自主研发的藏四味清肺合剂联合常规治疗对慢性阻塞性肺疾病急性加重期患者的临床疗效和安全性  

Clinical efficacy and safety of the self-developed Zangsiwei Qingfei Mixture combined with conventional treatment in patients with acute exacerbation of chronic obstructive pulmonary disease

作　　者：易琼[1,2,3,4,5] 李方[5] 雷思 彭菲 张权 吴艳娜[1,2,3,4,5] 孙静萍[1,2,3,4,5] 吴尚洁 YI Qiong;LI Fang;LEI Si;PENG Fei;ZHANG Quan;WU Yanna;SUN Jingping;WU Shangjie(Department of Pulmonary and Critical Care Medicine,Second Xiangya Hospital,Central South University,Changsha 410011;Research Institute of Respiratory Disease,Central South University,Changsha 410011;Hunan Provincial Clinical Medical Research Center for Pulmonary and Critical Care Medicine,Changsha 410011;Hunan Provincial Diagnosis and Treatment Center of Respiratory Disease,Changsha 410011;Hunan Provincial Evidence-based Medicine Center,Changsha 410011;Department of General Medicine,Second Xiangya Hospital,Central South University,Changsha 410011,China)

机构地区：[1]中南大学湘雅二医院呼吸与危重症医学科,长沙410011 [2]中南大学呼吸疾病研究所,长沙410011 [3]湖南省呼吸与危重症疾病临床医学研究中心,长沙410011 [4]湖南省呼吸疾病诊疗中心,长沙410011 [5]湖南省循证医学中心,长沙410011 [6]中南大学湘雅二医院全科医学科,长沙410011

出　　处：《中南大学学报（医学版）》2024年第6期921-931,共11页Journal of Central South University ：Medical Science

基　　金：国家临床重点专科建设项目;青海省重大科技成果转化专项(2017-SF-122);湖南省科技厅重点研发计划项目(2024JK2125);湖南省中医药科研计划项目(D2022017)。

摘　　要：目的:慢性阻塞性肺疾病(chronic obstructive pulmonary disease,COPD)是世界重大公共卫生问题,现代医学的治疗方式利弊参半,传统民族医药逐渐得到各国学者的关注。藏四味清肺合剂是从经典藏药方中得到的全新自主研发处方合剂,用以治疗慢性呼吸系统疾病。本研究使用藏四味清肺合剂联合常规方法治疗慢性阻塞性肺疾病急性加重期(acute exacerbation of chronic obstructive pulmonary disease,AECOPD)患者,探讨其临床疗效及安全性。方法:纳入2021年5月至2023年5月在中南大学湘雅二医院住院治疗的60例AECOPD患者,随机分为2组,每组30例。对照组给予常规治疗,包括舒张支气管、抗感染、化痰、吸氧;实验组在对照组治疗基础上,加口服藏四味清肺合剂。2组疗程均为7 d。收集患者的一般资料,包括性别、年龄、体重指数(body mass index,BMI)、吸烟情况、慢性阻塞性肺疾病全球倡议(Global Initiative for Chronic Obstructive Lung Disease,GOLD)分级、COPD病程、过去1年内COPD加重次数。以改良版英国医学研究委员会(the modified Medical Research Council,mMRC)呼吸困难量表分级、改良Borg量表评分作为主要疗效指标,动脉血乳酸(lactic acid,LAC)、血清肿瘤坏死因子-α(tumor necrosis factor alpha,TNF-α)水平作为次要疗效指标,安全性指标包括反映肝肾功能、凝血功能的相关指标[丙氨酸转氨酶(alanine transaminase,ALT)、天冬氨酸转氨酶(aspartate transaminase,AST)、血清肌酐(serum creatinine,SCr)、血清尿酸(serum uric acid,SUA)、活化部分凝血活酶时间(activated partial thromboplastin time,APTT)、凝血酶原时间(prothrombin time,PT)、纤维蛋白原(fibrinogen,FIB)、D-二聚体(D-dimer)]。运用广义线性混合模型(generalized linear mixed model,GLMM)评估藏四味清肺合剂的临床疗效和安全性。结果:治疗前,2组患者一般资料、mMRC呼吸困难量表分级、改良Borg量表评分、动脉血LAC、ALT、AST�Objective:Chronic obstructive pulmonary disease(COPD)is a significant global public health issue.Modern medical treatments have both benefits and limitations,prompting increasing attention from scholars worldwide on traditional ethnic medicine,and the Zangsiwei Qingfei Mixture is a newly developed formula derived from the effective components of classical Tibetan medicine to treat chronic respiratory diseases.This study aims to investigate the clinical efficacy and safety of the Zangsiwei Qingfei Mixture combined with conventional treatment in patients with acute exacerbation of chronic obstructive pulmonary disease(AECOPD).Methods:Sixty AECOPD patients admitted to the Second Xiangya Hospital of Central South University from May 2021 to May 2023 were enrolled and randomly divided into 2 groups,with 30 patients in each group.The control group received conventional treatment,including bronchodilators,anti-infection agents,expectorants,and oxygen therapy.The experimental group received the Zangsiwei Qingfei Mixture in addition to conventional treatment.The treatment duration was 7 d for both groups.Baseline data such as gender,age,body mass index(BMI),smoking status,Global Initiative for Chronic Obstructive Lung Disease(GOLD)classification,COPD course,and the number of COPD exacerbations in the past year were collected.The primary efficacy indicators were assessed using the modified Medical Research Council(mMRC)dyspnea scale and the modified Borg scale.Secondary indicators included arterial lactic acid(LAC)and serum tumor necrosis factor alpha(TNF-α)levels.Safety indicators included liver and kidney function[alanine transaminase(ALT),aspartate transaminase(AST),serum creatinine Results:Before treatment,there were no statistically significant differences in general baseline data,grading of mMRC dyspnea scale,score of modified Borg scale,arterial LAC,ALT,AST,SCr,SUA,APTT,FIB,and D-dimer between the 2 groups(all P>0.05).However,serum TNF-αand PT levels in the experimental group were significantly lower than those in

关 键 词：藏四味清肺合剂 慢性阻塞性肺疾病急性加重期 临床疗效 安全性 

分 类 号：R563.9[医药卫生—呼吸系统]