松栀丸治疗湿热蕴结兼气滞血瘀证慢性丙型肝炎临床研究

Clinical study of Songzhi pill in the treatment of humid heat heap and stagnation of vital energy and blood stasis with Chronic hepatitis C

目的:评价松栀丸治疗湿热蕴结兼血瘀证慢性丙型肝炎(CHC)的临床疗效。方法:采用随机、盲法、阳性药物平行对照方法,将409例湿热蕴结兼血瘀证CHC患者按3:1的比例随机分为治疗组305例和对照组104例。治疗组患者给予松栀丸(5g/次,2次/d,口服),对照组患者给予利肝f片(3片/次,2次/d,口服),疗程为6个月,停药后各随访6个月。观察两组患者治疗前后的临床症状体征、中医证候积分、肝功能(ALT、AST、ALP、GGT、TBil、DBil)、HCV RNA、肝组织病理的变化。结果:治疗后,治疗组和对照组的临床总有效率分别为70.00%和34.15%,两组比较差异有显著性意义(P<0.00);两组患者中医证候积分较治疗前均有显著性下降(P<0.01),且治疗组较对照组下降更为显著(P<0.01);两组患者ALT、AST、GGT、TBil、DBil水平较治疗前均有显著性下降(P<0.01),且治疗组患者ALT、AST、GGT的水平较对照组下降更为显著(P<0.01);治疗后两组患者HCV RNA阴转率分别为36.55%、2.43%,两组比较差异有显著性意义(P<0.01),治疗组患者HCV RNA水平下降幅度较对照组明显(P<0.01);治疗结束后随访6个月,治疗组与对照组HCV RNA阴转率分别为48.15%、1.75%(P<0.01);治疗结束后两组患者肝功能正常者随访6个月ALT、AST的反跳率分别为11.7%、11.46%和26.67%、20.00%(P>0.05);治疗结束后两组患者肝功能异常者随访6个月ALT、AST的复常率分别为54.74%、49.46%和7.14%、19.15%(P<0.05)。治疗组治疗后肝脏炎症活动度、肝脏纤维化程度与治疗前比较均有一定程度的改善(P<0.05);治疗组患者主要症状除身目发黄与蜘蛛痣外,其他症状改善情况与对照组比较差异有显著性意义(P<0.01)。治疗中未观察到与试验药物有关的不良反应。结论:松栀丸可显著改善湿热蕴结兼血瘀证CHC患者的临床症状和体征,抑制HCV RNA病毒复制,改善肝功能,在临床上具有一定的推广作用。

Objective：To observe the clinical effect of Songzhi Pill on Patients of humid heat heap and blood stasis with Chronic hepatitis C.Methods：Adopted by the methods of random 、double- blind and masculine medieine parallel contrast,409 patients of humid heat heap and blood stasis with Chronic hepatitis C were randomly divided into treatment group with 305 patients and the control group with 104 patients.The treatment group was treated with Songzhi Pill（5g/time,2 times/day,oral）and the control group was treated with LiganLong Tabs（3tables/time,3 times/day,oral） with a coutse of six months.After discontinuation of the drug,the patients were followed up for 6 months.Observing the clinical symptom and physical sign,traditional Chinese medicine（TCM） syndrome integral,Hepatic function（ALT、 AST、AKP、GGT、TBil、DBil） 、HCV-RNA and changes of liver tissue pathology.Results：The total effective rates of treatment group and control group were 70%and 34.15%,respectively,with significant difference between two groups（P〈0.01）.After treatment,TCM syndrome integral,the levels of ALT,AST and GGT were decreased in treatment group more obviously than those in control group（P〈0.01）.The levels of TBIL and DBIL were decreased in two groups（P〈0.01）.The HCV-RNA negative conversion rate of two groups were 36.55%and2.43%,with significant difference between the two groups（P〈0.01）,and the level of HCV-RNA in treatment group was decreased significantly than the control group（P〈0.01）.After 6 months follow-up,the negative conversion rates of RNA HCV in the treatment group and the control group were 48.15%and 1.75%（P〈0.01）,respectively;while,the jump rates of ALT and AST in the two groups of patients with normal liver function were 11.7%,11.46%and 26.67%,20%（P〈0.05）.At the same time,the recovery rates of AST and ALT in the two groups of patients with abnormal liver function were 54.74%,49.46%and 7.14%,19.15%（P〈0.05）.After treatment,the degree of liver inflammation and liver fibrosis were improved in a certain extent（P〈0.05）.In the treatment group,the main symptoms were Body and eyes yellow dye and the spider naevi;compared with the control group,the difference of other symptoms improved were significant（P〈0.01）.Adverse drug reactions related to the drug were not observed in the treatment.Conclusion：For the patients of humid heat heap and blood stasis with Chronic hepatitis C,Songzhi Pill can significantly improve the clinical symptoms and signs,inhibit viral replication and improve liver function.These suggest that there is a certain role in the clinical practice.