Intermittent administration of inhaled tobramycin in patients with cystic fibrosis
Intermittent administration of inhaled tobramycin in patients with cystic fibrosis
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DOI：
10.1056/nejm199901073400104
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发表时间：
1999-01-07
影响因子：
158.5
通讯作者：
Smith, AL
中科院分区：
文献类型：
--
作者：
Ramsey, BW;Pepe, MS;Smith, AL
背景和方法我们进行了两项多中心、双盲、安慰剂对照试验，研究间歇性吸入妥布霉素治疗囊性纤维化和铜绿假单胞菌感染的患者。共有520例患者（平均年龄21岁）被随机分配接受300 mg吸入妥布霉素或安慰剂，每日两次，持续四周，随后四周不使用研究药物。患者分三个开-关周期接受治疗或安慰剂，总共24周。结果吸入妥布霉素组第20周第1秒用力呼气量（FEV 1）较0周平均增加10%，而安慰剂组第1秒用力呼气量（FEV 1）较0周平均下降2%（P
Background and Methods We conducted two multicenter, double-blind, placebo-controlled trials of intermittent administration of inhaled tobramycin in patients with cystic fibrosis and Pseudomonas aeruginosa infection. A total of 520 patients (mean age, 21 years) were randomly assigned to receive either 300 mg of inhaled tobramycin or placebo twice daily for four weeks, followed by four weeks with no study drug. Patients received treatment or placebo in three on-off cycles for a total of 24 weeks. The end points included pulmonary function, the density of Fl aeruginosa in sputum, and hospitalization.Results The patients treated with inhaled tobramycin had an average increase in forced expiratory volume in one second (FEV1) of 10 percent at week 20 as compared with week 0, whereas the patients receiving placebo had a 2 percent decline in FEV1 (P