Berkovitch M, Segal-Socher I, Greenberg R, Bulkowshtein M, Arnon J, Merlob P, Or-Noy A
Clinical Pharmacology and Toxicology Unit, Assaf Harofeh Medical Center, Zerifin, Israel.
Br J Clin Pharmacol. 2000 Aug;50(2):161-5. doi: 10.1046/j.1365-2125.2000.00240.x.
There are no published studies on the safety of cefuroxime use during pregnancy. We therefore investigated prospectively the possible teratogenic effect of intrauterine exposure to cefuroxime.
One hundred and six women who received cefuroxime during the first trimester of pregnancy were recruited from three teratogen information centres in Israel. Exposed women were paired for age, smoking habits and alcohol consumption with references being exposed to nonteratogenic antibiotics administered for the same indications.
Maternal history, birthweight, gestational age at delivery, rates of live births, spontaneous abortions and fetal distress were comparable among the two groups. Rates of major malformations in the cefuroxime group (3.2%) did not differ from references (2%) (P = 0. 61, relative risk = 1.56, 95% confidence interval 0.27-9.15). There was a significantly higher rate of induced abortions among the cefuroxime exposed women as compared to the references (P = 0.04, relative risk = 3.33, 95% confidence interval 0.94-11.77).
Our data may suggest that exposure to cefuroxime during the first trimester is probably not associated with an increased risk for malformations or spontaneous abortions; however, in light of the small sample size and the broad confidence limits, larger studies are needed to confirm these findings.
目前尚无关于孕期使用头孢呋辛安全性的已发表研究。因此，我们前瞻性地研究了宫内暴露于头孢呋辛可能产生的致畸作用。
从以色列的三个致畸物信息中心招募了106名在妊娠早期接受头孢呋辛治疗的妇女。将暴露组妇女按年龄、吸烟习惯和饮酒量与因相同适应症使用非致畸性抗生素的对照组妇女进行配对。
两组在产妇病史、出生体重、分娩时的孕周、活产率、自然流产率和胎儿窘迫率方面具有可比性。头孢呋辛组的严重畸形发生率（3.2%）与对照组（2%）无差异（P = 0.61，相对风险 = 1.56，95%置信区间0.27 - 9.15）。与对照组相比，暴露于头孢呋辛的妇女中人工流产率显著更高（P = 0.04，相对风险 = 3.33，95%置信区间0.94 - 11.77）。
我们的数据可能表明，妊娠早期暴露于头孢呋辛可能与畸形或自然流产风险增加无关；然而，鉴于样本量小且置信区间宽，需要更大规模的研究来证实这些发现。
