932例喜炎平注射液儿童不良反应的调研分析

[摘要]目的：调研分析932例喜炎平注射液在儿童用药引起的药品不良反应（ADR）的规律及其特点，为促进儿童临床合理用药提供参考。方法：采用回顾性分析方法，对山东省药品不良反应监测中心数据库中2015-2017年932例喜炎平注射液引起的儿童不良反应报告进行统计分析。结果：932例ADR报告中男568例（60.94%），女364例（39.06%），ADR发生的不同性别年龄分布比较差异无统计学意义（P>0.05）；婴幼儿ADR发生率最高，年龄0~1岁364例（39.06%），>1~3岁250例（26.82%）；ADR发生时间在30 min之内461例（49.46%）；给药途径采用静脉滴注896例（96.14%）；932例ADR共累及多个系统/器官共计1 320例次，最常见的临床表现是皮肤及其附件损害 (937例次，70.98%)；严重ADR 77例（8.26%），联合用药224例（24.03%）。结论：临床应加强喜炎平注射液的临床合理用药，掌握其适应证，尽可能的减少不良反应的发生。

Investigation and Analysis of 932 Children with Adverse Drug Reactions Induced by Xiyanping Injection

[Abstract] Objective: To investigate and analyze the characteristics and regularities of 932 children with adverse drug reactions (ADR) induced by Xiyanping injection, and provide references for promoting clinical rational drug use in children. Methods: Retrospective method was adopted, statistical analysis was conducted on 932 cases of ADR induced by Xiyanping injection from the database of Shandong Provincial Center for ADR monitoring from 2015 to 2017. Results: Among the 932 ADR reports, 568 cases were male (60.94%), 364 cases were female (39.06%), yet the difference was not statistically significant (P>0.05). The incidence of ADR in infants was the highest, with 364 cases (39.06%) aged from 0 to 1 year old, and 250 cases (26.82%) aged >1 to 3 years old. ADR occurred in 461 cases (49.46%) within 30 minutes. Intravenous drip was the main administration route, totally 896 cases (96.14%). Nine hundred and thirty-two cases of ADR involved multiple systems/organs, totally 1,320 cases, and the most common clinical manifestation was skin and its accessory lesions (937 cases, 70.98%). There were 77 cases (8.26%) of severe ADR and 224 cases (24.03%) of drug combination. Conclusion: It is necessary to strengthen the rational clinical use of Xiyanping injection, grasp the clinical indications, and reduce the incidence of adverse drug reactions as much as possible.