新生儿的万古霉素血药浓度监测及安全性评价  

A clinical study of the safety of vancomycin in newborn infants and determination of plasma concentration of vancomycin

作　　者：徐进[1] 许静[1] 李燕[1] 赵幽燕[1] 谭家风[1] 徐英美[1] 赵真龄[1] 

机构地区：[1]南京医科大学附属南京儿童医院,江苏南京210008

出　　处：《中国医院药学杂志》2007年第9期1200-1203,共4页Chinese Journal of Hospital Pharmacy

基　　金：江苏省药学会奥赛康临床药学研究基金课题(编号:200205)

摘　　要：目的:建立以高效液相色谱(HPLC)法测定万古霉素血药浓度的方法,探讨万古霉素在新生儿的血药浓度与临床疗效、不良反应之间的关系。方法:采用Hypersil-ODS柱,流动相为乙腈-磷酸二氢钾(0.05mol.L-1,pH3.21)(10∶90),检测波长为236nm,流速为1.00mL.min-1;新生儿重症感染病例30例,用万古霉素治疗7～14d,给药剂量按每次10～15mg.kg-1,观察给药前后患儿肝、肾功能指标(ALT、AST、T-Bil、D-Bil、BUN、CCr)及不良反应情况;监测患儿万古霉素的峰(坪)浓度和谷浓度。结果:30例患儿治疗中未见明显不良反应,万古霉素的谷浓度的平均值为(5.8±3.4)mg.L-1,峰(坪)浓度的平均值为(30.9±12.0)mg.L-1,给药前后肝、肾功能指标比较差异无显著性。结论:万古霉素对治疗新生儿重症感染疗效确切,临床应用时必须严格掌握适应症、剂量,在血药浓度的监测下个体化治疗。OBJECTIVE To establish a HPLC assay for tween the plasma concentration and the clinical outcomes plasma concentration of vancomycin and to study the relationship beand adverse effects in newborn infants. METHODS Hypersil ODS column （4. 0 mm × 125 mm, 5 μm） was used, the mobile phase was 0.05 mol·L^-1 KH2PO3-acetonitrile（90： 10）, the flowing rate was 1.0 mL·min^-1, and the detecting wave length was at 236 nm. Thirty newborn infants with severe infection were treated by vancomycin with 10-15 mg·kg^-1,7-14 d. The hepatic and renal functional parameters were collected before and after treatment. The plasma concentration of vancomycin in each patient was monitored. RESULTS Apparent ADRs were not found among thirty cases. The peak and trough concentration of vancomycin were （30. 9 ± 12. 0） mg·L^-1 and （5.8 ± 3. 4）mg·L^-1 respectively. And the hepatic and renal functional parameters were not changed before and after treatment. CONCLUSION Vancomycin is useful to treat severe infections in newborn infants. When applying vancomycin in newborn infants,more attention should be paid to proper medical manipulation and TDM is needed to get individual therapy.

关 键 词：万古霉素 新生儿 安全性 高效液相色谱法 

分 类 号：R969[医药卫生—药理学]