不同剂型沙美特罗氟替卡松粉吸入剂治疗慢性阻塞性肺疾病稳定期的效果比较

Efficacy of different formulations of fluticasone salmeterol powder inhaler for stable status chronic obstructive pulmonary disease

目的观察不同剂型的沙美特罗氟替卡松粉吸入剂（舒利迭）（沙美特罗／丙酸氟替卡松：50μg／500μg与沙美特罗／丙酸氟替卡松：50μg／250μg））在慢性阻塞性肺疾病（COPD）稳定期中的疗效。方法将60例中、重度COPD患者随机分为治疗组和对照组。对照组给予舒利迭（50μg／250μg），每12小时1次，疗程24周；治疗组给予吸入舒利迭（50μg／500μg），每12小时1次，疗程24周。观察治疗前、后肺功能的变化，并进行临床症状问卷调查及体征检查评分。结果治疗前，两组各项指标差异均无统计学意义（P均〉0．05）。治疗后，治疗组临床症状体征评分显著低于对照组，差异有统计学意义[（4．0±0．5）分与（4．8±0．3）分，t=2．63，P〈0．05]；治疗组6min步行距离（6MWD）显著高于对照组，差异有统计学意义[（451．6±22．9）m与（401．2±25．4）m，t=2．51，P〈0．05]；治疗组的第1秒用力呼气容积（FEV1）、第1秒用力呼气容积占预计值百分比（FEV1／预计值％）、第1秒用力呼气容积／用力肺活量（FEV1／FVC）均高于对照组，差异均有统计学意义[FEV1：治疗组（2．18±0．38）L，对照组（1．78±0．45）L；FEV1／预计值％：治疗组（63．19±9．08）％，对照组（57．19±9．25）％；FEV1／FVC：治疗组（73．8±5．6）％，对照组（67．3±11．5）％。t值分别为：2．61、2．48、2．52，P均〈0．05]。结论高剂量的舒利迭更能有效地改善中、重度慢性阻塞性肺疾病患者的肺功能指标，改善患者临床症状，改善生命质量。

Objective To compare the clinical efficacy of seretide （50 I±g/500 pLg salmeterol/ fluticasone propionate） with seretide （50 Ixg/250 I±g salmeterol/fluticasone propionate） in single inhaler in the treatment of patients with stable status moderate to severe chronic obstructive pulmonary disease （COPD） Methods Sixty patients with COPD were randomly divided into the treatment and the control groups. Baseline treatments were similar in all patients,patients in the treatment group received seretide （50 μg/500 μg） while the control group received seretide （50 μg/250μg） inhalation once every 12 hours for 24 weeks. Before and after the therapeutic course, tests for lung function in patients of the two groups were conducted and compared with each other. Clinical symptoms and physical signs were graded by questionnaire. Results There was no significant difference on indexes of lung function between the two groups at baseline （ P 〉 0. 05 ） . After treatment, the score of clinical symptoms and signs in the treatment group was lower than that in the control group （ （4.0 ± 0. 5 ） vs. （4. 8 ± 0. 3 ）, t = 2. 63, P 〈 0. 05 ）. Six minutes walking distance was longer in the treatment group than that in the control group （ （451.6 ± 22. 9） meter vs. （401.2 ± 25.4） meter, t = 2. 51, P 〈 0.05 ）. The levels of forced exhaled gas volume 1 （FEV1）, FEV1 /forced vital capacity （FVC） and FEV1/pred in the treatment group were higher than those in the control group （ [ FEV1 ： （2. 18 ± 0. 38 ） L vs. （ 1.78 ± 0.45 ） L; FEV1/pred： （63.19 ±9.08）% vs. （57.19 ±9.25）%; FEV1/FVC%： （73.8 ±5.6）% vs. （67.3 ± 11.5 ） % ;P 〈 0. 05 ）. Conclusion High dosage of seretide had better effect in the treatment of stable moderate and severe COPD ,and can obviously improve patients＇ lung function,clinical symptoms and quality of life.