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目的观察国产拉米夫定-贺甘定优化治疗HBeAg阳性慢性乙型肝炎(乙肝)患者48周的疗效和病毒耐药发生情况。方法入组93例HBeAg阳性慢性乙肝患者,符合我国《慢性乙肝防治指南(2010年版)》治疗指征,口服国产拉米夫定-贺甘定100mg/d,如治疗至24周时血清HBV DNA>300拷贝/ml或发生病毒学突破的患者,则加用国产阿德福韦酯-阿甘定10mg/d;如治疗至24周时血清HBV DNA≤300拷贝/ml,则继续用贺甘定100mg/d单药治疗。在治疗48周中,每12周应用罗氏荧光定量PCR试剂检测血清HBV DNA及雅培化学发光试剂检测HBsAg、抗-HBs、HBeAg和抗-HBe。用PCR产物直接测序法进行血清HBV DNA耐药检测。结果 93例HBeAg阳性慢性乙肝患者治疗至48周时有6例失访,失访率为6.5%。贺甘定优化治疗慢性乙肝患者48周时,病毒学应答率(HBV DNA≤300拷贝/ml)为49.4%(43/87),HBsAg阴转率为1.1%(1/87),HBeAg阴转率为23.0%(20/87),HBeAg血清学转换率为19.5%(17/87),丙氨酸氨基转移酶(ALT)复常率为80.2%(69/86),天冬氨酸氨基转移酶(AST)复常率为95.3%(82/86),耐药发生率为4.6%(4/87)。结论贺甘定优化抗病毒治疗HBeAg阳性慢性乙肝患者48周可有效抑制HBV复制,改善肝功能,促进HBeAg血清学转换,且耐药突变率较低。
Objective To observe the curative effect and virus resistance of domestic lamivudine-Heganding in the optimization of 48-week HBeAg-positive chronic hepatitis B (HBV) patients. Methods Ninety-three patients with HBeAg-positive chronic hepatitis B were enrolled in our study. The patients were given lamivudine-gagarin 100mg / d orally. If serum HBV DNA was detected at 24 weeks after treatment, > 300 copies / ml or virological breakthrough in patients with the addition of domestic adefovir dipivoxil - Agamidine 10mg / d; if the treatment of serum HBV DNA ≤ 300 copies / ml until 24 weeks, then continue with Hegan Set 100mg / d monotherapy. During the 48 weeks of treatment, serum HBV DNA and Abbott chemiluminescence reagent were detected every 12 weeks for detection of HBsAg, anti-HBs, HBeAg and anti-HBe by Roche Fluorescence Quantitative PCR Reagents. Serum HBV DNA resistance was detected by direct sequencing of PCR products. Results 93 cases of HBeAg-positive chronic hepatitis B patients were treated at 48 weeks when there are 6 cases of loss of follow-up, the rate of loss was 6.5%. Hepadam optimal treatment of chronic hepatitis B patients 48 weeks, the virological response rate (HBV DNA ≤ 300 copies / ml) was 49.4% (43/87), HBsAg negative conversion rate was 1.1% (1/87), HBeAg negative The seroconversion rate of HBeAg was 19.5% (17/87) and the normalization rate of alanine aminotransferase (ALT) was 80.2% (69/86) in 23.0% (20/87) The normalization rate of transaminase (AST) was 95.3% (82/86) and the resistance rate was 4.6% (4/87). Conclusion Hepadam optimal antiviral treatment of HBeAg-positive chronic hepatitis B patients 48 weeks can effectively inhibit HBV replication, improve liver function and promote HBeAg seroconversion, and the mutation rate of drug resistance is low.