母体TDF使用对母体/胎儿骨密度无显着影响

StephenW

April 26, 2019
No Significant Effect on Maternal/Fetal Bone Mineral Density With Maternal TDF Use
There was no significant effect of maternal tenofovir disoproxil fumarate (TDF) use for the prevention of mother-to-child transmission of hepatitis B virus (HBV) on bone mineral density in either the mother or child 1 year after delivery, according to a brief report published in Clinical Infectious Diseases.

In this secondary end point analysis of a randomized, double-blind, multicenter clinical trial conducted in Thailand (iTAP; ClinicalTrials.gov identifier: NCT01745822), women with chronic HBV infection who received either TDF or placebo from 28 weeks gestational age to 2 months postpartum and breastfed their infants were invited to participate in a bone mineral density assessment 1 year after delivery.

During the bone mineral density assessment study, participants, investigators, operators, and dual-energy X-ray absorptiometry specialists were blinded to the treatment group. Total hip bone mineral density in mothers and lumbar spine bone mineral density in both mothers and infants were the main outcome measures.

The study included 135 mother-infant pairs (69 TDF, 66 placebo), 5 singleton mothers (2 TDF, 3 placebo), and 2 singleton infants (1 TDF, 1 placebo). After taking into account invalid measurements resulting from movement or improper positioning, hip bone mineral density measurements were valid in 129 mothers (64 TDF, 65 placebo) and lumbar spine bone mineral density measurements were valid in 138 mothers (71 TDF, 67 placebo) and 115 infants (62 TDF, 53 placebo).

Results showed no significant differences between TDF and placebo groups in maternal hip bone mineral density (mean difference, 0.008 g/cm2; 95% CI, −0.028 to 0.044; P =.67), maternal lumbar spine bone mineral density (mean difference, 0.010 g/cm2; 95% CI, −0.026 to 0.046; P =.59), or infant lumbar spine bone mineral density (mean difference, −0.006 g/cm2; 95% CI, −0.019 to 0.007; P =.38). Sensitivity analysis yielded similar results.

Researchers noted that as the study provided information on women with HBV mono-infection and their infants, the results should not be extrapolated to other populations, such as individuals who are HIV monoinfected or HIV/HBV co-infected.

“TDF prophylaxis to prevent mother-to-child transmission of HBV in HBV-monoinfected women in Asia appeared safe with regard to bone mineralization for both mothers and infants,” concluded the researchers.

Reference

Salvadori N, Fan B, Teeyasoontranon W, et al. Maternal and infant bone mineral density 1 year after delivery in a randomized, controlled trial of maternal tenofovir disoproxil fumarate to prevent mother-to-child transmission of hepatitis B virus [published March 29, 2019]. Clin Infect Dis. doi:10.1093/cid/ciy982

StephenW

2019年4月26日
母体TDF使用对母体/胎儿骨密度无显着影响
根据简要说明，母亲替诺福韦地索普西富马酸盐（TDF）在分娩后1年内用于预防母婴传播乙型肝炎病毒（HBV）对母亲或儿童的骨密度没有显着影响。报告发表于临床传染病。

在泰国进行的一项随机，双盲，多中心临床试验的二级终点分析（iTAP; ClinicalTrials.gov标识符：NCT01745822），患有慢性HBV感染的妇女，从胎龄28周到2个月接受TDF或安慰剂治疗产后和母乳喂养他们的婴儿在分娩后1年被邀请参加骨密度评估。

在骨矿物质密度评估研究期间，参与者，研究者，操作者和双能X射线吸收测定专家对治疗组不知情。母亲的总髋骨矿物质密度和母亲和婴儿的腰椎骨密度是主要的结果指标。

该研究包括135对母婴对（69名TDF，66名安慰剂），5名单身母亲（2名TDF，3名安慰剂）和2名单身婴儿（1名TDF，1名安慰剂）。考虑到由于移动或定位不当导致的无效测量，髋骨矿物质密度测量在129名母亲（64 TDF，65安慰剂）中有效，腰椎骨密度测量在138名母亲（71 TDF，67安慰剂）和115名婴儿（62名TDF，53名安慰剂）。

结果显示TDF和安慰剂组之间在母体髋骨矿物质密度上没有显着差异（平均差异，0.008 g / cm2; 95％CI，-0.028至0.044; P = .67），母体腰椎骨密度（平均差异， 0.010 g / cm2; 95％CI，-0.026至0.046; P = .59），或婴儿腰椎骨矿物质密度（平均差异，-0.006 g / cm2; 95％CI，-0.019至0.007; P = .38 ）。灵敏度分析产生了类似的结果。

研究人员指出，由于该研究提供了有关HBV单一感染妇女及其婴儿的信息，因此不应将结果外推至其他人群，例如HIV单一感染或HIV / HBV共感染的个体。

研究人员总结说：“对于母亲和婴儿的骨矿化，TDF预防在HBV单一感染妇女中预防HBV母婴传播似乎是安全的。”

参考

Salvadori N，Fan B，Teeyasoontranon W，et al。母亲替诺福韦地索普西富马酸盐的随机对照试验中，母亲和婴儿的骨密度在分娩后1年，以预防母婴传播乙型肝炎病毒[2019年3月29日出版]。 Clin Infect Dis。 DOI：10.1093 / CID / ciy982