益生菌VSL＃3，降低肝脏疾病的严重程度和住院的肝硬化患者

StephenW

Probiotic VSL#3 Reduces Liver Disease Severity and Hospitalization in Patients With Cirrhosis: A Randomized, Controlled Trial
Radha K. Dhimanemail,
Baldev Rana,
Swastik Agrawal,
Ashish Garg,
Madhu Chopra,
Kiran K. Thumburu,
Amit Khattri,
Samir Malhotra,
Ajay Duseja,
Yogesh K. Chawla
Received: June 3, 2014; Accepted: August 19, 2014; Published Online: August 26, 2014
DOI: http://dx.doi.org/10.1053/j.gastro.2014.08.031


Background & Aims

Little is known about whether probiotics can affect outcomes of patients with cirrhosis and hepatic encephalopathy (HE). We assessed the efficacy of a probiotic preparation in preventing the recurrence of HE (primary outcome) and reducing the number of hospitalizations and severity of liver disease in patients with cirrhosis.
Methods

We performed a double-blind trial at a tertiary care hospital in India. Patients with cirrhosis who had recovered from an episode of HE during the previous month were assigned randomly (using computer-generated allocation) to groups given a probiotic preparation (VSL#3, 9 × 1011 bacteria; CD Pharma India Private Limited, New Delhi, India) (n = 66) or placebo (n = 64) daily for 6 months.
Results

There was a trend toward a reduction in the development of breakthrough HE among patients receiving the probiotic (34.8% in the probiotic group vs 51.6% in the placebo group; hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.38–1.11; P = .12). Fewer patients in the probiotic group were hospitalized for HE (19.7% vs 42.2%, respectively; HR, 0.45; 95% CI, 0.23–0.87; P = .02) or for complications of cirrhosis (24.2%) than in the placebo group (45.3%) (HR, 0.52; 95% CI, 0.28–0.95; P = .034). Child–Turcotte–Pugh and model for end-stage liver disease scores improved significantly from baseline to 6 months in the probiotic group, but not in the placebo group. There were no adverse events related to VSL#3.
Conclusions

Over a 6-month period, daily intake of VSL#3 significantly reduced the risk of hospitalization for HE, as well as Child–Turcotte–Pugh and model for end-stage liver disease scores, in patients with cirrhosis. ClinicalTrials.gov number: NCT01110447.

Conflicts of interest The authors disclose no conflicts.

Funding This study was supported by CD Pharma India Private Limited (New Delhi, India), who also provided VSL#3 and placebo. The funders did not participate in any part of the study, including the study design, data analysis, or manuscript preparation.

StephenW

益生菌VSL＃3，降低肝脏疾病的严重程度和住院的肝硬化患者：一项随机，对照试验
妲K. Dhimanemail，
巴尔德夫林蛙，
SWASTIK阿格拉瓦尔，
阿希什加尔格，
马杜·乔普拉，
基兰K. Thumburu，
阿米特Khattri，
萨米尔·马尔霍特拉，
阿贾伊Duseja，
Yogesh K.乔拉
收稿日期：2014年6月3日;接受日期：2014年8月19日;发布时间：2014年8月26日
DOI：http://dx.doi.org/10.1053/j.gastro.2014.08.031


背景与目的

鲜为人知的是，益生菌是否能影响患者预后的肝硬化和肝性脑病（HE）。我们评估了益生菌制剂的功效在防止HE的复发（主要终点）和肝硬化减少患者住院和肝脏疾病的严重程度的数量。
方法

我们进行了一项双盲试验在三级医院在印度。肝硬化患者谁从HE的情节上月已恢复，随机给定的益生菌制剂（VSL＃3组分配（使用计算机生成的分配），9×1011的细菌; CD制药印度私人有限公司，新德里，印度）（N =66）或安慰剂（n =64）每天6个月。
结果

有朝着突破HE的发展减少了中，安慰剂组VS51.6％，接受益生菌（34.8％，在益生菌组患者的趋势;风险比[HR]，0.65;95％置信区间[CI]，0.38 -1.11; P =0.12）。少数病人在益生菌组住院HE（分别为19.7％和42.2％; HR，0.45;95％CI，0.23-0.87; P = 0.02）或肝硬化（24.2％），并发症较安慰剂组（45.3％）（HR，0.52;95％CI，0.28-0.95; P =0.034）。小孩子特科特-Pugh分级和模型终末期肝病分数显著从基线在益生菌组提高至6个月，但在安慰剂组。有相关VSL＃3没有不良反应。
结论

超过6个月的时间，每天摄入VSL＃3显著降低住院HE的风险，以及儿童特科特-Pugh分级和型号为终末期肝病评分，肝硬化患者。 ClinicalTrials.gov编号：NCT01110447。

利益冲突的作者公开冲突。

资助这项研究是由CD制药印度私人有限公司（印度新德里），谁也提供了VSL＃3和安慰剂的支持。在出资者没有参加任何部分的研究，包括研究设计，数据分析，或手稿的准备。