Pregnancy outcome after cyclosporine therapy during pregnancy: A meta-analysis
Pregnancy outcome after cyclosporine therapy during pregnancy: A meta-analysis
复制标题
DOI：
10.1097/00007890-200104270-00006
复制
发表时间：
2001-04-27
期刊：
影响因子：
6.2
通讯作者：
Koren, G
中科院分区：
文献类型：
--
作者：
Bar-Oz, B;Hackman, R;Koren, G
背景。环孢素 (CsA) 治疗通常必须在怀孕期间持续进行，以在器官移植和自身免疫性疾病等情况下维持孕产妇健康。进行这项荟萃分析是为了确定怀孕期间接触 CsA 是否与先天畸形、早产或低出生体重的风险增加相关。方法。搜索了各种健康科学数据库以识别相关文章。选择纳入该研究的文章必须不存在任何明显的选择偏差，并报告至少 10 名在子宫内暴露于 CsA 的新生儿的结果，特别评论是否存在先天畸形。文章选择和数据提取由两名独立审稿人进行，如有分歧则进行裁决。为了评估 CsA 暴露的风险，计算了总结比值比。畸形患病率计算为所有暴露于环孢菌素的活产儿和确定的亚组的发生率。为比值比和患病率构建了 95% 的置信区间。结果。 15 项研究（6 项为不使用环孢菌素的移植对照组；患者总数：410 例）符合重大畸形的纳入标准，其中 10 项研究为早产（4 项为对照组；患者总数：379 例），5 项为低出生体重（1 项为对照组；患者总数：314 例）。计算出的畸形比值比为 3.83，未达到统计显着性（CI 0.75-19.6）。研究人群中主要畸形的总体患病率（4.1%）也与一般人群中报告的没有显着差异。尽管总患病率为 56.3%，但早产儿的 OR [1.52 (CI 1.00-2.32)] 未达到统计学显着性。低出生体重的 OR [1.5（CI 0.95-2.44，基于 1 项研究）]。结论。 CsA 似乎不是主要的人类致畸剂。它可能与早产率增加有关。需要更多的研究来评估环孢素是否会增加致畸风险。
Background. Cyclosporine (CsA) therapy must often be continued during pregnancy to maintain maternal health in such conditions as organ transplantation and autoimmune disease. This meta-analysis was performed to determine whether CsA exposure during pregnancy is associated with an increased risk of congenital malformations, preterm delivery, or low birthweight.Methods. Various health science databases were searched to identify relevant articles. Articles selected for inclusion in the study were required to be free of any apparent selection bias and report outcomes in at least 10 newborns exposed to CsA in utero, specifically commenting on the presence or absence of congenital malformations. Article selection and data extraction were performed by two independent reviewers, with adjudication in cases of disagreement. To assess risks of CsA exposure, a summary odds ratio was calculated. Prevalence of malformations was calculated as a rate for all cyclosporine exposed live births and for the subgroups identified. Ninety-five percent confidence intervals were constructed for both the odds ratio and prevalence rates.Results. Fifteen studies (6 with control groups of transplant without use of cyclosporine; total patients: 410) met the inclusion criteria for major malformations, 10 for preterm delivery (4 with control groups; total patients: 379) and 5 for low birth weight (1 with control groups; total number of patients: 314). The calculated odds ratio of 3.83 for malformations did not achieve statistical significance (CI 0.75-19.6), The overall prevalence of major malformations in the study population (4.1%) also did not vary substantially from that reported in the general population. OR for prematurity [1.52 (CI 1.00-2.32)] did not reach statistical significance although the overall prevalence rate was 56.3%. The OR for low birth weight [1.5 (CI 0.95-2.44 based on 1 study)].Conclusions. CsA does not appear to be a major human teratogen. It may be associated with increased rates of prematurity. More research is needed to evaluate whether cyclosporine increases teratogenic risk.