Adachi Mitsuru, Aizawa Hisamichi, Ishihara Kyousuke, Ohta Ken, Sano Yasuyuki, Taniguchi Hiroyuki, Nakashima Mitsuyoshi
First Department of Internal Medicine, School of Medicine, Showa University, Tokyo, Japan.
Respir Med. 2008 Jul;102(7):1055-64. doi: 10.1016/j.rmed.2008.01.021. Epub 2008 Apr 3.
To compare the efficacy and safety of the salmeterol/fluticasone propionate combination product with concurrent sustained release theophylline plus fluticasone propionate in adult Japanese patients with persistent asthma.
Multicentre, randomised, double-blind, double-dummy, parallel-group study.
Three hundred and eighty-three asthmatic patients receiving sustained release theophylline 200-400mg/day entered the study and were randomised to receive either salmeterol/fluticasone propionate combination (SFC) 50microg/250microg+1 placebo tablet, fluticasone propionate 250microg+1 sustained release theophylline 200mg (SR-T+FP), twice daily for 8 weeks.
The adjusted mean change morning peak expiratory flow (PEF) over 8 weeks was 29.8L/min in the SFC group and 16.3L/min in the SR-T+FP group, with a treatment difference of 13.4L/min (p=0.0004). SFC improved evening PEF, FEV1, V50 and V25 at the completion of treatment to a greater extent than SR-T+FP (all p<0.05). A higher percentage of patients on SFC were symptom free (p=0.0286) and rescue free (ns) than those on SR-T+FP. There was not a statistically significant difference between treatments in symptom scores. Both treatments were well tolerated.
The finding that SFC was associated with greater improvements in lung function than SR-T+FP, a commonly employed treatment for asthmatic patients in Japan, suggests that SFC should be the preferred therapeutic option in these patients.
比较沙美特罗/丙酸氟替卡松联合制剂与同时使用的缓释茶碱加丙酸氟替卡松在成年日本持续性哮喘患者中的疗效和安全性。
多中心、随机、双盲、双模拟、平行组研究。
383例接受每日200 - 400mg缓释茶碱治疗的哮喘患者进入研究，随机分为接受沙美特罗/丙酸氟替卡松联合制剂（SFC）50μg/250μg + 1片安慰剂，或丙酸氟替卡松250μg + 1片200mg缓释茶碱（SR-T + FP），每日两次，共8周。
SFC组8周内调整后的平均晨起呼气峰值流速（PEF）变化为29.8L/min，SR-T + FP组为16.3L/min，治疗差异为13.4L/min（p = 0.0004）。治疗结束时，SFC在改善夜间PEF、FEV1、V50和V25方面比SR-T + FP更显著（所有p < 0.05）。与SR-T + FP组相比，接受SFC治疗的患者无症状（p = 0.0286）和无需使用缓解药物（无统计学差异）的比例更高。治疗组间症状评分无统计学显著差异。两种治疗耐受性均良好。
SFC比日本常用的哮喘治疗药物SR-T + FP在肺功能改善方面更显著，这表明SFC应是这些患者的首选治疗方案。
