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产前接触喹诺酮后的妊娠结局。欧洲致畸学信息服务网络(ENTIS)病例登记处的评估。

Pregnancy outcome after prenatal quinolone exposure. Evaluation of a case registry of the European Network of Teratology Information Services (ENTIS).

作者信息

Schaefer C, Amoura-Elefant E, Vial T, Ornoy A, Garbis H, Robert E, Rodriguez-Pinilla E, Pexieder T, Prapas N, Merlob P

机构信息

Abteilung Embryotoxikologie, Landesberatungsstelle für Vergiftungserscheinungen und Embryotoxikologie, Berlin, Germany.

出版信息

Eur J Obstet Gynecol Reprod Biol. 1996 Nov;69(2):83-9. doi: 10.1016/0301-2115(95)02524-3.

Abstract

OBJECTIVE

To study potential teratogenic effects of quinolone exposure during pregnancy.

STUDY DESIGN

Prospective follow-up study. Subjects are pregnant women who contacted a teratology information center for risk information on quinolone treatment. A total of 549 pregnancies was collected by the European Network of Teratology Information Services between 1986 and 1994. In addition 116 prospectively documented pregnancies and 25 retrospective case reports on malformed children from other databases were analyzed.

RESULTS

The malformation rate among the live-born babies in the prospective ENTIS cohort was approximately 4.8%. No specific patterns of congenital abnormalities were found. The results do not suggest an elevated risk for spontaneous abortion, prematurity, intrauterine growth retardation and postnatal disorders.

CONCLUSION

The present study does not reveal any clear adverse reactions (fetal and neonatal toxicity, including birth defects) due to the in utero exposure to quinolones. Hence, termination of pregnancy because of such exposure is not indicated. However, considering the limitations of this study and the fact that diseases urgently requiring quinolone treatment are rare, it appears advisable to prefer penicillin, cephalosporins and erythromycin as antibiotics of choice.

摘要

目的

研究孕期接触喹诺酮类药物的潜在致畸作用。

研究设计

前瞻性随访研究。研究对象为因喹诺酮类药物治疗风险信息而联系致畸学信息中心的孕妇。1986年至1994年间,欧洲致畸学信息服务网络共收集了549例妊娠病例。此外,还分析了116例前瞻性记录的妊娠病例以及来自其他数据库的25例关于畸形儿童的回顾性病例报告。

结果

前瞻性ENTIS队列中活产婴儿的畸形率约为4.8%。未发现特定的先天性异常模式。结果未提示自然流产、早产、宫内生长迟缓及产后疾病风险增加。

结论

本研究未发现宫内接触喹诺酮类药物有任何明确的不良反应(胎儿及新生儿毒性,包括出生缺陷)。因此,不建议因此类接触而终止妊娠。然而,考虑到本研究的局限性以及急需喹诺酮类药物治疗的疾病罕见这一事实,似乎宜首选青霉素、头孢菌素和红霉素作为抗生素。

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