Bu-Fei Yi-Shen granule combined with acupoint sticking therapy in patients with stable chronic obstructive pulmonary disease: A randomized, double-blind, double-dummy, active-controlled, 4-center study
Bu-Fei Yi-Shen granule combined with acupoint sticking therapy in patients with stable chronic obstructive pulmonary disease: A randomized, double-blind, double-dummy, active-controlled, 4-center study
复制标题
DOI：
10.1016/j.jep.2011.08.060
复制
发表时间：
2012-06-01
影响因子：
5.4
通讯作者：
Wang, Yan-Fang
中科院分区：
文献类型：
--
作者：
Li, Jian-Sheng;Li, Su-Yun;Wang, Yan-Fang
民族药理学相关性：补肺益肾冲剂配合穴位贴敷治疗缓解期慢性阻塞性肺疾病(COPD)是治疗慢性阻塞性肺疾病(COPD)稳定期的主要传统干预措施。目的：评价补肺益肾冲剂配合穴位贴敷治疗稳定期慢性阻塞性肺疾病(COPD)的疗效和安全性。方法：采用四中心双盲双模拟随机对照研究方法。将244例患者随机分为治疗组122例，采用补肺益肾颗粒配合舒肺贴压加口服安慰剂缓释茶碱治疗；对照组122例，采用口服缓释茶碱、补肺益肾颗粒配合安慰剂舒肺贴压治疗。观察4个月内患者急性加重的次数和持续时间、肺功能、临床症状、6分钟步行距离、呼吸困难程度和生活质量。结果：221例患者完全完成研究，意向治疗人数2 34人，按方案治疗人数2 2 1人。治疗4个月及随访6个月后，研究组与对照组在急性加重次数(P=0.007，P=0.013；P=0.045，P=0.046)、急性加重持续时间(P=0.030，P=0.005；PP：P=0.048，P=0.006)、症状评分(P=0.000，P=0.000；PP：P=0.000，P=0.000)、6min步行距离(P=0.002，P=0.000)、6min步行距离(P=0.002，P=0.000)、症状评分(P=0.000，P=0.000)、6min步行距离(P=0.002，P=0.000)、6min步行距离(P=0.002，P=0.000)、症状评分(P=0.000，P=0.000)、6min步行距离(P=0.002，P=0.000)、6min步行距离(P=0.002，P=0.000)、症状评分(P=0.000，P=0.000)、6min步行距离(P=0.002，P=0.002，P=0.000)、症状评分(P=0.000，P=0.000)、6min步行距离(P=0.002，P=0.002，P=0.000)、症状呼吸困难分级(ITT：P=0.014，P=0.009；PP：P=0.018，P=0.012)；生理方面(ITT：P=0.003，P=0.000；PP：P=0.001)。WHOQOL-BREF问卷的心理方面(P=0.000)、心理方面(P=0.007，P=0.001；P=0.001，P=0.000)和环境方面(P=0.003，P=0.000；P=0.001，P=0.000)。两组FVC、FEV1、FEV1%及不良事件发生率差异无统计学意义。结论：补肺益肾颗粒配合穴位贴敷治疗稳定期COPD患者治疗4个月及随访6个月以上各项指标均有良好疗效，不良事件组间差异无统计学意义。(C)2011爱思唯尔爱尔兰有限公司。保留所有权利。
Ethnopharmacological relevance: Bu-Fei Yi-Shen granule combined with acupoint sticking therapy has been used in the patients with stable chronic obstructive pulmonary disease (COPD) as major traditional interventions for the treatment of the disease.Aim of the study: The objective of this study was to evaluate the efficacy and safety of traditional Chinese herbal medicine, the Bu-Fei Yi-Shen granule combined with acupoint sticking therapy in patients with stable COPD.Methods: A 4-center, double-blinded, double-dummy and randomized controlled method was conducted. 244 patients who were divided into the trial group (n=122, treated with Bu-Fei Yi-Shen granule combined with Shu-Fei Tie acupoint sticking therapy and oral placebo sustained-release theophylline) and the control group (n=122, treated with oral sustained-release theophylline and placebo Bu-Fei Yi-Shen granule combined with placebo Shu-Fei Tie acupoint sticking therapy). The frequency and duration of acute exacerbation, lung function, clinical symptoms, six-minute walking distance, dyspnea grade and quality of life were observed during the 4-month treatment period, and for a further 6 months follow-up.Results: Two hundred and twenty one patients fully completed the study, intent-to-treat (ITT) population was 234 and per-protocol (PP) population was 221. After treatment for 4 months and follow-up for 6 months, there were differences between the experimental and control group in frequency of acute exacerbation (ITT: P=0.007 P=0.013; PP: P=0.045, P=0.046); duration of acute exacerbation (ITT: P=0.030, P=0.005; PP: P=0.048, P=0.006); scores of symptoms (ITT: P=0.000, P=0.000; PP: P=0.000, P=0.000): six-minute walking distance (ITT: P=0.002, P=0.001; PP: P=0.002, P=0.001); dyspnea grade (ITT: P=0.014, P=0.009; PP: P=0.018, P=0.012); physiological aspects (ITT: P=0.003, P=0.000; PP: P=0.001. P=0.000); psychological aspects (ITT: P=0.007, P=0.001; PP: P=0.001, P=0.000) and environment aspects (ITT: P=0.003, P=0.000; PP: P=0.001, P=0.000) of the WHOQOL-BREF questionnaire. There were no differences between the experimental and control group in FVC, FEV1 and FEV1% and adverse events.Conclusions: Bu-Fei Yi-Shen granule combined with acupoint sticking therapy showed beneficial effects for patients with stable COPD in the measured parameters over the 4-month treatment period and 6 months follow-up, with no relevant between-group differences in adverse events. (C) 2011 Elsevier Ireland Ltd. All rights reserved.