CAJ | 학술논문

观察普通干扰素α-2b联合阿德福韦酯治疗HBeAg阳性慢性乙型肝炎患者的疗效和安全性。方法采用随机、开放、多中心对照临床试验研究，纳入87例HBeAg阳性慢性乙型肝炎患者，将其随机分为普通干扰素α-2b治疗组32例，给予注射600万单位普通干扰素α-2b，1次/隔日，疗程48w；阿德福韦酯治疗组27例，给予阿德福韦酯10 mg口服，1次/d，疗程72w；和联合治疗组28例，同时给予普通干扰素α-2b，48w和阿德福韦酯72w。每隔12w检测各组患者ALT、血清HBV标志物和HBV DNA 水平。结果干扰素单药治疗、阿德福韦酯单药治疗和联合治疗组患者平均年龄分别为（31.8±6.6）岁、（34.2±6.4）岁和（30.5±7.2）岁，基线HBV DNA水平分别为（7.68±1.56）log10IU/ml、（7.61±2.00）log10IU/ml和（7.80±1.79）log10IU/ml，三组患者间两指标无统计学差异（P>0.05）；三组间性别构成和基线ALT水平亦无显著统计学差异（P>0.05）；在治疗72w时，干扰素单药治疗和阿德福韦酯单药治疗患者HBeAg转阴率分别为41%和19%，HBV DNA转阴率分别为53%和63%，ALT复常率分别为63%和67%，HBsAg血清学转换率为0.0%，均显著低于联合治疗组患者（57%、89%、93%和14%，P<0.05）。结论在病毒抑制、转氨酶复常和血清学转换率方面，普通干扰素α-2b 与阿德福韦酯联合治疗HBeAg阳性慢性乙型肝炎患者72w的疗效明显优于两药单独应用的效果。
관찰보통간우소α-2b연합아덕복위지치료HBeAg양성만성을형간염환자적료효화안전성。방법채용수궤、개방、다중심대조림상시험연구，납입87례HBeAg양성만성을형간염환자，장기수궤분위보통간우소α-2b치료조32례，급여주사600만단위보통간우소α-2b，1차/격일，료정48w；아덕복위지치료조27례，급여아덕복위지10 mg구복，1차/d，료정72w；화연합치료조28례，동시급여보통간우소α-2b，48w화아덕복위지72w。매격12w검측각조환자ALT、혈청HBV표지물화HBV DNA 수평。결과간우소단약치료、아덕복위지단약치료화연합치료조환자평균년령분별위（31.8±6.6）세、（34.2±6.4）세화（30.5±7.2）세，기선HBV DNA수평분별위（7.68±1.56）log10IU/ml、（7.61±2.00）log10IU/ml화（7.80±1.79）log10IU/ml，삼조환자간량지표무통계학차이（P>0.05）；삼조간성별구성화기선ALT수평역무현저통계학차이（P>0.05）；재치료72w시，간우소단약치료화아덕복위지단약치료환자HBeAg전음솔분별위41%화19%，HBV DNA전음솔분별위53%화63%，ALT복상솔분별위63%화67%，HBsAg혈청학전환솔위0.0%，균현저저우연합치료조환자（57%、89%、93%화14%，P<0.05）。결론재병독억제、전안매복상화혈청학전환솔방면，보통간우소α-2b 여아덕복위지연합치료HBeAg양성만성을형간염환자72w적료효명현우우량약단독응용적효과。
Objective To investigate the therapeutic effect of standard interferon plus adefovir dipivoxil for patients with HBeAg-positive chronic hepatitis B. Methods In this randomized multi-centered controlled clinical trial,87 patients with HBeAg-positive chronic hepatitis B were randomly divided into interferon α-2b monotherapy group (32 cases,with injection of 6 million units of interferon α-2b every other days for 48 weeks),adefovir dip-ivoxil monotherapy group (27 cases,with oral 10 mg per day for 72 weeks)and combinational treatment group(28 cases,with interferon α-2b 6 MU every other day for 48 weeks and 10 mg of adefovir dipivoxil per day for 72 weeks). Serum ALT,serum HBV markers and HBV DNA levels in these patients were tested every 12 weeks. Re-sults The average ages of patients receiving interferon α-2b alone,adefovir dipivoxil alone or the combinational treatment were(31.8±6.6),(34.2±6.4) and (30.5±7.2) years,respectively,and the baseline serum HBV DNA lev-els in the three groups were(7.68±1.56)log10 IU/ml,(7.61±2.00)log10IU/ml and(7.80±1.79) log10IU/ml,respective-ly,and there were no significant difference in average age and baseline HBV DNA level among three groups (P>0.05),either gender composition or the baseline ALT level (P>0.05);At the end of week 72,the HBeAg sero-conversion rates were 41% and 19%,the rates of HBV DNA loss were 53% and 63%,the ALT normalization rates were 63% and 67%,and HBsAg seroclearance rates were 0% in interferon or adefovir dipivoxil monotherapy pa-tients,all of which were significantly lower than those in patients receiving combinational treatment (57%,89%,93%and 14,respectively,P<0.05). Conclusion In terms of viral suppression,ALT normalization,and HBeAg or HBsAg seroconversion rates,the therapy of stan-dard interferon α-2b plus adefovir dipivoxil for 48 weeks is significantly better than using them alone.