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

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 young patients. Lamivudine has a good assessment of safety when used to treat children. a better effect in raising the Conclusion Lamivudine shows rates of loss of HBeAg,HBeAg seroconversion,and ALT normalization,but can not be effiective in raising the rate of lowering of HBV DNA to undetectable levels until treating after 48 weeks. It can improve the liver function of young patients and has little side effects. The safety and tolerance of this medicine is also good.