甘露聚糖肽胶囊干预治疗肝纤维化开放性对照研究

目的:研究甘露聚糖肽胶囊干预治疗慢性乙型肝炎肝纤维化的临床疗效及其安全性。方法:前瞻性、随机、开放性、平行对照的方法,纳入年龄18~65岁的慢性乙型肝炎肝纤维化患者。治疗组采用甘露聚糖肽胶囊(30mg/d)联合葫芦根素胶囊(0.9mg/d)和对照组采用葫芦根素胶囊+安慰剂,疗程24周。结果:纳入196例患者,治疗组131例,对照组65例,24周治疗后结果显示:(1)治疗组非创伤性综合疗效显效率(50.4%vs30.7%)及总有效率(87%vs70.7%)均优于对照组(P<0.05),血清学纤维指标(HA,LN,IV-C),B超评分两组均有改善(6.6±1.4)vs(4.6±1.2),治疗组改善程度优于对照组(P<0.05),另外对照组P-Ⅲ-P不降低,治疗组水平则显著降低(P<0.05)。(2)组织病理学综合疗效,治疗组炎症及纤维化SSS评分下降更为明显(P<0.05)。(3)治疗组细胞因子水平(TGF-β,TNF-α,IL-6,IL-8)下降程度显著高于对照组(P<0.05)。(4)治疗过程中部分患者有轻度发热症状。结论:甘露聚糖肽可以调节肝纤维化免疫紊乱,激活宿主免疫,提高抗感染能力,减轻炎症,因此可作为肝纤维化免疫疗法的一种用药选择。

Randomized Controlled Prospective Clinical Trial of Mannatide Capsule in the Treatment with Hepatitis B Liver Fibrosis

Objective:To study the efficacy and safety of Mannatide Capsule(FZHYCapsule) in treatment of liver fibrosis with chronic hepatitis B.Methods:Prospective,randomized,open and paralleled controlled trial was conducted on patients(aged between 18 and 65) with liver fibrosis in chronic hepatitis B.the treatment group were given Mannatide Capsule(30mg/d) and Hu lu gen su Capsule(0.9mg/d) and the control group were only given Hu lu gen su Capsule for 24 weeks.Results:There were 196 patients enrolled,131 cases in treatment,65 in the control group.the results showed as followed:(1)The non-traumatic General Efficacy such as Significant efficiency(50.4% vs 30.7%) and total effective rate(87% vs 70.7%) of treatment group were prefer to control group(P<0.05).serological indexes(HA,LN,P-Ⅲ-P,Ⅳ-C) and B ultrasound(6.6±1.4)vs(4.6±1.2) of both groups ameliorated,however the degree ameliorated of treatment were better.Besides the level of P-Ⅲ-P did not changed after 24 weeks,while it decreased in treatment(P<0.05).(2)Inflammation and fibrosis SSS grade of treatment decreased more than that of control group(P<0.05).(3)Cell factors such as TGF-β,TNF-α,IL-6,IL-8 decreased more than that of control group too(P<0.05).(4)Several patients got fever in treatment in treat period.Conclusion:Mannatide Capsule regulated immune disorders and activated immunity to improve the ability of anti-infection to Reduce Inflammation.Hence it can be as a choice of immunotherapy.