Randomized contorl clinical study on safety and efficacy of domestic cefepime in the treatment of lower-respiratory tract bacterial infections

YUAN Zhe; et al

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Randomized contorl clinical study on safety and efficacy of domestic cefepime in the treatment of lower-respiratory tract bacterial infections

更新时间：2024-01-17

- Randomized contorl clinical study on safety and efficacy of domestic cefepime in the treatment of lower-respiratory tract bacterial infections
- Journal of Chongqing Medical University Issue 3, Pages: 290-293(2007)
- 作者机构：
  
  1. 重庆医科大学附属第一医院感染科
  2. 重庆市传染病寄生虫病学重点实验室
- 作者简介：
- 基金信息：
- DOI：
  CLC： R56
- Published：2007，
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[1]袁喆,辛小娟,黄文祥,李崇智.国产头孢吡肟治疗下呼吸道细菌感染疗效及安全性评价[J].重庆医科大学学报,2007(03):290-293.

YUAN Zhe, et al. Randomized contorl clinical study on safety and efficacy of domestic cefepime in the treatment of lower-respiratory tract bacterial infections. [J]. Journal of Chongqing Medical University (3):290-293(2007)
[1]袁喆,辛小娟,黄文祥,李崇智.国产头孢吡肟治疗下呼吸道细菌感染疗效及安全性评价[J].重庆医科大学学报,2007(03):290-293. DOI：

YUAN Zhe, et al. Randomized contorl clinical study on safety and efficacy of domestic cefepime in the treatment of lower-respiratory tract bacterial infections. [J]. Journal of Chongqing Medical University (3):290-293(2007) DOI：

摘要

目的:评价国产头孢吡肟治疗呼吸系统细菌感染的有效性与安全性。方法:采用多中心随机双盲对照试验设计

以进口头孢吡肟为对照药

试验组和对照组剂量均为每次2g

静脉滴注

每日2次

疗程7￣14天。结果:试验组30例

对照组30例。试验组与对照组的临床有效率与痊愈率分别为93.33%、63.33%与96.67%、70%

细菌清除率分别为96%和100%

不良事件发生率分别为3.3%和0%

以上结果统计学均无显著性差异（P>0.05）。MIC值测定显示

头孢吡肟对大多数细菌的MIC值低于或与其它5种抗菌药物相近。结论:国产头孢吡肟抗菌谱广、抗菌活性强

是一个治疗下呼吸道细菌性感染的高效、安全的抗菌药物

与进口头孢吡肟相当。

Abstract

Objective:To evaluate the safety and efficacy of domestic cefepime in the treatment of lower-respiratory tract bacterial infections.Methods:A double-blind

randomized control clinical trial of intravenous cefepime on patients with lower-respiratory tract bacterial infections were conducted.The regimen of the two groups were 2g

twice daily for 7 to14ds.Both drugs were given intravenously.Results:In this trial

30 patients were enrolled in trial group and other 30 patients were enrolled in control group.The overall efficacy rates and cure rate in trial and control group were 93.33%?63.33% and 96.67%?70% respectively.The bacterial clearance rates were 96% and 100% respectively

and the adverse drug reaction rates were 3.3% and 0%. There was no statistical significant differences in the above results between the two groups.The activity of cefepime against gram-positive organisms was generally higher than that of the other 4 antibacterial agents.Conclusion:The results suggested that demostic cefepime with powerful antibacterial activity and wide spectrum has the same safety and efficacy as imported one in treating lower-respiratory tract bacterial infections.

关键词

头孢吡肟随机对照双盲法呼吸系统感染细菌感染

Keywords

CefepimeRandomized controlDouble-blind methodRespiratory tract infectionsBacterial infections

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Department of Clinical Laboratory, College of Clinical Medicine, Chongqing Medical University

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北京大学临床药理研究所

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