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头孢羟氨苄与头孢氨苄治疗儿童和青少年脓疱病的比较评估。头孢羟氨苄每日一次脓疱病研究组。

Comparative evaluation of cefadroxil and cephalexin in children and adolescents with pyodermas. Cefadroxil Once Daily Pyoderma Study Group.

作者信息

Linder C W, Nelson K, Paryani S, Stallworth J R, Blumer J L

机构信息

Medical College of Georgia, Augusta.

出版信息

Clin Ther. 1993 Jan-Feb;15(1):46-56.

PMID:8458054
Abstract

This randomized, multicenter study compared the safety and efficacy of cefadroxil with that of cephalexin for the treatment of pyodermas in children and adolescents (1-18 years of age). Cefadroxil was given as a single oral daily dose of 30 mg/kg, and cephalexin 30 mg/kg/day was given in two divided doses. The maximum daily dose for both drugs was 1 gm, and treatment was administered for 10 days. Clinical and bacteriologic evaluations were made on days 4 or 5 during therapy and 2 to 4 days after therapy was completed. Of the 462 patients enrolled in the study, 156 patients in the cefadroxil group and 133 patients in the cephalexin group were evaluable. Staphylococcus aureus (56% of isolates) and Streptococcus pyogenes (39% of isolates) were isolated most frequently. The bacteriologic response was statistically greater in the patients treated with cefadroxil than in those treated with cephalexin (96% versus 89%; P = 0.042). A satisfactory clinical response was reported in 147 (94%) cefadroxil-treated patients and 122 (92%) cephalexin-treated patients (P = 0.476). The overall effective response to treatment was significantly higher with cefadroxil than with cephalexin (94% versus 86%; P = 0.024). Compliance with 9 or 10 days of therapy was similar in both treatment groups, although there was a difference between the two treatment groups with respect to completion of medication regimen: 95% of patients taking cefadroxil once daily--versus 65% of patients taking cephalexin twice daily--took 100% of their medication (P < 0.0001). Adverse events were infrequent and mild. The results of this study demonstrate that once-daily cefadroxil offers greater bacteriologic eradication and a better overall effective response than twice-daily cephalexin for the treatment of pyodermas caused by gram-positive pathogens in children and adolescents.

摘要

这项随机、多中心研究比较了头孢羟氨苄与头孢氨苄治疗儿童和青少年(1至18岁)脓疱病的安全性和疗效。头孢羟氨苄每日口服单剂量30mg/kg,头孢氨苄30mg/kg/天分两次给药。两种药物的最大日剂量均为1g,治疗持续10天。在治疗第4或5天以及治疗完成后2至4天进行临床和细菌学评估。在该研究纳入的462例患者中,头孢羟氨苄组有156例患者、头孢氨苄组有133例患者可进行评估。最常分离出的是金黄色葡萄球菌(分离株的56%)和化脓性链球菌(分离株的39%)。头孢羟氨苄治疗的患者细菌学反应在统计学上高于头孢氨苄治疗的患者(96%对89%;P = 0.042)。147例(94%)接受头孢羟氨苄治疗的患者和122例(92%)接受头孢氨苄治疗的患者报告了满意的临床反应(P = 0.476)。头孢羟氨苄治疗的总体有效反应显著高于头孢氨苄(94%对86%;P = 0.024)。两个治疗组对9天或10天治疗的依从性相似,尽管在完成用药方案方面两个治疗组存在差异:每日服用一次头孢羟氨苄的患者中有95%——相比每日服用两次头孢氨苄的患者中的65%——服用了100%的药物(P < 0.0001)。不良事件很少且轻微。该研究结果表明,对于治疗儿童和青少年革兰氏阳性病原体引起的脓疱病,每日一次的头孢羟氨苄比每日两次的头孢氨苄具有更强的细菌清除能力和更好的总体有效反应。

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