最新临床研究：益生菌可能有助于防治术后认知功能障碍

本文由“小麻哥的日常”授权转载

摘要译文（供参考）

益生菌对接受骨科手术的老年患者术后认知功能障碍的疗效：

一项多中心随机对照试验的研究方案

背景：

术后认知功能障碍（POCD）是指大手术和麻醉后的神经功能障碍。它在老年患者中很常见，其特点是手术麻醉后意识、定向、思维、记忆和执行功能受损。然而，目前尚无明确的预防或治疗策略。先前的动物实验表明，在手术前给小鼠服用益生菌可以预防POCD，但缺乏临床证据。本研究旨在在围手术期使用益生菌干预肠道菌群失调，以降低骨科手术后老年患者POCD的发生率，并为POCD的临床预防和治疗提供新的思路和方法。

方法：

将进行一项多中心、双盲、安慰剂对照的临床试验，以评估益生菌在接受骨科手术的老年患者中的疗效。参与者（n=220）将在术前1天至术后6天接受益生菌（培肥康，活组合双歧杆菌，每粒210 mg，每天两次，每次四粒，其中含有长双歧杆菌、嗜酸乳杆菌和粪链球菌，活菌分别不少于1.0×10∧7 CFU）或安慰剂。手术前1天、手术后1周和1个月进行神经心理测试。

本研究的主要结局指标是术后7天POCD的发生率。我们的次要结局指标是评估术后1个月POCD的发生率；认知状态将根据电话访谈确定，并通过TICS-m进行评估；术后谵妄将在术后7天使用谵妄评估量表（CAM）进行评估。

讨论：

发现肠道微生物群与POCD之间的相关性是一项重要突破。基于肠道微生物群在其他认知障碍中的关键作用，我们希望益生菌能够降低老年骨科患者的发病率。

试验注册：

ClinicalTrials.gov NCT04017403。于2019年8月15日注册。

关键词：

骨科手术；术后认知功能障碍；益生菌；随机对照试验。

原文摘要

Efficiency of probiotics in elderly patients undergoing orthopedic surgery for postoperative cognitive dysfunction: 

a study protocol for a multicenter, randomized controlled trial

Background: 

Postoperative cognitive dysfunction (POCD) refers to a neurological dysfunction after a major surgery and anesthesia. It is common in elderly patients and is characterized by impairment in consciousness, orientation, thinking, memory, and executive function after surgical anesthesia. However, at present, there is no definite preventive or treatable strategy for it. Previous animal experiments showed that giving probiotics to mice before operation can prevent POCD, but there is a lack of clinical evidence. This study aims to intervene with the intestinal flora imbalance using probiotics during the perioperative period to reduce the incidence of POCD in elderly patients after orthopedic surgery and to provide new ideas and methods for the clinical prevention and treatment of POCD.

Methods: 

A multicenter, double-blind, placebo-controlled clinical trial will be performed to evaluate the efficacy of probiotics in elderly patients undergoing orthopedic surgery. Participants (n = 220) will receive probiotics (Peifeikang, Live Combined Bifidobacterium, 210 mg per capsule, twice a day, four capsules each time, which contains Bifidobacterium longum, Lactobacillus acidophilus and Streptococcus faecalis no less than 1.0 × 107 CFU viable bacteria respectively) or placebo from 1 day before surgery to 6 days after surgery. Neuropsychological tests will be performed 1 day before surgery and 1 week and 1 month after surgery. The main outcome of this study is the incidence of POCD 7 days after surgery. Our secondary objective is to assess the incidence of POCD 1 month after surgery; the cognitive status will be determined based on a telephone interview and will be evaluated via TICS-m; postoperative delirium will be assessed 7 days after surgery using the Confusion Assessment Method (CAM).

Discussion: 

Discovering the correlation between the intestinal microbiota and POCD is an important breakthrough. Based on the key role of the intestinal microbiota in other cognitive disorders, we hope that probiotics can reduce its incidence in elderly orthopedic patients.

Trial registration: 

ClinicalTrials.gov NCT04017403. Registered on August 15, 2019.

Keywords: 

Orthopedic surgery; Postoperative cognitive dysfunction; Probiotics; Randomized controlled trial.

免责声明：

平台所刊载原创或转载内容不代表米勒之声的观点或立场。文中所涉及药物使用、疾病诊疗等内容仅供医学专业人士参考。

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编辑：MiSuper.米超

校对：Michel.米萱

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