双环醇片治疗乙型肝炎病毒YMDD变异株感染的临床研究

Bicycolol tablets in treatment of patients with YMDD mutations of HBV

目的评估双环醇片治疗HBV YMDD变异株感染者的疗效和安全性。方法选择HBV YMDD变异株感染者68例，非变异株感染者100例，均口服双环醇片，50mg／次，3次／d，疗程24周。观察受试者的临床症状、体征变化及不良反应，在治疗前、治疗期间（第12周）及治疗结束时（第24周），分别检测患者的血常规、肝功能、HBV血清学标志物和HBV DNA水平。结果HBV YMDD变异株感染者治疗24周末的ALT及AST复常率分别为79．4％（54／68）和70．6％（48／68），显效率为16．2％（11／68），有效率为20．6％（14／68），血清HBeAg阴转率为27．9％（17／61），HBeAg血清学转换率为14．7％（9／61），HBVDNA阴转率为17．6％（12／68）；变异株组的总体疗效与非变异组相近。结论双环醇片能明显改善HBVYMDD变异株感染者的肝功能，对HBV YMDD变异株病毒的复制有一定的抑制作用。

Objective To evaluate the clinical efficacy and safety of bicyclol tablets in treatment of hepatitis B patients infected with YMDD mutation of HBV. Methods Sixty-eight chronic hepatitis paiients infected with HBV YMDD mutants and 100 patients with non-mutants HBV were enrolled in the study. All patients received bicyclol tablets orally 150 mg/d, t. i. d, for 24 weeks. Clinical symptoms, signs and adverse effects were observed, and the blood routine, liver function tests, serum HBV markers and HBV DNA loads were examined at 12th and 24th week of the study. Results After treatment for 24 weeks, the normalization rates of ALT and AST in mutant group were 79. 4% （ 54/68 ） and 70. 6% （ 48/68 ） ; 11 （ 16. 2% ） patients were markedly effective and 14 （20. 6% ） were effective. Clearance rates of HBeAg and HBV DNA were 27.9% （ 17/61 ） and 17.6% （12/68） , while the seroconversion rate of HBeAg was 14. 7% （9/61）. The differences of the above indexes were not statistically significant between mutant group and non-mutant group. Conclusion Bicyclol can both protect liver functions and inhibit virus replication in patients infected with HBV YMDD mutants.