2023 年第 1 期 第 18 卷

吲哚布芬用于治疗动脉硬化所致的缺血性心血管病变的临床有效性与安全性的系统评价与Meta分析

Clinical efficacy and safety of indobufen in the treatment of ischemic cardiovascular disease caused by atherosclerosis: a systematic review and Meta-analysis

作者：朱云珊赵紫楠张亚同金鹏飞

英文作者：Zhu Yunshan Zhao Zinan Zhang Yatong Jin Pengfei

单位：北京医院药学部国家老年医学中心中国医学科学院老年医学研究院北京市药物临床风险与个体化应用评价重点实验室（北京医院），北京100730

英文单位：Department of Pharmacy Beijing Hospital National Center of Gerontology Institute of Geriatric Medicine Chinese Academy of Medical Sciences Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application(Beijing Hospital) Beijing 100730 China

关键词：动脉硬化所致的缺血性心血管病变；吲哚布芬；Meta分析；随机对照试验

英文关键词：Ischemiccardiovasculardiseasecausedbyatherosclerosis;Indobufen;Meta-analysis;Randomizedcontrolledtrial

• 摘要：

• 目的  评价吲哚布芬在治疗动脉硬化所致的缺血性心血管病变中的有效性与安全性。方法 以“吲哚布芬”和“indobufen”作为关键词设定一定策略计算机检索The Cochrane Library、PubMed、EMbase、ClinicalTrial.gov、中国知网和万方数据库（时间由建库至2021年4月）的数据。按纳入与排除标准筛选文献、提取资料并评价纳入研究的方法学质量后，采用Rev Man 5.3软件进行Meta分析。结果 共29项随机对照试验纳入分析，包括3 329例患者，其中观察组1 674例、对照组1 655例。有效性结局显示，在不稳定型心绞痛治疗的总有效率方面吲哚布芬单药显著优于阿司匹林（风险比=1.29，95%置信区间：1.21～1.38，P<0.000 01）；吲哚布芬联合氯吡格雷治疗急性冠状动脉综合征的总有效率显著优于阿司匹林联合氯吡格雷（风险比=1.19，95%置信区间：1.03～1.36，P=0.01）；吲哚布芬联合替格瑞洛在冠心病（冠状动脉粥样硬化性心脏病）经皮冠状动脉介入术后总心血管事件发生率显著低于阿司匹林联合替格瑞洛（I2=0，风险比=0.25,95%置信区间：0.10～0.65，P<0.01）；吲哚布芬治疗冠心病冠状动脉旁路移植术后患者移植血管闭塞事件的短期发生率显著低于阿司匹林联合双嘧达莫（风险比=0.26，95%置信区间：0.10～0.65，P<0.01）。安全性结果显示，吲哚布芬联合氯吡格雷治疗不稳定型心绞痛导致出血事件和胃肠道反应的发生率显著低于阿司匹林联合氯吡格雷；吲哚布芬联合氯吡格雷在冠心病经皮冠状动脉介入术后轻微出血事件和胃肠道反应的发生率显著低于阿司匹林联合氯吡格雷。结论 吲哚布芬在治疗动脉硬化所致的缺血性心血管病变方面已积累了一定的循证证据，吲哚布芬单药或与氯吡格雷联合使用在有效性和安全性方面均显示出较好的优势。

• Objective To evaluate the efficacy and safety of indobufen in the treatment of ischemic cardiovascular disease caused by atherosclerosis. Methods "Indobufen" was used as a keyword to set strategies to retrieve the data of The Cochrane Library, PubMed, EMbase, ClinicalTrial.gov, China National Knowledge Infrastructure and Wanfang Database(from the establishment of the database to April 2021). After screening the literature according to the inclusion and exclusion criteria, extracting data and evaluating the methodological quality of the included studies, a Meta-analysis was performed using Rev Man 5.3 software. Results A total of 29 randomized controlled trials involving 3 329 patients were included. There were 1 674 patients in the observation group and 1 655 patients in the control group. The efficacy results  showed that the overall response rate of indobufen in the treatment of unstable angina pectoris was significantly better than that of aspirin［risk ratio (RR)=1.29, 95% confidence interval (CI): 1.21-1.38, P<0.000 01］; the total response rate of indobufen combined with clopidogrel in the treatment of acute coronary syndrome was significantly better than that of aspirin combined with clopidogrel(RR=1.19, 95% CI:1.03-1.36, P=0.01); the incidence of overall cardiovascular events of indobufen combined with ticagrelor was significantly lower than that of aspirin combined with ticagrelor after percutaneous coronary intervention(I2=0, RR=0.25, 95% CI:0.10-0.65, P<0.01); the short-term incidence of grafting vessel occlusion of indobufen was significantly lower than that with aspirin combined with dipyridamole after coronary artery bypass grafting(RR=0.26, 95% CI:0.10-0.65, P<0.01). Safety outcomes showed that the incidences of bleeding events and gastrointestinal reactions caused by indobufen combined with clopidogrel in the treatment of unstable angina pectoris were significantly lower than those caused by aspirin combined with clopidogrel. The incidences of bleeding events and gastrointestinal reactions caused by indobufen combined with clopidogrel after percutaneous coronary intervention were significantly lower than those caused by aspirin combined with clopidogrel. Conclusions Indobufen has accumulated a certain amount of evidence-based evidence in the treatment of ischemic cardiovascular disease caused by atherosclerosis. Indobufen or in combination with clopidogrel has advantages in efficacy and safety.