从气道炎症和气道黏液高分泌研究清热化痰法治疗慢性阻塞性肺疾病急性加重期痰热阻肺证的机制

目的：观察在常规西医治疗的基础上,痰热清注射液治疗慢性阻塞性肺疾病急性加重期（acute exacerbation of chronic obstructive pul monary disease,AECOPD）痰热阻肺证患者的临床疗效,并从气道炎症和气道黏液高分泌研究清热化痰法治疗AECOPD痰热阻肺证的机制。方法：选择AECOPD患者90例,将其随机分为痰热清组、盐酸氨溴索组和对照组。对照组仅给予西医基础治疗;痰热清组给予西医基础治疗的同时,静脉滴注痰热清注射液20ml＋5%葡萄糖注射液250ml,1次/d;盐酸氨溴索组给予西医基础治疗的同时,静脉滴注盐酸氨溴索注射液15mg＋5%葡萄糖注射液100ml,2次/d,疗程均为10d。观察治疗前后中医症状积分、血浆白细胞介素8（interleukin-8,IL-8）、IL-10和中性粒细胞弹性蛋白酶（neutrophil elastase,NE）水平。结果：痰热清注射液可使咳嗽、痰量、咳痰、气喘、发热、舌苔、脉象等中医症状和体征明显改善（P〈0.05）;其改善咳嗽、痰量和咳痰的疗效明显优于对照组（P〈0.05）,但与盐酸氨溴索组比较,差异无统计学意义（P〉0.05）;痰热清组舌苔变化均较盐酸氨溴索组和对照组有所改善（P〈0.05）。治疗后,痰热清组及盐酸氨溴索组IL-8、IL-10和NE水平均明显下降（P〈0.05）,而对照组仅IL-8和IL-10明显下降（P〈0.05）;痰热清组IL-8治疗前后变化高于其他两组,盐酸氨溴索组IL-10和NE治疗前后的变化高于其他2组,但3组间IL-8、IL-10和NE治疗前后的变化比较,差异均无统计学意义（P〉0.05）。3组总显效率比较,痰热清组及盐酸氨溴索组均优于对照组（P〈0.05）,痰热清组和盐酸氨溴索组显效率比较,差异无统计学意义（P〉0.05）;3组总有效率比较,差异均无统计学意义（P〉0.05）。结论：清热化痰法代表方痰热清注射液在西医的基础治疗上能够较好地改善AECOPD（痰热阻肺证）患者中医症状及体征,其治疗的机制之一可能是通过促进IL-8、NE水平的下降以及延缓IL-10水平下降而改善气道炎症及气道黏液高分泌。

A study of the mechanism of Qingre Huatan therapy in treatment of acute exacerbation of chronic obstructive pulmonary disease by improving airway inflammation and mucus hypersecretion

Objective: To explore the effects of Tanreqing injection, a traditional Chinese herbal preparation for clearing heat and resolving phlegm, in treatment of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) by improving airway inflammation and airway mucus hypersecretion. Methods: A randomized controlled trial (RCT) was designed. Ninety AECOPD patients were randomly divided into Tanreqing group, ambroxol hydrochloride group and control group. The patients in the three groups were all treated with conventional therapy. Furthermore, intravenous drip infusion of 20 ml Tanreqing injection (once daily) and 15 mg ambroxol hydrochloride injection (twice daily) were administered respectively to the patients in the Tanreqing group and ambroxol hydrochloride group. They were all treated for 10 days. Symptom score of traditional Chinese medicine (TCM), plasma concentrations of interleukin-8 (IL-8), IL-10 and neutrophil elastase (NE) were detected before and after treatment. Results: Cough, sputum amount, expectoration, dyspnea, fever, coated tongue and pulse tracings were improved obviously in Tanreqing group (P<0.05), and the effects of Tanreqing on improving cough, sputum amount and expectoration were better than the conventional therapy (P<0.05), while there was no significant difference between Tanreqing group and ambroxol hydrochloride group (P>0.05). Compared with ambroxol hydrochloride group and the control group, the coated tongue was improved obviously in Tanreqing group (P>0.05). After treatment, plasma concentrations of IL-8, IL-10 and NE were decreased in Tanreqing group and ambroxol hydrochloride group (P<0.05), and the levels of IL-8 and IL-10 in the control group were decreased (P<0.05). The change of IL-8 level before and after treatment in Tanreqing group was greater than that in ambroxol hydrochloride group and the control group. The changes of IL-10 and NE levels in ambroxol hydrochloride group were greater than those in Tanreqing group and the control group, while there was no significant difference in the changes of serum levels of IL-8, IL-10 and NE among the three groups (P>0.05). Total response rates in Tanreqing group and ambroxol hydrochloride group were higher than that in the control group (P<0.05), while there was no significant difference in total response rate between Tanreqing group and ambroxol hydrochloride group (P>0.05). There was no significant difference in total response rate among the three groups (P>0.05).