复方牛胎肝提取物联合拉米夫定对慢性乙型肝炎患者肝纤维化的影响

Effect of Compound Fetal Bovine Liver Extract Tablets in Combination with Lamivudine on Hepatic Fibrosis in Patients with Chronic Hepatitis B

目的研究复方牛胎肝提取物联合拉米夫定对慢性乙型病毒性肝炎患者肝纤维化的影响。方法将慢性乙型病毒性肝炎患者174例随机分为对照组56例、阳性对照组58例和治疗组60例。对照组给予水飞蓟素片和对症治疗,疗程6个月。阳性对照组在对照组治疗基础上,加用拉米夫定100 mg.d-1,po,疗程至少1 a。治疗组在阳性对照组治疗基础上,联合复方牛胎肝提取物片,每次2片,po,tid,疗程6个月。各组病例在治疗前和治疗第3,6个月末,采用放免法检测Ⅲ型前胶原(PCⅢ)、玻璃酸(HA)、层粘蛋白(LN)、Ⅳ型胶原(Ⅳ-C)水平,采用彩色多普勒超声仪观察门静脉主干内径、平均血流速度、门静脉血流量、脾脏厚度,并对其中60例患者在治疗前和治疗6个月后进行肝组织学检测。结果治疗6个月后,阳性对照组与治疗组血清PCⅢ、HA、LN、Ⅳ-C水平与对照组比较明显改善,差异均有极显著性(P<0.01),而且治疗组PCⅢ、HA、LN、Ⅳ-C水平下降程度均优于阳性对照组(P<0.01);阳性对照组与治疗组肝脏门静脉内径、脾脏厚度以及治疗组肝脏门静脉血流量与对照组比较,均明显改善(P<0.01),阳性对照组与治疗组门静脉血流速度、阳性对照组门静脉血流量与对照组比较,亦有改善(P<0.05),而且治疗组门静脉内径、脾脏厚度改善程度优于阳性对照组(P<0.05或P<0.01);阳性对照组与治疗组肝脏炎症活动度计分及纤维化程度计分与对照组比较,均明显改善(P<0.01),而且治疗组改善程度优于阳性对照组(P<0.01)。结论复方牛胎肝提取物片联合拉米夫定治疗慢性乙型肝炎肝纤维化有显著疗效。

Objective To study the effect of compound fetal bovine liver extract tablets in combination with lamivudine on hepatic fibrosis in patients with chronic hepatitis B. Methods 174 patients with chronic hepatitis B were randomly divided into 3 groups ： the control group（n=56）, positive control group （n=58） and treatment group （n=60）. Patients of the control group were submitted to a 6 month treatment course with oral medication of 2 Fructus silybi tablets and drugs for symptomatic treatment . On the basis of the treatment for patients of the control group, patients of the positive control group were given each additionally 100 mg of lamivudine q.d. PO for at least one year. Based on the treatment for patients of the positive control group, patients of the treatment group were given each 2 tablets of compound fetal bovine liver extract PO t. i. d. for 6 months. Serum levels of hyaluronidase （HA）, type Ⅲ procollagen （PC Ⅲ）, laminin（LN） , type Ⅳ collagen （Ⅳ-C） were determined with radioimmunoassay （RIA）in patients of all 3 groups before and 3 as well as 6 months after the beginning of the treatment. The internal diameter of the trunk of the portal vein, the average speed and volume of blood flow in the portal vein and the thickness of the spleen were examined with color Doppler. Light microscopic examination of the liver pathohistology was carried out in 60 patients before and 6 months after the beginning of treatment. Results After 6 months of treatment, levels of serum PC Ⅲ, HA, LN and Ⅳ-C in patients of the positive control group and treatment group were notably lower than those in patients of the control group（P〈0.01 ）, and these hepatic fibrosis indexes were also significantly lower in patients of the treatment group than those in patients of the positive control group（P〈0.01）. Situations of the internal diameter of the trunk of the portal vein, the speed and volume of the blood flow in the portal vein and the thickness of the spleen were strikingly improved in patients of the positive control group and treatment group as compared with those of the control group（P〈0.01 or P〈0.05）. Among these, the extent of improvement in the internal diameter of the trunk of the portal vein and the thickness of the spleen was greater in patients of the treatment group than that in patients of the control group（P〈0.05 or P〈0.01）. Striking improvement in the scoring of the activity of the liver inflammation and the extent of hepatic fibrosis was demonstrated in patients of the positive control and treatment group as compared with that in patients of the control group （P〈0.01）. The improvement in these parameters, however, was more significant in patients of treatment group than in patients of the positive control group （P〈0.01）. Conclusion It was shown that compound fetal bovine liver extract tablets in combination with lamivudine exerted a definite therapeutic effect in the treatment of chronic hepatitis B with hepatic fibrosis.