Herting R L, Lorber R R, Miller M, Danzig M R
Arzneimittelforschung. 1981;31(2):366-70.
Netilmicin and gentamicin were compared in a multicenter clinical trial in 12 study locations. The two aminoglycosides were randomly assigned to hospitalized adult patients with systemic infections, and were administered by i.m. injection or slow i.v. infusion in divided doses generally calculated to deliver either 4-6.5 mg/kg per day of netilmicin, or 3-5 mg/kg per day of gentamicin. Lower dosages were given to patients with impaired renal function. Data from 210 patients receiving netilmicin and 212 receiving gentamicin were analyzed for efficacy. Favorable bacteriologic responses occurred in 95.5% (255/267) of the netilmicin-treated sites and in 90.1% (247/274) of the gentamicin-treated sites (p = 0.05). Netilmicin eliminated or reduced 95.6% (283/296) of all pathogens isolated from all infection sites compared with 89.5% (289/323) for gentamicin (p = 0.012). Favorable clinical responses were observed in 94.2% (275/292) of the netilmicin-treated patients and 89.5% (289/323) of the gentamicin-treated patients. Data from 377 netilmicin-treated patients and 378 gentamicin-treated patients were analyzed for safety. Evidence of nephrotoxicity probably related to treatment was observed in 8 of the netilmicin-treated patients and 14 of the gentamicin-treated patients. Audiometrically documented hearing loss probably related to treatment was observed in one gentamicin-treated patient. In one netilmicin-treated patient there were transient auditory and vestibular effects. Local tolerance to parenteral administration of the two drugs was excellent.
在12个研究地点开展的一项多中心临床试验中，对奈替米星和庆大霉素进行了比较。将这两种氨基糖苷类药物随机分配给患有全身感染的住院成年患者，通过肌肉注射或静脉缓慢输注给药，通常将剂量分成几份，计算得出每天给予奈替米星4 - 6.5毫克/千克，或每天给予庆大霉素3 - 5毫克/千克。肾功能受损的患者给予较低剂量。分析了210例接受奈替米星治疗的患者和212例接受庆大霉素治疗的患者的数据以评估疗效。在接受奈替米星治疗的部位，95.5%（255/267）出现了良好的细菌学反应，而在接受庆大霉素治疗的部位，这一比例为90.1%（247/274）（p = 0.05）。与庆大霉素（89.5%，289/323）相比，奈替米星清除或减少了从所有感染部位分离出的所有病原体的95.6%（283/296）（p = 0.012）。在接受奈替米星治疗的患者中，94.2%（275/292）观察到良好的临床反应，而在接受庆大霉素治疗的患者中，这一比例为89.5%（289/323）。分析了377例接受奈替米星治疗的患者和378例接受庆大霉素治疗的患者的数据以评估安全性。在接受奈替米星治疗的患者中有8例出现了可能与治疗相关的肾毒性证据，在接受庆大霉素治疗的患者中有14例出现了此类证据。在1例接受庆大霉素治疗的患者中观察到经听力测定记录的可能与治疗相关的听力损失。在1例接受奈替米星治疗的患者中出现了短暂的听觉和前庭效应。两种药物经胃肠外给药的局部耐受性都很好。
