替罗非班治疗急性缺血性脑卒中的快速卫生技术评估

Rapid Health Technology Assessment of Tirofiban in the Treatment of Acute Ischemic Stroke

目的:基于快速卫生技术评估(HTA)的方法,评价替罗非班治疗急性缺血性脑卒中的有效性、安全性和经济性,为临床合理用药提供循证依据。方法:系统检索PubMed、the Cochrane Library、中国知网和万方数据库等国内外数据库,搜集替罗非班治疗急性缺血性脑卒中的HTA报告、系统评价/Meta分析和药物经济学研究(干预组患者采用替罗非班单药或联合其他治疗;对照组患者给予安慰剂或其他治疗),检索时限为建库至2021年9月。由2名研究者独立地根据纳入、排除标准筛选文献、提取数据、评价文献质量,将研究结果汇总并进行定性描述分析。结果:共纳入15篇系统评价/Meta分析。有效性方面,与对照组比较,替罗非班可显著改善患者的神经功能损伤及日常生活活动能力,差异有统计学意义(P<0.05);两组患者再闭塞率的差异无统计学意义(P>0.05);改善90 d预后、血管再通率及死亡率方面,各研究得出的结论不一致。安全性方面,与对照组比较,替罗非班未升高颅内出血发生率、症状性颅内出血发生率、颅内出血转化率、脑实质内血肿2型发生率及其他部位出血不良事件发生率,两组间的差异无统计学意义(P>0.05);替罗非班组患者的致命性颅内出血发生率显著升高,可能与给药途径、剂量有关。结论:替罗非班治疗急性缺血性脑卒中具有良好的有效性和安全性。因观察到替罗非班组患者致命性颅内出血发生率显著升高,未来可考虑更多地开展大规模、多中心的随机对照研究,进一步验证替罗非班治疗急性缺血性脑卒中的安全性,为临床和决策者提供参考。

OBJECTIVE:To evaluate the efficacy,safety and economy of tirofiban in the treatment of acute ischemic stroke based on rapid health technology assessment(HTA),so as to provide evidence-based basis for clinical rational drug use.METHODS:Domestic and foreign databases such as PubMed,the Cochrane Library,CNKI and Wanfang Data were retrieved to collect HTA reports,systematic review/Meta-analysis and pharmacoeconomic studies of tirofiban in the treatment of acute ischemic stroke(the intervention group was treated with tirofiban alone or in combination with other treatment,the control group received placebo or other treatment).The retrieval time was from the establishment of the database to Sept.2021.Two researchers independently screened the literature according to inclusion and exclusion criteria,extracted data,evaluated the literature quality,summarized the research results and analyzed qualitatively.RESULTS:A total of 15 systematic review/Meta-analysis were included.In terms of effectiveness,compared with the control group,tirofibancan could significantly improve patients’neurological function and activity of daily living,with statistically significant difference(P<0.05);there was no statistically significant difference in the rate of reocclusion between two groups(P>0.05);in terms of improving 90-day prognosis,vascular revascularization rate and mortality,the results of various studies were inconsistent.In terms of safety,compared with the control group,tirofiban did not increase the incidence of intracranial hemorrhage,the incidence of symptomatic intracranial hemorrhage,the conversion rate of intracranial hemorrhage,the incidence of intracranial parenchymal hematoma type 2 and the incidence of adverse bleeding events at other sites,and there was no statistical significance between two groups(P>0.05);the incidence of fatal intracranial hemorrhage increased significantly in tirofiban group,which might be related to the route and dose of administration.CONCLUSIONS:Tirofiban has significant effectiveness and safety in the treatment of acute ischemic stroke.Due to the significant increase in the incidence of fatal intracranial hemorrhage of tirofiban,more large-scale,multicenter randomized controlled studies can be considered in the future to further confirm the safety of tirofiban in the treatment of ischemic stroke and provide reference for clinical and decision-makers.