咳喘宁胶囊治疗稳定期慢性阻塞性肺疾病随机对照试验

Random-controlled Trial of Kechuanning Capsules on Chronic Obstructive Pulmonary Disease Patients

目的观察咳喘宁胶囊治疗稳定期慢性阻塞性肺疾病(COPD)的临床疗效。方法将110例稳定期COPD患者随机分为治疗组和对照组各55例。2组均予复方异丙托溴铵溶液气雾吸入,在此基础上,治疗组口服咳喘宁胶囊,每次4粒,每日3次;对照组口服等剂量安慰剂胶囊。疗程均为3个月。观察2组患者临床疗效、BODE指数、COPD评估测试(CAT)评分及不良反应。结果治疗组与对照组分别脱落5、4例。治疗组临床总有效率为96.00%(48/50),对照组为88.24%(45/51),2组比较差异有统计学意义(P<0.05)。2组治疗后BODE指数和CAT评分均下降,且治疗组低于对照组(P<0.05)。治疗组治疗前后肝、肾功能未见明显异常。结论咳喘宁胶囊能有效降低稳定期COPD患者BODE指数及CAT评分,提高患者生活质量和临床疗效,无明显不良反应。

Objective To observe the clinical efficacy of Kechuanning capsules for the treatment of chronic obstructive pulmonary disease （COPD） in stable phase.Methods Totally 110 patients with stable COPD were randomly divided into the therapy group and the control group, 55 cases in each group. Patients in both groups were given ipratropium bromide solution for inhalation. On the basis of western medicine treatment, the therapy group took Kechuanning capsules orally at the same time, 4 softgels for each time, 3 times a day;on the basis of western medicine treatment, the control group took the same amount of placebo capsules. The treatment lasted three months. Meanwhile, the clinical efficacy, BODE index, CAT score and ADRs of patients in the two groups were observed.Results The clinical efficacy in the therapy group was 96.00% （48/50）, and 88.24% （45/51） in the control group, with statistical significance （P〈0.05）. BODE index and CAT score in the two groups decreased and the therapy group was lower than the control group （P〈0.05）. Liver and kidney function had no obvious abnormalities in the treatment group before and after treatment.Conclusion Kechuanning capsules can effectively reduce the BODE index and CAT score in patients with stable COPD, improve patients＇ life quality and clinical outcomes, and no obvious side effect has been found.