冬病夏治消喘膏穴位贴敷疗法治疗稳定期慢性阻塞性肺病的随机对照研究

Randomized Controlled Trial of Xiaochuangao Acupoint Paste to Treat Chronic Obstructive Pulmonary Disease in the Stable Phase:Treating Winter Diseases in Summer

目的验证冬病夏治消喘膏穴位贴敷疗法治疗稳定期慢性阻塞性肺病(chronic obstructive pulmonary disease,COPD)的临床疗效。方法采用多中心、随机、安慰剂对照、双盲设计,将142例患者随机分为2组,分别予消喘膏和安慰剂贴敷治疗,每年三伏天贴治3次,连续贴敷2年。观察圣乔治量表(SGRQ)评分、BODE指数、年均感冒和急性发作次数、急诊和住院次数、肺功能等项目。结果两组治疗1、2年SGRQ量表评分均较治疗前下降,与治疗1年比较,消喘膏组治疗2年活动部分、影响部分及总分评分下降差异均有统计学意义(P<0.05),且消喘膏组下降幅度大于对照组(P<0.05);消喘膏组治疗2年与治疗前及治疗1年比较,BODE指数下降值均大于对照组同期(P<0.01);消喘膏组治疗2年年均感冒和急性发作次数明显低于对照组同期,且低于本组治疗前和治疗1年(P<0.05);消喘膏组治疗2年年均急诊次数和住院次数明显低于治疗前以及对照组同期(P<0.05);治疗后两组肺功能差异无统计学意义。结论冬病夏治消喘膏穴位贴敷疗法在提高稳定期COPD生活质量、减少患者年均急性加重次数、降低医疗负担方面有较好疗效。

Objective To verify the clinical efficacy of Xiaochuangao Acupoint Paste（XAP） to treat chronic obstructive pulmonary disease（COPD） in the stable phase.Methods By using a multi-center randomized double-blinded placebo controlled design,142 patients with COPD were randomly assigned to two groups.Patients in the treatment group were treated with XAP,while those in the control group were treated with the placebo paste.One therapeutic course consisted of six pastes,three times on dog-days within one year,for two successive years.The SGRQ life quality score,BODE index,yearly average times of common cold and acute attack,times of emergency clinics and hospitalization,the lung function,and so on were observed.Results The post-treatment 1-and 2-year SGRQ life quality scores decreased more than before treatment in the two groups.Compared with one year after treatment,the post-treatment 2-year activities and influence of SGRQ life quality score,and the total score decreased significantly in the treatment group（P0.05）.Besides,the decrement was more in the treatment group than in the control group（P0.05）.The decrement of the BODE index between the post-treatment 2-year and before treatment and between the post-treatment 2-year and the post-treatment 1-year was higher in the treatment group when compared with the control group during the same time periods（P0.01）.The yearly average times of common cold and acute attack were obviously lower 2 years after treatment than those of the control group 2 years after treatment,Besides,they were lower than those before treatment and 1 year after treatment in the treatment group（P0.05）.The yearly average times of emergency clinics and hospitalization were obviously less in the treatment group 2 years after treatment than before treatment of the same group and those of the control group during the same time period（P0.05）.There was no statistical difference in the lung function between the two groups.Conclusion XAP showed positive effects on improving the quality of life of patients with COPD in the stable phase,lessening their acute aggravation times,and lowering medical costs.