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麝香保心丸治疗冠状动脉慢血流的Meta分析和试验序贯分析

Meta-analysis and trial sequential analysis of shexiang baoxin pill for coronary slow flow.

作者信息

Guo Hongxin, Li Xingyuan, Zhu Mingjun

机构信息

First Clinical Medical College, Henan University of Chinese Medicine, Zhengzhou, China.

Department of Cardiovascular Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, China.

出版信息

Front Pharmacol. 2022 Aug 22;13:955146. doi: 10.3389/fphar.2022.955146. eCollection 2022.

Abstract

Coronary slow flow (CSF) is a common cardiovascular phenomenon with no effective treatment in conventional Western medicine (CWM). Shexiang Baoxin Pill (SXBXP) is a widely used Chinese medicine for cardiovascular disease in China, and clinical studies have shown that it has good efficacy for CSF. To systematically evaluate the efficacy and safety of SXBXP for CSF. Seven databases were searched to identify related randomized controlled trials (RCTs). The Meta-analysis, trial sequential analysis (TSA), and Grades of Recommendation, Assessment, Development and Evaluation (GRADE) were performed using Stata 14.1, TSA 0.9.5.10 Beta and GRADE profiler 3.2.2 software respectively. A total of 10 RCTs were included. Meta-analysis showed that compared with CWM treatment alone, SXBXP combined with CWM further improved the angina pectoris efficacy [RR = 1.37, 95% CI (1.23, 1.52), < 0.000 01] and nitric oxide (NO) level [WMD = 11.32, 95% CI (0.04, 22.59), = 0.049], decreased the mean corrected TIMI frame count (CTFC) [WMD = -4.23, 95% CI (-5.51, -2.95), < 0.000 01], CTFC of the left anterior descending artery (LAD) [WMD = -6.36, 95% CI (-12.07, -0.65), = 0.029], left circumflex artery (LCX) [WMD = -5.73, 95% CI (-8.79, -2.67), < 0.000 01], and right coronary artery (RCA) [WMD = -6.72, 95% CI (-10.60, -2.84), = 0.001], decreased the positive rate of treadmill exercise test [RR = 0.45, 95% CI (0.25, 0.83), = 0.010], endothelin-1 (ET-1) level [WMD = -11.03, 95% CI (-13.92, -8.14), < 0.000 01], high-sensitivity C-reactive protein (hs-CRP) [WMD = -1.95, 95% CI (-2.57, -1.34), < 0.000 01], and adverse reactions [RR = 0.20, 95% CI (0.05, 0.85), = 0.030]. The GRADE evidence quality rating presented with moderate, low or very low quality of evidence. TSA further affirmed the clinical efficacy. Although some results suggest that there may be a positive effect of SXBXP for CSF, the quality of the primary study including the reporting is too poor and therefore, no benefits could be demonstrated. More high-quality studies are still needed to further confirm the efficacy and safety. https://www.crd.york.ac.uk/PROSPERO/, identifier (CRD42022329469).

摘要

冠状动脉慢血流(CSF)是一种常见的心血管现象,在传统西医(CWM)中尚无有效治疗方法。麝香保心丸(SXBXP)是中国广泛用于治疗心血管疾病的中药,临床研究表明其对CSF有良好疗效。为系统评价SXBXP治疗CSF的疗效和安全性。检索了七个数据库以识别相关的随机对照试验(RCT)。分别使用Stata 14.1、TSA 0.9.5.10 Beta和GRADE profiler 3.2.2软件进行Meta分析、试验序贯分析(TSA)和推荐分级、评估、制定与评价(GRADE)。共纳入10项RCT。Meta分析表明,与单纯CWM治疗相比,SXBXP联合CWM进一步提高了心绞痛疗效[RR = 1.37,95%CI(1.23,1.52),<0.000 01]和一氧化氮(NO)水平[WMD = 11.32,95%CI(0.04,22.59),=0.049],降低了平均校正TIMI帧计数(CTFC)[WMD = -4.23,95%CI(-5.51,-2.95),<0.000 01]、左前降支(LAD)的CTFC[WMD = -6.36,95%CI(-12.07,-0.65),=0.029]、左旋支(LCX)[WMD = -5.73,95%CI(-8.79,-2.67),<0.000 01]和右冠状动脉(RCA)[WMD = -6.72,95%CI(-10.60,-2.84),=0.001],降低了平板运动试验阳性率[RR = 0.45,95%CI(0.25,0.83),=0.010]、内皮素-1(ET-1)水平[WMD = -11.03,95%CI(-13.92,-8.14),<0.000 01]、高敏C反应蛋白(hs-CRP)[WMD = -1.95,95%CI(-2.57,-1.34),<0.000 01]以及不良反应[RR = 0.20,95%CI(0.05,0.85),=0.030]。GRADE证据质量评级显示证据质量为中等、低或极低。TSA进一步证实了临床疗效。尽管一些结果表明SXBXP对CSF可能有积极作用,但包括报告在内的原始研究质量太差,因此无法证明其益处。仍需要更多高质量研究来进一步证实其疗效和安全性。https://www.crd.york.ac.uk/PROSPERO/,标识符(CRD42022329469)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/07ca/9441803/b82962b17e85/fphar-13-955146-g001.jpg

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