This research analyzes the potential of long non-coding RNAs (lncRNAs) as markers in determining the necessity of antiviral treatment in pregnant women by examining alterations in the expression profile of serum lncRNAs in pregnant women with elevated hepatitis B viral load (HBVL) under antiviral and non-antiviral treatment regimens between the second trimester and delivery. Serum was obtained from 6 s-trimester pregnant women with high HBVL and no intrauterine infection. Then, 3 of these women were randomly selected for antiviral treatment, with the remaining 3 women undergoing non-antiviral treatment as control. Serum samples were again collected from these 6 women before delivery. The expression profile of lncRNAs was analyzed with microarray technology, followed by Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analyses. The axes of hub lncRNA-miRNA-mRNA were identified based on the competing endogenous RNA (ceRNA) network. The expression profile of serum lncRNAs in pregnant women with high HBVL changed significantly from the second trimester of pregnancy until delivery under antiviral or non-antiviral treatment. The Venn diagram was utilized to screen out the jointly up-regulated and down-regulated lncRNAs in the serum of pregnant women under antiviral and non-antiviral treatment before delivery. Additionally, the KEGG pathway enrichment analysis results showed that lncRNAs might mediate the Hippo pathway in HBV infection. Based on the ceRNA network, 3 hub lncRNAs (CATG00000076041.1, LINC01310, and G014655) were found to potentially regulate the key gene TP73 in the Hippo pathway. In this study, we retrieved co-differentially expressed lncRNAs in pregnant women with high HBVL under antiviral or non-antiviral treatment, which may be used as markers for evaluating whether pregnant women with high HBVL may be free of antiviral treatment. This study may provide a basis for preventing potential adverse effects of antiviral treatment on maternal and fetal health.

乙型肝炎病毒(hepatitis B virus,HBV)感染是全球公共卫生的主要问题.其长期慢性感染可能引发慢性肝炎、肝硬化及肝癌等严重肝脏疾病,对患者的身心健康构成严重威胁.母婴传播(mother-to-child transmission,MTCT)是HBV感染的重要途径,尤其在慢性乙型肝炎(chronic hepatitis B,CHB)感染中占据重要地位.在妊娠期间实施预防性干预,能有效降低新生儿对HBV的感染风险,从而减少乙肝的社区传播,最终降低CHB的发病率和死亡率.因此,妊娠期间预防和控制HBV MTCT的重要性不言而喻,它对保护个体和公共健康具有关键作用.本文对乙型肝炎疫苗、乙型肝炎免疫球蛋白(hepatitis B immunoglobulin,HBIG)、抗病毒治疗等方面的最新研究成果进行了综述和分析,目的在于提供有效策略以更好地保护母婴健康.

Objective:To compare the efficacy and safety of telbivudine (LDT) and tenofovir disoproxil fumarate (TDF) treatment during the second and third trimester in pregnant women with high viral load of hepatitis B virus (HBV).Methods:Totally 506 pregnancy women with HBV infection who received antiviral therapy during the second and third trimester of pregnancy in the obstetrical clinic of The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine from January 1, 2016 to December 31, 2018 were retrospectively enrolled, and the anti-viral efficacy and safety in mothers and neonates were evaluated. Pregnancy women were divided into TDF group and LDT group according the medications. The efficacies including decline and negative rate of HBV DNA, the vertical transmission (VT) rate, the normalization rate of liver function in mothers between the two groups were compared. The safeties including birth weight of neonates, congenital deformities and the rates of preterm between the two groups were also compared. Chi-square test, independent sample t test or rank sum test were used for statistical analysis. Results:There were 239 pregnant women in the LDT group and 267 in the TDF group. The maternal HBV DNA levels before treatment in the LDT and TDF groups were (7.83±0.75) lg IU/mL and (7.82±0.66) lg IU/mL, respectively, while the maternal HBV DNA levels prior to delivery were 2.91(1.20) lg IU/mL and 2.83(1.01) lg IU/mL, respectively. The normalization rates of alanine aminotransferase (ALT) of chronic hepatitis B (CHB) pregnant women prior to delivery in TDF group and LDT group were 95.00%(38/40) and 98.18%(54/55), respectively. There were all no significant differences between the two groups ( t=0.097, U=1.040 and χ2=0.767, respectively, all P>0.05). For CHB pregnant women, the HBV DNA negative rate at one month postpartum in TDF group was 85.45%(47/55) and that in LDT group was 82.50%(33/40). The normalization rate of ALT in TDF group was 94.55%(52/55), and that in LDT group was 92.50%(37/40). There were no significant differences between the two groups ( χ2=0.152 and 0.164, respectively, P=0.697 and 0.687, respectively). The VT rates were 0(0/262) in TDF group and 0.43%(1/231) in LDT group, which had no significant difference between the two groups ( χ2=1.127, P=0.288). Two patients in LDT group who continued taking LDT 11 months postpartum switched to TDF because of HBV rt204 mutation, and no one had virus mutation in TDF group. No significant increased in creatine kinase in LDT group, and no significant abnormal calcium and phosphorus metabolism in the TDF group. The preterm rate was 7.87%(21/267) in TDF group and 4.18%(10/239) in LDT group, but there was no significant difference between the two groups ( χ2=2.970, P=0.085). However, the birth weight of neonates in TDF group ((3 204.72±490.50) g) was lower than that in LDT group ((3 374.31±467.50) g), and the difference was statistically significant ( t=3.780, P<0.01). During the course of treatment, no pregnant women discontinued treatment due to drug intolerance, and no infants presented with drug-related birth defects. Safeties for mothers and neonates were both good. Conclusions:Both LDT and TDF treatment could reduce the VT rate in pregnant women with high HBV viral load. The safety is good for both mothers and neonates. However, for CHB pregnant women who continue antiviral therapy postpartum, TDF is superior to LDT because of lower virus mutation, thus to reduce the risk of drug resistance.

目的 探讨妊娠期合并梅毒螺旋体感染的患者在妊娠期间进行规范驱梅治疗对妊娠结局及新生儿血清学转归的影响.方法 回顾性分析2009年1月至2014年2月在南京中医药大学附属南京医院妇产科收治的192例妊娠合并梅毒螺旋体感染孕妇的临床资料,所有患者经梅毒快速血浆反应试验(RPR)和梅毒螺旋体颗粒凝集试验(TPPA)筛查,根据孕妇孕期是否接受规范驱梅治疗,分为治疗组162例和未治疗组30例,对所有活产新生儿完成12个月的血清学RPR跟踪随访,比较妊娠期规范驱梅治疗对妊娠结局和分娩新生儿血清RPR转阴率的影响.结果 治疗组与未治疗组孕母足月活产率(91.4％vs 40.0％)、死胎死产率(0.6％vs 10.0％)、畸形引产率(1.2％vs 16.7％)、子代先天性梅毒率(0.6％vs 13.3％)组间比较差异均有统计学意义(P<0.05).治疗组与未治疗组子代血清RPR累积转阴率在9个月(96.2％vs 75.0％)和12个月(97.4％vs 80.0％)差异均有统计学意义(P<0.01).结论 妊娠期梅毒螺旋体的筛查及规范驱梅治疗能显著降低妊娠不良结局的发生,降低子代感染先天梅毒的风险,其影响可持续至出生后12个月.

目的:探讨18例妊娠合并重症肝炎的病因、治疗方法、终止妊娠的时机方式及妊娠结局,期望找到改善妊娠结局的方法.方法:回顾性分析了本科近5年来18例妊娠合并重症肝病患者的临床资料(病因、临床症状及体征、治疗方法和妊娠结局).结果:妊娠合并重症肝病中由乙肝病毒感染导致的重症肝病7例,占比例较大(38.8％),妊娠急性脂肪肝4例(22.2％)占第2位,其他原因有甲状腺功能异常2例(11.1％)、免疫系统疾病1例(5.5％)、药物性肝损害1例(5.5％)、肝癌1例(5.5％)、Hellp综合征1例(5.5％)、恙虫病感染导致的肝衰1例(5.5％).其中晚孕14例,早孕1例,中孕3例.18例患者经确诊后立即给予综合治疗,积极纠正凝血功能,适时终止妊娠、应用人工肝及对症处理,孕妇存活17例,死亡1例.晚孕胎儿13例存活,1例死亡.剖宫产13例,顺产1,引产3例,1例继续妊娠.结论:乙肝病毒的感染仍然是孕妇重症肝病的主要原因,但是近年来其他原因引起的重症肝病逐渐增多,病因多元化.无论什么原因引起的重症肝病病情均非常凶险,应及时终止妊娠、适时地行人工肝治疗是提高孕妇生存率及改善妊娠结局的关键.

目的:分析妊娠合并人类免疫缺陷病毒(HIV)感染产妇分娩前后情况,以及母婴阻断效果.方法:回顾分析东南大学附属南京市第二医院妇产科2005年3月至2016年10月住院分娩的30例妊娠合并HIV感染患者的临床资料.患者于孕前或孕期采用高效抗逆转录病毒治疗(HAART).选取同期住院分娩的排除传染性疾病的正常孕妇90例.比较两组的孕期合并症、分娩情况、分娩方式及新生儿情况.监测研究组的阻断效果及新生儿生长发育情况.结果:研究组和对照组的孕期贫血、羊水过少、羊水污染发生率比较,差异均有统计学意义(26.67% vs 13.33%,33.33% vs 15.55%,23.33% vs 6.67%,P<0.05).研究组的剖宫产率高于对照组,差异有统计学意义(93.33% vs 48.89%,P<0.05).两组的新生儿体质量比较,差异有统计学意义[(3045.67±341.69)g vs (3273.44±430.19)g,P<0.05];两组的男婴数及1min Apgar评分比较,差异无统计学意义(P>0.05).截稿为止,随访至18月婴儿无一例感染(3例失访),随访的婴儿生长发育情况与同龄婴儿比较,未发现明显异常.结论:合并HIV感染孕妇分娩前后合并症及并发症发生概率相对较高.孕期运用HARRT方案,择期行剖宫产分娩、新生儿预防性使用抗病毒药物及人工喂养是阻断HIV母婴传播的重要措施.

妊娠合并肝衰竭是一种极为凶险的孕期合并症,母儿死亡率较高,预后差. 病毒性肝炎是发生妊娠期急性肝衰竭的主要原因. 本院2016年7月27日收治1例慢加急性肝衰竭胎死宫内患者,经积极抢救好转出院,现报道如下.

目的：观察慢性乙型病毒性肝炎（乙肝）患者妊娠早期服用替比夫定抗病毒治疗的母儿结局。方法回顾性分析慢性乙肝患者在核苷类似物抗病毒治疗中妊娠而不愿终止的18例孕妇于妊娠早期改为或继续替比夫定（600 m g／d ）治疗。婴儿出生后均接受主、被动联合免疫。分析孕妇替比夫定治疗前及分娩前 HBV M 及 HBV DNA的变化，均随访母儿至产后12个月。观察其 HBV母婴传播率、治疗应答率、肝功能复常率、不良反应、妊娠合并症及婴儿畸形发生情况。结果（1）1例阿德福韦服药中妊娠换为替比夫定者治疗无应答，余患者替比夫定治疗均有效。（2）分娩前2例肝功能仍异常，此2例患者均合并妊娠肝内胆汁淤积症，5例E抗原转阴，其中2例于分娩前发生血清学转换，分娩前 HBV DNA 滴度（2.91±0.71）log10，低于替比夫定治疗前（6.35±2.11） log10（t＝6.02，P＜0.01），15例患者于分娩前HBV DNA转阴。（3）随访婴儿至12个月龄，无一例婴儿发生宫内感染。（4）患者服药中无一例因不能耐受而停药；其中1例肝癌患者的婴儿2个月时发现胆道不全闭锁，余婴儿随访至12个月龄时未发现畸形。结论慢性乙肝妊娠患者抗病毒治疗中改为替比夫定治疗能明显阻断 HBV母婴传播及维持妊娠稳定性，但妊娠早期安全性需进一步观察。

目的 观察高病毒载量免疫耐受期的慢性乙型肝炎病毒(HBV)感染孕妇产后肝功能指标的变化,探讨分娩对肝功能的影响,为临床诊治提供依据.方法 选出2011年1月1日-2014年1月1日在东南大学附属第二医院妇产科检查、分娩、产后定期复查的慢性HBV感染孕妇共114例进行回顾性研究.根据产后肝功能是否异常分为肝功能正常组69例和肝功能异常组45例,观察产后1、3、6个月时肝功能轻、中、重度异常的发生情况与转归.结果 114例慢性HBV感染孕妇,产后丙氨酸转氨酶(ALT)活力升高的发生率为39.5％(45/114).肝功能异常组45例,其中ALT轻度异常率为77.8％(35/45),中度异常率为13.3％(6/45),重度异常率为8.9％(4/45).肝功能正常组和异常组孕妇孕晚期(孕28周以后)ALT和天冬氨酸转氨酶(AST)水平比较,差异有统计学意义(P＜0.05).随着产后时间的推移,肝功能逐渐趋于复常.肝功能异常组有4例发生中重度肝功能异常(ALT 201.1～599.1 U/L)而出现HBVe抗原(HBeAg)血清学转阴,自发HBeAg血清学转阴率为8.89％(4/45).结论 高病毒载量免疫耐受期的慢性HBV感染孕妇产后可发生重度肝功能异常,尤其是孕晚期ALT和AST水平有所升高时,需重视产后肝功能指标的随访,必要时及时干预治疗,以免发生重症肝炎.

INTRODUCTION:Maternal 25-hydroxyvitamin D [25(OH)D] deficiency has a negative influence on the health of the mother and the developing fetus. The aim of this study was to assess serum 25(OH)D status and its relationship to virologic and biochemical parameters in pregnant women with chronic hepatitis B virus (HBV) infection.METHODOLOGY:Serum 25(OH)D levels among 142 pregnant women with chronic HBV infection and 251 healthy pregnant women were measured using enzyme-linked immunosorbent assay.RESULTS:The mean±SD values for serum 25(OH)D levels were 13.63±5.5 ng/mL in healthy pregnant women and 12.05±3.3 ng/mL in pregnant women with chronic HBV infection (p < 0.01). Serum 25(OH)D levels were associated with seasonal variation in healthy pregnant women (p = 0.01); however, similar results were not observed in pregnant women with chronic HBV infection (p = 0.10). Furthermore, multivariate analysis indicated that only ALT level was independently associated with severe vitamin D deficiency (p = 0.01). A significant positive correlation was found between serum 25(OH)D level and ALT level in pregnant women with chronic HBV infection (r = 0.32; p < 0.001).CONCLUSIONS:Vitamin D levels were lower in pregnant women with chronic HBV infection compared with healthy pregnant women. Vitamin D supplementation can be routinely recommended for pregnant women in China.

目的 观察乙型肝炎(乙肝)疫苗(HBVac)接种次数对阻断高HBV载量母婴传播效果的影响.方法 抽取30例HBeAg阳性孕妇足月分娩婴儿(A组,孕妇临产时HBV DNA均＞1×106 copies/ml)和27例同期条件匹配生产的婴儿(B组)血液标本检查HBVM和HBV DNA定量,予出生时和15d肌肉注射乙肝免疫球蛋白(HBIG) 200 IU各1针;HBVac 20 μg肌肉注射:A组婴儿按0、1、2、6个月方案;B组婴儿按0、1、6个月方案注射.结果 随访至7个月龄.免疫程序结束后,A、B两组婴儿抗-HBs滴度、HBeAg值下降速度相仿(P＞0.05),但B组有2例婴儿抗-HBs阴性,7例抗-HBs低于100 mIU/ml.A、B两组婴儿的ALT和AST差异均无统计学意义(P＞0.05).结论 HBeAg阳性高病毒载量孕妇所生婴儿出生后应用HBIG及HBVac可以获得较好的免疫保护,增加HBVac注射次数可提高婴儿抗-HBs滴度.

目的:探讨孕母梅毒快速血浆反应试验(rapid plasma regain,RPR)滴度与新生儿RPR阳性率及围生结局关系.方法:对2009年1月1日-2014年2月1日经RPR和梅毒螺旋体颗粒凝集试验筛查,192例妊娠合并梅毒孕母分娩前及其部分新生儿出生时及6月龄时外周血检测,比较孕母RPR滴度与新生儿RPR阳性率、阴转率及不良围生结局的关系.结果:新生儿RPR滴度与孕母呈正相关,孕母RPR滴度1∶1时,新生儿RPR阳性率68.4％;孕母RPR滴度1∶2时,新生儿RPR阳性率87.0％;当孕母RPR滴度≥1∶8时,新生儿RPR阳性率100.0％;孕母RPR滴度≥1∶8与≤1∶4比较,新生儿RPR阳性率差异有统计学意义(P＜ 0.05).孕母RPR滴度≥1∶8时,婴儿6月龄RPR阴转率下降,与RPR滴度≤1∶4比较,差异有统计学意义(P＜0.05).随着孕母RPR滴度的升高,畸形、死胎及新生儿死亡、早产及先天性梅毒的风险升高,婴儿不良结局风险升高.当孕母RPR滴度≥1∶8时,与孕母RPR滴度≤1∶4比较,新生儿畸形、早产、先天性梅毒增多,差异有统计学意义(P＜0.05).结论:随着孕母RPR滴度的升高,新生儿RPR阳性率升高,当RPR滴度≥1∶8时,新生儿RPR阳性率为100％,6月龄阴转率下降,胎儿畸形、早产、先天性梅毒发生率显著升高.

OBJECTIVE To compare the various combined immunization schemes available for treatment of babies born to mothers with high-load hepatitis B virus (HBV) infection. METHODS A total of 118 mothers with HBV infection status of hepatitis B surface antigen-positive (HBsAg+), hepatitis B e antigen-positive (HBeAg+) and HBV DNA load of more than 1.0 * 61og10 IU/mL were included in the study. All of the participants' babies received the main-passive immunization therapy according to the wishes of their families. For analysis,the infants were grouped according to the various dosages of the vaccine program (group A: hepatitis B immunoglobulin (HBIG) 200 IU and HBVac 20 mug intramuscular;group B:HBIG 200 IU and HBVac 10 mug intramuscular; group C HBIG 100 IU and HBVac 20 mug intramuscular injection) and times, and followed-up to 7 months of age.All results were statistically analyzed using SPSS software. RESULTS All of the infants produced anti-HBs after vaccination.After the HBIG injection schedule was completed in January, the mean concentrations of anti-HBs in groups A, B, and C were 263.56 ± 50.98,231.06 ± 74.07, and 99.23 ± 29.82 mIU/mL respectively;the concentrations were significantly different between groups A and C, and between groups B and C (P < 0.001). In July, the titers of anti-HBs in groups A, B, and C were 788.10 ± 281.96,428.39 ± 347.48, and 708.44 ± 315.69 mIU/mL respectively; the concentrations were significantly different between groups A and B, and between groups B and C (P < 0.05). CONCLUSION AdminisWation of the hepatitis B vaccine combined with HBIG at birth can achieve immune protection for babies born to highly viremic mothers. In January, the HBIG dosage of 200 IU was more reliable than 100 IU. The hepatitis B 20 tg dose vaccine was safe and effective.

Objective To analyze the relationship between rapid plasma regain(RPR) titer of syphilis and adverse pregnancy outcomes in pregnant woman with syphilis .Methods Screened by treponema pallidum particle agglutination (TPPA ) test ,RPR titer of syphilis was examined in 192 pregnant women with syphilis before delivery .Adverse pregnancy outcomes were analyzed and compared between the pregnant women with syphilis treated by anti-syphilis therapy (group A ,162 cases) and those without treatment (group B ,30 cases ) .Results The risks for malformation , stillbirth ,congenital syphilis ,preterm birth and neonatal death were increased as RPR titer of syphilis elevated .The incidence rates of preterm birth ,neonatal malformation ,and congenital syphilis were higher in the cases with RPR titer of syphilis ≥1:8 than those ≤1:4(P＜0 .05) .The incidence rates of neonatal malformation ,congenital syphilis and neonatal death were higher in group A than those in group B(P＜0 .05) .Conclusion The risks for adverse pregnancy outcomes are increased as RPR titer of syphilis increases in pregnant woman with syphilis .The pregnancy outcomes can be improved significantly by anti-syphilis therapy in pregnant woman with syphilis .

OBJECTIVE To evaluate the therapeutic efficacy and safety of lamivudine treatment in late pregnancy by analyzing the maternal-fetal outcomes of chronic hepatitis B (CHB) mothers featuring hepatitis B e antigen (HBeAg)-positivity and highly viremic status. METHODS A total of 256 pregnant women in the second or third trimester with monoinfected CHB, HBeAg-positivity, and HBV DNA more than 6 log10 copies/mL were divided into two groups: lamivudine (lam) treatment (n=164) or no treatment (controls; n=92). All infants were treated with hepatitis B immune globin (HBIg; 200 IU) within 12 hrs of birth and 15 days later, and were given the recombinant HBV vaccine (20 mug) at 0, 1 and 6 months. All infants were followed-up to at least seven months and hepatitis B surface antigen (HBsAg) and HBV DNA levels were used to determine perinatal transmission (PT) rates. The mothers' data from routine blood analysis, tests of hepatic and renal function, detection of HBV markers and HBV DNA were retrospectively analyzed to determine changes associated with the lam treatment. Correlations of lam treatment with HBV PT rate, alanine aminotransferase (ALT) normalization, adverse reactions, pregnancy complications, congenital deformities, and infants' growth/development were determined by statistical analyses. RESULTS Prior to delivery, the lam-treated mothers had significantly lower HBV DNA levels (3.72+/-1.78 vs. controls: 7.83+/-0.67 log10 c/ml; t=-22.359, P less than 0.001). The rate of virological response in the lam-treated group was 97.56% (160/164). The lam-treated group had significantly higher ALT normalization rate (90.20% vs. controls: 55.88%; X2=13.349, P less than 0.001) and significantly lower HBeAg titer (957.73+/-458.42 vs. controls: 1296.35+/-383.14 S/CO; t=-5.410, P less than 0.001). At birth, the infants from lam-treated mothers had significantly lower HBsAg-positivity (15.24% (25/164) vs. controls: 30.43% (28/92); X2=8.284, P=0.004). By 7-12 months after birth, none of the infants born to lam-treated mothers tested positive for HBsAg, compared to 8.70% (8/92) of the infants born to mothers in the control group (X2=14.721, P less than 0.001). None of the lam-treated mothers required treatment discontinuation due to adverse events or lam-resistance. No congenital deformities were observed during the study and follow-up periods. There were no differences between the lam-treated and control groups for postpartum hemorrhage, gestational age, infants' height/weight or Apgar scores. CONCLUSION In highly viremic HBsAg+ mothers with CHB, lam treatment in the second or third trimester of pregnancy is safe and effective for reducing HBV maternal-neonatal transmission.

BACKGROUND & AIMS:Telbivudine reduces hepatitis B virus (HBV) DNA and normalizes levels of alanine aminotransferase (ALT) in patients with chronic hepatitis B (CHB). We investigated its use in preventing vertical transmission. METHODS:We performed an open-label, prospective study of 88 hepatitis B (HB) e antigen (HBeAg)-positive pregnant women with CHB, levels of HBV DNA >6 log(10) copies/mL, and increased levels of ALT. Women were given telbivudine (n = 53) starting in the 2nd or 3rd trimester, or no treatment (controls, n = 35) and followed until postpartum week (PPW) 28. All infants received standard immunoprophylaxis after birth. RESULTS:At 28 weeks, none of the infants whose mothers received telbivudine had immunoprophylaxis failure, whereas 8.6% of the infants of control mothers did (P = .029). There were no differences between groups in mothers' adverse events or infants' congenital deformities, gestational age, height, and weight, or Apgar scores. At postpartum week 28, significantly more telbivudine-treated mothers had levels of HBV DNA <500 copies/mL, normalized levels of ALT, and hepatitis B e antigen seroconversion compared with controls (58% vs none, P < .001; 92% vs 71%; P = .008; and 15% vs none; P < .001, respectively) but none had loss of hepatitis B surface antigen. Telbivudine-treated mothers had no virologic breakthrough (HBV DNA >1 log(10) increase from <500 copies/mL) or discontinuations from adverse events. After delivery, 13/52 patients discontinued telbivudine due to preference. There were no episodes of severe hepatitis (levels of ALT >10 times the upper limit of normal) in either group during 28 weeks of postpartum observation. CONCLUSIONS:Women with CHB given telbivudine during the second or third trimester of pregnancy have reduced rates of perinatal transmission. Telbivudine produced no adverse events in mothers or infants by 28 weeks.

OBJECTIVE:To evaluate the efficacy and safety of telbivudine use during the second and third trimester of pregnancy for reducing hepatitis B virus (HBV) transmission from highly viremic hepatitis B e antigen-positive (HBeAg+) mothers to their fetuses.METHODS:Pregnant women, between weeks 20 to 32 of gestation, who were HBeAg+ and had HBV DNA more than 1.0*10(7) copies/mL were enrolled in our study. The women were offered inclusion into one of two treatment arms, based upon their personal preference: telbivudine or no telbivudine. The patients in the telbivudine treatment arm were administered 600 mg/d telbivudine at least until postpartum week 4. All delivered infants in both treatment arms were administered hepatitis B immune globulin (HBIG; 200 IU) within 12 hours of delivery and recombinant HBV vaccine (20 mug) at 0, 1 and 6 months. The HBV perinatal transmission rate was determined by measuring HBsAg and HBV DNA in infants at postpartum week 28.RESULTS:A total of 220 pregnant women were enrolled in our study, 120 chose the telbivudine arm and 100 chose the control arm. All telbivudine treated subjects were registered in the Antiretroviral Pregnancy Registry. Telbivudine treatment was associated with a marked reduction in the mothers' serum HBV DNA, HBeAg and ALT levels before delivery. A striking decline of HBV DNA levels in treated mothers was observed at week 2 of treatment, which was followed by a gradual and steady decrease that continued until delivery. Thirty-seven (31%) of the telbivudine-treated mothers and none (0%) of the untreated controls had polymerase chain reaction-undetectable viremia at delivery. At week 28, 0% of the infants delivered from telbivudine-treated mothers were HBsAg+ or HBV DNA+, as compared to 8% HBsAg+ or HBV DNA+ in the untreated control arm (P = 0.002). No telbivudine discontinuations occurred from adverse events, and no congenital deformities were observed in the infants delivered to telbivudine-treated mothers. Eighty mothers discontinued telbivudine at week 4 postpartum, and there were no cases of severe hepatitis. There were no significant differences between the two treatment arms for postpartum hemorrhage, adverse events during pregnancy, cesarean section, gestational age, or infants' height/weight or Apgar scores.CONCLUSIONS:Telbivudine use during the second and third trimester of pregnancy in HBeAg+ highly viremic mothers can safely reduce perinatal HBV transmission rates. Telbivudine was well-tolerated by our patient group. Furthermore, no safety concerns were observed in either the telbivudine-treated mothers or their delivered infants in short term follow-up.

目的 评价妊娠晚期应用替比夫定治疗后阻断HBV宫内感染及胎盘HBV感染的效果.方法 38例HBeAg阳性、HBV DNA>7.00 log<,10>拷贝/ml孕妇分为2组:替比夫定组18例,自妊娠(28±2)周行替比夫定600 mg/d阻断治疗至产后1个月;对照组20例,未予替比夫定治疗;新生儿均予主被动联合免疫.ELISA法定量检测孕妇和新生儿乙肝两对半,PCR方法定量检测外周血及胎盘组织HBV DNA.结果 替比夫定组孕妇于分娩前血清HBV DNA显著下降至(3.87±1.12)log<,10>拷贝/ml,明显低于对照组的(7.42±0.53)log<,10>拷贝/ml(P<0.01).替比夫定组胎盘组织HBV DNA为(4.35±0.56)log<,10>拷贝/ml,也明显低于对照组的(5.16±0.40)log<,10>拷贝/ml(P%0.01).结论 妊娠晚期替比夫定抗病毒治疗可有效降低母亲外周血HBV DNA,阻断宫内传播.