@article {Brin10.1212 / WNL。0000000000207375,作者={米切尔·布林和罗素年代Kirby和安妮Slavotinek和奥布里米亚当斯和Lori帕克和Ahunna Ukah和拉维尼娅Radulian和莫妮卡·r·p·爱尔摩和拉里萨Yedigarova和Irina Yushmanova}, title ={患者暴露于OnabotulinumtoxinA治疗妊娠结局:累计29安全更新},elocation-id = {10.1212 / WNL。={2023}0000000000207375},年,doi = {10.1212 / WNL。出版商0000000000207375}= {Wolters Kluwer健康,公司代表美国神经病学学会},文摘={背景和目标:以前出版的妊娠结果onabotulinumtoxinA-expos首页ed母亲表明主要的流行胎儿缺陷(0.9 \ %,1/110)与背景利率一般人群。有兴趣继续更好地理解onabotulinumtoxinA怀孕期间的安全。这种分析评估妊娠结果onabotulinumtoxinA接触后提供一个累积29更新。方法:艾尔建全球安全数据库搜索1/1/1990 12/31/2018。数据从妇女怀孕期间(或未知\ < 65年)前或< = 3个月受孕治疗onabotulinumtoxinA评估估计出生缺陷发病率仅从未来的怀孕的活产率。结果:913怀孕,397(43.5 \ %)都有资格与已知的结果。母亲的年龄是215年怀孕:45.6 \ % > = 35年。表明在340年怀孕:最常见的审美(35.3 \ %)头痛和偏头痛/ (30.3 \ %)。暴露于318年已知怀孕的时机:94.6 \ %是怀孕之前或在妊娠前三个月。242年被怀孕OnabotulinumtoxinA剂量信息; the majority (83.5\%) were exposed to \<200 U. Of 195 prospective pregnancies with 197 fetuses, there were 152 (77.2\%) live births and 45 (22.8\%) fetal losses (32 spontaneous, 13 elective). Of 152 live births, 148 (97.4\%) had normal outcomes, 4 had abnormal outcomes. Among the 4 abnormal outcomes, there were 1 major birth defect, 2 minor fetal defects, and 1 birth complication. The prevalence rate for overall fetal defects was 2.6\% (4/152, 95\% CI: 1.0-6.6\%) and 0.7\% (1/152, 95\% CI: 0.1-3.6\%) for major fetal defects (3-6\% in the general population). Among cases of live births and known determinable exposure times, there was 1 birth defect with preconception exposure and 2 with first-trimester exposure.Discussion: Although subject to reporting bias due to the nature of the post-marketing database review, this 29-year retrospective analysis of safety data in pregnant women exposed to onabotulinumtoxinA demonstrates that the prevalence rate of major fetal defects among live births is consistent with rates reported in the general population. Even though there are limited data available for second- and third-trimester exposure, this updated and expanded safety analysis provides important real-world evidence to healthcare providers and their patients.Classification of Evidence: This analysis provides Class III data that demonstrate that the prevalence rate of major fetal defects among live births subsequent to in utero onabotulinumtoxinA exposure is comparable to reported background rates.}, issn = {0028-3878}, URL = {//www.ez-admanager.com/content/early/2023/05/03/WNL.0000000000207375}, eprint = {//www.ez-admanager.com/content/early/2023/05/03/WNL.0000000000207375.full.pdf}, journal = {Neurology} }