摘要
目的研究恩替卡韦联合双环醇片治疗HBeAg阳性慢性乙型肝炎患者的疗效和安全性。方法选择未应用其他抗病毒药物的HBeAg阳性慢性乙型肝炎患者113例，并将其随机分成两组。试验组57例，每日口服恩替卡韦0．5mg，同时每日服用双环醇片75mg；对照组56例，仅给予口服恩替卡韦每日0．5mg，两组均连续用药104周，观察治疗前后血清丙氨酸氨基转移酶（ALT）水平及病毒学指标的改变。结果两组患者血清AⅡ均明显下降，试验组更为显著（P〈0．01）。治疗12周时，两组患者HBeAg转阴率及血清学转换方面比较，差异均无统计学意义（P〉0．05）。随治疗时间延长，在治疗24、52、104周各时间点，试验组HBeAg转阴率及血清学转换均优于对照组，两组比较差异有统计学意义（P〈0．05）。两组HBVDNA水平均出现明显下降，但各治疗时间点HBVDNA下降水平及检测不到比率比较，差异无统计学意义（P〉0．05）。治疗52周时，试验组和对照组各出现1例和2例耐药，耐药率分别为1．75％和3．57％，两组比较差异无统计学意义（P〉0．05）；治疗104周时，试验组耐药1例，对照组耐药3例，耐药率分别为1．75％和5．36％，两组比较差异有统计学意义（P〈0．05）。2组患者均未发生与研究药物相关的不良反应。结论恩替卡韦与双环醇片联合应用治疗HBeAg阳性慢性乙型肝炎，在肝功能及病毒学方面均取得较好疗效且安全。
Objective To evaluate the efficacy and safety of treatment with enteeavir combined with bicyelol in patients with HBeAg positive chronic hepatitis B. Methods A total of 113 untreated pa- tients with HBeAg positive chronic hepatitis B were selected and randomly divided into two groups. 57 ca- ses in the experiment group received entecavir 0.5 mg and bicyclol 75 mg once daily, whereas 56 cases in the control group received entecavir 0.5 mg only once daily. The treatment in both groups lasted for 104 weeks. Serum aminotransferase levels and virological indicators were observed. Results Serum amin- otransferase decreased in both groups, and much more significantly in the experimental group（ P 〈 0.01 ）. At 12 weeks, the HBeAg seroconversion rate and seroconversion were compared in both groups, no signifi- cant differences were found between these 2 groups. With prolonged treatment of 24 weeks ,52 weeks and 104 weeks, serum HBeAg negative conversion rate was higher in the experimental group than in the control group. HBV DNA levels decreased in both groups, but no significant differences were found in HBV DNA undeteetable rate at different time point （ P 〉 O. 05 ）. At 52 weeks, drug resistance occurred in 1 case of treatment group and 2 cases of control group respectively. At 104 weeks,resistance occurred in 1 case of the treatment group （1.75 % ） and 3 cases of the control group （5.36%）respectively, difference was sig- nificant between them（P 〈 0.05） and without any drug related adverse reactions. Conclusion Treatment of entecavir combined with bicyclol for HBeAg positive chronic hepatiits B is effective and safe.
出处
《临床内科杂志》
CAS
2012年第10期679-681,共3页
Journal of Clinical Internal Medicine
