替比夫定阻断乙型肝炎宫内感染的系统评价

Telbivudine for Blocking Intrauterine Infection of Hepatitis B: Systematic Review

目的对妊娠晚期使用替比夫定阻断宫内感染的有效性、安全性进行评价。方法按Cochrane系统评价方法,检索从1976至2014年11月Cochrane library、Medline、EMbase、China National Knowledge Infrastructure（CNKI）、China Biomedicine（CBM）相关文献。检索出13篇设有对照组的临床研究。用Rev Man5.0软件进行Meta分析。结果 1试验组分娩前检测孕妇的血清HBV DNA（log10拷贝/m L）低于对照组分娩前血清HBV DNA[WMD=-3.81,95%CI（-4.39,-3.22）,P〈0.01]（差异有统计学意义）。2使用替比夫定治疗前检测孕妇的血清HBV DNA（log10拷贝/ml）高于治疗后（分娩前）检测孕妇的血清HBV DNA[WMD=3.91,95%CI（3.32,4.49）,P〈0.01]。3试验组新生儿6~7个月时的HBV DNA阳性率低于对照组新生儿[OR=0.10,95%CI（0.04,0.22）,P〈0.01]。试验组新生儿12月时的HBV DNA阳性率低于对照组[OR=0.12,95%CI（0.04,0.36）,P〈0.01]。结论对HBV DNA高载量（≥1×106Iu/m L）的孕妇于妊娠晚期（28~32周）使用替比夫定（600mg/日）治疗可有效降低孕妇血清HBV DNA载量及新生儿出生后6~12个月的HBV DNA或HBs Ag阳性率;结合新生儿联合免疫方法,可有效阻断HBV的母婴传播。现有的研究尚不能确定孕期使用替比夫定的安全性,需要更好设计的RCT研究。

Objective To evaluate the effectiveness and security of using Telbivudine to block intrauterine infection.Methods According to methods of Cochrane systematic review,realted documents from 1976 to November 2014 were searched for in Cochrane library,Medline,Embase,China National Knowledge Infrastructure（ CNKI）,China Biomedicine（ CBM）. 13 clinical studies with control group were retrieved,and Meta analysis was performed with Rev Man5. 0 software. Results 1Serum HBV DNA（ log10 copies / ml） of gravidas in trial group was lower than that of the control group before delivery,HBV DNA[WMD =-3. 81,95%CI（-4. 39,-3. 22） ],and the difference was statistically significant（ P〈0. 01）.2Serum HBV DNA（ log10copies/ ml） detected before treatment with telbivudine in gravidas was higher than that after treatment（ before delivery）,HBV DNA[WMD= 3. 91,95%CI（ 3. 32,4. 49）,P〈0. 01].3The HBV DNA positive rate of newborns 6 to 7 months after birth in trial group was lower than that in control group[OR = 0. 10,95%CI（ 0. 04,0. 22）,P〈0. 01]. The HBV DNA positive rate of newborns 12 months after birth in trial group was lower than that in control group[OR = 0. 12,95% CI（ 0. 04,0. 36）,P〈0. 01].Conclusion Treating the HBV DNA high loading（ ≥1×106Iu / ml） gravidas with Telbivudine（ 600 mg /） in late pregnancy（ 28 ~ 32weeks） can effectively reduce the maternal serum HBV DNA load and HBV DNA or HBs Ag positive rate of newborns 6-12 months after birth; combined with neonatal combined immunization,it can effectively block mother-to-child transmission of HBV. Existing research still can not determine the security of the use of telbivudine during pregnancy,so better-designed RCTs are needed.