中国中西医结合杂志2025，Vol.45Issue(7)：784-792,9.DOI:10.7661/j.cjim.20250605.047
中医辨证治疗慢阻肺慢性呼吸衰竭随机对照研究
Syndrome Differentiation-Based Treatment For Chronic Obstructive Pulmonary Disease Patients with Chronic Respiratory Failure:A Randomized Controlled Trial
摘要
Abstract
Objective To evaluate the efficacy and safety of syndrome differentiation-based treatment(SDBT)in patients with stable chronic obstructive pulmonary disease(COPD)and chronic respiratory failure(CRF).Methods A multicenter,randomized,double-blind,placebo-controlled trial was conducted at four Grade Ⅲ A hospitals.A total of 120 patients were centrally randomized into an experimental group(60 cases)and a control group(60 cases).Both groups received guideline-recommended therapy,with the experimental group additionally receiving SDBT(Buyi Xinfei Formula granules for cardiopulmonary qi deficiency syndrome;Bushen Baofei Formula granules for Fei-Shen qi deficiency syndrome),while the control group received placebo.The intervention lasted 26 weeks,followed by a 26-week follow-up.Primary efficacy endpoint included the frequency and incidence of acute exacerbations of chronic obstructive pulmonary disease(AECOPD),as well as all-cause rehospitalization rates.These endpoints were assessed at weeks 4,13,and 26 during the treatment phase,and at weeks 13 and 26 during the follow-up period.Secondary efficacy endpoint comprised the duration of oxygen therapy;clinical symptom burden,as measured by the modified Medical Research Council(mMRC)dyspnea scale;and health-related quality of life,evaluated using the COPD Assessment Test(CAT)and the Clinical COPD Questionnaire(CCQ).These parameters were recorded at the same time points as the primary outcomes.Arterial blood gas measurements-including partial pressure of arterial oxygen(PaO2)and carbon dioxide(PaCO2)were obtained at baseline,at the end of treatment(week 26),and at the end of follow-up(week 26).Pulmonary function was assessed through forced vital capacity(FVC),forced expiratory volume in one second(FEV1),and the percentage of predicted FEV1(FEV1％pred),all of which,along with safety endpoints were evaluated at baseline and at week 26 of treatment.Results Among 120 enrolled patients,15 withdrew,yielding a per-protocol set of 105(52 patients in the experimental group,53 patients in the control group).Compared with the control group,the experimental group reduced frequency/rate of AECOPD and rehospitalization rates at week 13 and week 26 of treatment,as well as week 13 and week 26 of follow-up(P＜0.05).Concurrently,PaO2 levels improved at week 26 of treatment and week 26 of follow-up(P＜0.05),with mMRC scores decreasing at week 26 of treatment and weeks 13 and 26 of follow-up(P＜0.05).CAT scores,CCQ total and subdomain scores(except CCQ functional domain at week 4)were lower in the experimental group(P＜0.05).No significant differences were observed in duration of oxygen therapy or pulmonary function(P＞0.05).No severe adverse events occurred,and adverse event rates did not statistical different between the two groups(P＞0.05).Conclusions SDBT reduced AECOPD frequency,AECOPD rates,and all-cause rehospitalization,improved PaO2,alleviated symptoms,enhanced quality of life,and demonstrated a favorable safety profile in COPD patients with CRF.(ClinicalTrials.gov No.NCT04694755).关键词
慢性阻塞性肺疾病/慢性呼吸衰竭/辨证治疗/急性加重/生活质量/中医药/中西医结合/随机对照试验Key words
chronic obstructive pulmonary disease/chronic respiratory failure/syndrome differentiation/acute exacerbation/quality of life/Chinese medicine/integrative medicine/randomized controlled trial引用本文复制引用
李建生,王明航,杨江,鄢子涵,周淼,候聪霞,李利华..中医辨证治疗慢阻肺慢性呼吸衰竭随机对照研究[J].中国中西医结合杂志,2025,45(7):784-792,9.基金项目
河南省特色学科中医学学科建设项目(No.STG-ZYXKY-2020002) （No.STG-ZYXKY-2020002）
国家重点研发计划(No.2023YFC3502602) （No.2023YFC3502602）
国家自然科学基金资助项目(No.82474483) （No.82474483）
