Gibson G T, Colley D P, McMichael A J, Hartshorne J M
Med J Aust. 1981 Apr 18;1(8):410-4.
Recent publicity regarding possible teratogenic effects of the doxylamine/dicyclomine/pyridoxine combination (Debendox) has led to a degree of apprehension in women for whom the drug is prescribed, and in doctors who prescribe it. This study, based on an ongoing epidemiological surveillance programme, reports an analysis of the records of 1817 women for whom the drug was prescribed compared with 5771 non-users. The object of the study was to evaluate the outcome of pregnancy against exposure to the drug, taking into account the coexistent influences of other factors. Thorough statistical analysis disclosed no evidence of teratogenicity of the doxylamine/dicyclomine/pyridoxine overall, nor in relation to the skeletal or cardiovascular systems in particular. Two unexpected findings were an apparent moderate increase in genital tract abnormalities in users of this drug, and the possibility of a synergistic relationship between tobacco and this drug in early pregnancy, both aspects warranting further investigation.
最近关于多西拉敏/双环胺/吡哆醇组合药物（复方苯乙哌啶）可能具有致畸作用的宣传，已在服用该药的女性及其开处方的医生中引起了一定程度的担忧。本研究基于一项正在进行的流行病学监测项目，报告了对1817名服用该药的女性与5771名未服用者的记录分析。该研究的目的是评估妊娠结局与接触该药物之间的关系，同时考虑其他因素的共同影响。全面的统计分析表明，总体上没有证据表明多西拉敏/双环胺/吡哆醇具有致畸性，特别是在骨骼或心血管系统方面。有两个意外发现：服用该药物的女性生殖道异常明显适度增加，以及在妊娠早期烟草与该药物之间可能存在协同关系，这两个方面都值得进一步研究。
