参麦注射液联合沙美特罗替卡松治疗慢性阻塞性肺疾病急性加重期临床研究

Clinical Study of Shenmai Injection Combined with Salmeterol/Fluticasone in Treating AECOPD

目的:观察参麦注射液联合沙美特罗替卡松治疗慢性阻塞性肺疾病急性加重期(AECOPD)的临床疗效。方法:选取128例AECOPD患者,按照随机数字表法分为观察组和对照组各64例,对照组在常规用药基础上给予沙美特罗替卡松粉吸入剂治疗,观察组在对照组治疗基础上予参麦注射液治疗,2组均治疗2周,观察治疗前后2组临床症状(咳嗽、咯痰、喘息)、肺功能指标[第1秒用力呼气容积(FEV1)、用力肺活量(FVC)、FEV_1/FVC比值(FEV_1/FVC)]、炎性因子[C-反应蛋白(CRP)、白细胞介素-8(IL-8)及肿瘤坏死因子-α(TNF-α)]的改善情况,并对2组的T细胞亚群指标(CD3^+、CD4^+、CD8^+、CD4^+/CD8^+)进行检测。结果:治疗总有效率观察组为95.3%,高于对照组的79.7%,差异有统计学意义(P<0.05)。治疗后,2组咳嗽、咯痰及喘息临床症状积分均较治疗前下降(P<0.05),观察组3项积分均低于对照组(P<0.05);2组FEV_1、FVC、FEV_1/FVC均较治疗前改善(P<0.05),观察组改善较对照组更为明显(P<0.05);2组CD3^+、CD4^+、CD4^+/CD8^+值均较治疗前升高,CD8^+值均较治疗前降低,差异均有统计学意义(P<0.05),观察组改善较对照组更为明显(P<0.05)。结论:在常规用药基础上予参麦注射液联合沙美特罗替卡松治疗可显著改善AECOPD患者的临床症状和肺功能,临床疗效好,其作用机制可能增强患者的免疫功能和控制全身炎症反应有关。

Objective：To observe the clinical effect of Shenmai injection combined with salmeterol/fluticasone in treating acute exacerbation of chronic obstructive pulmonary disease（AECOPD）.Methods：Selected 128 patients with AECOPD,divided them into the observation group and the control group randomly,64 cases in each.The control group was given the therapy of salmeterol/fluticasone,the observation group was given the therapy of Shenmai injection combined with salmeterol/fluticasone.Treatment last for 2 weeks.Observed improvements of clinical symptoms（cough,expectoration,wheezing）,Lung Function index[the first second forced expiratory volume（FEV1）,forced vital capacity（FVC）,predicted values percentage of FEV1/FVC],inflammatory factors[C-reactive protein（CRP）,interleukin-8（IL-8）,tumor necrosis factor-a（INF-α）],detected indexes of T cell subsets（CD3^＋、CD4^＋、CD8^＋、CD4^＋/CD8^＋） of the two groups.Results：The total effective rate in the observation group was 95.3%,higher than that of 79.7%in the control group,difference being significant（P〈0.05）.After treatment,scores of cough,expectoration and wheezing were decreased（P〈0.05）,scores of the above three indexes in the observation group were lower than those in the control group（P〈0.05）.FEV1、FVC、FEV1/FVC were improved in the two groups after treatment,scores of CD3^＋、CD4^＋、CD4^＋/CD8^＋ were increased,scores of CD8^＋ were decreased（P〈0.05）.Improvement was more obvious in the observation group（P〈0.05）.Conclusion：Shenmai injection combined with salmeterol/fluticasone can improve clinical symptoms and lung function in patients with AECOPD,has good clinical efficacy.The mechanism may be correlated to improvement of immune function and control systemic inflammatory response of the patients.