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。
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.作者: 与HBV同行 时间: 2013-4-30 00:15
