清热类中药注射剂不良反应流行病学特点研究

目的:探讨清热类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,收集清热类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信息进行分析。结果:共收集23个注射剂品种详细的1129例不良反应个案,其中双黄连注射剂病案数量最多(486例);不良反应涉及人体多个系统,其中呼吸系统损伤424例(37.56%)和皮肤损害403例(35.70%)数量较多;男性患者601例(53.23%),女性患者528例(46.77%),平均年龄(29.98±19.76)岁;有25例患者(2.21%)因严重ADR死亡。结论:谨慎合理用药,增强预防意识,是减少中药注射剂不良反应发生的关键。

Epidemiological Characteristics of Adverse Reaction Induced by Chinese Herbal Injection for Clearing Heat

Objective：To investigate the epidemiological characteristics of adverse reaction induced by traditional chinese herbal injection for clearing heat. Methods：We searched domestic medicinal periodicals from 1972 through 2011, collected and analyzed adverse drug reaction（ADR） cases by database establishment and statistic method. Results：1129 ADR cases involving 23 different kinds of clearing heat type of traditional chinese medicine injection were collected and 486 cases were related to Shuanghuanglian injection.clearing heat type of traditional chinese medicine injection induced multiple systematic ADRs.The incidence of respiratory damage, skin lesion were 424（37.56%）, 403（35.70%） ,respectively. The incidence of ADR was 53.23% in the male and 46.77% in the female. Average age of patients was （29.98±19.76）years old.25 patients（2.21%）died of severe ADRs.Conclusion：Chinese herbal injection should be used with more rationality and enhance prevention awareness of patients to reduce the occurrence of ADR.