阿托西班防治早产的药品不良反应/事件文献分析

Literature Analysis of Adverse Drug Reaction/Event Induced by Atosiban in the Treatment of Preterm Labor

目的:探讨阿托西班应用于早产时其药品不良反应/事件(ADR/ADE)的表现及发生规律,为其临床合理用药提供参考。方法:全面检索该药用于防治早产的所有国内、外临床研究,并对其出现的母体与新生儿ADR/ADE分别进行系统整理与分析。结果:阿托西班涉及母体的ADR/ADE主要为用药部位损害(47.11%)、胃肠系统损害(22.99%)、心率及心律紊乱(7.93%)、代谢和营养障碍(6.68%)等,具体表现为注射部位局部反应、恶心、呕吐、高血糖、心动过速等;涉及新生儿的ADR/ADE主要为呼吸系统损害(44.80%)、心外血管系统损害(9.27%)、胎儿异常(8.99%)及代谢和营养障碍(8.85%),具体表现为新生儿呼吸窘迫综合征、窒息、脑出血、动脉导管开放、低血糖、脓毒病、贫血等。阿托西班在东亚人群中最常见的不良反应为高血糖(7.25%)、心动过速(3.62%)、恶心(2.17%)、头痛(2.17%)、胸痛(2.17%)、呼吸困难(1.45%)及心悸(1.45%)等。结论:阿托西班在防治早产时可发生多种ADR/ADE,临床应用时需重视其安全性。

OBJECTIVE： To analyze and investigate the manifestations and regularity of adverse drug reactions/effects （ADR/ ADE） of atosiban applied in preterm labor, and to provide reference for rational drug use in the clinic. METHODS： Clinical trails about atosiban in the treatment of preterm labor were collected at home and abroad, maternal and neonatal/infant ADR/ADE of ato- siban were summarized and analyzed. RESULTS： The maternal ADR/ADE primarily contained application site disorders （47.11%）, gastro-intestinal system disorders （22.99%）, heart rate disorder or arrhythmia （7.93%）, metabolism disorder and al- ogotrophy （6.68%）, etc., presenting as application site reactions, nausea, vomiting, hyperglycemia, tachycardia, etc. The infant ADR/ADE mainly contained respiratory system damage （44.80%）, vascular damage （9.27%）, fetal abnormality （8.99%） and me- tabolism disorder and alogotrophy （8.85%）, presenting as respiratory distress syackome, ap^ea, eerebra~ hemorrhage, patent due- ms arteriosus, hypoglycemia, sepsis, anaemia, etc. The most frequently occurred ADR/ADEs of atosiban in East Asian population were hyperglycemia （7.25%） , tachycardia （3.62%）, nausea （2.17%）, headache （2.17%）, chest pain （2.17%）, dyspnoea （ 1.45% ） and palpitation （ 1.45% ）, etc. CONCLUSIONS： Atosiban can cause a variety of ADR/ADE in the treatment of preterm la- bor, so we should pay attention to its clinical safety.