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185例儿童使用阿奇霉素不良反应/事件报告分析
李郁,傅存冀,刘磊
0
(乌鲁木齐市第一人民医院,新疆乌鲁木齐 830000)
摘要:
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。
关键词:  阿奇霉素  儿童  不良反应/事件
DOI:doi:10.13407/j.cnki.jpp.1672-108X.2017.01.010
基金项目:乌鲁木齐市卫生局科学技术计划项目课题,编号201336
Analysis on 185 Cases of Children with Azithromycin Adverse Reaction/Event Reports
Li Yu, Fu Cunji, Liu Lei
(The First People's Hospital of Urumqi , Xingjiang Urumqi 830000, China)
Abstract:
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.
Key words:  azithromycin  children  adverse reaction/event

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