Department of General, Transplant and Liver Surgery, Medical University of Warsaw, Warsaw, Poland.
Department of General, Transplant and Liver Surgery, Medical University of Warsaw, Warsaw, Poland.
Clin Nutr. 2017 Dec;36(6):1530-1539. doi: 10.1016/j.clnu.2017.04.021. Epub 2017 May 4.
BACKGROUND & AIMS: Although there is increasing evidence for the benefits of probiotics in patients with liver diseases, data on the benefits of pre-LT administration of probiotics are lacking. The aim of this study was to evaluate the effects of continuous administration of probiotics before liver transplantation (LT) on pre- and post-transplant patient outcomes.
In this randomized, double-blind, and placebo-controlled trial adult cirrhotic patients listed for LT received a 4-strain probiotic preparation or placebo daily from enrollment until LT. The primary outcome measures were postoperative mortality and infection rates. The secondary outcome measures were 5-day post-transplant aspartate and alanine aminotransferase activities, bilirubin concentration, and international normalized ratio; waiting-list mortality; pre-transplant Model for End-stage Liver Disease score and Child-Turcotte-Pugh class changes; and pre-transplant infections.
A total of 55 patients were randomized. The 90-day postoperative mortality rates were 0% and 4.3% in the probiotic and placebo groups, respectively (p > 0.99). Patients receiving probiotics had significantly reduced 30-day (4.8% versus 34.8%, p = 0.02) and 90-day (4.8% versus 47.8%, p = 0.002) infection rates, lower post-LT bilirubin concentration (p = 0.02), and more rapid decrease of aspartate (p = 0.03) and alanine (p = 0.03) aminotransferase activities. Probiotics did not have significant effects on other secondary outcome measures.
Although continuous administration of probiotics before LT does not appear to affect postoperative mortality, it effectively prevents postoperative infections and improves early biochemical parameters of allograft function. CLINICALTRIALS.
NCT01735591.
尽管越来越多的证据表明益生菌对肝病患者有益，但关于肝移植（LT）前应用益生菌的益处的数据尚缺乏。本研究旨在评估 LT 前连续应用益生菌对移植前和移植后患者结局的影响。
在这项随机、双盲、安慰剂对照试验中，接受 LT 的成人肝硬化患者从登记至 LT 前每日接受 4 种菌株益生菌制剂或安慰剂治疗。主要结局指标为术后死亡率和感染率。次要结局指标为移植后第 5 天天冬氨酸和丙氨酸氨基转移酶活性、胆红素浓度和国际标准化比值；等待名单死亡率；移植前终末期肝病模型评分和 Child-Turcotte-Pugh 分级变化；以及移植前感染。
共随机分配了 55 例患者。益生菌组和安慰剂组的 90 天术后死亡率分别为 0%和 4.3%（p＞0.99）。接受益生菌治疗的患者 30 天（4.8%比 34.8%，p=0.02）和 90 天（4.8%比 47.8%，p=0.002）感染率显著降低，术后胆红素浓度更低（p=0.02），天冬氨酸（p=0.03）和丙氨酸（p=0.03）氨基转移酶活性下降更快。益生菌对其他次要结局指标没有显著影响。
尽管 LT 前连续应用益生菌似乎不会影响术后死亡率，但它可有效预防术后感染，并改善移植物功能的早期生化参数。临床试验.gov 标识符：NCT01735591。
