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社区获得性肺炎患者每日单次剂量头孢地嗪:一项开放标签、对照、随机研究。意大利多中心社区获得性肺炎研究组。

Single daily dose of cefodizime in patients with community-acquired pneumonia: an open-label, controlled, randomized study. The Italian Multicentre Community-Acquired Pneumonia Group.

作者信息

De Palma M, Rocchi D, Canepa G, Peri A, Cantone V

机构信息

II Divisione Pneumologica, Ospedale San Martino, Genova, Italy.

出版信息

Clin Ther. 1995 May-Jun;17(3):413-24. doi: 10.1016/0149-2918(95)80106-5.

DOI:10.1016/0149-2918(95)80106-5
PMID:7585845
Abstract

The objective of this study was to compare the clinical and bacteriologic efficacy and safety of cefodizime 1 g intramuscularly (IM) once daily (group A) versus cefodizime 1 g IM twice daily (group B) and versus ceftriaxone 1 g IM once daily (group C) in patients with community-acquired pneumonia. A total of 298 patients, affected by bronchopneumonia or pneumonia with known or suspected bacterial cause, new focal signs on examination of chest, and radiographic evidence of a recent infiltrate, were randomized in three comparable groups. The infection was rated as mild, moderate, or severe. A total of 283 patients were assessable for efficacy: 95 in group A, 94 in group B, and 94 in group C. Mean (+/- SD) duration of treatment was 5.96 +/- 1.39 days in group A, 6.24 +/- 1.57 days in group B, and 6.66 +/- 1.95 days in group C. Symptoms such as purulent sputum, cough, and dyspnea improved significantly after treatment in all groups; temperature normalized by about day 3. Clinical efficacy was rated good in 94.74% of patients in group A, in 92.55% in group B, and in 87.23% in group C. Positive bacteriologic cultures were obtained before treatment from 144 patients: bacteriologic responses were rated good in 98.11%, 98.08%, and 92.80% in groups A, B, and C, respectively. No significant differences were found between the three treatment groups for any measures of clinical efficacy. No serious adverse event occurred in any of the groups. We conclude that cefodizime 1 g IM once daily is an effective dosing regimen in the treatment of patients with community-acquired pneumonia.

摘要

本研究的目的是比较每日1次肌内注射(IM)1g头孢地嗪(A组)、每日2次IM 1g头孢地嗪(B组)和每日1次IM 1g头孢曲松(C组)对社区获得性肺炎患者的临床和细菌学疗效及安全性。共有298例受支气管肺炎或已知或疑似细菌感染的肺炎影响、胸部检查有新的局灶性体征且有近期浸润的影像学证据的患者被随机分为三个可比组。感染程度分为轻度、中度或重度。共有283例患者可评估疗效:A组95例,B组94例,C组94例。A组的平均(±标准差)治疗持续时间为5.96±1.39天,B组为6.24±1.57天,C组为6.66±1.95天。所有组治疗后脓性痰、咳嗽和呼吸困难等症状均有显著改善;体温约在第3天恢复正常。A组94.74%的患者、B组92.55%的患者和C组87.23%的患者临床疗效被评为良好。144例患者在治疗前获得了阳性细菌培养结果:A组、B组和C组的细菌学反应良好率分别为98.11%、98.08%和92.80%。三个治疗组在任何临床疗效指标上均未发现显著差异。任何一组均未发生严重不良事件。我们得出结论,每日1次IM 1g头孢地嗪是治疗社区获得性肺炎患者的一种有效给药方案。

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引用本文的文献

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Ceftriaxone: an update of its use in the management of community-acquired and nosocomial infections.头孢曲松:其在社区获得性感染和医院感染管理中应用的最新情况
Drugs. 2002;62(7):1041-89. doi: 10.2165/00003495-200262070-00005.
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BTS Guidelines for the Management of Community Acquired Pneumonia in Adults.英国胸科学会成人社区获得性肺炎管理指南
Thorax. 2001 Dec;56 Suppl 4(Suppl 4):IV1-64. doi: 10.1136/thorax.56.suppl_4.iv1.