著者
赤沢 学
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.5, pp.245-252, 2010 (Released:2010-11-25)
参考文献数
18
被引用文献数
1 1

A number of new vaccines for preventable diseases such as meningitis and cervical cancer are getting available for Japanese children. However, those vaccines are categorized as voluntary vaccination and their costs should be paid by recipients. Therefore, high cost is a barrier for access to the preventive care. In addition, subsidiary by local governments causes their regional disparities. On the other hand, the Advisory Committee on Immunization Practices (ACIP) in the United States recognizes importance of economic analyses in establishing policy for addition of new vaccines to routine immunization schedules. The ACIP publishes guidance for health economic studies to ensure that high quality economic data are presented in a standard format. In this study, a critical review of economic analyses for childhood vaccine programs in Japan was conducted. Six original studies that included varicella, mumps, Hib (haemophilus influenza type B), pneumococcal disease and human papillomavirus vaccines were identified by a systematic literature review. The results of all studies suggested that these new vaccines should be included to routine immunization schedules because expected benefits would outweigh additional costs of vaccines. However, according to the check lists recommended by ACIP guideline, these studies utilized various sources of cost information and calculated opportunity costs differently. Some studies did not consider discounting of future costs. Therefore, direct comparisons between studies were very difficult. Economic analyses to evaluate the priority of vaccine programs should follow a standard method to increase comparability and quality of studies.

24 0 0 0 OA 4.JIKEI HEART研究

著者
三輪 宜一
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.5, pp.157-161, 2008 (Released:2009-02-05)
参考文献数
18
著者
永井 恒司
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.2, pp.189-195, 1971-04-30 (Released:2010-06-28)
参考文献数
22
著者
三輪 英人
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.40, no.4, pp.145-150, 2009 (Released:2009-10-15)
参考文献数
17

The placebo effect can be observed in various medical conditions, and has been documented by randomized placebo-controlled drug studies. One of the best examples is the placebo effect in Parkinson's disease (PD). The placebo effect is observable not only in drug trials but also with surgical therapies, such as deep brain stimulation, fetal tissue transplantation, and infusion therapy of a neurotrophic factor. A recent study using positron emission tomography (PET) with raclopride demonstrated that the release of endogeneous dopamine in the dorsal striatum mediates the placebo effect in PD, suggesting that the placebo effectiveness is achieved by endogenous dopamine supplementation. Although the detailed pathophysiological mechanism underlying the placebo effect is unclear, the placebo effect has been explained by two mechanisms: the conditioning theory (pavlovian conditioning) and the cognitive or expectancy theory (expectation of clinical improvement). Speculatively, it may be that the placebo effect in PD is related more to cognitive mechanisms. Numerous studies have suggested a functional relationship between dopamine and the reward system. Understanding the placebo effect is important for designing clinical trials and interpreting their results.
著者
小野寺 博志
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.4, pp.147-152, 2010 (Released:2010-10-08)
参考文献数
18

Drugs have to be evaluated from a different viewpoint from other toxic substances such as natural toxins, environment substances and chemicals. Toxicological evaluations are also important to clarify the benefits and risks of pharmaceuticals to humans. Many of the toxicology studies are conducted according to guidelines. The type and timing of toxicology studies have been harmonized internationally. Recently, the ICH guidelines have been revised in light of technological advances and reduction of animal usage in accordance with the 3R (reduce/refine/replace) principle. The results of toxicology studies must always be evaluated based on extrapolation to humans. The goal of regulatory science is to predict a risk based on the latest information and evaluate safety. Even if the toxicological findings are similar, the toxicological acceptability assessment is not always the same. It is important that the toxicology for pharmaceutical products is evaluated on a case-by-case basis.

2 0 0 0 OA 3. 片頭痛

著者
中島 健二 竹島 多賀夫
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.36, no.6, pp.277-283, 2005-11-30 (Released:2010-06-28)
参考文献数
24
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

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)