注射用氨苄西林钠/舒巴坦钠在患儿中的药动学研究

Pharmacokinetics of Sodium Ampicillin and Sodium Sulbactam for Injection in Pediatric Patients

目的:研究注射用氨苄西林钠/舒巴坦钠在患儿中的药动学。方法:非抗生素治疗腹腔内感染、皮肤和/或皮肤结构感染、眶周-眶隔前和面部蜂窝组织炎的住院患儿(<12岁)共计56例纳入本研究,注射剂量为37.5～72mg·kg-1的注射用氨苄西林钠/舒巴坦钠(2∶1)。采用带紫外检测器的高效液相色谱仪测定血清或血浆中氨苄西林和舒巴坦浓度,并计算药动学参数。结果:剂量或性别不影响氨苄西林或舒巴坦的药动学。3个年龄组的平均CL、Vss、t1/2相似(P>0.05)。氨苄西林或舒巴坦清除率与患儿年龄之间的关系无显著相关性。注射用氨苄西林钠/舒巴坦钠可通过静脉给药于≥1岁患儿,给药剂量为72mg·kg-1(2∶1),q6h。结论:注射用氨苄西林钠/舒巴坦钠的药动学与剂量和性别无关。

OBJECTIVE： To study the pharmacokinetics of Sodium ampicillin and sodium sulbactam for injection in pediatric patients. METHODS： A total of 56 hospitalized children （under 12 years old） with non-antibiotic treatment of intra-abdominal infections, skin and/or skin structure infections, periorbital-orbital and face cellulitis were included in the study. The dose was 37.5～72 mg·kg-1 of sodium ampicillin and sodium sulbactam （2∶1） every 6 h. HPLC equipped with UV detector was adopted to determine the concentration of ampicillin and sulbactam in serum or plasma, and pharmacokinetic parameters were calculated. RESULTS： The dose or gender didn’t affect the pharmacokinetics of ampicillin or sulbactam. The average levels of CL,Vss and t1/2 in 3 age groups were similar （P0.05）. There was no significant relationship between clearance rate of ampicillin or sulbactam and patient age. CONCLUSION： Sodium ampicillin/sodium sulbactam for injection can be administered intravenously to children aged 1 year or over with dose of 72 mg·kg-1 every 6 h（2∶1）.