 ; 高木, 敏治 ; 増江, 俊子 ; 石崎, 純子 ; 木村, 和子 ; 宮本, 謙一
概要:
Immediate post-marketing surveillance (IPMS) is a new safety management system in Japan without parrallel in the rest of the world; the effective enforcement of this system is expected in order to minimize the health hazard caused by
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critical adverse drug reactions (ADR). However, from the medical institution side, there are some problems which need to be resolved in order to carry out IPMS smoothly. To solve these problems, an experimental investigation using a model medicine was conducted in our institution. At the same time, the research on the status of efforts and activities made by pharmaceutical companies toward IPMS was conducted, followed by problem analysis in implementation of IPMS and a review of the countermeasures. The main problems found in the new IPMS operation is the lack of cooperation from medical institutions. In order to obtain cooperation from the medical institutions, some incentives are needed, such as, limiting medical institutions for the use of a new developed medicine or design a contract between the pharmaceutical company and medical institution. Two types of contractual coverage are available; one is to provide the prescriber list to medical representative (MR) in written form, and the other is to provide the ADR information collected in the clinical setting by pharmacists in addition to the prescriber list. And, as a contact point of MR visit, the drug information service center may be considered. Moreover, a model was created based on the contract betweena a pharmaceutical company and medical institution for conducting IPMS effectively and smoothly in the medical institution. This model is characterized by the clear distinction of the pharmacist's role for effective operation of IPMS.
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| 23.
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嶋田, 努 ; 山崎, 賢 ; 伊藤, 千恵 ; 吉原, 裕美 ; 野村, 政明 ; 横川, 弘一 ; 宮本, 謙一
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| 24.
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吉冨, 克則 ; 古川, 裕之 ; 宮本, 謙一
概要:
In the current clinical trials, clinical data which was originally recorded on source data is transcribed into CRF by physicians or CRCs, and CRAs verify source data and CRF. However, transcription and verification are labor-intensive
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jobs. If the information of source data could be electronically transmitted to CRF, transcription and verification jobs are unnecessary. However, transmission of all necessary data is difficult. Therefore, we carried out surveys for CRCs and CRAs about which data items should be transmitted and what problems might occur. We obtained responses from 370 CRCs and 252 CRAs. It was suggested that data items which can improve efficiency of clinical trials are "Concomitant Medications", "Medical History/Complications", "Laboratory Test Results", "Adverse Event", and "Vital Signs". And various problems were listed ; in paticular, CRCs were concerned about "Security" and CRAs were concerned about "Reliability and Assurance of the System".
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| 25.
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古川, 裕之 ; 分校, 久志 ; 宮本, 謙一
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| 26.
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寺田, 愛 ; 嶋田, 努 ; 金子, 寛子 ; 打和, 寿子 ; 横川, 弘一 ; 鍛冶, 恭介 ; 金子, 周一 ; 小林, 健一 ; 宮本, 謙一
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| 27.
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横井, 祐子 ; 古川, 裕之 ; 永平, 廣則 ; 林, 修嗣 ; 長田, 幸恵 ; 松嶋, 由紀子 ; 石崎, 純子 ; 神谷, 晃 ; 宮本, 謙一
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| 28.
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古居, 奈歩 ; 伏田, 幸夫 ; 横川, 弘一 ; 宮本, 謙一
概要:
〈抄録〉第25回 日本臨床薬理学会年会 2004年9月17～18日 静岡
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| 29.
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小川, 智美 ; 古川, 裕之 ; 宮本, 謙一
概要:
In recent years, the use of the EDC system in clinical trials has expanded rapidly. Many medical institutions have accepted the installation of the EDC system for clinical trials. However, a few systems reflect a paticular opinion
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on the data entry side in former system development. Therefore, we undertook an investigation which focused on the problems of the system and based on the results we considered means of improvement for enhanced usability of the EDC system. A questionnaire survey was sent to CRCs which are the clinical trial implementation hospitals of national organizations and university hospitals (in total 131 facilities), the 61 member companies of Japanese SMO society, and the attendees of luncheon seminars 1 and 2 of CRC meeting 2008 in Kanazawa. A total of 811 questionnaire survey responses were obtained. Of the respondents 93.6% had prior experience using the EDC system, and 69.5% implementing EDC system with English entry. The items with the most frequent responses were training program (38%), inconsistent entry form (36%), the limitation of the usable system (34%), data entry using English language (31%) and management of identification number and password (28%). The EDC system has rapidly become popular, and it is expected that use of the EDC system with English entry will increase in the future. In this investigation, problems such as system improvement in the design process and interface were extracted. These problems have been extracted for system improvement, and based on the addressing these problems there is hope for the realization of correct and quick data acquisition.
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| 30.
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松嶋, 由紀子 ; 長田, 幸恵 ; 松田, 静枝 ; 石崎, 純子 ; 古川, 裕之 ; 分校, 久志 ; 宮本, 謙一
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| 31.
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松嶋, 由紀子 ; 横山, 英子 ; 長田, 幸恵 ; 石崎, 純子 ; 片田, 真理子 ; 越野, みつ子 ; 松田, 静枝 ; 古川, 裕之 ; 分校, 久志 ; 宮本, 謙一
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| 32.
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松嶋, 由紀子 ; 横井, 祐子 ; 横山, 英子 ; 長田, 幸恵 ; 石崎, 純子 ; 鉄野, 和美 ; 越野, みつ子 ; 松田, 静枝 ; 古川, 裕之 ; 分校, 久志 ; 宮本, 謙一
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| 33.
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内潟, 将宏 ; 古川, 裕之 ; 石崎, 純子 ; 松嶋, 由紀子 ; 長田, 幸恵 ; 松田, 静枝 ; 横山, 英子 ; 片田, 真理子 ; 越野, みつ子 ; 清水, 栄 ; 分校, 久志 ; 宮本, 謙一
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| 34.
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小川, 充 ; 小松原, 明哲 ; 古川, 裕之 ; 宮本, 謙一 ; 坂尾, 雅子 ; 和田出, 静子
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| 35.
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古川, 裕之 ; 北川, 明 ; 工藤, 正純 ; 中尾, 泰史 ; 手島, みどり ; 山口, 辰哉 ; 西原, 茂樹 ; 比嘉, 保 ; 手塚, 春樹 ; 宮本, 謙一 ; 中野, 眞汎
概要:
金沢大学医学部附属病院臨床試験管理センター
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| 36.
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涌沢, 伸哉 ; 宮本, 謙一 ; 柳岡, 利一 ; 越浦, 良三
概要:
金沢大学医学部附属病院薬剤部<br />The relationship between the intracellular accumulation of vinblastine (VBL) and the effect of reser
…
pine in four rat ascites hepatoma cell lines having different sensitivities to VBL was investigated. The order of the sensitivity to VBL was AH66 cells<AH109A cells<AH44 cells<AH13 cells. The intracellular VBL content for 30 min incubation was higher in sensitive cells than in natural resistant cells and after washing out extracellular VBL, VBL retained in sensitive cells was more than that in resistant cells. Reserpine suppressed the extrusion of VBL, accumulated VBL in all cells, and enhanced VBL sensitivity of the cells. These effects of reserpine were significant in VBL resistant cell lines, AH66 cells and AH109A cells, rather than in sensitive cell lines, AH13 cells and AH44 cells, and the VBL resistance was completely overcome by reserpine. The activities of adenosine triphosphatase (ATPase), especially Mg^<2+> ATPase, in the plasma membrane of VBL resistant cells were higher than those of sensitive cells. Reserpine markedly suppressed the activities of Mg^<2+> ATPase and Ca^<2+> ATPase but had no effect on (Na^+-K^+) ATPase activity. From these results, it was indicated that rat ascites hepatoma cells possessing higher ATPase activities in the plasma membrane were more resistant to VBL and reserpine overcame the natural resistance to VBL suppressing the active efflux of VBL.
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| 37.
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古居, 奈歩 ; 山崎, 賢 ; 横川, 弘一 ; 伏田, 幸夫 ; 三輪, 晃一 ; 宮本, 謙一
概要:
金沢大学医学部附属病院薬剤部<br />We evaluated the disposition kinetics of taxanes, an antitumor agent after the intraperitoneal admin
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istration in nine patients with peritoneal tumors. The intraperitoneal concentrations of docetaxel or paclitaxel decreased slowly following the I.p. infusion administration of either docetaxel (60-80mg/day) or paclitaxel (120-180mg/day) over a 1-hour period in patients. There was no difference in the concentration-time courses between both drugs in each patient, and the elimination half-time was about 8hr. The area under the intraperitoneal concentration-time curve (AUC_p) of paclitaxel relative to the dose was about 3-times larger than that of docetaxel. On the other hand, the permeability of these drugs from the peritoneal cavity into the systemic circulation was extremely small. The plasma concentrations and the AUC_s of both drugs showed large individual variations among the patients. The ratios of AUC_s/AUC_p of docctaxel and paclitaxel relative to the dose were 7.1×10^<-2> and 3.8×10^<-3>, respectively. The permeability of paclitaxel was only about 1/20 that of docetaxel.
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| 38.
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大川, 浩子 ; 渡辺, 真生 ; 斎藤, 義正 ; 打和, 寿子 ; 藤井, 奨 ; 井野, 秀一 ; 横川, 弘一 ; 宮本, 謙一
概要:
金沢大学医学部附属病院薬剤部<br />The unbound concentration of disopyramide (DP) in plasma was studied to determine whether or not it
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is a useful index to assess the effectiveness of DP in anti-arrhythmic therapy. In 20 arrhythmic patients administered DP (Rythmodan®, 100-600 mg/day), there was no correlation between the dose and total or unbound plasma concentration of DP. The values of unbound fraction (fp) of DP in plasma widely varied from 0.25 to 0.57. The fp values were not correlated with the albumin concentration in plasma, but did correlate with the concentration of α1-acid glycoprotein. We further examined the relationship between the total or unbound plasma concentrations of DP and it's effectiveness in 16 of the 20 patients (4 patients had side effects). There was significant difference in the plasma concentrations of DP between the effective group and the ineffective group. However, as the range of the concentration for the two groups overlapped in 75%, the total concentration cannot be used to define the effectiveness. On the other hand, the unbound concentration of DP was greater than 0.8 μg/mL in the effective group, whereas it was lower than 0.8 μg/ mL in the ineffective group. There was no correlation between the unbound concentration of mono-N-dealkyldisopyramide (MND) and the effectiveness. The range of the unbound plasma concentration of MND was 0.1-1.0 μg/mL, and no patient developed side effects such as tachycardia or constipation due to the anticholinergic effect. In conclusion, an unbound concentration of DP in plasma of over 0.8 μg/mL can be used as an index of the effectiveness of anti-arrhythmic therapy in therapeutic drug monitoring.
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| 39.
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古川, 裕之 ; 内潟, 将宏 ; 石崎, 純子 ; 松嶋, 由紀子 ; 長田, 幸恵 ; 松田, 静枝 ; 横山, 英子 ; 清水, 栄 ; 分校, 久志 ; 宮本, 謙一
概要:
金沢大学医学部附属病院臨床試験管理センター
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| 40.
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佐藤, 美佳 ; 古川, 裕之 ; 松嶋, 由紀子 ; 横井, 祐子 ; 宮本, 謙一
概要:
金沢大学医学部付属病院薬剤部<br />In clinical trials, patient name, date of birth, and sex are items of medical information used to re
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fer to patients. Generally speaking, patient names are indicated by their initials. However, there are doubts as to whether patients may remain completely unidentified when initials are used. In this study, we investigated the identification levels of patients through the combination of the above three patient data items in post marketing surveillance data. We also investigated the necessity of items recorded in case registration forms for pharmaceutical companies and medical institutions. We investigated combinations of "K.K" and "Jan. 2, 1947" which were assumed to relate to the largest populations in the database of patient medical information at Kanazawa University Hospital. The total number of patients in the database with combinations of the above was 358,251. The number of patients with the initials "K.K." was 7,892 (1/45), that with the initials "K.K" and "1947" was 173(1/2000), and that with the initials "K.K", "1947" and "Jan" was 23, while there were only 4 patients (1/8500) with the initials "K.K.""1947", "Jan" and "2". These results indicate that it would be possible to identify patients from the combination of their initials and their date of birth (DD/MM/YY). However, the size of the patient population in each medical institution's database would be an important factor since it would determine the extent to which this could be done. From the point of view of protecting personal information, it is thus necessary to consider whether it is appropriate to use patients' initials and dates of birth based on the size of patient population.
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| 41.
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古川, 裕之 ; 宮本, 謙一 ; 神谷, 晃 ; 伊賀, 立二 ; 宗近, 誠一郎
概要:
金沢大学医学部附属病院臨床試験管理センター
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| 42.
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宮本, 謙一 ; 涌沢, 伸哉 ; 柳岡, 利一 ; 越浦, 良三
概要:
金沢大学医学部附属病院薬剤部<br />The effect of six Rauwolfia alkaloids on the growth inhibitory effect of vinblastine (VBL) in rat as
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cites hepatoma AH66 cells was investigated. When cells were treated with VBL and each alkaloid for 30 min, reserpine, rescinnamine, syrosingopine, and ajmaline markedly potentiated the effect of VBL, but dimethylaminoethylreserplinate hydrochloride (DMAR) and yohimbine did not influence. On the other hand, in the continuous treatment for 2 d, DMAR and yohimbine also potentiated the effect of VBL. All of alkaloids increased the intracellular VBL content. Among these alkaloids, reserpine markedly suppressed the activities of Mg^<2+>ATPase and Ca^<2+>ATPase in the plasma membrane and DMAR suppressed the activities of adenosine triphosphatase (ATPase) except (Na^+-K^+) ATPase. Reserpine and DMAR did not affect the VBL binding to microtubules. Reserpine inhibited the microtubule polymerization by itself and synergistically acted with VBL on microtubules but DMAR did not affect the polymerization and the effect of VBL. From the results, it was indicated that all of Rauwolfia alkaloids suppressed the active extrusion of VBL, increased the intracellular VBL content, and potentiated the effect of VBL on AH66 cells. Moreover, it was suggested that some of alkaloids including reserppine could enhance the effect of VBL even by a short term treatment because of their synergistical interaction with VBL on microtubules.
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| 43.
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涌沢, 伸哉 ; 柳岡, 利一 ; 宮本, 謙一 ; 越浦, 良三
概要:
金沢大学医学部附属病院薬剤部<br />The influence of Ca^<2+> antagonists and metabolic inhibitors on the membrane transport of vinblasti
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ne (VBL) in rat ascites hepatoma AH66 cells was investigated. Such Ca^<2+> antagonists as ruthenium red (RR) and lanthanum chloride (La) decreased the uptake of VBL but did not influence the intracellular retention of VBL. In contrast, verapamil markedly increased the uptake and decreased the efflux of VBL. Since AH66 cells are not excitable cells, it was considered that verapamil which is a Ca^<2+> channel antagonist showed a different action from other Ca^<2+> antagonists. Iodoacetic acid increased the uptake of VBL and suppressed the extrusion of VBL but dinitrophenol and ouabain did not influence the intracellular content of VBL in the glucose rich medium. On the other hand, RR and La specifically inhibited the activity of (Ca^<2+>-Mg^<2+>) ATPase. Ouabain also specifically inhibited the activity of (Na^+-K^+) ATPase. Iodoacetic acid suppressed the activities of ATPase except (Na^+-K^+) ATPase. Therefore, in the influx of VBL, the presence of Ca^<2+> on the plasma membrane or in the cell seemed to be necessary. Moreover, it was suggested that VBL was not extruded by neither (Na^+-K^+) ATPase nor (Ca^<2+>-Mg^<2+>) ATPase in the plasma membrane and a different active transport system might be concerned with the efflux of VBL.
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| 44.
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河原, 昌美 ; 石田, 智之 ; 江本, 千恵 ; 松下, 良 ; 市村, 藤雄 ; 片岡, 治 ; 向, 智里 ; 花岡, 美代次 ; 石崎, 純子 ; 旭, 満里子 ; 宮本, 謙一
概要:
金沢大学医学部附属病院薬剤部
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| 45.
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郡司, 聖子 ; 古川, 裕之 ; 宮下, 知治 ; 西村, 元一 ; 安藤, 絹子 ; 坂尾, 雅子 ; 飛田, 敦子 ; 山田, 清文 ; 宮本, 謙一
概要:
金沢大学附属病院薬剤部<br />Currently, normal saline lock or normal saline containing heparin lock are routinely used after IVH or
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intermittent peripheral infusion in the clinical setting. Up till now, however, there has been no evidence for the optimal concentration of heparin in the lock solution for preventing thrombus formation in peripheral vein catheters and central venous catheters. The purpose of this study was to evaluate the effectiveness of normal saline against normal saline containing 10U/mL or 100U/mL heparin for preventing blood clotting in peripheral vein catheters. Patients (N=60) in Kanazawa University Hospital were randomized to 3 groups (saline lock group, 10U/mL heparin lock group and 100U/mL heparin lock group : N=20 for each). We evaluated the rates of thrombus formation and thrombus protein content after 24 hours of lock in peripheral vein catheters. Our results indicated that when the 100U/mL heparin lock solution was used, both thrombus formation rates catheters and protein contents were significantly lower than for the other 2 groups. However, at 100U/mL, the heparin lock solution caused most pain at the insertion site, though the reason for this was not clearly known. In conclusion, as compared with the normal saline solution and the 10U/mL heparin lock solution, the 100U/mL heparin lock solution was more effective in preventing the thrombus formation in the peripheral vein catheter.
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| 46.
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山田, 澄 ; 越浦, 良三 ; 宮本, 謙一 ; 早苗, 富士子
概要:
金沢大学医学部附属病院薬剤部<br />The pharmacological properties of DL-1-(γ-chloropropyl)-2-chloromethylpiperidine hydrobromide (CAP-2
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), a new nitrogen mustard type antitumor agent, were investigated in various experimental animals. The LD_<50> value by intraperitoneal single injection of CAP-2 was 60.0 mg/kg for female mice and 65.0 mg/kg for male mice 7 days after injection. Female and male received a maximum tolerated dose of 30 mg/kg and 25 mg/kg, respectively, of CAP-2 intraperitoneally once a day for 7 days. Decrease of spontaneous motalities, mild prolongation of sleeping time, hypothermia, and analgesic action were observed by intraperitoneal injection in mice of a dose of 30 mg/kg of CAP-2,but not at smaller doses. In the isolated large intestine of the guinea pig, a low concentration of CAP-2 caused relaxation and a decrease of activity which was antagonistic for acetylcholine, but not for barium chloride. Intestinal relaxation disappeared and changed to intestinal contraction by the repeated application of CAP-2 (1×10^<-4>g/ml). CAP-2 (1×10^<-4>g/ml) caused intestines relaxed by atropine to contract and increased their activity. This contraction was inhibited by paraverine. In the isolated heart of the frog, CAP-2 showed a negative inotropic action and a concentration of 1×10^<-4>g/ml inhibited the diastric standstill by acetylcholine. CAP-2 did not affect femoral vessel flow in the frog even at a concentration of 3×10^<-2>g/ml. CAP-2 tended to contract the rectus abdominis muscle of the frog. In the rabbit, CAP-2 (1-5mg/kg, i.v.) exhibited a temporary hypotensive action and weak respiratory stimulation. From these results, it was confirmed that CAP-2 has a depressant effect on the central nervous system and an anticholinergic action on the peripheria.
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| 47.
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大川, 浩子 ; 谷本, 明日香 ; 旭, 満里子 ; 成橋, 和正 ; 松下, 良 ; 坂尻, 顕一 ; 宮本, 謙一
概要:
The control of drug use for Parkinson's disease is very important for both the QOL and ADL of patients. Nowadays, patients with Parkinson's disease are treated with the concomitant use with L-dopa, dopamine receptor agonists and
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norepinephrine receptor agonists. However, these drugs elicit some adverse effects. Therefore, we tried to search for the effects and adverse effects, based on patient histories. As a result of our investigations, most patients broke out with tremors and were administered anticholinergic drugs, while a few patients were treated with L-dopa as the first drug of choice. Avoid the administration of L-dopa at first seemed to help prevent the onset of Wearing-off or On-off phenomenon. Gastric mucosal cytoprotective drugs appeared to be effective for preventing of gastric symptoms due to drugs for Parkinson's disease. Moreover, we found that mental symptoms only rarely occurred after the readministration of anticholinergic drugs. We must be careful to treat patients with brain infarction after the onset of mental symptoms. These results are valuable for helping to improve the treatment of Parkinson's disease, and may also help in performing further studies on the use of new drugs.
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| 48.
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古川, 裕之 ; 塚本, 均 ; 空閑, 正浩 ; 土屋, 文人 ; 木村, 昌臣 ; 大倉, 典子 ; 宮本, 謙一
概要:
The effectiveness of printing an “Indication Symbol” and the product name on a systemic transdermal absorbent preparatio
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n of isosorbide dinitrate (Frandol® tape-S) in preventing medication errors was evaluated through a questionnaire survey of health care professionals and patients. The numbers of completed questionnaire sheets collected for health care professionals were 7, 078 from physicians, 7, 018 from nurses, and 7, 361 from pharmacists (collection rates 70.2-73.6% of the target of 10000). The number of completed questionnaire postcards collected from patients was 1, 339 (44.6% of target of 3, 000). Both health care professionals and patients thought it was a good idea to print an indication symbol, a heart, and the product name on the preparation as a measure to prevent medication errors. Some differences were observed in the answers given to some of the questions among the former, however, indicating the importance of asking many different health care professionals to evaluate measures for preventing medication errors. Sixty percent of the patients returning the questionnaire said that they though it was a good idea to print an indication symbol and product name on the preparation and they had not seen any other product with this feature, but they were not particularly concerned about this. We hope that unified indication symbols will be adopted by all pharmaceutical companies and that their use will be expanded to all categories of systemic transdermal absorbent preparations in order to prevent medication errors.
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| 49.
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論文
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郡司, 聖子 ; 古川, 裕之 ; 宮下, 知治 ; 西村, 元一 ; 安藤, 絹子 ; 坂尾, 雅子 ; 飛田, 敦子 ; 山田, 清文 ; 宮本, 謙一
概要:
Currently, normal saline lock or normal saline containing heparin lock are routinely used after IVH or intermittent peripheral infusion in the clinical setting. Up till now, however, there has been no evidence for the optimal
…
concentration of heparin in the lock solution for preventing thrombus formation in peripheral vein catheters and central venous catheters. The purpose of this study was to evaluate the effectiveness of normal saline against normal saline containing 10 U/mL or 100 U/mL heparin for preventing blood clotting in peripheral vein catheters. Patients (N=60) in Kanazawa University Hospital were randomized to 3 groups (saline lock group, 10 U/mL heparin lock group and 100 U/mL heparin lock group : N=20 for each). We evaluated the rates of thrombus formation and thrombus protein content after 24 hours of lock in peripheral vein catheters. Our results indicated that when the 100 U/mL heparin lock solution was used, both thrombus formation rates catheters and protein contents were significantly lower than for the other 2 groups. However, at 100 U/mL, the heparin lock solution caused most pain at the insertion site, though the reason for this was not clearly known. In conclusion, as compared with the normal saline solution and the 10 U/mL heparin lock solution, the 100 U/mL heparin lock solution was more effective in preventing the thrombus formation in the peripheral vein catheter.
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| 50.
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論文
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真野, 泰成 ; 西上, 潤 ; 打和, 壽子 ; 井野, 秀一 ; 岡田, 俊英 ; 馬渕, 宏 ; 宮本, 謙一
概要:
Clinical pharmacists now participate in drug therapy as members of the patient care team and play a role in the safety management of drugs. Our role is thus expanding into the realm of clinical practice and we have more chances to
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communicate with other medical staff. They often ask us for information on drugs and providing them with such information can have an effect on drug therapy. With this situation in mind, we investigated the nature of questions asked by medical staff and determined the differences between the information requested by doctors and that asked for by nurses, targeting questions and answers give at Kanazawa University Hospital from April through October in 2003. There were 206 questions in total consisting of 91 questions from doctors and 111 questions from nurses. We found that 27.7% of the responses we gave resulted in therapy changes such as prescription adjustment. The rate for therapy changes was higher for doctors than for nurses (41.8% versus 17.1%). In conclusion, the involvement of pharmacists helps to ensure proper drug use and leads to qualitative improvements in medical care but it is necessary to accumulate data as evidence of the useful role that pharmacists can play in this respect.
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