“补肺益肾方联合穴位贴敷治疗慢性阻塞性肺疾病稳定期患者的多中心随机、双盲、阳性药平行对照临床试验”的研究方案（英文）

背景：慢性阻塞性肺疾病（chronic obstructive pulmonary disease,COPD）是一种严重危害公众健康的疾病,加强COPD防治的临床研究已成为重要的研究内容。中医药治疗COPD具有明显的特色和优势,能够改善患者的症状和体征,减少急性加重次数,提高生存质量。因此,在补肺益肾方或＂舒肺贴＂穴位贴敷单一干预措施研究的基础上,本试验旨在研究两种干预措施联合使用对COPD稳定期患者的疗效。方法与设计：采用多中心、随机、双盲、阳性药平行对照的临床试验方法,以COPD稳定期患者为研究对象,治疗4个月,随访6个月。观察研究方案实施前后患者急性加重次数及持续时间、肺功能、临床症状、6分钟步行距离、呼吸困难分级和生存质量等指标的变化,并进行随访,以评价研究方案的有效性和安全性。讨论：本次试验研究补肺益肾方联合穴位贴敷综合干预措施对COPD患者的疗效和安全性,为制定适合COPD患者的中医干预方案提供临床依据。

Bufei Yishen Granule combined with acupoint-sticking therapy in patients with stable chronic obstructive pulmonary disease: study protocol of a multicenter, randomized, double-blind, active-controlled trial

Background: Chronic obstructive pulmonary disease (COPD) is a serious disease constituting a major threat to public health.Current popularity of traditional Chinese medicine (TCM) in treating COPD implies its potential advantage in improving symptoms,reducing the frequency of acute exacerbation and improving the patients' quality of life.This study is to evaluate the efficacy and safety of a comprehensive intervention,Bufei Yishen Granule combined with acupoint-sticking therapy,in patients with stable COPD.Methods and design: A multicenter,double-blind,double-dummy and randomized controlled design will be adopted.A total of 244 cases meeting the inclusion criteria will be enrolled into this study with 122 cases in the trial group and 122 in the control group,respectively.Patients in the trial group will receive Bufei Yishen Granule combined with acupoint-sticking therapy and dummy sustained-release theophylline,while patients in the control group will receive sustainedrelease theophylline and dummy Bufei Yishen Granule combined with dummy acupoint-sticking therapy.The frequency and duration of acute exacerbation,lung function,clinical symptoms,six-minute walking distance,dyspnea grade and quality of life will be observed during a fourmonth treatment period and a further six-month follow-up.Discussion: It is hypothesized that Bufei Yishen Granule combined with acupoint-sticking therapy will have beneficial effects in reducing the frequency and duration of acute exacerbation,ameliorating the symptoms,and improving the quality of life of patients with stable COPD.The results of this study will provide evidence for developing a TCM-based regimen for patients with COPD.Trial registration: ChiCTR-TRC-11001409.