药物试验方法和试验结果的临床解释。

Bulletin on narcotics Pub Date : 1993-01-01
B M Kapur
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引用次数: 0

摘要

本文讨论了与药物检测有关的主要问题。例如,药物测试技术可以测量一种或多种药物的存在,但还不够复杂,无法测量药物使用造成的损害。此外,很难根据实验室结果确定给药途径、剂量或频率以及服药时间。选择要检验的药物应取决于该药物在当地的可得性、其滥用可能性和临床效果,以及在检验和解释实验室结果方面是否有分析技术和专门知识。最复杂的药物检测方法是气相色谱-质谱联用(GC/MS),被认为是“金标准”;它用于验证性测试。通常,在GC/MS之前要进行快速免疫分析,以消除大多数“阴性”样品。尽管存在复杂的药物检测方法,但仍然有可能获得不正确的检测结果。这种结果可能是由于存在干扰物质或尿样掺假造成的。可以采用许多技术来减少获得错误结果和检测掺假尿液样本的可能性。"阳性"药物检测结果可能对个人的生计产生严重影响,因此,进行此类检测的人员应遵守最严格的实验室工作标准。只有有资质和经验的人员和适当的实验室设备才能进行这些分析。实验室的工作标准必须符合当地法律和法医的要求。必须限制获取患者样本和实验室记录,以防止篡改样本和结果。为了保密,必须只向医务审查干事通报结果。监管链文件和所有文件,以便在遇到法律挑战时进行审查。实验室必须有完整的质量控制记录。最后,应该满足特定的初始和确认性测试需求。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Drug-testing methods and clinical interpretations of test results.

In the present paper, major issues related to drug testing are discussed. For example, drug-testing techniques measure the presence of a drug or drugs but are not sophisticated enough to measure impairment from drug use. Moreover, it is difficult to determine the route of drug administration, quantity or frequency, as well as when the drug was taken, on the basis of the laboratory results. Selection of the drug to be tested should depend on the local availability of the drug, its abuse potential and clinical effects, as well as on the availability of analytical technology and expertise in testing and in interpreting laboratory results. The most sophisticated drug-testing approach is gas chromatography coupled with mass spectrometry (GC/MS), which is regarded as a "gold standard"; it is used in confirmatory testing. Typically, GC/MS is preceded by a rapid immunoassay method to eliminate the majority of the "negative" samples. Despite the existence of sophisticated drug-testing methods, it is still possible to obtain incorrect test results. Such results may be caused by the presence of interfering substances or adulteration of the urine sample. A number of techniques can be employed to reduce the likelihood of obtaining erroneous results and to detect adulterated urine samples. A "positive" drug finding can have a serious impact on the livelihood of an individual, therefore, persons conducting such tests should adhere to the strictest standards of laboratory performance. Only qualified and experienced individuals with proper laboratory equipment should perform these analyses. The standards of laboratory performance must meet local legal and forensic requirements. Access to patient samples and laboratory records must be restricted in order to prevent the tampering of samples and results. In order to maintain confidentiality, the results must be communicated only to the medical review officer. Chain-of-custody documents and all file so that they can be examined in case of a legal challenge. The laboratory must have a complete record on quality control. Finally, specific initial and confirmatory testing requirements should be met.

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