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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 confirm the rationality of the overseas recommended administration of nevirapine (NVP) in Chinese population and to explore the feasibility of administering NV200 mg once per day in Chinese population. Methods Peripheral venous blood samples were collected from 530 HIV / AIDS patients at baseline and at the 2nd, 4th, 12th and 24th weeks of follow-up. Plasma NVP concentrations were measured by HPLC. Meanwhile, hematuria routine was tested and recorded. Liver and kidney function, serological indicators of hepatitis B (HBV) and hepatitis C (HCV), T cell subsets and plasma HIV viral load. Results The mean trough concentration of NVP plasma (4.56 mg / L) and the mean peak concentration (5.74 mg / L) of NVP reached the lower limit of internationally accepted effective treatment concentration at the end of the induction period. Stratified analysis showed that NVP plasma Valley concentration was significantly higher than the control group (P = 0.041), but no such trend after 4 weeks of treatment. Conclusions NVP 200 mg once / d is feasible in Chinese population. Combining with HCV infection may affect the metabolism of NVP during the induction phase, resulting in a significant increase in plasma trough concentration of NVP, which should be paid more attention to in clinic.