CAJ | 학술논문

目的：探讨恩替卡韦与阿德福韦酯联合治疗高病毒载量慢性乙型肝炎（CHB）的疗效及安全性。方法收集2008年12月至2011年12月收治的高病毒载量CHB初治患者80例，随机分为观察组和对照组各40例。对照组采用恩替卡韦（ETV）治疗，观察组采用ETV联合阿德福韦酯（ADV）治疗。观察2组患者治疗前和治疗3、6、12、24个月时的HBV DNA载量、HBsAg或HBeAg血清学转换、ALT复常及不良反应情况。计量资料2组间比较采用两独立样本t检验；计数资料2组间比较用χ2检验。结果观察组6、12、24个月时的HBV DNA载量（拷贝/ml）的对数值（3．4±0．4、2．6±0．3、1．2±0．4）比同期对照组降低程度更明显（3．7±0．3、2．9±0．4、1．6±0．7）（t值分别为3．339、5．657、2．806，P值均＜0．05）。观察组治疗12、24个月时HBV DNA阴转率（87．5％、95．0％）、HBeAg转阴率（80．0％、90．0％）明显高于对照组（70．0％、77．5％；55．0％、70．0％）（P值均＜0．05）。观察组治疗24个月时HBeAg血清学转换率及ALT复常率较对照组明显提高（77．5％vs 50．0％；82．5％vs 55．0％，P值均＜0．05）。治疗期间，2组不良反应发生率差异无统计学意义（P＞0．05），观察组病毒学突破发生率明显低于对照组（0 vs 10．0％，P＜0．05）。结论初始联合ETV、ADV治疗高病毒载量CHB具有较强的抗病毒作用，可减少应答不佳和耐药的发生，长期临床疗效比单一使用ETV好，且安全可靠。
목적：탐토은체잡위여아덕복위지연합치료고병독재량만성을형간염（CHB）적료효급안전성。방법수집2008년12월지2011년12월수치적고병독재량CHB초치환자80례，수궤분위관찰조화대조조각40례。대조조채용은체잡위（ETV）치료，관찰조채용ETV연합아덕복위지（ADV）치료。관찰2조환자치료전화치료3、6、12、24개월시적HBV DNA재량、HBsAg혹HBeAg혈청학전환、ALT복상급불량반응정황。계량자료2조간비교채용량독립양본t검험；계수자료2조간비교용χ2검험。결과관찰조6、12、24개월시적HBV DNA재량（고패/ml）적대수치（3．4±0．4、2．6±0．3、1．2±0．4）비동기대조조강저정도경명현（3．7±0．3、2．9±0．4、1．6±0．7）（t치분별위3．339、5．657、2．806，P치균＜0．05）。관찰조치료12、24개월시HBV DNA음전솔（87．5％、95．0％）、HBeAg전음솔（80．0％、90．0％）명현고우대조조（70．0％、77．5％；55．0％、70．0％）（P치균＜0．05）。관찰조치료24개월시HBeAg혈청학전환솔급ALT복상솔교대조조명현제고（77．5％vs 50．0％；82．5％vs 55．0％，P치균＜0．05）。치료기간，2조불량반응발생솔차이무통계학의의（P＞0．05），관찰조병독학돌파발생솔명현저우대조조（0 vs 10．0％，P＜0．05）。결론초시연합ETV、ADV치료고병독재량CHB구유교강적항병독작용，가감소응답불가화내약적발생，장기림상료효비단일사용ETV호，차안전가고。
Objective To investigate the efficacy and safety of entecavir (ETV)combined with adefovir (ADV)in chronic hepatitis B (CHB)patients with high viral load.Methods Eighty CHB patients with high viral load who were admitted to our hospital from December 2008 to December 201 1 were equally and randomly divided into observation group and control group.The control group was given ETV,while the observation group was treated with ETV combined with ADV.HBV DNA load,HBsAg or HBeAg seroconversion,alanine aminotransferase (ALT)normalization,and adverse reactions before and after 3,6,12,and 24 months of treatment were evaluated.Comparison of continuous data between the two groups was made by independent-samples t test,and comparison of categorical data was made by chi-square test.Re-sults Compared with the control group,the observation group had significantly lower HBV DNA load after 6,12,and 24 months of treatment (3.7 ±0.3 vs 3.4 ±0.4 log copies/ml,t=3.339,P<0.05;2.9 ±0.4 vs 2.6 ±0.3 log copies/ml,t=5.657,P<0.05;1.6 ±0.7 vs 1.2 ± 0.4 log copies/ml,t=2.806,P<0.05 ).The HBV DNA clearance rate and HBeAg clearance rate in observation group were significantly higher than those in control group after 12 months of treatment (87.5%vs 70.0%,P<0.05;80.0%vs 55.0%,P<0.05)and 24 months of treatment (95.0%vs 77.5%,P<0.05;90.0%vs 70.0%,P<0.05).The observation group had significantly higher HBeAg seroconversion rate and ALT normalization rate than the control group after 24 months of treatment (77.5% vs 50.0%,P<0.05;82.5% vs 55.0% P<0.05).During the treatment,there was no significant difference in the incidence of adverse reactions between the two groups (P>0.05),but the observation group had a significantly lower viral breakthrough rate than the control group (0 vs 10.0%,P<0.05).Conclusion For CHB patients with high viral load,ETV combined with ADV has strong antiviral activity,reduces drug resistance and poor response,and shows bet-ter long-term clinical efficacy than ETV alone,suggesting that it is a safe and reliable therapy.