纤溶酶注射剂不良反应/事件的定性系统评价  

Adverse Drug Reaction/Adverse Event of Fibrinogenase Agents:a Qualitative Systematic Review

作　　者：张姗 闫文硕 杨宇彤 杨兴华[1,2] Zhang Shan;Yan Wenshuo;Yang Yutong;Yang Xinghua(School of Public Health,Capital Medical University,Beijing 100069,China;Beijing Municipal Key Laboratory of Clinical Epidemiology)

机构地区：[1]首都医科大学公共卫生学院 [2]临床流行病学北京市重点实验室

出　　处：《药物流行病学杂志》2020年第12期814-821,共8页Chinese Journal of Pharmacoepidemiology

基　　金：首都医科大学第二课堂项目(编号:D2KT2019044)。

摘　　要：目的:调查文献中纤溶酶注射剂的不良反应/事件(ADR/ADE)发生情况,评价纤溶酶注射剂的安全性。方法:以"注射用纤溶酶"及"纤溶酶注射液"为检索词,检索CNKI、Wanfang Data及VIP等数据库,检索时间从建库至2020年7月,对获得的纤溶酶注射剂临床研究文献中报道的ADR/ADE进行系统评价。结果:共纳入文献31篇,其中随机对照试验(RCT)18篇(纤溶酶组1089例,对照组1062例),病例报道13篇(共215例)。7篇(38.9%)RCT、38例(17.7%)病例报道在应用纤溶酶前排除了纤溶酶过敏者。RCT中共发生ADR/ADE 126例次,均为轻型,其中纤溶酶组发生ADR/ADE 72例次,以胃肠道损害、皮肤及其附件损害为主,新的ADR/ADE占56.9%;对照组发生ADR/ADE 54例次,以胃肠损害及呼吸系统损害为主。病例报道中发生ADR/ADE 457例次,以全身性损害、皮肤及其附件损害为主,新的ADR/ADE占93.0%,严重的ADR/ADE病例19例,其中过敏性休克病例6例,未报道死亡病例。结论:当前证据表明,纤溶酶注射剂可引起多系统不同程度ADR/ADE,皮试阴性者仍可能发生ADR/ADE,提示临床应用时应随时观察患者状态,及时治疗。Objective:Investigate the adverse drug reaction or adverse drug event(ADR/ADE)of fibrinogenase agents in the literature to evaluate the safety of fibrinogenase agents.Methods:Using the keywords of"fibrinogenase for injection"and"fibrinogenase injection",CNKI,WanFang Data,and VIP databases were searched up to July,2020.The literature was chosen according to including and excluding standards.Results:18 randomized clinical trials(RCTs)and 13 case reports were included.Among them,7 RCTs and 38 individuals in case reports excluded fibrinogenase hypersensitivity patients before use it.In RCTs,72 cases of ADR/ADE occurred in the fibrinogenase group,all of them were mild,mainly involved in gastrointestinal and skin and it accessories.And 56.9%of them were newly found.In the control group,54 cases of ADR/ADE occurred,mainly in gastrointestinal and respiratory system.A total of 457 cases of ADR/ADE were reported in 7 case reports,mainly systemic reaction and skin and it accessories damage,and 93.0%were newly found.There were 19 patients with severe ADR/ADE,including 6 patients with anaphylactic shock.No death cases were reported.Conclusion:Current evidence indicates that the fibrinogenase agents can cause multiple systems of varying degrees ADR/ADE.ADR/ADE may still occur in patients with a negative skin test,suggesting that the state of the patient should be observed at any time during clinical application.

关 键 词：纤溶酶注射液 注射用纤溶酶 药品不良反应/事件 系统评价 

分 类 号：R973.3[医药卫生—药品]