心悦胶囊对经皮冠状动脉介入治疗后冠心病的疗效与安全性：一项随机临床试验的系统评价与Meta分析
Efficacy and Safety of Xinyue Capsule for Coronary Artery Disease after Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.
作者信息
Jiang Zhonghui, Qu Hua, Zhang Ying, Zhang Fan, Xiao Wenli, Shi Dazhuo, Gao Zhuye, Chen Keji
机构信息
Department of Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.
National Clinical Research Center for Chinese Medicine Cardiology, Beijing 100091, China.
出版信息
Evid Based Complement Alternat Med. 2021 Apr 8;2021:6695868. doi: 10.1155/2021/6695868. eCollection 2021.
To evaluate the efficacy and safety of Xinyue capsule (XYC) in the treatment of coronary artery disease (CAD) after percutaneous coronary intervention (PCI), databases including MEDLINE, EMBASE (Ovid), PubMed, Google Scholar, Cochrane Central Register of Controlled Trials (CENTRAL), China National Knowledge Infrastructure database (CNKI), Wanfang, and VIP were searched to identify randomized controlled trials (RCTs) on XYC in CAD after PCI published before October 2020. Data extraction, methodological quality assessment, and data analysis were performed according to the Cochrane standard. Dichotomous data were shown as risk ratios (RRs) with a 95% confidence interval (CI). All analyses were done with Review Manager, version 5.3. The quality of evidence was assessed by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. A total of 9 related studies from 166 related articles were identified, which included 2979 patients. Compared with conventional treatment alone (or placebo plus), XYC decreased cardiovascular events [RR = 0.37, 95% CI (0.27, 0.51), = 0%] (nonfatal myocardial infarction [RR = 0.26, 95% CI (0.10, 0.70), = 0%], revascularization [RR = 0.38, 95% CI (0.24, 0.61), = 0%], and rehospitalization due to ACS [RR = 0.48, 95% CI (0.33, 0.68), = 0%]) and improved cardiac function (LVEF [RR = 6.93, 95% CI (4.99, 8.87), = 81%], LVEDV [RR = -4.07, 95% CI (-5.61, -2.54), = 7%], and LVESV [RR = -4.32, 95% CI (-5.90, -2.74), = 50%]) in patients after PCI. In addition, XYC reduced serum NT-pro-BNP [RR = -126.91, 95% CI (-231.51, -22.31), = 69%]. However, XYC had little effect on cardiovascular death [RR = 0.47, 95% CI (0.13, 1.68), = 0%], stroke [RR = 0.52, 95% CI (0.23, 1.20), = 0%], heart failure [RR = 0.53, 95% CI (0.24, 1.20), = 0%], and quality of life [RR = -1.37, 95% CI (-4.97, 2.22), = 93%]. Thus, this meta-analysis suggests that XYC has potential advantages in reducing the occurrence of cardiovascular events after PCI, improving cardiac function, and reducing serum NT-pro-BNP. This potential benefit requires a high-quality RCT to assess.
为评价心悦胶囊（XYC）在经皮冠状动脉介入治疗（PCI）后冠心病（CAD）治疗中的有效性和安全性，检索了包括MEDLINE、EMBASE（Ovid）、PubMed、谷歌学术、Cochrane对照试验中心注册库（CENTRAL）、中国知网数据库（CNKI）、万方和维普在内的数据库，以识别2020年10月之前发表的关于XYC治疗PCI术后CAD的随机对照试验（RCT）。根据Cochrane标准进行数据提取、方法学质量评估和数据分析。二分数据以风险比（RRs）和95%置信区间（CI）表示。所有分析均使用Review Manager 5.3版完成。证据质量采用推荐分级评估、制定与评价（GRADE）方法进行评估。从166篇相关文章中总共确定了9项相关研究，共纳入2979例患者。与单纯常规治疗（或安慰剂加常规治疗）相比，XYC可降低心血管事件发生率[RR = 0.37，95%CI（0.27，0.51），I² = 0%]（非致死性心肌梗死[RR = 0.26，95%CI（0.10，0.70），I² = 0%]、血运重建[RR = 0.38，95%CI（0.24，0.61），I² = 0%]以及因急性冠状动脉综合征（ACS）再次住院[RR = 0.48，95%CI（0.33，0.68），I² = 0%]），并改善PCI术后患者的心脏功能（左心室射血分数[LVEF，RR = 6.93，95%CI（4.99，8.87），I² = 81%]、左心室舒张末期容积[LVEDV，RR = -4.07，95%CI（-5.61，-2.54），I² = 7%]和左心室收缩末期容积[LVESV，RR = -4.32，95%CI（-5.90，-2.74），I² = 50%]）。此外，XYC可降低血清N末端脑钠肽前体（NT-pro-BNP）水平[RR = -126.91，95%CI（-231.51，-22.31），I² = 69%]。然而，XYC对心血管死亡[RR = 0.47，95%CI（0.13，1.68），I² = 0%]、卒中[RR = 0.52，95%CI（0.23，1.20），I² = 0%]、心力衰竭[RR = 0.53，95%CI（0.24，1.20），I² = 0%]及生活质量[RR = -1.37，95%CI（-4.97，2.22），I² = 93%]影响不大。因此，这项荟萃分析表明，XYC在降低PCI术后心血管事件发生率、改善心脏功能及降低血清NT-pro-BNP方面具有潜在优势。这种潜在益处需要高质量的RCT进行评估。
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