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目的观察小剂量茶碱联合沙美特罗氟替卡松50μg/250μg治疗中重度稳定期慢性阻塞性肺疾病(COPD)的疗效和安全性,并与单独吸入沙美特罗氟替卡松50μg/500μg相比较。方法 99例中重度稳定期COPD患者随机分为两组,A组予茶碱(0.1 g,po,bid)+沙美特罗氟替卡松(50μg/250μg,吸入,bid),B组予沙美特罗氟替卡松(50μg/500μg,吸入,bid),均治疗6个月。观察两组治疗前后肺功能、慢性阻塞性肺病评估测试问卷(CAT)评分、诱导痰中性粒细胞计数及不良反应的差异。结果 A组完成42例,B组完成41例。两组治疗6个月后,第一秒用力呼气容积(FEV_1)占预计值百分比、FEV_1/用力肺活量(FVC)、深吸气量(IC)占预计值百分比明显改善(P<0.05),组间比较均无显著差异(P>0.05)。两组治疗后CAT评分、诱导痰中性粒细胞计数均显著下降(P<0.05),组间比较差异无显著意义(P>0.05)。两组不良反应发生率无显著差异(均为8%,P>0.05)。结论小剂量茶碱联合沙美特罗氟替卡松50μg/250μg治疗中重度稳定期COPD安全有效,疗效与单独吸入沙美特罗氟替卡松50μg/500μg相当,而氟替卡松用量更少。
Objective To observe the efficacy and safety of low-dose theophylline combined with salmeterol and fluticasone 50 μg / 250 μg in the treatment of moderate-severe chronic obstructive pulmonary disease (COPD) and compared with 50 μg / 500 μg of salmeterol and fluticasone alone. Methods Ninety-nine patients with moderate-to-severe stable COPD were randomly divided into two groups: group A was givenophylline (0.1 g, po, bid) and salmeterol • fluticasone (50 μg / 250 μg, (50μg / 500μg, inhalation, bid) were treated for 6 months. The differences of lung function, chronic obstructive pulmonary disease evaluation test (CAT) score, induced sputum neutrophil count and adverse reactions before and after treatment were observed. Results A group of 42 cases completed, B group completed 41 cases. After six months of treatment, FEV 1, FEV 1, FVC and IC, as a percentage of the predicted value, were significantly improved (P 0.05) There was no significant difference between groups (P> 0.05). After treatment, CAT score and induced sputum neutrophil count decreased significantly in both groups (P <0.05). There was no significant difference between the two groups (P> 0.05). No significant difference in the incidence of adverse reactions between the two groups (8%, P> 0.05). Conclusions Small dose of theophylline combined with salmeterol and fluticasone 50μg / 250μg is safe and effective in the treatment of COPD with moderate-severe stable COPD. The efficacy is similar to that of salmeterol and fluticasone 50μg / 500μg, while the amount of fluticasone used is less.