INFANT Research Centre, University College Cork, Cork, Ireland.
Department of Obstetrics and Gynaecology, Cork University Maternity Hospital, Cork, Ireland.
BJOG. 2022 Jul;129(8):1236-1246. doi: 10.1111/1471-0528.17093. Epub 2022 Feb 16.
Biologic medications, specifically tumour necrosis factor-α (TNF-α) inhibitors, have become increasingly prevalent in the treatment of chronic inflammatory disease (CID) in pregnancy.
To determine pregnancy outcomes in women with CID exposed to biologics during pregnancy.
PubMed and EMBASE databases were searched through January 1998-July 2021.
Peer-reviewed, English-language cohort, case-control, cross-sectional studies, and case series that contained original data.
Two authors independently conducted data extraction. A meta-analysis of proportions using a random-effects model was used to pool outcomes. Linear regression analysis was used to compare the mean of proportions of outcomes across exposure groups using the 'treated' group as the reference category. All studies were evaluated using an appropriate quality assessment tool. The GRADE approach was used to assess the overall certainty of evidence.
Thirty-five studies, describing 11 172 pregnancies, were eligible for inclusion. Analysis showed pooled proportions for congenital malformations as follows: treated 0.04 (95% CI 0.03-0.04; I = 77) versus disease-matched 0.04 (95% CI 0.03-0.05. I = 86; p = 0.238); preterm delivery treated 0.04 (95% CI 0.10-0.14; I = 88) versus disease-matched 0.10 (95% CI 0.09-0.12; I = 87; p = 0.250); severe neonatal infection: treated 0.05 (95% CI 0.03-0.07; I = 88) versus disease-matched 0.05 (95% CI 0.02-0.07; I = 94; p = 0.970); low birthweight: treated 0.10 (95% CI 0.07-0.12; I = 93) versus disease-matched 0.08 (95% CI 0.07-0.09; I = 0; p = 0.241); pooled miscarriage: treated 0.13 (95% CI 0.10-0.15; I = 77) versus disease-matched 0.08 (95% CI 0.04-0.11; I = 5; p = 0.078); pre-eclampsia; treated 0.01 (95% CI 0.01-0.02; I = 0) versus disease-matched 0.01 (95% CI 0.00-0.01; I = 0; p = 0.193). No statistical differences in proportions were observed. GRADE certainty of findings was low to very low.
We demonstrated comparable pregnancy outcomes in pregnancies exposed to biologics, disease-matched controls and CID-free pregnancies using the GRADE approach.
生物制剂，特别是肿瘤坏死因子-α（TNF-α）抑制剂，在治疗妊娠期间的慢性炎症性疾病（CID）方面变得越来越普遍。
确定接受生物制剂治疗的 CID 女性在妊娠期间的妊娠结局。
通过 1998 年 1 月至 2021 年 7 月，在 PubMed 和 EMBASE 数据库中进行了检索。
同行评议的、以英语发表的队列、病例对照、病例系列研究，其中包含原始数据。
两名作者独立进行了数据提取。使用随机效应模型对比例进行了荟萃分析，以汇总结果。使用线性回归分析，使用“治疗”组作为参考类别，比较暴露组中各结局的平均比例。所有研究均使用适当的质量评估工具进行评估。使用 GRADE 方法评估证据的总体确定性。
有 35 项研究，共描述了 11172 例妊娠，符合纳入标准。分析显示，先天性畸形的合并比例如下：治疗组为 0.04（95%CI 0.03-0.04；I 2 = 77），与疾病匹配对照组为 0.04（95%CI 0.03-0.05；I 2 = 86；p = 0.238）；早产的治疗组为 0.04（95%CI 0.10-0.14；I 2 = 88），与疾病匹配对照组为 0.10（95%CI 0.09-0.12；I 2 = 87；p = 0.250）；严重新生儿感染：治疗组为 0.05（95%CI 0.03-0.07；I 2 = 88），与疾病匹配对照组为 0.05（95%CI 0.02-0.07；I 2 = 94；p = 0.970）；低出生体重：治疗组为 0.10（95%CI 0.07-0.12；I 2 = 93），与疾病匹配对照组为 0.08（95%CI 0.07-0.09；I 2 = 0；p = 0.241）；流产：治疗组为 0.13（95%CI 0.10-0.15；I 2 = 77），与疾病匹配对照组为 0.08（95%CI 0.04-0.11；I 2 = 5；p = 0.078）；子痫前期；治疗组为 0.01（95%CI 0.01-0.02；I 2 = 0），与疾病匹配对照组为 0.01（95%CI 0.00-0.01；I 2 = 0；p = 0.193）。未观察到比例存在统计学差异。GRADE 证据确定性为低至极低。
我们使用 GRADE 方法表明，接受生物制剂治疗的妊娠、疾病匹配对照组和无 CID 妊娠的妊娠结局相似。
