Norrby S R, Newell P A, Faulkner K L, Lesky W
Department of Microbiology, Chinese University of Hong Kong, Sha Tin, N.T., Hong Kong.
J Antimicrob Chemother. 1995 Jul;36 Suppl A:207-23. doi: 10.1093/jac/36.suppl_a.207.
Data from 3125 patients (3220 patient exposures) treated with meropenem were compared with those from 2886 patients (2960 patient exposures) treated with a variety of comparator agents including cephalosporins (alone or in combination with aminoglycosides or an anti-anaerobe agent) and imipenem/cilastatin. Patients treated included those with bacterial infections of the lower respiratory tract, urinary tract and skin and soft tissues, abdominal, obstetric and gynaecological infections, meningitis, febrile episodes in neutropenic patients and paediatric patients with infections. In three studies, meropenem was administered intramuscularly; in the remainder, meropenem was given by 15-30 min iv infusion or by bolus injection over approximately 5 min. The usual dosages were 500 mg or 1 g 8 hourly in adults and 10 or 20 mg/kg 8 hourly in children. In bacterial meningitis, the meropenem dosage in adults was 2 g 8 hourly and 40 mg/kg 8 hourly in children. The overall pattern and frequency of adverse events with meropenem were similar to those of the other beta-lactam antibiotics with which it was compared. The most frequently reported adverse events were diarrhoea, rash, nausea and vomiting, thrombocytosis, eosinophilia and changes in hepatic biochemistry. Abnormal laboratory tests occurred with similar frequencies between meropenem and the comparator agents. The safety profile of meropenem was similar in adults and children, and the presence of renal impairment did not alter the safety profile of meropenem. Experience in clinical studies in 3220 patient exposures has revealed no unusual or unexpected toxicity. The possibility of administration by either iv infusion or bolus injection with a low incidence of nausea and vomiting also provides flexibility in the clinical management of patients. Moreover, the low incidence of reported seizures and good tolerability at high doses, make meropenem particularly useful for the treatment of meningitis and other indications which carry a risk of seizures, or in the treatment of serious infections where high doses of antibiotics are frequently indicated.
将3125例接受美罗培南治疗的患者（3220次患者暴露）的数据与2886例接受包括头孢菌素（单独使用或与氨基糖苷类或抗厌氧菌药物联合使用）和亚胺培南/西司他丁在内的多种对照药物治疗的患者（2960次患者暴露）的数据进行了比较。接受治疗的患者包括患有下呼吸道、泌尿道、皮肤和软组织细菌感染、腹部、产科和妇科感染、脑膜炎、中性粒细胞减少患者的发热发作以及感染的儿科患者。在三项研究中，美罗培南通过肌肉注射给药；其余情况下，美罗培南通过15 - 30分钟静脉输注或约5分钟内推注给药。成人常用剂量为每8小时500毫克或1克，儿童为每8小时10或20毫克/千克。在细菌性脑膜炎中，成人美罗培南剂量为每8小时2克，儿童为每8小时40毫克/千克。美罗培南不良事件的总体模式和频率与与之比较的其他β-内酰胺类抗生素相似。最常报告的不良事件为腹泻、皮疹、恶心和呕吐、血小板增多、嗜酸性粒细胞增多以及肝脏生化指标变化。美罗培南与对照药物之间异常实验室检查的发生频率相似。美罗培南在成人和儿童中的安全性概况相似，肾功能损害的存在并未改变美罗培南的安全性概况。3220次患者暴露的临床研究经验表明没有异常或意外的毒性。静脉输注或推注给药且恶心和呕吐发生率低的可能性也为患者的临床管理提供了灵活性。此外，报告的癫痫发作发生率低且高剂量耐受性良好，使得美罗培南特别适用于治疗脑膜炎和其他有癫痫发作风险的适应症，或用于治疗经常需要高剂量抗生素的严重感染。
