【摘要】 目的评估强肝胶囊治疗日本血吸虫病早期肝纤维化的效果及可能的副作用。方法138例日本血吸虫病早期肝纤维化病人随机分为试验组(68例)和对照组(70例)。试验组服强肝胶囊2.0g/次,每日2次,连续6个月,加维生素类和肝泰乐。对照组服用安慰剂加维生素类和肝泰乐等一般护肝药。在治疗前、治疗后分别进行肝脏B超、肝功能、血清肝纤维化四项指标,即透明质酸(HA)、Ⅲ型前胶原(PCⅢ)、Ⅳ型胶原(ⅣC)和层粘蛋白(LN)检查以及临床症状改善情况观察,比较试验组和对照组间结果有无差异。结果治疗前,试验组与对照组间各项指标差异均无显著意义(均为P>0.05)。治疗后的临床症状,试验组比对照组改善明显(P<0.01);试验组肝脏纤维化程度从Ⅱ级降到Ⅰ级的人数多于对照组,但差异无显著性(均为P>0.05);二组间转氨酶恢复正常的人数的比例的差异有显著意义(P<0.05);二组间肝纤维化四项指标值的差异有显著意义(均为P<0.05)。服药期间,未见严重药物不良反应。试验组一般副反应与对照组差异无显著性。结论强肝胶囊有减轻血吸虫病早期肝纤维化的作用,用药安全,可选择作为治疗血吸虫病早期肝纤维化的药物。更多还原

【Abstract】 Objective To evaluate effects on Qianggan capsule for liver fibrosis of schistosomiasis japonica(S. j) in early stage. Methods 138 patients with liver fibrosis of S. japonica in early stage were randomly allocated into two groups: trial group, 68 cases, Qianggan capsule 2.0g/time, twice a day were orally administrated with multivitamins and Gantaile tables for 6 months and control group, 70 cases, the placebo were given with multivitamins and Gantaile tables. All patient’s clinical manifestations during taking medicine were observed daily throughout the study period. And pre- and right 6 month after treatment, liver B ultrasound, liver functions, 4 serum indexes of liver fibrosis were also assessed. Side effects were consistently observed for 6 months during taking medicine. Results Pre-treatment: there was no significant difference in all parameters observed between two groups (P >0.05). Patients’ clinical condition in trial groups have been significantly improved compared with that in control group (P <0.01). There were more patients whose liver function normalized in trial group than in the control (P <0.05). Serum fibrosis markers decreased significantly in trial group compared with that in control (P <0.05). Furthermore, there were more patients whose fibrosis of liver regressed from stageⅡto stageⅠin trial group than in control but no significant difference between two groups by B ultrasound. Meanwhile, no serious adverse events were observed during 6 months medication. Mild side effects showed but no significant difference between two groups. Conclusion Qianggan capsule is effective and safe and can be chosen as a medicine to treat fibrosis of liver of S. japonica in early stage更多还原