Chen Yuanbin, Shergis Johannah Linda, Wu Lei, Yu Xuhua, Zeng Qigang, Xu Yinji, Guo Xinfeng, Zhang Anthony Lin, Xue Charlie Changli, Lin Lin
Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, Guangdong Province, China; Department of Respiratory Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, Guangdong Province, China.
China-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Melbourne, Australia.
Complement Ther Med. 2016 Dec;29:94-108. doi: 10.1016/j.ctim.2016.09.017. Epub 2016 Sep 15.
To systematically evaluate the efficacy and safety of Buzhong Yiqi Tang (BZYQT) for stable chronic obstructive pulmonary disease (COPD).
Three electronic English databases (PubMed, EMBASE and CENTRAL) and four Chinese databases (CBM, CNKI, CQVIP and WFMO) were searched from their inceptions until 30th June 2016. Participants were diagnosed with COPD according to the Chinese Medical Association's COPD diagnosis and treatment guidelines or Global Initiative for Chronic Obstructive Lung Disease (GOLD), and were in stable stage. Randomized controlled trials (RCTs) of oral BZYQT, alone or combined with conventional treatment, compared with conventional treatment alone or plus placebo were included in the review. Clinical improvement and the six-minute walking test (6MWT) were the primary outcome measures. The secondary outcome measures were defined as forced expiratory volume in one second (FEV1), forced vital capacity (FVC), respiratory muscle strength index with maximum inspiratory pressure (MIP), COPD Assessment Test (CAT), and frequency of acute exacerbations. To assess risk of bias the Cochrane, Risk of Bias tool was used, and statistical analysis was performed using RevMan 5.3.0 software.
Sixteen studies (1400 participants) were included. The results of meta-analysis indicated patients receiving BZYQT alone or BZYQT in combination with conventional treatment showed a significant increase in clinical improvement (RR 1.25, 95% CI 1.18 to 1.33, I=0%), enhanced exercise capacity 6MWT (MD 51.22m, 95% CI 45.56 to 56.89, I=44%), improved lung function FVC (L) (MD 0.26 liters, 95% CI 0.18 to 0.33, I=37%), reduced respiratory muscle fatigue MIP (MD 0.46 liters, 95% CI 0.11 to 0.80, I=0%), and improved quality of life CAT (MD -2.56 points, 95% CI -3.40 to -1.72, I=0%) when compared with conventional treatment alone, or plus placebo. BZYQT also showed small but significant improvements in FEV1% and decreased acute exacerbations of COPD. Four studies reported that no adverse events occurred, other studies did not mention adverse events. The finding should be considered with caution because the included studies had methodological shortfalls.
BZYQT improves clinically important outcomes for patients with stable COPD, such as improved clinical symptoms, exercise capacity, lung function and quality of life. Moreover, it has an excellent safety profile. However further evaluation is needed to validate these preliminary findings in high quality RCTs.
系统评价补中益气汤（BZYQT）治疗稳定期慢性阻塞性肺疾病（COPD）的疗效和安全性。
检索3个英文电子数据库（PubMed、EMBASE和CENTRAL）以及4个中文数据库（CBM、CNKI、CQVIP和WFMO），检索时间从建库至2016年6月30日。根据中华医学会COPD诊断与治疗指南或慢性阻塞性肺疾病全球倡议（GOLD），纳入诊断为COPD且处于稳定期的患者。本综述纳入口服BZYQT单独治疗或联合常规治疗，与单独常规治疗或加用安慰剂进行比较的随机对照试验（RCT）。临床改善情况和6分钟步行试验（6MWT）为主要结局指标。次要结局指标定义为1秒用力呼气容积（FEV1）、用力肺活量（FVC）、最大吸气压呼吸肌力量指数（MIP）、慢性阻塞性肺疾病评估测试（CAT）以及急性加重发作频率。采用Cochrane偏倚风险工具评估偏倚风险，并使用RevMan 5.3.0软件进行统计分析。
共纳入16项研究（1400名参与者）。Meta分析结果表明，单独接受BZYQT治疗或BZYQT联合常规治疗的患者，与单独常规治疗或加用安慰剂相比，临床改善情况显著增加（RR 1.25，95%CI 1.18至1.33，I=0%），运动能力6MWT增强（MD 51.22m，95%CI 45.56至56.89, I=44%），肺功能FVC（L）改善（MD 0.26升，95%CI 0.18至0.33，I=37%），呼吸肌疲劳MIP降低（MD 0.46升，95%CI 0.11至0.80，I=0%），生活质量CAT改善（MD -2.56分，95%CI -3.40至-1.72，I=0%）。BZYQT在FEV1%方面也显示出虽小但显著的改善，并减少了COPD的急性加重发作。4项研究报告未发生不良事件，其他研究未提及不良事件。由于纳入研究存在方法学缺陷，该研究结果应谨慎看待。
补中益气汤可改善稳定期COPD患者的重要临床结局，如改善临床症状、运动能力、肺功能和生活质量。此外，其安全性良好。然而，需要进一步评估以在高质量RCT中验证这些初步发现。
