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提高新型肺动脉高压药物实验研究的可重复性。对四百项动物研究数据的分析。

Toward Better Reproducibility in Experimental Research on New Agents for Pulmonary Hypertension. An Analysis of Data from Four Hundred Animal Studies.

机构信息

Department of Biopharmacy, Medical University of Łódź, ul. Muszyńskiego 1, 90-151, Lodz, Poland.

出版信息

Cardiovasc Drugs Ther. 2021 Aug;35(4):707-718. doi: 10.1007/s10557-020-07109-3. Epub 2020 Dec 9.

DOI:10.1007/s10557-020-07109-3
PMID:33294946
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8266793/
Abstract

PURPOSE

Pre-clinical data can provide a rationale for subsequent clinical trials and they are the first step in drug development; however, the therapeutic effect observed during animal studies does not necessarily translate to similar results in humans.

METHODS

Taking the example of pulmonary hypertension, the present study explores whether the methodological aspects of preclinical experiments can determine the final result.

RESULTS

The present paper describes a systematic analysis of 409 studies conducted on a variety of animal models to identify potential drug candidates for PH treatment; it explores the influence of various aspects of study design on the final outcome, e.g. type of animal model of PH, dosage schedules of tested agents, type of anesthesia, measurement of exercise intolerance or animal survival.

CONCLUSIONS

The animal models of PH used for pre-clinical studies are diverse and there are several methodological items within the established protocols that can determine the obtained result. Graphical abstract.

摘要

目的

临床前数据可为后续临床试验提供依据，也是药物开发的第一步；然而，动物研究中观察到的治疗效果不一定能转化为人类的相似结果。

方法

本研究以肺动脉高压为例，探讨临床前实验的方法学方面是否能决定最终结果。

结果

本文系统分析了 409 项在各种动物模型上进行的研究，以确定潜在的肺动脉高压治疗药物候选物；探讨了研究设计的各个方面对最终结果的影响，例如肺动脉高压动物模型的类型、受试药物的剂量方案、麻醉类型、运动不耐受或动物生存的测量。

结论

用于临床前研究的肺动脉高压动物模型多种多样，既定方案中有几个方法学项目可以决定所获得的结果。图表摘要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1011/8266793/0a9362022d18/10557_2020_7109_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1011/8266793/e870590939f4/10557_2020_7109_Figa_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1011/8266793/6977d44e869a/10557_2020_7109_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1011/8266793/abcf061cc814/10557_2020_7109_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1011/8266793/8a6c3826046d/10557_2020_7109_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1011/8266793/f9c448f5f716/10557_2020_7109_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1011/8266793/0a9362022d18/10557_2020_7109_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1011/8266793/e870590939f4/10557_2020_7109_Figa_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1011/8266793/6977d44e869a/10557_2020_7109_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1011/8266793/abcf061cc814/10557_2020_7109_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1011/8266793/8a6c3826046d/10557_2020_7109_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1011/8266793/f9c448f5f716/10557_2020_7109_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1011/8266793/0a9362022d18/10557_2020_7109_Fig5_HTML.jpg

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Animal models of pulmonary arterial hypertension: A systematic review and meta-analysis of data from 6126 animals.
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Pharmacol Res. 2017 Nov;125(Pt B):201-214. doi: 10.1016/j.phrs.2017.08.003. Epub 2017 Sep 1.
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