Gooch W M, Kaminester L, Cole G W, Binder R, Morman M R, Swinehart J M, Wisniewski M, Yilmaz H M, Collins J J
Primary Children's Hospital, Salt Lake City, Utah.
Dermatologica. 1991;183(1):36-43. doi: 10.1159/000247629.
This study was designed to compare the clinical and bacteriological efficacy of three oral cephalosporins, cefuroxime axetil, cephalexin and cefadroxil, in the treatment of patients with mild to moderate infections of the skin or skin structures. A total of 330 patients were enrolled at 10 centers and were randomly assigned to receive cefuroxime axetil 250 mg (n = 107), cephalexin 500 mg (n = 111) or cefadroxil 500 mg (n = 112), twice daily for 10 days. Patients were assessed for their clinical and bacteriological responses once during treatment (3-5 days) and twice after treatment (1-3 and 10-14 days). A total of 353 bacterial isolates were obtained: Staphylococcus aureus (41%), Staphylococcus epidermidis (33%) and Streptococcus pyogenes (5%). A satisfactory clinical outcome (cure or improvement) was achieved in 97% (89/92), 89% (80/90) and 94% (82/87) of the clinically evaluable patients treated with cefuroxime axetil, cephalexin or cefadroxil, respectively (p = 0.047, cefuroxime axetil vs. cephalexin). With respect to the eradication of the bacterial pathogens, a satisfactory outcome (cure or presumed cure) was obtained in 96% (69/72), 85% (60/71) and 93% (63/68) of bacteriologically evaluable patients treated with cefuroxime axetil, cephalexin and cefadroxil, respectively (p = 0.026, cefuroxime axetil vs. cephalexin). All three study drugs were well tolerated, with adverse events affecting the gastrointestinal system most commonly reported. There were no significant differences between treatment groups in the incidence of drug-related adverse events.
本研究旨在比较三种口服头孢菌素（头孢呋辛酯、头孢氨苄和头孢羟氨苄）治疗轻至中度皮肤或皮肤结构感染患者的临床和细菌学疗效。共有330例患者在10个中心入组，并随机分配接受头孢呋辛酯250mg（n = 107）、头孢氨苄500mg（n = 111）或头孢羟氨苄500mg（n = 112），每日两次，共10天。在治疗期间（3 - 5天）对患者进行一次临床和细菌学反应评估，治疗后（1 - 3天和10 - 14天）进行两次评估。共获得353株细菌分离株：金黄色葡萄球菌（41%）、表皮葡萄球菌（33%）和化脓性链球菌（5%）。接受头孢呋辛酯、头孢氨苄或头孢羟氨苄治疗的可临床评估患者中，分别有97%（89/92）、89%（80/90）和94%（82/87）取得了满意的临床结局（治愈或改善）（头孢呋辛酯与头孢氨苄相比，p = 0.047）。关于细菌病原体的根除，接受头孢呋辛酯、头孢氨苄和头孢羟氨苄治疗的可细菌学评估患者中，分别有96%（69/72）、85%（60/71）和93%（63/68）取得了满意的结局（治愈或推定治愈）（头孢呋辛酯与头孢氨苄相比，p = 0.026）。所有三种研究药物耐受性良好，但最常报告的不良事件是影响胃肠道系统。治疗组之间药物相关不良事件的发生率没有显著差异。
