依达拉奉临床应用的安全性评价

目的 回顾分析依达拉奉治疗急性脑梗死等国内文献资料中依达拉奉的不良反应.了解依达拉奉不良反应的发生率及其临床应用的安全性.方法 计算机检索Pubmed、中国生物医学文献数据库及所获文献的参考文献,对8645例患者进行不良反应分析,并对依达拉奉治疗急性脑梗死随机对照试验研究应用Meta分析来全面分析依达拉奉的安全性.结果 依达拉奉不良反应最多见的是轻度氨基转移酶升高、肾功能异常及皮疹,不良反应(283例)占总例数(8645例)比例为3.27 % ;共纳入10项依达拉奉治疗急性脑梗死的随机对照试验研究,Meta分析显示:依达拉奉+常规治疗组与常规治疗组的不良事件发生率差异(OR=1.18,95 % CI 0.70-2.00,P=0.536)、氨基转移酶升高发生率差异(OR=1.23,95 % CI 0.57-2.68,P=0.595)以及肾功能异常(蛋白尿、肌酐升高、尿素氮升高)发生率差异(OR=1.65,95 % CI 0.57-4.79,P=0.353)均无统计学意义.结论 依达拉奉的不良反应发生率很低,临床应用较为安全.

Safety evaluation of edaravone in clinical application

Objective To analyze the adverse drug reactions(ADRs)of edaravone in treatment of patients with acute cerebral infarction(ACI)by reviewing Chinese medical literature and to evaluate safety of edaravone treatment in ACI.Methods Publications from Pubmed and Chinese Biomedical Literature Datababe(CBMdisc)were reviewed and the ADR of edaravone was analyzed among the published 8645 cases.Literatures about randomed-control clinical trails(RCTs)on security of edaravone for treating ACI Was analyzed by meta-analysis.Results Abnormal hepatic function,especially mild elevation of aminotransferase,renal dysfunction and skin rash induced by edaravone were tIle most common ADRs.Among 8645 patients,ADRs were reported in 283(3.27 % ).The meta-analysis in RCTs showed that between the group treated with a combination of edaravone and routine and the group treated with routine treatment only,there was no significant difference in the occurrence rate of ADRs(OR=1.18,95 % CI0.70-2.00,P=0.536),elevation of aminotransferase(OR=1.23,95 % CI 0.57-2.68,P=0.595)or renal dysfunction including albuminutia,increased level of serum ereatinine and nitrogen(OR=1.65.95 % CI0.57- 4.79.P=0.353).Conclusion Edaravone has a low ADRs OCCurrence rate and iS safely used in cerebral infarction treatment.