苦参素联合拉米夫定、阿德福韦酯用于慢性乙型肝炎抗病毒治疗的临床观察

Clinical Observation of Matrine in combination with l Adefovir dipivoxil , adefovir dipivoxil for the treatment of chronic hepatitis B virus

目的探讨苦参素、拉米夫定、阿德福韦酯三联用于慢性乙型肝炎抗病毒治疗的有效性及安全性。方法将116例慢性乙型肝炎患者随机分为试验组54例与对照组62例。试验组采用苦参素、拉米夫定、阿德福韦酯三联疗法;对照组采用拉米夫定、阿德福韦酯进行治疗;两组均持续治疗6个月。在治疗前、治疗后,及停药后6个月后随访。观察肝功能、乙型肝炎病毒标记物变化及安全指标。结果试验组在治疗后总应答率为77.8%,对照组为56.5%(P<0.05),6个月后随访持续总应答率为83.3%,对照组为48.4%(P<0.01);治疗后肝功能改善(ALT复常率)、HBVDNA转阴率、HbeAg转阴率、HbeAg/HbeAb转换率,治疗组分别为53.7%,81.5%,55.6%,48.1%,对照组33.9%(P<0.05),67.7%(P<0.05),27.4%(P<0.01),35.5%(P<0.05);6个月后随访肝功能改善(ALT复常率)、HBVDNA转阴率、HbeAg转阴率、HbeAg/HbeAb转换率,治疗组分别为83.6%,83.3%,51.9%,48.1%,对照组45.1%(P<0.01),67.7%(P<0.05),37.1%(P<0.05),38.7%(P<0.05)。结论苦参素联合拉米夫定、阿德福韦酯三联用于慢性乙型肝炎抗病毒治疗有更好的治疗效果,且无明显不良反应。

Objective To evaluate the eficacy and safety of matrine combined with lamivudine （LAM）and adefovir dipivoxil （ADV） in the treatment of chronic hepatitis B. Methods 116 patients with chronic hepatitis B were randomly divided into the treatment group （matrine combined with lamivttdine （LAM）and adefovir dipivoxil （ADV））and control group （lamivudine （LAM） and adefovir dipivoxil （ADV））. Each group received 6-months-treatment separeately. The serum HBV-DNA levels, HBV serologic marker, liver function tests, and the safety results were measured respectively at the time both when the treatment was done and after 6 months follow-up without treatment. Results After the treatment, the complete response rate of the treatment group was77.8%, while in the control group was 56.5%（P〈 0.05）, The response rate of the treatment group was83.3%, while in the control group was48.4% （P〈 0.01） when follow-up; After the treatment, ALT normalization rate, HBV DNA negative rate, seroeonversion rate of HBeAg, negative rate of HBeAg/HBeAb of the treatment group was53.7%, 81.5%, 55.6%, 48.1%, while in the control group was 33.9% （P〈 0.05）, 67.7% （P〈 0.05）, 27.4% （P〈 0.01）, 35.5% （P〈 0.05） ; The ALT normalization rate, HBV DNA negative rate, seroeonversion rate of HBeAg, negative rate of HBeAg/HBeAb of the treatment group was83.6%, 83.3%, 51.9%, 48.1%, while in the control group was45.1% （P〈 0.01）, 67.7% （P〈 0.05）, 37.1% （P〈 0.05）, 38.7% （P〈 0.01 ） when follow-up. Conclusion Matrine combined with lamivudine （LAM） and adefovir dipivoxil （ADV） is elective and safe in the treatment of CHB patients, and has better overall efficacy.