目的:通过慢性阻塞性肺疾病(COPD)稳定期患者临床辨证诊疗信息采集、分析和评价,筛选构建疗效评价指标体系。方法:收集河南中医学院第一附属医院、河南省人民医院2007年-2008年收治的符合研究标准的COPD稳定期患者190例,肺气虚患者171人(90.0%),进行疾病情况、临床症状体征、呼吸困难量表(MMRC)、6min步行距离(6MWD)、肺功能、生活质量等进行调查研究,采用频数分布、回归分析、相关分析等方法,对肺气虚证相关疗效指标进行评价分析,初步构建COPD中医疗效评价指标体系。根据各指标间相互关系,并结合统计分析参数大小,初步筛选疗效评价指标体系。结果:基于临床调查研究初步构建的COPD稳定期疗效评价指标体系包括医护人员注重的指标(近1年急性加重次数和持续时间、病程、MMRC、6MWD等)、患者注重的指标(咳嗽、咯痰、喘息、气短、活动气短加重、胸闷痛、乏力等临床症状,生活质量等)、实验室指标(肺功能、体质量指数等)、中医相关指标(自汗、盗汗、腰腿酸软、饮食、易感冒、因劳累而加重、因天气变化而加重、因心情不好而加重等)。结论:COPD疗效评价指标体系包括中医相关指标等4方面内容,其筛选方法有待进一步深入研究。
Objective: To collect, analyze and evaluate clinical differentiation information of chronic obstructive pulmonary disease (COPD) at stable stage patients, to screen and construct the effect evaluation indexes systems. Methods: Patients with the COPD at stable stage qualified with research standards were enrolled from Affiliated Hospital of Henan University of TCM, Henan Provincial People's Hospital during 2007 to 2008. There were 190 volunteers. The research collected 171 volunteers with pulmonary Qi deficiency syndrome. The volunteers were surveyed with the diseases condition, clinical symptoms and signs, dyspnea, the 6-min walking distance, pulmonary function, quality of life and so on. The dates were analyzed by the frequency distribution, regression analysis and correlation analysis to preliminary construct the effect evaluation indexes systems for COPD. According to indexes, we screened out efficacy evaluation systems. Results: The effect evaluation indexes systems of COPD at Stable Stage based on clinical investigation included the index of the medical staff (times and duration of AECOPD in one year, course of disease, MMRC, 6MWD), index of the patients (cough, expectoration, asthmatic, shortness of breath, aggravated after activity, chest pain, hypodynamia, quality of life, etc), index of laboratory (pulmonary function, body mass index, etc) and TCM syndrome, or related indexes of TCM effect advantage indexes (spontaneous perspiration, night sweat, soreness-tired of waist and knee, diet, likely to catch cold, aggravated for tiredness, aggravated for weather change, aggravated for bad mood, etc). Conclusion: The COPD effect evaluation indexes systems included the four domains such as the TCM syndrome while the screening technique would need further in-depth investigation.