Källén Bengt, Olausson Petra Otterblad
Tornblad Institute, University of Lund, and Swedish National Board of Health and Welfare, Stockholm, Sweden.
Int J Med Sci. 2006;3(3):106-7. doi: 10.7150/ijms.3.106. Epub 2006 Jun 1.
The original report published in 2001 on a possible association between maternal use of loratadine and an increased risk of infant hypospadias, based on data in the Swedish Medical Birth Register 1995-2001, has been followed up by continued surveillance in the same register. The original "signal" was based on 15 infants with hypospadias among 2780 loratadine-exposed infants born, representing an adjusted odd ratio of about 2.3, statistically significant. Since then another 10 cases have been identified, and 12.5 expected. For the period 2001-2004, another 1911 loratadine-exposed infants have been identified and only two had hypospadias (4 expected). Our present position is that the primary finding was a "signal" which had occurred by chance and the follow-up agrees with independent studies which indicate an absence of an association. This illustrates the care with which apparent statistically significant increases have to be handled when no prior hypothesis exists.
2001年发表的一份关于母亲使用氯雷他定与婴儿尿道下裂风险增加之间可能存在关联的原始报告，基于1995 - 2001年瑞典医学出生登记处的数据。此后，在同一登记处持续监测对其进行了跟进。最初的“信号”基于2780名出生时暴露于氯雷他定的婴儿中有15例尿道下裂，经调整后的比值比约为2.3，具有统计学意义。从那时起，又发现了10例病例，预期为12.5例。在2001 - 2004年期间，又识别出1911名暴露于氯雷他定的婴儿，其中只有2例患有尿道下裂（预期为4例）。我们目前的观点是，最初的发现是一个偶然出现的“信号”，后续跟进与独立研究一致，这些研究表明不存在关联。这说明了在没有先前假设的情况下，处理明显具有统计学意义的增加时需要谨慎。
