吸入舒利迭治疗稳定期COPD的临床研究

目的观察吸入丙酸氟替卡松/沙美特罗（舒利迭）（Fluticasone prpionate,FP）对稳定期COPD的临床疗效。方法 60例稳定期Ⅱ级COPD患者随机分成4组,分别给予不同剂量的丙酸氟地卡松和安慰剂（对照组）吸入治疗12周,于治疗前及治疗2周后、6周后、12周后测定FEV1、血浆皮质醇、骨密度,并记录临床症状记分和生活质量记分。结果临床症状评分各治疗组吸入丙酸氟地卡松迭2周后较治疗前明显下降（P〈0.05）,但治疗后不同时间段间比较无显著性差异（P〉0.05）;各组FEV1治疗前与治疗12周后比较无显著性差异（P〉0.05）。生活质量评分各组治疗前较治疗12周后无显著性差异（P〉0.05）。血浆皮质醇水平高剂量组治疗2周后即较前降低（P〈0.05）,治疗12周后更降低（P〈0.01）;中剂量组治疗12周后较治疗前降低（P〈0.05）;低剂量组和对照组治疗前较治疗12周后无显著性差异（P〉0.05）。股骨颈的股密度各组治疗前后无显著性差异（P〉0.05）。结论吸入一定剂量的丙酸氟地卡松,可减轻稳定期COPD患者的临床症状,而不引起骨密度降低,但不能改善其FEV1,不能改善生活质量,但有可能引起血浆皮质醇水平下降。

Clincal study of inhaled fluticasone propionate in stable chronic obstructive pulmonary disease

Objective To observe the effect of fluticasone propionate（FP）in the treatment of stable moderate chronic obstructive pulmonary disease（COPD）.Methods 60 stable moderate COPD patients in stageⅡwere randomly divided into four groups.Both groups including the control group were given different doses of fluorine to fluticasone propionate and placebo inhalation for 12 weeks.Before and 2 weeks,6 weeks,12 weeks after the treatment,the pulmonary function,plasma level of cortisol and bone density were measured,and the scores of clinical symptoms and the scores of quality of life were recorded.Results Scores of clinical symptoms after 2 weeks treatment were significantly lower than before the treatment in the each treatment group（P〈0.05）,but there was no significant difference after 2 weeks,6 weeks,12 weeks treatment;forced expiratory volume showed no significant difference before the treatment and after 12 weeks treatment in each group（P〉0.05）;scores of life quality showed no significant difference before the treatment and after 12 weeks treatment in each group（P〉0.05）;the high dose plasma level of cortisol treatment group was lower after 2 weeks treatment than before the treatment（P〈0.05）,and was lower more remarkably after 12 weeks treatment（P〈0.01）,the medium dose group was lower after 12 weeks treatment than before the treatment（P〈0.05）,and there was no significant difference in the low dose group and control group before and after 12 weeks treatment（P〈0.05）;bone density in neck of femur showed no significant difference in each group before and after the treatment（P〈0.05）.Conclusion The study suggests that the treatment of inhaled FP（250～750 μg daily for 12 weeks）can improve clinical symptoms in patients with stable moderate COPD,but can decrease plasma level of cortisol,and cannot improve FEV1 and the quality of life,cannot affect the bone density.