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炎症性肠病抗 TNF 治疗的治疗药物监测:胃肠病学家态度和障碍的调查研究。

A Survey Study of Gastroenterologists' Attitudes and Barriers Toward Therapeutic Drug Monitoring of Anti-TNF Therapy in Inflammatory Bowel Disease.

机构信息

Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.

出版信息

Inflamm Bowel Dis. 2017 Dec 19;24(1):191-197. doi: 10.1093/ibd/izx023.

Abstract

BACKGROUND

Therapeutic drug monitoring (TDM) may improve the efficacy and cost-effectiveness of anti-TNF therapy. A standardized approach of utilizing TDM has not been established. The objective of this study was to determine gastroenterologists' attitudes and barriers toward TDM of anti-TNF therapy in clinical practice.

METHODS

An 18-question survey was distributed to members of the American College of Gastroenterology and Crohn's and Colitis Foundation via email. We collected physician characteristics, practice demographics, and data regarding TDM use and perceived barriers to TDM. Factors associated with the use of TDM were determined by logistic regression analysis.

RESULTS

A total of 403 gastroenterologists from 42 US states (76.4% male) met inclusion criteria: 90.1% use TDM, mostly reactively for secondary loss of response (87.1%) and primary nonresponse (66%); 36.6% use TDM proactively. The greatest barriers to TDM implementation were uncertainty about insurance coverage (77.9%), high out-of-pocket patient costs (76.4%), and time lag from serum sample to result (38.5%). Factors independently associated with the use of TDM and proactive TDM were practice in an academic setting (P = 0.019), and more IBD patients seen per month (P = 0.015), and Crohn's and Colitis Foundation membership (P < 0.001), and more IBD patients on anti-TNF therapy per month (P = 0.006), respectively. If all barriers were removed, an additional one-third of physicians would apply proactive TDM.

CONCLUSIONS

Lack of insurance coverage, high out-of-pocket costs, and the time lag from test to result limit use of TDM in the United States. Validation of low-cost assays, point of care testing, and studies that standardize the use of TDM are needed to make TDM more commonplace.

摘要

背景

治疗药物监测(TDM)可能会提高抗 TNF 治疗的疗效和成本效益。但尚未建立标准化的 TDM 应用方法。本研究的目的是确定胃肠病学家在临床实践中对抗 TNF 治疗的 TDM 的态度和障碍。

方法

通过电子邮件向美国胃肠病学会和克罗恩病和结肠炎基金会的成员分发了一份包含 18 个问题的调查问卷。我们收集了医生的特征、实践人口统计学数据以及 TDM 使用和 TDM 感知障碍的数据。通过逻辑回归分析确定与 TDM 使用相关的因素。

结果

共有来自美国 42 个州的 403 名胃肠病学家符合纳入标准(76.4%为男性):90.1%的人使用 TDM,主要是为了二次应答丧失(87.1%)和原发性无应答(66%)的反应性使用;36.6%的人主动使用 TDM。实施 TDM 的最大障碍是对保险覆盖范围的不确定性(77.9%)、患者自费费用高(76.4%)以及从血清样本到结果的时间滞后(38.5%)。与 TDM 使用和主动 TDM 使用相关的独立因素分别为在学术环境中执业(P = 0.019)、每月就诊的 IBD 患者更多(P = 0.015)、克罗恩病和结肠炎基金会会员资格(P < 0.001)以及每月接受抗 TNF 治疗的 IBD 患者更多(P = 0.006)。如果消除所有障碍,将有三分之一的医生会主动使用 TDM。

结论

在美国,缺乏保险覆盖、自费费用高以及从检测到结果的时间滞后限制了 TDM 的使用。需要验证低成本检测、即时检测和标准化 TDM 使用的研究,以使 TDM 更为普及。

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