妊娠期缺血性卒中溶栓治疗的母婴安全性结局：系统评价与汇总病例系列。
完整摘要 · 中文译文
背景与目的：妊娠期缺血性卒中静脉溶栓治疗的安全性在很大程度上尚不清楚。我们进行了一项系统综述，以识别已发表的妊娠期卒中溶栓治疗使用情况，旨在评估母婴安全性结局。为提供额外的安全性数据，我们纳入了妊娠期深静脉血栓形成、机械瓣血栓形成和肺栓塞的溶栓病例。 方法：我们采用PRISMA和MOOSE指南进行本综述。我们检索了3个数据库（OVID Medline、EMBASE、Scopus）中截至2025年10月发表的研究。我们在贝叶斯聚合病例系列中分析结局，以将我们队列中的不良结局发生率与一般人群中的发生率进行比较。选择性终止妊娠和自然流产被归为一组，因为通常难以确定溶栓并发症是否可能对终止妊娠的决定产生了影响。 结果：我们纳入了123项研究，共216例妊娠期接受溶栓治疗的患者（中位年龄31岁），其中85例为缺血性卒中。32例胎儿死亡中有6例被认为可能与溶栓药物存在因果关系（其中3例为卒中）。我们溶栓人群中流产风险比已发表的一般妊娠人群发生率高出12.4%（95%可信区间[CrI]：2.6%，23.2%），死产风险高出5.9%（95% CrI：1.6%，12.7%）。妊娠队列中症状性颅内出血的患者比例与年轻非妊娠 在接受溶栓治疗的患者中（风险差 -0.4%；95% 可信区间：-0.8%，2.7%）。 讨论：溶栓药物很可能与已发表的妊娠期溶栓后胎儿死亡病例中的一小部分存在因果关联。未发现溶栓对母亲造成伤害增加的信号，包括症状性颅内出血发生率相似。在许多病例中，难以将溶栓药物对胎儿结局的影响与疾病本身的影响区分开来；因此，应谨慎解读我们的结果。尽管如此，我们的发现总体上支持在其他方面符合条件的妊娠患者中使用溶栓药物，但强调了在此类患者中进行风险-获益评估的重要性。 试验注册信息：研究方案已在 PROSPERO 上预注册（注册号：CRD42024605043）。
完整摘要 · 英文原文
BACKGROUND AND OBJECTIVES: The safety of intravenous thrombolytics for ischemic stroke in pregnancy is largely unknown. We performed a systematic review to identify published use of thrombolytics for stroke during pregnancy, with the aim of assessing maternal and fetal safety outcomes. To provide additional safety data, we included cases of thrombolysis for deep vein thrombosis, mechanical valve thrombosis, and pulmonary embolism in pregnancy. METHODS: We used the PRISMA and MOOSE guidelines to conduct the review. We searched 3 databases (OVID Medline, EMBASE, Scopus) for studies published up to October 2025. We analyzed outcomes in a Bayesian aggregated case series to compare rates of adverse outcomes in our cohort with those in the general population. Elective termination and spontaneous abortion were grouped together, given that it was often difficult to determine whether complications of thrombolysis may have played a role in the decision for termination. RESULTS: We included 123 studies of 216 patients (median age 31 years) treated with thrombolytics during pregnancy, of whom 85 had ischemic stroke. Six of the 32 total fetal deaths were deemed likely to be causally related to thrombolytics (3 in stroke). The risk of miscarriage in our thrombolysis population was 12.4% higher (95% credible interval [CrI]: 2.6%, 23.2%) than published general pregnant population rates, and the risk of stillbirth was 5.9% higher (95% CrI: 1.6%, 12.7%). The proportion of pregnant patients with symptomatic intracerebral hemorrhage was similar between our pregnant cohort and young, nonpregnant patients receiving thrombolytics (risk difference -0.4%; 95% CrI: -0.8%, 2.7%). DISCUSSION: Thrombolytics were likely causally associated with a small minority of published cases of fetal death after thrombolysis in pregnancy. There was no signal of increased harm from thrombolysis to the mother, including similar rates of symptomatic intracerebral hemorrhage. In many cases, it was difficult to discern effects of thrombolytics on fetal outcomes from the effects of the disease itself; hence, our results should be interpreted with caution. Nonetheless, our findings broadly support the use of thrombolytics in otherwise-eligible pregnant patients but underscore the importance of the risk-benefit assessment in such patients. TRIAL REGISTRATION INFORMATION: The study protocol was pre-registered on PROSPERO (registration number: CRD42024605043).