三拗片治疗稳定期慢性阻塞性肺疾病的临床疗效研究

Clinical Efficacy of San'ao Tablets on Stable Chronic Obstructive Pulmonary Disease

目的了解三拗片治疗稳定期慢性阻塞性肺疾病(COPD)的临床疗效。方法于2014年5—8月,选取在山东中医药大学附属医院(n=78)、山东省千佛山医院(n=64)、同济大学附属东方医院(n=64)、同济大学附属上海市肺科医院(n=73)进行治疗的稳定期COPD患者279例。根据《慢性阻塞性肺疾病的诊断、治疗与预防的全球策略(2014版)》综合评估标准,将纳入患者分为A、B、C、D 4组;采用中央随机方法,将各组分为观察组(XE,X代表A、B、C、D)和对照组(XC)。各对照组采用西医常规治疗,各观察组在西医常规治疗的基础上加服三拗片,治疗时间均为2周。比较各组治疗前后的COPD患者自我评估量表(CAT)评分、COPD专用改良版生活质量量表(SGRQ-C)评分、6 min步行距离及主要症状评分,并记录两组治疗期间的不良反应发生情况。结果对照组和观察组治疗前后CAT评分、SGRQ-C评分、6 min步行距离及主要症状评分差值比较,差异有统计学意义(P<0.05)。其中,AC组和AE组治疗前后CAT评分、SGRQ-C评分差值比较,差异有统计学意义(P<0.05);BC组和BE组治疗前后CAT评分、主要症状评分差值比较,差异有统计学意义(P<0.05);CC组和CE组治疗前后CAT评分、SGRQ-C评分、6 min步行距离、主要症状评分差值比较,差异均有统计学意义(P<0.05);DC组和DE组治疗前后CAT评分、SGRQ-C评分差值比较,差异有统计学意义(P<0.05)。结论三拗片治疗稳定期COPD的临床疗效较好,对不同分组患者的临床症状、生活质量及活动能力均有一定程度的改善作用。

Objective To investigate the clinical efficacy of San＇ao tablets on stable chronic obstructive pulmonary disease（ COPD）. Methods From May to Aguster in 2014,we enrolled 279 patients with stable COPD who received treatment in the Affiliated Hospital of Shandong University of Traditional Chinese Medicine（ n = 78）, Shandong Province Qianfoshan Hospital（ n = 64）, East Hospital Affiliated to Tongji University（ n = 64）, and Shanghai Pulmonary Hospital Affiliated to Tong Ji University（ n = 73）. According to GOLD 2014, we divided the patients into A, B, C, D group. Using central randomized method,we divided each group into observation group（ XE,X represents A,B,C,D） and control group（ XC）.Each control group was administrated with western medicine conventional treatment,and each observation group was administrated with western medicine conventional treatment plus San＇ ao tablets, and the treatment lasted for 2 weeks for all the groups. Comparison was made among all the groups in CAT score,SGRQ-C score,6-min walking distance and the scores of major symptoms, and the adverse reactions of the two groups during treatment were recorded. Results Control group and observation group were significantly different in CAT score,SGRQ-C score,6 min walking distance and the scores of major symptoms（ P 〈0. 05）. AC group and AE group were significantly different in CAT score and SGRQ-C score（ P 〈0. 05）. BC group and BE group were significantly different in CAT score and the scores of major symptoms（ P 〈0. 05）. CC group and CE group were significantly different in CAT score,SGRQ-C score,6 min walking distance and the scores of major symptoms（ P 〈0. 05）. DC group and DE group were significantly different in CAT score and SGRQ-C score（ P 〈0. 05）. Conclusion San＇ao tablets have favorable clinical efficacy on stable COPD,and can improve the clinical symptoms,quality of life and capacity for action of patients in each group.