替罗非班治疗急性冠状动脉综合征的快速卫生技术评估
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篇名: 替罗非班治疗急性冠状动脉综合征的快速卫生技术评估
TITLE: Rapid Health Technology Assessment of Tirofiban in the Treatment of Acute Coronary Syndrome
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=0.0001]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%CI(2.99.10.97),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%CI(0.61,0.96),P=0.018],但显著增加了出血风险[OR=1.49,95%CI(1.12,1.98),P=0.006],而对其全因死亡率[RR=0.80,95%CI(0.64,1.01),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TIMI3级发生率[OR=3.18,95%CI(2.4,4.22),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10.07QALYs,采用肝素联合替罗非班治疗的患者可获得9.98QALYs,比伐芦定相对于后者的增量成本-效果比为28575.77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相比,该药会增加一定的出血风险。采用国产比伐芦定治疗ACS比替罗非班联合肝素可能更具成本-效果优势。
ABSTRACT: 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%CI(0.35,1.05),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 was no significant difference in its effects on bleeding risk (P>0.05). The included pharmacoeconomic study showed that patients treated with bivalutine could get 10.07 QALYs,patients treated with heparin combined with tirofiban could get 9.98 QALYs,and the incremental cost-effectiveness ratio bivalutine compared to the latter one was 28 575.77 yuan/QALYs,which was lower than 3 times of the per capita GDP of some cities. CONCLUSIONS :Tirofiban has good efficacy in the treatment of ACS,but it can increase the risk of bleeding than eptifibatide and placebo. Domestic bivalirudin treating for ACS has a cost-effectiveness advantage over tirofiban combined with heparin.
期刊: 2020年第31卷第15期
作者: 钱晨月,张晶晶,谢林俊,胡展红,门鹏,杨毅恒,朱建国,缪丽燕,翟所迪,潘杰
AUTHORS: QIAN Chenyue,ZHANG Jingjing, XIE Linjun,HU Zhanhong,MEN Peng,YANG Yiheng,ZHU Jianguo,MIAO Liyan,ZHAI Suodi,PAN Jie
关键字: 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
KEYWORDS: Tirofiban;Acute coronary syndrome ;Effectiveness;Safety;Economics;Rapid health technology assessment
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