摘要
采用国产奈替米星和阿米卡星随机对照治疗各种类型急性细菌性感染２０４例，奈替米星７７例与阿米卡星７６例作随机对照，开放试验５１例。治愈率和有效率分别为７５．３％、９６．１％；６７．１％、９３．４％；８６．３％、９４．１％（Ｐ＞０．１，Ｐ＞０．２５）。细菌清除率分别为９０．７％；８８．０％；９３．０％（Ｐ＞０．０５）。不良反应发生率分别为５．１％、３．９％、３．９％（Ｐ＞０．５）。试验组和对照组临床疗效、细菌学疗效及不良反应均无显著性差异，奈替米星和阿米卡星纸片敏试敏感率相似，奈替米星对葡萄球菌的ＭＩＣ比阿米卡星略低，对链球菌两者相似或奈替米星略低，对革兰氏阴性细菌两者相似或阿米卡星略低，头孢噻肟对革兰氏阳性及阴性细菌抗菌活性比较强，庆大霉素较弱。８名健康自愿受试者静脉滴注或肌肉注射１００ｍｇ奈替米星，血峰浓度分别为１３．１２及７．６ｍｇ／Ｌ，半衰期（Ｔ１／２β）分别为３．２及２．８ｈ，分布容积分别为１５．４７及１１．５８ｈｍｇ／Ｌ，８ｈ后血药浓度分别为０．８８和０．８５ｍｇ／Ｌ。尿药浓度分别为１３．６４及１４．７９ｍｇ／Ｌ。血药浓度均超过绝大多数细菌的最低抑菌浓度，故获得较好临床疗效。
The studies included two parts. One is a nonblind randomized controlled clinical trial on netilmicin and amikacin, an open trial on netilmicin only. The second is pharmacokinetics of netilmicin. The purpose of the clinical trial is to evaluate the efficacy and safety of netilmicin in the treatment of acute infections. The dosage regimen and course were as follows: netilmicin 100￣150mg intravenous infusion q12h for 7￣14 days; amikacin 200￣300mg ivgtt 7￣14 days. In the controlled trial 153 patients were randomized to receive either netilmicin (77 cases) or amikacin (76 cases). The efficacy rates of netilmicin and amikacin were 96.1% and 93.4% respectively and there was no statistically significant difference (P>0.1), the bacteriological eradication rates of the two groups were 90.7% and 88.0% respectively (P>0.05). 51 patients entered the open trial, the rates of efficacy and bacteriological eradication were 94.1%, 93.0% respectively. The sideeffect rates of the three groups were 5.1%, 3.9% and 3.9%, respectively. Peak concentrations after single dose ivgtt or im of 100mg netilmicin in 8 normal volunteers were 13.12±.2.26 and 7.6±0.83mg/L respectively. The elimination of half life of the drug administrated by both routes were 3.23±0.80 and 2.87±0.63 hours.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
1998年第1期31-35,73,共6页
Chinese Journal of Antibiotics
