补肺益肾颗粒联合穴位贴敷疗法对稳定期慢性阻塞性肺疾病患者生活质量的影响。

Effectiveness of Bufei Yishen Granule combined with acupoint sticking therapy on quality of life in patients with stable chronic obstructive pulmonary disease.

机构信息

Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.

出版信息

Chin J Integr Med. 2013 Apr;19(4):260-8. doi: 10.1007/s11655-013-1438-2. Epub 2013 Apr 2.

DOI:10.1007/s11655-013-1438-2

PMID:23546629

Abstract

OBJECTIVE

To evaluate the efficacy of Bufei Yishen Granule BFYSG) combined with Shufei Tie acupoint sticking therapy on quality of life of patients with stable chronic obstructive pulmonary disease (COPD).

METHODS

A multi-center, double-blinded, double-dummy and randomized controlled method was adopted in this trial. A total of 244 patients were randomly assigned to a trial group and a control group according to the random number, each with 122 patients; treatment allocation occurred when the participants met the inclusion criteria and signed the informed consent form. In the trial group, patients were treated with BFYSG combined with "Shufei Tie" acupoint sticking therapy and sustained-release theophylline dummy, and in the control group patients were treated with oral sustained-release theophylline and BFYSG dummy combined with "Shufei Tie" acupoint sticking therapy dummy. The therapeutic course for two groups was 4 months and the follow-up was 6 months. The frequency and duration of acute exacerbation calculated by adding up each frequency and duration of acute exacerbation in treatment and follow-up time respectively, the quality of life measured by the World Health Organization Quality of Life (WHOQOL)-BREF scale and adult COPD quality of life (COPD-QOL) scale were observed.

RESULTS

Among the 244 enrolled patients, 234 were screened for full analysis set (FAS); 221 were screened for per-protocol analysis set (PPS). After 4-month treatment and 6-month follow-up there were differences between the trial group and the control group in frequency of acute exacerbation (FAS: P=0.013; PPS: P=0.046); duration of acute exacerbation (FAS: P=0.005; PPS: P=0.006); scores of physiological, psychological and environment aspects of the WHOQOL-BREF questionnaire (FAS: P=0.002, P=0.006, P=0.000; PPS: P=0.00, P=0.001, P=0.000); scores of daily living ability, social activity, depression symptoms aspects of the COPD-QOL questionnaire (FAS: P=0.000, P=0.000, P=0.006; PPS: P=0.002, P=0.001, P=0.001).

CONCLUSION

BFYSG combined with acupoint sticking therapy could improve the quality of life of patients with stable COPD.

摘要

目的

评价补肺益肾颗粒（BFYSG）联合舒肺贴膏穴位贴敷疗法对稳定期慢性阻塞性肺疾病（COPD）患者生活质量的影响。

方法

本研究采用多中心、双盲、双模拟、随机对照的方法，将 244 例患者按照随机数字表法分为试验组和对照组，每组 122 例；当患者符合纳入标准并签署知情同意书后，即进行分配处理。试验组给予 BFYSG 联合舒肺贴膏穴位贴敷疗法及茶碱控释片治疗，对照组给予茶碱控释片联合 BFYSG 模拟剂及舒肺贴膏穴位贴敷疗法模拟剂，两组疗程均为 4 个月，随访 6 个月。分别统计两组患者在治疗及随访时间内每次急性加重的频率和持续时间，计算急性加重的总频率和总持续时间，采用世界卫生组织生存质量测定量表简表（WHOQOL-BREF）和成人慢性阻塞性肺疾病生存质量量表（COPD-QOL）评价患者的生活质量。

结果

纳入的 244 例患者中，234 例进入全分析集（FAS），221 例进入符合方案集（PPS）。经过 4 个月的治疗和 6 个月的随访，试验组与对照组比较，急性加重的总频率（FAS：P=0.013；PPS：P=0.046）、总持续时间（FAS：P=0.005；PPS：P=0.006）、WHOQOL-BREF 问卷生理、心理、环境领域评分（FAS：P=0.002、P=0.006、P=0.000；PPS：P=0.00、P=0.001、P=0.000）、COPD-QOL 问卷日常生活能力、社会活动、抑郁症状领域评分（FAS：P=0.000、P=0.000、P=0.006；PPS：P=0.002、P=0.001、P=0.001）差异均有统计学意义。