复方鳖甲软肝片治疗慢性乙型肝炎肝纤维化Ⅱ期临床试验总结

Clinical Observation of Phase Ⅱ of Therapeutic Effect of Composed Amyda Sinensis Soft Liver Tablet on Hepatic Fibrosis of ChronicHepatitis B

复方鳖甲软肝片是解放军302医院研制的三类复方中药新药,本文总结了该药治疗慢性乙型肝炎肝纤维化并属瘀血阻络,气阴亏虚,热毒未尽症候者的Ⅱ期临床试验结果。临床试验为1997年5月30日至1998年8月20日,由卫生部上海中医药大学曙光医院牵头,参加单位有湖北中医学院附属医院,北京地坛医院,北京佑安医院,北京中医医院,北京军区总医院,空军总医院,天津传染病医院。经以上八家医院采用多中心随机对照双盲原则,联合观察疗效结果显示如下:治疗组300例,男性267例,女性33例,平均年龄40.77±12.00岁(18～65岁)。服用复方鳖甲软肝片4片,3/日(每片含生药0.85克)。对照组120例,男性100例,女性20例,平均年龄41.77±11.50岁(18～65岁)。服用和络舒肝胶囊5粒,3/日(每粒含生药0.93克)。疗程6个月结束时综合疗效评价,治疗组显效率55.67％,有效率26.00％,总有81.67％,与对照组比较(15.83％,44.17％,60％)有显著差异(P<0.05)。其中,中医症状,体征治疗组显效率为62.67％,有效率23％,总有效率85.67％,与对照组比较(28.33％,40.48％,69.17％)有明显差异(P<0.05);肝纤维化血清学指标(HA,LN,Ⅳ一C,PCⅢ)治疗组显效率为59.67％,有效率21.67％,总有效率81.34％与对照组比较(21.67％,33.33％,55.00％)有显著差别(P<0.05)。肝组织病理改变治疗组治疗前肝组织活检104例,疗程结束时,前后两次肝组织活检者52例,对照组治疗前肝组织活检41例,其中前后两次肝组织活检29例。肝组织病理改变治疗组显效率40.38％,有效率30.67％,总有效率71.14％,与对照组比较(0％,27.59％,27.59％)有显著差别(P<0.05)。乙型病毒性肝炎在我国是常见病多发病。感染率达到10％,其中1/3患者可发展为慢性肝病。慢性肝病多有肝纤维化,而肝纤维化进一步发展导致肝硬变,其中有的可发展为肝癌,危害性较大。因此,如何阻断和治疗肝纤维化及早期肝硬变是亟待解决的课题。复方鳖甲软肝片是302医院多年临床应用治疗慢性乙型肝炎肝纤维化及早期肝硬变的经验方,由鳖甲、赤芍、三七、冬虫夏草等十一味中药组成,有软坚散结,化瘀解毒,益气养阴的功效。经本试验多中心观察疗效结果证明,复方鳖甲软肝片治疗慢性乙型肝炎肝纤维化患者在改善中医症状,肝组织病理改变及血清学肝纤维化指标等方面疗效确切,整个过程未见明显不良反应,提示本品是治疗慢性乙型肝炎肝纤维化及早期肝硬变有效的中药复方制剂。

Objective To observe the therapeutic effect of composed Amyda sinensis soft liver tablet on hepatic fibrosis of the patients with chronic hepatitis B. Methods 420 patients were chosen by eight hospitals according to the standard criterion and randomly divided into two groups, one group (involved 300 cases) treated with composed Amyda sinensis soft liver tablet, the other (involved 120 cases) treated with HeLuoShuGan capsules as control. Results After treatment with composed Amyda sinensis soft liver tablet for 6 months, the total effective rate of treatment group was 81.67％, that of the control group was 60％ (P<0.05). In the composed Amyda simensis soft liver tablet treatment group, the percentage which represented that the patients (52 cases) had a obvious histological improvement by observation of the biopsy liver tissues from the pre-and post-treatment was 71.14％, which was higher than that (27.59％) in the control group (P<0.05). Meanwhile, in the sera of the patients with composed Amyda sinensis soft liver tablet treatmentthe decreased levels of the hepatic fibrosis markers (HA,LN, Ⅳ-C and PC Ⅲ ) and the improvement of the hepatic function markers (ALT, AST, TBIL and γ-globulin) were 81.34％ and 85.67％, respectively, which is significantly different when compared with those of the control group (P<0. 05, respectively). Conclusions These results show that composed Amyda sinensis soft liver tablet is a group of effective herbs against hepatic fibrosis and early cirrhosis of the patients with chronic hepatitis B.