Meguro H, Terashima I, Takeuchi Y, Kantake M
Department of Pediatrics, Teikyo University Ichihara Hospital.
Jpn J Antibiot. 1997 Dec;50(12):945-52.
The efficacy, safety and pharmacokinetics of cefozopran (CZOP) were evaluated in neonates and the following results were obtained: 1. Of the 12 patients treated with CZOP, judgment of clinical efficacy was evaluable in 10 patients (including 5 with pneumonia and 3 with urinary tract infections). The treatment was effective and the causative organism was eradicated in 100% of the patients. 2. No adverse signs and symptoms were recognized during the treatment with CZOP. A slight elevation of direct bilirubin was recognized as an abnormal alteration of laboratory test values in one patient. The value, however, returned to the normal range after the completion of treatment. 3. The pharmacokinetic evaluation was made in 3 of the 12 patients. The blood CZOP levels were recognized in proportion with the dosages. The elimination half lives (T 1/2) in those patients were 8.92, 2.90 and 2.76 hours. Prolongation of T 1/2 was recognized in the patient aged 0 day. It was possible to examine the urinary excretion only in one patient aged 18 days. The excretion rate of the drug was 68.6% of dose by 8 hours after administration. These results suggest that CZOP is a drug useful for treatment of infections in neonates as well, with high efficacy and safety.
对头孢唑肟（CZOP）在新生儿中的疗效、安全性及药代动力学进行了评估，结果如下：1. 在接受CZOP治疗的12例患者中，10例患者（包括5例肺炎患者和3例尿路感染患者）的临床疗效可评估。治疗有效，100%的患者病原菌被根除。2. 使用CZOP治疗期间未发现不良体征和症状。1例患者直接胆红素轻度升高被视为实验室检查值的异常改变。然而，治疗结束后该值恢复到正常范围。3. 在12例患者中的3例进行了药代动力学评估。血中CZOP水平与剂量成正比。这些患者的消除半衰期（T 1/2）分别为8.92、2.90和2.76小时。出生0天的患者T 1/2延长。仅对1例18天龄的患者进行了尿排泄检查。给药后8小时药物排泄率为剂量的68.6%。这些结果表明，CZOP也是一种用于治疗新生儿感染的有效且安全的药物。
