Division of Allergic Diseases, Mayo Clinic, Rochester, Minnesota, USA.
Allergy Asthma Proc. 2012 Jul-Aug;33(4):e35-9. doi: 10.2500/aap.2012.33.3568.
Although the National Asthma Education and Prevention Program Expert Panel Report 3 recommends referral to specialists to address adherence, guidelines do not provide a tool to determine nonadherence. This study was designed to prospectively evaluate the characteristics of urinary analysis of fluticasone propionate-17beta-carboxylic acid (FP17betaCA) as a test to verify if a specific patient has not taken fluticasone propionate (FP) within 16-24 hours. Urine of asthmatic subjects was prospectively analyzed 16-24 hours after witnessed administration of orally inhaled FP using liquid chromatography tandem mass spectrometry (LC-MS/MS) analysis; limit of quantitation was 10.3 pg/mL. Results were compared with those from asthmatic subjects not receiving inhaled FP. Thirty asthmatic subjects receiving inhaled FP (2 oral inhalations of FP at 110 micrograms each or 1 oral inhalation twice daily of fluticasone and salmeterol in fixed combination at 250/50 micrograms for 1 week) were compared with 30 asthmatic subjects not receiving FP. FP17betaCA was detected in the urine of 30 of 30 asthmatic subjects receiving FP (median, interquartile range [IQR; 413.5, 212.8-1230.0] range 12.4-3290.0 pg/mL [corrected for urine creatinine: median, IQR {576.2, 188.1-1306.6} range 6.3-5425.9 ng/g Cr]) and was undetectable in 30 of 30 subjects not receiving inhaled FP. The sensitivity and specificity of LC-MS/MS to detect FP17betaCA in urine were 100% (95% exact binomial confidence interval, 88-100) and 100% (95% exact binomial confidence interval, 88-100), respectively. Analysis of FP17betaCA in urine provides a sensitive method that may be used to verify that a specific patient may not have administered FP within a 16- to 24-hour window before testing.
虽然《国家哮喘教育和预防计划专家小组报告 3》建议将患者转介给专家以解决药物依从性问题，但指南并未提供确定不依从的工具。本研究旨在前瞻性评估氟替卡松丙酸酯-17β-羧酸（FP17βCA）尿液分析作为验证特定患者在 16-24 小时内是否未使用氟替卡松丙酸酯（FP）的测试方法的特征。使用液相色谱串联质谱（LC-MS/MS）分析，前瞻性分析了在经口吸入 FP 后 16-24 小时内接受过哮喘治疗的受试者的尿液；定量下限为 10.3 pg/mL。结果与未接受吸入 FP 的哮喘患者的结果进行了比较。将 30 名接受吸入 FP（每次 110 微克，口服吸入 2 次，或每天 2 次吸入氟替卡松和沙美特罗固定剂量组合，每次 250/50 微克，持续 1 周）的哮喘患者与 30 名未接受 FP 的哮喘患者进行了比较。在 30 名接受 FP 的哮喘患者中，30 名患者（中位数，四分位距[IQR；413.5，212.8-1230.0]范围 12.4-3290.0 pg/mL [校正尿肌酐后：中位数，IQR {576.2，188.1-1306.6}范围 6.3-5425.9 ng/g Cr]）尿液中检测到 FP17βCA，而在 30 名未接受吸入 FP 的患者中未检测到。LC-MS/MS 检测尿液中 FP17βCA 的灵敏度和特异性均为 100%（95%精确二项置信区间，88-100）和 100%（95%精确二项置信区间，88-100）。尿液中 FP17βCA 的分析提供了一种敏感的方法，可用于验证特定患者在测试前的 16-24 小时内可能未使用 FP。
