Abstract：
Hydroxychloroquine (HCQ) has been used to treat Sjögren\'s disease (SjD) patients. However, there are no studies evaluating drug adherence through HCQ blood levels, pharmacy refill (PR) and medication adherence questionnaires. The relationship of HCQ blood levels with glandular/extraglandular disease parameters was also poorly assessed. This cross-sectional observational study included 74 adult SjD patients, who were receiving a stable HCQ dose (4-5.5 mg/kg/day, actual weight) for at least 3 months before study inclusion. HCQ blood levels were quantified by high-performance liquid chromatography coupled to mass spectrometry. Adherence was assessed by PR and Medida de Adesão aos Tratamentos (MAT) questionnaire. The following parameters were evaluated: Xerostomia Inventory, Ocular Surface Disease Index, EULAR (European League Against Rheumatism) Sjögren\'s Syndrome Disease Activity Index, EULAR Sjögren\'s Syndrome Patient Reported Index, Schirmer\'s I test and non-stimulated/stimulated salivary flow rates. HCQ blood levels were 775.3(25.0-2,568.6)ng/mL. Eleven patients (14.9%) had HCQ blood levels < 200ng/mL (non-adherent group); 11(14.9%), 200-499ng/mL (sub-therapeutic levels group); and 52(70.2%), ≥ 500ng/mL (adherent group). PR classified incorrectly all non-adherent/sub-therapeutic patients and 2/52(3.9%) adherent patients. Using MAT, the overall misclassification was 24/52(46.2%) in the adherent group, and were correctly identified 9/11(81.8%) patients in non-adherent and 7/11(63.6%) in sub-therapeutic groups. MAT sensitivity and specificity to identify non-adherent/sub-therapeutic patients were 72.7% and 53.9%, respectively. The three groups were comparable regarding glandular/extraglandular disease parameters (p > 0.05). The assessment of HCQ blood levels is a promising tool for evaluating drug adherence in SjD. This is particularly crucial as one-third of patients exhibited non-adherence/sub-therapeutic levels, and neither PR nor MAT reliably identified these patients.
摘要：
羟氯喹（HCQ）已用于治疗干燥病（SjD）患者。然而,没有通过HCQ血液水平评估药物依从性的研究，药房补充(PR)和药物依从性问卷。HCQ血液水平与腺体/腺外疾病参数的关系也未得到评估。这项横断面观察研究包括74名成年SjD患者，谁正在接受稳定的HCQ剂量（4-5.5mg/kg/天，实际体重)在纳入研究前至少3个月。HCQ血液水平通过与质谱联用的高效液相色谱定量。通过PR和MedidadeAdesãoosTratamentos（MAT）问卷评估依从性。评估了以下参数：口干症清单，眼表疾病指数,欧洲抗风湿病联盟Sjögren综合征疾病活动指数，EULARSjögren综合征患者报告指数，SchirmerI试验和非刺激/刺激唾液流速。HCQ血液水平为775.3（25.0-2,568.6）ng/mL。11例（14.9%）HCQ血药浓度<200ng/mL（非粘附组）；11例（14.9%），200-499ng/mL（亚治疗水平组）；52（70.2%），≥500ng/mL(贴壁组)。PR错误地分类了所有非粘附/亚治疗患者和2/52（3.9％）粘附患者。使用MAT，粘附组的总体错误分类为24/52（46.2％），并且在非粘附组中被正确识别为9/11（81.8％）患者，在亚治疗组中被正确识别为7/11（63.6％）。MAT识别非粘附/亚治疗患者的敏感性和特异性分别为72.7%和53.9%，分别。三组在腺体/腺外疾病参数方面具有可比性（p>0.05）。HCQ血液水平的评估是评估SjD中药物依从性的有前途的工具。这一点尤其重要，因为三分之一的患者表现出非依从性/亚治疗水平，PR和MAT都不能可靠地识别这些患者。
