在2013年欧洲肝病学会（European Association for the Study of the Liver,EASL）主办的国际肝病大会（the International Liver Congress,ILC）上公布了一项来自印度的前瞻性研究，研究发现益生菌可显著降低难治性肝性脑病的发生。
该研究将没有明显HE病史的患者分为2组：第1组（n=86，服用VSL#3益生菌），第2组（对照组，n=74）。
所有患者进行心理测试，临界闪烁频率（CFF）测试，葡萄糖氢呼气试验（GHBT）测定小肠细菌过度生长（SIBO），乳果糖氢呼气试验测定（LHBT）为口盲传输时间（OCTT）。主要终点是出现明显的HE。
结果发现给予益生菌治疗三个月后，在降低患者动脉血氨水平方面有显著改善。
评论：
Bernardi教授
肝性脑病是一种隐匿性疾病，通常由血液中在正常情况下应由肝脏去除的毒素累积而引起。治疗通常包括使用抗生素或泻药，抑制肠道内毒性物质的产生，但仍然有很大的改善余地，所以如果能看到进一步的研究成果，特别是使医师手中多了新治疗手段，那将更令人兴奋。
论文摘要：
An open label randomised controlled trial of probiotics for primary prophylaxis of hepatic encephalopathy in patients with cirrhosis
Background: Hepatic encephalopathy (HE) is associated with poor prognosis. Probiotics alter gut flora with non urease producing organism with decrease ammonia production. Present study assessed effects of probiotics for primary prophylaxis of HE.
Methods: In prospective randomised controlled trial, patients with no history of overt HE were divided into:group 1 (Probiotics, n = 86, received VSL#3, one capsule TDS) and group 2 (control, n = 74). Minimal HE (MHE) was diagnosed when psychometric hepatic encephalopathy score (PHES) was ≤5 and overt HE withWest Haven criteria.All patients underwent psychometric tests, critical flicker frequency (CFF), glucose hydrogen breath test (GHBT) for small intestinal bacterial overgrowth (SIBO) and lactulose hydrogen breath test (LHBT) for oro-cecal transit time (OCTT). Primary end point was development of overt HE.
Results: 160 patients (age 48.6±11.1 years, M:F 96:64) were included. 25 (15.6%), 51 (31.9%) and 82 (52.5%) patients were in CTP class A, B and C respectively. Mean CTP score was 9.74±2.63 and MELD score was 19.32±5.91. Baseline laboratory parameters, CTP score, MELD score, CFF, PHES and OCTT were comparable. 42 (48.8%) in group 1 and 33 (44.6%) in group 2 had MHE (p = 0.88). 33 (38.4%) and 26 (35.1%) patients in group 1 and 2 had SIBO respectively. Mean follow up of group 1 and group 2 patients was 28.5±11.8 and 27.3±12.8 weeks respectively (p = 0.87). 11 (6.9%) patients were lost during follow up. 6 (7.5%) in group 1 and 7 (10.1%) in group 2 died (p = 0.81). There was significant improvement in arterial ammonia levels, SIBO, OCTT, PHES, CFF and MHE after 3 months of treatment with probiotics. 7 (8.8%) patients in Group 1 and 14 (20.3%) patients in Group 2 developed overt HE (p < 0.05, hazard ratio 2.1, 95% CI, 1.31–6.53). In patients without MHE, absolute risk reduction (ARR) was 7.8% (95% CI, 2.2–11.4%) and number need to treat (NNT) was 31 (95% CI, 14.2–58.6). However, in patients with MHE (ARR) was 23.8% (95% CI, 5.4–42.2%) and NNTwas 5.1 (95% CI, 2.4–18.4).
Conclusion: Probiotics are effective in primary prophylaxis of HE.
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