Nakazawa S, Niino K, Sato H, Narita A, Matsumoto K, Nakazawa S, Suzuki H, Nakanishi Y
Department of Pediatrics, School of Medicine, Showa University.
Jpn J Antibiot. 1990 May;43(5):799-807.
We have evaluated norfloxacin (NFLX), a fluoroquinolone agent, in tablet form for its efficacy and safety in the field of pediatrics. 1. Mean serum concentrations of NFLX following oral administration to 3 children at dose levels of 3.2 mg/kg, 3.7 mg/kg and 5.4 mg/kg were, respectively, 0.7 microgram/ml, 0.18 microgram/ml and 0.64 microgram/ml at 2-4 hours. Mean serum half-lives (T1/2) of NFLX were 2.5-2.9 hours and mean urinary recovery rates in the first 6 hours after administrations were 7.1-30.7%, depending on dose levels. 2. Antibacterial activities of NFLX against clinically isolated 30 organisms from children were determined. MIC of NFLX against Staphylococcus aureus was similar to that of ABPC, 0.39-25 micrograms/ml. MIC of NFLX against Escherichia coli was approximately less than or equal to 0.10 microgram/ml. This MIC value was lower than other antibiotics. MIC of NFLX against Vibrio parahaemolyticus was less than or equal to 0.10 microgram/ml. 3. NFLX was administered to 30 patients (7 patients with Salmonella enteritis, 7 patients with Campylobacter enteritis, 5 patients with other enteritis, 1 patient with bacillary dysentery, 8 patients with urinary tract infection, 2 patients with skin soft tissue infection). The clinical responses of these 30 patients were as follows; excellent: 24 patients, good: 4 patients. The efficacy rate was 93.3%. 4. The bacteriological efficacy rate of NFLX against clinically isolated 29 organisms from children was 75.9%, including 3 cases in which other antimicrobial agents had been ineffective. Especially against Salmonella spp. was superior to other agents tested. 5. Neither clinical adverse reaction nor abnormal laboratory data was found in any of these 33 patients.(ABSTRACT TRUNCATED AT 250 WORDS)
我们评估了氟喹诺酮类药物诺氟沙星（NFLX）片剂在儿科领域的疗效和安全性。1. 3名儿童分别以3.2 mg/kg、3.7 mg/kg和5.4 mg/kg的剂量口服给药后，2 - 4小时诺氟沙星的平均血清浓度分别为0.7微克/毫升、0.18微克/毫升和0.64微克/毫升。诺氟沙星的平均血清半衰期（T1/2）为2.5 - 2.9小时，给药后前6小时的平均尿回收率为7.1 - 30.7%，具体取决于剂量水平。2. 测定了诺氟沙星对从儿童中临床分离出的30种菌株的抗菌活性。诺氟沙星对金黄色葡萄球菌的最低抑菌浓度（MIC）与氨苄青霉素（ABPC）相似，为0.39 - 25微克/毫升。诺氟沙星对大肠杆菌的MIC约小于或等于0.10微克/毫升。该MIC值低于其他抗生素。诺氟沙星对副溶血性弧菌的MIC小于或等于0.10微克/毫升。3. 对30例患者（7例沙门氏菌肠炎患者、7例弯曲杆菌肠炎患者、5例其他肠炎患者、1例细菌性痢疾患者、8例尿路感染患者、2例皮肤软组织感染患者）给予诺氟沙星。这30例患者的临床反应如下：优：24例患者；良：4例患者。有效率为93.3%。4. 诺氟沙星对从儿童中临床分离出的29种菌株的细菌学有效率为75.9%，其中包括3例其他抗菌药物治疗无效的病例。特别是对沙门氏菌属的疗效优于其他受试药物。5. 在这33例患者中均未发现临床不良反应或实验室数据异常。（摘要截选至250字）
