【摘要】 目的比较低剂量的沙美特罗/丙酸氟替卡松干粉剂(SM/FP)与中等剂量的布地奈德干粉(BUD)吸入治疗成年轻、中度支气管哮喘(简称哮喘)患者的临床疗效和安全性。方法采用多中心、随机、开放、平行对照试验,389例18～70岁哮喘患者按随机数字表法分为试验组[199例,吸入SM/FP1泡/次(每泡SM50μg、FP100μg),每天2次]和对照组(193例,吸入BUD,每次400μg,每天2次)。结果试验组和对照组患者晨间呼气峰流速(PEFam)在治疗的第1周末较基线值分别提高(26±2)L/min和(7±5)L/min(P均<0.01);6周后两组的改善分别为(54±6)L/min和(31±8)L/min(P均<0.01);治疗期间试验组每周均改善更明显;晚间呼气峰流速(PEFpm)与PEFam结果相似;日间和夜间症状评分在试验组和对照组治疗第1周比较差异均有统计学意义(P<0.05);6周时试验组下降的程度与对照组比较差异有统计学意义(P<0.01);全天无症状天数的百分数试验组由治疗前的6.9%增加至治疗后的55.2%,对照组则由8.4%增加至36.1%。沙丁胺醇气雾剂的揿数在两组分别由治疗前的(3.32±3.15)揿和(3.21±3.23)揿下降至治疗结束时的(1.06±1.79)揿和(2.03±3.17)揿,两组比较差异有统计学意义(P<0.01),试验组的用药揿数显著少于对照组;无需沙丁胺醇的天数试验组与对照组比较差异有统计学意义(P<0更多还原

【Abstract】 Objective To evaluate the efficacy and the safety of low dose salmeterol/fluticasone（SM/FP） combination therapy as compared to morate dose of budesonide（BUD） in the management of adult asthma. Methods A multicentre, randomised,open-label,parallel-group,6-week treatment study was conducted. 398 patients（18-70 years） were given SM/FP（50/100 μg） twice daily via Accuhaler or BUD 400 μg twice daily via Turbuhaler . Results The morning and the evening peak expiratory flow（PEF） measurements both increased significantly（P<0.01） in the SM/FP group, and the increase was greater than that in the BUD group. The significant benefit of SM/FP was evident from the first week. SM/FP led to a more significant reduction in the use of rescue medication and in the day- and night- time asthma symptom scores,as compared to budesonide. Both treatments were well tolerated,and the adverse reactions showed no significant difference between the two groups. Conclusions Combination use of low doses of SM/FP is a better choice for the control of asthma. The addition of a low-dose long-acting β₂ agonist is superior to the simple increase of the dosage of inhaled corticosteroids.更多还原