论文部分内容阅读
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 investigate the manifestation and occurrence of ADR / ADE when it is used in premature delivery and provide a reference for its clinical rational use. Methods: All the domestic and foreign clinical trials of this medicine for prevention and treatment of premature labor were searched comprehensively, and the ADR / ADE of maternal and newborn appeared in the hospital were systematically collated and analyzed respectively. Results: The main ADR / ADE related to Atosiban were as follows: drug site damage (47.11%), gastrointestinal system damage (22.99%), heart rate and heart rhythm disorders (7.93%), metabolic and nutritional disorders (6.68% The most common cause of ADR / ADE in newborns was respiratory system damage (44.80%), extrahepatic vascular system damage (9.27%) and fetal abnormality 8.99%) and metabolic and nutritional disorders (8.85%), which are manifested as neonatal respiratory distress syndrome, asphyxia, cerebral hemorrhage, patent ductus arteriosus, hypoglycemia, sepsis and anemia. The most common adverse reactions to atosiban in East Asians were hyperglycemia (7.25%), tachycardia (3.62%), nausea (2.17%), headache (2.17%), chest pain (2.17%), dyspnea 1.45%) and palpitations (1.45%) and so on. Conclusion: Atosiban can play a variety of ADR / ADE in the prevention and treatment of prematurity, and its safety should be emphasized in clinical application.