Physician Monitoring System for Nicotine and Metabolites

描述(由申请人提供)：在美国，吸烟和接触二手烟平均每年导致438,000人过早死亡。在烟草产品中共同管理的尼古丁是一种令人上瘾的物质，它会导致个人继续使用烟草，尽管人们一致努力戒烟。尼古丁代谢物监测是监测吸烟者成瘾和治疗的重要工具。目前的监测技术使用的是以临床分析实验室为基础的分析设备，这使得监测变得不便和昂贵。目前还没有商业上可用的适合医生办公室使用的监测系统。这项拟议的计划将开发一个先进、快速和方便的以家庭和医生办公室为基础的系统，该系统将对那些正在接受吸烟治疗的人的健康和福祉产生重大影响。这项工作的创新之处在于开发了一种由新型高性能微电极组成的电化学传感器，该微电极利用灵敏和选择性的电化学技术来测量临床环境中尿样中尼古丁代谢物的浓度。所提出的电化学检测方法的开发是证明产品可行性的关键，也是第一阶段的重点。电化学技术的硬件和软件可在商业上以合理的价格获得，以适应这一应用。最终产品将具有办公室监护仪的易用性，并为临床医生提供患者最佳和具有成本效益的治疗所需的尼古丁代谢物测量。第一阶段项目的设计是为了确定所提出的电化学方法的可行性。第一阶段将包括：1)优化先进材料微传感器芯片电极；2)选择电解液和溶剂；3)开发一种强大的电分析算法，用于灵敏和选择性地检测尿液中的尼古丁及其代谢物；4)测试所开发的技术；以及5)设计第二阶段集成仪器。 与公众健康相关：拟议的项目是开发一种便携式、自给自足、易于使用的电化学监测仪，用于从单个尿样中几乎实时地同时现场测量尼古丁及其主要代谢物[可替宁(Cot)和3-羟基可替宁(3HC)]，以评估个人接触情况。在医生办公室准确、方便、安全和经济有效地测量尼古丁、COT和3HC并将结果报告给临床医生的能力将以更低的成本改进治疗和监测。该测试将是用户友好的，用于医生的办公室，以优化和个性化戒烟计划，其中包括尼古丁替代和蟾酥药物疗法。该监测仪还有可能具有足够的灵敏度，可以检测到接触二手烟的情况，用于健康监测和研究。

DESCRIPTION (provided by applicant): Cigarette smoking and secondhand exposure to tobacco smoke cause an estimated average of 438,000 premature deaths each year in the United States. Nicotine, coadministered in tobacco products, is an addicting substance that causes individuals to continue use of tobacco despite concerted efforts to quit. Nicotine-metabolites monitoring is an important tool for monitoring smoker addictions and treatment. Current monitoring techniques utilize analytic equipment that is based in a clinical analytical laboratory making monitoring inconvenient and costly. There is currently no commercially-available monitoring system suitable for physician's office use. This proposed program will develop an advanced, rapid, and convenient home and physician office-based system which could make a significant impact in the health and well-being of those individuals being treated for smoking. The innovation in the proposed work is to develop an electrochemical sensor comprised of a novel high performance microelectrode utilizing a sensitive and selective electrochemical technique to measure nicotine-metabolites concentration in the clinical setting from urine samples. The development of the proposed electrochemical detection method is key to the demonstration of product feasibility and is the emphasis in Phase I. The hardware and software for the electrochemical technique are commercially available at a reasonable price for adaptation to this application. The final product will have the ease of use of an office monitor and provide the clinician with nicotine-metabolites measurements needed for optimal and cost-effective treatment of the patient. The Phase I project is designed to determine the feasibility of the proposed electrochemical method. Phase I will include: 1) optimization of an advanced material microsensor chip electrode; 2) selection of electrolyte and solvent; 3) development of a powerful electroanalytical algorithm for sensitive and selective detection of nicotine and it metabolites in urine analog solutions; 4) testing of the developed technique; and 5) design of a Phase II integrated instrument. PUBLIC HEALTH RELEVANCE: The proposed project is to develop a portable, self-contained, easy-to-use, electrochemical monitor for simultaneous on-site measurement of nicotine and its major metabolites [cotinine (COT) and 3-hydroxycotinine (3HC)] from a single urine sample in near real time to assess personal exposure. The ability to accurately, conveniently, safely and cost-effectively measure nicotine, COT and 3HC in physician's offices with the results reported to the clinician would improve treatment and monitoring with lower cost. The test will be user-friendly for use in physician's offices to optimize and personalize smoking cessation programs that include nicotine replacement and buproprion pharmacotherapies. The monitor also has the potential to be sufficiently sensitive to detect exposure to second hand smoke for health monitoring and research studies.