Dagan R, Einhorn M, Lang R, Pomeranz A, Wolach B, Miron D, Raz R, Weinstock A, Steinberger J
Soroka University Medical Center, Beer-Sheva, Israel.
Pediatr Infect Dis J. 1992 Mar;11(3):198-203. doi: 10.1097/00006454-199203000-00005.
We conducted a randomized prospective multicenter study to compare the safety and efficacy of once daily oral cefixime (8 mg/kg) to twice daily oral trimethoprim/sulfamethoxazole (TMP/SMX) (8/40 mg/kg/day) for the treatment of acute urinary tract infection in children ages 6 months to 13 years. Seventy-six patients (38 in each group) were studied. Thirty-seven percent were younger than 3 years of age. Escherichia coli was the most common isolate in both groups (85%). Eighty-five percent of all Gram-negative organisms were susceptible to TMP/SMX and all were susceptible to cefixime. Seventy-two percent of all patients were febrile at the time of diagnosis. Both groups were treated for 7 to 10 days. Peripheral white blood cell counts, erythrocyte sedimentation rate, body temperature and urinalysis returned to normal at the same rate in both groups. No failures were observed and relapse occurred in 3 cases within the 4 weeks after treatment (2 in the cefixime group and one in the TMP/SMX group). Side effects were observed in 14% of the cefixime group and 16% of the TMP/SMX group and were all mild enough not to necessitate discontinuation of therapy. We conclude that the efficacy and safety of cefixime administered once daily compared favorably with TMP/SMX administered twice daily for acute uncomplicated urinary tract infection.
我们进行了一项随机前瞻性多中心研究，以比较每日一次口服头孢克肟（8毫克/千克）与每日两次口服甲氧苄啶/磺胺甲恶唑（TMP/SMX）（8/40毫克/千克/天）治疗6个月至13岁儿童急性尿路感染的安全性和有效性。研究了76例患者（每组38例）。37%的患者年龄小于3岁。大肠杆菌是两组中最常见的分离菌株（85%）。所有革兰氏阴性菌中，85%对TMP/SMX敏感，所有菌株对头孢克肟均敏感。所有患者中，85%在诊断时发热。两组均治疗7至10天。两组外周血白细胞计数、红细胞沉降率、体温和尿液分析恢复正常的速度相同。未观察到治疗失败，治疗后4周内有3例复发（头孢克肟组2例，TMP/SMX组1例）。头孢克肟组14%的患者和TMP/SMX组16%的患者出现副作用，且均轻微，无需停药。我们得出结论，对于急性单纯性尿路感染，每日一次服用头孢克肟的疗效和安全性优于每日两次服用TMP/SMX。
