扶正清痰化瘀胶囊治疗慢性阻塞性肺疾病稳定期临床研究

目的:观察扶正清痰化瘀法治疗慢性阻塞性肺疾病(COPD)稳定期的临床效果。方法:COPD稳定期患者140例随机分为治疗组和对照组各70例,分别给予扶正清痰化瘀胶囊和茶碱缓释片、氨溴索片,疗程均为1年。观察患者的临床综合疗效,圣.乔治呼吸问卷(SGRQ)评分,6min步行距离(6MWT),肺功能,年均急性发作、急诊及住院次数,安全性。结果:两组共脱落12例。显效率、总有效率治疗组分别为33.33%、93.94%,对照组分别为16.13%、67.71%,两组比较有显著性差异(P0.05);治疗组SGRQ总分及症状、活动、影响部分评分较治疗前均明显下降(P0.01),且下降优于对照组(P0.01)。治疗组6MWT改善较治疗前及对照组治疗后有明显差异(P0.05),治疗组第1秒用力呼气量(FEV1)、第1秒用力呼气量占用力肺活量的比值(FEV1/FVC)、第1秒用力呼气量占预计值百分比(FEV1%预计值)较治疗前均有明显增高(P0.05),治疗组FEV1增高较对照组改善明显(P0.05),治疗组治疗后年均急性发作、急诊及住院次数较治疗前及对照组治疗后有显著性差异(P0.05);两组安全性评价指标无显著性差异(P0.05)。结论:扶正清痰化瘀法治疗COPD稳定期效果较好,可提高生存质量、减少急性发作,且安全性好。

Clinical Study of Fuzheng Qingtan Huayu Capsules for Treating Chronic Obstructive Pulmonary Disease at Stable Stage

Objective：To evaluate the clinical efficacy of Fuzheng Qingtan Huayu Capsule（Capsule for reinforcing resistance,eliminating phlegm and stasis） on chronic obstructive pulmonary disease（COPD） in stable stage.Methods：Totally 140 selected COPD patients in stable stage were randomized into treatment group in which 70 cases were treated with Fuzheng Qingtan Huayu Capsules and control group in which 70 cases were given theophylline sustained-release tablets and ambroxol,both groups were treated for one year.Changes in general effects;scores of the St.George＇s Respiratory Questionnaire（SGRQ）;6-minute walking distance（6MWT）;pulmonary functions;annual average times of acute aggravation,emergency consultation and hospitalization;safety were observed.Results：Totally 12 cases dropped out.Of the 66 cases in treatment group,the significant rate and total effective rate were 33.33% and 93.94%,and these were 16.13% and 67.71% respectively for the control group,there was significant difference in the comparison of the two groups on general effects（P〈0.05）.Of the treatment group,the comparison between after treatment and before treatment showed significant decrease in the total score of SGRQ and scores of symptoms,activities and influences（P〈0.01）;there was statistical difference in the decrease of total score,scores of activities and influences between treatment group and control group（P〈0.01）.6-minute walking distence（6MWT） of the treatment group was significantly increased compared with before treatment and control group（P〈0.05）.Of the treatment group,forced expiratory volume in one second（FEV1）,the ratio of the forced expiratory volume in one second and forced volume capacity（FEV1/FVC） and forced expiratory volume in one second% prediction（FEV1%pred） increased significantly after treatment（P〈0.05）,the FEV1 increased significantly of the treatment group in compared with the control group（P〈0.05）.Annual average times of acute aggravation,emergency consultation and hospitalization of the treatment group was significantly decreased compared with before treatment and control group（P〈0.05）.The safety of both groups were without statistical difference（P〈0.05）.Conclusion：Fuzheng Qingtan Huayu Capsule has good efficacy on COPD in stable stage,improving life quality,reducing acute aggravation,and it＇s safe during clinical treatment.