Effects of comprehensive therapy based on traditional Chinese medicine patterns in stable chronic obstructive pulmonary disease: a four-center, open-label, randomized, controlled study.
Effects of comprehensive therapy based on traditional Chinese medicine patterns in stable chronic obstructive pulmonary disease: a four-center, open-label, randomized, controlled study.
复制标题
中医辨证综合疗法治疗稳定期慢性阻塞性肺疾病的四中心、开放、随机、对照研究
DOI：
10.1186/1472-6882-12-197
复制
发表时间：
2012-10-29
影响因子：
--
通讯作者：
Pan YC
中科院分区：
文献类型：
--
作者：
Li SY;Li JS;Wang MH;Xie Y;Yu XQ;Sun ZK;Ma LJ;Zhang W;Zhang HL;Cao F;Pan YC
研究背景中医药治疗慢性阻塞性肺疾病（COPD）已有多年历史。本研究旨在评价以三种常见中医证型为基础的综合疗法治疗稳定期COPD患者的疗效和安全性。将352例患者随机分为治疗组（n= 176）和对照组（n= 176），治疗组采用西医常规治疗，对照组采用西医常规治疗，治疗组根据中医证型分别给予补肺健脾颗粒、补肺益肾颗粒、益气滋肾颗粒。在6个月的治疗期间和12个月的随访中观察急性加重的频率和持续时间、肺功能、临床症状、6分钟步行距离（6 MWD）、呼吸困难量表和生活质量。全分析集（FAS）人群为350例，符合方案分析集（PPS）人群为306例。治疗6个月及随访12个月后，试验组与对照组在以下方面存在显著差异：急性加重频率（FAS：P = 0.000; PPS：P = 0.000）;急性加重持续时间（FAS：P = 0.000; PPS：P = 0.001）; FEV1（FAS：P = 0.007; PPS：P = 0.008）;症状（FAS：P = 0.001; PPS：P = 0.001）; 6MWD（FAS：P = 0.045; PPS：P = 0.042）;呼吸困难量表（FAS：P = 0.002; PPS：P = 0.004）;和物理域（FAS：P = 0.000; PPS：P = 0.000），心理领域WHOQOL-BREF问卷的社会领域（FAS：P = 0.008; PPS：P = 0.011）、社会领域（FAS：P = 0.001; PPS：P = 0.000）和环境领域（FAS：P = 0.015; PPS：P = 0.009）。结论补肺健脾颗粒、补肺益肾颗粒、益气滋肾颗粒对COPD稳定期患者的临床疗效有明显的改善作用，且治疗6个月及随访12个月时疗效较好。试验注册本试验在中国临床试验注册中心注册，ChiCTR-TRC-11001406。
BackgroundTraditional Chinese medicine (TCM) has been used to treat chronic obstructive pulmonary disease (COPD) for many years. This study aimed to evaluate the efficacy and safety of the comprehensive therapy based on the three common TCM patterns in stable COPD patients.MethodsA four-center, open-label randomized controlled method was conducted. A total of 352 patients were divided into the trial group (n= 176, treated with conventional Western medicine and Bu-Fei Jian-Pi granules, Bu-Fei Yi-Shen granules, and Yi-Qi Zi-Shen granules based on the TCM patterns respectively) and the control group (n= 176, treated with conventional Western medicine). The frequency and duration of acute exacerbation, lung function, clinical symptoms, 6-minute walking distance (6MWD), dyspnea scale and quality of life were observed during a 6-month treatment period and at a further 12-month follow-up.ResultsA total of 306 patients completed the study fully. The full analysis set (FAS) population was 350 and the per-protocol analysis set (PPS) population was 306. After the 6-month treatment and 12-month follow-up, there were significant differences between the trial and control group in the following: frequency of acute exacerbation (FAS: P = 0.000; PPS: P = 0.000); duration of acute exacerbation (FAS: P = 0.000; PPS: P = 0.001); FEV1 (FAS: P = 0.007; PPS: P = 0.008); symptoms (FAS: P = 0.001; PPS: P = 0.001); 6MWD (FAS: P = 0.045; PPS: P = 0.042); dyspnea scale (FAS: P = 0.002; PPS: P = 0.004); and physical domain (FAS: P = 0.000; PPS: P = 0.000), psychological domain (FAS: P = 0.008; PPS: P = 0.011), social domain (FAS: P = 0.001; PPS: P = 0.000) and environment domain (FAS: P = 0.015; PPS: P = 0.009) of the WHOQOL-BREF questionnaire. There were no differences between the trial and control group in FVC, FEV1% and adverse events.ConclusionsBased on the TCM patterns, Bu-Fei Jian-Pi granules, Bu-Fei Yi-Shen granules and Yi-Qi Zi-Shen granules have beneficial effects on measured outcomes in stable COPD patients over the 6-month treatment and 12-month follow-up, with no relevant between-group differences in adverse events.Trial RegistrationThis trial was registered at Chinese Clinical Trial Register Center, ChiCTR-TRC-11001406.
登录
查看更多内容
影响因子：
168.9
作者：
Lin, Hsien-Ho;Murray, Megan;Cohen, Ted;Colijn, Caroline;Ezzati, Majid
通讯作者：
Ezzati, Majid
影响因子：
24.3
作者：
Bourbeau, J.;Ford, G.;Ruberto, G.
通讯作者：
Ruberto, G.
影响因子：
105.7
作者：
FLETCHER, CM;ELMES, PC;WOOD, CH
通讯作者：
WOOD, CH
影响因子：
39.2
作者：
Qaseem, Amir;Wilt, Timothy J.;Shekelle, Paul
通讯作者：
Shekelle, Paul
影响因子：
158.5
作者：
Celli, BR;Cote, CG;Cabral, HJ
通讯作者：
Cabral, HJ