97例小儿严重不良反应报告分析

Analysis of Report of 97 Cases of Serious Adverse Reactions in Children

目的：探讨严重不良反应发生的特点,为临床安全用药提供参考。方法：对某院2005年10月1日-2015年10月1日上报的严重不良反应报告进行统计分析。结果：共收集97例严重不良反应报告,多数为0-3岁患儿（84例,86.60%）,涉及药物品种主要为中药注射液（25例,25.77%）、维生素类（20例,20.62%）、抗菌药物（16例,16.49%）;临床表现主要有全身性损害（38例,26.95%）、循环系统（29例,20.57%）和呼吸系统损害（25例,17.73%）,大部分对症治疗后好转。结论：医院应加强中药注射剂、抗菌药物不良反应监测,重新评价水溶性维生素和脂溶性维生素的安全性,保障儿童用药安全。

Objective： To investigate the characteristics of severe adverse drug reactions（ADRs） so as to provide a reference for safe drug application in clinic. Methods ： The severe ADRs reported from October 1, 2005 to October 1, 2015 in a hospital were analyzed. Result ： A total of 97 cases of serious ADRs were collected, most of which（84 cases, 86.60%） occurred in children at ages of 0 - 3 years, and were mainly caused by traditional Chinese medicine injections（25 cases, 25.77%）, vitamins（20 cases, 20.62%） and antibacterial drugs（16 cases, 16.49%）. The clinical manifestations of ADRs included systemic damage（38 cases, 26.95%） as well as damages in circulatory system（29 cases, 20.57%） and respiratory system（25 cases, 17.73%）, most of which were improved after symptomatic treatment. Conclusion ： The monitoring on ADRs caused by antibiotics and traditional Chinese medicine injection should be further strengthened, and the safety of water-soluble and fat-soluble vitamins for injection should be re-evaluated to ensure the safety of medication in children.