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2.6.6.6 Reproductive and developmental toxicology Tetracylines, as a class, are known to cross the placenta and penetrate into fetal tissue. Toxic effects on the developing fetus include retardation of skeletal development. Embryotoxicity has also been noted in animals treated early in pregnancy. Teratogenicity was not reported in developmental toxicity studies of doxycycline in rats, rabbits, and monkeys. The sponsor describes a case-controlled study in humans which demonstrated a statistically significant association with total malformations and use of doxycycline in pregnancy. A small prospective study of pregnant women treated in the first trimester revealed no apparent effects on the offspring. |

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2.6.6.6生殖和發(fā)育毒理學(xué) 作為一類,已知四環(huán)素(可以)穿過(guò)胎盤(pán)滲透到胎兒組織。對(duì)胎兒的毒性作用包括骨骼發(fā)育遲緩。在懷孕早期治療的動(dòng)物發(fā)現(xiàn)了其對(duì)胚胎的毒性作用。用大鼠、兔和猴進(jìn)行的發(fā)育毒性研究沒(méi)有多西環(huán)素致畸的報(bào)告。贊助商介紹,在人類進(jìn)行的一病例對(duì)照研究表明,總畸形和孕婦使用多西環(huán)素之間有顯著的統(tǒng)計(jì)相關(guān)性。在孕早期治療的孕婦小型前瞻性研究中沒(méi)有發(fā)現(xiàn)對(duì)后代有明顯影響。 |
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