白花香莲解毒方联合阿德福韦酯治疗HBeAg阳性慢性乙型肝炎的临床研究

目的通过观察壮药白花香莲解毒方联合阿德福韦酯对乙肝病毒e抗原(HBeAg)阳性的慢性乙型肝炎患者的影响,评估其临床疗效。方法采用多中心随机临床研究方法,240例HBeAg阳性的慢性乙型肝炎患者随机分为试验组和对照组,每组120例。对照组给予阿德福韦酯胶囊10mg,每日1次,试验组在对照组治疗基础上加用白花香莲解毒方,每日2次,疗程均为48周,观察治疗12、24、48周时两组患者的病毒学、血清学、生化学、慢性肝病量表(CLDQ)评分及不良事件。结果 (1)乙肝病毒脱氧核糖核酸(HBVD-NA)下降值、病毒应答率及阴转率:从治疗12周始,试验组HBVDNA下降的对数值与对照组比较,差异有统计学意义(P<0.05);试验组治疗12、24周病毒应答率分别为62.71%、77.97%,对照组为49.57%、67.52%,差异有统计学意义(P<0.05);而治疗48周,两组总的病毒应答率差异无统计学意义(P>0.05);试验组治疗12、24、48周的HBVDNA阴转率分别为22.03%、41.52%、55.08%,对照组为11.11%、21.37%、30.77%,差异有统计学意义(P<0.05)。(2)HBeAg/抗-HBe血清应答率:治疗24、48周试验组HBeAg血清应答率分别为26.27%、39.83%,对照组为13.68%、29.06%,差异有统计学意义(P<0.05);治疗48周,试验组HBeAg阴转率为22.03%,对照组为11.96%,差异有统计学意义(P<0.05)。(3)血清生化应答率:治疗24、48周,试验组血清生化应答率分别为74.58%、87.29%,对照组为60.68%、79.49%,差异有统计学意义(P<0.05)。(4)CLDQ评分:两组患者治疗后CLDQ评分均升高,与治疗前比较,差异有统计学意义(P<0.05);试验组治疗24、48周的CLDQ评分均优于对照组,差异有统计学意义(P<0.05)。(5)不良反应:两组患者主要不良反应为头痛、腹痛、恶心;并发生磷酸肌酸激酶升高9例,发生率为3.83%。结论白花香莲解毒方联合阿德福韦酯治疗HBeAg阳性慢性乙型肝炎患者,能显著提高对HBVDNA的抑制作用,增加HBeAg的血清学转换率,加快肝功能的恢复速度,改善生活质量,且安全性高。

Clinical Study on Baihua Xianglian Detoxification Recipe Combined with Adefovir Dipivoxil in Treating HBeAg Positive Chronic Hepatitis B

Objective To observe the effects on patients with HBeAg positive chronic hepatitis B by Baihua Xianglian Detoxification Recipe(BXDR) combined adefovir dipivoxil(AD),and to assess its clinical efficacy.Methods A multi-center randomized clinical trial was performed,and 240 patients with HBeAg positive chronic hepatitis B(CHB) were randomly assigned to the experimental group and the control group.Patients in the experimental group were given AD 10 mg,once daily,while BXDR was additionally given those in the control group,twice daily.The treatment course was 48 weeks.The virologic,serologic,biochemical,chronic liver disease questionnaire(CLDQ) score,and adverse event were observed for 12,24,and 48 weeks.Results(1) In aspect of virology:From the 12th week,statistical difference existed in the HBVDNA logarithm value between the experimental group and the control group(P<0.05).The virologic response rate was 62.71% and 77.97% in the experimental group at the 12th and 24th week,while it was 49.57% and 67.52% in the control group,showing statistical difference(P<0.05).There was no significant difference in the virological response rate at the 48th week(P>0.05).The HBVDNA negative rate in the experimental group was 22.03% at the 12th week,41.52% at the 24th week,and 55.08% at the 48th week.It was 11.11%,21.37%,and 30.77% in the control group,showing statistical difference(P<0.05).(2) In aspect of HBeAg/anti-HBe serology:The serum HBeAg response rate was 26.27% at the 24th week and 39.83% at the 48th week in the experimental group,while it was 13.68% at the 24th week and 29.06% at the 48th week in the control group,showing statistical difference(P<0.05).The HBeAg negative conversion rate at the 48th week of treatment was 22.03% in the experimental group and 11.96% in the control group,showing statistical difference(P<0.05).(3) In aspect of biochemistry:The biochemical response rate at the 24th week and the 48th week was 74.58% and 87.29% respectively in the experimental group,while it was 60.68% and 79.49% in the control group,showing statistical difference(P<0.05).(4) In aspect of CLDQ score:After treatment the CLDQ scores in the two groups were higher compared with before treatment with statistical difference(P<0.05).The CLDQ scores at the 24th week and the 48th week in the experimental group were superior to those in the control group,showing statistical difference(P<0.05).(5) In aspect of adverse reactions:The main adverse reactions were headache,abdominal pain,nausea.During the study period,the total creatine kinase(CK) increased in 9 cases with the occurrence rate of 3.83%.Conclusions In treating patients with HBeAg positive CHB,BXDR combined AD could significantly improve the inhibition of HBVDNA,increase the HBeAg seroconversion rates,accelerate the recovery of the liver function,improve the quality of life with higher safety.