背景:我们进行了这项更新的系统评价,以评估皮质类固醇与安慰剂或不治疗以改善患者相关的溶血结局,肝酶升高和低血小板(HELLP)综合征。
方法:中央,MEDLINE/PubMed,WebofScience,还有Scopus,从数据库开始到2024年2月3日进行了检索.彻底搜索了纳入研究的参考列表和系统综述。我们纳入了纳入HELLP综合征女性的RCT,无论是产前还是产后,接受任何皮质类固醇与安慰剂或不接受治疗。没有语言或发布日期限制。我们使用了一种双重独立的方法来筛选标题和摘要,全文筛选,和数据提取。使用Cochrane的RoB2工具评估纳入研究的偏倚风险。进行了成对荟萃分析,其中两项或多项研究符合纳入方法学标准。等级方法用于评估预先指定结果的证据的确定性。
结果:15项试验(821名女性)比较了皮质类固醇与安慰剂或不治疗。皮质类固醇对主要结局的影响是不确定的,即孕产妇死亡(风险比[RR]0.77,95%置信区间[CI]0.25至2.38,非常低的确定性证据)。在报告孕产妇死亡的6项研究中,5人被认为总体上具有“低风险”的偏见。皮质类固醇对其他重要结局的影响也不确定,包括肺水肿(RR0.70,95%CI0.23至2.09)。透析(RR3,95%CI0.13至70.78),肝脏发病率(血肿,破裂,和故障;RR0.22,95%CI0.03至1.83),或围产期死亡(0.64,95%CI0.21至1.97),因为证据的确定性非常低。低确定性证据表明,皮质类固醇对血小板输注的需要影响很小或没有影响(RR0.98,95%CI0.60至1.60),并可能导致急性肾功能衰竭的轻微减少(RR0.67,95%CI0.40至1.12)。亚组和敏感性分析显示结果与初级合成相似。
结论:在患有HELLP综合征的女性中,皮质类固醇的效果与安慰剂或无治疗是不确定的患者相关结局,包括产妇死亡,孕产妇发病率,和围产期死亡。关于这个关键问题的这些不确定性应该通过充分有力的严格试验来解决。
背景:开放科学中心,osf.io/yzku5.
BACKGROUND: We conducted this updated systematic review to assess the effects of corticosteroids vs. placebo or no treatment for improving patient-relevant outcomes in hemolysis, elevated liver enzymes and low platelets (HELLP) syndrome.
METHODS: CENTRAL, MEDLINE/PubMed, Web of Science, and Scopus, from the date of inception of the databases to February 3, 2024 were searched. Reference lists of included studies and systematic reviews were thoroughly searched. We included RCTs that enrolled women with HELLP syndrome, whether antepartum or postpartum, to receive any corticosteroid versus placebo or no treatment. No language or publication date restrictions were made. We used a dual independent approach for screening titles and abstracts, full text screening, and data extraction. Risk of bias was assessed in the included studies using Cochrane\'s RoB 2 tool. Pairwise meta-analyses were conducted, where two or more studies met methodological criteria for inclusion. GRADE approach was used to assess certainty of evidence for the pre-specified outcomes.
RESULTS: Fifteen trials (821 women) compared corticosteroids with placebo or no treatment. The effect of corticosteroids is uncertain for the primary outcome i.e., maternal death (risk ratio [RR] 0.77, 95% confidence interval [CI] 0.25 to 2.38, very low certainty evidence). Out of 6 studies reporting maternal death, 5 were judged overall to have \"low risk\" of bias. The effect of corticosteroids is also uncertain for other important outcomes including pulmonary edema (RR 0.70, 95% CI 0.23 to 2.09), dialysis (RR 3, 95% CI 0.13 to 70.78), liver morbidity (hematoma, rupture, and failure; RR 0.22, 95% CI 0.03 to 1.83), or perinatal death (0.64, 95% CI 0.21 to 1.97) because of very low certainty evidence. Low certainty evidence suggests that corticosteroids have little or no effect on the need for platelet transfusion (RR 0.98, 95% CI 0.60 to 1.60) and may result in a slight reduction in acute renal failure (RR 0.67, 95% CI 0.40 to 1.12). Subgroup and sensitivity analyses showed results that were similar to the primary synthesis.
CONCLUSIONS: In women with HELLP syndrome, the effect of corticosteroids vs. placebo or no treatment is uncertain for patient-relevant outcomes including maternal death, maternal morbidity, and perinatal death. These uncertainties regarding this critical question should be addressed by adequately powered rigorous trials.
BACKGROUND: Center for Open Science, osf.io/yzku5.