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放射性碘治疗分化型甲状腺癌患者的预防性止吐治疗:一项单中心、非随机临床试验。

The prophylactic antiemetic therapies in management of differentiated thyroid cancer patients with radioactive iodine therapy: a single-center, non-randomized clinical trial.

机构信息

Department of Nuclear Medicine, the Second Hospital of Shandong University, Jinan, China.

School of Basic Medical Sciences, Shandong University, Jinan, China.

出版信息

Front Endocrinol (Lausanne). 2024 Apr 19;15:1310223. doi: 10.3389/fendo.2024.1310223. eCollection 2024.

Abstract

OBJECTIVE

The present study was to investigate three different single-drug regimens to show which was more effective to reduce radioactive iodine therapy (RAI) associated nausea and vomiting, and to compare the occurrence of long-term gastrointestinal diseases after RAI therapy.

METHOD

We performed a single-center, non-randomized clinical trial among patients who underwent RAI therapy from March 2016 to July 2022. Enrolled patients were divided into four cohorts based on the date of the treatment. cohort 1, with no preventive antiemetics; cohort 2, received 20 mg of pantoprazole per day for 3 days; cohort 3, received a 10 mg metoclopramide tablet two times daily for 3 days; cohort 4, oral ondansetron, 8 mg, twice daily for 3 days. The primary endpoints were proportion of patients who experience vomiting episodes and nausea during the 7-day hospital period. Secondary end points included Functional Living Index Emesis (FLIE) quality-of life questionnaires and the occurrence of gastrointestinal diseases.

RESULTS

A total of 1755 patients were analyzed, comprised of 1299 (74.0%) women and 456 (26.0%) men, with a median age of 44 years (range 18-78 years). The characteristics of patient were similar within the four groups. 465 (26.4%) patients developed RAI-associated nausea, and 186 (14.4%) patients developed RAI-associated vomiting. The rate of nausea was significantly decreased in the patients who were taking ondansetron when compared with the other cohorts (<0.05), while the rate of vomiting (≥6 episodes) was slightly lower. As secondary endpoint, FLIE measures ondansetron scored highly compared to other cohorts, from baseline (mean score of 110.53 ± 17.54) to day 7 (mean score of 105.56 ± 12.48). In addition, 48 (2.7%) patients were found to be with gastrointestinal diseases at the end of one year follow up. Multiple RAI therapy and higher dose of I-131 per body weight revealed a significantly independent risk factors of developing gastrointestinal disorders.

CONCLUSIONS

In conclusion, the present study demonstrated that short-term ondansetron could be an effective prophylactic agent in controlling RAI-associated nausea and vomiting. Furthermore, the risk of developing gastrointestinal disorders was significantly higher for patients with multiple RAI therapy and higher dose of I-131 per body weight.

摘要

目的

本研究旨在探讨三种不同的单药方案,以确定哪种方案更能有效减少放射性碘治疗(RAI)相关的恶心和呕吐,并比较 RAI 治疗后长期胃肠道疾病的发生情况。

方法

我们在 2016 年 3 月至 2022 年 7 月期间接受 RAI 治疗的患者中进行了一项单中心、非随机临床试验。纳入的患者根据治疗日期分为四组。组 1,无预防性止吐药;组 2,每天口服泮托拉唑 20mg,连用 3 天;组 3,每天口服甲氧氯普胺 10mg,每日 2 次,连用 3 天;组 4,口服昂丹司琼,每日 2 次,每次 8mg,连用 3 天。主要终点是在 7 天住院期间发生呕吐发作和恶心的患者比例。次要终点包括功能性生活指数呕吐(FLIE)生活质量问卷和胃肠道疾病的发生情况。

结果

共分析了 1755 例患者,其中 1299 例(74.0%)为女性,456 例(26.0%)为男性,中位年龄为 44 岁(18-78 岁)。四组患者的患者特征相似。465 例(26.4%)患者发生 RAI 相关性恶心,186 例(14.4%)患者发生 RAI 相关性呕吐。与其他组相比,接受昂丹司琼治疗的患者恶心发生率显著降低(<0.05),而呕吐(≥6 次)发生率略低。作为次要终点,FLIE 测量结果表明,昂丹司琼与其他组相比得分较高,从基线(平均得分 110.53±17.54)到第 7 天(平均得分 105.56±12.48)。此外,在 1 年随访结束时,发现 48 例(2.7%)患者存在胃肠道疾病。多次 RAI 治疗和每公斤体重 I-131 剂量较高提示是发生胃肠道疾病的显著独立危险因素。

结论

总之,本研究表明短期昂丹司琼可作为控制 RAI 相关性恶心和呕吐的有效预防药物。此外,多次 RAI 治疗和每公斤体重 I-131 剂量较高的患者发生胃肠道疾病的风险显著增加。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d6db/11066171/00cae9177f4d/fendo-15-1310223-g001.jpg

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