Schaad U B, Eskola J, Kafetzis D, Fishbach M, Ashkenazi S, Syriopoulou V, Boulesteix J, De Pril V, Grès J J, Rollin C
Department of Pediatrics, University Children's Hospital, Basel, Switzerland.
Pediatr Infect Dis J. 1998 Jul;17(7):639-44. doi: 10.1097/00006454-199807000-00012.
Cefepime has been used in clinical therapeutic trials for meningitis, serious infection and febrile neutropenia, comprising more than 800 pediatric patients. This agent has also been used in patients 12 years of age and older with uncomplicated and complicated urinary tract infections including pyelonephritis, but not in younger patients. In this study the safety and efficacy of cefepime were compared with those of ceftazidime for treatment of pyelonephritis in pediatric patients younger than 12 years of age.
Two hundred ninety-nine pediatric patients (ages 1 month to 12 years) with pyelonephritis (300 episodes) were enrolled in a randomized, open label, multicenter trial. Individual results were evaluated by a blinded committee of experts. Cefepime was compared with ceftazidime, both administered parenterally at 50 mg/kg every 8 h. Patients were to receive the assigned study drug until at least 48 h after becoming afebrile. The i.v. treatment was then to be continued or replaced by oral trimethoprimsulfamethoxazole for a maximum of 12 to 14 days.
The predominant causative pathogens were Escherichia coli, 88%; Proteus spp., 6%; Pseudomonas aeruginosa, 2%; and Klebsiella spp., 2%. Bacteriologic eradication was achieved in 96 and 94% of cefepime and ceftazidime patients, respectively, at the end of i.v. study drug treatment and was maintained in 94 and 91%, respectively, at the end of total study therapy. After study therapy bacteriologic eradication was maintained after 4 to 6 weeks in 86% of cefepime cases and in 83% of ceftazidime cases. A satisfactory clinical response occurred in 98 and 96% of cefepime and ceftazidime patients, respectively, at the end of i.v. treatment and in 93% at the end of total study therapy in both treatment arms. Drug-related clinical adverse events occurred in 14 cefepime patients (91%) and in 10 ceftazidime patients (7%).
Cefepime and ceftazidime are equally safe and efficacious treatment for pyelonephritis in pediatric patients.
头孢吡肟已用于脑膜炎、严重感染和发热性中性粒细胞减少症的临床治疗试验，涉及800多名儿科患者。该药物也已用于12岁及以上患有包括肾盂肾炎在内的单纯性和复杂性尿路感染的患者，但未用于年龄较小的患者。在本研究中，比较了头孢吡肟与头孢他啶治疗12岁以下儿科患者肾盂肾炎的安全性和有效性。
299名患有肾盂肾炎（共300例发作）的儿科患者（年龄1个月至12岁）参加了一项随机、开放标签、多中心试验。个体结果由一个盲法专家委员会评估。将头孢吡肟与头孢他啶进行比较，两者均以每8小时50mg/kg的剂量胃肠外给药。患者接受指定的研究药物治疗，直至退热后至少48小时。然后静脉治疗持续进行或改为口服甲氧苄啶-磺胺甲恶唑，最长12至14天。
主要致病菌为大肠杆菌，占88%；变形杆菌属，占6%；铜绿假单胞菌，占2%；克雷伯菌属，占2%。在静脉注射研究药物治疗结束时，头孢吡肟组和头孢他啶组的细菌清除率分别为96%和94%，在总研究治疗结束时分别维持在94%和91%。在研究治疗后，4至6周后，头孢吡肟组86%的病例和头孢他啶组83%的病例细菌清除率得以维持。在静脉注射治疗结束时，头孢吡肟组和头孢他啶组分别有98%和96%的患者出现满意的临床反应，在两个治疗组的总研究治疗结束时均为93%。14名头孢吡肟患者（9%）和10名头孢他啶患者（7%）发生了与药物相关的临床不良事件。
头孢吡肟和头孢他啶治疗儿科患者肾盂肾炎的安全性和有效性相当。
