替罗非班治疗急性冠状动脉综合征的快速卫生技术评估  

Rapid Health Technology Assessment of Tirofiban in the Treatment of Acute Coronary Syndrome

作　　者：钱晨月 张晶晶[2] 谢林俊 胡展红[1] 门鹏[4,5] 杨毅恒 朱建国[2,6] 缪丽燕 翟所迪[4,5] 潘杰 QIAN Chenyue;ZHANG Jingjing;XIE Linjun;HU Zhanhong;MEN Peng;YANG Yiheng;ZHU Jianguo;MIAO Liyan;ZHAI Suodi;PAN Jie(Dept.of Pharmacy,the Second Affiliated Hospital of Soochow University,Jiangsu Suzhou 215004,China;Dept.of Pharmacy,the First Affiliated Hospital of Soochow University,Jiangsu Suzhou 215006,China;Dept.of Pharmacy,Suzhou Municipal Hospital,Jiangsu Suzhou 215002,China;Dept.of Pharmacy,Peking University Third Hospital,Beijing 100191,China;Institute for Drug Evaluation,Peking University Health Science Center,Beijing 100191,China;Medical Security and Drug Evaluation Professional Committee,Jiangsu Medical Insurance Research Association,Nanjing 215004,China)

机构地区：[1]苏州大学附属第二医院药剂科,江苏苏州215004 [2]苏州大学附属第一医院药剂科,江苏苏州215006 [3]苏州市立医院药剂科,江苏苏州215002 [4]北京大学第三医院药剂科,北京100191 [5]北京大学医学部药物评价中心,北京100191 [6]江苏省医疗保险研究会医疗保障与药物评价专业委员会,南京215004

出　　处：《中国药房》2020年第15期1891-1896,共6页China Pharmacy

基　　金：国家自然科学基金资助项目(No.31700722);江苏省药学会-奥赛康医院药学基金项目(No.A201913)。

摘　　要：目的:对替罗非班治疗急性冠脉综合征(ACS)的获益与风险进行评价,为临床药物选择和决策提供循证依据。方法:系统检索PubMed、Cochrane图书馆、中国知网、万方数据等国内外数据库,检索时限均为建库起至2020年4月。由2名研究人员根据纳入与排除标准独立筛选文献并提取资料。对纳入文献进行质量评价后,基于快速卫生技术评估方法,对提取的结果进行分类评价和描述性分析。结果:共纳入13篇系统评价/Meta分析和1篇药物经济学研究。与安慰剂相比,替罗非班可显著降低ACS患者的全因死亡率[OR=0.68,95%CI(0.54,0.86),P=0.000 1]和主要心血管不良事件(MACE)发生率[RR=0.24,95%CI(0.14,0.40),P<0.01],同时可提高患者心肌梗死溶栓治疗(TIMI)3级发生率[OR=5.73,95%C(I2.99.10.97),P<0.01];替罗非班与依替巴肽治疗ACS的疗效相当,但替罗非班会增加ACS患者的TIMI小出血风险的发生率[RR=0.61,95%CI(0.38,0.98),P=0.04]。对于非ST段抬高型ACS患者,与安慰剂相比,替罗非班可显著降低其MACE发生率[RR=0.76,95%C(I0.61,0.96),P=0.018],但显著增加了出血风险[OR=1.49,95%C(I1.12,1.98),P=0.006],而对其全因死亡率[RR=0.80,95%C(I0.64,1.01),P=0.066]的影响则无统计学意义。对于ST段抬高型ACS患者,与安慰剂相比,替罗非班可显著降低其全因死亡率[RR=0.61,95%CI(0.35,1.05),P=0.007]和MACE发生率[RR=0.63,95%CI(0.44,0.90),P=0.007];替罗非班联合血脂抽吸亦可显著降低患者的MACE发生率[RR=2.05,95%CI(1.71,2.46),P<0.01],并显著提高其TIMI 3级发生率[OR=3.18,95%C(I2.4,4.22),P<0.01],但对出血风险的影响则无显著性差异(P>0.05)。纳入的药物经济学研究表明,使用比伐芦定治疗的患者可获得10.07 QALYs,采用肝素联合替罗非班治疗的患者可获得9.98 QALYs,比伐芦定相对于后者的增量成本-效果比为28 575.77元/QALYs,低于部分城市人均GDP的3倍。结论:替罗非班治疗ACS的有效性较好,但与依替巴肽和安慰剂OBJECTIVE:To evaluate the benefit and risk of tirofiban in the treatment of acute coronary syndrome(ACS),and to provide evidence-based reference for clinical drug selection and decision. METHODS:Retrieved from domestic and foreign database as PubMed,the Cochrane Library,CNKI and Wanfang database,during the establishment of database to Apr. 2020,two researcher independently screened the literature based on inclusion and exclusion criteria and extracted the data. After the quality evaluation of the included literatures,based on rapid health technology assessment,the extracted results were classifiedly evaluated and comprehensively analyzed. RESULTS: A total of 13 researches of systematic review/Meta-analysis and 1 research of pharmacoeconomics were included. Compared with placebo,tirofiban could significantly reduce all-cause mortality [OR=0.68,95%CI(0.54,0.86),P=0.000 1] and the incidence of major adverse cardiac events(MACE)in patients with ACS [RR=0.24,95%CI(0.14,0.40),P<0.01],and increased the incidence of TIMI 3 [OR=5.73,95%CI(2.99.10.97),P<0.01]. Tirofiban and eptifibatide had similar therapeutic efficacy in the treatment of ACS,but tirofiban significantly increased the risk of TIMI small bleeding in patients with ACS [RR=0.61,95%CI(0.38,0.98),P=0.04]. For ACS patients with non-ST elevation(NSTE-ACS),compared with placbo,tirofiban significantly reduced the incidence of MACE [RR=0.76,95% CI(0.61,0.96),P=0.018],but significantly increased the risk of bleeding [OR=1.49,95%CI(1.12,1.98),P=0.006],while there was no significant difference in its effects on the all-cause mortality of NSTE-ACS patients(P>0.05). For STEMI patients,compared with placebo,tirofiban significantly reduced the all-cause mortality [RR=0.61,95%C(I0.35,1.05),P=0.007] and the incidence of MACE [RR=0.63,95%CI(0.44,0.90),P=0.007]. When combined with liposuction,tirofiban also significantly reduced the incidence of MACE [RR=2.05,95%CI(1.71,2.46),P<0.01],and significantly increased the incidence of TIMI 3 [OR=3.18,95% CI(2.4,4.22),P<0.01],but there

关 键 词：替罗非班 急性冠状动脉综合征 有效性 安全性 经济性 快速卫生技术评估 

分 类 号：R541.4[医药卫生—心血管疾病]