郑文江,彭紫荆,严倩,张超源,刘碧娥,洪榆,刘小虹
ZHENG Wen-jiang,PENG Zi-jing,YAN Qian,ZHANG Chao-yuan,LIU Bi-e,HONG Yu,LIU Xiao-hong

• 1:广州中医药大学第一临床医学院
• 2:广州中医药大学针灸康复临床医学院
• 3:广州中医药大学第一附属医院

摘要(Abstract)：

电子检索中国学术期刊全文数据库(CNKI)、PubMed等7大中英文数据库,检索时间限定为自建库至2018年12月5日,检出所有桑白皮汤加减治疗慢性阻塞性肺疾病急性加重期(AECOPD)患者(试验组)的临床随机对照试验(RCTs),由2名研究员各自独立严格按照纳入和排除标准进行纳入研究的质量评价和资料提取,用Stata/SE 14. 0进行Meta分析、TSA0. 9. 5. 10 Beta软件进行试验序贯分析,系统评价桑白皮汤加减治疗AECOPD患者的临床疗效和安全性。共纳入25个RCT包括1 784例患者。Meta分析:与对照组相比,试验组在改善AECOPD患者的临床症状方面优于对照组(RR=1. 18,95%CI[1. 13,1. 22],P=0);在肺功能方面,改善第1秒用力呼气量(FEV1)(WMD=0. 44,95%CI[0. 01,0. 87],P=0. 046)和用力肺活量(FVC)(WMD=0. 14,95%CI[0. 07,0. 22],P=0),但对FEV1占预计值的百分比(FEV1%)(P=0. 067)、第1秒用力呼吸容积占用力肺活量百分比(FEV1/FVC)(P=0. 238)则无统计学差异;提高患者动脉血氧分压(PaO2)(SMD=0. 85,95%CI[0. 41,1. 30],P=0)、降低二氧化碳分压(PaCO2)(SMD=-0. 94,95%CI[-1. 70,-0. 18],P=0. 016);在感染指标方面,改善白细胞计数(WBC)(WMD=-0. 94,95%CI[-1. 17,-0. 70],P=0);同时,试验组的不良反应较少且无严重不良反应事件。试验序贯分析(TSA)显示临床有效率累积纳入的研究穿过了传统界值和TSA界值,表明试验组的临床疗效得到进一步肯定。研究表明,在常规西医治疗基础上联合桑白皮汤加减治疗AECOPD患者,可提高临床疗效、提高PaO2、降低PaCO2、安全性较好,在改善肺功能方面疗效欠佳。该研究受纳入研究质量的限制,所得结论尚需要更多高质量RCT进一步验证。
The randomized controlled trials about modified Sangbaipi Decoction in the treatment of acute exacerbation of chronic obstructive pulmonary disease( AECOPD) patients were collected from 7 databases( PubMed,CNKI,et al) from the establishment to December 5,2018. All the studies searched were strictly evaluated. Literatures were independently screened by two researchers according to the inclusion and exclusion criteria,and the methodological quality of included studies was evaluated. To systematically review the efficacy of modified Sangbaipi Decoction in 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 25 RCTs involving 1 784 patients were included. According to the results of Meta-analysis,compared with the control groups,the trial group had a higher clinical efficacy in AECOPD patients( RR =1. 18,95%CI[1. 13,1. 22],P = 0),improved pulmonary functions including forced expiratory volume in one second( FEV1,WMD =0. 44,95%CI[0. 01,0. 87],P = 0. 046),and the forced vital capacity( FVC,WMD = 0. 42,95%CI[0. 07,0. 22],P = 0),but no statistical significance in the percentage of forced expiratory volume in one second( FEV1%,P = 0. 067) and the first seconds breathing volume percentage of forced vital capacity( FEV1/FVC,P = 0. 238); it improved the arterial oxygen partial pressure( PaO2,SMD =0. 85,95%CI[0. 41,1. 30],P = 0) and decreased the arterial partial pressure of carbon dioxide( PaCO2,SMD =-0. 94,95% CI[-1. 70,-0. 18],P= 0. 016); and in terms of inflammatory markers,it improved the white blood cell count( WBC,WMD=-0. 94,95%CI[-1. 17,-0. 70],P = 0). The trial sequential analysis showed that the studies included with the improvement of clinical efficacy had passed the conventional and TSA threshold,so as to further confirm the evidence. According to the findings,in addition to conventional Western medicine treatment,modified Sangbaipi Decoction could improve the efficiency in treating acute exacerbation patients with chronic obstructive pulmonary disease,increase PaO2,and decrease PaCO2,with a high safety but no effect on pulmonary function. However,restricted by the low quality of studies included,this conclusion shall be further verified by more high-quality clinical trials.

关键词(KeyWords)： 桑白皮汤;加减;慢性阻塞性肺疾病;急性加重期;Meta分析;试验序贯分析
Sangbaipi Decoction;modified;chronic obstructive pulmonary disease;acute exacerbation;Meta-analysis;trial sequential analysis

Abstract:

Keywords:

基金项目(Foundation): 广东省中医药局名优中成药二次开发项目(粤中医办函20174007);; 刘小虹广东省名中医传承工作室建设项目(粤中医办函[2018]5)

作者(Author): 郑文江,彭紫荆,严倩,张超源,刘碧娥,洪榆,刘小虹
ZHENG Wen-jiang,PENG Zi-jing,YAN Qian,ZHANG Chao-yuan,LIU Bi-e,HONG Yu,LIU Xiao-hong

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