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【medical-news】沙美特罗/丙酸氟替卡松与COPD生存率
Peter M.A. Calverley, M.D., Julie A. et al.
From NEJM, Volume 356:775-789 February 22, 2007 Number 8 本人已认领该文,48小时交稿 Salmeterol and Fluticasone Propionate and Survival in Chronic Obstructive Pulmonary Disease
Peter M.A. Calverley, M.D., Julie A. et al.
From NEJM, Volume 356:775-789 February 22, 2007 Number 8
沙美特罗、氟替卡松丙酸酯与COPD的生存率----来自NEJM的报道
ABSTRACT
摘要
Background Long-acting beta-agonists and inhaled corticosteroids are used to treat chronic obstructive pulmonary disease (COPD), but their effect on survival is unknown.
背景：长效ß-受体激动剂和吸入性糖皮质激素可用于治疗慢性阻塞性肺病（COPD），但对其生存率的影响尚不清楚。
Methods We conducted a randomized, double-blind trial comparing salmeterol at a dose of 50 μg plus fluticasone propionate at a dose of 500 μg twice daily (combination regimen), administered with a single inhaler, with placebo, salmeterol alone, or fluticasone propionate alone for a period of 3 years. The primary outcome was death from any cause for the comparison between the combination regimen and placebo; the frequency of exacerbations, health status, and spirometric values were also assessed.
方法：我们采用随机双盲试验，将50 μg沙美特罗联合500 μg的氟替卡松丙酸酯（联合方案）每天两次吸入，与单独给予安慰剂，单独给予沙美特罗和单独给予氟替卡松丙酸酯三组进行比较，观察三年。所记录的原始结果包括由比较联合给药组和安慰剂组所得各种原因引起的死亡，以及对恶化的频率、健康状况和肺活量检查数值。
Results Of 6112 patients in the efficacy population, 875 died within 3 years after the start of the study treatment. All-cause mortality rates were 12.6% in the combination-therapy group, 15.2% in the placebo group, 13.5% in the salmeterol group, and 16.0% in the fluticasone group. The hazard ratio for death in the combination-therapy group, as compared with the placebo group, was 0.825 (95% confidence interval [CI], 0.681 to 1.002; P=0.052, adjusted for the interim analyses), corresponding to a difference of 2.6 percentage points or a reduction in the risk of death of 17.5%. The mortality rate for salmeterol alone or fluticasone propionate alone did not differ significantly from that for placebo.
从有效人群中选出的6112位患者中，875人在开始研究性治疗的三年内死亡。联合治疗组的全因死亡率为12.6%，安慰剂组为15.2%，美沙特罗组为13.5% ，氟替卡松丙酸酯组为16.0%。
联合治疗组与安慰剂组的死亡风险比率为0.825（95%的可信区间[CI], 0.681 to 1.002; P=0.052, 按期中分析进行了调整）相当于相差2.6个百分点或者是降低17.5%的死亡率。单给美沙特罗和单给氟替卡松丙酸酯两组的死亡率分别与安慰剂组相比均无显著差别。
As compared with placebo, the combination regimen reduced the annual rate of exacerbations from 1.13 to 0.85 and improved health status and spirometric values (P<0.001 for all comparisons with placebo). There was no difference in the incidence of ocular or bone side effects. The probability of having pneumonia reported as an adverse event was higher among patients receiving medications containing fluticasone propionate (19.6% in the combination-therapy group and 18.3% in the fluticasone group) than in the placebo group (12.3%, P<0.001 for comparisons between these treatments and placebo).
与安慰剂组相比，联合用药将恶化年增长率由1.13 降至0.85，并且提高了健康状况和肺功能指标（P<0.001均与安慰剂组进行对照）。对视力和骨骼的影响两组无差异。在接受含有氟替卡松丙酸酯的药物治疗的患者中（联合治疗组为19.6%， 氟替卡松丙酸酯组为18.3%），以肺炎作为恶化事件而上报的概率高于安慰剂组（12.3%, P<0.001 比较治疗组与安慰剂组）。
Conclusions The reduction in death from all causes among patients with COPD in the combination-therapy group did not reach the predetermined level of statistical significance. There were significant benefits in all other outcomes among these patients.
结论：联合治疗对COPD患者死亡率的降低并未达到预期的水平和统计学意义。这些患者的其他所有统计结果都有其重要意义。 沙美特罗、氟替卡松丙酸酯与COPD的生存率----来自NEJM的报道
摘要
背景：长效ß-受体激动剂和吸入性糖皮质激素可用于治疗慢性阻塞性肺病（COPD），但对其生存率的影响尚不清楚。
方法：我们采用随机双盲试验，将50 μg沙美特罗联合500 μg的氟替卡松丙酸酯（联合方案）每天两次吸入，与单独给予安慰剂，单独给予沙美特罗和单独给予氟替卡松丙酸酯三组进行比较，观察三年。所记录的原始结果包括由比较联合给药组和安慰剂组所得各种原因引起的死亡，以及对恶化的频率、健康状况和肺活量检查数值。
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作者:admin@医学,生命科学 2011-02-14 18:22
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