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目的:研究孕期使用异烟肼和其他抗结核药治疗对人类致畸的可能性。 设计及背景:病例人群选自匈牙利先天畸形病例对照监测中心一大型人群资料库,对照组资料来自国家出生人口登记处1980到1996年间出生的人群。所有关于孕期口服抗结核药治疗的情况都有医疗记录。研究对象:有先天畸形的新生儿或胎儿的母亲(病例组)和没有先天畸形儿的母亲(对照组)。主要结果的判断标准:新生儿和胎儿先天畸形诊断于出生前第二和第三个3个月期间及出生后是从出生到1岁内。 结果:对照组38 151人中,29例(0.08％)在孕期接受过抗结核药物治疗;病例组则分别为22 856人和11例(0.05％)。患病率OR值为0.6(95％CI0.3-1.3)。经过对孕期第二、三个月应用过异烟肼及其它口服抗结核药物的分析(此阶段是发生畸形的危险期)病例-对照均未显示这些药物有致畸作用。 结论:母亲在孕期接受口服抗结核药物治疗对胎儿无可察觉的致畸危险性;但是在先天畸形形成的关键期使用这些药物的女性人数有限(病例组6人,对照组21人)。
PURPOSE: To study the possibility of teratogenicity in humans treated with isoniazid and other anti-TB drugs during pregnancy. DESIGN AND BACKGROUND: The case population was selected from a large population database of the case control surveillance center of the Congenital Malformations in Hungary. The data of the control group were from the population born in the National Birth Registry between 1980 and 1996. All medical records about the treatment of oral anti-TB drugs during pregnancy. Participants: Neonates or fetuses with congenital malformations (case group) and mothers without congenital malformations (control group). Criteria for the Outcome of Primary Outcomes: Diagnosis of congenital malformations in newborns and fetuses occurs during the second and third trimester of birth and after birth from birth to within 1 year of age. RESULTS: Of the 38 151 patients in the control group, 29 (0.08%) received anti-TB drugs during pregnancy; 22 856 and 11 (0.05%) patients, respectively. The odds ratio was 0.6 (95% CI 0.3-1.3). After the second and third trimester of pregnancy analysis of isoniazid and other oral anti-tuberculosis drugs (this phase is the risk of deformity) case-control did not show that these drugs have teratogenic effects. CONCLUSIONS: There was no detectable teratogenic risk to the fetus for mothers receiving oral anti-TB medication during pregnancy; however, the number of women using these drugs in the critical period of congenital malformations was limited (6 in the case group and 21 in the control group).