清咳平喘颗粒联合噻托溴铵粉雾剂治疗慢性阻塞性肺疾病稳定期痰热壅肺证40例临床观察

Qingke Pingchuan Granule (清咳平喘颗粒) Combined with Tiotropium Bromide Inhalation Spray for Treatment of 40 Cases of Chronic Obstructive Pulmonary Disease of Stable Stage with Phlegm-heat Obstructing the Lung Pattern

目的观察清咳平喘颗粒联合噻托溴铵粉雾剂治疗慢性阻塞性肺疾病(COPD)稳定期痰热壅肺证患者的临床疗效并探讨其可能的作用机制。方法80例COPD稳定期痰热壅肺证患者随机分成治疗组和对照组各40例。对照组给予噻托溴铵粉雾剂吸入治疗,每次1粒,每日1次;治疗组在此基础上口服清咳平喘颗粒每次10 g,每日3次;疗程均为8周。观察两组患者肺功能指标[包括最大呼气中期流量(MMEF)、第一秒用力呼气容积占用力肺活量百分比(FEV1/FVC)、第一秒用力呼气容积(FEV1)、用力肺活量(FVC)]、COPD患者自我评估测试问卷(CAT)、气道黏液高分泌指标(包括咳嗽、咯痰难度、昼夜痰量及痰液性状)及血清肿瘤坏死因子α(TNF-α)、白细胞介素17(IL-17)、白三烯B4(LTB4)水平变化情况,观察两组临床疗效,并记录不良反应。结果治疗组总有效率为95%,对照组为75%(P=0.025)。治疗后两组患者MMEF、FEV1/FVC、FEV1和FVC均高于治疗前(P<0.05),且治疗组均高于对照组(P<0.05或P<0.01);治疗后两组患者气道黏液高分泌各项指标评分、CAT评分、血清TNF-α、IL-17和LTB4与本组治疗前比较均明显降低(P<0.05),且治疗组均低于对照组(P<0.05或P<0.01)。治疗组出现恶心、胃肠胀气各1例;对照组出现1例恶心,均未经处理后症状消失,两组比较差异无统计学意义(P=1.000)。结论清咳平喘颗粒联合噻托溴铵粉雾剂较单用西药可能通过减轻气道黏液高分泌和降低血清TNF-α、IL-17及LTB4水平的途径,达到改善COPD稳定期患者肺功能和临床症状的目的,且未见明显不良反应。

Objective To investigate the clinical effect of Qingke Pingchuan Granule(清咳平喘颗粒,QPG)combined with tiotropium bromide inhalation spray for the treatment of chronic obstructive pulmonary disease(COPD)of stable stage with phlegm-heat obstructing the lung pattern,and to explore the possible mechanism.Methods Eighty patients with stable COPD were randomly divided into intervention group and control group,with 40 patients in each group.The control group was treated with tiotropium bromide inhalation spray,1 capsule each time,once daily;additionally,the intervention group was treated with QPG,10 g each time,three times daily;the course of treatm was 8 weeks in both groups.The pulmonary function paramsuch as maximum mid-expiratory flow(MMEF),forced expiratory volume in the first second(FEV1)/forced vital capacity(FVC),and FEV1/FVC,the COPD assessment test(CAT)score,the airway mucus hypersecretion indexes such as cough,expectoration difficulty,daytime and night-time sputumvolume and sputum properties,and the levels of serum tumor necrosis factor alpha(TNF-α),interleukin 17(IL-17),and leukotriene B4(LTB4)were assessed.The clinical effect was evaluated,and adverse reactions of both groups were recorded and compared.Results In terms of total effective rate,the intervention group(95%)was significantly higher than the control group(75%,P=0.025).MMEF,FEV1/FVC,FEV1 and FVC significantly increased after treatment in both groups(P<0.05),and more increases were seen in the intervention group than in the control group(P<0.05 or P<0.01).The airway mucus hypersecretion indexes,the CAT score,and the levels of serum TNF-α,IL-17 and LTB4 in both groups were significantly reduced after treatment(P<0.05),and more reductions were found in the intervention group(P<0.05 or P<0.01).There was one case of nausea and one case of flatulence in the intervention group,while one case of nausea occurred in the control group,all of which disappeared without treatment,and there was no significant difference between groups(P=1.000).Conclusion QPG combined with tiotropium bromide inhalation spray has better effects than inhalation spray alone on iung function and relieving clinical symptoms in patients with stable COPD,which may be related to QPG’s function of inhibiting airway mucus hypersecretion and down-regulating serum TNF-α,IL-17,and LTB4 levels.