Probiotic VSL#3 Reduces Liver Disease Severity and Hospitalization in Patients With Cirrhosis: A Randomized, Controlled Trial
Probiotic VSL#3 Reduces Liver Disease Severity and Hospitalization in Patients With Cirrhosis: A Randomized, Controlled Trial
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DOI：
10.1053/j.gastro.2014.08.031
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发表时间：
2014-12-01
期刊：
影响因子：
29.4
通讯作者：
Chawla, Yogesh K.
中科院分区：
文献类型：
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作者：
Dhiman, Radha K.;Rana, Baldev;Chawla, Yogesh K.
背景与目的：益生菌能否影响肝硬变和肝性脑病(HE)患者的预后，目前知之甚少。我们评估了益生菌制剂在预防肝硬变患者HE复发(主要结果)、减少住院次数和肝病严重程度方面的有效性。方法：我们在印度的一家三级保健医院进行了一项双盲试验。前一个月从HE发作中康复的肝硬变患者被随机分配(使用计算机生成的分配)，每天给予益生菌制剂(VSL#3，9x10(11)细菌；CD Pharma India Private Limited，印度新德里)(n=66)或安慰剂(n=)，连续6个月。结果：在接受益生菌治疗的患者中，突破性肝性脑病的发生有减少的趋势(益生菌组为34.8%，安慰剂组为51.6%；危险比[HR]，0.65；95%可信区间[CI]，0.38-1.11；P=.12)。益生菌组因HE(19.7%比42.2%；HR，0.45；95%CI，0.23-0.87；P=.02)或因肝硬变并发症(24.2%)住院的患者比安慰剂组(45.3%)少(HR，0.52；95%CI，0.28-0.95；P=.034)。益生菌组的Child-Turcotte-Pugh和终末期肝病模型评分从基线到6个月有显著改善，但安慰剂组没有改善。没有与VSL#3相关的不良事件。结论：在6个月的时间里，每天服用VSL#3显著降低了肝硬变患者因HE住院的风险，以及Child-Turcotte-Pugh和终末期肝病模型评分。ClinicalTrials.gov编号：NCT01110447。
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 x 10(11) 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.