基于数据库分析的中药注射剂不良反应流行病学特点研究

Study on Epidemiological Characteristics study of Adverse Reaction Induced by Chinese Medicine Injection Based on Database Establishment and Analysis

目的探讨中药注射剂不良反应发生的流行病学特点。方法通过检索文献,收集中药注射剂不良反应详细个案,建立病案数据库,应用统计学方法对不良反应特点进行分析。结果共收集82个注射剂品种的详细不良反应个案2333例,其中双黄连注射剂病案数量最多(422例);不良反应涉及人体多个系统,其中以皮肤损害(598例,21.06%)和过敏性休克(580例,20.43%)数量最多;患者中,男性1215例(52.28%),女性1109例(47.72%),平均年龄(40.67±21.45)岁;51例患者(2.19%)因严重ADR死亡。结论增强预防意识,审慎合理用药,是减少中药注射剂不良反应发生的关键。

Objective To investigate the epidemiological characteristics of adverse reaction induced by Chinese medicine injection. Methods Domestic medicinal periodicals issued from the year 1972 to 2007 were searched, and 2 333 adverse reaction （ADR） cases were analyzed by database establishment and statistic method. Results 2 333 ADR cases involving 82 different kinds of Chinese medicine injection were collected and 422 cases were related to Shuanghuanglian Injection. Chinese medicine injection induced multiple systematic ADRs. The incidence of skin lesion（598, 21.06 % ）and that of anaphylactic shock （580, 20.43 % ）dominated in ADRs. The incidence of ADR was 54.05 % in the male and 45.95 % in the female. Average age of patients was（40.67 ± 21.45）years old. Fifty - one patients （2. 19 % ）died of severe ADRs. Conclusion Chinese medicine injection should be used with more rationality and enhance prevention awareness to reduce the occurrence of ADR.