软坚化瘀方联合解毒消痞散内服外敷治疗乙型肝炎早期肝硬化临床研究

目的观察验方软坚化瘀方联合解毒消痞散外敷治疗瘀血阻络型乙型肝炎早期肝硬化的临床疗效。方法将符合纳入标准的80例瘀血阻络型乙型肝炎早期肝硬化患者随机分为对照组、内服组、外敷组、联合组，每组各20例。对照组予恩替卡韦片口服，内服组予软坚化瘀方及恩替卡韦片内服，外敷组予解毒消痞散外敷及恩替卡韦片口服，联合组予软坚化瘀方内服联合解毒消痞散外敷及恩替卡韦片口服；每组疗程均为6个月。观察肝功能、肝纤维化指标变化情况，并评价临床疗效。结果对照组、外敷组、内服组、联合组总有效率分别为45．o％、55．O％、60．0％、90．o％，其中联合组疗效明显优于其他3组（P〈0．05，P〈0．01）；各组治疗后ALT、AST及肝纤维化指标HA、LN、PIIIP、IV—C均较治疗前差异有统计学意义（P〈0．05，P〈0．01），且联合组改善程度优于其他3组（P〈0．05，P〈0．01）。结论软坚化瘀方内服联合解毒消痞散外敷治疗瘀血阻络型乙型肝炎早期肝硬化，能改善患者临床症状，并可保肝降酶、抗肝纤维化。

Clinical study on oral administration of "Ruanjian Huayu Decoction" with external application of "Jiedu Xiaopi Powder" in treating early HBV-related cirrhosis of blood-stasis obstruction

Objective To observe and evaluate the therapeutic efficacy of "Ruanjian Huayu Decoction" with external application of "Jiedu Xiaopi Powder" in the treatment of early HBV-related cirrhosis of blood-stasis obstructing type.Methods A total of 80 early HBV-related cirrhosis patients diagnosed with blood-stasis obstruction were randomly divided into four groups: control group treated with entecavir only,internal application group treated with "Ruanjian Huayu Decoction" orally and entecavir,external application group treated with entecavir and point application of "Jiedu Xiaopi Powder",and integrated group with internal application of "Ruanjian Huayu Decoction",external application of "Jiedu Xiaopi Powder" and entecavir.After 6-month treatment,the changes of the clinical symptoms and syndromes,liver function,indexes of liver fibrosis were observed.Results The total effective rate was 90.0% in integrated group,which was significantly higher than those in control group,internal application group and the external application group(45.0%,55.0% and 60.0%)(P<0.05,P<0.01).All groups had significant improvement in ALT,AST and indexes of liver fibrosis after the treatment(P<0.05,P<0.01),and the difference of integrated group was superior to the other three groups(P<0.05,P<0.01).Conclusion "Ruanjian Huayu Decoction" with external application of "Jiedu Xiaopi Powder" have positive effects on protecting liver,lowering transaminase and fighting fibrosis for early HBV-related cirrhosis of blood-stasis obstruction.