基于群案信息分析的中药注射剂不良反应发生率研究

Study on Incidence of Adverse Reaction Induced by Chinese Herbal Injection Based on Multiple Cases Analysis

目的探讨中药注射剂不良反应发生规律和特点。方法通过检索文献,收集中药注射剂不良反应群案报告文献,应用文献计量学和统计学方法对不良反应发生率进行分析。结果共收集中药注射剂不良反应群案文献56篇,涉及16个中药注射剂品种,67299名用药患者,1348例不良反应,总体不良反应发生率为2.00%;不良反应发生率最高的品种是华蟾素注射剂(43.28%),最低的是莪术油注射剂(0.25%);不良反应临床表现主要包括皮肤损害、循环和消化系统损害等。结论中药注射剂不良反应发生率存在较大差异,这可能受中药注射质量、论文发表性偏倚等多种因素的影响,应全面分析,客观看待。

Objective To investigate the epidemiological characteristics of adverse reaction induced by Chinese herbal injection. Methods Multiple cases report in domestic medical periodicals were searched and analysed by bibliometric and statistic methods. Results Fifty - six reports on muti - ADR cases related to 16 different kinds of Chinese herbal injection were collected. There were 67299 patients and 1348 ADR cases related to Chinese herbal injection. The average ADR incidence was 2.00 % ; the highest incidence of 43.28 % was shown in cinobufotalin injection and the lowest incidence of 0. 25 % in zedoary turmeric oil injection）. Skin lesion, and circulatory and digestive lesion dominated in ADRs. Conclusion we should use Chinese herbal injection more rationally, and enhance prevention awareness to reduce the incidence of ADR induced by Chinese herbal injection.