拉米夫定治疗儿童慢性乙型肝炎疗效及安全性Meta分析  

Meta-analysis of efficacy and safety of lamivudine alone in children with chronic hepatitis B

作　　者：汪萌[1] 聂青和[1] 

机构地区：[1]第四军医大学唐都医院感染病科/全军感染病诊疗中心,西安市710038

出　　处：《实用肝脏病杂志》2012年第6期496-499,共4页Journal of Practical Hepatology

摘　　要：目的应用Meta分析评价拉米夫定治疗儿童慢性乙型肝炎(CHB)的疗效和安全性。方法计算机检索中英文数据库中有关拉米夫定治疗儿童CHB的临床随机对照试验。结果选中8项随机对照试验,包括1309例儿童CHB患者。Meta分析显示:拉米夫定组HBeAg阴转率、HBeAg血清学转换率和ALT复常率均明显高于安慰剂组:①HBeAg/抗HBe血清转换率:48周[OR=2.96,95%CI(1.71,5.12),P<0.001];②HBeAg阴转率:24周[OR=2.96,95%CI(1.71,5.12),P<0.001]。48周[OR=6.64,95%CI(3.47,12.7);Z=5.72,P<0.00001]。52周[OR=2.52,95%CI(1.44,4.42),P<0.01]。96周[OR=10.98,95%CI(3.26,37.05),P<0.001];③ALT复常率:12周[OR=2.84,95%CI(1.61,5.00),P<0.001]。24周[MD=4.56,95%C(I 1.46,14.28),P<0.01]。48周[OR=6.17,95%C(I 3.2,11.92),P<0.00001]。然而,在治疗12周和24周,患者HBV DNA阴转率与对照组比,差异无明显统计学意义[OR=56.66,95%CI(0.12,27661),P>0.05]、[OR=120.84,95%CI(0.67,21659.97),P>0.05],而在治疗48周[OR=66.02,95%CI(3.65,1195.7),P<0.01]、52周[OR=4.97,95%CI(2.35,10.51),P<0.0001]和96周[OR=46.92,95%CI(3.27,673.4),P<0.0001]时,HBV DNA阴转率明显提高。随访发现:拉米夫定治疗儿童CHB不影响正常的身高与体重的增长。结论拉米夫定可有效提高CHB患儿HBeAg阴转率、HBeAg血清学转换率和ALT复常率,治疗48周后HBVDNA阴转率才有明显提高。拉米夫定治疗儿童CHB,无明显的副作用,安全性较好。Objective To evaluate the efficacy and safety of lamivudine monotherapy for treating young patients who have chronic hepatitis B （CHB） with Meta-analysis. Methods Retrieved from databases to find the randomized controlled trials （RCTs） about treating young patients who have hepatitis B with lamivudine alone. Time is from 2000.1 to 2012.2. In addition, Google Scholar was also used to find relevant journals. Meta-analysis of included studies were conducted by the software RevManS.0. Results Eight RCTs including 1309 young hepatitis cases met the inclusion criteria. Meta-analysis showed that： Patients in lamivudine group had the higher rates of loss of HBeAg,HBeAg seroconversion,and ALT normalization as compared with placebo group. ①The OR values of lowering of HBeAg seroconversion：treating for 48 weeks[OR=2.96,95%CI（1.71,5.12） ;P〈0.001].②The OR values of lowering of loss of HbeAg：treating for 24 weeks [OR=2.96,95%CI （1.71,5.12）;P〈0.001];48 weeks [OR= 6.64,95% CI （ 3.47,12.7 ）, P〈0.00001] ; 52 weeks [OR =2.52,95% CI （ 1.44,4.42 ）, P〈0.01 ] ; 96 weeks [OR = 10.98,95% CI （3.26,37.05）,P=0.0001]. ③The OR values of ALT normalization： treating for 12 weeks [OR=2.84,95%CI （ 1.61,5.00 ）, P〈0.001 ] ; 24 weeks[MD=4.56,95%CI （ 1.46,14.28 ）, P〈0.0 1 ] ; 48 weeks[OR=6.17,95%CI （3.2,11.92）, P〈 0.00001]. But when facing with the reduction of HBV DNA,this method can be noneffective until treating for 48 weeks： treating for 12 weeks,no signficant difference exists between these two groups [OR=56.66,95%CI （0.12,27661）,P〉0.05];24 weeks,the phenomenon is the same [OR=120.84,95%CI （0.67,21659.97）]P〉0.05;48 weeks,the conclusion in lamivudine group is better then placebo group[OR=66.02,95%CI（3.65,1195.7）,Z=2.84,P〈 0.01]; 52weeks [OR=4.97,95% CI （2.35,10.51 ）, P〈0.0001] ; 96weeks [OR=4.97,95% CI （3.65,1195.7 ）,P〈0.0001 ]. It wasfound in follow-up that the lamivudine monotherapy has no effect with the normal growth of the height and weight of

关 键 词：慢性乙型肝炎 拉米夫定 儿童 META分析 

分 类 号：R725.7[医药卫生—儿科]