Mozaffari S, Abdolghaffari A H, Nikfar S, Abdollahi M
Department of Toxicology and Pharmacology, Tehran, Iran.
Pharmacology and Applied Medicine, Department of Medicinal Plants Research Centre, Institute of Medicinal Plants, ACECR, Karaj, Iran International Campus, Tehran University of Medical Sciences, Tehran, Iran.
Hum Exp Toxicol. 2015 May;34(5):445-59. doi: 10.1177/0960327114550882. Epub 2014 Nov 5.
Several studies have indicated the harmful effect of flare-up periods in pregnant women with inflammatory bowel disease (IBD) on their newborns. Therefore, an effective and safe medical treatment during pregnancy is of great concern in IBD patients. The aim of this study was to perform a meta-analysis on the outcomes of thiopurines use and a systematic review of antitumor necrosis factor (anti-TNF) drugs used during pregnancy in women with IBD. The results of cohorts evaluating the safety of anti-TNF drugs during pregnancy up to July 2013 were collected and analyzed. In the meta-analysis, a total of 312 pregnant women with IBD who used thiopurines were compared with 1149 controls (women with IBD who were not treated with any medication and women who were exposed to drugs other than thiopurines) to evaluate the drug effect on different pregnancy outcomes, including prematurity, low birth weight, congenital abnormalities, spontaneous abortion, and neonatal adverse outcomes. Results of statistical analysis demonstrated that congenital abnormalities were increased significantly in thiopurine-exposed group in comparison with control group who did not receive any medicine for IBD treatment. The summary odds ratio was 2.95 with 95% confidence interval = 1.03-8.43 (p = 0.04). We observed no significant differences in occurrence of other adverse pregnancy outcomes between compared groups. The results of cohorts evaluated the safety of anti-TNF drugs during pregnancy demonstrated no increase in occurrence of adverse pregnancy outcomes in comparison with controls except for the significant decrease in gestational age of newborns of drug-exposed mothers in one trial. In conclusion, a benefit-risk ratio should be considered in prescribing or continuing medicinal therapy during pregnancy of IBD patients.
多项研究表明,患有炎症性肠病(IBD)的孕妇病情发作期会对其新生儿产生有害影响。因此,IBD患者孕期有效且安全的药物治疗备受关注。本研究的目的是对硫唑嘌呤使用的结果进行荟萃分析,并对IBD女性孕期使用的抗肿瘤坏死因子(抗TNF)药物进行系统评价。收集并分析了截至2013年7月评估抗TNF药物孕期安全性的队列研究结果。在荟萃分析中,将总共312名使用硫唑嘌呤的IBD孕妇与1149名对照者(未接受任何药物治疗的IBD女性以及暴露于硫唑嘌呤以外药物的女性)进行比较,以评估药物对不同妊娠结局的影响,包括早产、低出生体重、先天性异常、自然流产和新生儿不良结局。统计分析结果表明,与未接受任何IBD治疗药物的对照组相比,硫唑嘌呤暴露组的先天性异常显著增加。汇总比值比为2.95,95%置信区间为1.03 - 8.43(p = 0.04)。我们观察到,比较组之间其他不良妊娠结局的发生率没有显著差异。评估抗TNF药物孕期安全性的队列研究结果表明,与对照组相比,除一项试验中药物暴露母亲的新生儿孕周显著缩短外,不良妊娠结局的发生率没有增加。总之,IBD患者孕期开药或继续药物治疗时应考虑利弊比。