Pichichero M, Aronovitz G H, Gooch W M, McLinn S E, Maddern B, Johnson C, Darden P M
Department of Pediatrics, University of Rochester, NY 14642.
South Med J. 1990 Oct;83(10):1174-7. doi: 10.1097/00007611-199010000-00013.
In this randomized, blinded, multicenter comparison study, 377 infants and children with acute otitis media (AOM) received a 10-day course of an oral suspension of one of the following: cefuroxime axetil (CAE), 30 mg/kg/day; cefaclor (CEC), 40 mg/kg/day; or amoxicillin-clavulanate potassium (AMX-CL), 40 mg/kg/day. Clinical efficacy was determined by pneumatic otoscopy and tympanometric testing 3 to 5, 11 to 14, and 22 to 26 days after the initiation of therapy. There was a statistically significant difference among the three treatment groups with respect to clinical outcome; more patients in the CAE group (62%) than in the CEC group (46%) or the AMX-CL group (52%) had complete resolution of signs and symptoms of AOM (including effusion). Paired comparisons revealed a significant difference in efficacy between CAE and CEC and a nearly significant difference between AMX-CL and CEC. Taste acceptability was highest for CEC and lowest for this formulation of CAE. Significantly more patients in the AMX-CL group than in the CAE or CEC group had a side effect, primarily diarrhea, vomiting, or diaper rash. We conclude that CAE suspension has greater clinical efficacy than CEC and fewer side effects than AMX-CL.
在这项随机、双盲、多中心对照研究中，377例急性中耳炎（AOM）婴幼儿和儿童接受了为期10天的以下口服混悬液疗程治疗：头孢呋辛酯（CAE），30mg/kg/天；头孢克洛（CEC），40mg/kg/天；或阿莫西林-克拉维酸钾（AMX-CL），40mg/kg/天。在治疗开始后3至5天、11至14天和22至26天，通过鼓气耳镜检查和鼓室导抗测试确定临床疗效。三个治疗组在临床结局方面存在统计学显著差异；CAE组（62%）中完全缓解AOM体征和症状（包括积液）的患者比CEC组（46%）或AMX-CL组（52%）更多。配对比较显示CAE和CEC之间疗效存在显著差异，AMX-CL和CEC之间疗效存在近乎显著差异。CEC的口味接受度最高，该剂型的CAE口味接受度最低。AMX-CL组出现副作用（主要为腹泻、呕吐或尿布疹）的患者明显多于CAE组或CEC组。我们得出结论，CAE混悬液比CEC具有更高的临床疗效，且比AMX-CL副作用更少。
