State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao SAR, China.
Evid Based Complement Alternat Med. 2013;2013:282707. doi: 10.1155/2013/282707. Epub 2013 Mar 24.
Objective. The randomized controlled trials (RCTs) on Guanxinning injection (GXN) in treating angina pectoris were published only in Chinese and have not been systematically reviewed. This study aims to provide a PRISMA-compliant and internationally accessible systematic review to evaluate the efficacy of GXN in treating angina pectoris. Methods. The RCTs were included according to prespecified eligibility criteria. Meta-analysis was performed to evaluate the symptomatic (SYMPTOMS) and electrocardiographic (ECG) improvements after treatment. Odds ratios (ORs) were used to measure effect sizes. Subgroup analysis, sensitivity analysis, and metaregression were conducted to evaluate the robustness of the results. Results. Sixty-five RCTs published between 2002 and 2012 with 6064 participants were included. Overall ORs comparing GXN with other drugs were 3.32 (95% CI: [2.72, 4.04]) in SYMPTOMS and 2.59 (95% CI: [2.14, 3.15]) in ECG. Subgroup analysis, sensitivity analysis, and metaregression found no statistically significant dependence of overall ORs upon specific study characteristics. Conclusion. This meta-analysis of eligible RCTs provides evidence that GXN is effective in treating angina pectoris. This evidence warrants further RCTs of higher quality, longer follow-up periods, larger sample sizes, and multicentres/multicountries for more extensive subgroup, sensitivity, and metaregression analyses.
目的。关于冠心宁注射液（GXN）治疗心绞痛的随机对照试验（RCTs）仅以中文发表，尚未进行系统评价。本研究旨在提供符合 PRISMA 标准且国际可获取的系统评价，以评估 GXN 治疗心绞痛的疗效。
方法。根据预设的纳入标准，纳入 RCTs。采用荟萃分析评估治疗后症状（SYMPTOMS）和心电图（ECG）的改善。采用比值比（ORs）衡量效应大小。进行亚组分析、敏感性分析和荟萃回归，以评估结果的稳健性。
结果。纳入了 2002 年至 2012 年间发表的 65 项 RCT，共 6064 名参与者。与其他药物相比，GXN 在 SYMPTOMS 和 ECG 方面的总体 OR 分别为 3.32（95%CI：[2.72, 4.04]）和 2.59（95%CI：[2.14, 3.15]）。亚组分析、敏感性分析和荟萃回归均未发现总体 OR 与特定研究特征存在统计学上的显著依赖性。
结论。对合格 RCTs 的荟萃分析提供了证据表明 GXN 治疗心绞痛有效。该证据需要进一步进行更高质量、更长随访时间、更大样本量以及多中心/多国家的 RCT，以进行更广泛的亚组、敏感性和荟萃回归分析。
