Kieft H, Hoepelman A I, Rozenberg-Arska M, Branger J M, Voskuil J H, Geers A B, Kluyver M, Hart H C, Poest-Clement E, van Beugen L
Department of Internal Medicine, University Hospital Utrecht, The Netherlands.
Antimicrob Agents Chemother. 1994 Mar;38(3):415-21. doi: 10.1128/AAC.38.3.415.
In an open randomized multicenter comparative study, we evaluated the safety and efficacy of cefepime (CP; 2.0 g given intravenously every 12 h) and ceftazidime (CZ; 2.0 g given intravenously every 8 h) as initial treatment for adult patients with suspected serious bacterial infections. A total of 133 patients entered the study, of whom 114 were evaluable for clinical and microbiological response assessment: 56 received CP and 58 received CZ. About 50% (30 who received CP and 25 who received CZ) fulfilled the criteria of the sepsis syndrome. The treatment groups were comparable with respect to sex distribution, mean age, underlying diseases, treatment duration, APACHE II score, and type of infection. The most commonly cultured microorganisms were members of the family Enterobacteriaceae, Streptococcus pneumoniae, and Staphylococcus aureus. The causative microorganisms were eradicated from 92% (37 of 40) of patients with a microbiologically documented infection who underwent treatment with CP; they were eradicated from 86% (42 to 49) of patients who received CZ. The responses of only clinically documented infections in the CP group were 90% (27 of 30 patients); in the CZ group they were 87% (26 of 30 patients). When patients fulfilled the criteria of the sepsis syndrome (septic shock excluded), the causative microorganisms were eradicated from 89% (16 of 18) of CP-treated patients and 86% (12 of 14) of CZ-treated patients. None of these differences was statistically significant. Mortality was the same in both groups (four patients in each group) and was not attributable to the study medication. In conclusion, CP is at least as effective and as safe as CZ, as initial antimicrobial therapy for suspected serious bacterial infections in nonneutropenic patients with or without the sepsis syndrome. CP has the additional advantage in that it can be given twice daily, which may lead to a decrease in hospital costs.
在一项开放性随机多中心对照研究中,我们评估了头孢吡肟(CP;每12小时静脉注射2.0 g)和头孢他啶(CZ;每8小时静脉注射2.0 g)作为疑似严重细菌感染成年患者初始治疗药物的安全性和有效性。共有133例患者进入研究,其中114例可进行临床和微生物学反应评估:56例接受CP治疗,58例接受CZ治疗。约50%(接受CP治疗的30例和接受CZ治疗的25例)符合脓毒症综合征标准。治疗组在性别分布、平均年龄、基础疾病、治疗持续时间、APACHE II评分和感染类型方面具有可比性。最常培养出的微生物为肠杆菌科成员、肺炎链球菌和金黄色葡萄球菌。微生物学记录感染且接受CP治疗的患者中,92%(40例中的37例)的致病微生物被清除;接受CZ治疗的患者中,86%(42至49例)的致病微生物被清除。仅临床记录感染的CP组患者反应率为90%(30例患者中的27例);CZ组为87%(30例患者中的26例)。当患者符合脓毒症综合征标准(排除感染性休克)时,接受CP治疗的患者中89%(18例中的16例)的致病微生物被清除,接受CZ治疗的患者中86%(14例中的12例)的致病微生物被清除。这些差异均无统计学意义。两组死亡率相同(每组4例患者),且与研究用药无关。总之,作为有或无脓毒症综合征的非中性粒细胞减少患者疑似严重细菌感染的初始抗菌治疗,CP至少与CZ一样有效和安全。CP的额外优势在于其每日给药两次,这可能会降低医院成本。