中华肝脏病杂志
中華肝髒病雜誌
중화간장병잡지
CHINESE JOURNAL OF HEPATOLOGY
2011年
1期
25-28
,共4页
金瑞%郭新会%黄建峰%刘庄%李捍卫%王贞彪%张斌%谢玉民
金瑞%郭新會%黃建峰%劉莊%李捍衛%王貞彪%張斌%謝玉民
금서%곽신회%황건봉%류장%리한위%왕정표%장빈%사옥민
肝炎,乙型,慢性%肝炎e抗原,乙型%干扰素α%拉米夫定
肝炎,乙型,慢性%肝炎e抗原,乙型%榦擾素α%拉米伕定
간염,을형,만성%간염e항원,을형%간우소α%랍미부정
Hepatitis B,chronic%Hepatitis B e antigens%Interferon-alpha%Lamivudine
目的 观察重组人干扰素(IFN)α-1b和重组人IFN α-1b联合拉米夫定(LAM)治疗HBeAg阳性慢性乙型肝炎患者的疗效,并分析影响疗效的因素.方法收集HBeAg阳性慢性乙型肝炎患者111例,其中49例为单药治疗组,给予重组人IFN α-1b治疗(50μg/次,隔日1次,肌肉注射),62例为联合治疗组,给予重组人IFN α-1b(50μg/次,隔日1次,肌肉注射)加LAM(100 mg/d,口服)联合治疗,疗程为6～12个月或＞12个月.在治疗前、治疗后3、6、9、12、18个月及治疗结束时比较两组患者的HBV DNA低于检测下限率、HBeAg及HBsAg血清转换率.同时检测LAM的耐药变异情况.采用t检验和x2检验进行统计分析.结果 (1)治疗3、6、9、12、18个月后,单药治疗组HBeAg血清学转换率分别为6.1%、8.2%、14.3%、28.6%、36.7%,联合治疗组HBeAg血清学转换率分别为1.6%、8.1%、14.5%、29.0%、38.7%,两组比较,x2值分别为1.602、0.000、0.001、0.003、1.500,P值均＞0.05,差异均无统计学意义;(2)治疗3、6、9、12、18个月后,单药治疗组HBV DNA低于检测下限率分别为0、8.2、36.7%、53.1%、57.1%,联合治疗组HBV DNA低于检测下限率分别为30.7%、66.1%、79.0%、83.9%、88.7%,两组比较,x2值分别为25.205、38.150、20.465、12.073、14.459,P值均＜0.05,差异有统计学意义;(3)单药治疗组,男性患者组和女性患者组HBeAg血清学转换率分别为34.5%、40.0%两组比较,差异无统计学意义.年龄≥40岁和＜40岁的患者的HBeAg血清转换率分别为50.0%、34.9%,两组比较,差异无统计学意义.HBV DNA≥6 log10拷贝/ml和HBV DNA＜6 log10拷贝/ml的患者HBeAg血清转换率分别为52.4%、25.0%两组比较,x2=3.871,P＜0.05,差异有统计学意义.结论 (1)适当延长疗程有利于HBeAg阳性慢性乙型肝炎患者HBeAg血清学的转换;(2)联合治疗组HBV DNA低于检测下限率高于单药治疗组;(3)单药治疗组中,高HBVDNA载量患者HBeAg血清转换率比低HBV DNA载量患者低.
目的 觀察重組人榦擾素(IFN)α-1b和重組人IFN α-1b聯閤拉米伕定(LAM)治療HBeAg暘性慢性乙型肝炎患者的療效,併分析影響療效的因素.方法收集HBeAg暘性慢性乙型肝炎患者111例,其中49例為單藥治療組,給予重組人IFN α-1b治療(50μg/次,隔日1次,肌肉註射),62例為聯閤治療組,給予重組人IFN α-1b(50μg/次,隔日1次,肌肉註射)加LAM(100 mg/d,口服)聯閤治療,療程為6～12箇月或＞12箇月.在治療前、治療後3、6、9、12、18箇月及治療結束時比較兩組患者的HBV DNA低于檢測下限率、HBeAg及HBsAg血清轉換率.同時檢測LAM的耐藥變異情況.採用t檢驗和x2檢驗進行統計分析.結果 (1)治療3、6、9、12、18箇月後,單藥治療組HBeAg血清學轉換率分彆為6.1%、8.2%、14.3%、28.6%、36.7%,聯閤治療組HBeAg血清學轉換率分彆為1.6%、8.1%、14.5%、29.0%、38.7%,兩組比較,x2值分彆為1.602、0.000、0.001、0.003、1.500,P值均＞0.05,差異均無統計學意義;(2)治療3、6、9、12、18箇月後,單藥治療組HBV DNA低于檢測下限率分彆為0、8.2、36.7%、53.1%、57.1%,聯閤治療組HBV DNA低于檢測下限率分彆為30.7%、66.1%、79.0%、83.9%、88.7%,兩組比較,x2值分彆為25.205、38.150、20.465、12.073、14.459,P值均＜0.05,差異有統計學意義;(3)單藥治療組,男性患者組和女性患者組HBeAg血清學轉換率分彆為34.5%、40.0%兩組比較,差異無統計學意義.年齡≥40歲和＜40歲的患者的HBeAg血清轉換率分彆為50.0%、34.9%,兩組比較,差異無統計學意義.HBV DNA≥6 log10拷貝/ml和HBV DNA＜6 log10拷貝/ml的患者HBeAg血清轉換率分彆為52.4%、25.0%兩組比較,x2=3.871,P＜0.05,差異有統計學意義.結論 (1)適噹延長療程有利于HBeAg暘性慢性乙型肝炎患者HBeAg血清學的轉換;(2)聯閤治療組HBV DNA低于檢測下限率高于單藥治療組;(3)單藥治療組中,高HBVDNA載量患者HBeAg血清轉換率比低HBV DNA載量患者低.
목적 관찰중조인간우소(IFN)α-1b화중조인IFN α-1b연합랍미부정(LAM)치료HBeAg양성만성을형간염환자적료효,병분석영향료효적인소.방법수집HBeAg양성만성을형간염환자111례,기중49례위단약치료조,급여중조인IFN α-1b치료(50μg/차,격일1차,기육주사),62례위연합치료조,급여중조인IFN α-1b(50μg/차,격일1차,기육주사)가LAM(100 mg/d,구복)연합치료,료정위6～12개월혹＞12개월.재치료전、치료후3、6、9、12、18개월급치료결속시비교량조환자적HBV DNA저우검측하한솔、HBeAg급HBsAg혈청전환솔.동시검측LAM적내약변이정황.채용t검험화x2검험진행통계분석.결과 (1)치료3、6、9、12、18개월후,단약치료조HBeAg혈청학전환솔분별위6.1%、8.2%、14.3%、28.6%、36.7%,연합치료조HBeAg혈청학전환솔분별위1.6%、8.1%、14.5%、29.0%、38.7%,량조비교,x2치분별위1.602、0.000、0.001、0.003、1.500,P치균＞0.05,차이균무통계학의의;(2)치료3、6、9、12、18개월후,단약치료조HBV DNA저우검측하한솔분별위0、8.2、36.7%、53.1%、57.1%,연합치료조HBV DNA저우검측하한솔분별위30.7%、66.1%、79.0%、83.9%、88.7%,량조비교,x2치분별위25.205、38.150、20.465、12.073、14.459,P치균＜0.05,차이유통계학의의;(3)단약치료조,남성환자조화녀성환자조HBeAg혈청학전환솔분별위34.5%、40.0%량조비교,차이무통계학의의.년령≥40세화＜40세적환자적HBeAg혈청전환솔분별위50.0%、34.9%,량조비교,차이무통계학의의.HBV DNA≥6 log10고패/ml화HBV DNA＜6 log10고패/ml적환자HBeAg혈청전환솔분별위52.4%、25.0%량조비교,x2=3.871,P＜0.05,차이유통계학의의.결론 (1)괄당연장료정유리우HBeAg양성만성을형간염환자HBeAg혈청학적전환;(2)연합치료조HBV DNA저우검측하한솔고우단약치료조;(3)단약치료조중,고HBVDNA재량환자HBeAg혈청전환솔비저HBV DNA재량환자저.
Objective To compare the efficacy and safety of interferon α -1b and interferon α-1b combined with lamivudine in the treatment of HBeAg positive chronic hepatitis B (CHB), to analyze the impact of variable factors on the efficacy, and to investigate the individualized anti-viral regimen for CHB patients. Methods 111 CHB patients were enrolled and randomly divided into two groups. Group A:patients received interferon α -1b (49 patients, 50 μg I. M., qod. ), Group B: interferon α -1b (idem)combined with lamivudine for 6-12 months or longer(62 patients, 100 mg, P. O., q. d. ). Results (1) The HBeAg seroconversion rates of treatment by 12 and 18 months were 28.6% and 36.7% in group A, 29.0% and 38.7% in group B, respectively, no significant difference found between the two groups at the end of treatment( x2 = 0.003, P ＞ 0.05; x2 = 1.500, P ＞ 0.05). (2) The HBV DNA undetectable rates of treatment by 6months, 12 months and 18 months were 8.2%, 53.1% and 57.1% in group A,66.1%, 83.9% and 88.7% in group B, respectively, still no significant difference existed between the two groups ( x2 = 38.150, P ＜ 0.05;x2 = 12.073, P ＜ 0.05, x2 = 14.459, P ＜ 0.05). (3) In group A, the HBeAg seroconversion rates for male and female patients were 34.5% and 40.0% respectively, no significant difference found between. As regard ages the rates were 34.9% and 50.0% for patients younger or more than 40 years of age, no significant difference existed between. The HBeAg seroconversion rate was higher in patients with lower baseline serum HBV DNA loads (＜ 6 log10copies/ml). (4) The rates of patients with fever and blood abnormality were 36.7% and 34.7% in group A, 32.3% and 27.4% in group B, respectively. The total incidences of adverse events were similar between group A and B ( x2 = 0.244, P ＞ 0.05; x2 = 0.682, P ＞ 0.05). (5) The ratio of drug resistance in group B was only 1.6%. Conclusion The adverse events of interferon α -1b treatment for CHB are low and mild. The HBeAg seroconversion rate persistently raises with the extension of interferon α -1b treatment course. The HBV DNA undetectable rate of interferon α -1b combined with lamivudine is significantly higher than that of interferon α -1b and the drug resistance of lamlvudine can be reduced obviously by combination therapy.
