炙甘草汤联合美托洛尔治疗心律失常的随机对照试验：系统评价与Meta分析
Randomized Controlled Trials of Zhigancao Decoction Combined With Metoprolol in the Treatment of Arrhythmia: A Systematic Review and Meta-Analysis.
作者信息
Yang Yan, Ge Fei-Lin, Huang Qian, Zeng Rui, Zhang Xin-Yue, Liu Ping, Luo Gang, Yang Si-Jin, Sun Qin
机构信息
Integrated Chinese and Western Medicine School, Southwest Medical University, Luzhou, China.
School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, China.
出版信息
Front Cardiovasc Med. 2022 Feb 23;9:795903. doi: 10.3389/fcvm.2022.795903. eCollection 2022.
OBJECTIVE
Cardiac arrhythmia remains a major public health problem worldwide. Combinations of traditional medicine (TM) and conventional medicine (CM) have been used for arrhythmia treatment, yet the effectiveness and safety of many TM preparations can be controversial. We analyzed the safety and effectiveness of Zhigancao decoction (ZGCD) combined with metoprolol for arrhythmia treatment.
METHODS
Systematic searches for randomized clinical trials (RCTs) were conducted in eight databases (January 2010-September 2020) without language restrictions. According to the Cochrane system evaluation method, the overall effectiveness and safety were evaluated by meta-analysis using Review Manager software (version 5.3), and publication bias was qualitatively analyzed using STATA 12.0.
RESULTS
A total of 39 RCTs were incorporated, including 4,260 patients with arrhythmia, with 2,133 patients in the experimental group (ZGCD + metoprolol, ZGCD + BB) and 2,127 patients in the control group (metoprolol only, BB). Meta-analysis revealed that compared with BB, ZGCD + BB could significantly increase the total efficacy (OR = 4.74, 95% CI: 3.78-5.94, < 0.01) and lower the incidences of arrhythmia (MD = -3.39, 95% CI: -4.09 to -2.68, < 0.01). Moreover, mean HR reductions were reported in patients receiving ZGCD + BB the ZGCD + BB group (MD = -8.48, 95% CI: -10.98 to -5.97, < 0.01) and a decrease in TCM symptoms were reported also (MD = -2.92, 95% CI: -3.08 to -2.76, < 0.01). The incidence of adverse events was lower in patients treated with ZGCD + BB (RR = 0.36, 95% CI: 0.26-0.51, < 0.01). These results appeared consistent across common arrhythmias. Nevertheless, the majority of included studies were unable to be formally assessed for bias, and funnel-plot analysis implied a moderate risk of publication bias.
CONCLUSION
ZGCD + BB appeared to demonstrate good efficacy and fewer adverse reactions compared to BB in the treatment of arrhythmia, and this may represent a useful complementary therapy. However, our findings must be cautiously evaluated because of the small sample size and low quality of the clinic trials cited in the review. Rigorous and large-scale RCTs are warranted in the future to confirm these results.
SYSTEMATIC REVIEW REGISTRATION
目的
心律失常仍是全球主要的公共卫生问题。传统医学（TM）与传统西医（CM）联合用于心律失常的治疗，但许多传统医学制剂的有效性和安全性仍存在争议。我们分析了炙甘草汤（ZGCD）联合美托洛尔治疗心律失常的安全性和有效性。
方法
在八个数据库（2010年1月至2020年9月）中进行系统检索，纳入无语言限制的随机临床试验（RCT）。根据Cochrane系统评价方法，使用Review Manager软件（5.3版）通过Meta分析评估总体有效性和安全性，并使用STATA 12.0对发表偏倚进行定性分析。
结果
共纳入39项RCT，包括4260例心律失常患者，其中试验组（ZGCD+美托洛尔，ZGCD+β受体阻滞剂）2133例，对照组（仅美托洛尔，β受体阻滞剂）2127例。Meta分析显示，与β受体阻滞剂相比，ZGCD+β受体阻滞剂可显著提高总有效率（OR=4.74，95%CI：3.78-5.94，P<0.01），并降低心律失常的发生率（MD=-3.39，95%CI：-4.09至-2.68，P<0.01）。此外，ZGCD+β受体阻滞剂组患者的平均心率降低（MD=-8.48，95%CI：-10.98至-5.97，P<0.01），中医症状也有所减轻（MD=-2.92，95%CI：-3.08至-2.76，P<0.01）。ZGCD+β受体阻滞剂治疗患者的不良事件发生率较低（RR=0.36，95%CI：0.26-0.51，P<0.01）。这些结果在常见心律失常中似乎是一致的。然而，大多数纳入研究无法进行正式的偏倚评估，漏斗图分析表明存在中度发表偏倚风险。
结论
与β受体阻滞剂相比，ZGCD+β受体阻滞剂在治疗心律失常方面似乎具有良好的疗效且不良反应较少，这可能是一种有用的辅助治疗方法。然而，由于本综述中引用的临床试验样本量小且质量低，我们的研究结果必须谨慎评估。未来有必要进行严格的大规模RCT以证实这些结果。
系统评价注册
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