著者

鈴木 渉太 笠原 正登

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.52, no.6, pp.179-181, 2021-11-30 (Released:2021-12-15)

著者

山下 修司 飯原 大稔 鈴木 昭夫 林 秀樹

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.52, no.5, pp.149-152, 2021-09-30 (Released:2021-10-20)

著者

北川 晴雄 鎌滝 哲也

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.2, no.3, pp.266-281, 1971-07-30 (Released:2010-06-28)

参考文献数

114

被引用文献数

1 1

著者

吉冨 克則 古川 裕之 宮本 謙一

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.39, no.3, pp.99-104, 2008 (Released:2009-02-04)

参考文献数

4

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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 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.

著者

梅月 恵美 小手川 勤 中村 紘一 中野 重行 中塚 和夫

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.27, no.1, pp.89-90, 1996-03-31 (Released:2010-06-28)

参考文献数

4

著者

鈴木 哲哉

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.1, no.1, pp.46-54, 1970-06-30 (Released:2010-06-28)

著者

黒沢 顕三 内田 直樹 岩瀬 万里子 保田 国伸 江花 莉華 平嶋 勇人 石垣 征一郎 松田 和弘 矢野 怜 佐久間 大 安原 一

出版者

The Japanese Society of Clinical Pharmacology and Therapeutics

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.37, no.5, pp.283-290, 2006-09-30 (Released:2010-06-28)

参考文献数

16

被引用文献数

2 3

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Drewell ® (diphenhydramine: DPH) is a histamine H1 receptor antagonist and the first OTC sleep aid in Japan. There are few studies which objectively evaluate the sedative effects in elderly subjects. The aim of present study was to evaluate the sedative effects of Drewell ® in healthy elderly and to compare the results with data from young subjects on which we reported previously.A placebo controlled, double-blind, crossover clinical pharmacological study was performed. Eight Japanese healthy elderly male volunteers received 2 tablets of Drewell ®, containing 50mg DPH, or matched placebo orally. Plasma levels of DPH after administration were measured hourly up to 4 hours and every 2 hours up to 8 hours. The sedative effects after the dose were measured by using the saccadic eye movement analyzing system for objective assessment and visual analogue scale (VAS) for subjective assessment.After Drewell ® administration the saccadic peak velocity (SPV) was decreased and saccade inaccuracy (IAC) was increased compared with placebo. There were no significant differences in saccade latency and VAS. The onset of significant decrease of SPV in elderly was delayed compared to young subjects (90 min in elderly vs 30 min in young) although pharmacokinetic parameters were similar in elderly and young subjects. However, the available data of both pharmacokinetic and pharmacodynamic at the same time point until sedation onset was only 60 min. Therefore further investigation is necessary to precisely determine the differences of onset of the sedative effect up to 90 min after Drewell ® administration.

著者

上村 尚人

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.42, no.4, pp.222-225, 2011 (Released:2011-10-03)

参考文献数

4

著者

守内 匡 高田 加寿代 浅野 聡美 田中 治 金本 郁男

出版者

日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.34, no.2, pp.43-47, 2003-03-31 (Released:2010-06-28)

参考文献数

26

被引用文献数

1

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A family history of diabetes and genetic predisposition are established as risk factors for diabetes mellitus, lifestyle factors also play an important role in the etiology of diabetes. Alcohol consumption may be related to risk for type 2 diabetes mellitus (type 2 DM) through effects on insulin secretion and sensitivity. Several large-scale epidemiological studies have suggested an inverse association between moderate alcohol consumption and reduced risk for type 2 DM. We assessed whether or not moderate alcohol consumption is associated with DM.Among 2, 338 men, 150 cases of incident DM were newly identified by means of an oral 75 g glucose tolerance test. The newly diagnosed DM percentages of drinking 0 g/day, 1-9.9 g/day, 10-29.9 g/day, 30-49.9 g/day and ≥50 g/day were 8 .3, 6.3, 5 .1, 5.2, 7.2, respectively. The newly diagnosed DM percentage of drinking 1-9.9 g/day had a significantly lower risk than 0 g/day. The frequency of alcohol consumption was significantly inversely associated with diabetes ; a frequency of greater than 6 times per week showed a significantly lower risk than 0 times per week. HbA1c of drinking 10-29.9 g/day, 30-49.9 g/day, and 5≥0g/day were significantly lower than that of 0 g/day.These data suggest that light moderate and frequent alcohol consumption have a decreased subsequent risk of diabetes mellitus.

著者

景山 茂

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.34, no.6, pp.297-300, 2003-11-30 (Released:2010-06-28)

参考文献数

9

著者

還田 悠平 髙山 茜 成川 衛

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.48, no.1, pp.9-14, 2017-01-31 (Released:2017-02-17)

参考文献数

13

被引用文献数

1 1

---

Background: In Japan, delay in marketing approval of new drugs, known as “drug lag”, was believed to hinder patient access to innovative treatments. The Japanese government took several corrective measures, and the median review time for new drugs was shortened. However, in many cases, new drugs are developed in the United States (US) and European Union (EU) , and these drugs are usually approved first in the US and EU prior to approval in Japan. Increase of drugs approved in Japan before the rest of the world or simultaneous with other countries is expected to further improve patient access to innovative drugs.Method: For all New Active Substances (NASs)that were approved in Japan between January 2008 and December 2014 , detailed information including the regions where the new drugs were developed and the countries of first global approval were identified. We also collected information about safety concerns that were identified before approval.Result: Two hundred and thirty-nine NASs obtained Japanese approval during the study period. Of the 239 NASs, 44 (18.4%) were approved in Japan before the rest of the world. Drugs that obtained Japanese approval first in the world were more often developed in Japan from the early stage. Furthermore, the data suggested that these drugs were launched with relatively limited safety information. Conclusion: For better patient access to new drugs, it is important to facilitate early development of new drugs in Japan and at the same time to ensure further strengthening of post-marketing safety measures.

著者

堀井 俊宏

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.38, no.6, pp.413-415, 2007-11-30 (Released:2008-10-31)

参考文献数

2

被引用文献数

1 1

著者

神田 藍 川崎 淳史 森田 理恵子 武者 愛美 櫻田 大也 小林 江梨子 佐藤 信範

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.44, no.4, pp.313-318, 2013-07-31 (Released:2013-08-22)

参考文献数

10

被引用文献数

1 3

---

As the number of chronic kidney disease patients increases every year, a concomitant increase in drug use among patients with renal impairment is anticipated in daily clinical practice. For patient safety, drug information should be useful and meet the needs of medical workers. The aim of this study was to investigate the problem of the descriptions in package inserts of prescription drugs regarding: 1) drug administration to patients with renal impairment, and 2) effects of the drug on the kidney (hereinafter “information on renal function” ). Also, we evaluated the usefulness of the renal function information for medical workers. For this survey, 337 prescription drugs that require careful attention for use in patients with renal impairment were selected. We extracted “the information on renal function” described in the package inserts of these 337 prescription drugs from the website of Pharmaceuticals and Medical Devices Agency. We compared the contents of the information regarding the pharmacokinetics of patients with renal impairment described in the package insert with those described in the corresponding interview form. In 44.8% of the 337 package inserts, information on pharmacokinetics in patients with renal impairment was not included. Only 21.2% of the inserts contained useful information on drug administration to such patients, such as clear dose adjustment. Therefore, our survey suggests that the package inserts do not provide sufficient information on “renal function” for medical workers. In conclusion, improvement of the information regarding “renal function” in the prescription drug package inserts is necessary in order to meet the needs of medical workers. (Jpn J Clin Pharmacol Ther 2013; 44(4): 313-318)

著者

砂原 茂一

出版者

The Japanese Society of Clinical Pharmacology and Therapeutics

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.1, no.1, pp.5-7, 1970

著者

藤井 儔子 藤井 恵美子 安達 加代子 原 博子

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.4, no.3-4, pp.209-211, 1973-12-30 (Released:2010-06-28)

著者

高瀬 浩造

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.30, no.2, pp.487-488, 1999-03-31 (Released:2011-02-25)

著者

三輪 亮寿

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.41, no.1, pp.75-78, 2009 (Released:2010-04-02)

著者

二木 芳人 松島 敏春 原田 和博

出版者

日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.37, no.1, pp.41-48, 2006-01-31 (Released:2010-06-28)

参考文献数

15

被引用文献数

1

---

The effects of concomitant gastrointestinal drugs on the absorptivity of cefcapene-pivoxil hydrochloride (CFPN-PI) were examined in patients who were hospitalized due to infection and were to be treated with a gastrointestinal drug. CFPN-PI was orally administrated at a dose of 100mg after meals concomitant with a gastrointestinal drug. The urinary recovery rate of CFPN was determined from the urine collected for 12 hours after the first administration of CFPN-PI. In addition, the clinical efficacy and safety of CFPNPI was evaluated. The results were as follows:1. The mean urinary recovery rate of CFPN in 25 cases evaluable for the absorptivity of CFPN-PI was 24.7% (95% confidence interval: 21.0-28.3%). The mean urinary recovery rate of CFPN was 25 .6% in the famotidine group, 23.9% in the dried alminium hydrooxide gel group, and 25.2% in the teprenone group.Thus, there was no significant difference in the urinary recovery rate of CFPN among the concomitant drug groups (p-value: 0.9239).2. Clinical efficacy was judged as “excellent” in 4 cases, “good” in 16 cases, and “poor” in 2 cases, generating a clinical efficacy rate of 90.9%.3. The incidence of adverse drug reactions (ADRs) was 16.7%. All of the ADRs were slight in severity and were resolved without any treatment.Based on these results, it is suggested that the concomitant administration of the gastrointestinal drugs used in this study does not largely affect the absorptivity of CFPN-PI and the drug shows a sufficient antibacterial effect at the approved dose in such concomitant administration.

著者

廣崎 真史

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.37, no.4, pp.91S-91S, 2006-07-31 (Released:2010-06-28)

著者

吉川 由佳子 曽根 弘子 高田 寛治

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.27, no.1, pp.171-172, 1996-03-31 (Released:2010-06-28)