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加替沙星治疗老年社区获得性肺炎门诊患者的疗效与安全性

Efficacy and safety of gatifloxacin in elderly outpatients with community-acquired pneumonia.

作者信息

Nicholson Susan C, Wilson Walter R, Naughton Bruce J, Gothelf Samantha, Webb C Douglas

机构信息

Bristol-Myers Squibb Company, Plainsboro, New Jersey, USA.

出版信息

Diagn Microbiol Infect Dis. 2002 Sep;44(1):117-25. doi: 10.1016/s0732-8893(02)00465-0.

Abstract

To evaluate the safety and efficacy of gatifloxacin in adults <65, 65 to 79, or > or =80 years old with community-acquired pneumonia, adult male and female outpatients from general community-based practices were enrolled in an open-label, multicenter, noncomparative study. Gatifloxacin 400 mg once daily was administered for seven to 14 days. Medical history, physical examination, signs and symptoms of infection, Gram stain and culture if specimen available, clinical response, and safety were determined. Of 1655 treated patients, 1103 were at least 65 years old, 405 were 65 to 79, and 147 were at least 80. Patients > or =80 years old presented with chills, chest pain, fever, or headache less often than younger patients. Cure rates were 95.5% for patients <65 years old, 96.2% for those 65 to 79, and 90.2% for those at least 80 years old. Neither the frequency nor susceptibility of isolated pathogens appeared to differ with age. Between 93.7% and 100% of subsets of the two younger groups with verified Streptococcus pneumoniae or Hemophilus influenzae were cured. All oldest-group patients in the subset with verified S. pneumoniae and 71.4% (7) of patients with H. influenzae were cured. Each age group, including current or past smokers and patients receiving medications for concomitant conditions, tolerated treatment well. Gatifloxacin is safe and efficacious in adults of any age with community-acquired pneumonia, including the elderly up to 100 years old and patients with S. pneumoniae including penicillin-resistant strains.

摘要

为评估加替沙星用于年龄小于65岁、65至79岁或大于或等于80岁的社区获得性肺炎成年患者的安全性和有效性,来自普通社区医疗机构的成年男女门诊患者被纳入一项开放标签、多中心、非对照研究。每日一次给予加替沙星400mg,疗程为7至14天。记录病史、体格检查、感染的体征和症状、如有标本则进行革兰氏染色和培养、临床反应及安全性。在1655例接受治疗的患者中,1103例年龄至少65岁,405例年龄在65至79岁之间,147例年龄至少80岁。年龄大于或等于80岁的患者出现寒战、胸痛、发热或头痛的频率低于年轻患者。年龄小于65岁患者的治愈率为95.5%,65至79岁患者为96.2%,年龄至少80岁患者为90.2%。分离病原体的频率和敏感性似乎均不随年龄而不同。两个较年轻年龄组中经证实为肺炎链球菌或流感嗜血杆菌感染的亚组,治愈率在93.7%至100%之间。经证实为肺炎链球菌感染的最年长组所有患者以及71.4%(7例)流感嗜血杆菌感染患者均治愈。各年龄组,包括目前或既往吸烟者以及因合并症接受药物治疗的患者,对治疗耐受性良好。加替沙星对于任何年龄的社区获得性肺炎成年患者,包括100岁以下的老年人以及包括耐青霉素菌株的肺炎链球菌感染患者,均安全有效。

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