国产克林霉素磷酸酯注射液药品说明书项目标注的调查
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篇名: 国产克林霉素磷酸酯注射液药品说明书项目标注的调查
TITLE:
摘要: 目的:为进一步规范国产克林霉素磷酸酯注射液的药品说明书提供参考。 方法:根据《药品说明书和标签管理规定》《化学药品和生物制品说明书规范细则》等对2006年1月-2015年12月批准上市的国产克林霉素磷酸酯注射液药品说明书中各项内容进行调查和统计,并对不同批准文号药品说明书内容差异较大的项目进行重点分析。结果:所收集的25份克林霉素磷酸酯注射液药品说明书中,临床试验项目标注率为0,有效期项目标注率为44%,老年患者用药项目标注率为68%,药物过量项目标注率为76%,其余项目标注率均为100%。内容差异较大的项目主要是特殊人群用药、用法用量、不良反应、有效期、贮藏条件和注意事项。结论:国产克林霉素磷酸酯注射液药品说明书差异较大,部分内容不准确、不全面,缺乏科学性,可能会导致临床误用,给患者增加用药风险。建议国内生产企业参考国外原研药品说明书,进一步对药品说明书的内容加以修订、补充和完善;药品监督管理部门应加强对药品说明书的监管。
ABSTRACT: OBJECTIVE: To provide reference for the instructions of domestic Clindamycin phosphate injection. METHODS: The contents in the instructions of domestic Clindamycin phosphate injection approved the listing from Jan. 2006 to Dec. 2015 were statistically investigated according to Regulation for Drug Package Inserts and Label Management and Regulatory Guidelines for Chemicals and Biologicals, and the items with great differences in different approval number were analyzed comparatively. RESULTS: The labeling rate of clinical experiment in the collected 25 instructions of domestic Clindamycin phosphate injection was 0, the labeling rate of validity was 44%, the labeling rate of use for elderly patients was 68%, the labeling rate of overdosage was 76%, and the labeling rate of others was 100%. The items with great differences were mainly special populations, usage and dosage, adverse reactions, validity, storage conditions and precautions. CONCLUSIONS: There are great differences in instructions of domestic Clindamycin phosphate injection, some items are inaccurate, incomplete  and lack of scientificity, which may result in irrational drug use in patients and increase the risk of medication. It is suggested that the domestic enterprises should modify and perfect the contents of the instructions of domestic Clindamycin phosphate injections referring to the instructions of foreign brand name drug; and the drug regulatory department should strengthen the monitoring of drug instructions.
期刊: 2016年第27卷第27期
作者: 周鹏,王娇,崔岚
AUTHORS: ZHOU Peng,WANG Jiao,CUI Lan
关键字: 克林霉素磷酸酯注射液;药品说明书;调查分析
KEYWORDS: Clindamycin phosphate injection; Drug instruction; Investigation and analysis
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