Solórzano-Santos F, Miranda-Novales M G, Díaz-Peña R, Bernaldez-Ríos R, Díaz-Bensussen S, Rivera-Márquez H, Díaz-Ponce H
Departamento de Infectología, Hospital de Pediatría, Centro Médico Nacional Siglo XXI, Mexico, D.F.
Rev Invest Clin. 1996 Jan-Feb;48(1):13-8.
A randomized clinical trial was performed in children with cancer, fever and neutropenia, to evaluate the efficacy of amikacin once daily versus thrice daily dosing plus carbenicillin in both groups. Fifty patients were included, 25 patients in group A who received amikacin once daily and 25 in group B who received amikacin thrice daily. No intergroup differences were observed, i.e., fever diminished in a median of 6 days (2-8 days) vs. 7 days (3-12 days) in groups A and B respectively (p = 0.37);clinical improvement was observed in a median of 6 days (3-10 days) vs 7 days (2-14 days) (p = 0.68). One patient in group A and two in B died. The peak levels of amikacin on the 7th day of treatment were 10-60 and 7-25 micrograms/mL in groups A and B respectively, and the serum creatinine levels were 0.3 - 0.7 for group A and 0.2 - 0.8 mg/dL for group B; none of the patients presented a creatinine above 40% of the basal value. Three patients of group A had amikacin levels higher than 40 micrograms/mL without increasing the creatinine levels; our observations do not suggest that toxicity is higher. We conclude that the administration of aminoglycoside once daily seems to be as effective as the traditional dosing.
对患有癌症、发热和中性粒细胞减少症的儿童进行了一项随机临床试验,以评估阿米卡星每日一次给药与两组中每日三次给药加羧苄青霉素的疗效。纳入了50名患者,A组25名患者接受阿米卡星每日一次给药,B组25名患者接受阿米卡星每日三次给药。未观察到组间差异,即A组和B组发热分别在中位数6天(2 - 8天)和7天(3 - 12天)时减退(p = 0.37);临床改善分别在中位数6天(3 - 10天)和7天(2 - 14天)时观察到(p = 0.68)。A组1例患者和B组2例患者死亡。治疗第7天阿米卡星的峰值水平在A组和B组分别为10 - 60微克/毫升和7 - 25微克/毫升,血清肌酐水平A组为0.3 - 0.7,B组为0.2 - 0.8毫克/分升;没有患者的肌酐水平高于基础值的40%。A组3例患者的阿米卡星水平高于40微克/毫升,但肌酐水平未升高;我们的观察结果并不表明毒性更高。我们得出结论,氨基糖苷类药物每日一次给药似乎与传统给药方式一样有效。