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分析建模技术在实体器官移植中增强他克莫司剂量的应用:系统评价方案

Analytical modelling techniques for enhancing tacrolimus dosing in solid organ transplantation: a systematic review protocol.

机构信息

Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

Carleton University, Ottawa, Ontario, Canada.

出版信息

BMJ Open. 2024 Nov 1;14(10):e088775. doi: 10.1136/bmjopen-2024-088775.

DOI:10.1136/bmjopen-2024-088775
PMID:39486813
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11529584/
Abstract

INTRODUCTION

Tacrolimus is an immunosuppressant commonly administered in transplant recipients. Given its narrow therapeutic range and susceptibility to various influencing variables, determining its optimal dosage is challenging. This systematic review seeks to identify effective analytical modelling techniques and methods for optimal tacrolimus dose prediction in solid transplant recipients.

METHODS AND ANALYSIS

This review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria. The study will review the literature published from database inception to 11 March 2024, that assesses predictive models of tacrolimus dosing through analytical modelling techniques. We will include both randomised and non-randomised, as well as cross-sectional, qualitative and before-and-after studies and will perform our searches in four main databases-Ovid/MEDLINE, PubMed/MEDLINE, Scopus, Embase and Web of Science, and search engines including Centers for Disease Control (CDC) and Google Scholar. Papers that are not published in English or French are excluded from this study. A narrative synthesis and meta-analysis will be done if the extracted information permits such analysis. Conference abstracts will be ignored unless they are recent (published within 2 years of the search date).

ETHICS AND DISSEMINATION

Ethics clearance is not required for this study as no primary data will be collected. The completed manuscript will be published, and the results of the study will be presented at conferences.

STUDY REGISTRATION

International Prospective Register of Systematic Reviews (PROSPERO), CRD42024537212.

摘要

简介

他克莫司是一种常用于移植受者的免疫抑制剂。鉴于其治疗窗较窄且易受多种影响因素的影响,确定其最佳剂量具有挑战性。本系统评价旨在确定有效的分析建模技术和方法,以预测实体器官移植受者他克莫司的最佳剂量。

方法和分析

本综述将遵循系统评价和荟萃分析的首选报告项目(PRISMA)标准。该研究将回顾截至 2024 年 3 月 11 日从数据库开始发表的文献,这些文献评估了通过分析建模技术进行他克莫司剂量预测的预测模型。我们将包括随机和非随机、横断面、定性和前后研究,并在四个主要数据库(Ovid/MEDLINE、PubMed/MEDLINE、Scopus、Embase 和 Web of Science)和包括疾病控制中心(CDC)和谷歌学术在内的搜索引擎中进行搜索。不发表英文或法文的论文将被排除在本研究之外。如果提取的信息允许进行这种分析,将进行叙述性综合和荟萃分析。除非是近期(在搜索日期的 2 年内发表)的会议摘要,否则将被忽略。

伦理和传播

本研究不需要伦理批准,因为不会收集原始数据。完成的手稿将发表,并将在会议上展示研究结果。

研究注册

国际前瞻性系统评价注册库(PROSPERO),CRD42024537212。

相似文献

1
Analytical modelling techniques for enhancing tacrolimus dosing in solid organ transplantation: a systematic review protocol.分析建模技术在实体器官移植中增强他克莫司剂量的应用:系统评价方案
BMJ Open. 2024 Nov 1;14(10):e088775. doi: 10.1136/bmjopen-2024-088775.
2
Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas.在流行地区,服用抗叶酸抗疟药物的人群中,叶酸补充剂与疟疾易感性和严重程度的关系。
Cochrane Database Syst Rev. 2022 Feb 1;2(2022):CD014217. doi: 10.1002/14651858.CD014217.
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Health Technol Assess. 2016 Aug;20(62):1-594. doi: 10.3310/hta20620.
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Med J Aust. 2020 Dec;213 Suppl 11:S3-S32.e1. doi: 10.5694/mja2.50881.
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Effect of metformin use on graft and patient survival in kidney transplant recipients with type 2 diabetes: a systematic review protocol.二甲双胍对 2 型糖尿病肾移植受者移植物和患者生存的影响:系统评价方案。
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Sublingual administration of tacrolimus: current trends and available evidence.他克莫司的舌下给药:当前趋势与现有证据
Pharmacotherapy. 2014 Nov;34(11):1209-19. doi: 10.1002/phar.1492. Epub 2014 Sep 24.
8
Population pharmacokinetic models of tacrolimus in paediatric solid organ transplant recipients: A systematic review.他克莫司在儿科实体器官移植受者中的群体药代动力学模型:系统评价。
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Immunosuppressive therapy for kidney transplantation in children and adolescents: systematic review and economic evaluation.儿童和青少年肾移植的免疫抑制治疗:系统评价与经济评估
Health Technol Assess. 2016 Aug;20(61):1-324. doi: 10.3310/hta20610.
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Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients.提高实体器官移植受者免疫抑制剂药物依从性的干预措施。
Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.

本文引用的文献

1
A prospective validation of a population pharmacokinetic model of tacrolimus in Tunisian kidney transplant patients.在突尼斯肾移植患者中进行他克莫司群体药代动力学模型的前瞻性验证。
Transpl Immunol. 2023 Oct;80:101906. doi: 10.1016/j.trim.2023.101906. Epub 2023 Jul 24.
2
Developing supervised machine learning algorithms to evaluate the therapeutic effect and laboratory-related adverse events of cyclosporine and tacrolimus in renal transplants.开发监督机器学习算法来评估环孢素和他克莫司在肾移植中的治疗效果和与实验室相关的不良事件。
Int J Clin Pharm. 2023 Jun;45(3):659-668. doi: 10.1007/s11096-023-01545-5. Epub 2023 Feb 27.
3
Physiologically based pharmacokinetic modeling of tacrolimus for food-drug and CYP3A drug-drug-gene interaction predictions.
基于生理的他克莫司药代动力学模型用于食物-药物和 CYP3A 药物-药物-基因相互作用预测。
CPT Pharmacometrics Syst Pharmacol. 2023 May;12(5):724-738. doi: 10.1002/psp4.12946. Epub 2023 Mar 10.
4
Genotype-guided model significantly improves accuracy of tacrolimus initial dosing after liver transplantation.基因型指导模型显著提高肝移植后他克莫司初始给药的准确性。
EClinicalMedicine. 2022 Nov 24;55:101752. doi: 10.1016/j.eclinm.2022.101752. eCollection 2023 Jan.
5
Controversial Interactions of Tacrolimus with Dietary Supplements, Herbs and Food.他克莫司与膳食补充剂、草药和食物之间存在争议的相互作用。
Pharmaceutics. 2022 Oct 10;14(10):2154. doi: 10.3390/pharmaceutics14102154.
6
Compare the performance of multiple machine learning models in predicting tacrolimus concentration for infant patients with living donor liver transplantation.比较多种机器学习模型在预测活体供肝移植婴儿患者他克莫司浓度方面的性能。
Pediatr Transplant. 2023 Feb;27(1):e14379. doi: 10.1111/petr.14379. Epub 2022 Aug 30.
7
Race and sex associations with tacrolimus pharmacokinetics in stable kidney transplant recipients.种族和性别与稳定的肾移植受者中环孢素药代动力学的关系。
Pharmacotherapy. 2022 Feb;42(2):94-105. doi: 10.1002/phar.2656. Epub 2022 Feb 1.
8
Identifying the association between tacrolimus exposure and toxicity in heart and lung transplant recipients: A systematic review.确定他克莫司暴露与心肺移植受者毒性之间的关联:一项系统评价。
Transplant Rev (Orlando). 2021 Apr;35(2):100610. doi: 10.1016/j.trre.2021.100610. Epub 2021 Feb 27.
9
Marked change in blood tacrolimus concentration levels due to grapefruit in a renal transplant patient.肾移植患者因食用葡萄柚导致血他克莫司浓度显著变化。
J Clin Pharm Ther. 2019 Oct;44(5):819-822. doi: 10.1111/jcpt.13002. Epub 2019 Jun 23.
10
Therapeutic Drug Monitoring of Tacrolimus-Personalized Therapy: Second Consensus Report.他克莫司治疗药物监测-个体化治疗:第二版共识报告。
Ther Drug Monit. 2019 Jun;41(3):261-307. doi: 10.1097/FTD.0000000000000640.