紫叶丹胶囊治疗恩替卡韦经治的HBeAg阳性慢性乙型肝炎患者的临床研究

Clinical Study of Zi Ye Dan capsule combined with Enticavir for HBeAg positive Chronic Hepatitis B patients

目的:研究紫叶丹胶囊对恩替卡韦经治HBeAg阳性慢性乙型肝炎(CHB)患者的临床疗效。方法:将上海中医药大学附属曙光医院肝病科门诊78例符合要求的恩替卡韦经治的HBeAg阳性CHB患者,按2∶1比例,随机双盲分为治疗组52例和对照组26例,分别给予恩替卡韦联合紫叶丹胶囊和恩替卡韦联合安慰剂治疗,疗程为48周。观察两组患者治疗前后血清HBeAg水平和血清学转换、HBsAg水平和中医证候量表积分的变化。结果:治疗48周后,两组患者HBeAg水平和中医症候积分均明显下降(P<0.05),且治疗组患者HBeAg和中医症候积分下降幅度明显优于对照组(P<0.05),但两组患者HBeAg阴转率和血清学转换率、HBsAg下降水平均无统计学差异(P>0.05)。结论:紫叶丹胶囊能明显提高恩替卡韦经治的HBeAg阳性CHB患者HBeAg下降水平,改善患者临床症状。

Objective:To study the clinical efficacy of Zi Ye Dan capsule on HBeAg-positive Chronic Hepatitis B(CHB)patients after entecavir treatment.Methods:Seventy-eight patients with HBAg-positive CHB patients after entecavir treatment from the outpatient department of hepatology,Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine were randomly divided into treatment group(52cases)and control group(26 cases)according to the ratio of 2∶1.Treatment group was treated with entecavir combined with Zi Ye Dan capsule and control group was treated with entecavir combined with placebo for 48 weeks.The changes of serum HBeAg level and serological conversion,HBsAg level and TCM Syndrome Scale scores were observed after treatment.Results:After 48 weeks of treatment,the levels of HBeAg and the scores of TCM symptoms in the two groups decreased significantly(P<0.05),and the scores of HBeAg and TCM symptoms in the treatment group were significantly lower than those in the control group(P<0.05),but there were no significant differences in the negative and serological conversion rate of HBeAg,and the decrease level of HBsAg between the two groups(P>0.05).Conclusion:Zi Ye Dan Capsule can significantly increase the HBeAg level and improve TCM symptoms of HBeAg-positive CHB patients treated with entecavir.