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一项关于益生菌在肝移植前使用对肝移植后结局影响的随机对照试验的事后分析。

Post-hoc analysis of a randomized controlled trial on the impact of pre-transplant use of probiotics on outcomes after liver transplantation.

机构信息

Department of General, Transplant and Liver Surgery, Medical University of Warsaw, Warsaw, Poland.

Second Department of Clinical Radiology, Medical University of Warsaw, Banacha 1A, 02-097, Warsaw, Poland.

出版信息

Sci Rep. 2020 Nov 17;10(1):19944. doi: 10.1038/s41598-020-76994-3.

Abstract

Perioperative use of probiotics serves as efficient prophylaxis against postoperative infections after liver transplantation, yet data on long-term effects of pre-transplant probiotic intake is lacking. The aim of this study was to assess the effects of pre-transplant probiotic administration on long-term results of liver transplantation. This was secondary analysis of a randomized trial. Patients were randomized to receive either 4-strain probiotic or placebo before liver transplantation. Five year graft survival was set as the primary end-point. Secondary end-points comprised serum bilirubin and C-reactive protein (CRP) concentration, international normalized ratio (INR), serum transaminases and gamma-glutamyl transferase (GGT) activity. Study group comprised 44 patients, of whom 21 received probiotics and 23 received placebo with 5-year graft survival of 81.0% and 87.0%, respectively (p = 0.591). Patients in the probiotic arm exhibited lower INR (p = 0.001) and CRP (p = 0.030) over the first 6 post-transplant months. In the absence of hepatitis B or C virus infection, pre-transplant administration of probiotics also reduced aspartate transaminase activity (p = 0.032). In the intervention arm, patients receiving probiotics for under and over 30 days had 5-year graft survival rates of 100% and 66.7%, respectively (p = 0.061). Duration of probiotic intake > 30 days was additionally associated with increased INR (p = 0.031), GGT (p = 0.032) and a tendency towards increased bilirubin (p = 0.074) over first 6 post-transplant months. Pre-transplant administration of probiotics has mild positive influence on 6-month allograft function, yet should not exceed 30 days due to potential negative effects on long-term outcomes. (ClinicalTrials.gov Identifier: NCT01735591).

摘要

围手术期使用益生菌可有效预防肝移植术后感染,但缺乏移植前益生菌摄入对长期效果的数据。本研究旨在评估移植前给予益生菌对肝移植长期结果的影响。这是一项随机试验的二次分析。患者随机接受 4 种益生菌或安慰剂治疗。5 年移植物存活率为主要终点。次要终点包括血清胆红素和 C 反应蛋白(CRP)浓度、国际标准化比值(INR)、血清转氨酶和γ-谷氨酰转移酶(GGT)活性。研究组包括 44 例患者,其中 21 例接受益生菌治疗,23 例接受安慰剂治疗,5 年移植物存活率分别为 81.0%和 87.0%(p=0.591)。益生菌组患者在移植后 6 个月内 INR(p=0.001)和 CRP(p=0.030)较低。在没有乙型肝炎或丙型肝炎病毒感染的情况下,移植前给予益生菌还可降低天冬氨酸转氨酶活性(p=0.032)。在干预组中,接受益生菌治疗 30 天以下和 30 天以上的患者 5 年移植物存活率分别为 100%和 66.7%(p=0.061)。益生菌摄入时间>30 天与移植后 6 个月内 INR(p=0.031)、GGT(p=0.032)升高以及胆红素升高趋势(p=0.074)有关。移植前给予益生菌对 6 个月同种异体移植物功能有轻微的积极影响,但由于对长期结果的潜在负面影响,不应超过 30 天。(ClinicalTrials.gov 标识符:NCT01735591)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/18d0/7672052/c93a365276ca/41598_2020_76994_Fig1_HTML.jpg

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