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Neurology:多发性硬化症女性 妊娠期暴露于那他珠单抗对胎儿有何影响?

2018-03-20 王淳 环球医学

2018年3月,发表在《Neurology》上的一项研究,考察了多发性硬化症(MS)女性患者,在妊娠期暴露于那他珠单抗后对胎儿的影响情况。

2018年3月,发表在《Neurology》上的一项研究,考察了多发性硬化症(MS)女性患者,在妊娠期暴露于那他珠单抗后对胎儿的影响情况。

目的:评估MS女性妊娠期暴露于那他珠单抗后的胎儿风险,特别针对自然流产(SA)和先天性异常(CA)。

方法:收集了2009~2015年间,19家参与研究的站点里,使用那他珠单抗治疗MS患者的全部妊娠数据,并与未经治疗的和注射免疫调节药物治疗的患者妊娠数据进行比较。同时,与报道的意大利人群对比SA率和CA率。使用多变量逻辑和线性回归模型。

结果:在83名女性中共有92例妊娠。在多变量分析中,那他珠单抗暴露与SA相关(比值比[OR] 3.9,95%置信区间[CI] 1.9~8.5,p<0.001)。但是,SA率在普通人群的估算值范围内,主要CA率(3.7%)也同样如此。此外,暴露于那他珠单抗和干扰素-β(IFN-β)与婴儿较低的体长和体重相关(p<0.001)。

结论:研究人员的结果显示那他珠单抗暴露长达12孕周与SA风险的增加相关,尽管这在普通人群预期的范围内,但CA风险还需进一步被调查。考虑到那他珠单抗停药后疾病再复发的高风险,在严格监测的情况下,妊娠期可以计划继续服用那他珠单抗。

证据的分类:本研究提供了III级证据,在MS女性中,与IFN-β暴露或未治疗的患者相比,那他珠单抗暴露会增加自发性流产的风险(OR 3.9,95%CI 1.9~8.5)。

原始出处:

Portaccio E, et al. Pregnancy decision-making in women with multiple sclerosis treated with natalizumab: I: Fetal risks. Neurology. 2018 Mar 6;90(10):e823-e831. doi: 10.1212/WNL.0000000000005067. Epub 2018 Feb 7.

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    2019-01-02 yinhl1978
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    2018-10-12 jml2009
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