加味清气化痰汤治疗咳嗽痰热郁肺证单中心、随机对照临床试验  

Single-center and randomized comparison clinical trial of modified Qingqi Huatan Decoction for treating cough with phlegm-heat stagnated in lung syndrome

作　　者：徐海燕 贾维 Xu Haiyan;Jia Wei(Department of Respiratory,Shanghai TCM-Integrated Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200082)

机构地区：[1]上海中医药大学附属上海市中西医结合医院呼吸科,上海200082

出　　处：《山西中医药大学学报》2024年第11期1232-1236,1242,共6页Journal of Shanxi University of Chinese Medicine

基　　金：上海市虹口区卫生健康委员会临床重点扶持专科建设项目(HKZK2020A04)。

摘　　要：目的:评价加味清气化痰汤治疗咳嗽痰热郁肺证的有效性与安全性。方法:采用单中心、随机对照试验设计,共纳入患者85例,随机分为观察组和对照组。其中对照组43例,观察组42例。对照组给予常规西医治疗,观察组在对照组治疗基础上口服加味清气化痰汤,疗程7 d。从临床疗效、中医症状积分、咳嗽症状积分、炎症指标及不良反应等方面进行疗效和安全性评价。结果:观察组治疗后临床有效率高于对照组,咳嗽、咳痰、喘息、胸闷等主症及发热、啰音、便秘、口干口渴欲饮等次症症状积分、中医症状总积分、白细胞计数(WBC)、中性粒细胞百分比(NE%)、C反应蛋白(CRP)、血清淀粉样蛋白(SAA)水平均低于对照组,差异均有统计学意义(P<0.05,P<0.01)。未发现与治疗药物相关的不良反应。结论:加味清气化痰汤可改善咳嗽痰热郁肺证患者的临床症状,降低炎症反应,临床应用安全。Objective:To evaluate the effectiveness and safety of modified Qingqi Huatan Decoction in treating cough with phlegm-heat stagnated in lung syndrome.Methods:A single-center and randomized comparison trial design was used,and a total of 85 patients were included,including 43 in the control group and 42 in the observation group.Patients in the control group were given conventional Western medicine treatment,and patients in the observation group took modified Qingqi Huatan Decoction orally on the treatment basis of the control group for 7 days.The efficacy and safety were evaluated from the aspects of clinical efficacy,TCM symptom score,cough symptom score,inflammation index and adverse reactions.Results:The clinical effective rate of the observation group was higher than that of the control group.The scores of main symptoms such as cough,expectoration,wheeze,chest distress and secondary symptoms such as fever,rale,constipation,dry mouth,thirst and desire to drink,total TCM symptom score,white blood cell count(WBC),neutrophil percentage(NEP),C-reactive protein(CRP)and serum amyloid protein(SAA)levels were all lower than those of the control group,with statistical significances(P<0.05,P<0.01).No adverse reactions related to treatment drugs were found.Conclusion:Modified Qingqi Huatan Decoction can improve the clinical symptoms of patients with cough with phlegm-heat stagnated in lung syndrome,reduce inflammatory response,and is safe in clinical application.

关 键 词：咳嗽 痰热郁肺证 加味清气化痰汤 临床疗效 炎症指标 随机对照试验 

分 类 号：R256.11[医药卫生—中医内科学]