阿德福韦酯联合苦参素治疗HBeAg阳性慢性乙型肝炎临床疗效观察

Efficacy of adefovir dipivoxil combined with oxymatrine in the treatment of patients with HBeAg-positive chronic hepatitis B

目的探讨阿德福韦酯(ADV)联合苦参素治疗HBe Ag阳性慢性乙型肝炎(CHB)患者的临床疗效及安全性。方法将80例确诊为HBe Ag阳性的CHB患者随机分为对照组和治疗组,对照组40例使用ADV治疗,治疗组40例使用ADV联合苦参素治疗,两组均治疗12 m;在治疗3、6、9、12 m后,观察临床表现、血生化、血清HBV DNA载量、HBV血清学标志物变化及不良反应。结果在治疗6、9和12 m时,治疗组患者血清HBV DNA载量为(3.97±1.15)lg copies/ml、(3.38±1.24)lg copies/ml和(3.09±1.19)lg copies/ml,均显著低于对照组水平[(4.61±1.32)lg copies/ml、(4.17±1.12)lg copies/ml和(3.81±1.26)lg copies/ml,P<0.05];在3、6、9 m两组患者血清ALT水平无显著性差异,但均低于治疗前水平,在12 m时治疗组ALT为(30.1±15.4)U/L,显著低于对照组患者[(39.9±14.5)U/L,P<0.05];在治疗3 m时,两组间血清HBV DNA转阴率和ALT复常率无统计学差异,但在治疗6、9、12 m时,治疗组患者血清HBV DNA转阴率为55.0%、65.0%和77.5%,显著高于对照组[32.5%、42.5%和57.5%,P<0.05)];在治疗9和12 m时,治疗组患者ALT复常率为82.5%和92.5%,显著高于对照组水平[60.0%和75.0%,P<0.05];在治疗12 m时,治疗组血清HBe Ag阴转率及HBe Ag血清学转换率分别为47.5%和42.5%,显著高于对照组[25.0%和20.0%,P<0.05];两组治疗期间未出现严重的不良反应。结论 ADV联合苦参素治疗HBe Ag阳性CHB患者临床疗效和安全性好。

Objective To investigate the efficacy and safety of adefovir dipivoxil combined with oxymatrine in the treatment of patients with HBeAg-positive chronic hepatitis B （CHB）. Methods Eighty patients with HBeAg-positive CHB were randomly divided into control group （n=40） and treatment group （n=40）. Patients in control group were treated with ADV,while patients in treatment group were treated with ADV combined with oxymatrine. All patients were treated for 12 months. At 3,6,9 and 12 month,symptoms and signs, serum biochemical parameters,serum HBV DNA levels,serological HBV markers and adverse events were observed. Results At 6,9 and 12 month,serum HBV DNA levels in treatment group were （3.97±1.15）lg copies/ml,（3.38± 1.24） lg copies/ml and（3.09±1.19） lg copies/ml,significantly lower than in the controls[（4.61±1.32） lg copies/ml, （4.17±1.12） lg copies/ml and （3.81±1.26） lg copies/ml,respectively,P〈0.05];serum alanine aminotransferase （ALT） levels at 3,6 and 9 m were similar between the two groups and were lower than in the pre-treatment levels;serum ALT levels in patients of treatment group at 12 m was （30.1 ±15.4） U/L,significantly lower than in the controls [（39.9±14.5）U/L,P〈0.05];serum HBV DNA loss at 3 m and normalization rates of ALT level at 3 m and 6 m did not differ between the two groups,but the rates of HBV DNA loss in patients in treatment group at 6,9 and 12 m were 55.0%,65.0% and 77.5%,respectively,significantly higher than in the controls [32.5%,42.5% and 57.5%,respectively,P〈0.05];normalization rates of ALT level of patients in treatment group at 9 and 12 m were 82.5% and 92.5%,significantly higher than in the controls [60.0% and 75.0%,respectively,P〈0.05];negative rates and seroconversion rates of HBeAg for patients in treatment group at 12 m were 47.5% and 42.5%,respectively, significantly higher than in the controls [25.0% and 20.0%,respectively,P〈0.05]. Serious adverse reactions did not occur during the treatment process in the two groups. Conclusions ADV combined with oxymatrine in treatment of patients with HBeAg-positive CHB is of good efficacy and safe.