著者

小林 睦 関戸 聡子 北田 徳昭 西山 祐美 吉岡 睦展 辻 隆志 渡 雅克 安藤 厚志 黒田 和夫

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.27, no.3, pp.262-270, 2001-06-10 (Released:2011-03-04)

参考文献数

5

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We developed a computer program for drug information for patients using File Maker Pro® software package (ver 4.0). This program consists of four databases : 1) a main database which manages data of drug efficacies, the initial symptoms of serious side effects, cautions, drug interactions, 2) standardization for drug efficacies, 3) standardization of the initial symptoms of serious side effects, and 4) information on the package insert for drugs.These four databases enabled pharmacists to provide standardized drug information rapidly not only to patients but also to other medical staff members.Moreover, these four databases connected with a relational function of File Maker Pro® enabled us to automatically update the data on drug efficacies and initial symptoms of serious side effects by in putting the drug code numbers designated by the Ministry of Health Labor and Welfare into this program.These results suggested this program to be useful for the standardization of drug information and the automatic updating of the data.

著者

下村 一徳 名徳 倫明 村山 洋子 陶山 忠士 長嶋 三香子 土師 久幸

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.27, no.3, pp.255-261, 2001-06-10 (Released:2011-03-04)

参考文献数

6

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A system that included both images and voice using a personal computer was developed to provide pharmaceutical instructions for outpatients at the medication counter. A touch panel was adopted for easy use by a wide range of age groups. The system consisted of such items as the “usage of externally applied drug”, “information on disease”, “patient education” and comprised eight items over all. A survey of 105 patients was conducted and almost all patients (95%) understood the drug-related information provided. This system was found to be an effective method for providing patients with easily understood drug-related information and most patients actually enjoyed using this system which led to an improved dissemination of important medication related information.

著者

蒲沢 一行 内藤 由子 佐々木 辰也

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.27, no.3, pp.245-254, 2001-06-10 (Released:2011-03-04)

参考文献数

13

被引用文献数

1

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This paper investigated the distribution of environmental bacteria during the 13-year-period after Iwate Prefectural Central Hospital moved to a new building.(1) The change in airborne bacteria during the 13-year-period was found to be virtually the same as when the building was new.(2) A reduction in airborne bacteria through the use of HEPA filters was observed.(3) Within the hospital and depending on the season, the number of airborne bacteria fluctuated.(4) The detection ratios of airborne bacteria during the 13-year-period hovered in the following ranges : Gram Positive Coccus (GPC) : 75.9 to 77.3%; Gram Positive Bacillus (GPB) : 17.3 to 18.3%; Neisseria spp. : 0.2 to 1.3%; Gram Negative Rod (GNR) : 2.9% to 4.8%; and mycetes : 1.2%.(5) With respect to the number of airborne bacteria detected, assigning a semi-sterile room as 1.0, the nurse's center registered 4.81 times this number and general wards registered 7.22 times this number.(6) The installation of HEPA filters is an effective way of reducing bacteria in the hospital.(7) Cooperation with epidemiologists is needed for improved in-hospital surveillance of airborne bacteria.

著者

平井 みどり 八木 敬子 木口 敏子 長嶺 幸子 冨田 尚子 上田 久美子 平井 由華 岩川 精吾 松田 芳久

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.27, no.3, pp.235-244, 2001-06-10 (Released:2011-03-04)

参考文献数

4

被引用文献数

3 5

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In Japan, pharmacy students are not well trained in either communicating with patients/customers nor providing information about drugs. At our university, most of fourth year students have practical training in hospital or community pharmacy. To complement this practical training, we have a pre-training program modeling exchanges between pharmacists and their customers. As we have no communication training in our curriculum, we implemented training for providing drug information, while taking the necessity of communication training activities into consideration. The program was as follows : one was role-play at the pharmacy counter and the other was for documenting and supplying information for junior high school students about drug and health information. After providing drug information, the students evaluated each other and discussed the various aspects of the communication activities. Through such training, the students were able to overcome some communication barriers and in the end felt satisfied with their own presentations. This training proved to be a useful way of improving the information and communication skills of pharmacy students.

著者

斉藤 嘉津彦 清水 瓊子 岡崎 正子 伊林 至洋 端 和夫 前野 康次郎 石井 清二 土橋 和文 島本 和明 戸田 貴大 黒澤 菜穂子 大和田 栄治 加藤 芳伸 大山 徹 梅津 有理 千田 道洋 有吉 範高 鎌滝 哲也 板谷 幸一

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.27, no.3, pp.228-234, 2001-06-10 (Released:2011-03-04)

参考文献数

11

被引用文献数

1 1

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In recent years, genome science has undergone radical changes and numerous advances have led to the development of its use in medical practice. In particular developments in pharmacogenetics have demonstrated that genetic polymorphism is responsible for inter-individual differences in the drug metabolism. This study was conducted to identify the genetic polymorphisms of CYP 2C 9 and CYP 2 C19 using PCR-RFLP, and the application of a gene analysis was investigated in TDM or pharmaceutical management and in counseling services for patients. In a patient with the following pharmacokinetic parameters for phenytoin, for Km=6.69 μg/mL and Vmax = 3.62 mg/day/kg, and a largely decreased metabolic activity of CYP 2 C9 compared to the general population, the genetic differences in CYP 2 C9 could be determined in genomic DNA based on the patient's peripheral blood. Based on this finding, the effective dose for medication was calculated and administered to the patient. In addition, during medical consultations, both written and oral information in an easily comprehensible form could be given to patients with genetic polymorphism. These procedures allow a for the careful matching of the patient to the right medication and dose. This study indicates the possible application of a genetic analysis of CYP to “Evidence-Based Medicine” in the field of pharmaceutical management in order to control the dosage in individuals and to improve patient counseling.

著者

大石 雅子 片岡 和三郎 中川 知子 勝浦 正人 池田 賢二 黒川 信夫

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.27, no.3, pp.212-220, 2001-06-10 (Released:2011-03-04)

参考文献数

9

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In this study, the present state of the air cleanliness in the drug preparation room at a hospital pharmacy was evaluated, and factors affecting airborne particle numbers (APN) such as the number and the movement of workers and the materials on working clothes and cloths were investigated. In addition, the effect of environmental conditions on air cleanliness on a clean bench was compared. APN was measured with an Aerosol Particle Counter.The maximum 0.5μm APN values while working in the aseptic preparation room were 3, 610, 1, 312 (less than 10, 000 in GMP) and the non-aseptic room were 8, 008, 2, 660 (less than 100, 000) respectively. The conditions of all rooms were sufficiently suitable for drug preparation according to the criteria of GMP.Concerning factors affecting APN, the movement of workers increased the APN much more than the number of workers. The degree of dispersing particles differed greatly depending on the materials of the working clothes and cloths. A decrease to less than 1 /100 can be obtained by the selection of suitable materials for working clothes such as Overall made of polypropylene non-woven fabric from which few of fibers disperse. It is remarkable that smaller particles are dispersed from clothes even after passing through an air shower. In addition, it was confirmed that the dispersing of particles from cloths and rags was also a problem.As long as prescribed methods were used for the clean bench, the air cleanliness inside the clean bench was kept sufficient even through the external air conditions or locations were not so clean.

著者

寒河江 喜紀 福井 了三 吉岡 克己 近藤 克幸 松本 喜良 鈴木 敏夫

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.27, no.2, pp.159-166, 2001-04-10 (Released:2011-03-04)

参考文献数

5

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The ordering system for injections in the total medical informational system in the Akita University Hospital was established after modifying the old system in 1999. The Auto Ample dispense (AAD) system was combined with this ordering system by TCP/IP protocol and was also introduced in our department. The stable use of this total system has been underway for the dispensation of injections since November 1999. The usefulness and efficacy of this system was evaluated in our department based on the findings of working charts, time courses, and appropriate prescriptions of the injections.The smooth and stable dispensation of all injections using this AAD system was carried out not only for regular orders, but also for temporary orders. All nurses gave this system a favorable evaluation. The statistical data indicated that more prescription sheets were issued with this system than with the previous system, and it required much time for the packaging of injections in this system compared with the manual way. However, the efficient transport of the drugs was maintained in all wards using this system. A minor revision in this system was introduced in order to promote the appropriate dosage for every injection. The incidence of injection mistakes was thus reduced to less than 10 per month.

著者

祢宜田 和正 山下 雅代 久保田 敏行 杉浦 洋二 三浦 崇則 勝見 章男 太田 満 齋竹 達郎 戸澤 良夫 水谷 勝

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.27, no.2, pp.123-131, 2001-04-10 (Released:2011-03-04)

参考文献数

17

被引用文献数

1 2

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Although vancomycin has been exclusively used for methicillin-resistant Staphylococcus aureus (MRSA) therapy, there are many patients recently observed to suffer from gram negative bacteria, Pseudomonas aeruginosa as well as MRSA.Arbekacin (ABK), an aminoglycoside antibiotic (AG) is an alternative medication for such patients with those infection disease. However, it seems that the dosage of ABK used according to the manufacture's recommendations is insufficient for MRSA therapy to obtain a sufficient patient outcomes. Moreover, the relationship between the effectiveness of ABK on MRSA infection and the serum ABK concentration remains unclear. For the long-term treatment of AG, we can not rule out the possibility that AG may induce nephrotoxicity and ototoxicity.Therefore, the present study was carried out to clarify the significance of therapeutic drug monitoring (TDM) of ABK for patients with an MRSA infection, and elucidate the relationship between the serum ABK level and its clinical outcomes, including its antibacterial action and side effects. We investigated 30 patients with an MRSA infection, who received ABK at the Anjo Kosei Hospital from September 1996 to June 1998. The treatment of the patients by ABK but without TDM showed a 46.6% (7/15) therapeutic efficacy, while the patients with drug monitoring had a remarkably successful therapeutic efficacy (100% : 21/21) with a peak serum ABK concentration over 10μg/mL. Dysphagia badly affected the efficacy of ABK therapy in patients with an MRSA infection even when the serum ABK level was well-controlled. The incidence of ABK induced nephrotoxicity was observed in all patients when ABK was administered at a total dose of over 5, 000mg, while it was 4% at a total dose of less than 5, 000mg. When the duration of ABK therapy was longer than 2 weeks, the incidence of nephrotoxicity also significantly increased.These results thus suggest that TDM of ABK is useful for increasing the efficacy of ABK therapy in patients with an MRSA infection. In light of nephrotoxicity, these results indicate that ABK therapy may be completed within 2 weeks with an ABK dose of less than 5, 000mg, as the total dose.

著者

Masanori Iwata Toyozo Takahashi Yuri Takahashi Akihiko Ito Yoshiharu Machida

出版者

Japanese Society of Pharmaceutical Health Care and Sciences

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.27, no.1, pp.63-68, 2001-02-10 (Released:2011-03-04)

参考文献数

16

被引用文献数

3 4

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The therapy of mass alimentary intoxication caused by Salmonella and Enteropathogenic Escherichia coli is discussed. Endotoxin causes fervescence, disseminated intravascular coagulation or shock. When antibiotics are administered for the treatment of alimentary intoxication, toxicity of the endotoxin from the defluvium of bacillus mort body can cause serious symptoms.We noted the strong adsorption force of medicinal carbon and evaluated the endotoxin adsorption ability of medicinal carbon quantitatively using a chromogenic endotoxin specific assay quantitatively. Methods for evaluating damage due to the oral invasion of endotoxin have hardly been developed. The presence of alimentary intoxication due to a large quantity of endotoxin in intestine was assumed, and an in vivo test was performed to evaluate the endotoxin adsorption ability of medicinal carbon based on the influence of particle size. An in vitro test showed the adsorption coefficient to increase with the reaction times of medicinal carbon and endotoxin. The quantity of adsorption of endotoxin decreased as the particle size of medicinal carbon increased. As in vivo test showed that a change in the body temperature of mouse, which is an index of the physiological activity of endotoxin, was reduced by the oral administration of medicinal carbon. Consisting of small sized particles is thus considered to have a useful synergistic effect on the antibiotic treatment of food poisoning.

著者

宮津 大輔 江田 陽一 今給 黎修 桑名 寿幸 松浦 徹 竹下 龍次 與田 賢作 秋吉 正貴 手嶋 由加 田中 博和 長郷 あかね 平川 雅章 首藤 英樹 片岡 泰文

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.43, no.1, pp.45-52, 2017-01-10 (Released:2018-01-10)

参考文献数

14

被引用文献数

2

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Hypertensive emergency is a situation in which uncontrolled hypertension is associated with acute end-organ damage. Nicardipine hydrochloride is a calcium channel blocker indicated for the treatment of hypertensive emergencies. However, nicardipine infusion-related phlebitis is a common and significant problem in clinical practice. The aim of this study was to survey the incidence of nicardipine infusion-related phlebitis and to identify associated risk factors for phlebitis. We conducted a retrospective observational study at Fukuoka Tokushukai medical center. A total of 79 patients who received precision continuous infusion of nicardipine were enrolled in this study. Nicardipine infusion-related phlebitis occurred in 34 (25.7%) of 132 peripheral intravenous catheters. On multivariate logistic analysis, “the dosing period over 24 hours” and “no co-infusion of saline” were significantly associated with an increased risk of nicardipine infusionrelated phlebitis. The odds ratio (OR) and 95% confidence interval (95% CI) for the occurrence of phlebitis with respect to “the dosing period over 24 hours” and “no co-infusion of saline” were 5.04 (2.012 - 12.657) and 3.36 (1.190 - 9.514), respectively. In addition, the optimal cut-off level of the dilution rate of saline was determined to be 4.23 times (sensitivity 73.5%, specificity 58.8%) based on receiver operating characteristic (ROC) analysis for predicting the occurrence of phlebitis. To minimize the risk of peripheral phlebitis, we propose that medical professionals should consider changing the infusion site every 24 hours at least and co-infusing saline diluted more than 4-5 times.

著者

本間 真人 田辺 正樹 小宅 典子 幸田 幸直

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.31, no.1, pp.77-80, 2005-01-10 (Released:2011-03-04)

参考文献数

10

被引用文献数

2 1

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We report on a case of rhabdomyolysis induced by Shakuyaku-kanzo-To, a herbal medicine for spastic muscle pain. The patient was a 76-year-old female who received Shakuyaku-kanzo-To (TJ-68) and dichlofenac for lumbago. Fifteen weeks later, she was admitted to hospital because of liver dysfunction as determined from increases in AST, ALT and LDH. She was diagnosed with rhabdomyolysis due to marked elevation of CPK and myogloblin levels. The hypertension, hypokalemia and reduced renin and aldosterone levels that were also noted suggested that the rhabdomyolysis was associated with pseudoaldosteronism caused by the licorice extracts contained by Shakuyaku-kanzo-To. We confirmed that blood levels of glycyrrhetinic acid (257 ng/mL), a licorice component known to induce pseudoaldosteronism, were high and found the serum cortisone/cortisol ratio (O.09) to be low indicating reduced activity of 11 β-hydroxysteroid dehydrogenase, which catalyzes the conversion of cortisol to cortisone. The results we obtained suggested that blood glycyrrhetinic acid levels and cortisone/cortisol ratios could be used as diagnostic indicators for pseudoaldosteronism caused by herbal remedies containing licorice extracts.

著者

船越 順子 濱名 則子 岩城 晃一 松林 照久 西庄 京子 栄田 敏之 奥村 勝彦

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.27, no.6, pp.548-552, 2001-12-10 (Released:2011-03-04)

参考文献数

4

被引用文献数

1 1

---

Follow-up case by telephone was conducted for the discharged patients, who had received the medication consulting services from clinical pharmacists of Kobe university hospital. In this trial, we focused on the patients in the Department of Circulation and Respiratory Diseases. The follow-up case by telephone was carried out from the time of discharge until the next visit (almost 2 weeks after discharge). The patients consisted of 30 men and 17 women (average age was 66.9 years old). By telephone, the following issues were questioned; 1 : medication compliance, 2 : side effects and/or the changes of physical condition, 3 : other issues (such a when an inappropriate use of medicine had been suspected during hospitalization). When the patients so desire they could come in for a check-up anytime. More than about 90% of patients reported to keep good medication compliance and to have no significant side effects. However, 34% of patients claimed a slight of change in their physical condition including dropsical swelling, boiling and gasping. The claims were found more frequency in patients who had been suspected of inappropriately taking their medication. Follow-up care by telephone was found to be an effective way to avoid any kind of risks including the discontinuation of medicine. As a result, although further examinations should be addressed, follow-up care by telephone appears to be a good way to ensure the appropriate use of medicine.

著者

中村 敏明 岩尾 岳洋 東 高士 谷 大輔 矢野 良一 政田 幹夫

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.37, no.9, pp.551-558, 2011 (Released:2012-09-10)

参考文献数

13

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Paclitaxel injection [NK] (PTX [NK]) is a generic of Taxol® Injection (Taxol) but no non-clinical study comparing the safety of the 2 drugs has been conducted because the active ingredient is the same.We compared the safety of PTX [NK] and Taxol in rats to see if there were any differences. PTX [NK] and Taxol were intravenously administered to CD (SD) male rats at doses of 2.0 and 4.0 mg/kg/day for 9 days. There were very slight differences in toxicological findings regarding such items as clinical observations, food consumption, gross necropsy, organ weight and histopathology. These differences, however, were generally observed after administration of a cytocidal anticancer drug. Therefore, such differences were not thought to be toxicologically significant and we concluded that the safety of PTX [NK] was no different from that of Taxol in rats.

著者

渡辺 享平 矢野 良一 五十嵐 敏明 塚本 仁 中村 敏明 政田 幹夫

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.35, no.9, pp.622-628, 2009 (Released:2011-01-14)

参考文献数

12

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As the effect of the filling process of portable pumps on the homogeneity of drug concentrations had not been investigated,in this study,we examined the influence of the filling process of the anticancer agent 5-fluorourcil (5-FU) and saline in this respect.We used 3 types of pump and filled the pump in 3 different ways (5-FU first and then saline,saline first and then 5-FU,and mixing 5-FU and saline beforehand and then filling).There was a significant variation in the 5-FU concentration when 5-FU and saline were added separately but the drug concentration did not vary when 5-FU and saline were mixed before filling the pumps.The result also varied with the type of pump.Our findings suggested that the drug and saline were not mixed uniformly in some types of pump when 5-FU and saline were added separately.Therefore,it is important to mix the drug and saline well before filling pumps.

著者

根來 寛 矢野 良一 谷 大輔 渡辺 享平 塚本 仁 五十嵐 敏明 中村 敏明 脇屋 義文 後藤 伸之 横山 照由 政田 幹夫

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.320-327, 2008 (Released:2009-09-04)

参考文献数

23

被引用文献数

2 1

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During cancer chemotherapy,myelosuppression is a frequently observed toxicity manifestation which may sometimes cause severe infections.In this regard,though leukopenia-induced infections are more closely related to neutrophil counts than leukocyte counts,it is important to evaluate both leukocyte counts and neutrophil counts as markers of myelosuppression.Neutrophil counts,however,are sometimes estimated to be half leukocyte counts without conducting differential leukocyte counts.In the present study,the authors evaluated the necessity of differential leukocyte counts during cancer chemotherapy using pooled laboratory data at the University of Fukui Hospital.Variation in the percentage of neutrophils in leukocytes was observed in each leukocyte range,with the neutrophil count decreasing in pace with decreases in the leukocyte count.As an alternative index to the neutrophil count,the utility of the leukocyte count is thus considered to be low in cancer chemotherapy.There was also a divergence between adverse event grade between neutrophil and leukocyte numbers.In addition,neutrophil counts in 14.8% of the patients (26)were less than 1000/μL in spite of the fact that their leukocyte counts were higher than 3000/μL,and it was noted that 23 of them had undergone a paclitaxel-containing regimen.These results suggested that leukocyte differential counts should be measured during cancer chemotherapy,especially during the nadir period and when receiving chemotherapy containing paclitaxel.

著者

吉田 仁 甲田 茂樹 吉田 俊明 西田 升三 熊谷 信二

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.37, no.3, pp.145-155, 2011 (Released:2012-04-25)

参考文献数

25

被引用文献数

4 5

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This study was conducted to develop a tool for evaluating the work environment for the preparation of antineoplasticdrugs and identify issues in safety assessment.We prepared a checklist for the safe handling of antineoplastic drugs,whichincluded the following items : A) safety equipment and its maintenance,B) training and training documentation,C) devicesfor ensuring safety,D) personal protective equipment and E) emergency care.Further,we examined relationships betweenattainment levels for checklist items and occupational contamination levels for cyclophosphamide (CPA),fluorouracil (5FU),gemcitabine (GEM) and platinum-containing drugs (Pt) based on wipe samples from equipment in the preparationroom (wipe test).Next,pharmacists in a particular hospital were asked to improve their work environment using the checklist.To evaluate their improvements,we collected wipe samples and one-day urine samples from them,before and afterthey took improvement measures.The results showed that an increase in safety attainment scores was reflected in a decrease in CPA,GEM and Pt contaminationlevels in the wipe test,as well as one in urinary levels of CPA.However,the 5FU level in the wipe test increased,probably due to a 6-fold increase in the amount of 5FU prepared,compared to before the improvement measures weretaken.From these findings,we concluded that the checklist would be useful for improving the hospital work environment.

著者

小林 由佳 岩根 裕紀 中西 弘和

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.40, no.6, pp.352-359, 2014-06-10 (Released:2015-06-10)

参考文献数

12

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Onco-TainTM Vial, which was developed to prevent occupational exposures to hazardous drugs such as antineoplastic drugs, is a vial preparation equipped with sheathings (a PVC reinforced base and a shrink wrapping of a protective PET sleeve on the vial). The shatter-resistance of the Onco-Tain™ vial was evaluated with a free fall test. Four types (9 strengths in total) of Onco-Tain™ vials, which contain antineoplastic agents and are available worldwide, were used in the test. Vials with the PVC bases and PET sleeves removed from the Onco-Tain™ vial were used as the control. Mimicking the fall of vials in the medical setting, the falling heights were set at 70, 135 and 180 cm, and the breakage ratios of vials and the scattering area of contents were measured.In the control group (Non-OT group), 3.5, 9.4 and 8.9 percent of vials were broken at the heights of 70, 135 and 180 cm, respectively, and the scattering of contents was observed in all broken vials. The breakage ratios of vials in the Onco-Tain™ vial group (OT group) were statistically significantly lower (0.0 and 2.4%) at the heights of 70 and 135 cm, and tended to be lower (3.3%) at the height of 180 cm. No leakage was observed in vials broken in the OT group. The significant improvement of shatter-resistance of vials was confirmed by applying the protection sleeves to the surface of the vials. By applying these concepts in the future, a decrease of occupational exposures to hazardous drugs caused by the breakage of containers is expected.

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

相宮 光二 宮川 慶子 林 誠 長岡 宏一 阿部 康治 北 俊之

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.36, no.7, pp.469-475, 2010 (Released:2012-03-10)

参考文献数

12

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Sulbactam sodium-ampicillin sodium (hereinafter referred to as SBT/ABPC) injections are widely used for the treatment of infection and in view of this,we conducted a study to examine the therapeutic equivalence of original and generic preparations of SBT/ABPC.In it,we compared efficacy and safety in patients diagnosed with pneumonia,acute bronchitis,or acute bronchiolitis who received the original or a generic SBT/ABPC injection at the National Organization Kanazawa Medical Center from May 2007 to March 2008.We analyzed the efficacy endpoints of body temperature,white blood cell count,and CRP level and the safety endpoints of AST (GOT),ALT (GPT),and BUN in 121 subjects receiving the original preparation and 112 receiving the generic one.Our results suggest therapeutic equivalence for both efficacy and safety,and we conclude that the generic version can definitely be used as an alternative to the original preparation.

著者

松浦 克彦 林 秀樹 杉山 正 片桐 義博

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.32, no.4, pp.306-313, 2006-04-10 (Released:2007-11-09)

参考文献数

20

被引用文献数

5 5

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A comparative study was carried out to evaluate the quality of one brand name tablet (A) and five generic tablets (B∼F) containing 5 mg of enalapril maleate (ENA). Tablet quality was evaluated based on such characteristics as content, impurities, dissolution profile, hygroscopic properties, and stability. In the purity test, we measured the quantities of degradation products such as diacid compound (DA) and diketopiperazine compound (DKP) and in the hygroscopicity test, the weight and hardness of the tablets without blister packaging was measured initially and after 2 weeks and 4 weeks of storage at 0%, 43%, 75% and 93% relative humidity (RH). To test stability, we measured the quantities of ENA, DA, and DKP in tablets stored without blister packaging at 40°C and 75% RH for 12 weeks.The ENA content in all preparations was approximately equal to the indicated content. Initially, DA was not detected in any of the preparations. About 0.3% DKP was detected in preparation B and C. The dissolution profiles of all generic tablets were similar to those of the brand name tablet. For preparations A, B, and D, a marked increase in tablet weight and decrease in tablet hardness was observed with increasing RH. In the stability test, the remaining ENA content in preparations A, B, and D after 12 weeks was significantly lower than the initial content. The DA content in preparations A and D had increased markedly after 12 weeks and so had the DKP content in preparation B.Our study showed that the quality of the generic tablets C, E, and F was comparable to that of brand name tablet A with respect to stability and resistance to humidity. We conclude that if generic manufacturers continue to produce such high quality drugs, this will lead to greater confidence in their effectiveness and an increase in their use in the clinical setting.