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妊娠晚期应用替比夫定阻断乙型肝炎病毒宫内感染疗效和安全性的系统评价

Efficacy and Safety of Telbivudine in Preventing Intrauterine Transmission of Hepatitis B Virus in the Third Trimester of Pregnancy:a Systematic Review

【作者】 陈君

【导师】 孙晓风;

【作者基本信息】 新疆医科大学 , 内科学(专业学位), 2014, 硕士

【摘要】 目的:探讨在妊娠晚期应用替比夫定阻断乙型肝炎病毒母婴传播的临床疗效和安全性。方法:应用计算机检索中国生物医学文献数据库、万方医学数据库、中文科技期刊数据库、中国学术期刊网络出版总库、PubMed、ISI web of knowledge、 EMbase、Cochrane Library、BIOSIS Previews等数据库,全面收集应用替比夫定阻断乙型肝炎病毒宫内感染的相关文献,检索截止日期为2013年12月。参照纳入和排除标准进行文献筛选,采用RevMan5.1软件进行Meta分析。结果:纳入文献12篇,共1301例孕妇,其中应用替比夫定632例,对照组669例;Meta分析结果显示,随访6-12月龄婴儿,替比夫定组]TBsAg和HBV DNA阳性率均低于对照组,差异有统计学意义[RR=0.15,95%CI (0.08,0.27), P<0.00001; RR=0.12,95%CI (0.05,0.32), P <0.0001],替比夫定组Anti-HBs阳性率高于对照组[RR=1.27,95%CI(1.09,1.47),P=-0.002];替比夫定组孕妇分娩前HBV DNA、ALT水平低于对照组,差异有统计学意义[MD=-3.77,95%CI(-4.38,-3.15), P<0.00001; MD=-17.71,95%CI(-24.51,-10.91), P<0.00001];替比夫定组肌酸激酶升高率高于对照组,差异有统计学意义[MD=-3.86,95%CI(-4.55,-3.16), P<0.00001],应用替比夫定孕妇所产新生儿无畸形等并发症发生。结论:替比夫定阻断HBV宫内感染有一定的临床疗效与安全性,但由于现有证据质量普遍不高,纳入研究存在不同程度的方法学质量缺陷,因此有必要继续开展前瞻性、高质量、大样本、多中心的随机对照试验。

【Abstract】 Objective:To systematically review the efficacy and safety of telbivudine in pr eventing mother-to-infant transmission of hepatitis B virus in the third trimester of pregnancy.Methods:Chinese Biomedical Literature Database,WanFang Database Onli ne,Chinese Scientific Journals Database,CNKI,PubMed,ISI web of knowledge,EMbas e,Cochrane Library and BIOSIS Previews were searched for related articles till Dec ember2013.Two reviewers independently screened these articles according to inclus ion and exclusion criterion.Meta-analysis was performed by using software Rvman5.1.Results:Twelve papers were included in this study, with a total of1301pregna nt women,including632cases received telbivudine and669cases of control;Meta-a nalysis showed that,after a6to12month of follow-up,the seropositive rates for H BsAg and HBV DNA in babies of telbivudine-treated mothers were significantly lo wer than in babies of non-treated mothers[RR=0.15,95%CI(0.08,0.27),P<0.00001;RR=0.12,95%CI(0.05,0.32),P<0.0001],the seropositive rates for Anti-HBs in babies of telbivudine-treated mothers were significantly higher than in babies of non-treated mothers[RR=1.27,95%CI(1.09,1.47),P=0.002].Maternal HBV DNA and ALT levels pr ior to delivery was significantly lower in telbivudine-treated women than in non-tre ated women[MD=-3.77,95%CI(-4.38,-3.15),P<0.00001;MD=-17.71,95%CI(-24.51,-10.91),P<0.00001];The rate of elevation in serum creatine kinase was significantly hig her in telbivudine-treated mothers than in non-treated mothers[MD=-3.86,95%CI(-4.55,-3.16),P<0.00001];The neonates in telbivudine group were born without deformity and other complications.Conclusion:Telbivudine is effective and safe in blocking HBV intrauterine infection to some extent.However,it is a bit less persuasive becau se of the low quality of included studies and the methodological quality of include d studied was generally low.Therefore,the prospective,high-quailty,large sample and multicentre randomized controlled trial was needed.

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