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痰热清注射液治疗慢性阻塞性肺疾病急性加重期(痰热阻肺证)的随机对照试验
引用本文:张颖,李廷谦,王刚,常静,毛兵,王蕾,迟焕海,万美华.痰热清注射液治疗慢性阻塞性肺疾病急性加重期(痰热阻肺证)的随机对照试验[J].中国循证医学杂志,2004,4(5):300-305,336.
作者姓名:张颖  李廷谦  王刚  常静  毛兵  王蕾  迟焕海  万美华
作者单位:四川大学华西医院,国家药品临床研究基地,中药,成都,610041
摘    要:目的评价痰热清注射液对慢性阻塞性肺疾病(COPD)急性加重期患者的临床疗效、安全性及其对血浆细胞因子白介素-17(IL-17)、白介素-8(IL-8)及白三烯B4表达的影响.方法按中华医学会呼吸病学会2002年<慢性阻塞性肺疾病诊治指南>和国家中医药管理局1994年发布的<中医病证诊断疗效标准>,将60例COPD急性加重期患者随机分为治疗组和对照组,每组各30例,进行随机对照临床试验.中医痰热阻肺症诊断标准为:咳嗽气粗,痰多质粘厚或稠黄,咳吐不爽,或有身热,口干欲饮,舌红苔黄,脉滑数.治疗组在基础治疗的基础上,用痰热清注射液20ml 5%糖水250 ml,iv gtt,q 24 h治疗;对照组在基础治疗的基础上,给予生理盐水20 ml 5%糖水250 ml,iv gtt,q 24 h治疗,两组疗程均为12 d.结果ITT和PP分析,治疗组总有效率分别为96.67%和96.55%,总显效率分别为70.00%和72.41%;对照组总有效率分别为86.67%和89.65%,总显效率分别为46.67%和48.28%,两组间疗效比效有统计学意义(P<0.05),且治疗后治疗组血浆细胞因子IL-17、IL-8水平明显低于对照组(P<0.05).结论痰热清注射液治疗COPD急性加重期患者的临床疗效明显优于对照组,且未发现明显毒副作用.其作用机理可能与痰热清注射液能有效降低COPD急性加重期患者血浆IL-17和IL-8的水平有关.

关 键 词:痰热清注射液  慢性阻塞性肺疾病  白介素-17  白介素-8  白三烯B4  中西医结合治疗  随机对照试验
文章编号:1672-2531(2004)05-0300-07

Randomized Controlled Trial of TanReqing Injection in Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease( Syndrome of Retention of Phlegm-Heat in the Lung)
ZHANG Ying,LI Ting-qian ,WANG Gang,CHANG Jing,MAO Bing,WANG Lei,CHI Huan-hai,Wan Mei-hua. National Center for Drug Clinical Trial.Randomized Controlled Trial of TanReqing Injection in Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease( Syndrome of Retention of Phlegm-Heat in the Lung)[J].Chinese Journal of Evidence-based Medicine,2004,4(5):300-305,336.
Authors:ZHANG Ying  LI Ting-qian  WANG Gang  CHANG Jing  MAO Bing  WANG Lei  CHI Huan-hai  Wan Mei-hua National Center for Drug Clinical Trial
Abstract:Objective To evaluate the clinical efficacy and safety of TanReqing Injection in the treatment of acute exacerbations of chronic obstructive pulmonary disease (COPD), and to observe its effects on the plasma levels of cytokine IL-17, IL- 8 and Leukotriene B4 in such cases. Methods A randomized, single blind controlled trial (RCT) was designed. Sixty hospitalized COPD patients with an acute exacerbation were randomly allocated to the treatment group (20 ml of TanReqing Injection iv gtt q 24 h) or the control group (20 ml of placebo Injection iv gtt q 24 h) based on the Guideline for Dignosis and Management of COPD issued by Chinese Society for Respiratory Disease and the Criteria of Dignosis and Efficacy Measures of Traditional Chinese Medicine Syndrome and Illness enacted by The State Administration of Traditional Chinese Medicine. All patients were received standard therapy. Each group contained 30 patients. The therapeutic course of both groups was 12 days. The criterias of TCM syndrome of retention of phlegm-heat in the lung were: cough with rough breath, accumulation of sticky or yellow thick sputum, cough with difficulty in expectoration, or accompanied by fever, thirst with desire of drink, red tougue with yellow fur, slippery and rapid pulse. Results According to the analysis on the basis of intention -to -treat and per-protocol population, it showed that the markedly effective rates were 70.00% and 72.41% respectively, and effective rates were 96.67% and 96.55% in the treatment group respectively. While in the control group the markedly effective rates were 46.67% and 48.28% respectively, and effective rates were 86.67% and 89.65% respectively. Significantly lower plasma concentration of IL-17 and IL-8 in the treatment group was noted when compared with control group. There was a statistically significant difference between two groups ( P<0.05). Conclusions TaReqing Injection shows a definite clinical effectiveness without obvious toxic-adverse effects in the treatment of patients with acute exacerbations of COPD and its mechnical function may related to the level of the excess expression of plasma cytokine IL-17,IL-8 in such cases.
Keywords:TanReqing Injection  COPD  IL-17  IL-8  LTB4  Integrated traditional Chinese with western medicine treatment  Randomized controlled trial
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