[头孢吡肟用于慢性呼吸道感染的剂量探索研究]

[Dose finding study of cefepime for chronic respiratory infections].

作者信息

Saito A, Shigeno Y, Irabu Y, Fukuhara H, Saito A, Nakayama I, Hiraga Y, Ohmichi M, Oizumi K, Watanabe A

机构信息

First Department of Internal Medicine, Faculty of Medicine, University of the Ryukyus.

出版信息

Kansenshogaku Zasshi. 1992 Jul;66(7):837-58. doi: 10.11150/kansenshogakuzasshi1970.66.837.

DOI:10.11150/kansenshogakuzasshi1970.66.837

PMID:1431363

Abstract

In order to determine the optimal dose of cefepime (CFPM) for respiratory tract infections, a dose finding study was conducted in patients with chronic respiratory tract infections, and the clinical properties of the drugs were compared with those of ceftazidime (CAZ). Each drug was administered by intravenous drip infusion at the dose of 2 g/day of CFPM, 4 g/day of CFPM or 2 g/day of CAZ for 14 days. 1. The overall efficacy rates evaluated by the committee were 82.6% (19/23) for the CFPM 2 g/day group, 85.0% (17/20) for the 4 g/day group and 79.3% (23/29) for the CAZ 2 g/day group, with no statistically significant difference among the three groups. 2. The overall efficacy rates evaluated by the attending physicians were 91.3% (21/23) for the CFPM 2 g/day group, 78.9% (15/19) for the CFPM 4 g/day group and 75.9% (22/29) for the CAZ 2 g/day group, with no significant difference among the three groups. 3. Bacteriological eradication rates were 88.2% (15/17) for the CFPM 2 g/day group, 68.8% (11/16) for the CFPM 4 g/day group and 63.2% (12/19) for the CAZ 2 g/day group, with no statistically significant difference among the three groups. 4. The incidences of adverse reactions were 3.8% (1/26) for the CFPM 2 g/day group, 9.1% (2/22) for the CFPM 4 g/day group and 3.4% (1/29) for the CAZ 2 g/day group, with no significant difference among the three groups. The incidences of abnormal laboratory findings were 37.5% (9/24) for the CFPM 2 g/day group, 15.0% (3/20) for the CFPM 4 g/day group and 3.4% (1/29) for the CAZ 2 g/day group. There was a significant difference among the three groups. 5. Utility rates assessed by the committee were 81.8% (18/22) for the CFPM 2 g/day group, 76.2% (16/21) for the CFPM 4 g/day group and 75.9% (22/29) for the CAZ 2 g/day group. Utility rates assessed by attending physicians were 90.9% (20/22), 78.9% (15/19) and 72.4% (21/29), respectively. There was no significant difference among the three groups. From the above results, it is concluded that the optimal dosage of CFPM is 2 g/day for chronic respiratory tract infections.

摘要

为确定头孢吡肟（CFPM）治疗呼吸道感染的最佳剂量，对慢性呼吸道感染患者进行了剂量探索研究，并将该药的临床特性与头孢他啶（CAZ）进行比较。每种药物均通过静脉滴注给药，CFPM剂量为2g/天、4g/天或CAZ剂量为2g/天，持续14天。1. 委员会评估的总有效率，CFPM 2g/天组为82.6%（19/23），4g/天组为85.0%（17/20），CAZ 2g/天组为79.3%（23/29），三组间无统计学显著差异。2. 主治医生评估的总有效率，CFPM 2g/天组为91.3%（21/23），CFPM 4g/天组为78.9%（15/19），CAZ 2g/天组为75.9%（22/29），三组间无显著差异。3. 细菌清除率，CFPM 2g/天组为88.2%（15/17），CFPM 4g/天组为68.8%（11/16），CAZ 2g/天组为63.2%（12/19），三组间无统计学显著差异。4. 不良反应发生率，CFPM 2g/天组为3.8%（1/26），CFPM 4g/天组为9.1%（2/22），CAZ 2g/天组为3.4%（1/29），三组间无显著差异。实验室检查异常发生率，CFPM 2g/天组为37.5%（9/24），CFPM 4g/天组为15.0%（3/20），CAZ 2g/天组为3.4%（1/29）。三组间存在显著差异。5. 委员会评估的效用率，CFPM 2g/天组为81.8%（18/22），CFPM 4g/天组为76.2%（16/21），CAZ 2g/天组为75.9%（22/29）。主治医生评估的效用率分别为90.9%（20/22）、78.9%（15/19）和72.4%（21/29）。三组间无显著差异。从上述结果得出结论，对于慢性呼吸道感染，CFPM的最佳剂量为2g/天。