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目的:评价妊娠晚期应用替比夫定阻断乙型肝炎病毒(HBV)母婴传播的疗效和安全性。方法:选择HBsAg和HBeAg阳性,HBVDNA≥1×106copies/mL的孕妇120例,分为2组:替比夫定组(年龄23～36岁)和对照组(年龄24～37岁),每组60例。替比夫定组受试者自孕28周开始口服替比夫定600mg,1次/d,至分娩后1个月,对照组不服用替比夫定。观察替比夫定组受试者服药后出现的不良反应;检测2组受试者在孕28周、分娩时和产后6个月时血清HBVDNA水平;2组婴儿在出生后即刻和1月龄时肌内注射乙肝免疫球蛋白各200U;在出生即刻、1月龄和6月龄时肌内注射乙型肝炎疫苗各10μg。检测2组婴儿出生后24h、6月龄和1岁时血清HBsAg及HBVDNA阳性率。结果:孕28周时,替比夫定组受试者血清HBVDNA水平[6.62±0.90)×106copies/mL]与对照组[(7.22±1.27)×106copies/mL]比较差异无统计学意义;分娩即刻替比夫定组[(0.49±0.54)×103copies/mL]较对照组[(7.46±1.06)×106copies/mL]明显降低,差异有统计学意义(P<0.05);产后6个月时替比夫定组[(6.23±0.85)×106copies/mL]与对照组[(7.55±1.88)×106copies/mL]比较差异无统计学意义。替比夫定组有13例受试者在孕28～36周出现血清肌酸激酶轻度升高,停药2周后恢复正常。替比夫定组孕妇所生婴儿6月龄时血清HBsAg和HBVDNA阳性例数(1例)显著低于对照组(11例),差异有统计学意义(P<0.05)。替比夫定组和对照组孕妇所生婴儿12月龄时HBV母婴传播阻断率分别为98.3%和81.7%,差异有统计学意义(P<0.05)。2组婴儿均未出现发育不良。结论:用替比夫定可以较安全有效地阻断乙肝病毒母婴传播且不影响婴儿发育。
OBJECTIVE: To evaluate the efficacy and safety of telbivudine in the prevention of mother-to-child transmission of hepatitis B virus (HBV) in the third trimester of pregnancy. Methods: 120 pregnant women with positive HBsAg and HBeAg and HBVDNA ≥1 × 106copies / mL were divided into two groups: telbivudine group (23-36 years old) and control group (24-37 years old) 60 cases. Subjects in the telbivudine group started telbivudine 600 mg once daily for 28 weeks from birth to 1 month after delivery, and the control group did not take telbivudine. Serum HBVDNA levels were observed at 28 weeks of gestation, at delivery and at 6 months postpartum in both groups. The infants in the two groups were tested immediately after birth and at 1 month of age Intramuscular injection of hepatitis B immunoglobulin each 200U; at birth, 1 month and 6 months of age intramuscular injection of hepatitis B vaccine of 10μg. The positive rates of serum HBsAg and HBVDNA were detected at 24h, 6months and 1year after birth in two groups of infants. Results: Serum HBVDNA level in the telbivudine group was significantly higher than that in the control group [(6.62 ± 0.90) × 106 copies / mL vs [(7.22 ± 1.27) × 106 copies / mL] at 28 weeks’ gestation. (0.49 ± 0.54) × 103copies / mL] was significantly lower than that of the control group [(7.46 ± 1.06) × 106copies / mL], the difference was statistically significant (P <0.05); 6 months after delivery There was no significant difference in telbivudine group ((6.23 ± 0.85) × 106copies / mL vs control group (7.55 ± 1.88 × 106copies / mL]. Thirteen subjects in the telbivudine group experienced a slight increase in serum creatine kinase at 28-36 weeks of gestation, returning to normal after 2 weeks of withdrawal. Serum HBsAg and HBVDNA positive cases (1 case) were significantly lower in the telbivudine group than those in the control group (n = 11) at 6 months of age. The difference was statistically significant (P <0.05). The blocking rates of mother-to-child transmission of HBV at twelfth month of pregnancy in telbivudine group and control group were 98.3% and 81.7%, respectively, with statistical significance (P <0.05). Both groups of infants did not develop dysplasia. CONCLUSION: Telbivudine can block the mother-to-child transmission of hepatitis B virus more safely and effectively without affecting infant development.