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目的为建立和完善药品上市后安全性评价制度提供参考。方法以《中国期刊全文数据库》为检索工具,检索并统计分析1994—2008年国内公开发表的有关喹诺酮类药品上市后安全性评价的文献。结果通过检索获得喹诺酮类药品上市后安全性评价文献254篇,其中综述占一半以上,回顾性研究、临床试验研究及文献计量研究分别占到了17.3%、15.0%和13.4%,前瞻性随访研究极少。试验样本量主要在500例以下,占88%。评价主体的82%为医疗机构,评价对象集中在氟喹诺酮类,单种不良反应研究文献少。结论喹诺酮类药品上市后安全性评价的文献数量虽然逐年增多,但质量参差不齐,大多数文献的评价方法和试验设计尚不规范,需要通过建立科学的技术规范、控制评价质量、加强多机构的合作来提高上市后评价水平。
Objective To provide a reference for establishing and improving the safety evaluation system after listing drugs. Methods The Chinese Journal Full-text Database was used as a search tool to retrieve and statistically analyze the published literature about the safety evaluation of quinolones released after the market in 1994-2008. Results A total of 254 safety evaluations of quinolones were listed after searching, accounting for over half of them. Retrospective studies, clinical trials and bibliometrics accounted for 17.3%, 15.0% and 13.4%, respectively. Prospective follow-up studies less. The sample size is below 500, accounting for 88%. 82% of the main body of evaluation for the medical institutions, evaluation of the object focused on fluoroquinolones, a single type of adverse reactions less literature. Conclusions Although the quantity of quinolone drugs marketed after the safety evaluation has been increasing year by year, the quality varies widely. The evaluation methods and experimental design of most of the literature are not standardized. It is necessary to establish scientific technical specifications, control the quality of evaluation, Cooperation to improve post-market evaluation.