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目的观察阿德福韦酯联合恩替卡韦治疗阿德福韦酯疗效欠佳慢性乙型病毒性肝炎(chronic hepatitis B,CHB)的效果及安全性。方法 58例阿德福韦酯治疗效果欠佳CHB患者,依据后续治疗意愿分为对照组26例和观察组32例,对照组继续给予阿德福韦酯10mg/次,1次/d,口服;观察组在对照组治疗基础上给予恩替卡韦0.5mg/次,1次/d,口服。2组疗程均为48周。测定治疗12、24、48周后2组谷丙转氨酶(glutamic-pyruvic transaminase,GPT)、白蛋白(albumin,ALB)及总胆红素(total bilirubin,TBIL)水平,计算GPT复常率、乙型肝炎病毒(hepatitis B virus,HBV)-DNA转阴率、HBV-DNA突破率、HBeAg/HBeAb转换率。结果2组治疗12、24、48周后GPT、ALB、TBIL水平及GPT复常率、HBeAg/HBeAb转换率比较差异均无统计学意义(P>0.05);观察组治疗12、24、48周HBV-DNA水平[(5.1±0.9)×103、(4.0±1.4)×103、(2.9±1.4)×103 copies/mL]低于对照组[(5.8±1.1)×103、(5.0±1.2)×103、(4.2±1.6)×103 copies/mL](P<0.05),HBV-DNA转阴率(53.1%、71.9%、87.5%)高于对照组(24.0%、30.8%、26.9%)(P<0.05);治疗12周2组HBV-DNA突破率比较差异无统计学意义(P>0.05),治疗24、48周观察组HBVDNA突破率(0、0)低于对照组(15.4%、26.9%)(P<0.05);观察组不良反应发生率(21.9%)与对照组(19.2%)比较差异无统计学意义(P>0.05)。结论阿德福韦酯疗效欠佳CHB患者联合恩替卡韦治疗可更好地抑制HBV病毒复制。
Objective To observe the efficacy and safety of adefovir dipivoxil and entecavir in the treatment of chronic hepatitis B (CHB) patients with poor response to adefovir dipivoxil. Methods Fifty-eight patients with unsatisfied CHB treated with adefovir dipivoxil were divided into control group (n = 26) and observation group (n = 32) according to the intention of follow-up treatment. The control group was given adefovir dipivoxil 10 mg once daily ; The observation group was given entecavir 0.5mg / time on the basis of the control group, once a day, orally. The two groups were treated for 48 weeks. The level of glutamic-pyruvic transaminase (GPT), albumin (ALB) and total bilirubin (TBIL) were measured at 12, 24 and 48 weeks after treatment, Hepatitis B virus (HBV) -DNA negative rate, HBV-DNA breakthrough rate, HBeAg / HBeAb conversion rate. Results There was no significant difference in GPT, ALB, TBIL, GPT normalization rate and HBeAg / HBeAb conversion rate between the two groups at 12, 24 and 48 weeks (P> 0.05) HBV DNA levels were significantly lower than those in the control group [(5.8 ± 1.1) × 103, (5.0 ± 1.2), (5.1 ± 0.9) × 103, (4.0 ± 1.4) × 103, (2.9 ± 1.4) × 103 copies / mL, (53.1%, 71.9%, 87.5%) were significantly higher than those in the control group (24.0%, 30.8%, 26.9%, P <0.05) (P <0.05). There was no significant difference in the breakthrough rate of HBV-DNA between the two groups at 12 weeks of treatment (P> 0.05). The breakthrough rate of HBVDNA in the observation group at 24 and 48 weeks was lower than that of the control group (15.4% , 26.9%, respectively) (P <0.05). The incidence of adverse reactions in the observation group (21.9%) was not significantly different from that in the control group (19.2%) (P> 0.05). Conclusion Adefovir dipivoxil treatment in CHB patients with poor response to entecavir can better inhibit HBV replication.