沙美特罗/丙酸氟替卡松吸入治疗中重度COPD的临床观察

Clinical Observation of Inhalation Therapy of Salmeterol/fluticasone for Moderate and Severe Chronic Obstructive Pulmonary Disease

目的探讨吸入型肾上腺糖皮质激素(ICS)与长效β2-受体激动剂(LABA)的预混制剂沙美特罗/丙酸氟替卡松(SAL/FP)对中重度慢性阻塞性肺疾病(COPD)的治疗作用。方法COPD病人70例(全部病例入组前未使用过任何剂型的激素、受体激动剂、抗胆碱药,无氧疗史),随机分成两组,A组35例,吸入沙美特罗/丙酸氟替卡松(SAL/FP)干粉剂,1吸/次,2次/天;B组35例,不吸入上述药物;两组病人均服用沐舒坦30mg/tid。观察治疗3月、6月、12月三个时间点病人临床症状、乔治生活质量评分、肺功能、血中IL-8和TNF-α的水平、急性发作次数、住院次数、住院费用。结果观察期各不同时间点A、B两组肺功能、圣.乔治生活质量评分(SGRQ)、急性加重发生次数及、健康状态和住院次数、等各项观察指标差异有显著性(P<0.05);A组明显优于B组,治疗前后诱导痰IL-8和TNF-α明显减低(P<0.05);但住院费用A、B两组无明显差别(P>0.05)。结论ICS与LABA治疗中重度COPD具有良好协同作用,其预混制剂(SAL/FP 50/250μg)干粉剂使用方便,近期疗效好,有临床应用价值,可短期改善COPD的FEV1的水平,对全身炎症反应无明显抑制作用,医疗费用没有明显增加。

Objective To discuss the curative effect of inhaled giucooorticoid （ICS） in combination with long - acting β2 agonist （LABA） on patients with moderate and severe chronic obstructive pulmonary disegse （COPD）. Methods 70 patients with COPD were randomly divided into 2 groups： Group A and Group B, 35 in each group ; all the patients, before this treatment, had no application history of any type of hormones, receptor agonists and anticholinergic drugs and they never had oxygen therapy; ambroxol was given to all the patients in both groups, 30mg once and 3 times a day, and for patients in Group A, inhalation of Seretide Dry Powder （salmeterol/ fluticasone, SM/FP, 50μg of salmeterol/259μg of fluticasone） was added twice a day; an observation was made at 3 time points （3 months, 6 months and 12 months after treatment） to the following： the clinical symptoms, the score of St. George＇s respiratory questionnaire （SGRQ）, pulmonary function, the level of blood interleukin - 8 （IL-8） and TNF-α , the acute exacerbations, times and expenses of hospitalization. Results The difference between the 2 groups in pulmonary function, the score of SGRQ, the acute exacerbation, the health status and the times of hospitalization was of significance （ P 〈 0.05 ） ; the level of IL-8 in induced spuium and TNF-α in Group A decreased significantly （ P 〈 0.05 ） ; the comparison of hospitalization expenses between the 2 groups was of no obvious difference （ P 〈 0.05）. Conclusions ICS and LABA play good synergetic effect on moderate and severe COPD, the administration of SM/FP （50/ 250μg） is simple and the short - term curative effect is good, it can soon improve FEV1 but has no obvious inhibition on systemic inflammatory response ; there exists no obvious increase of the hospitalization expenses.