Background data for: Patient-Tailored Levothyroxine Dosage with Pharmacokinetic/Pharmacodynamic Modeling: A Novel Approach After Total Thyroidectomy

<p>This dataset constitutes the background data for the study: Patient-Tailored Levothyroxine Dosage with Pharmacokinetic/Pharmacodynamic Modeling: A Novel Approach After Total Thyroidectomy (doi: 10.1089/thy.2021.0125). The study's objective was to investigate whether a new pharmacokinetic/pharmacodynamic model for Levothyroxine dosage lead to better and faster levothyroxine dosage. Patients >18 years with a planned total thyroidectomy were eligible for participation.</p>
<p>Data were collected in two phases. The first phase, conducted from 2016 to 2017, comprised the pilot study. Data from the pilot study was used to develop the pharmacokinetic/pharmacodynamic model.</p>
<p>The second phase, conducted from 2017 to 2019, consisted of a randomised controlled trial utilizing the Pharmacokinetic/pharmacodynamic model for calculating each patient's optimal levothyroxine dosage.</p>
<p>Data collected in the two phases are patient demographics, laboratory results and levothyroxine dosage. Laboratory results and levothyroxine dosage were collected at multiple time points during the study, both before and after surgery. Data from the pilot study and the RCT have been merged and anonymised.</p>
<p>All participants provided written informed consent for data collection.</p>

本数据集为下述研究的背景数据：《基于药代动力学/药效动力学（Pharmacokinetic/Pharmacodynamic）建模的患者个体化左甲状腺素（Levothyroxine）剂量方案：全甲状腺切除术后的新型干预策略》（DOI: 10.1089/thy.2021.0125）。本研究旨在探究针对左甲状腺素剂量的新型药代动力学/药效动力学模型，是否能够实现更优质且更快速的左甲状腺素剂量优化调整。年龄18周岁以上、计划接受全甲状腺切除术的患者符合本研究的入组标准。
本数据集的数据分为两个阶段采集。第一阶段于2016年至2017年间开展，为预试验阶段，预试验所获数据用于构建前述药代动力学/药效动力学模型。
第二阶段于2017年至2019年间开展，为随机对照试验（Randomised Controlled Trial, RCT）阶段，该阶段采用前述药代动力学/药效动力学模型计算每位患者的最优左甲状腺素给药剂量。
两阶段采集的数据涵盖患者人口统计学资料、实验室检测结果以及左甲状腺素给药剂量。研究期间，于手术前后的多个时间点采集实验室检测结果与左甲状腺素给药剂量数据。预试验与随机对照试验（RCT）的数据已完成合并并匿名化处理。
所有受试者均签署了书面知情同意书，同意参与本次研究的数据采集工作。