慢性阻塞性肺疾病稳定期疗效评价指标体系验证研究  

A Validation Study on Clinical Evaluation Index System for Chronic Obstructive Pulmonary Disease Stabilization Period

作　　者：王明航[1] 李素云[1] 李建生[1,2] 余学庆[1] 

机构地区：[1]河南中医学院第一附属医院,河南省郑州市人民路19号450000 [2]河南中医学院老年医学研究所

出　　处：《中医杂志》2013年第20期1742-1746,1750,共6页Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金资助项目(81102665);国家中医临床研究基地科研专项资助项目(JDZX2012030);河南省科技攻关计划资助项目(112102310148);河南省教育厅科技攻关计划资助项目(2011B360009);河南省高校科技创新人才支持计划资助项目(13HASTIT028);河南中医学院科技创新人才支持计划资助项目(2012XCXRC01)

摘　　要：目的验证并评价慢性阻塞性肺疾病(COPD)稳定期的疗效评价指标体系。方法将306例COPD稳定期患者随机分为试验组155例和对照组151例。对照组给予健康教育指导及西药规范治疗,试验组在对照组基础上给予中医辨证治疗(肺脾气虚证给予补肺健脾方颗粒、肺肾气虚证给予补肺益肾方颗粒、气阴两虚证给予益气滋肾方颗粒),两组均治疗6个月。观察两组治疗前后COPD急性加重次数及持续时间、肺功能、临床症状及体征评分、6分钟步行距离、呼吸困难评分和生存质量评分等变化。结果试验组急性加重次数低于对照组、急性加重持续时间少于对照组(P<0.01)。治疗后两组肺功能中用力肺活量比较差异无统计学意义(P>0.05),第1秒用力呼气容积(FEV1)及1秒钟用力呼气容积占预计值百分数(FEV1%)试验组均优于对照组(P<0.05)。除对照组紫绀外,治疗后两组其他临床症状、体征评分及总分均较治疗前下降,且试验组下降程度优于对照组(P<0.05或P<0.01)。治疗后两组6分钟步行距离均较治疗前增加,呼吸困难评分均较治疗前下降(P<0.05或P<0.01);治疗后以上指标两组间比较差异有统计学意义(P<0.01)。试验组生存质量评分较治疗前明显改善,且改善程度优于对照组(P<0.05或P<0.01))。结论所构建的COPD稳定期疗效评价指标体系能够较好的反应辨证治疗方案的临床疗效,区别治疗效果。Objective To verify and evaluate the clinical evaluation index system for chronic obstructive pulmonary disease （COPD） in stabilization period. Methods Totally 306 cases of COPD in stabilization period were randomized into the experimental group and control group, with 155 and 151 in each. Both groups were given health education and guidance. The control group was given routine western medication. The experimental group was added with TCM treatment such as lung- supplementing spleen-fortifying formula granules for lung-spleen qi deficiency pattern, lung-supplementing kidney-boosting formula granules for lung-kidney qi deficiency pattern and qi-boosting kidney-nourishing formula granules for qi-yin deficiency pattern on the basis of the control group. The treatment lasted for 6 months. The changes of frequency and duration of acute exacerbations, lung function, clinical symptom and sign score, 6-minute walk distance, dyspnea score and quality of life （QOL） score were observed before and after treatment in both groups. Results Comparing with the control group, the acute exacerbations in the experimental group were less frequent and short in duration （P 〈 0.01 ）. There was no significant difference between groups in forced vital capacity （FVC） after treatment （P〈0.05）. The forced expiratory volume in one second （FEV1） and FEV1% in the experimental group were superior to those in the control group （P〈0.05）. The symptom scores, sign scores and total scores in both groups were significantly decreased after treatment except cyanotic score in the control group, especially in the experimental group （P〈0.05 or P〈0.01）. The f-minute walk distances were increased and dyspnea scores were decreased in both groups after treatment （P〈0.05 or P〈0.01）. There were significant differences between groups in the index mentioned above after treatment （P〈0.01）. The QOL score in the experimental group was significantly improved after treatment and the degree of improvement was super

关 键 词：慢性阻塞性肺疾病 疗效评价 指标体系 临床验证 

分 类 号：R259[医药卫生—中西医结合]