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神经内分泌肿瘤门诊患者长效生长抑素类似物安全监测方案

Long-Acting Somatostatin Analogue Safety Monitoring Protocol for Outpatients With Neuroendocrine Tumors.

作者信息

Gabrielsen Jordan, Girone Gianna, Bennett Bonita, Jung Anna

机构信息

Thomas Jefferson University, Philadelphia, Pennsylvania.

Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania.

出版信息

J Adv Pract Oncol. 2019 Sep-Oct;10(7):646-659. doi: 10.6004/jadpro.2019.10.7.2. Epub 2019 Sep 1.

DOI:10.6004/jadpro.2019.10.7.2
PMID:33391850
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7517774/
Abstract

Somatostatin analogues (SSAs) are widely used in the long-term treatment of neuroendocrine tumors (NETs) and have a relatively favorable safety profile. However, SSAs are associated with specific side effects that are important to monitor. Currently, there is no standardized safety monitoring protocol for health-care professionals to use as a reference when initiating patients on long-acting SSAs. With the expansion of SSA use from symptomatic control to include antiproliferative tumor treatment in patients with NETs, it is increasingly important that patients taking these medications are properly monitored. The purpose of this analysis was to develop a comprehensive, practical SSA safety monitoring protocol for patients with NETs in the outpatient setting. This strategy was based on side effect frequencies that were reported and the monitoring parameters used in influential clinical and safety trials. Based on our assessment, we consider monitoring gallbladder imaging, laboratory tests (including blood chemistry, thyroid-stimulating hormone, hemoglobin A1c, and stool studies), vital signs, and physical examinations as the most important parameters when evaluating the safety of long-term SSA therapy. Due to the frequency at which patients experienced diarrhea as a side effect in clinical trials, questions about urgency, frequency, timing, consistency, odor, and color of bowel movements should be asked as part of the follow-up visits every 6 months to help differentiate between drug-induced vs. disease-associated causes. This broad monitoring strategy for patients receiving long-term SSAs was developed specifically for patients with NETs; however, the use of this protocol could be expanded to other indications in the future.

摘要

生长抑素类似物(SSAs)广泛用于神经内分泌肿瘤(NETs)的长期治疗,且安全性相对良好。然而,SSAs会引发一些需要密切监测的特定副作用。目前,对于医疗保健专业人员在开始为患者使用长效SSAs时,尚无标准化的安全监测方案可供参考。随着SSAs的应用从症状控制扩展到包括对NETs患者进行抗肿瘤增殖治疗,对服用这些药物的患者进行适当监测变得越来越重要。本分析的目的是为门诊环境中的NETs患者制定一个全面、实用的SSA安全监测方案。该策略基于已报告的副作用发生频率以及在有影响力的临床和安全性试验中使用的监测参数。根据我们的评估,我们认为在评估长期SSA治疗的安全性时,监测胆囊成像、实验室检查(包括血液化学、促甲状腺激素、糖化血红蛋白和粪便检查)、生命体征和体格检查是最重要的参数。由于在临床试验中患者出现腹泻副作用的频率较高,因此在每6个月的随访中,应询问有关排便的急迫性、频率、时间、性状、气味和颜色等问题,以帮助区分药物引起的与疾病相关的原因。这种针对接受长期SSAs治疗患者的广泛监测策略是专门为NETs患者制定的;然而,该方案的应用未来可能会扩展到其他适应症。

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