Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, India.
Department of Hepatology, Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, India.
Gastroenterology. 2014 Dec;147(6):1327-37.e3. doi: 10.1053/j.gastro.2014.08.031. Epub 2014 Aug 27.
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.
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 × 10(11) bacteria; CD Pharma India Private Limited, New Delhi, India) (n = 66) or placebo (n = 64) daily for 6 months.
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.
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.
关于益生菌是否能影响肝硬化和肝性脑病（HE）患者的结局，我们知之甚少。我们评估了一种益生菌制剂预防 HE 复发（主要结局）和减少肝硬化患者住院次数及肝脏疾病严重程度的疗效。
我们在印度一家三级护理医院进行了一项双盲试验。在上个月的 HE 发作中恢复的肝硬化患者，随机（采用计算机生成的分配方案）分为益生菌组（VSL#3，9×10（11）个细菌；CD Pharma India Private Limited，新德里，印度）（n=66）或安慰剂组（n=64），每天服用益生菌或安慰剂 6 个月。
益生菌组患者发生突破性 HE 的风险呈下降趋势（益生菌组为 34.8%，安慰剂组为 51.6%；风险比[HR]，0.65；95%置信区间[CI]，0.38-1.11；P=0.12）。益生菌组因 HE 住院的患者（19.7%比 42.2%；HR，0.45；95%CI，0.23-0.87；P=0.02）或因肝硬化并发症住院的患者（24.2%）均少于安慰剂组（45.3%）（HR，0.52；95%CI，0.28-0.95；P=0.034）。与基线相比，益生菌组的 Child-Turcotte-Pugh 和终末期肝病模型评分在 6 个月时显著改善，但安慰剂组没有改善。VSL#3 无相关不良反应。
在 6 个月期间，每日摄入 VSL#3 可显著降低肝硬化患者因 HE 住院的风险，以及 Child-Turcotte-Pugh 和终末期肝病模型评分。临床试验注册号：NCT01110447。
