Zheng Wen-Jiang, Peng Zi-Jing, Chen Shu-Wan, Hong Yu, Huang Hui-Ting, Liao Hui-Li, Liu Xiao-Hong
the First Clinical College,Guangzhou University of Chinese Medicine Guangzhou 510405,China.
the First Affiliated Hospital,Guangzhou University of Chinese Medicine Guangzhou 510405,China.
Zhongguo Zhong Yao Za Zhi. 2019 May;44(10):2171-2178. doi: 10.19540/j.cnki.cjcmm.20190122.001.
The randomized controlled trials( RCTs) about modified Sanzi Yangqin Decoction in the treatment of patients with exacerbation of chronic obstructive pulmonary disease( AECOPD) were collected from 7 databases( PubMed,CNKI,etc.) till December25,2018 from their inception. All the studies searched were strictly evaluated and independently screened by two researchers according to the inclusion and exclusion criteria,and the methodological quality of included studies was evaluated. In order to systematically review the efficacy and safety of modified Sanzi Yangqin Decoction for treating AECOPD,the Meta-analysis and trial sequential analysis were conducted by using Stata/SE 14. 0 and TSA 0. 9. 5. 10 Beta,respectively. A total of 22 RCTs involving 2 012 patients were included. The results of Meta-analysis suggested that: as compared with the control group,the clinical symptoms in AECOPD patients were improved( RR = 1. 19,95%CI[1. 15,1. 24],P = 0); the pulmonary functions including forced expiratory volume in one second( FEV_1)( SMD= 0. 96,95%CI[0. 39,1. 52],P= 0. 001),the percentage of forced expiratory volume in one second( FEV_1%)( SMD =0. 80,95%CI[0. 20,1. 41],P = 0. 009),forced vital capacity( FVC)( SMD = 0. 69,95% CI[0. 06,1. 31],P = 0. 032),first seconds breathing volume percentage of forced vital capacity( FEV_1/FVC) were improved( SMD = 0. 81,95%CI[0. 64,0. 97],P = 0);the arterial oxygen partial pressure( PaO_2) was improved( SMD= 0. 87,95%CI[0. 41,1. 32],P= 0); the arterial partial pressure of carbon dioxide( PaCO_2) was decreased( SMD =-0. 91,95%CI[-1. 33,-0. 49],P = 0) in the trial group. In addition,the incidence of adverse reactions in the experimental group was low,and there were no serious adverse events. The trial sequential analysis( TSA) showed that the studies included in the improvement of clinical efficacy had passed the conventional and TSA threshold at the same time,further confirming the efficacy of trial group. This research showed that,conventional Western medicine treatment,combined with modified Sanzi Yangqin Decoction in treating acute exacerbation patients with chronic obstructive pulmonary disease could improve the clinical efficiency and pulmonary functions,improve the PaO_2,decrease the PaCO_2,with a high safety. However,the quality of existing research is low,requiring more high quality clinical trials for further validation.
从7个数据库（PubMed、中国知网等）建库至2018年12月25日，收集关于三子养亲汤加味治疗慢性阻塞性肺疾病急性加重期（AECOPD）患者的随机对照试验（RCT）。由两名研究人员根据纳入和排除标准对检索到的所有研究进行严格评估和独立筛选，并对纳入研究的方法学质量进行评价。为系统评价三子养亲汤加味治疗AECOPD的有效性和安全性，分别采用Stata/SE 14.0和TSA 0.9.5.10 Beta软件进行Meta分析和试验序贯分析。共纳入22项RCT，涉及2 012例患者。Meta分析结果显示：与对照组相比，AECOPD患者的临床症状得到改善（RR = 1.19，95%CI[1.15，1.24]，P = 0）；肺功能指标一秒用力呼气容积（FEV_1）（SMD = 0.96，95%CI[0.39，1.52]，P = 0.001）、一秒率（FEV_1%）（SMD = 0.80，95%CI[0.20，1.41]，P = 0.009）、用力肺活量（FVC）（SMD = 0.69，95%CI[0.06，1.31]，P = 0.032）、一秒率（FEV_1/FVC）均得到改善（SMD = 0.81，95%CI[0.64，0.97]，P = 0）；动脉血氧分压（PaO_2）得到改善（SMD = 0.87，95%CI[0.41，1.32]，P = 0）；动脉血二氧化碳分压（PaCO_2）降低（SMD = -0.91，95%CI[-1.33，-0.49]，P = 0）。此外，试验组不良反应发生率低，未发生严重不良事件。试验序贯分析（TSA）显示，在改善临床疗效方面纳入的研究同时通过了传统和TSA界值，进一步证实了试验组的疗效。本研究表明，在常规西医治疗基础上，加用三子养亲汤治疗慢性阻塞性肺疾病急性加重期患者，可提高临床疗效和改善肺功能，提高PaO_2，降低PaCO_2，安全性高。然而，现有研究质量较低，需要更多高质量的临床试验进一步验证。
