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化疗和干细胞移植后出血的预防性血小板输注

Prophylactic platelet transfusion for haemorrhage after chemotherapy and stem cell transplantation.

作者信息

Stanworth S J, Hyde C, Heddle N, Rebulla P, Brunskill S, Murphy M F

机构信息

National Blood Service, UK National Health Service, Level 2 , John Ratcliffe Hospital, Heddington, Oxford, UK, OX3 9DU.

出版信息

Cochrane Database Syst Rev. 2004 Oct 18(4):CD004269. doi: 10.1002/14651858.CD004269.pub2.

Abstract

BACKGROUND

Platelet transfusions are used in modern clinical practice to prevent and treat bleeding in thrombocytopenic patients with bone marrow failure. Although considerable advances have been made in platelet transfusion therapy in the last 30 years, some areas continue to provoke debate, especially the use of prophylactic platelet transfusions for the prevention of thrombocytopenic bleeding.

OBJECTIVES

To determine the optimal use of platelet transfusion for the prevention of haemorrhage (prophylactic platelet transfusion) in patients with haematological malignancies undergoing chemotherapy or stem cell transplantation.

SEARCH STRATEGY

Randomised controlled trials (RCTs) were searched for in the Cochrane Central Register of Controlled Trials (CENTRAL). Searching was also undertaken on the OVID versions of MEDLINE and EMBASE using an RCT search filter strategy.

SELECTION CRITERIA

Randomised controlled trials involving transfusions of platelet concentrates, prepared either from individual units of whole blood or by apheresis, and given prophylactically to prevent bleeding in patients with haematological malignancies and receiving treatment with chemotherapy and/or stem cell transplantation.

DATA COLLECTION AND ANALYSIS

All electronically derived citations and abstracts of papers identified by the review search strategy were initially screened for relevancy by one reviewer. Studies clearly irrelevant were excluded at this stage. The full text of all potentially relevant trials was then formally assessed for eligibility by two reviewers independently. Two reviewers completed data extraction independently. Missing data were requested from the original investigators, as appropriate. Disagreements were resolved by discussion with the other reviewers.

MAIN RESULTS

Eight completed published trials, with a total of 390 participants in the intervention groups and 362 participants in the control groups, were included in the review for further analysis. The eight studies were classified as: * three trials relevant to prophylactic platelet transfusions versus therapeutic platelet transfusions; * three trials relevant to prophylactic platelet transfusion with one trigger level versus prophylactic platelet transfusion with another trigger level; * two trials relevant to prophylactic platelet transfusion with one dose schedule versus prophylactic platelet transfusion with another dose schedule. The few reports of controlled trials addressing prophylactic versus therapeutic transfusions contained small numbers of patients and were all undertaken over 25 years ago. None of these three studies explicitly clarified whether the lack of a reported difference was a reflection of insufficient power in the trials. The findings of the meta-analyses for this group of three small studies must be interpreted with caution. In contrast, more contemporary trials addressed the question of what platelet count thresholds should apply for prophylactic transfusion; three identified studies broadly compared platelet transfusion thresholds of 10 versus 20 x 109/litre for different clinical groups of patients. There were no statistically significant differences between the groups with regards to mortality, remission rates, number of participants with severe bleeding events or red cell transfusion requirements. However, it was unclear whether the studies had sufficient power to demonstrate in combination non-inferiority in terms of safety of the lower threshold, 10 x 109/litre. Insufficient randomised trials have been undertaken to make clinically relevant conclusions about the effect of different platelet doses.

REVIEWERS' CONCLUSIONS: There are no reasons to change current practice but uncertainty about the practice of prophylactic transfusion therapy should be recognised, particularly in the light of concerns about the scenario that blood products, including platelets, could become an increasingly scarce resource in the future and for which adequate alternatives do not exist. Consideration should be given to developing adequately powered trials comparing strategies of prophylaxis versus therapeutic platelet transfusion.

摘要

背景

在现代临床实践中,血小板输注用于预防和治疗骨髓衰竭的血小板减少患者的出血。尽管在过去30年里血小板输注治疗取得了相当大的进展,但一些领域仍存在争议,尤其是预防性血小板输注用于预防血小板减少性出血的应用。

目的

确定在接受化疗或干细胞移植的血液系统恶性肿瘤患者中,预防出血(预防性血小板输注)的血小板输注的最佳应用。

检索策略

在Cochrane对照试验中心注册库(CENTRAL)中检索随机对照试验(RCT)。还使用RCT检索筛选策略在OVID版的MEDLINE和EMBASE上进行检索。

选择标准

随机对照试验,涉及输注由单个全血单位制备或通过单采术制备的血小板浓缩物,并预防性给予以预防血液系统恶性肿瘤患者在接受化疗和/或干细胞移植治疗时的出血。

数据收集与分析

由综述检索策略确定的所有电子来源的文献引用和论文摘要最初由一名审阅者筛选相关性。在这个阶段,明显不相关的研究被排除。然后由两名审阅者独立正式评估所有潜在相关试验的全文是否符合纳入标准。两名审阅者独立完成数据提取。如有必要,向原始研究者索取缺失数据。通过与其他审阅者讨论解决分歧。

主要结果

八项已完成并发表的试验被纳入综述以进行进一步分析,干预组共有390名参与者,对照组有362名参与者。这八项研究分类如下:*三项试验涉及预防性血小板输注与治疗性血小板输注;*三项试验涉及一种触发阈值的预防性血小板输注与另一种触发阈值的预防性血小板输注;*两项试验涉及一种剂量方案的预防性血小板输注与另一种剂量方案的预防性血小板输注。关于预防性与治疗性输注的对照试验报告较少,患者数量少,且均在25年前进行。这三项研究均未明确说明未报告差异是否反映试验中检验效能不足。对这三项小型研究的荟萃分析结果必须谨慎解释。相比之下,更多当代试验探讨了预防性输注应采用何种血小板计数阈值的问题;三项纳入研究大致比较了不同临床患者组血小板输注阈值为10×10⁹/升与20×10⁹/升的情况。在死亡率、缓解率、严重出血事件参与者数量或红细胞输注需求方面,各组之间无统计学显著差异。然而,尚不清楚这些研究是否有足够的检验效能来联合证明较低阈值10×10⁹/升在安全性方面的非劣效性。进行的随机试验不足,无法就不同血小板剂量的效果得出临床相关结论。

审阅者结论

没有理由改变当前做法,但应认识到预防性输血治疗做法存在不确定性,特别是考虑到未来包括血小板在内的血液制品可能日益稀缺且不存在足够替代物的情况。应考虑开展检验效能充足的试验,比较预防性与治疗性血小板输注策略。

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