中药注射剂致儿童不良反应情况分析

Adverse reactions analysis in the children caused by traditional chinese medicine injections

目的:了解中药注射剂在儿童人群中的ADR发生情况,为临床用药提供参考。方法:对932例中药注射剂致儿童不良反应病例,从性别、年龄、用药情况、严重程度、发生时间及ADR的主要表现、转归等多角度进行统计分析。结果:中药注射剂致儿童ADR占中药注射剂ADR总体的23.7%;中药注射剂引起的儿童ADR以对皮肤及其附件的损害为主,占42.38%,其次是全身性损害,占31.99%,对消化系统的损害占8.88%;清热类的中药注射剂引起儿童ADR例次数最多,占88.84%,其中又以双黄连注射液引起的ADR病例数最多,占29.51%。结论:对儿童患者要合理使用中药注射剂,加强对中药注射剂不良反应的监测。

Objective： To provide a reference for clinical use of drugs by the situation of traditional chinese medicine in- jections （TCMIs） of adverse drug reactions （ADRs） in the children. Methods： By means of retrospective study, 932 ADRs case reports caused by TCMIs were analysed by the gender, age, drug therapy status, serious degree, occurrence time, the main performance of ADRs and clinical outcome. Resuhs： The proportion of ADRs caused by TCMIs in the children is 23.7% in total ADRs caused by TCMIs. The ADRs concerned body as skin and appendages disorders, a whole-general disorders and al- imentary system disorders were 42.38%, 31.99% and 8.88% in the ADRs caused by TCMIs in the children. Reducingfever categories of TCMIs caused ADR in the children were respectly 88.84%. Conclusion： The TCMIs should be used reasonably in the children; the postmarket survillance of the ADRs of TCMIs should be strengthened.