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中药治疗慢性阻塞性肺疾病稳定期随机对照试验的系统评价
引用本文:周维,钟云青,杨红梅,蒋红丽,付娟娟,张文斌,毛兵.中药治疗慢性阻塞性肺疾病稳定期随机对照试验的系统评价[J].中国循证医学杂志,2009,9(3):311-318.
作者姓名:周维  钟云青  杨红梅  蒋红丽  付娟娟  张文斌  毛兵
作者单位:四川大学华西医院中西医结合科,成都,610041
基金项目:国家中医药管理局中医药科学技术研究专项基金 
摘    要:目的评价中药治疗慢性阻塞性肺疾病(COPD)稳定期的临床疗效和安全性。方法计算机检索MEDLINE(1950~2008)、PubMed(1996~2008)、VIP(1989~2008)、万方数据库(1998~2008)、CNKI(1979~2008)、CBM(1978~2008),收集中药治疗慢性阻塞性肺疾病稳定期的随机对照试验(RCT)。按纳入排除标准筛选试验、评价研究质量、提取有效数据,并采用RevMan4.2.7进行统计分析。结果共纳入30个RCT,均以中文发表。结果显示:(1)单纯中药治疗组与空白或安慰剂组比较:①显效率:共纳入3个RCT。有1个RCT结果显示中药治疗组显效率优于空白或安慰剂组。②肺功能:共纳入5个RCT,有2个RCT治疗后两组FEV1%预计值中药治疗组优于空白或安慰剂组。③生存质量:共纳入4个RCT,3个RCT结果显示治疗后中药治疗组生活质量改善优于空白组。(2)单纯中药治疗组与单纯西医治疗组比较:共纳入2个RCT,结果显示两组显效率差异无统计学意义,但文献数量少,尚须进一步评价。(3)中西医结合治疗与单纯西医治疗相比较:①显效率:共纳入11个RCT,3个RCT显示中西结合治疗组显效率高于单纯西医组。②肺功能:共纳入8个RCT,2个RCT结果显示治疗后FEV1%预计值中西医结合治疗组优于单纯西医组。③6min步行距离:共纳入3个RCT,结果均显示中西医结合治疗组优于单纯西医组。④生存质量:共纳入4个RCT,结果显示治疗后中西医结合治疗组均较单纯西医组质量改善。所纳文献均未报道与中药相关的严重不良反应。结论在COPD稳定期治疗中,中药可改善临床症状、提高生活质量,且未见明显不良反应。由于纳入试验方法学质量普遍较低,缺乏一些重要的中间指标和终点指标,尚需进一步开展设计科学、指标合理的随机对照试验。

关 键 词:慢性阻塞性肺疾病  中药  系统评价  随机对照试验

Traditional Chinese Medicine in the Treatment of Chronic Obstructive Pulmonary Disease in Stable Stage: A Systematic Review of Randomized Controlled Trials
ZHOU Wei,ZHONG Yun-qing,YANG Hong-mei,JIANG Hong-li,FU duan-juan,ZHANG Wen-bing,MAO Bing.Traditional Chinese Medicine in the Treatment of Chronic Obstructive Pulmonary Disease in Stable Stage: A Systematic Review of Randomized Controlled Trials[J].Chinese Journal of Evidence-based Medicine,2009,9(3):311-318.
Authors:ZHOU Wei  ZHONG Yun-qing  YANG Hong-mei  JIANG Hong-li  FU duan-juan  ZHANG Wen-bing  MAO Bing
Institution:ZHOU Wei, ZHONG Yun-qing, YANG Hong-mei, JIANG Hong-li, FU Juan-juan, ZHANG Wen-bing, MAO Ring( Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu 610041, China )
Abstract:Objective To evaluate the efficacy and safety of traditional Chinese medicine (TCM) in treating chronic obstructive pulmonary disease (COPD) in a stable stage. Methods We searched MEDLINE (1950 to July 2008), PubMed (1996 to July 2008), VIP (1989 to July 2008), WanFang (1998 to July 2008), CNKI (1979 to July 2008), and CBM (1978 to July 2008)for randomized control trials about TCM to treat stable COPD. Trial screening, quality assessment of included trials, and data extract were conducted. Statistical analysis was conducted by using RevMan 4.2.7 software. Results A total of 30 randomized controlled trials (RCTs) in the Chinese language were identified. No pooled analysis was performed because of the significant heterogeneity among the included trials. (1) For TCM alone versus blank therapy or placebo: 3 RCTs reported the clinical effective rate and only 1 indicated TCM was more effective; 5 RCTs reported forced expiratory volume in one second (FEV1)% after treatment and 2 indicated TCM alone as more effective in improving lung function; 4 RCTs reported quality of life after therapy and 2 indicated TCM alone was more effective in improving quality of life after therapy. (2) For integrated tradtional and western medicine versus western medicine alone: 11 RCTs induded the clinical effective rate, 3 RCTs showed that integrated traditional and western medicine was more effective. Of 8 RCTs reporting FEV1%, 2 RCTs suggested that integrated traditional and western medicine was more effective. There were 3 RCTs studying 6 minute walking distance and 4 RCTs about quality of life, which also showed that integxated traditional and western medicine was more effective. No obvious adverse reaction to TCM was reported. Conclusions The current evidence shows TCM tends to relieve the symptoms and improve quality of life for patients with stable COPD without obvious adverse reaction. Due to the low methodological quality of trials included, more RCTs of high quality and large scale are required.
Keywords:Chronic obstructive pulmonary disease  Traditional Chinese medicine  Meta-analyses  Randomized controlled trials
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