185例儿童使用阿奇霉素不良反应/事件报告分析

目的:探讨儿童使用阿奇霉素的安全性及不良反应/事件(ADR/ADE)发生的规律、特点及原因,为儿童安全使用阿奇霉素提供参考。方法:回顾性分析185例阿奇霉素致儿童ADR/ADE 的报告,从患儿年龄、性别、原患疾病、药品用法用量、给药途径及ADR/ADE 发生时间、累及系统/器官和报告类型等方面进行统计分析。结果:16岁以下患儿发生ADR/ADE的严重程度为一般ADR 184例(99.46%),严重ADR 1 例(0.54%);74.05%的ADR/ADE集中在3~12岁患儿;静脉滴注73.53% ADR/ADE发生在用药后3 h内,口服用药74.70% ADR/ADE发生在用药后24 h内;按说明书规定的用法用量为123例(66.49%);累及器官/系统以消化系统(61.09%)为主。在积极对症治疗后,痊愈及好转180例(97.30%),死亡1例(0.54%)。结论:临床不合理使用阿奇霉素是ADR/ADE 发生的重要因素;加强风险防范,将不良反应的伤害降到最低;药品生产企业仍需完善注射剂说明书,确保临床用药安全。

Analysis on 185 Cases of Children with Azithromycin Adverse Reaction/Event Reports

Objective: To explore the regularities, characteristics and reasons of children with azithromycin adverse reaction/event (ADR/ADE), in order to provide a reference for safety clinical use and make a warning. Methods: By adopting retrospective study method, we counted and analyzed 185 cases of children with azithromycin ADR/ADE reports from age, gender, original disease, drug usage and dosage, administration route and ADR/ADE occurring time, involving system or organ, and report type, etc. Results: The characteristics of cases under 16 were as follows: there were 184 cases of general adverse reactions (99.46%), 1 severe case (0.54%). 74.05% of ADR/ADE cases were concentrated in 3 to 12 years old, 73.53% of intravenous drip occurred within 3 hours after drug, 123 cases were using according to the specification (66.49%), involved digestive system (61.09%), 74.70% of oral medications occurred withing 24 hours after drug. After symptomatic treatment actively, 180 cases cured or recovered, 1 case (0.54%) died. Conclusion: Irrational use of azithromycin is an important factor of ADR/ ADE occurrence. We should strengthen prevention of risk, minimize the damage of adverse reactions. Also, the drug producing companies need to improve the drug instruction to ensure clinical medication safety.