Pantazi Eirini, Bejaoui Mohamed, Folch-Puy Emma, Adam René, Roselló-Catafau Joan
a Experimental Hepatic Ischemia-Reperfusion Unit , Institute of Biomedical Research of Barcelona (IIBB-CSIC) , Barcelona , Spain.
b AP-HP Hôpital Paul Brousse , Centre Hepato-Biliaire, Univ Paris-Sud Villejuif , Paris , France.
Expert Opin Pharmacother. 2016;17(2):169-79. doi: 10.1517/14656566.2016.1115015. Epub 2016 Jan 8.
Ischemia-reperfusion injury (IRI) involves a complex sequence of events and limits the outcome of various surgical interventions. Clinical trials, based on the data of experimental models, aim to prove whether a pharmacological or technical approach could be suitable to provide a beneficial effect in humans. Due to the complexity of IRI, few pharmacological treatments have been investigated in clinical Phase III.
In this review we report clinical trials that test specific drugs in clinical trials of organ transplantation. These studies form part of Phase II trials and examine the administration of caspase inhibitors, P-selectin antagonist or an antioxidant component in order to attenuate cold IRI during transplantation. Moreover, we provide a brief description of drugs tested on trials of different clinical situations associated to IRI, such as the coronary artery bypass graft surgery and percutaneous coronary intervention.
Future clinical trials could be centered on the application of techniques suitable for organs with increased vulnerability toward IRI. Furthermore, the standardization of reliable biomarkers and a careful estimation of the impact of high risk factors may be the key in order to achieve a more critical evaluation of the obtained results.
缺血再灌注损伤(IRI)涉及一系列复杂事件,并限制了各种外科手术干预的效果。基于实验模型数据的临床试验旨在证明某种药理学或技术方法是否适合对人类产生有益效果。由于IRI的复杂性,很少有药物治疗进入临床III期研究。
在本综述中,我们报告了在器官移植临床试验中测试特定药物的临床试验。这些研究属于II期试验的一部分,研究了半胱天冬酶抑制剂、P-选择素拮抗剂或抗氧化成分的给药情况,以减轻移植过程中的冷缺血再灌注损伤。此外,我们简要介绍了在与IRI相关的不同临床情况试验中测试的药物,如冠状动脉搭桥手术和经皮冠状动脉介入治疗。
未来的临床试验可以围绕适用于对IRI易感性增加的器官的技术应用展开。此外,可靠生物标志物的标准化以及对高风险因素影响的仔细评估可能是对所获结果进行更严格评估的关键。