健脾清肺-补肾纳气序贯法干预2级COPD疗效评价

The evaluation of clinical curative effects of the Jianpi Qingfei-Bushennaqi sequential therapy in intervention of the chronic obstructive pulmonary disease at grade 2

目的评价中医健脾清肺-补肾纳气序贯疗法干预慢性阻塞性肺疾病(COPD)全程(急性加重期-缓解期)的临床疗效。方法以前瞻性,三中心,分层随机,单盲,阳性药物对照试验。共入组328例患者,按1∶1随机分配至中西药联合组和西药组,治疗4周,随访12个月。以COPD急性再发作为主要终点,同时分别观测治疗前后中医证候评分、mMRC/CAT量表、肺功能等以评价安全性和疗效。结果随机入组的328例患者中319例行意向分析(intention-to-treat analysis,ITT),以及307例患者行符合方案集分析(per-protocol analysis,PP)。中西药联合组有87例达到主要终点,相对于西药组93例(HR1.59,95%CI1.20~2.01;P=0.01)。中药序贯组复发间期中位数时间188d(IQR103~211.5),西药组117d(IQR84~178)(HR0.53,95%CI0.36~0.78,P=0.012)。同时中西药联合组中医证候评分、mMRT/CAT积分、肺功能都较西药组改善(P<0.05)。2组在死亡及其他不良事件的发生差异无统计学意义(P>0.05)。结论健脾清肺-补肾纳气序贯疗法全程干预COPD能有效缓解急性加重、减少急性再发作,改善肺功能、提高生活质量。

Objective To evaluate the clinical efficacy of the traditional Chinese medicin(TCM) of Jianpi Qingfei-Bushennaqi sequential therapy in intervention of the whole course (acute aggravating period-remission period) in patients with chronic obstructive pulmonary disease (COPD). Methods The experiments of prospective, stratified random, single blind, positive drug as controls were performed in the study. A total of 328 patients with COPD were randomly divided into chinese medicine sequential group and conventional western medicine group according to the ratio of 1 ∶1,with the treatment course of 4 weeks, and 12-month follow-up for both groups.The TCM syndrome scores, mMRC/CAT scale, lung function were observed before and after treatment to evaluate the safety and efficacy. Results Among the 328 patients who were randomly divided into groups, there were 319 cases were performed intentional analysis (intention-to-treat analysis, ITT), and 307 cases were performed compliance scheme set analysis (per-protoco lanalysis, PP). There were 87 cases of achieving the primary end point, as compared with the 93 cases in western medicine group (HR 1.59, 95% CI 1.20~2.01;P <0.05). The median time of recrudesce interphase in TCM sequential group was 188 days (IQR103-211.5), however which in western medicine group was 117 days (IQR are much less 84~178)(HR 0.53, 95% CI 0.36~0.78, P =0.012). Moreover the TCM syndrome score, mMRT/CAT integrals, lung function in combination treatment group (chinese and western medicine) were significantly improved,as compared with those in western medicine group( P <0.05). However there were no significantly differences in death and the incifence rates of the other adverse reactions between the two groups ( P >0.05). Conclusion the Jianpi Qingfei-Bushennaqi sequential therapy intervention in the whole course can effectively relieve acute exacerbation of COPD and reduce the acute recrudescence, improve lung function and life quality of patients.