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在腰椎穿刺或硬膜外麻醉前使用血小板输注以预防血小板减少症患者的并发症。

Use of platelet transfusions prior to lumbar punctures or epidural anaesthesia for the prevention of complications in people with thrombocytopenia.

作者信息

Estcourt Lise J, Malouf Reem, Hopewell Sally, Doree Carolyn, Van Veen Joost

机构信息

Haematology/Transfusion Medicine, NHS Blood and Transplant, Level 2, John Radcliffe Hospital, Headington, Oxford, UK, OX3 9BQ.

出版信息

Cochrane Database Syst Rev. 2018 Apr 30;4(4):CD011980. doi: 10.1002/14651858.CD011980.pub3.

Abstract

BACKGROUND

People with a low platelet count (thrombocytopenia) often require lumbar punctures or an epidural anaesthetic. Lumbar punctures can be diagnostic (haematological malignancies, subarachnoid haematoma, meningitis) or therapeutic (spinal anaesthetic, administration of chemotherapy). Epidural catheters are placed for administration of epidural anaesthetic. Current practice in many countries is to correct thrombocytopenia with platelet transfusions prior to lumbar punctures and epidural anaesthesia, in order to mitigate the risk of serious procedure-related bleeding. However, the platelet count threshold recommended prior to these procedures varies significantly from country to country. This indicates significant uncertainty among clinicians regarding the correct management of these patients. The risk of bleeding appears to be low, but if bleeding occurs it can be very serious (spinal haematoma). Consequently, people may be exposed to the risks of a platelet transfusion without any obvious clinical benefit.This is an update of a Cochrane Review first published in 2016.

OBJECTIVES

To assess the effects of different platelet transfusion thresholds prior to a lumbar puncture or epidural anaesthesia in people with thrombocytopenia (low platelet count).

SEARCH METHODS

We searched for randomised controlled trials (RCTs), non-randomised controlled trials (nRCTs), controlled before-after studies (CBAs), interrupted time series studies (ITSs), and cohort studies in CENTRAL (the Cochrane Library 2018, Issue 1), MEDLINE (from 1946), Embase (from 1974), the Transfusion Evidence Library (from 1950), and ongoing trial databases to 13 February 2018.

SELECTION CRITERIA

We included RCTs, nRCTs, CBAs, ITSs, and cohort studies involving transfusions of platelet concentrates, prepared either from individual units of whole blood or by apheresis, and given to prevent bleeding in people of any age with thrombocytopenia requiring insertion of a lumbar puncture needle or epidural catheter.The original review only included RCTs.

DATA COLLECTION AND ANALYSIS

We used standard methodological procedures expected by Cochrane for including RCTs, nRCTs, CBAs, and ITSs. Two review authors independently assessed studies for eligibility and risk of bias and extracted data. Results were only expressed narratively.

MAIN RESULTS

We identified no completed or ongoing RCTs, nRCTs, CBAs, or ITSs. No studies included people undergoing an epidural procedure. No studies compared different platelet count thresholds prior to a procedure.In this update we identified three retrospective cohort studies that contained participants who did and did not receive platelet transfusions prior to lumbar puncture procedures. All three studies were carried out in people with cancer, most of whom had a haematological malignancy. Two studies were in children, and one was in adults.The number of participants receiving platelet transfusions prior to the lumbar puncture procedures was not reported in one study. We therefore only summarised in a narrative form the relevant outcomes from two studies (150 participants; 129 children and 21 adults), in which the number of participants who received the transfusion was given.We judged the overall risk of bias for all reported outcomes for both studies as 'serious' based on the ROBINS-I tool.No procedure-related major bleeding occurred in the two studies that reported this outcome (2 studies, 150 participants, no cases, very low-quality evidence).There was no evidence of a difference in the risk of minor bleeding (traumatic tap) in participants who received platelet transfusions before a lumbar puncture and those who did not receive a platelet transfusion before the procedure (2 studies, 150 participants, very low-quality evidence). One of the 14 adults who received a platelet transfusion experienced minor bleeding (traumatic tap; defined as at least 500 x 10/L red blood cells in the cerebrospinal fluid); none of the seven adults who did not receive a platelet transfusion experienced this event. Ten children experienced minor bleeding (traumatic taps; defined as at least 100 x 10/L red blood cells in the cerebrospinal fluid), six out of the 57 children who received a platelet transfusion and four out of the 72 children who did not receive a platelet transfusion.No serious adverse events occurred in the one study that reported this outcome (1 study, 21 participants, very low-quality evidence).We found no studies that evaluated all-cause mortality within 30 days from the lumbar puncture procedure, length of hospital stay, proportion of participants who received platelet transfusions, or quality of life.

AUTHORS' CONCLUSIONS: We found no evidence from RCTs or non-randomised studies on which to base an assessment of the correct platelet transfusion threshold prior to insertion of a lumbar puncture needle or epidural catheter. There are no ongoing registered RCTs assessing the effects of different platelet transfusion thresholds prior to the insertion of a lumbar puncture or epidural anaesthesia in people with thrombocytopenia. Any future study would need to be very large to detect a difference in the risk of bleeding. A study would need to be designed with at least 47,030 participants to be able to detect an increase in the number of people who had major procedure-related bleeding from 1 in 1000 to 2 in 1000. The use of a central data collection register or routinely collected electronic records (big data) is likely to be the only method to systematically gather data relevant to this population.

摘要

背景

血小板计数低(血小板减少症)的患者常需要进行腰椎穿刺或硬膜外麻醉。腰椎穿刺可用于诊断(血液系统恶性肿瘤、蛛网膜下腔出血、脑膜炎)或治疗(脊髓麻醉、化疗给药)。放置硬膜外导管用于给予硬膜外麻醉。目前许多国家的做法是在腰椎穿刺和硬膜外麻醉前通过输注血小板来纠正血小板减少症,以降低与操作相关的严重出血风险。然而,这些操作前推荐的血小板计数阈值在不同国家差异很大。这表明临床医生在这些患者的正确管理方面存在很大的不确定性。出血风险似乎较低,但如果发生出血可能非常严重(脊髓血肿)。因此,人们可能在没有任何明显临床益处的情况下暴露于血小板输注的风险中。这是Cochrane系统评价的更新版,首次发表于2016年。

目的

评估血小板减少症(血小板计数低)患者在腰椎穿刺或硬膜外麻醉前不同血小板输注阈值的效果。

检索方法

我们检索了CENTRAL(Cochrane图书馆2018年第1期)、MEDLINE(从1946年起)、Embase(从1974年起)、输血证据图书馆(从1950年起)以及截至2018年2月13日的正在进行的试验数据库中的随机对照试验(RCT)、非随机对照试验(nRCT)、前后对照研究(CBA)、中断时间序列研究(ITS)和队列研究。

选择标准

我们纳入了涉及输注血小板浓缩物的RCT、nRCT、CBA、ITS和队列研究,血小板浓缩物由单个全血单位制备或通过单采法制备,用于预防任何年龄的血小板减少症患者在需要插入腰椎穿刺针或硬膜外导管时出血。最初的评价仅纳入了RCT。

数据收集与分析

我们采用了Cochrane预期的标准方法程序来纳入RCT、nRCT、CBA和ITS。两位综述作者独立评估研究的纳入资格和偏倚风险并提取数据。结果仅以叙述形式呈现。

主要结果

我们未识别到已完成或正在进行的RCT、nRCT、CBA或ITS。没有研究纳入接受硬膜外操作的人群。没有研究比较操作前不同的血小板计数阈值。在本次更新中,我们识别出三项回顾性队列研究,其中包含在腰椎穿刺操作前接受和未接受血小板输注的参与者。所有三项研究均在癌症患者中进行,其中大多数患有血液系统恶性肿瘤。两项研究针对儿童,一项针对成人。一项研究未报告腰椎穿刺操作前接受血小板输注的参与者数量。因此,我们仅以叙述形式总结了两项研究(150名参与者;129名儿童和21名成人)的相关结果,这两项研究给出了接受输血的参与者数量。根据ROBINS - I工具,我们将两项研究所有报告结果的总体偏倚风险判定为“严重”。两项报告此结果的研究(2项研究,150名参与者,无病例,极低质量证据)中均未发生与操作相关的严重出血。没有证据表明在腰椎穿刺前接受血小板输注的参与者与未接受血小板输注的参与者发生轻微出血(穿刺损伤)的风险存在差异(2项研究,150名参与者,极低质量证据)。接受血小板输注的14名成人中有1名发生轻微出血(穿刺损伤;定义为脑脊液中至少500×10/L红细胞);未接受血小板输注的7名成人中无人发生此事件。10名儿童发生轻微出血(穿刺损伤;定义为脑脊液中至少100×10/L红细胞),接受血小板输注的57名儿童中有6名,未接受血小板输注的72名儿童中有4名。一项报告此结果的研究(1项研究,21名参与者,极低质量证据)中未发生严重不良事件。我们未找到评估腰椎穿刺操作后30天内全因死亡率、住院时间、接受血小板输注的参与者比例或生活质量的研究。

作者结论

我们未从RCT或非随机研究中找到证据来评估在插入腰椎穿刺针或硬膜外导管前正确的血小板输注阈值。目前没有正在进行的注册RCT评估血小板减少症患者在腰椎穿刺或硬膜外麻醉前不同血小板输注阈值的效果。未来的任何研究都需要非常大的样本量才能检测出出血风险的差异。一项研究需要设计至少纳入47,030名参与者,才能检测出与操作相关的严重出血人数从千分之一增加到千分之二。使用中央数据收集登记册或常规收集的电子记录(大数据)可能是系统收集该人群相关数据的唯一方法。

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