中华传染病杂志
中華傳染病雜誌
중화전염병잡지
CHINESE JOURNAL OF INFECTIOUS DISEASES
2012年
6期
354-358
,共5页
徐京杭%于岩岩%斯崇文%陈新月%韩忠厚%陈勇%张文瑾%徐道振%陈宇萍%李雪迎%仇杰
徐京杭%于巖巖%斯崇文%陳新月%韓忠厚%陳勇%張文瑾%徐道振%陳宇萍%李雪迎%仇傑
서경항%우암암%사숭문%진신월%한충후%진용%장문근%서도진%진우평%리설영%구걸
肝炎,乙型,慢性%肝炎e抗原,乙型%干扰素α-2b%拉米夫定%变异(遗传学)
肝炎,乙型,慢性%肝炎e抗原,乙型%榦擾素α-2b%拉米伕定%變異(遺傳學)
간염,을형,만성%간염e항원,을형%간우소α-2b%랍미부정%변이(유전학)
Hepatitis B,chronic%Hepatitis B e antigens%Interferon alfa-2b%Lamivudine%Variation (Genetics)
目的 比较拉米夫定-干扰素序贯治疗与拉米夫定单药治疗HBeAg阳性慢性乙型肝炎患者的疗效和安全性.方法 选择172例HBeAg阳性慢性乙型肝炎患者,随机分为序贯治疗组83例和拉米夫定单药治疗组89例.序贯治疗组先用拉米夫定100mg/d治疗,从第25周开始加用干扰素α2b(5MU,皮下注射,隔日1次),总疗程48周,停药后随访24周.单药治疗组单用拉米夫定100mg/d治疗,共48周,停药后随访24周.计量资料方差齐性用t检验,方差不齐用秩和检验,率的比较用x2检验或Fisher确切概率法.结果 序贯治疗组和单药治疗组的基线HBV DNA分别为(7.8±1.0)和(7.9±1.1)1g拷贝/mL(P＞0.05),基线ALT分别为(210.5±150.1)和(211.9±160.9)U/L(P＞0.05).治疗结束时,序贯治疗组ALT为(78.4±146.1)U/L,单药治疗组ALT为(36.1±32.4)U/L,两组比较,差异有统计学意义(P＜0.05);序贯治疗组HBV DNA为(4.5±1.5)1g拷贝/mL,单药治疗组HBV DNA为(3.8±1.3)1g拷贝/mL(P＜0.05);应答率分别为65.8％、83.5％(P＜0.05);HBeAg阴转率分别为31.6％、22.2％(P＞0.05);血清学转换率分别为27.6％、16.0％(P＞0.05).随访结束时,序贯治疗组ALT为(126.0±143.1)U/L,单药治疗组ALT为(82.7±83.0)U/L,两组比较,差异有统计学意义(P＜0.05);序贯治疗组HBV DNA为(5.3±1.5)1g拷贝/mL,单药治疗组HBV DNA为(5.0±1.5)1g拷贝/mL,两组比较,差异无统计学意义(P＞0.05);HBeAg阴转率分别为25.0％、32.3％(P＞0.05);血清学转换率分别为25.0％、26.2％(P＞0.05).治疗48周时YMDD耐药变异率序贯治疗组低于单药治疗组(10.5％比26.9％,P＜0.05).结论 拉米夫定-干扰素序贯治疗和拉米夫定单药治疗对HBeAg阳性慢性乙型肝炎患者疗效相似,但序贯治疗可减少病毒变异.
目的 比較拉米伕定-榦擾素序貫治療與拉米伕定單藥治療HBeAg暘性慢性乙型肝炎患者的療效和安全性.方法 選擇172例HBeAg暘性慢性乙型肝炎患者,隨機分為序貫治療組83例和拉米伕定單藥治療組89例.序貫治療組先用拉米伕定100mg/d治療,從第25週開始加用榦擾素α2b(5MU,皮下註射,隔日1次),總療程48週,停藥後隨訪24週.單藥治療組單用拉米伕定100mg/d治療,共48週,停藥後隨訪24週.計量資料方差齊性用t檢驗,方差不齊用秩和檢驗,率的比較用x2檢驗或Fisher確切概率法.結果 序貫治療組和單藥治療組的基線HBV DNA分彆為(7.8±1.0)和(7.9±1.1)1g拷貝/mL(P＞0.05),基線ALT分彆為(210.5±150.1)和(211.9±160.9)U/L(P＞0.05).治療結束時,序貫治療組ALT為(78.4±146.1)U/L,單藥治療組ALT為(36.1±32.4)U/L,兩組比較,差異有統計學意義(P＜0.05);序貫治療組HBV DNA為(4.5±1.5)1g拷貝/mL,單藥治療組HBV DNA為(3.8±1.3)1g拷貝/mL(P＜0.05);應答率分彆為65.8％、83.5％(P＜0.05);HBeAg陰轉率分彆為31.6％、22.2％(P＞0.05);血清學轉換率分彆為27.6％、16.0％(P＞0.05).隨訪結束時,序貫治療組ALT為(126.0±143.1)U/L,單藥治療組ALT為(82.7±83.0)U/L,兩組比較,差異有統計學意義(P＜0.05);序貫治療組HBV DNA為(5.3±1.5)1g拷貝/mL,單藥治療組HBV DNA為(5.0±1.5)1g拷貝/mL,兩組比較,差異無統計學意義(P＞0.05);HBeAg陰轉率分彆為25.0％、32.3％(P＞0.05);血清學轉換率分彆為25.0％、26.2％(P＞0.05).治療48週時YMDD耐藥變異率序貫治療組低于單藥治療組(10.5％比26.9％,P＜0.05).結論 拉米伕定-榦擾素序貫治療和拉米伕定單藥治療對HBeAg暘性慢性乙型肝炎患者療效相似,但序貫治療可減少病毒變異.
목적 비교랍미부정-간우소서관치료여랍미부정단약치료HBeAg양성만성을형간염환자적료효화안전성.방법 선택172례HBeAg양성만성을형간염환자,수궤분위서관치료조83례화랍미부정단약치료조89례.서관치료조선용랍미부정100mg/d치료,종제25주개시가용간우소α2b(5MU,피하주사,격일1차),총료정48주,정약후수방24주.단약치료조단용랍미부정100mg/d치료,공48주,정약후수방24주.계량자료방차제성용t검험,방차불제용질화검험,솔적비교용x2검험혹Fisher학절개솔법.결과 서관치료조화단약치료조적기선HBV DNA분별위(7.8±1.0)화(7.9±1.1)1g고패/mL(P＞0.05),기선ALT분별위(210.5±150.1)화(211.9±160.9)U/L(P＞0.05).치료결속시,서관치료조ALT위(78.4±146.1)U/L,단약치료조ALT위(36.1±32.4)U/L,량조비교,차이유통계학의의(P＜0.05);서관치료조HBV DNA위(4.5±1.5)1g고패/mL,단약치료조HBV DNA위(3.8±1.3)1g고패/mL(P＜0.05);응답솔분별위65.8％、83.5％(P＜0.05);HBeAg음전솔분별위31.6％、22.2％(P＞0.05);혈청학전환솔분별위27.6％、16.0％(P＞0.05).수방결속시,서관치료조ALT위(126.0±143.1)U/L,단약치료조ALT위(82.7±83.0)U/L,량조비교,차이유통계학의의(P＜0.05);서관치료조HBV DNA위(5.3±1.5)1g고패/mL,단약치료조HBV DNA위(5.0±1.5)1g고패/mL,량조비교,차이무통계학의의(P＞0.05);HBeAg음전솔분별위25.0％、32.3％(P＞0.05);혈청학전환솔분별위25.0％、26.2％(P＞0.05).치료48주시YMDD내약변이솔서관치료조저우단약치료조(10.5％비26.9％,P＜0.05).결론 랍미부정-간우소서관치료화랍미부정단약치료대HBeAg양성만성을형간염환자료효상사,단서관치료가감소병독변이.
Objective To compare the efficacy and safety of Iamivudine-interferon sequential therapy and lamivudine monotherapy in HBeAg-positive chronic hepatitis B (CHB) patients.Methods A total of 172 patients with HBeAg-positive CHB were randomized to sequential group (n=83) or lamivudine group (n=89).Sequential group were administrated with lamivudine 100 mg/d and 5 million units interferon alpha 2b subcutaneous injection every other day for 24 weeks were added since week 25 of treatment.Lamivudine group were administrated with lamivudine 100 mg/d for 48 weeks.All subjects were followed up for 24 weeks after drug withdrawal.Measurement data with homogeneity of variance were analyzed by using t test and data with heterogeneity of variance were analyzed by using rank sum test.The comparison of rates was done by chi square test or Fisher exact test.Results The baseline hepatitis B virus (HBV) DNA levels of patients in sequential group and lamivudine group were (7.8±1.0) and (7.9±1.1) lg copy/mL,respectively (P＞0.05),and the baseline alanine aminotransferase (ALT) levels were (210.5 ± 150.1 ) and (211.9 ± 160.9) U/L,respectively (P＞0.05).At the end of treatment,higher ALT levels [(78.4±146.1) vs (36.1±32.4) U/L,P＜0.05)] and HBV DNA levels [(4.5±1.5) vs (3.8±1.3) lg copy/mL,P＜0.05)] levels,lower response rates (65.8％ vs 83.5％,P＜0.05),and similar HBeAg loss rates (31.6％ vs 22.2％,P＞0.05) and HBeAg seroconversion rates (27.6％ vs 16.0％,P＞0.05) were found in sequential group compared with lamivudine group.At the end of follow-up,higher ALT levels [(126.0±143.1) vs (82.7±83.0) U/L,P＜0.05)],similar HBV DNA levels [(5.3±1.5) vs (5.0±1.5) lg copy/mL,P＞0.05)],similar HBeAg loss rates (25.0％ vs 32.3％,P＞0.05) and HBeAg seroconversion rates (25.0 ％ vs 26.2 ％,P＞0.05) were found in sequential group compared with lamivudine group.YMDD motif mutation rate in sequential group was lower than lamivudine group at week 48 of treatment (10.5％ vs 26.9％,P＜0.05).Conclusions Lamivudine-interferon sequential therapy and lamivudine monotherapy are both effective in HBeAg-positive CHB patients,while HBV mutations are reduced in patients with sequential therapy.
