Dosing Strategy of Ramosetron to Prevent Postoperative Nausea and Vomiting and Development of Prediction Models Using Data Obtained From Randomized Controlled Trials: A Comparative Study

IF 3.2 4区 医学 Q2 PHARMACOLOGY & PHARMACY
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Abstract

Purpose

The study aimed to compare the postoperative nausea and vomiting (PONV) preventive effect of repeated administration of ramosetron with the standard treatment group and compare models to predict the incidence of PONV using machine-learning techniques.

Methods

A total of 261 patients scheduled for breast surgery were analyzed to evaluate the effectiveness of repeated intravenous administration of ramosetron. All patients were administered 0.3 mg ramosetron just before the end of surgery. For the repeated dose of ramosetron group, an additional dose of 0.3 mg was administered at 4, 22, and 46 hours after the end of the surgery. Postoperative nausea, vomiting, and retching were evaluated using the Rhodes Index of Nausea, Vomiting, and Retching at 6, 24, and 48 hours postoperatively. Previously published randomized controlled data were combined with the data of this study to create a new dataset of 1390 patients, and machine-learning–based PONV prediction models (classification tree, random forest, extreme gradient boosting, and neural network) was constructed and compared with the Apfel model.

Findings

Fifty patients (38.5%) and 60 patients (45.8%) reported nausea, vomiting, or retching 48 hours postoperatively in the standard and repeated-dose groups, respectively (P = 0.317, χ2 test). Median sensitivity, specificity, and accuracy of the Apfel model analyzed using the training set were 0.815, 0.344, and 0.495, respectively.

Implications

The repeated administration of ramosetron did not reduce the incidence of PONV. The Apfel model had high sensitivity, however, its specificity and accuracy were lower than that in machine-learning–based models.

使用雷莫司琼预防术后恶心和呕吐的剂量策略以及利用随机对照试验获得的数据建立预测模型:比较研究。
目的:该研究旨在比较重复给药瑞莫司琼与标准治疗组的术后恶心呕吐(PONV)预防效果,并比较使用机器学习技术预测 PONV 发生率的模型:对261名计划接受乳腺手术的患者进行了分析,以评估重复静脉注射拉莫司琼的效果。所有患者均在手术结束前服用 0.3 毫克雷莫司琼。对于重复给药的雷莫司琼组,则在手术结束后 4、22 和 46 小时再给药 0.3 毫克。术后恶心、呕吐和反胃的评估采用罗氏恶心、呕吐和反胃指数(Rhodes Index of Nausea, Vomiting, and Retching),分别在术后 6、24 和 48 小时进行。将之前发表的随机对照数据与本研究数据相结合,创建了一个包含 1390 名患者的新数据集,并构建了基于机器学习的 PONV 预测模型(分类树、随机森林、极端梯度提升和神经网络),并与 Apfel 模型进行了比较:标准剂量组和重复剂量组分别有 50 名患者(38.5%)和 60 名患者(45.8%)在术后 48 小时出现恶心、呕吐或反胃(P = 0.317,χ2 检验)。使用训练集分析的 Apfel 模型的灵敏度、特异性和准确性中位数分别为 0.815、0.344 和 0.495:意义:重复给药拉莫司琼并不能降低 PONV 的发生率。Apfel模型具有较高的灵敏度,但其特异性和准确性低于基于机器学习的模型。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Clinical therapeutics
Clinical therapeutics 医学-药学
CiteScore
6.00
自引率
3.10%
发文量
154
审稿时长
9 weeks
期刊介绍: Clinical Therapeutics provides peer-reviewed, rapid publication of recent developments in drug and other therapies as well as in diagnostics, pharmacoeconomics, health policy, treatment outcomes, and innovations in drug and biologics research. In addition Clinical Therapeutics features updates on specific topics collated by expert Topic Editors. Clinical Therapeutics is read by a large international audience of scientists and clinicians in a variety of research, academic, and clinical practice settings. Articles are indexed by all major biomedical abstracting databases.
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