摘要
以多中心临床试验以奈替米星为对照药，采用随机对照平行开放的试验方法，目的是评价国产依替米星治疗临床常见细菌性感染的安全有效性。奈替米星与依替米星剂量均为１００ ｍｇ，每１２ ｈ静脉注射，疗程７－１０ ｄ。本项临床试验共入选病例２４３例，其中入选依替米星组１２２例，临床疗效评价病例１０３例，安全性评价倒数１０６例，入选奈替米星组１２１例，临床疗效评价病例１０Ｉ例，安全性评价病例１０２例。试验治疗结果如下：两组总有效率分别为８７．４％和８７．１％，治疗各种致病菌感染临床有效率分别为８６．７％和８７．６％，细菌清除率分别为８９．９％和８９．７％，药物不良反应发生率分别为８．５％与８．８％。结果表明，依替米星与奈替米星治疗临床常见急性细菌性感染安全、有效，两组结果无统计学显著性差异（Ｐ＞０．０５）。
Etimicin sulfate is a new drug developed by the institute of Microbiology of Jiangsu Province, China. Invitro antibacterial activity showed that it had good activity against clinical isolates. In order to compare its efficacy and safety of two aminoglycoside antibiotics-etimicin and netilmicin in the treatment of bacterial infections, a randomized open labeled controlled multicenter clinical trial was conducted for the treatment of 243 hospitalized patients with respiratory tract infection, urinary tract infection, skin and tissue infections. The dosage of both drugs was 100 mg every 12 hours by intravenous infusion. The duration of treatment was 7~ 10 days in both groups. In the randomized controlled study, 122 patients were enrolled in etimicin group, 106 patients were assessable for safety and 103 patients assessable for efficacy while 121 patients were enrolled in netilmicin group, 102 patients were assessed safety and 101 patients assessed efficacy. The results showed that the overall efficacy rates were 87.4% for etimicin group and 87.l% for netilmicin group, whereas the bacterial efficacy rates were 86.7% and 87.6%, the bacterial clearance rates were 89.9% and 89.7%, respectively. The incidence of adverse reaction was 8.5% and 8.8%, respectively. The results showed that there was no statistical difference between two groups (P>0.05).
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2000年第1期10-14,共5页
The Chinese Journal of Clinical Pharmacology
