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游容东广
发表于 2022-1-16 18:26:01
这个东西是雌激素受体抑制剂, 和雌激素竞争结合雌激素受体。
遗憾的是这玩意可以透过胎盘直达胎儿。胎盘屏障没有用。
长期, 大量使用这玩意会有多种不良反应, 包括但不限于胎停, 胎儿体重减轻,胎儿四肢发育不良等。而一次使用似乎没有数据。
激素代谢是很奇妙的玩意,同样的两个人体内的激素水平相差可以达到几倍甚至几十倍。
如图, 有文章研究了胎盘和脐带内的雌激素水平, 有的人雌激素低至0.8ng/ml, 有的人高至30ng/ml。 雌激素抑制剂在0.8ng/ml和30ng/ml环境中的抑制效率显然是不同的, 放在这个吃错药的环境下就可能有人吃了对胎儿没啥事,有人胎儿畸形。 所以临床研究现在非常依赖大样本对照和统计学。
从药物代谢来说, 不同人代谢这个药物的能力不一样, 有的人可以很快清除药物,有的就要四五天。基因异质性特别大。
另外目前无法确定孕妇吃了多少, 也就无法确定这抑制剂对胎儿的影响有多大。
所以现在没法判断。烧香等b超排畸再看看吧。
如果是一次吃了两片(120毫克, 吃了几天, 我觉得问题挺严重的。
以上是科学
以下是人性
如果我是当事人我宁愿选择要一笔赔偿赶紧药流也不冒风险把孩子下来。 万一孩子生下来有畸形,肯定无法得到能够保障他一生的赔偿。
所以病人拿到药还是自己读一下标签然后问一下医生吧, 医生也要有点耐心解释一下比方说为啥治阴道炎的药也能治牙疼, 不要嘲笑病人。
8.1 Pregnancy
Pregnancy Category D [see Warnings and Precautions (5.6).]
Based on its mechanism of action in humans and findings of increased pregnancy loss and fetal malformation in animal studies, FARESTON can cause fetal harm when administered to a pregnant woman. Toremifene caused embryo-fetal toxicities at maternal doses that were lower than the 60 mg daily recommended human dose on a mg/m2 basis. There are no adequate and well-controlled studies in pregnant women using FARESTON. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
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Reference ID: 4097849
In animal studies, toremifene crossed the placenta and accumulated in the rodent fetus. Administration of toremifene to pregnant rats during organogenesis at doses of approximately 6% the daily maximum recommended human dose of 60 mg (on a mg/m2 basis) resulted in signs of maternal toxicity and increased preimplantation loss, increased resorptions, reduced fetal weight, and fetal anomalies. Fetal anomalies include malformation of limbs, incomplete ossification, misshapen bones, ribs/spine anomalies, hydroureter, hydronephrosis, testicular displacement, and subcutaneous edema. Maternal toxicity may have contributed to these adverse embryo-fetal effects. Similar embryo- fetal toxicities occurred in rabbits that received toremifene at doses approximately 40% the daily recommended human dose of 60 mg (on a mg/m2 basis). Findings in rabbits included increased preimplantation loss, increased resorptions, and fetal anomalies, including incomplete ossification and anencephaly.
Animal doses resulting in embryo-fetal toxicities were ≥1.0 mg/kg/day in rats and ≥1.25 mg/kg/day in rabbits.
In rodent models of fetal reproductive tract development, toremifene produced inhibition of uterine development in female pups similar to effects seen with diethylstilbestrol (DES) and tamoxifen. The clinical relevance of these changes is not known. Neonatal rodent studies have not been conducted to assess the potential for toremifene to cause other DES-like effects in offspring (i.e., vaginal adenosis). Vaginal adenosis in animals occurred following treatment with other drugs of this class and has been observed in women exposed to diethylstilbestrol in utero.
怀孕
D 类妊娠 [见警告和注意事项 (5.6)。]
根据其在人类中的作用机制和动物研究中增加的流产和胎儿畸形的发现,FARESTON 在给予孕妇时可能会导致胎儿伤害。托瑞米芬在母体剂量低于 60 mg 每日推荐人用剂量(以 mg/m2 为基础)时引起胚胎-胎儿毒性。没有对使用 FARESTON 的孕妇进行充分和良好对照的研究。如果在怀孕期间使用该药,或如果患者在服用该药期间怀孕,应告知患者对胎儿的潜在危害。
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参考编号:4097849
在动物研究中,托瑞米芬穿过胎盘并在啮齿动物胎儿体内积累。在器官形成期向妊娠大鼠施用托瑞米芬,剂量约为每日最大推荐人用剂量 60 mg(以 mg/m2 为基础)的 6%,导致母体毒性迹象和植入前丢失增加、吸收增加、胎儿体重减轻和胎儿异常。胎儿异常包括四肢畸形、骨化不完全、骨骼畸形、肋骨/脊柱异常、输尿管积水、肾积水、睾丸移位和皮下水肿。母体毒性可能促成了这些不利的胚胎-胎儿影响。类似的胚胎-胎儿毒性发生在接受托瑞米芬剂量约为每日推荐人用剂量 60 mg 的 40%(以 mg/m2 为基础)的兔中。兔子的发现包括植入前丢失增加、吸收增加和胎儿异常,包括不完全骨化和无脑畸形。
导致胚胎-胎儿毒性的动物剂量在大鼠中≥1.0 mg/kg/day,在兔中≥1.25 mg/kg/day。
在胎儿生殖道发育的啮齿动物模型中,托瑞米芬对雌性幼崽的子宫发育产生抑制作用,与己烯雌酚 (DES) 和他莫昔芬所见的效果相似。这些变化的临床相关性尚不清楚。尚未进行新生儿啮齿动物研究来评估托瑞米芬在后代中引起其他 DES 样作用(即阴道腺病)的可能性。动物的阴道腺病是在用其他此类药物治疗后发生的,并且在子宫内暴露于己烯雌酚的妇女中观察到。
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