CAJ | 학술논문

目的：对干扰素单药治疗24周应答不佳的HBeAg阳性慢性乙型肝炎（CHB）患者采用不同的治疗方案进行后续治疗，分析比较其疗效和安全性。方法回顾性分析2010年9月~2013年1月南方医科大学南方医院193例干扰素治疗24周时应答不佳的HBeAg阳性的CHB患者，根据不同后续治疗方案分成：联用恩替卡韦（ETV）或阿德福韦（ADV）治疗（A组），继续干扰素单药治疗（B组），换为NAs治疗（C组），直接停止治疗（D组）。观察比较第24、48、72周时各组患者的临床疗效与安全性。结果继续治疗至疗程48周时，A组和C组HBV DNA转阴率、ALT复常率均高于B组（A组：χ2=26.808，P<0.001和χ2=5.485，P=0.017；C组：χ2=21.257，P<0.001和χ2=5.369，P=0.018）；同时发现，加ETV组HBV DNA转阴率高于加ADV组（χ2=8.255，P=0.004）。疗程72周时，A组患者有27例（39.7%）发生HBeAg血清学转换，明显高于B、C两组（χ2=4.238，P=0.04和χ2=7.681，P=0.006）；58例（85.3%）获得HBV DNA转阴，59例（86.8%）ALT恢复正常，均高于B组（χ2=23.018，P<0.001和χ2=5.987，P=0.014），但与C组比较差异无统计学意义（P>0.05）；同时发现，联合ETV组HBV DNA转阴率和HBeAg血清学转换率均高于加ADV组（χ2=9.823，P=0.002和χ2=5.450，P=0.020）。D组，28例患者的HBV DNA均持续较高水平复制，HBeAg水平升高，ALT反复波动。结论对于干扰素单药治疗24周时应答不佳的CHB患者，联用NAs并延长疗程可明显提高HBeAg血清学转换率、HBV DNA转阴率及ALT复常率，特别是联用ETV并延长疗程时。
목적：대간우소단약치료24주응답불가적HBeAg양성만성을형간염（CHB）환자채용불동적치료방안진행후속치료，분석비교기료효화안전성。방법회고성분석2010년9월~2013년1월남방의과대학남방의원193례간우소치료24주시응답불가적HBeAg양성적CHB환자，근거불동후속치료방안분성：련용은체잡위（ETV）혹아덕복위（ADV）치료（A조），계속간우소단약치료（B조），환위NAs치료（C조），직접정지치료（D조）。관찰비교제24、48、72주시각조환자적림상료효여안전성。결과계속치료지료정48주시，A조화C조HBV DNA전음솔、ALT복상솔균고우B조（A조：χ2=26.808，P<0.001화χ2=5.485，P=0.017；C조：χ2=21.257，P<0.001화χ2=5.369，P=0.018）；동시발현，가ETV조HBV DNA전음솔고우가ADV조（χ2=8.255，P=0.004）。료정72주시，A조환자유27례（39.7%）발생HBeAg혈청학전환，명현고우B、C량조（χ2=4.238，P=0.04화χ2=7.681，P=0.006）；58례（85.3%）획득HBV DNA전음，59례（86.8%）ALT회복정상，균고우B조（χ2=23.018，P<0.001화χ2=5.987，P=0.014），단여C조비교차이무통계학의의（P>0.05）；동시발현，연합ETV조HBV DNA전음솔화HBeAg혈청학전환솔균고우가ADV조（χ2=9.823，P=0.002화χ2=5.450，P=0.020）。D조，28례환자적HBV DNA균지속교고수평복제，HBeAg수평승고，ALT반복파동。결론대우간우소단약치료24주시응답불가적CHB환자，련용NAs병연장료정가명현제고HBeAg혈청학전환솔、HBV DNA전음솔급ALT복상솔，특별시련용ETV병연장료정시。
Objective To evaluate the efficacy and safety of 4 treatment options for HBeAg-positive chronic hepatitis B (CHB) patients following a suboptimal response to 24-week interferon monotherapy. Methods The data of 193 HBeAg-positive CHB patients with suboptimal response to 24-week interferon monotherapy were collected from Nanfang Hospital between September, 2010 and January, 2013. According to the subsequent treatments, the patients were divided into group A with additional entecavir or adefovir, group B with further interferon monotherapy, group C with conversion to NAs therapy, and group D with direct therapy withdrawal, and the biochemical and virological results at weeks 24, 48 and 72 were analyzed in the 4 groups. Results At week 48, the HBV DNA negative rates and serum alanine aminotransferase (ALT) normalization rates were both significantly higher in group A and C than in group B (P<0.05); in group A, ETV therapy subgroup had a significantly higher HBV DNA negative rate than ADV therapy subgroup at week 48 (90.3% vs 59.5%, χ2=8.255, P=0.004). At week 72, 39.7%(27/68) of the patients in group A achieved HBeAg seroconversion, a rate significantly higher than those in groups B (χ2=4.238, P=0.040) and C (χ2=7.681, P=0.006); the HBV DNA negative rate and ALT normalization rate in group A were 85.3%(58/68) and 86.8%(59/68), respectively, both significantly higher than those in group B (χ2=23.018, P<0.001; χ2=5.987, P=0.014) but comparable to those in group C (P>0.05). In the two subgroups in group A, the HBV DNA negative rate and HBeAg seroconversion rate were both significantly higher in ETV subgroup (χ2=9.823, P=0.002;χ2=5.450, P=0.020). In group D, all the patients remained HBeAg- positive with abnormal ALT levels and high level of HBV DNA. Conclusion For HBeAg-positive CHB patients with suboptimal response to 24- week interferon monotherapy, combined treatment with NAs (especially ETV) and extension of the treatment course can significantly improve the HBeAg seroconversion rates, HBV DNA negative rates, and ALT normalization rates.