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基于免疫分析的药物检测在监测慢性疼痛患者的用药依从性方面灵敏度不足。

Immunoassay-Based Drug Tests Are Inadequately Sensitive for Medication Compliance Monitoring in Patients Treated for Chronic Pain.

作者信息

Snyder Marion L, Fantz Corrine R, Melanson Stacy

机构信息

Brigham and Women's Hospital.

出版信息

Pain Physician. 2017 Feb;20(2S):SE1-SE9.

PMID:28226337
Abstract

BACKGROUND

Enzyme immunoassays (EIA) have notable limitations for monitoring therapeutic compliance in pain management. Chromatography coupled with mass spectrometry provides definitive results and superior sensitivity and specificity over traditional EIA testing.

OBJECTIVE

To analyze and compare the sensitivity of EIA results together with known prescriptions to liquid chromatography-tandem mass spectrometry (LC-MS/MS) for monitoring drug use (and abuse) in patients treated for chronic pain.

STUDY DESIGN

A total of 530 urine samples from patients being treated for chronic pain were studied.

SETTING

Pain management clinic in the United States.

METHODS

The samples were tested for a profile of chronic pain medications and illicit drugs with commercially available EIA kits followed by analysis with Agilent LC-MS/MS system.

RESULTS

The EIAs exhibited poor sensitivity and high rates of false negative results in the pain management setting. For example, 21% of EIA for opiates show false negative results. Mass spectrometry methods were more sensitive, detected a broader range of drugs and metabolites, and could detect non-prescribed drug use and simulations in compliance.

LIMITATIONS

Patients do not always accurately report drug use information, and some drugs do not have EIA methods available for comparative purposes.

CONCLUSIONS

Mass spectrometry is a more robust and reliable method for detection of drugs used in the pain management setting. Due to the extent of undisclosed use and abuse of medications and illicit drugs, LC-MS/MS testing is necessary for adequate and accurate drug detection. In addition, LC-MS/MS methods are superior in terms of sensitivity and number of compounds that can be screened, making this a better method for use in pain management. Key words: Pain management, enzyme immunoassays, mass spectrometry, urine drug testing, prescription status, compliance.

摘要

背景

酶免疫测定法(EIA)在疼痛管理中监测治疗依从性方面存在显著局限性。色谱联用质谱法能提供确切结果,且与传统EIA检测相比具有更高的灵敏度和特异性。

目的

分析并比较EIA结果与已知处方对于液相色谱 - 串联质谱法(LC-MS/MS)监测慢性疼痛治疗患者药物使用(及滥用)情况的灵敏度。

研究设计

共研究了530例慢性疼痛治疗患者的尿液样本。

研究地点

美国的疼痛管理诊所。

方法

使用市售EIA试剂盒对样本进行慢性疼痛药物和非法药物检测,随后用安捷伦LC-MS/MS系统进行分析。

结果

在疼痛管理环境中,EIA表现出较差的灵敏度和较高的假阴性率。例如,21%的阿片类药物EIA显示假阴性结果。质谱法更灵敏,能检测到更广泛的药物和代谢物,且能检测到未处方药物的使用及依从性造假情况。

局限性

患者并不总是准确报告药物使用信息,且一些药物没有可用于比较的EIA方法。

结论

质谱法是检测疼痛管理中使用药物更稳健、可靠的方法。由于药物和非法药物未公开使用及滥用的程度,LC-MS/MS检测对于充分、准确的药物检测是必要的。此外,LC-MS/MS方法在灵敏度和可筛查化合物数量方面更具优势,使其成为疼痛管理中更好的方法。关键词:疼痛管理;酶免疫测定法;质谱法;尿液药物检测;处方状态;依从性

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