PDF(Pubmed)
Abstract：
BACKGROUND: Inflammatory Bowel Disease (IBD) affects reproductive-aged women. Active disease can lead to decreased fertility. Although the vast majority of international guidelines recommend for the continuation of anti-TNF-α during pregnancy, recent studies have raised concerns about the safety of anti-tumor necrosis factor-α (TNF-α) therapy during pregnancy, both for patients and for physicians.
METHODS: Studies that evaluate the safety of anti-TNF-α therapy in pregnant women with IBD were identified using bibliographical searches. An updated meta-analysis was performed for pregnancy outcomes, such as live birth, abortion, still birth, preterm birth, low birth weight, congenital abnormalities, and neonatal infection. Odds ratio (OR) with 95% confidence interval (CI) are reported. Data on disease activity, timing of anti-TNF-α therapy were collected for further analysis.
RESULTS: Overall, 11 studies were screened from on-line databases and international meeting abstracts. An increased risk of abortion (OR, 1.33; 95% CI, 1.02-1.74; P = 0.04) and preterm birth (OR, 1.16; 95% CI, 1.05-1.28; P = 0.004), and a decreased risk of live birth (OR, 0.83; 95% CI, 0.74-0.94; P = 0.002]) were found in the anti-TNF-α therapy group compared with the control group (no use of anti-TNF-α therapy). The subgroup analyses based on the disease activity showed there is no significant association between the use of anti-TNF-α therapy during pregnancy on adverse pregnancy outcomes of abortion, preterm birth, and live birth. The rates of still birth, low birth weight, and congenital abnormalities in the anti-TNF-α therapy group were not significantly different from those in the control group.
CONCLUSIONS: Anti-TNF-α therapy does not increase the risks of still birth, low birth weight, and congenital abnormalities; however it may be assicated with increased risks of abortion and preterm birth, which are accompanied by a lower rate of live birth. Although these findings may be confounding by potential disease activity, they offer some opposite viewpoints with biologic agent use. Therefore, more studies are required to further confirm the safety of anti-TNF-α therapy in pregnancy with IBD.
METHODS: Studies that evaluate the safety of anti-TNF-α therapy in pregnant women with IBD were identified using bibliographical searches. An updated meta-analysis was performed for pregnancy outcomes, such as live birth, abortion, still birth, preterm birth, low birth weight, congenital abnormalities, and neonatal infection. Odds ratio (OR) with 95% confidence interval (CI) are reported. Data on disease activity, timing of anti-TNF-α therapy were collected for further analysis.
RESULTS: Overall, 11 studies were screened from on-line databases and international meeting abstracts. An increased risk of abortion (OR, 1.33; 95% CI, 1.02-1.74; P = 0.04) and preterm birth (OR, 1.16; 95% CI, 1.05-1.28; P = 0.004), and a decreased risk of live birth (OR, 0.83; 95% CI, 0.74-0.94; P = 0.002]) were found in the anti-TNF-α therapy group compared with the control group (no use of anti-TNF-α therapy). The subgroup analyses based on the disease activity showed there is no significant association between the use of anti-TNF-α therapy during pregnancy on adverse pregnancy outcomes of abortion, preterm birth, and live birth. The rates of still birth, low birth weight, and congenital abnormalities in the anti-TNF-α therapy group were not significantly different from those in the control group.
CONCLUSIONS: Anti-TNF-α therapy does not increase the risks of still birth, low birth weight, and congenital abnormalities; however it may be assicated with increased risks of abortion and preterm birth, which are accompanied by a lower rate of live birth. Although these findings may be confounding by potential disease activity, they offer some opposite viewpoints with biologic agent use. Therefore, more studies are required to further confirm the safety of anti-TNF-α therapy in pregnancy with IBD.
摘要：
背景：炎症性肠病（IBD）影响育龄妇女。活动性疾病可导致生育能力下降。尽管绝大多数国际指南建议在怀孕期间继续使用抗TNF-α，最近的研究引起了人们对怀孕期间抗肿瘤坏死因子-α（TNF-α）治疗安全性的关注，对于患者和医生来说。
方法：评估IBD孕妇抗TNF-α治疗安全性的研究是通过文献检索确定的。对妊娠结局进行了更新的荟萃分析，比如活产，流产,仍然出生，早产,低出生体重,先天性异常,和新生儿感染。报告了具有95%置信区间(CI)的赔率比(OR)。疾病活动数据，收集抗TNF-α治疗的时机用于进一步分析.
结果：总体而言，从在线数据库和国际会议摘要中筛选了11项研究。堕胎风险增加(OR，1.33；95%CI，1.02-1.74；P=0.04）和早产（OR，1.16；95%CI，1.05-1.28；P=0.004），和活产风险降低(OR，与对照组（未使用抗TNF-α治疗）相比，抗TNF-α治疗组发现了0.83；95％CI，0.74-0.94；P=0.002]）。基于疾病活动性的亚组分析显示，在妊娠期间使用抗TNF-α治疗与流产的不良妊娠结局之间没有显着关联。早产,和活产。静止出生率，低出生体重,抗TNF-α治疗组的先天性异常与对照组无明显差异。
结论：抗TNF-α治疗不会增加死胎的风险，低出生体重,和先天性异常；然而，它可能与堕胎和早产的风险增加有关，伴随着较低的活产率。尽管这些发现可能与潜在的疾病活动有关，他们对生物制剂的使用提出了一些相反的观点。因此,需要更多的研究来进一步证实抗TNF-α治疗妊娠合并IBD的安全性.
方法：评估IBD孕妇抗TNF-α治疗安全性的研究是通过文献检索确定的。对妊娠结局进行了更新的荟萃分析，比如活产，流产,仍然出生，早产,低出生体重,先天性异常,和新生儿感染。报告了具有95%置信区间(CI)的赔率比(OR)。疾病活动数据，收集抗TNF-α治疗的时机用于进一步分析.
结果：总体而言，从在线数据库和国际会议摘要中筛选了11项研究。堕胎风险增加(OR，1.33；95%CI，1.02-1.74；P=0.04）和早产（OR，1.16；95%CI，1.05-1.28；P=0.004），和活产风险降低(OR，与对照组（未使用抗TNF-α治疗）相比，抗TNF-α治疗组发现了0.83；95％CI，0.74-0.94；P=0.002]）。基于疾病活动性的亚组分析显示，在妊娠期间使用抗TNF-α治疗与流产的不良妊娠结局之间没有显着关联。早产,和活产。静止出生率，低出生体重,抗TNF-α治疗组的先天性异常与对照组无明显差异。
结论：抗TNF-α治疗不会增加死胎的风险，低出生体重,和先天性异常；然而，它可能与堕胎和早产的风险增加有关，伴随着较低的活产率。尽管这些发现可能与潜在的疾病活动有关，他们对生物制剂的使用提出了一些相反的观点。因此,需要更多的研究来进一步证实抗TNF-α治疗妊娠合并IBD的安全性.
