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临床儿科体重管理中对标签外用药的抵触:典型的双重标准。

Aversion to Off-label Prescribing in Clinical Pediatric Weight Management: The Quintessential Double Standard.

机构信息

Department of Pediatrics, Medical University of South Carolina, Charleston, SC 29425, USA.

Department of Pediatrics, University of Missouri, Kansas City, MO 65211, USA.

出版信息

J Clin Endocrinol Metab. 2021 Jun 16;106(7):2103-2113. doi: 10.1210/clinem/dgab276.

Abstract

CONTEXT

Pediatric obesity is now recognized as a chronic disease; yet few treatment options exist besides lifestyle modification therapy and bariatric surgery. We describe the limited availability of United States Food and Drug Administration (FDA)-approved antiobesity medications for adolescents and compare this to what is available for adults. We offer a rationale for off-label prescribing to assist with lifestyle modification therapy. We also highlight the need for more pharmacotherapy options and additional research into novel treatments for pediatric obesity.

CASE DESCRIPTION

We describe a patient who is struggling with managing her weight and starting to develop complications of obesity. We offer a framework in which off-label prescribing may be beneficial to patients who have been engaging in lifestyle modification therapy yet fail to see improvement.

CONCLUSION

Lifestyle modification therapy is necessary but often insufficient in stimulating clinically meaningful weight loss when used alone in children and adolescents who struggle with weight management. Until more FDA-approved antiobesity medications are available, pediatricians may be able to help more patients achieve weight reduction goals by familiarizing themselves with the responsible use of off-label medications and implementing these tools to improve clinical outcomes. There is a critical need for more pharmacotherapy options to help pediatric patients in managing their weight and preventing or improving the insidious complications resulting from untreated obesity.

摘要

背景

小儿肥胖现在被认为是一种慢性病;然而,除了生活方式改变疗法和减肥手术之外,几乎没有其他治疗选择。我们描述了美国食品和药物管理局 (FDA) 批准的青少年抗肥胖药物的有限可用性,并将其与成人可用的药物进行了比较。我们提供了一种在标签外开处方的理由,以帮助进行生活方式改变疗法。我们还强调了需要更多的药物治疗选择,并对小儿肥胖的新治疗方法进行更多的研究。

病例描述

我们描述了一位患者,她在控制体重方面遇到了困难,并开始出现肥胖并发症。我们提供了一个框架,在标签外开处方可能对那些一直在进行生活方式改变疗法但未见改善的患者有益。

结论

生活方式改变疗法是必要的,但在单独用于儿童和青少年体重管理困难的患者中,往往不足以刺激临床意义上的体重减轻。在更多的 FDA 批准的抗肥胖药物上市之前,儿科医生可以通过熟悉标签外药物的合理使用并实施这些工具来改善临床结果,从而帮助更多的患者实现减肥目标。迫切需要更多的药物治疗选择来帮助小儿患者控制体重,并预防或改善未经治疗的肥胖症导致的隐匿性并发症。

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