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药品上市后安全问题观察性研究的若干问题 被引量:2
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作者 王大猷 《药物流行病学杂志》 CAS 2013年第8期443-447,共5页
药物效用评估的金标准是随机对照试验(RCT),药物上市后安全性评估却并非如此,RCT并不能回答所有重要的所给干预的问题。医学研究中的许多问题通过观察性研究进行调查[1]。主要原因是RCT缺乏足够的能力检测罕见的不良事件,且通常与... 药物效用评估的金标准是随机对照试验(RCT),药物上市后安全性评估却并非如此,RCT并不能回答所有重要的所给干预的问题。医学研究中的许多问题通过观察性研究进行调查[1]。主要原因是RCT缺乏足够的能力检测罕见的不良事件,且通常与药品真实使用的环境大相径庭。观察性研究更适宜于发现罕见或迟发的药品不良反应,更可能提供药品在现实生活中应用的信息。 展开更多
关键词 观察性研究 上市后研究 药物警戒 药品安全评估 播种试验 药品风险管理
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The Safety-influencing Factors in Use of the Tonics of Chinese Medicine: A Meta-analysis Based on the Case Reports in Periodicals
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作者 于静 崔蒙 +1 位作者 李海燕 叶祖光 《Journal of Traditional Chinese Medicine》 SCIE CAS CSCD 2011年第2期130-135,共6页
Objective: To identify the possible safety-influencing factors in use of the tonics of Chinese medicine. Methods: The related case reports published in periodicals published from 1949 to 2006 were analyzed with the bi... Objective: To identify the possible safety-influencing factors in use of the tonics of Chinese medicine. Methods: The related case reports published in periodicals published from 1949 to 2006 were analyzed with the bibliometrics method. Possibility on safety assessment of Chinese materia medica was discussed as well with the method of link analysis. Results: The total number of the tonics selected for the present study was 101, including 44 single drugs and 46 set prescriptions with adverse drug reactions (ADR) found in these tonics. It was found that ADR of 10 single drugs and 29 preparations were not specified in authoritative Chinese materia medica monographs. Among all the set prescriptions, the problem of injection has been standing on the top. Statistical analysis on single factor demonstrates that the most frequently referred ADR come from drug abuse (accounting for 29.20%), and overdose (24.54%). Conclusion: The safety problem of injection remains in a trend of robust growth at least for a period of time, thus reappraisal of the safety issue for the tonics of injection is imperative. It is essential for the public to take doctor’s advice to guarantee safe administration of the tonics, especially for the patients with allergic constitution or those suffering from the liver and heart diseases. 展开更多
关键词 safety-influencing factors tonics of Chinese medicine case reports
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