Zhong Yunqing, Wang Xiufeng, Xu Guanglan, Mao Bing, Zhou Wei, Min Jie, Jiang Hongli, Diao Xiang, Fu Juanjuan
Department of Respiratory Medicine, The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine, Nanning, People's Republic of China.
Department of Herpetology, The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine, Nanning, People's Republic of China.
Afr J Tradit Complement Altern Med. 2013 Nov 2;11(1):1-14. eCollection 2014.
Chronic obstructive pulmonary disease (COPD), is a very common disease of respiratory system. An increasing number of clinical trials on Yupingfeng formula in the management of stable COPD have been performed. However, the evidence base for it remains unknown. This review aims at assessing the efficacy, and safety of modified Yupingfeng formula in the treatment of stable COPD through a systematic review of all available randomized controlled trials.
Literature retrieval was conducted using four English databases (CENTRAL, PubMed, EMBASE, and ISI Web of Science), and four Chinese databases (CBM, CNKI, VIP, and WANFANG), from respective inception to January 2013, and supplemented with a manual search. Review authors independently extracted the trial data, and assessed the quality of each trial. Methodological quality was assessed by Cochrane risk of bias and Jadad's scale. The following outcomes were evaluated: (1) lung function; (2) 6-minute walk distance (6MWD); (3) effective rate; (4) serum levels of IgA, IgG and IgE; and (5) adverse events. Data were analyzed using STATA 12.0 software.
A total of nine studies involving 660, stable COPD patients were identified. Patients from all studies included in this review were randomized to receive Yupingfeng formula combined with Western medications in comparison with Western medications. In general, the methodological quality of the included trials was poor. The results of this systematic review indicates that, compared with Western medications alone, the use of Yupingfeng formula, if combined with Western medications could significantly improve FEV1 (WMD = 0.30L; 95%CI: 0.19, 0.42), FEV1/FVC ratio (SMD = 0.69; 95%CI: 0.48, 0.91), 6MWD (WMD = 31.73m; 95% CI: 19.29, 44.17), and effective rate (RR = 1.24; 95% CI: 1.10, 1.41), and increase the serum levels of IgA (WMD = 0.25; 95%CI: 0.16, 0.34) and IgG (WMD = 1.10; 95%CI: 0.53, 1.68), but no difference was found in the serum IgE levels (WMD = 0.47; 95%CI: -0.32, 1.27) between the two groups. No serious adverse events were reported.
Within the limitations of this systematic review, we may conclude that compared with Western medications alone, Yupingfeng formula, when combined with Western medications can provide more benefits for patients with stable COPD, without any serious adverse reactions being identified. However, these benefits need to be further confirmed through high-quality prospective placebo-controlled trials that should be strictly conducted in accordance with methodological principles and procedures.
慢性阻塞性肺疾病（COPD）是一种非常常见的呼吸系统疾病。关于玉屏风配方治疗稳定期COPD的临床试验越来越多。然而，其证据基础仍不清楚。本综述旨在通过对所有可用的随机对照试验进行系统评价，评估改良玉屏风配方治疗稳定期COPD的疗效和安全性。
使用四个英文数据库（CENTRAL、PubMed、EMBASE和ISI Web of Science）和四个中文数据库（CBM、CNKI、VIP和万方）进行文献检索，检索时间从各数据库建库至2013年1月，并辅以手工检索。综述作者独立提取试验数据，并评估每个试验的质量。采用Cochrane偏倚风险和Jadad量表评估方法学质量。评估以下结局：（1）肺功能；（2）6分钟步行距离（6MWD）；（3）有效率；（4）血清IgA、IgG和IgE水平；（5）不良事件。使用STATA 12.0软件进行数据分析。
共纳入9项研究，涉及660例稳定期COPD患者。本综述纳入的所有研究中的患者均被随机分为接受玉屏风配方联合西药治疗与单纯西药治疗进行比较。总体而言，纳入试验的方法学质量较差。本系统评价结果表明，与单纯西药相比，玉屏风配方联合西药可显著改善第一秒用力呼气容积（WMD = 0.30L；95%CI：0.19，0.42）、第一秒用力呼气容积/用力肺活量比值（SMD = 0.69；95%CI：0.48，0.91）、6MWD（WMD = 31.73m；95%CI：19.29，44.17）和有效率（RR = 1.24；95%CI：1.10，1.41），并提高血清IgA（WMD = 0.25；95%CI：0.16，0.34）和IgG（WMD = 1.10；95%CI：0.53，1.68）水平，但两组血清IgE水平无差异（WMD = 0.47；95%CI：-0.32，1.27）。未报告严重不良事件。
在本系统评价的局限性内，我们可以得出结论，与单纯西药相比，玉屏风配方联合西药可为稳定期COPD患者带来更多益处，且未发现任何严重不良反应。然而，这些益处需要通过高质量的前瞻性安慰剂对照试验进一步证实，试验应严格按照方法学原则和程序进行。
