拉米夫定联合阿德福韦酯对比恩替卡韦单药治疗失代偿期乙型肝炎肝硬化疗效与安全性的Meta分析  

Efficacy and Safety of Lamivudine Combined with Adefovir Dipivoxil versus Entecavir Alone in the Treatment of Decompensated HBV-associated Cirrhosis:A Meta-analysis

作　　者：蔡敏[1] 周慧[1] 刘娜[1] 赵红[1] 

机构地区：[1]南京市第二医院国家药物临床试验机构,南京210003

出　　处：《中国药房》2016年第27期3814-3817,共4页China Pharmacy

摘　　要：目的:系统评价拉米夫定(LAM)联合阿德福韦酯(ADV)对比恩替卡韦(ETV)单药治疗失代偿期乙型肝炎肝硬化的疗效和安全性,为临床提供循证参考。方法:计算机检索Pub Med、Cochrane图书馆、中国生物医学文献数据库、中国期刊全文数据库、中文科技期刊数据库、万方数据库,纳入LAM联合ADV(联合组)对比ETV(对照组)单药治疗失代偿期乙型肝炎肝硬化的随机对照试验(RCT),提取资料并进行质量评价后,采用Stata 11.0统计软件进行Meta分析。结果:共纳入13项RCT,合计972例患者。Meta分析结果显示,两组患者血清丙氨酸转氨酶(ALT)[SMD=0.079,95%CI(-0.086,0.244),P=0.348]、总胆红素(TBIL)[SMD=0.056,95%CI(-0.118,0.230),P=0.529]、白蛋白(ALB)[SMD=-0.020,95%CI(-0.494,0.454),P=0.935]、HBV-DNA阴转率[RR=1.012,95%CI(0.950,1.079),P=0.710]、乙型肝炎e抗原(HBe Ag)血清转换率[RR=1.181,95%CI(0.969,1.439),P=0.099]、HBe Ag阴转率[RR=1.011,95%CI(0.860,1.189),P=0.893]、随访96周肝功能Child-Turcotte-Pugh(CTP)评分[SMD=-0.063,95%CI(-0.299,0.173),P=0.601]、病毒学突破率[RR=1.562,95%CI(0.471,5.178),P=0.466]、死亡率[RR=1.198,95%CI(0.624,2.300),P=0.587]、不良反应发生率[RR=1.552,95%CI(0.618,3.900),P=0.349]比较差异均无统计学意义;联合组随访48周肝功能CTP评分显著高于对照组,差异有统计学意义[SMD=0.352,95%CI(0.031,0.672),P=0.031]。结论:LAM联合ADV与ETV单药治疗失代偿期乙型肝炎肝硬化患者的疗效和安全性相似,但ETV在短期内(48周)更容易抑制失代偿期乙型肝炎患者肝纤维化发展,甚至逆转肝纤维化和肝硬化。OBJECTIVE： To systematically review the efficacy and safety of lamivudine （LAM） combined with adefovir dipiv- oxil （ADV） versus entecavir （ETV）alone in the treatment of decompensated HBV-associated cirrhosis. METHODS： Retrieved from PubMed, Cochrane Library, CBM, CNKI, VIP and WangFang Database, randomized controlled trails （RCT） about LAM combined with ADV （combination group） versus ETV （control group） in the treatment of decompensated HBV-associated cirrhosis were collected. Meta-analysis was performed by using Stata 11.0 software after data extraction and quality evaluation. RESULTS： Totally 13 RCTs were included, involving 972 patients. Results of Meta-analysis showed, there were no significant differences in the serum alanine transaminase （ALT）[SMD=0.079, 95%CI（-0.086, 0.244）,P=0.348], total bilirubin （TBIL） [SMD=0.056, 95 % CI （ - 0.118,0.230）, P= 0.529], ALB [SMD = - 0.020,95 % CI （ - 0.494,0.454）, P= 0.935], HBV-DNA negative conversion rate [RR= 1.012,95%CI（0.950, 1.079） ,P=0.710], HBV e antigen （HBeAg） seroconversion rate [RR= 1.181,95%CI（0.969, 1.439）, P=0.099], HBeAg negative conversion rate [RR=l.011, 95% CI（0.860, 1.189）, P=0.893], follow-up 96 week liver function Child-Yurcotte-Pugh score [SMD = - 0.063,95 % CI （ - 0.299, 0.173 ）, P = 0.601], virological breakthrough rate [RR- 1.562,95 % CI （0.471, 5.178）, P=0.466], mortality rate [RR= 1.198, 95% CI （0.624, 2.300）, P=0.587] and the incidence of adverse reactions [RR= 1.552,95%CI（0.618,3.900）, P=0.349]in 2 groups; follow-up 48 week liver function CTP score in combination group was significantly higher than control group, the difference was statistically significant [SMD = 0.352,95 % CI （0.031,0.672）, P= 0.031]. CONCLUSIONS： LAM combined with ADV shows similar efficacy and safety to ETV in the treatment of decompensated HBV-associated cirrhosis, but within short term （48 weeks）, ETV is more likely to inhibit the development of liver fibrosis of the chronic HBV

关 键 词：拉米夫定 阿德福韦酯 恩替卡韦 慢性乙型肝炎 失代偿期 肝硬化Meta分析 

分 类 号：R978.7[医药卫生—药品]