a From the Institute of Clinical Infectious Diseases, Catholic University of Sacred Heart , Rome , Italy.
b Institute of Pharmacology, Catholic University of Sacred Heart , Rome , Italy.
Infect Dis (Lond). 2016;48(1):48-55. doi: 10.3109/23744235.2015.1082034. Epub 2015 Sep 2.
The aim of the study was to explore relationships between self-reported adherence, antiretroviral drug concentration measurement (TDM) and self-reported symptoms.
We systematically administered to human immunodeficiency (HIV)-infected outpatients a questionnaire evaluating measures of self-reported adherence (missing doses during last week, deviations from the prescribed timing of therapy, self-initiated discontinuations for > 24 or 48 h, exhausting drugs and present sense of how patients are taking therapy) and a panel of referred symptoms (a symptom score was built summing self-reported scores for each listed symptom). We selected patients who completed the questionnaire and also had a TDM (mainly reflecting adherence in the past few days or weeks), thus comparing these two tools as measures of adherence.
A total of 130 patients (64.6% males, median age 44 years, 76.2% with HIV RNA < 50 copies/ml, median CD4 540 cells/μl) were included. Mean self-reported adherence (on a 0-100 visual analogue scale) was 80% (standard deviation, 18.7). Drug concentration was subtherapeutic in 16 patients (12.3%), of which 7 (5.4%) had undetectable drug levels (< 0.05 mg/L). Of these last seven patients, five (71.4%) reported an adherence below 80%. In a multivariable analysis, females and patients with undetectable drug levels (mean change -18.43%, 95% confidence intervals (CIs) -31.83 to -5.03, p = 0.007) showed a lower self-reported adherence, while those with HIV RNA < 50 copies/ml showed a higher adherence. Lower self-reported adherence (odds ratio 0.62 per 10% increase, 95% CI = 0.43-0.89, p = 0.009) and longer time from last drug intake were independently related to the development of undetectable drug levels. We also found that a higher symptom score was associated with a lower self-reported adherence and with a higher proportion of undetectable drug levels.
Self-reported adherence and TDM showed a correlation and seemed to be comparable tools for adherence estimation. Self-reported symptoms were associated with lower adherence and undetectable drug levels.
本研究旨在探索患者自我报告的服药依从性、抗逆转录病毒药物浓度测量(TDM)与自我报告症状之间的关系。
我们系统地向感染人类免疫缺陷病毒(HIV)的门诊患者发放问卷,评估自我报告的服药依从性(过去一周漏服的剂量、治疗时间偏离规定时间、因>24 或 48 小时而自行停药、药物用尽以及患者对当前治疗方法的感受)和一组上报症状(构建症状评分,对每个上报症状的自我报告评分进行求和)。我们选择了完成问卷且同时进行 TDM(主要反映过去几天或几周的服药依从性)的患者,从而将这两种工具作为服药依从性的衡量指标进行比较。
共纳入 130 例患者(64.6%为男性,中位年龄为 44 岁,76.2%的患者 HIV RNA<50 拷贝/ml,中位 CD4 细胞为 540 个/μl)。自我报告的服药依从性平均值(0-100 视觉模拟评分)为 80%(标准差,18.7)。16 例患者(12.3%)的药物浓度低于治疗范围,其中 7 例(5.4%)药物水平检测不到(<0.05mg/L)。在这 7 例最后检测不到药物水平的患者中,有 5 例(71.4%)报告的服药依从性低于 80%。多变量分析显示,女性和药物浓度检测不到的患者(平均变化-18.43%,95%置信区间(CI)-31.83 至-5.03,p=0.007)自我报告的服药依从性较低,而 HIV RNA<50 拷贝/ml 的患者自我报告的服药依从性较高。自我报告的服药依从性越低(每增加 10%,比值比 0.62,95%CI=0.43-0.89,p=0.009)和上次服药时间间隔越长与药物浓度检测不到独立相关。我们还发现,较高的症状评分与较低的自我报告服药依从性和较高的药物浓度检测不到比例相关。
自我报告的服药依从性和 TDM 具有相关性,似乎是评估服药依从性的两种相当的工具。自我报告的症状与较低的服药依从性和检测不到的药物水平有关。