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目的评价枯草杆菌肠球菌二联活菌胶囊治疗非酒精性脂肪性肝炎(NASH)的临床疗效和安全性。方法 72例NASH患者被随机分为治疗组(37例)和对照组(35例)。两组均接受生活方式干预和常规护肝(多烯磷脂酰胆碱胶囊456 mg/次,3次/d,口服;维生素E软胶囊0.1 g/次,2次/d,口服),治疗组在此基础上加用枯草杆菌肠球菌二联活菌胶囊500 mg/次,3次/d,口服。2组疗程均为4个月。观察两组患者治疗前及治疗后肝功能(ALT、AST、GGT)、空腹血糖(FBG)及血脂(TC、TG、HDL、LDL),检测血清内毒素、肿瘤坏死因子(TNF-α)、超敏C反应蛋白(CRP)水平及B超下脂肪肝影像变化。结果治疗后治疗组ALT、AST、GGT、FBG、TC、TG、LDL明显降低,HDL明显升高(P<0.05或P<0.01),对照组ALT、AST、GGT、TC、TG、LDL也明显降低(P<0.01),且治疗组较对照组降低更为明显,差异均有统计学意义(P<0.01)。治疗组内毒素、TNF-α、CRP水平明显降低(P<0.01),对照组TNF-α、CRP水平也明显降低(P<0.01),且治疗组较对照组降低更为明显,差异均有统计学意义(P<0.01)。治疗组B超分度变化有明显改善(P<0.01),但对照组治疗前后及两组治疗后差异无统计学意义(P>0.05);治疗过程中未发现明显不良反应。结论枯草杆菌肠球菌二联活菌胶囊可降低NASH患者血清内毒素、TNF-α、CRP水平,改善其肝功能、血脂及脂肪肝程度,无不良反应。
Objective To evaluate the clinical efficacy and safety of Bacillus subtilis and enterococci viable capsule in the treatment of non-alcoholic steatohepatitis (NASH). Methods 72 patients with NASH were randomly divided into treatment group (37 cases) and control group (35 cases). Both groups received lifestyle intervention and routine protection of the liver (polyene phosphatidylcholine capsules 456 mg / time, 3 times / d, oral; vitamin E soft capsule 0.1 g / times, 2 times / d, oral) On this basis, add Bacillus subtilis Enterobacter double viable capsule 500 mg / time, 3 times / d, orally. 2 groups of treatment are 4 months. The liver function (ALT, AST, GGT), fasting blood glucose (FBG) and serum lipids (TC, TG, HDL and LDL) were measured before and after treatment in the two groups. Serum endotoxin, tumor necrosis factor (TNF- Hypersensitive C-reactive protein (CRP) levels and B-ultrasound imaging of fatty liver changes. Results After treatment, the levels of ALT, AST, GGT, FBG, TC, TG and LDL in the treatment group were significantly lower than those in the control group (P <0.05 or P <0.01) (P <0.01), and the treatment group was more obvious than the control group, the differences were statistically significant (P <0.01). The levels of endotoxin, TNF-α and CRP in the treatment group were significantly decreased (P <0.01), while the levels of TNF-α and CRP in the control group were also significantly decreased (P <0.01), and the treatment group decreased more significantly than the control group Statistical significance (P <0.01). There was no significant difference between the two groups before and after treatment (P> 0.05). No obvious adverse reactions were found during the treatment. Conclusion Bacillus subtilis and Enterococcus faecalis can reduce the levels of endotoxin, TNF-α and CRP, and improve the liver function, blood lipid and fatty liver in NASH patients without any adverse reactions.