参仁活血颗粒联合恩替卡韦抗慢性乙型病毒性肝炎肝纤维化的疗效评价

Effect of Shenren Huoxue granules combined with Entecavir on hepatic fibrosis in chronic hepatitis B virus patients

[目的]通过观察参仁活血颗粒联合恩替卡韦抗慢性乙型病毒性肝炎肝纤维化相关指标的影响,评价其临床疗效。[方法]选取于我院就诊的符合慢性乙型病毒性肝炎肝纤维化诊断标准的60例患者,随机1∶1分为试验组和对照组,各30例。对照组口服恩替卡韦分散片0.5 mg/次,1次/d,试验组加用院内制剂参仁活血颗粒10g/次,3次/d;分别于治疗6个月时、12个月通过检测谷丙转氨酶(ALT)、谷草转氨酶(AST)、中医症状积分及肝脏弹性硬度值(LSM值)进行比较及综合疗效分析,以评价药物疗效、疗程长短是否对疗效存在影响;并行安全性评价。[结果](1)治疗6个月及12个月时ALT、AST均较治疗前下降(P<0.05),但两组组间比较差异无统计学意义(P>0.05);(2)LSM值及中医症状积分在治疗6个月及治疗12个月时均较治疗前下降,差异有统计学意义(P<0.05);治疗12个月时下降程度较治疗6个月时下降明显(P<0.05);试验组在治疗6个月及12个月时与对照组同时段对比下降程度明显(P<0.05);(3)综合疗效评价,试验组总有效率及显效率均高于对照组,2组治疗12个月时的总有效率及显效率均较同组治疗6个月时高。[结论]参仁活血颗粒联合恩替卡韦可能通过降低慢性乙型病毒性肝炎肝纤维化患者的LSM值,缓解中医症状发挥抗肝纤维化的作用;两者联用具有协同作用;且在一定时间内,联合用药的疗效与用药时间成正相关;该药无严重不良反应,安全、有效,值得临床推广。

[Objective]To observe the effect of Shenren Huoxue granules combined with Entecavir on liver fibrosis related indicators of chronic hepatitis B virus.[Methods]Sixty patients were selected in our hospital who met the diagnostic criteria of liver fibrosis in chronic hepatitis B.All patients were randomly divided into 1∶1 test group and control group,30 cases in each.The control group was treated with Entecavir dispersible tablets 0.5 mg/time,once daily.The experimental group treated with Entecavir 0.5 mg each day and in-hospital preparations,Shenren Huoxue granules,10 g/time,3 times per day.After 24-week and 48-week treatment,ALT,AST,TCM symptom scores,and liver elasticity hardness（LSM）values were compared and comprehensive curative effects were analyzed to evaluate the efficacy of the drug.[Results]（1） ALT and AST were decreased after 24-week and 48-week treatment（P〈0.05）,however,there was no significant difference between the two groups（P〉0.05）.（2）LSM scores and symptom scores of traditional Chinese medicine were lower after 24-week and 48-week treatment than before,and the difference was statistically significant（P〈0.05）.The decline in the 48-week treatment group was signifi-cantly lower than that of the 24-week treatment group（P〈0.05）.Compared with the control group at the same time in the treatment group,the test group showed a significant degree of decline（P〈0.05）,after 24-week and 48-week treatment.（3） The total effective rate and significant efficiency of the experimental group were higher than the control group,the total effective rate and significant efficiency of the two groups after 48-week treatment were higher than the same group after 24-week treatment.[Conclusion]Shenren Huoxue granules combined with Entecavir may reduce the hepatic elasticity hardness value of patients with chronic hepatitis B liver fibrosis,and relieve the effect of TCM symptoms on liver fibrosis.The combination of the two methods has a synergistic effect,and within a certain period of time,the efficacy of the combination drug is positively related to the treatment course.The drug has no obvious adverse reactions.