1978-2009年中药注射剂不良反应文献综合分析

Analysis of Adverse Drug Reaction Induced by Traditional Chinese Medicine Injection during 1978-2009: A Literature Analysis

目的:系统分析1978-2009年我国中药注射剂不良反应文献,为药学研究和相关政策制订提供参考。方法:采用文献计量学方法,对从中国生物医学文献数据库中检索出的中药注射剂不良反应文献进行评价与分析。结果:中药注射剂不良反应文献5651篇,共涉及181个中药注射剂。文献报道从1998年开始迅速逐年递增,山东地区文献量位居全国之首,丹参注射液、清开灵注射液等30个注射剂的不良反应文献量较多。结论:中药注射剂不良反应引起了广大医疗卫生工作者的广泛关注,不良反应涉及因素较多,具体原因还有待进一步探讨。

OBJECTIVE： To analyze the literatures about the adverse drug reactions （ADR） induced by traditional Chinese medicine （TCM） injection during 1978-2009 in order to provide reference for pharmaceutical research as well as the formulation of related policy. METHODS ： Literatures about the ADR induced by TCM Injection retrieving from CBM database were evaluated and analyzed by bibliometric statistical method. RESULTS： A total of 5 651 literatures were reported and involved 181 kinds of TCM injections. The number of literatures increased with years since 1998 while most literatures came from Shandong province. 30 kinds of injections, including Danshen injection and Qingkailing injection, were reported mostly. CONCLUSION： ADR induced by TCM injections concern of medical staff. ADR is related to many factors and the specific causes remain to be further explored.