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国产头孢吡肟与进口头孢吡肟随机对照治疗中重度细菌性感染临床研究

A Randomized Controlled Clinical Trial on Domestic and Imported Cefepime in the Treatment of Moderate to Severe Bacterial Infection

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【作者】 王进李家泰郝凤兰

【Author】 WANG Jin LI Jia-Tat HAO Feng-Lan (Institute Of Clinical Pharmacology, The First Teaching Hospital, Peking University Beijing 100034)

【机构】 北京大学临床药理研究所!北京100034

【摘要】 目的:旨在通过随机对照方法,对国产头孢吡肟与进口头孢吡肟在治疗中、重度细菌性感染的有效性和安全性作出评价。方法:本随机临床试验主要用于下呼吸道感染、复杂尿路感染、创伤烧伤后感染及腹腔感染、败血症。剂量均为2g·d-1,疗程10-14d。结果:本随机临床试验国产头孢吡肟与进口头孢吡肟组入选例数分别为37例和 36例,临床治愈率分别为 70.58%和 65.71%,临床有效率分别为 94.12%和97.14%,细菌清除率分别为 83.87%和 87.88%,药物不良反应发生率均为 11.43%。结论:国产头孢吡肟与进口头孢吡肟在临床疗效、细菌学疗效、药物不良反应等方面无明显差异,且对敏感菌引起的中重度感染疗效确切,药物不良反应少而轻微。

【Abstract】 OBJECTIVE: To compare the clinical efficacy and safety of cefepime manufactured in China and Import cefepime in the treatment of moderate to severe bacterial infection. METHODS: A randomized controlled clinical trial was conducted for the treatment of hospitalized patients with low-respiratory tract infection, urinary tract infection and after-hurt infection. The dosage of both drugs was 2g.The duration of treatment was 10-14 days in both groups. RESULTS: The results showed the efficacy rates were 94.12% and97.14%, whereas the bacterial efficacy rates were 93.55% and 96.88%, the bacterial clearance rate were 88.57% and 91.43%, respectively, both of the incidence of adverse reaction were 11.43%. CONCLUSION: The result showed that there was no statistical difference between the two groups (P>0.05).

【关键词】 头孢吡肟细菌性感染
【Key words】 cefepimebacterial infection
  • 【文献出处】 中国临床药理学杂志 ,The Chinese Journal of Clinical Pharmacology , 编辑部邮箱 ,2001年03期
  • 【分类号】R978.1
  • 【被引频次】11
  • 【下载频次】101
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