著者

寺田 真紀子 北澤 英徳 川上 純一 足立 伊佐雄

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.28, no.5, pp.425-434, 2002-10-10 (Released:2011-03-04)

参考文献数

82

被引用文献数

14 16

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In Japan, traditional herbal medicines (kampo medicines) have been widely used for various diseases as relatively safer drugs than Western medicines. However, serious adverse-events such as interstitial pneumonia (IP) and liver dysfunction (LD) have recently been reported. In this study, IP and LD associated with Kampo medicines were reviewed pharmacoepidemiologically to establish an effective monitoring protocol and appropriate treatment schedules while also elucidating the possible ingredients for IP and LD. Medline, JICST and J-Medicine databases were searched for IP and LD induced by Kampo medicines published in 1984-2000. Thirty-five cases of IP including 8 mortal cases and 28 cases of LD have been reported. As initial symptoms, 60-80% of IP patients developed dyspnea, fever and cough. On the other hand, the initial symptoms for LD patients were not characterized. Stopping the medications improved the symptoms in 29% of IP and 54% of LD patients. A total of 72 % of IP and 7 % of LD patients required corticosteroid treatment. Scutellariae radix was contained in Kampo medicines for 94% of IP patients and 89% of LD patients. A challenge test was positive in 9 cases of IP and 10 cases of LD. Scutellariae radix was contained in all positive Kampo medicines. Our review suggested that Scutellariae radix was a possible ingredient responsible for IP and LD. Monitoring the initial symptoms and immediately stopping medications were important steps for avoiding serious adverse-events associated with Kampo medicines.

著者

田辺 公一 竹内 都子 池崎 友明 北澤 英徳 豊本 貴嗣 中林 智之

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.34, no.4, pp.347-354, 2008 (Released:2009-09-04)

参考文献数

7

被引用文献数

4 3

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Pravastatin sodium tablets are widely used for the treatment of hyperlipidemia,and 22 generic products of this compound have been approved in Japan.A few studies have compared the clinical efficacy of the original and generic forms,and 1 study has questioned the reliability of biological equivalency tests.We therefore retrospectively examined the effect of substituting a generic product (Mevan TM ; Nichi-iko Pharmaceutical Co.,Ltd.) for the original product (Mevalotin TM ; Daiichi Sankyo Co.,Ltd.) on clinical efficacy and safety.We targeted patients who were initially treated with the original product and then the generic product,and from electronic medical records,obtained their prescription data for 3 months before and after generic substitution.Next,we investigated clinical equivalence with regard to changes in total cholesterol (TC),HDL cholesterol (HDL),LDL cholesterol (LDL),and triglyceride (TG) levels as indices of clinical efficacy,as well as in ALT,AST,γ-GTP,and CPK levels as indices of safety.We examined the changes in each of these laboratory parameters between 3 months before substitution and 3 months after substitution.In 293 patients,no significant differences were observed in the indices of efficacy between before and after substitution.We also examined records for presence of diabetes mellitus and familial hypercholesterolemia and their influence on TC levels before and after substitution but no significant differences were observed in this regard.Accordingly,we concluded that the generic product investigated in this study was clinically as effective as the original product.

著者

高木 昭佳 吉田 直子 渡部 有貴 中川 洋子 北澤 英徳 三村 泰彦 足立 伊佐雄 川上 純一

出版者

日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.33, no.1, pp.15-22, 2007-01-10

参考文献数

23

被引用文献数

1 3

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To improve the drug information service and standardize pharmaceutical care for inpatients of the Department of Japanese Oriental Medicine, Toyama University Hospital, we created a Kampo (Oriental) medicine database and used it in the preparation of medication instruction sheets. The database was configured on a Power Mac G4 (Apple Computer, Inc.; Cupertino, CA, USA) personal computer operating on Mac OS 10.4 using FileMaker Pro 6 database software. The database comprised 5 interlinked files-patient registration file, constituent crude drug registration file, Kampo formula registration file, and a file for the making and storing of instruction sheets. Information on 239 crude drugs and 560 Kampo formulae obtained from our "Hospital Manual for Japanese Oriental Medicine" was recorded in the database. Further, color photographs of the plants from which the herbal medicines were derived and other natural medicines were included in the instruction sheets to give patients a better understanding of Kampo pharmacotherapy. The database has made it easy to prepare personalized instruction sheets, which can be done by only entering the patient's ID and the Kampo formulae prescribed or crude drug name. In addition, the medication instructions for each inpatient and the indication(s) of prescribed Kampo formulae have been recorded in the database for later use in the management of inpatient histories and to provide utilization statistics for Kampo medicines. When a questionnaire survey of inpatients of the Department of Japanese Oriental Medicine was carried out to evaluate the usefulness of the medication instruction sheets prepared using the database, it was found that they gave patients a better understanding of Kampo pharmacotherapy and made them more interested in it. In conclusion, our database system will help improve the drug information service and quality of pharmaceutical care for inpatients treated with Kampo formulae prepared from crude drugs.