Data Sheet 1_The efficacy and safety of indobufen in patients with ischemic cardiovascular or cerebrovascular diseases: systematic review and meta-analysis.pdf

ObjectiveThis meta-analysis aims to evaluate the safety and efficacy of indobufen in the treatment of cardiovascular diseases, cerebrovascular diseases, and thromboembolic disorders. The primary focus is on the incidence of major adverse cardiovascular events (MACE), thrombosis, bleeding events, and adverse reactions. The results are intended to provide a reference for the clinical application of indobufen and suggest directions for further large-scale, multi-center, prospective studies.
MethodsThis review follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A comprehensive search was conducted in PubMed, Embase, Web of Science, and the Cochrane Library databases to identify all relevant studies on indobufen. Twelve trials, all randomized controlled trials (RCTs), met the inclusion criteria. The results were presented as risk ratios (RR) with 95% confidence intervals (CI), and meta-analysis was performed using RevMan 5.3 and Stata 18.0 software.
ResultsThe meta-analysis included 12 randomized controlled trials. Regarding safety, indobufen showed superior clinical outcomes compared to other antiplatelet agents regarding bleeding events, gastrointestinal adverse reactions, and overall adverse reactions, with these differences being more pronounced in cardiovascular diseases. However, the effects of both treatments on efficacy outcomes, including MACE, myocardial infarction, angina, mortality, and thrombotic events, were similar. For stroke events, particularly in patients with cerebrovascular diseases, the use of indobufen was associated with some risk.
ConclusionIndobufen is associated with a lower risk of adverse reactions and bleeding, making it a viable option for patients at risk of bleeding or adverse effects, particularly in those with cardiovascular diseases. However, compared to anticoagulants such as aspirin and clopidogrel, indobufen has a shorter history of use, and its evidence base is relatively limited, highlighting the need for further research. Currently, indobufen is widely used in secondary cardiovascular and cerebrovascular prevention and provides some guidance for antiplatelet therapy in patients with gastrointestinal discomfort or bleeding risk. However, due to the potential risks in MACE, stroke, and other events, further clinical trials are needed to assess the clinical applicability of indobufen.
Systematic Review Registrationhttps://www.crd.york.ac.uk/, identifier (CRD42024587938).

本项荟萃分析旨在评估吲哚布芬治疗心血管疾病、脑血管疾病及血栓栓塞性疾病的安全性与有效性。本研究的核心关注指标包括主要不良心血管事件（major adverse cardiovascular events, MACE）、血栓形成、出血事件以及不良反应的发生率。研究结果旨在为吲哚布芬的临床应用提供参考，并为后续开展大规模多中心前瞻性研究指明方向。

本综述遵循系统评价与荟萃分析优先报告条目（Preferred Reporting Items for Systematic Reviews and Meta-Analyses, PRISMA）指南。研究团队在PubMed、Embase、Web of Science及Cochrane Library数据库中进行全面检索，以筛选所有与吲哚布芬相关的研究。最终共有12项随机对照试验（randomized controlled trial, RCT）符合纳入标准。研究结果以风险比（risk ratio, RR）及95%置信区间（confidence interval, CI）进行呈现，并采用RevMan 5.3与Stata 18.0软件完成荟萃分析。

本次荟萃分析共纳入12项随机对照试验。安全性层面，相较于其他抗血小板药物，吲哚布芬在出血事件、胃肠道不良反应及总体不良反应方面展现出更优的临床结局，该差异在心血管疾病患者群体中更为显著。不过，两类治疗方案在主要疗效结局（包括主要不良心血管事件、心肌梗死、心绞痛、死亡率及血栓事件）上的效果并无显著差异。针对卒中事件，尤其是脑血管疾病患者群体，使用吲哚布芬或存在一定风险。

吲哚布芬的不良反应与出血风险更低，可作为存在出血或不良反应风险患者的可选治疗方案，尤其适用于心血管疾病患者。然而，相较于阿司匹林、氯吡格雷等抗凝药物，吲哚布芬的临床应用历史较短，证据基础相对有限，这凸显了开展后续研究的必要性。目前，吲哚布芬已广泛应用于心脑血管疾病的二级预防，并为存在胃肠道不适或出血风险的患者提供了抗血小板治疗的参考思路。但鉴于其在主要不良心血管事件、卒中等事件中存在潜在风险，仍需开展进一步临床试验以评估其临床适用性。

系统评价注册信息：https://www.crd.york.ac.uk/，标识符（CRD42024587938）。