拉米夫定联合阿德福韦酯治疗与恩替卡韦单药治疗HBeAg阳性慢性乙型肝炎患者48周疗效比较

摘要

Objective To compare treatment outcome,drug resistance rate,and safety between initial combination therapy with lamivudine (LAM) plus adefovir dipivoxil (ADV) and monotherapy with entecavir (ETV) in the treatment of HBeAg-positive chronic hepatitis B (CHB).Methods Fifty-six HBeAg-positive CHB patients,who received treatment in The First People's Hospital of Foshan from May 2008 to February 2010,were divided into combination therapy group and monotherapy group using a random number table.The combination therapy group received LAM (100 mg/d) plus ADV (10 mg/d) once daily for 48 weeks,while the monotherapy group received ETV (0.5 mg/d) once daily for 48 weeks.The alanine aminotransferase (ALT) normalization rate,hepatitis B virus (HBV) DNA clearance rate,and HBeAg clearance rate were compared between the two groups by chi-square test.Results After 48 weeks of treatment,the ALT normalization rate showed no significant difference between the two groups (x2 =1.018,P ＞0.05),but after 36 weeks of treatment,the ALT normalization rate was significantly higher in the monotherapy group than in the combination therapy group (x2 =4.082,P ＜ 0.05).After 12 and 48 weeks of treatment,the HBV DNA clearance rate showed no significant difference between the two groups (x2 =1.167,P ＞ 0.05;x2 =1.976,P ＞ 0.05),but after 24 and 36 weeks of treatment,the HBV DNA clearance rate was significantly higher in the monotherapy group than in the combination therapy group (x2 =5.600,P ＜ 0.05 ; x2 =9.164,P ＜ 0.05).There was no significant difference in HBeAg clearance rate between the two groups.Over the course of treatment,neither group developed drug resistance,and the two therapies had good safety.Conclusion Both initial combination therapy with LAM and ADV and monotherapy with ETV produce a good clinical effect in HBeAg-positive CHB patients after 48 weeks of treatment.ALT normalization and HBV DNA clearance occur earlier in patients receiving ETV alone than those receiving LAM plus ADV.The two therapies have good safety,cause little drug resistance,and produce good treatment outcome and hold promise for clinical application.%目的 观察拉米夫定(LAM)和阿德福韦酯(ADV)初始联合治疗与恩替卡韦(ETV)单药治疗HBeAg阳性慢性乙型肝炎(CHB)患者的疗效、耐药率及安全性.方法 选择2008年5月-2010年2月佛山市第一人民医院HBeAg阳性CHB患者56例,采用随机数字表法分为联合治疗组和单药治疗组,联合治疗组服用LAM(100 mg/d)和ADV(10 mg/d),1次/d,疗程为48周；单药组服用ETV (0.5 mg/d),1次/d,疗程48周.两组患者基线情况比较采用t检验,两组的ALT复常率、HBV DNA阴转率和HBeAg转阴率采用x2检验进行比较.结果 治疗48周时ALT复常率在联合治疗组与单药治疗组间差异无统计学意义(x2=1.018,P＞0.05),但治疗36周时单药组ALT复常率高于联合治疗组,差异有统计学意义(x2 =4.082,P＜0.05).治疗12和48周时,两组间的HBV DNA转阴率差异无统计学意义(x2=1.167、1.976,P＞0.05),治疗24和36周,单药治疗组HBV DNA转阴率高于联合治疗组,差异有统计学意义(x2=5.600、9.164,P＜0.05).两组间的HBeAg转阴率差异无统计学意义(P＞0.05).治疗过程中,两组均未出现耐药,安全性良好.结论 治疗48周时,LAM与ADV初始联合或ETV单药治疗HBeAg阳性CHB均具有较好的疗效；ETV单药治疗容易较早出现ALT复常和HBV DNA阴转；两组药物安全性好、耐药率低,疗效显著,值得推广应用.