导入期末奈韦拉平血浆药物浓度与稳态血药浓度比较

A comparison of concentrations of plasma nevirapine among patients in the treatment periods of drug lead-in and steady-state

目的证实国外推荐奈韦拉平(nevirapine,NVP)给药方式在中国人群应用的合理性并探讨NVP200 mg 1次/d的给药方式在中国人群中应用的可行性。方法采集530例HIV/AIDS患者基线和随访第2、4、12、24周外周静脉血标本,采用高效液相色谱技术测定血浆中NVP药物浓度,同时检测并记录患者采血同时段的血尿常规、肝肾功能、乙型肝炎病毒(hepatitis B,HBV)和丙型肝炎病毒(hepatitis C,HCV)血清学指标、T细胞亚群以及血浆HIV病毒载量等结果。结果导入期末的NVP血浆浓度谷浓度均值(4.56 mg/L)与峰浓度均值(5.74 mg/L)均已达到国际公认有效治疗浓度下限,分层分析发现服药第2周合并HCV感染组NVP血浆谷浓度显著高于对照组(P=0.041),而在服药4周后无此趋势。结论 NVP 200 mg 1次/d的给药方式在中国人群中具有可行性,合并HCV感染会影响导入期NVP代谢,造成NVP血浆谷浓度显著升高,临床应予以重视。

Objective To compare the concentrations of plasma nevirapine among patients in the treatment periods of drug lead-in and steady state.Methods A total of 530 antiretroviral-nave HIV-infected patients were recruited for the treatment of 200 mg once-daily dosing of nevirapine.Patients were followed-up for 24 weeks.The trough and peak concentrations of plasma nevirapine were determined by high performance liquid chromatography.Clinical features and the results of other laboratory tests were collected and summarized.Results The mean trough and peak concentrations of plasma nevirapine were 4.56 mg/L and 5.74 mg/L respectively in the period of lead-in,which reached the effective concentrations of medication.The mean trough and peak concentrations of plasma nevirapine were 4.0 mg/L and 7.2 mg/L respectively in the treatment period of drug steady state.The trough concentration of plasma nevirapine at the end of week 2 was significantly higher in HCV co-infected HIV/AIDS patients than HIV-infected patients only（P〈0.05）.Conclusions It is feasible to use 200 mg once-daily nevirapine for HIV-infected Chinese patients.HCV co-infection with HIV might affect the metabolism of nevirapine and lead to the high concentration of plasma nevirapine during the period of lead-in.