富马酸替诺福韦二吡呋酯对HBV感染孕妇肾功能和胎儿生长发育的安全性研究*

目的 评估HBV感染孕期应用富马酸替诺福韦二吡呋酯(TDF)抗病毒治疗对肾功能及对胎儿生长发育的影响。方法 2018年7月1 日～2019年6月30日首都医科大学附属北京佑安医院分娩的HBV感染孕妇120例,孕期全程口服TDF治疗40例(A组),孕中晚期口服TDF治疗40例(B组),未抗病毒治疗40例(C组)。检测血清磷(P)、肾小球滤过率(GFR)、肌酐(sCr)、肌酸激酶(CK)、尿蛋白(uPRO),记录新生儿出生时头围、身长、体质量和不良事件。结果 在孕36周时,A组血P、GFR、sCr、CK和uPRO分别为(1.2±0.1)mmol/L、(120.9±7.9)mL/(min·1.73 m²)、(52.1±7.9)μmol/L、(57.7±21.8)U/L、6例(15.0%),与B组【分别为(1.2±0.1)mmol/L、(119.5±9.4)mL/(min·1.73 m²)、(50.6±7.7)μmol/L、(56.6±18.8)U/L、5例(12.5%)】或C组【分别为(1.2±0.1)mmol/L、(125.7±8.7)mL/(min·1.73 m²)、(48.9±7.2)μmol/L、(53.9±16.1)U/L、4例(10.0%)】比,均无显著性差异(P>0.05);分娩时,A组孕妇新生儿身高、头围和体质量分别为(50.0±1.1)cm、(333.6±5.1)cm和(3383±319)g,与B组【分别为(49.9±1.2)cm、(333.9±5.1)cm和(3215±327)g】或C组【分别为(50.1±1.1)cm、(332.9±5.7)cm和(3284±328)g】比,均无显著性差异(P>0.05);在分娩不良事件方面,仅C组出现1例新生儿锁骨骨折。结论 TDF对HBV感染孕妇肾功能和胎儿生长发育无显著影响,母儿安全性良好。

Safety of tenofovir disoproxil fumarate in pregnant women with HBV infection: An observation on renal functions and fetal growths

Objective The aim of this study was to evaluate the safety of tenofovir disoproxil fumarate (TDF) therapy in pregnant women. Methods 120 pregnant female HBV carriers delivered in Beijing You'an Hospital, Capital Medical University,between July 1, 2018 and June 30, 2019. 40 carriers (group A) started taking TDF within one year before pregnancy until the delivery, 40 carriers (group B) taking at 24 to 28 weeks of pregnancy, and 40 carriers (group C) did not taking antiviral medicine. All pregnant women took blood and urine routine examination at the 12th and 36th weeks of pregnancy to evaluate the renal functions, such as serum phosphorus (P), glomerular filtration rate (GFR), creatinine (sCr), creatine kinase (CK) and urinary protein (uPRO). We also record the physical development indexes of newborns at birth, such as head circumference, body length and body mass. The adverse events of newborns recorded such as neonatal clavicle fracture, birth defect and neonatal death. Results At 36th week of gestation, serum P, GFR, sCr, CK and uPRO in group A were(1.2±0.1)mmol/L,(120.9±7.9)mL/(min·1.73 m²),(52.1±7.9)μmol/L, (57.7±21.8)U/L and 6 cases (15.0%) positive, in group B were (1.2±0.1)mmol/L, (119.5±9.4)mL/(min·1.73 m²), (50.6±7.7)μmol/L, (56.6±18.8)U/L and 5 cases (12.5%), and in group C were (1.2±0.1)mmol/L, (125.7±8.7)mL/(min·1.73 m²), (48.9±7.2)μmol/L, (53.9±16.1)U/L and 4 cases(10.0%), not significantly different among them (P>0.05); the height, head circumference and birth weight of newborns in group A were (50.0±1.1)cm, (333.6±5.1)cm and(3383±319)g, in group B were (49.9±1.2)cm, (333.9±5.1)cm and 3215±327)g, and in group C were (50.1±1.1) cm, (332.9±5.7)cm and(3284±328)g, not significantly different among them (P>0.05); only one neonatal had clavicular fracture in group C in our series. Conclusion TDF has no untoward effects on renal function tests and fetal growth in pregnant women with HBV infection. It might be administered safely during pregnancy.