天人平喘胶囊治疗慢性阻塞性肺病 (肺肾气虚型)随机双盲对照研究

目的:观察天人平喘胶囊治疗慢性阻塞性肺病(肺肾气虚型)的疗效和安全性.方法:采用随机双盲安慰剂对照试验设计方法,选择120例慢性阻塞性肺病患者,随机分为治疗组和对照组,每组60例,两组均采用最佳西医治疗方案,治疗组并在此基础上分别加口服天人平喘胶囊,对照加服安慰剂胶囊.两组服药方法为每日3次,每次3粒,每日总剂量450 mg.治疗疗程均为24周.观察中医证候、生活质量评分(SGRQ评分)、运动耐量(6MWT)、肺功能以及再次急性加重的例次及安全性指标.结果:治疗组和对照总有效率分别为89.28％和60.34％,差异有统计学意义(P＜0.01)；两组治疗后咳嗽、咯痰、气促、胸闷评分及总分与治疗前比较均降低(P＜0.01)；治疗组积分改变优于对照(P＜0.05)；治疗24周后,治疗组SGRQ评分较治疗前明显降低,而6MWT距离则明显提高(P＜0.01)；治疗组SGRQ评分及6MWT距离改善明显优于对照(P＜0.05).治疗组和对照病例再次发生急性加重的例次发生率分别为5.36％ (3/56)和20.68％( 12/58),差异有统计学意义(P＜0.05).结论:天人平喘胶囊能改善慢性阻塞性肺病(肺肾气虚型)通气功能,具有明显疗效和良好的安全性.

Randomized Double-blind Controlled Study on Tianren Pingchuan Capsules in Treatment of Chronic Obstructive Pulmonary Disease (Deficiency of Pulmonary and Renal Vital Energy)

Objective: To observe the curative effect and safety of Tianren Pingchuan capsule in treatment of chronic obstructive pulmonary disease (deficiency of pulmonary and renal vital energy). Method: A design of randomized, placebo-controlled, double-blind trial was adopted. The 120 cases of chronic obstructive pulmonary disease were selected and randomly divided into treatment group and control group, with 60 cases in each group respectively. The best western medical therapy solution was applied to both groups, on which basis Tianren Pingchuan capsules and placebo capsules was used respectively. Three times a day, 3 capsules each time and total daily dose of 450 mg.The course of treatment was 24 weeks. Tranditional Chinese medicine (TCM) syndromes, st. George vespiratory questimnaire scores(SGRQ), 6 minute walk test(6MWT), pulmonary function, cases and safety index of acute re-exacerbation were observed. Result: Curative effect of TCM syndromes: the total efficacious rate in treatment group and control group was 89.28% and 60.34% respectively, with statically significant differences (P<0.01), improvement of TCM syndromes: In both groups, the scores and total scores for cough, expectoration, anhelation and chest distress after treatment were lower than those before treatment (P<0.01); score changes in treatment group were superior to that in control group (P<0.05). Life quality and exercise tolerance: after 24-week treatment, SGRQ score in treatment group obviously decreased with remarkable improvement of 6MWT distances (P<0.01); SGRQ score in treatment group and 6MWT distances were better than those in control group (P<0.05). Cases of acute re-exacerbation: the incidence of acute re-exacerbation in treatment group and control group was 5.36% (3/56) and 20.68% (12/58) respectively, with statically significant differences (P<0.05). Conclusion: Tianren Pingchuan capsules can improve ventilation function for chronic obstructive pulmonary disease (deficiency of pulmonary and renal vital energy), with remarkable efficacy and satisfactory safety.