Long-term use of oseltamivir for the prophylaxis of influenza in a vaccinated frail older population
Long-term use of oseltamivir for the prophylaxis of influenza in a vaccinated frail older population
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DOI：
10.1046/j.1532-5415.2001.49204.x
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发表时间：
2001-08-01
影响因子：
6.3
通讯作者：
Ward, P
中科院分区：
文献类型：
--
作者：
Peters, PH;Gravenstein, S;Ward, P
目的：观察奥司他韦(TM)每日一次口服6周对居住在养老院的虚弱老年人预防实验室确诊的临床流感的有效性，并确定长期服用奥司他韦的安全性和耐受性。设计：双盲、安慰剂对照、平行组、随机、多中心研究。干预：奥司他韦75 mg或安慰剂预防6周，从局部检测到流感开始。测量：主要疗效终点是实验室确认的临床流感。结果：与安慰剂(安慰剂12/272(4.4%)，奥司他韦1/276(0.4%)；P=.002)相比，奥司他韦治疗实验室确认的临床流感的发病率降低了92%。在接种流感疫苗的受试者中，奥司他韦预防实验室确诊的临床流感的有效率为91%(安慰剂11/218(5.0%)，奥司他韦1/222(0.5%)；P=0.003)。奥司他韦的使用与继发并发症的发生率显著降低有关(安慰剂7/272(2.6%)，奥司他韦1/276(0.4%)；P=.037)。尽管几乎所有受试者在研究前和研究期间都同时服用药物，但奥司他韦耐受性良好。两组的不良事件发生率相似，包括胃肠道反应。在接受奥司他韦治疗的患者中，未发现抗体反应受到抑制。结论：在家庭护理环境中，口服奥司他韦75 mg，每天1次，连续6周，可有效预防接种疫苗的虚弱老年人的临床流感。该治疗耐受性良好，并提供了比接种疫苗更多的保护。
OBJECTIVES: To investigate the efficacy of once-daily oral oseltamivir for 6 weeks (Tamiflu (TM)) in prophylaxis against laboratory-confirmed clinical influenza in frail older subjects living in homes for seniors and to determine the safety and tolerability of long-term oseltamivir.DESIGN: Double-blind, placebo-controlled, parallel-group, randomized, multicenter study.SETTING: Thirty-one residential homes for seniors across United States and Europe.PARTICIPANTS: Five hundred forty-eight frail older occupants (mean age 81 years, > 80% vaccinated).INTERVENTION: Prophylaxis with oseltamivir 75 mg or placebo once daily for 6 weeks, beginning when influenza was detected locally.MEASUREMENTS: The primary efficacy endpoint was laboratory-confirmed clinical influenza.RESULTS: Oseltamivir administration resulted in a 92% reduction in the incidence of laboratory-confirmed clinical influenza compared with placebo (placebo 12/272 (4.4%), oseltamivir 1/276 (0.4%); P = .002). Of subjects vaccinated against influenza, oseltamivir was 91 % effective in preventing laboratory-confirmed clinical influenza (placebo 11/218 (5.0%), oseltamivir 1/222 (0.5%); P = .003). Oseltamivir use was associated with a significant reduction in the incidence of secondary complications (placebo 7/272 (2.6 %), oseltamivir 1/276 (0.4%); P = .037). Although nearly all subjects were taking concomitant medication both before and during the study, oseltamivir was well tolerated. A similar incidence of adverse events, including gastrointestinal effects, occurred in both groups. There was no suppression of antibody response in oseltamivir recipients.CONCLUSION: Oral oseltamivir 75 mg once daily for 6 weeks effectively prevented clinical influenza in vaccinated frail older subjects using significant concomitant medications in a residential care setting. The treatment was well tolerated and provided additional protection to that afforded by vaccination.