Aegis Sciences Corporation, Nashville, TN, USA.
J Anal Toxicol. 2012 Mar;36(2):75-80. doi: 10.1093/jat/bkr019.
A clinical study was conducted to compare the use of oral fluid to urine for compliance monitoring of pain patients. Patients (n = 133) undergoing treatment for chronic pain at four clinics participated in the study and provided paired oral fluid and urine specimens. Oral fluid specimens were collected with Quantisal(TM) saliva collection devices immediately following urine collection. Oral fluid specimens were analyzed for 42 drugs and/or metabolites by validated liquid chromatography-tandem mass spectrometry procedures. Accompanying urine specimens were initially screened by immunoassay and non-negative results were confirmed. Of the 1544 paired tests, 329 (21.3%) drug analytes were positive, and 984 (63.7%) were negative for both specimens resulting in an overall agreement of 85%. There were 83 (5.4%) analyte results that were positive in oral fluid and negative in urine, and 148 (9.6%) were negative in oral fluid and positive in urine for an overall disagreement of 15%. Cohen's Kappa value was 0.64, indicating "substantial" agreement. The primary exceptions to agreement were the lower detection rates for hydromorphone, oxymorphone, and benzodiazepines in oral fluid compared to urine. The authors conclude that, overall, oral fluid tests produced comparable results to urine tests with some minor differences in detection rates for different drug classes.
一项临床研究比较了使用唾液和尿液来监测疼痛患者的用药依从性。来自四家诊所的 133 名慢性疼痛患者参与了该研究，提供了配对的唾液和尿液样本。在收集尿液后，立即使用 Quantisal（TM）唾液采集装置采集唾液样本。通过验证的液相色谱-串联质谱程序分析了唾液样本中的 42 种药物和/或代谢物。尿液样本最初通过免疫测定进行筛选，非阴性结果得到确认。在 1544 对检测中，329 种（21.3%）药物分析物在唾液中呈阳性，984 种（63.7%）在两种样本中均呈阴性，总一致性为 85%。有 83 种（5.4%）分析物在唾液中呈阳性而在尿液中呈阴性，148 种（9.6%）在唾液中呈阴性而在尿液中呈阳性，总不一致率为 15%。Cohen's Kappa 值为 0.64，表明存在“实质性”一致性。一致性的主要例外是与尿液相比，唾液中氢吗啡酮、羟吗啡酮和苯二氮䓬类药物的检测率较低。作者得出结论，总体而言，唾液检测与尿液检测结果相当，但不同药物类别的检测率存在一些差异。
