Prinapori Roberta, Rosso Raffaella, Di Biagio Antonio, Miletich Franca, Furfaro Elisa, Taramasso Lucia, Ginocchio Francesca, Giacomet Vania, Nulvesu Loredana, Sormani Maria Pia, Schiavetti Irene, Signori Alessio, De Hoffer Laura, Viscoli Claudio
Infectious Diseases Clinic, San Martino Hospital, University of Genoa, Genoa, Italy.
Indian J Pediatr. 2014 Sep;81(9):856-60. doi: 10.1007/s12098-013-1198-1. Epub 2013 Sep 7.
To investigate the plasma levels of lopinavir by enzyme-linked immunosorbent assay (ELISA) in a cohort of patients who were vertically infected with human immunodeficiency virus 1 (HIV).
Plasma levels of lopinavir (Cmin) were determined by ELISA test in patients treated with lopinavir/ritonavir-based combined antiretroviral therapy who had achieved virological response after 4 wk of therapy. Reference lopinavir concentrations were Cmin 1-8 μg/mL. Correlation between lopinavir plasma concentration and continuous variables was evaluated by mean of Pearson correlation coefficient. Differences in lopinavir (LPV) concentration for binary categorical variables were assessed by Mann-Whitney test, while for variables with more than two categories Kruskal-Wallis test was used.
Thirty-four patients were enrolled; median age was 133 mo (15-265). The median lopinavir dose tested was 383.5 mg/kg (IQR: 266.6-400 mg/kg), with a median plasma concentration of 8.8 μg/mL (IQR: 5-14 μg/mL). Lopinavir Cmin was <1 μg/mL in only one sample (2.9 %), while 14 samples had Cmin between 1 and 8 μg/mL (41.2 %) and 19 (55.9 %) > 8 μg/mL. No significant correlations were found between plasma concentrations of lopinavir and the continuous variables considered in the study. A negative but, not completely significant, correlation was found between plasma drug concentration and body mass index (r = -0.29; p = 0.09).
The use of a simple and relatively cost-effective methodology might render therapeutic drug monitoring (TDM) appeal in the daily clinical practice.
采用酶联免疫吸附测定法（ELISA）检测一组母婴垂直感染人类免疫缺陷病毒1型（HIV）患者的洛匹那韦血浆水平。
对接受基于洛匹那韦/利托那韦的联合抗逆转录病毒治疗且治疗4周后达到病毒学应答的患者，通过ELISA检测洛匹那韦的血浆水平（Cmin）。洛匹那韦的参考浓度为Cmin 1 - 8μg/mL。采用Pearson相关系数评估洛匹那韦血浆浓度与连续变量之间的相关性。对于二元分类变量，采用Mann - Whitney检验评估洛匹那韦（LPV）浓度的差异；对于类别超过两类的变量，则使用Kruskal - Wallis检验。
共纳入34例患者；中位年龄为133个月（15 - 265个月）。所检测的洛匹那韦剂量中位数为383.5mg/kg（四分位间距：266.6 - 400mg/kg），血浆浓度中位数为8.8μg/mL（四分位间距：5 - 14μg/mL）。仅1个样本（2.9%）的洛匹那韦Cmin <1μg/mL，14个样本（41.2%）的Cmin在1至8μg/mL之间，19个样本（55.9%）的Cmin >8μg/mL。研究中未发现洛匹那韦血浆浓度与所考虑的连续变量之间存在显著相关性。血浆药物浓度与体重指数之间存在负相关，但不完全显著（r = -0.29；p = 0.09）。
使用一种简单且相对经济有效的方法可能会使治疗药物监测（TDM）在日常临床实践中具有吸引力。
