熏蒸疗法治疗稳定期肺肾气虚型慢性阻塞性肺疾病的临床疗效研究

Fumigation Therapy for Stable COPD Patients with Lung-Kidney Qi Deficiency Syndrome:a Randomized Controlled Trial Study

目的探讨熏蒸疗法联合常规西医治疗稳定期肺肾气虚型慢性阻塞性肺疾病(COPD)患者的临床疗效。方法选取2014年12月—2015年7月在上海市嘉定区南翔镇社区卫生服务中心建档的稳定期肺肾气虚型COPD患者150例。采用随机数字表法将所有患者分为对照组、口服中药组、熏蒸组,每组50例。对照组患者采用常规西医治疗方法,口服中药组患者在对照组的基础上采用口服补肺汤加减治疗,熏蒸组患者在对照组的基础上采用熏蒸治疗。比较3组患者干预前和干预后6个月时肺功能、COPD急性加重(AECOPD)次数、自我评估测试(CAT)问卷评分、6 min步行距离(6MWD)。结果干预及随访过程中对照组1例、口服中药组5例患者退出研究,最终纳入数据分析的患者为对照组49例、口服中药组45例、熏蒸组50例。干预后6个月时,3组第1秒用力呼吸容积(FEV1)、用力肺活量(FVC)、FEV1/FVC、FEV1实际值/预计值与干预前比较,差异无统计学意义(P>0.05);3组FEV1、FVC、FEV1/FVC、FEV1实际值/预计值比较,差异无统计学意义(P>0.05)。干预后6个月期间,3组AECOPD次数少于干预前6个月,差异有统计学意义(P<0.05);口服中药组、熏蒸组AECOPD次数均少于对照组,差异有统计学意义(P<0.05)。干预后6个月时,3组CAT问卷评分低于干预前,差异有统计学意义(P<0.05);口服中药组、熏蒸组CAT问卷评分均低于对照组,差异有统计学意义(P<0.05)。干预后6个月时,口服中药组和熏蒸组6MWD长于干预前,差异有统计学意义(P<0.05);口服中药组、熏蒸组6MWD均长于对照组,差异有统计学意义(P<0.05)。结论熏蒸疗法联合常规西医治疗对稳定期肺肾气虚型COPD患者肺功能无明显改善,但可明显减少急性发作次数、改善自身症状及增加步行距离,对提高患者生活质量有益。

Objective To explore the clinical effect of fumigation therapy combined with conventional western therapy for stable chronic obstructive pulmonary disease(COPD)patients with lung-kidney qi deficiency syndrome.Methods We recruited 150 stable COPD patients with lung-kidney qi deficiency syndrome who were documented in Jiading District Nanxiang Town Community Health Service Center located in Shanghai from December 2014 to July 2015 and randomized them into the control group receiving the conventional western therapy,oral administration of Chinese medicine group receiving the conventional western therapy plus modified bufei decoction,fumigation group receiving the conventional western therapy and fumigation therapy,with 50 cases in each.Comparisons of lung function,number of acute exacerbation of COPD(AECOPD)attacks,COPD Assessment Test(CAT)score,6-min walking distance(6MWD)were made between groups at 6 months before intervention and 6 months after intervention,respectively.Results Except 1 case in the control group and 5 in the oral administration of Chinese medicine group withdrew from the study during the intervention or follow-up period,the remaining cases were included in the analysis.Compared with 6 months before intervention,the forced expiratory volume in the first second(FEV1),forced vital capacity(FVC),FEV1/FVC ratio,actual FEV1/predicted FEV1 ratio demonstrated little changes at the end of 6-month intervention in all groups(P>0.05),and they were similar in all groups at the end of 6-month intervention(P>0.05).However,during the intervention period,the number of AECOPD attacks decreased significantly in all groups(P<0.05),but the control group had more attacks than other two groups(P<0.05).The CAT score measured at the end of intervention was much lower in all groups compared with 6 months before intervention(P<0.05),moreover,the control group had higher CAT score than other two groups(P<0.05).The 6MWD results improved significantly in both oral administration of Chinese medicine group and fumigation group at the end of intervention(P<0.05),and both groups demonstrated better 6MWD results than the control group(P<0.05).Conclusion Although fumigation therapy combined with conventional western therapy could not significantly improve the lung function of these patients,it could obviously reduce the number of AECOPD attacks,alleviate the impact of COPD on the life,and increase the walking distance,so it is beneficial to improving the quality of life.