中药注射剂致儿童不良反应情况分析

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。

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

Objective: To provide a reference for clinical use of drugs by the situation of traditional chinese medicine injections(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.Results: 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 alimentary 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.