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孕期镰状细胞病预防性输血与选择性输血的比较

Prophylactic versus selective blood transfusion for sickle cell disease in pregnancy.

作者信息

Okusanya Babasola O, Oladapo Olufemi T

机构信息

Experimental and Maternal Medicine Unit, Department of Obstetrics and Gynaecology, Faculty of Clinical Sciences, College of Medicine, University of Lagos, Idi-Araba, Lagos, Nigeria.

UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, Geneva, Switzerland, CH-1211.

出版信息

Cochrane Database Syst Rev. 2016 Dec 22;12(12):CD010378. doi: 10.1002/14651858.CD010378.pub3.

Abstract

BACKGROUND

Pregnant women with sickle cell disease (HbSS, HbSC and HbSβThal) may require blood transfusion to prevent severe anaemia or to manage potential medical complications. Preventive blood transfusion in the absence of complications starting from the early weeks of pregnancy or blood transfusion only for medical or obstetric indications have been used as management policies. There is currently no consensus on the blood transfusion policy that guarantees optimal clinical benefits with minimal risks for such women and their babies. This is an update of a Cochrane review that was published in 2013.

OBJECTIVES

To assess the benefits and harms of a policy of prophylactic versus selective blood transfusion in pregnant women with sickle cell disease.

SEARCH METHODS

We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 May 2016) and reference lists of retrieved studies. We did not apply any language or date restrictions.

SELECTION CRITERIA

Randomised controlled trials evaluating the effects of prophylactic versus selective (emergency) blood transfusion in pregnant women with sickle cell disease (SCD). Quasi-randomised trials and trials using a cluster-randomised design were eligible for inclusion but none were identified.

DATA COLLECTION AND ANALYSIS

Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. Two review authors independently assessed the quality of the evidence using the GRADE approach.

MAIN RESULTS

Out of six relevant reports identified by the search strategy, one trial involving 72 women with sickle cell anaemia (HbSS) met our inclusion criteria. The trial was at unclear risk of bias. Overall, there were few events for most of the reported outcomes and the results were generally imprecise. The included trial reported no maternal mortality occurring in women who received either prophylactic or selective blood transfusion. Very low-quality evidence indicated no clear differences in maternal mortality, perinatal mortality (risk ratio (RR) 2.85, 95% confidence interval (CI) 0.61 to 13.22; very low-quality evidence) or markers of severe maternal morbidity (pulmonary embolism (no events); congestive cardiac failure (RR 1.00, 95% CI 0.07 to 15.38; very low-quality evidence); acute chest syndrome (RR 0.67, 95% CI 0.12 to 3.75)) between the treatment groups (prophylactic blood transfusion versus selective blood transfusion). Low-quality evidence indicated that prophylactic blood transfusion reduced the risk of pain crisis compared with selective blood transfusion (RR 0.28, 95% CI 0.12 to 0.67, one trial, 72 women; low-quality evidence), and no differences in the occurrence of acute splenic sequestration (RR 0.33, 95% CI 0.01 to 7.92; low-quality evidence), haemolytic crises (RR 0.33, 95% CI 0.04 to 3.06) or delayed blood transfusion reaction (RR 2.00, 95% CI 0.54 to 7.39; very low-quality evidence) between the comparison groups.Other relevant maternal outcomes pre-specified for this review such as cumulative duration of hospital stay, postpartum haemorrhage and iron overload, and infant outcomes, admission to neonatal intensive care unit (NICU) and haemolytic disease of the newborn, were not reported by the trial.

AUTHORS' CONCLUSIONS: Evidence from one small trial of very low quality suggests that prophylactic blood transfusion to pregnant women with sickle cell anaemia (HbSS) confers no clear clinical benefits when compared with selective transfusion. Currently, there is no evidence from randomised or quasi-randomised trials to provide reliable advice on the optimal blood transfusion policy for women with other variants of sickle cell disease (i.e. HbSC and HbSβThal). The available data and quality of evidence on this subject are insufficient to advocate for a change in existing clinical practice and policy.

摘要

背景

患有镰状细胞病(HbSS、HbSC和HbSβ地中海贫血)的孕妇可能需要输血以预防严重贫血或处理潜在的医学并发症。从妊娠早期开始进行无并发症情况下的预防性输血,或仅针对医学或产科指征进行输血,已被用作管理策略。目前对于能保证此类妇女及其婴儿获得最佳临床益处且风险最小的输血政策尚无共识。这是对2013年发表的一篇Cochrane系统评价的更新。

目的

评估镰状细胞病孕妇预防性输血与选择性输血政策的益处和危害。

检索方法

我们检索了Cochrane妊娠与分娩组试验注册库(2016年5月30日)以及检索到的研究的参考文献列表。我们未施加任何语言或日期限制。

入选标准

评估预防性输血与选择性(急诊)输血对镰状细胞病(SCD)孕妇影响的随机对照试验。半随机试验和采用整群随机设计的试验符合纳入条件,但未检索到此类试验。

数据收集与分析

两名综述作者独立评估试验是否纳入及偏倚风险,提取数据并检查其准确性。两名综述作者使用GRADE方法独立评估证据质量。

主要结果

在检索策略确定的6篇相关报告中,一项涉及72名镰状细胞贫血(HbSS)女性的试验符合我们的纳入标准。该试验的偏倚风险尚不清楚。总体而言,大多数报告结局的事件较少,结果通常不精确。纳入的试验报告接受预防性或选择性输血的女性均未发生孕产妇死亡。极低质量证据表明,治疗组(预防性输血与选择性输血)在孕产妇死亡率、围产儿死亡率(风险比(RR)2.85,95%置信区间(CI)0.61至13.22;极低质量证据)或严重孕产妇发病标志物(肺栓塞(无事件);充血性心力衰竭(RR 1.00,95%CI 0.07至15.38;极低质量证据);急性胸综合征(RR 0.67,95%CI 0.12至3.75))方面无明显差异。低质量证据表明,与选择性输血相比,预防性输血可降低疼痛危象风险(RR 0.28,95%CI 0.12至0.67,一项试验,72名女性;低质量证据),且在急性脾梗死(RR 0.33,95%CI 0.01至7.92;低质量证据)、溶血危象(RR 0.33,9%CI 0.04至3.06)或延迟输血反应(RR 2.00,95%CI 0.54至7.39;极低质量证据)的发生方面,比较组之间无差异。该试验未报告本综述预先设定的其他相关孕产妇结局,如住院累计时长、产后出血和铁过载,以及婴儿结局、入住新生儿重症监护病房(NICU)和新生儿溶血病。

作者结论

一项质量极低的小型试验的证据表明,与选择性输血相比,对镰状细胞贫血(HbSS)孕妇进行预防性输血并无明显临床益处。目前,尚无随机或半随机试验的证据可为患有其他镰状细胞病变体(即HbSC和HbSβ地中海贫血)的女性提供关于最佳输血政策的可靠建议。关于该主题的现有数据和证据质量不足以支持改变现有临床实践和政策。

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