Ridola Lorenzo, Nardelli Silvia, Gioia Stefania, Riggio Oliviero
Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Italy.
Department of Clinical Medicine, Sapienza University of Rome, Italy.
J Clin Exp Hepatol. 2019 Jan-Feb;9(1):137-145. doi: 10.1016/j.jceh.2018.02.007. Epub 2018 Mar 13.
The design of clinical trials on Hepatic Encephalopathy (HE) is not an easy task, in fact there are several issues related to the performance of clinical trials in HE that have impeded progress in the field, mainly because most of the studies on HE therapy were performed before the era of rigorous Randomized Controlled Trials (RCTs). In this review we discuss the major problems affecting previously published trials on HE treatments aiming to provide evidences, suggestions and indications to prepare well designed RCTs in three different settings: (1) management of hospitalized patients with episodic HE; (2) secondary prophylaxis in patients following an episode of HE; and (3) management of minimal/covert HE.
肝性脑病（HE）临床试验的设计并非易事，事实上，与HE临床试验实施相关的几个问题阻碍了该领域的进展，主要是因为大多数关于HE治疗的研究是在严格的随机对照试验（RCT）时代之前进行的。在本综述中，我们讨论了影响先前发表的HE治疗试验的主要问题，旨在为在三种不同情况下设计良好的RCT提供证据、建议和指导：（1）住院发作性HE患者的管理；（2）HE发作后患者的二级预防；（3）轻微/隐匿性HE的管理。
