养肝软坚丸治疗乙肝纤维化气虚血瘀证疗效观察

Observation of curative effect of chronic hepatitis B with hepatic fibrosis with Qi-deficiency and blood-stasis syndrome treated by Yanggan Ruanjian pill

目的观察乙肝纤维化气虚血瘀证患者经口服养肝软坚丸治疗的临床疗效。方法选取60例证属气虚血瘀型慢性乙型肝炎肝纤维化患者。按随机数字表法分为两组:治疗组30例,对照组30例。治疗组口服养肝软坚丸(18g/次,2次/d);对照组口服扶正化瘀胶囊(1.5g/次,3次/d),6月为1个疗程,观察两组患者治疗前后常见临床症状、体征的改善,肝功能及肝纤维化指标变化,腹部彩超肝门静脉宽度、脾厚度及肝脏弹性测定(Fibroscan)的改变。结果治疗组和对照组患者总有效率分别为93.3%和86.7%,差异有统计学意义(P<0.05)。两组治疗后症状、体征积分较治疗前均明显降低(P<0.05),并且治疗组改善显著;肝功能均有改善,两组比较差异无统计学意义(P>0.05);肝纤维化指标较治疗前均有下降,治疗组与对照组比较差异有统计学意义(P<0.05);腹部彩超肝门静脉宽度、脾脏厚度及肝脏硬度检测情况均有好转,治疗组与对照组比较差异有统计学意义(P<0.05)。结论养肝软坚丸治疗气虚血瘀型乙肝后肝纤维化疗效较好,可缓解患者临床症状和体征,降低血清肝纤维化指标,改善肝功能,缩小肝门静脉宽度及脾脏厚度,降低肝脏硬度。养肝软坚丸无毒副作用且使用方便,可以作为慢性乙型肝炎抗肝纤维化综合治疗的重要方法。

Objective To observe the curative effect of chronic hepatitis B with hepatic fibrosis with Qi-deficiency and blood-stasis syndrome treated by Yanggan Ruanjian pill. Methods 60 chronic hepatitis B with hepatic fibrosis with Qi-defi-ciency and blood-stasis syndrome patients were selected and divided into treatment group and control group （30 cases in each group）. Patients in treatment group were treated with Yanggan Ruanjian pill（18g for each time,2 times per day）,and patients in control group were treated with Fuzheng Huayu capsule（1.5g for each time,3 times per day）, 6 months per period. Observed the change of clinical symptoms and signs,liver function, liver fibrosis indexes,hepatic vein width, thickness of spleen and liver e-lasticity by abdominal Doppler ultrasound of patients in two groups before and after treatment. Results The total effective rate of treatment group and control group was 93.3% and 86.7% respectively,the difference was statistical significant （P〈0.05）. Compared with pre-treatment,the symptoms and signs score of two groups were lower and the treatment group improved more significantly （P〈0.05）, liver function improved and there was no significant difference between the two groups （P〉0.05）, liver fibrosis indexes,hepatic vein width, thickness of spleen and liver elasticity by abdominal Doppler ultrasound improved,and there were significant differences between the two groups （P〈0.05）. Conclusion Yanggan Ruanjian pill has obvious effect on chronic hepatitis B with hepatic fibrosis with Qi-deficiency and blood-stasis syndrome ,it can improve clinical symptoms and signs and liver function,decrease liver fibrosis indexes and liver elasticity,reduce hepatic vein width and thickness of spleen. Yanggan Ruanjian pill could be a important therapy method for chronic hepatitis B with hepatic fibrosis with Qi-deficiency and blood-stasis syndrome because of its good curative effect ,safety and convenience.