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3楼
发表于 2002-2-24 12:57
Re:如果新生已经发生HBV感染是否有必要再打疫苗？
下面这份资料是我以前找的关于贺普定的资料
我没空仔细翻了。
怀孕期间用贺普定可以在比较大的程度上避免宫内传染病毒给胎儿
因为贺普定可以进入胎儿,可以防止病毒复制.
不过我认为对未来 有潜在的危险。
－－－－－－－－－－－－－－－－－－－－－－－
不管了， 发在这里。
下面的两份资料是我今天找的，太晚了，不翻了。还请其他方便的朋友帮忙。
说说核心意思
一份是贺普定厂家的说明，一份是HBV listserv的2000年的资料
提到： 目前没有证据证明孕妇用拉米是完全安全的。
动物（大鼠）大剂量实验表明是安全的。
兔子中同人的剂量可能导致早期怀孕问题。
另外， 胎儿和乳汁中都有拉米夫丁， 和母亲血清的浓度一样。
动物实验并不代表可以用在人身上.
人的可靠试验结果目前还没有.(因为没多少人愿意参加这种试验)加上拉米才出来没几年,结果还不了解.
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归结到一句话: 你要在传染给胎儿的可能性和用拉米潜在的未知危险性中选择一个
也就是说, 拿主意的还是你本人.这是一个选择
选也可,不选也可.
能不用最好不用.
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the following two from different resourse
one is from GSK'S discription of lamivudine
another is from HBV listserv
all this is about the relationship between lamivudine and pregnancy
we are not sure whether it's safe to use lamivudine when you are during pregnancy,you should choose frome the risk of transfect the virus to child and the unknown risk caused by lamivudine
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Pregnancy: Pregnancy Category C. Reproduction studies have been performed in rats and
rabbits at orally administered doses up to 4000 mg/kg per day and 1000 mg/kg per day
respectively, producing plasma levels up to approximately 35 times that for the adult HIV dose.
No evidence of teratogenicity due to lamivudine was observed. Evidence of early embryolethality
was seen in the rabbit at exposure levels similar to those observed in humans, but there was no
indication of this effect in the rat at exposure levels up to 35 times that in humans. Studies in
pregnant rats and rabbits showed that lamivudine is transferred to the fetus through the placenta.
There are no adequate and well-controlled studies in pregnant women. Because animal
reproductive toxicity studies are not always predictive of human response, lamivudine should be
used during pregnancy only if the potential benefits outweigh the risks.
Pregnancy & Lamivudine in HBV Infection
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Date: Wed, 8 Nov 2000 06:32:49 -0500
From: [email protected]
Subject: Pregnancy & Lamivudine in HBV Infection
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Lamivudine.
Use in Pregnancy : Category B3. There are limited data available on the
safety of lamivudine in human pregnancy. Studies in humans have
confirmed that lamivudine crosses the placenta. Lamivudine
concentrations in infant serum at birth were similar to those in
maternal and cord serum at delivery.
Lamivudine crosses the placenta in rats and rabbits. No evidence of
teratogenicity was observed in rats and rabbits at oral doses up to 2000
and 500mg/kg BID, respectively, resulting in systemic exposures of at
least 51 and 45 times (based on Cmax), respectively, of those observed
at the clinical dosage. However, embryonic loss was increased, with
consequent reduction in litter size, in rabbits at oral doses of 20mg/kg
BID and above, resulting in systemic exposures (based on both Cmax and
AUC) comparable to those observed at the clinical dosage. No embryonic
loss occurred in rats at systemic exposures of at least 51 times the
clinical exposure (Cmax).
The safety of lamivudine has not been established in human pregnancy.
Although the results of animal studies are not always predictive of
human response, the findings in the rabbit suggest a potential risk of
early embryonic loss.
Use in Lactation: Following oral administration lamivudine was excreted
in human breast milk at similar concentrations to those found in serum
(range 1- 8mcg/mL). The safety of lamivudine has not been established in
breast fed infants. No effects were observed in neonatal rats which
received lamivudine via maternal milk and supplemented with oral
(gavage) dosing, resulting in systemic exposures (Cmax) of 16 to 19
times those observed at the clinical dosage.
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