Li Liuying, Feng Peimin, Zhou Wenhua, Luo Biao, Deng Lvyu, Gan Daohui, Wu Xiaohan, Zhu Fengya, Zhou Xia
Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.
Traditional Chinese Medicine Department, Zigong First People's Hospital, Zigong, China.
Front Cardiovasc Med. 2024 Feb 13;11:1229299. doi: 10.3389/fcvm.2024.1229299. eCollection 2024.
BACKGROUND: Tongxinluo capsule (TXLC) is a common drug for treating angina pectoris of coronary heart disease (CHD). In recent years, many systematic reviews (SRs) and meta-analyses (MAs) have reported the efficacy and safety of TXLC for improving angina symptoms in patients with CHD. We aimed to comprehensively evaluate the existing SRs and MAs of TXLC in treating angina pectoris of CHD, summarize the evidence quality, and provide scientific evidence and recommendations. METHODS: We searched seven databases for relevant SRs/MAs published up to 1 June 2023. Two reviewers independently completed the literature retrieval, screening, and data extraction. We used A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR 2) to evaluate the methodological quality, the Risk of Bias in Systematic Reviews (ROBIS) to assess the risk of bias, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) to determine the strength of the evidence. RevMan 5.3 was used to synthesize data. RESULTS: We identified 15 SRs/MAs, including 329 RCTs and 33,417 patients. According to the evaluation results of AMSTAR-2, only one SR was of high methodological quality, the others were very low. ROBIS assessment showed that one SR (6.67%) had a low risk, 3 SRs (20%) had an unclear risk, and 11 SRs (73.33%) had a high risk. We assessed 42 outcomes by the GRADE, 10 (23.81%) for moderate-quality evidence, 17 (40.48%) for low-quality evidence, and 15 (35.71%) for very-low-quality evidence. Mate-analysis showed that TXLC combined with conventional western medications improved electrocardiogram efficacy (RR = 1.38, 95% CI: 1.23-1.43, < 0.001) and angina efficacy (OR = 3.58, 95% CI: 3.02-4.24, < 0.001), reduced angina attack frequency (SMD = -0.54, 95% CI: -0.64 to -0.44, < 0.001) and angina duration (SMD = -0.42, 95% CI: -0.57 to -0.28, < 0.001), with general heterogeneity. The pooled results showed that TXLC appears to have some efficacy in improving cardiac function and relieving angina symptoms, but there is limited evidence that it improves cardiovascular event rates, hemorheology, lipids, or hs-CRP. In the assessment of drug safety, TXLC was associated with different degrees of adverse drug reactions. CONCLUSION: Based on the evidence, TXLC may be effective as an adjuvant treatment for angina pectoris of CHD. However, the quality of the evidence is low, and the drug's safety must be carefully interpreted. In future studies, high-quality randomized controlled trials are needed to confirm the effectiveness and safety of TXLC. SYSTEMATIC REVIEW REGISTRATION: http://www.crd.york.ac.uk/PROSPERO/, identifier (CRD42022365372).
背景:通心络胶囊(TXLC)是治疗冠心病(CHD)心绞痛的常用药物。近年来,许多系统评价(SRs)和荟萃分析(MAs)报告了TXLC改善CHD患者心绞痛症状的疗效和安全性。我们旨在全面评估现有的TXLC治疗CHD心绞痛的SRs和MAs,总结证据质量,并提供科学依据和建议。 方法:我们检索了七个数据库,以获取截至2023年6月1日发表的相关SRs/MAs。两名评审员独立完成文献检索、筛选和数据提取。我们使用系统评价的测量工具2(AMSTAR 2)评估方法学质量,使用系统评价中的偏倚风险(ROBIS)评估偏倚风险,并使用推荐分级评估、制定和评价(GRADE)来确定证据的强度。使用RevMan 5.3进行数据合成。 结果:我们纳入了15项SRs/MAs,包括329项随机对照试验(RCTs)和33417名患者。根据AMSTAR-2的评估结果,只有1项SR的方法学质量高,其他的都非常低。ROBIS评估显示,1项SR(6.67%)风险低,3项SR(20%)风险不明确,11项SR(73.33%)风险高。我们通过GRADE评估了42项结局,10项(23.81%)为中等质量证据,17项(40.48%)为低质量证据,15项(35.71%)为极低质量证据。荟萃分析表明,TXLC联合传统西药可提高心电图疗效(RR = 1.38,95%CI:1.23 - 1.43,P < 0.001)和心绞痛疗效(OR = 3.58,95%CI:3.02 - 4.24,P < 0.001),降低心绞痛发作频率(SMD = -0.54,95%CI:-0.64至-0.44,P < 0.001)和心绞痛持续时间(SMD = -0.42,95%CI:-0.57至-0.28,P < 0.001),总体存在异质性。汇总结果显示,TXLC在改善心功能和缓解心绞痛症状方面似乎有一定疗效,但改善心血管事件发生率、血液流变学、血脂或高敏C反应蛋白(hs-CRP)的证据有限。在药物安全性评估中,TXLC与不同程度的药物不良反应相关。 结论:基于现有证据,TXLC作为CHD心绞痛的辅助治疗可能有效。然而,证据质量较低,药物安全性必须谨慎解读。未来的研究需要高质量的随机对照试验来证实TXLC的有效性和安全性。 系统评价注册:http://www.crd.york.ac.uk/PROSPERO/,标识符(CRD42022365372)。
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