目的 探讨中药配方颗粒和饮片汤剂治疗慢性阻塞性肺病(chronic obstructive pulmonary disease,COPD)的临床疗效差异及相关影响因素。方法 采用回顾性分析的方法,以2017年1月-2021年12月诊断为COPD的病例为研究对象,依据使用中药剂型的不同分为颗粒组和饮片组,采用倾向性评分对两组患者年龄、性别等混杂因素进行匹配。比较两组病例的中医证型、用药特点、中药费用及相关疗效指标差异,采用单因素及多因素Logistic回归分析研究影响疗效的主要因素。结果 倾向性评分匹配后,颗粒组和饮片组各94例,两组患者的一般情况、中医证型、用药特点未见显著性差异。治疗后,颗粒组和饮片组总有效率分别为92.6%和87.2%,但差异无统计学意义;与治疗前相比,两组患者肺功能指标第1 s用力呼气容积(forced expiratory volume in one second,FEV₁)、用力肺活量(forced vital capacity,FVC)、FEV₁/FVC,相关炎症指标白细胞计数(white blood cell,WBC)、中性粒细胞百分比(neutrophilic granulocyte percentage,NEU-P)、嗜酸性粒细胞计数(eosinophils,EOS)、淋巴细胞计数(lymphocyte,LYM)、超敏C反应蛋白(hypersensitive C-reactive protein,hs-CRP)、红细胞沉降率(erythrocyte sedimentation rate,ESR)及血气分析指标均有所改善(P<0.05);且配方颗粒和饮片对患者肺功能指标、炎症指标及缺氧状态的改善程度相当(P>0.05);但颗粒组平均中药费用明显高于饮片组(P<0.05);多因素回归分析显示,中药剂型(颗粒/饮片)、吸烟、病情严重程度等与COPD疗效无显著性相关,肺功能是COPD疗效的独立影响因素,且发挥显著的正向影响关系。结论 中药配方颗粒与饮片治疗COPD的临床疗效无显著性差异,二者均安全有效,值得推广应用。肺功能是影响疗效的关键因素,通过中医特色肺康复技术改善患者肺功能对提高疗效至关重要。

Objective To explore the differences in clinical efficacy and related influencing factors of traditional Chinese medicine granules and decoction in the treatment of chronic obstructive pulmonary disease (COPD). Methods Using a retrospective study method, cases diagnosed with COPD from January 2017 to December 2021 were selected as the research subjects, and they were divided into a granule group and a decoction piece group according to the different dosage forms of traditional Chinese medicine. The differences in TCM syndrome types, medication characteristics, hospitalization costs and related efficacy indicators were compared between the two groups, and univariate and multivariate Logistic regression analysis was used to study the main factors affecting the efficacy. ResultsAfter propensity matching, there were 94 cases in the granule group and the herbal decoction group, and there was no significant difference in the general conditions and TCM syndrome types of the two groups of patients. After treatment, the total effective rates of the granule group and the decoction piece group were 92.6% and 87.2%, respectively, but the difference was not statistically significant; Compared with before treatment, the pulmonary function forced expiratory volume in one second (FEV₁), forced vital capacity (FVC) and FEV₁/FVC indexes, related inflammatory indexes white blood cell (WBC), neutrophilic granulocyte percentage (NEU-P), eosinophils (EOS), lymphocyte (LYM), hypersensitive C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR) and blood gas analysis indexes of the two groups were improved (P ＜ 0.05); and formula granules and decoction pieces improved the lung function, inflammatory response and hypoxia state of patients in a similar degree (P ＞ 0.05); but the average cost of traditional Chinese medicine in the granule group was significantly higher than that in the decoction piece group (P ＜ 0.05); multivariate regression analysis showed that traditional Chinese medicine form (granules/pills), smoking and disease severity were not significantly correlated with the curative effect of COPD, and lung function was an independent factor affecting the curative effect of COPD. Conclusion There is no significant difference in the clinical efficacy of traditional Chinese medicine granules and herbal decoction pieces in the treatment of COPD, both of which are effective and safe, and are worthy of popularization and application. Pulmonary function is a key factor affecting the curative effect, and improving the pulmonary function of patients is crucial to improving the curative effect through traditional Chinese medicine pulmonary rehabilitation techniques.

R285.64

国家自然科学基金区域创新发展联合基金重点支持项目（U20A20398）；安徽省自然科学基金项目（2108085QH369）；安徽省科技重大专项（201903a07020015）；科技部国家重点研发计划（2018YFC1704804）；安徽省高校协同创新项目（GXXT-2021-084）；2021年安徽省高校研究生科研项目（YJS20210487）。