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Rapid Health Technology Assessment of Tirofiban in the Treatment of Acute Coronary Syndrome
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QIAN Chenyue ，ZHANG Jingjing ，XIE Linjun ，HU Zhanhong ，MEN Peng ，YANG Yiheng ，ZHU Jianguo ，
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MIAO Liyan ，ZHAI Suodi ，PAN Jie （1. Dept. of Pharmacy，the Second Affiliated Hospital of Soochow
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University，Jiangsu Suzhou 215004，China；2. Dept. of Pharmacy，the First Affiliated Hospital of Soochow
University，Jiangsu Suzhou 215006，China；3. Dept. of Pharmacy，Suzhou Municipal Hospital，Jiangsu Suzhou
215002，China；4. Dept. of Pharmacy，Peking University Third Hospital，Beijing 100191，China；5. Institute for
Drug Evaluation，Peking University Health Science Center，Beijing 100191，China；6. Medical Security and Drug
Evaluation Professional Committee，Jiangsu Medical Insurance Research Association，Nanjing 215004，China）
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.
KEYWORDS Tirofiban；Acute coronary syndrome；Effectiveness；Safety；Economics；Rapid health technology assessment

急性冠状动脉综合征（Acute coronary syndrome， 者进行冠状动脉血管成形术或冠状动脉内斑块切除术，
ACS）是以冠状动脉粥样硬化斑块破裂或侵袭、继发完 以预防与经治冠状动脉突然闭塞有关的心脏缺血并发
全或不完全闭塞性血栓形成为病理基础的一组临床综 症 [4-5] 。
[1]
合征 。临床根据心电图有无持续性 ST 段抬高可将 《2018年美国急性缺血性卒中早期管理指南》指出，
ACS 分为 ST 段抬高型心肌梗死（STEMI）和非 ST 段抬 静脉给予替罗非班和依替巴肽的有效性尚不完全确定，
高型急性冠脉综合征（NSTE-ACS） 。血小板活化和聚 需要进一步的临床试验（证据等级：Ⅱb） 。2019 年，由
[2]
[6]
集在动脉粥样硬化血栓形成的过程中起着关键作用，也 国家卫生计生委合理用药专家委员会和中国药师协会
[3]
是导致ACS 的直接原因 。因此，抗血小板治疗是冠状 联合发布的《急性 ST 段抬高型心机梗死溶栓治疗的合
动脉心脏病治疗的关键手段，贯穿整个治疗的过程。 理用药指南（第2版）》推荐对于发病时存在呕吐和消化
近年来，血小板糖蛋白Ⅱb/Ⅲa 受体拮抗剂（GPI）在 道功能障碍无法口服抗血小板药物的重症STEMI患者，
心血管方面的研究与应用逐渐增多。目前，临床应用的 可考虑应用适量替罗非班或依替巴肽（证据等级：Ⅱb） 。
[7]
GPI 主要有替罗非班、依替巴肽和 Abciximab（尚未在我 2019 年中国医师协会急诊医师分会等多机构联合发布
国上市）等3种 。盐酸替罗非班注射液与肝素联用，适 的《急性冠脉综合征急诊快速诊治指南（2019）》指出，在
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用于预防不稳定型心绞痛或非 Q 波心肌梗死患者心脏 有效的双联抗血小板及抗凝治疗情况下，不推荐 STEMI
缺血事件的发生，同时也适用于冠状动脉缺血综合征患 患者造影前常规应用GPl（证据等级：Ⅱb） 。此外，相对
[8]

·1892 · China Pharmacy 2020 Vol. 31 No. 15 中国药房 2020年第31卷第15期