白花香莲解毒颗粒联合恩替卡韦治疗HBeAg阳性慢性乙型肝炎的多中心、双盲对照研究

目的观察白花香莲解毒颗粒联合恩替卡韦治疗HBeAg阳性慢性乙型肝炎的临床疗效。方法选取2018年1月—2019年1月就诊于广西中医药大学第一附属医院、田东县中医医院、藤县中医医院、那坡县中医医院、南宁市武鸣区中医医院的HBeAg阳性慢性乙型肝炎患者320例,随机分为对照组和治疗组,每组各160例。对照组口服中药安慰剂,2袋/次,2次/d,同时餐前或餐后2h口服恩替卡韦分散片0.5mg/次,1次/d。治疗组在对照组服用恩替卡韦分散片基础上口服白花香莲解毒颗粒,2袋/次,2次/d。两组患者均治疗48周。观察两组患者临床疗效,同时比较治疗前后两组患者HBV DNA下降值、病毒应答率、HBVDNA转阴率、血清生化应答率、HBeAg转阴率、HBeAg血清转换率和症状积分。结果治疗后,对照组临床有效率为76.88%,显著低于治疗组的88.75%,两组比较差异有统计学意义(P0.05)。治疗24、48周时,治疗组症状积分与同组治疗前比较差异有统计学意义(P0.05),治疗组症状积分与对照组治疗同期比较差异有统计学意义(P0.05)。治疗12、24、48周时,两组HBVDNA下降值均较同组治疗前升高(P0.05)。治疗12、24、48周时,治疗组HBV DNA下降值显著高于对照组(P0.05)。治疗12、24周时,治疗组病毒应答率优于对照组(P0.05)。治疗12、24、48周时,治疗组HBVDNA转阴率、血清生化应答率均优于对照组(P0.05)。治疗48周时,治疗组HBeAg转阴率优于对照组(P0.05)。治疗24、48周时,治疗组HBeAg血清转换率优于对照组(P0.05)。结论白花香莲解毒颗粒能够显著提高HBV DNA转阴率,增加HBeAg血清学转换率,改善肝功能及临床症状。

Multi-center, double-blind controlled clinical study on Baihua Xianglian Jiedu Granules combined with entecavir in treatment of HBeAg positive chronic hepatitis B

Objective To observe the clinical efficacy of Baihua Xianglian Jiedu Granules combined with entecavir in treatment of HBeAg positive chronic hepatitis B. Methods Patients (320 cases) with HBeAg positive chronic hepatitis B in the First Affiliated Hospital of Guangxi University of Chinese Medicine, Tiandong Hospital of Traditional Chinese Medicine, Tengxian Hospital of Traditional Chinese Medicine, Wuming District Hospital of Traditional Chinese Medicine and Napo Hospital of Traditional Chinese Medicine from January 2018 to January 2019 were randomly divided into control and treatment groups, and each group had 160 cases. Patients in the control group were po administered with placebo of traditional Chinese medicine, 2 bags/time, twice daily, and at the same time they were po administered with Entecavir Dispersible Tablets before or after meals, 0.5 mg/time, once daily. Patients in the treatment group were po administered with Baihua Xianglian Jiedu Granules on the basis of Entecavir Dispersible Tablets in the control group, 2 bags/time, twice daily. Patients in two groups were treated for 48 weeks. After treatment, the clinical efficacy was evaluated, and the HBV DNA descending value, virus response rate, HBV DNA negative conversion rate, serum biochemical response rate, HBeAg negative conversion rate, serum conversion rate of HBeAg and symptom scores in two groups before and after treatment were compared. Results After treatment, the clinical efficacy in the control group was 76.88%, which was significantly lower than 88.75% in the treatment group, and there were differences between two groups (P < 0.05). After treatment for 24 and 48 weeks, the symptom scores in the treatment group were significantly different between before and after treatment, and there was a statistically significant difference in symptom scores between the treatment group and the control group over the same period (P < 0.05). After treatment for 12, 24 and 48 weeks, the HBV DNA descending value in two groups was significantly increased (P < 0.05), and which in the treatment was significantly higher than that in the control group. After treatment for 12 and 24 weeks, the virus response rate in the treatment was significantly better than that in the control group. After treatment for 12, 24 and 48 weeks, the HBV DNA negative conversion rate and serum biochemical response rate in the treatment were significantly better than those in the control group. After treatment for 48 weeks, the HBeAg negative conversion rate in the treatment was significantly better than that in the control group. After treatment for 24 and 48 weeks, the serum conversion rate of HBeAg in the treatment was significantly better than that in the control group. Conclusion Baihua Xianglian Jiedu Granules can significantly increase the negative conversion rate of HBV DNA, the serological conversion rate of HBeAg, and improve liver function and clinical symptoms.