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、SCr、SUA、APTT、FIB、D-dimer差异均无统计学意义(均P＞0.05),实验组血清TNF-α及PT水平均低于对照组,差异有统计学意义(均P＜0.05).GLMM分析结果显示:在调整了治疗前后、性别、年龄、BMI、吸烟情况、GLOD分级、COPD病程和过去1年内COPD加重次数后,相比于接受常规治疗的对照组,实验组mMRC呼吸困难量表分级(系数=-0.329,P=0.036)、改良Borg量表评分(系数=-1.077,P=0.001)、血清TNF-α(系数=-14.378,P＜0.001)和动脉血LAC(系数=-0.409,P=0.012)均更低,而藏四味清肺合剂干预对肝肾功能及凝血功能相关指标无明显影响(均P＞0.05).结论:藏四味清肺合剂联合常规治疗可改善AECOPD患者的临床症状,促进内环境稳定,且具备安全性及可靠性.现代医学结合传统民族医药的治疗方式是未来治疗慢性呼吸系统疾病的可行之路.
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
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(SCr),serum uric acid(SUA)],coagulation function[activated partial thromboplastin time(APTT),prothrombin time(PT),fibrinogen(FIB),and D-dimer].The generalized linear mixed model(GLMM)was used to evaluate the clinical efficacy and safety of the Zangsiwei Qingfei Mixture.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-α and PT levels in the experimental group were significantly lower than those in the control group(both P＜0.05).GLMM analysis showed that after adjusting for pre-and post-treatment,gender,age,BMI,smoking status,GOLD classification,COPD course,and the number of COPD exacerbations in the past year,the experimental group demonstrated significantly lower grading of mMRC dyspnea scale(coefficient=-0.329,P=0.036),score of modified Borg scale(coefficient=-1.077,P=0.001),serum TNF-α level(coefficient=-14.378,P＜0.001),and arterial LAC level(coefficient=-0.409,P=0.012)compared to the control group.The Zangsiwei Qingfei Mixture had no significant effect on liver,kidney,or coagulation function indicators(all P＞0.05).Conclusion:The Zangsiwei Qingfei Mixture combined with conventional treatment can improve clinical symptoms and promote homeostasis in AECOPD patients,demonstrating safety and reliability.Combining modem medicine with traditional ethnic medicine offers a feasible approach to treating chronic respiratory diseases in the future.
Zangsiwei Qingfei Mixtureacute exacerbation of chronic obstructive pulmonary diseaseclinical efficacysafety
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