| Background: hepatitis B virus(HBV)is an major health issue worldwide,causing hundreds of millions of people to be infected and millions of deaths.Liver disease that caused by HBV infection is the seventh most deadly reason in the world.MTCT is the main spread routes of hepatitis B.Blocking and preventing the route can effectively reduce the rate of hepatitis B infection.The World Health Organization proposes to eliminate viral hepatitis by 2030.To achieve grand plan,the MTCT of hepatitis B virus infection must be effectively curbed.Although the current immunization of newborns can reduce MTCT,there are still some infants who have failed in immunization.The main reason is the mother have a high viral load.Tenofovir is a nucleotide analogue that can effectively inhibit HBV replication and is the first choice for pregnant women with HBV.In recent years,some clinical studies have evaluated the effectiveness and safety of TDF in pregnant women with hepatitis B,but the conclusions are not coexistent.Therefore,we will conduct a meta-analysis of related research.Objective: The purpose of this analysis was to systematically assess the efficacy and safety of TDF in blocking MTCT of patients with high HBV viral load from the perspective of infants and mothers.Material and methods: Search for randomized controlled studies or observational studies that preventing the MTCT of the hepatitis B virus with tenofovir from English databases such as PubMed,Web of Science,Cochrane Library,MEDLINE,OVID,EMBASE,CALIS Foreign Language Journal Network and Clinical Trials.gov from the time of database establishment to March 1,2021.The search subjects included pregnant women with high HBV viral load and divided into two group.Treatment group administered with TDF daily and the contiol was placebo-treated or untreated.Two researchers browsed the titles and abstracts of literature by himself and eliminated irrelevant documents,then carefully read the full-text and re-screened them,evaluated the quality of the included documents and extracted data.A suitable model was used for analysis base on the results of the heterogeneity test.Data were pooled and analyzed by the Rev Man v5.3 and stata 12.0 software.Results: Seven studies were included in the analysis,which with a total of 894 pregnant women(425 patients in TDF group and 469 patients in control group)and 915 infants(433 infants in TDF group and 478 infants in control group).(1)Infant efficacy: The analysis results showed that the MTCT rate in the TDF group was significantly reduced compared to the control group(RR: 0.21,95% CI: 0.11-0.40)/(RR: 0.24,95% CI:0.13-0.44);The HBV DNA positivity in infants within 24 hours after birth in the treatment group was suppressed(RR: 0.19,95% CI:0.11-0.34).(2)Maternal efficacy: The rate of maternal HBV DNA positivity was also effectively inhibited(RR: 34.85,95% CI:16.72-72.60).(3)Infant safety: Compared with the control group,infants in the TDF group may have more mild adverse reactions(RR: 2.06,95%CI: 1.21-3.51).However,after classification and statistics of adverse events,there is no difference in symptoms such as headache,fever,jaundice,and skin abnormalities(p>0.05).And there were no considerable differences in serious adverse reactions,low birth weight,premature birth rate and congenital abnormalities between the two groups.In terms of development,there was a difference in birth weight of the infant between the two groups(MD=-0.10,95%CI:-0.18,-0.02,p=0.01),but this difference disappeared half a year after birth,while the body length and head circumference remained similar in the two groups.(4)mothers safety: the CK flare of pregnant women in TDF group(RR: 9.59,95% CI: 1.21-75.85).Besides,the pregnant women in the TDF group may be more prone to experience gastrointestinal reactions(RR: 4.75,95%CI: 1.53-14.69),but there are no results in the incidence of other adverse events,cesarean section,and pregnancy diseases.Conclusion: The current evidence shows that tenofovir has an effective MTCT blocking effect on pregnant women with high HBV load.Besides,tenofovir would not affect the infant’s intrauterine growth and postnatal development at1 years after birth.It will not increase the risk of serious adverse reactions in infants and mothers.TDF treatment during the perinatal period of HBV infected pregnant women can effectively and safely block MTCT of hepatitis B. |
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