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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)。
In a multicenter clinical trial of netilmicin as a reference drug, a randomized controlled parallel open trial was designed to evaluate the safety and efficacy of domestic etimicin in the treatment of clinically common bacterial infections. Netilmicin and etimicin dose were 100 mg, intravenous injection every 12 h, the treatment of 7-10 d. A total of 243 patients were enrolled in this clinical trial. Among them, 122 patients were enrolled in the etimicin group, 103 patients were evaluated clinically, 106 patients were counted as the last count, 121 patients were enrolled in the netilmicin group, 10 cases were evaluated clinically, Safety evaluation of 102 cases. The results of the trial were as follows: The total effective rates were 87.4% and 87.1% in both groups, respectively. The clinical effective rates of treating various pathogenic bacteria were 86.7% and 87.6% respectively, and the bacterial clearance rates were 89 .9% and 89.7% respectively. The incidences of ADRs were 8.5% and 8.8% respectively. The results showed that etimicin and netilmicin were safe and effective in the treatment of common clinical bacterial infections. There was no significant difference between the two groups (P> 0.05).