清热化痰方治疗慢性阻塞性肺疾病急性加重期(痰热阻肺证)的疗效观察及机制探讨

Clinical Effect and Mechanism of Heat-clearing and Phlegm-resolving Recipe in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease(Phlegm Heat and Phlegm Turbidity in Lungs)

目的观察清热化痰协定方治疗慢性阻塞性肺疾病急性加重期(AECOPD)(痰热阻肺证)患者的临床疗效,并探讨其作用机制。方法 2009年10月-2010年3月选择AECOPD(痰热阻肺证)患者60例,随机分为试验组和对照组(各30例),对照组仅给予西医基础治疗,试验组在西医治疗基础上加用清热化痰协定方汤药(100 m L,3次/d),共治疗10 d。主要观察中医症候疗效及气道炎症指标包括血浆白细胞介素(IL)-8、IL-10、杀菌/通透性增加蛋白(BPI)水平。结果 1痰热阻肺证证候:两组治疗前后中医证候总积分差值组间比较差异有统计学意义(P<0.05),清热化痰协定方在改善咳嗽、痰量、咳痰、舌苔方面优于对照组(P<0.05)。2疾病疗效:试验组的总显效率和总有效率分别为82.1%和92.9%,对照组的总显效率和总有效率分别为56.0%和84.0%,两组总显效率比较,试验组优于对照组,差异有统计学意义(P<0.05),两组总有效率比较差异无统计学意义(P>0.05)。3气道炎症指标:两组治疗后IL-8水平明显下降,IL-10及BPI水平明显升高,两组治疗前后组内比较差异均有统计学意义(P<0.05),IL-8下降幅度及BP2升高幅度组间比较差异均无统计学意义(P>0.05),IL-10升高幅度试验组大于对照组,差异有统计学意义(P<0.05)。结论在西医治疗基础上,清热化痰协定方能改善AECOPD(痰热阻肺证)患者中医症状及体征,其疗效的机制之一可能是通过促进IL-10水平的升高。

Objective To investigate the clinical effect and mechanism of Chinese heat-clearing and phlegm- resolving recipe in the treatment of acute exacerbation of chronic obstructive pulmonary disease （AECOPD）. Methods A randomized controlled trial （RCT） was conducted. A total of sixty in-patients with AECOPD of phlegm heat and phlegm turbidity in lungs were randomly allocated to treatment group and control group with an equal number of patients between October 2009 and March 2010. The treatment duration was 10 days. Symptom scores of traditional Chinese medicine （TCM）, pulmonary function, white blood cell count, polymorphonuclear neutrophils, C-reactive protein and the plasma concentration of bactericidal/permeability increasing protein （BPI） and intedeukin （IL）-8 and IL- 10were detected. Results For TCM syndrome of phlegm heat and phlegm turbidity, there was a statistical difference between the two groups after treatment （P 〈 0.05）. Cough, sputum amount, expectoration and coated tongue were improved obviously in the treatment group （P 〈 0.05）. The total explicit efficiency rate and effective rate were 56.0% and 84.0% in the control group and 82.1% and 92.9% in the treatment group respectively. The total explicit efficiency rate was significantly different between the two groups （P 〈 0.05）, while the total effective rate was not significantly different（P 〉 0.05）. Plasma concentration of IL-8 decreased markedly in the treatment group and IL-10 and BPI increased obviously. There was no significant difference in the change of BPI, IL-8 between the two groups （P 〉 0.05）, except for IL-10 （P 〈 0.05）. Conclusion Chinese heat-clearing and phlegm-resolving recipe can improve signs and symptoms of TCM in the treatment of AECOPD （phlegm heat and phlegm turbidity in lungs）, by the potential mechanism of increasing the level of IL-10.