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受伤前使用氯吡格雷是否会增加成年患者头部受伤后颅内出血的风险?一项系统评价和荟萃分析。

Does pre-injury clopidogrel use increase the risk of intracranial haemorrhage post head injury in adult patients? A systematic review and meta-analysis.

作者信息

Moffatt Samuel, Venturini Sara, Vulliamy Paul

机构信息

Emergency Department, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK

Queen Mary University of London, London, UK.

出版信息

Emerg Med J. 2023 Mar;40(3):175-181. doi: 10.1136/emermed-2021-212225. Epub 2022 Sep 30.

DOI:10.1136/emermed-2021-212225
PMID:36180167
Abstract

BACKGROUND

Several current guidelines do not include antiplatelet use as an explicit indication for CT scan of the head following head injury. The impact of individual antiplatelet agent use on rates of intracranial haemorrhage is unclear. The primary objective of this systematic review was to assess if clopidogrel monotherapy was associated with traumatic intracranial haemorrhage (tICH) on CT of the head within 24 hours of presentation following head trauma compared with no antithrombotic controls.

METHODS

Eligible studies were non-randomised studies with participants aged ≥18 years old with head injury. Studies had to have conducted CT of the head within 24 hours of presentation and contain a no antithrombotic control group and a clopidogrel monotherapy group.Eight databases were searched from inception to December 2020. Assessment of identified studies against inclusion criteria and data extraction were carried out independently and in duplicate by two authors.Quality assessment and risk of bias (ROB) were assessed using the Newcastle-Ottawa Quality Assessment tool and Risk Of Bias In Non-randomised Studies of Interventions (ROBINS-I) tool. Meta-analysis was conducted using a random-effects model and reported as an OR and 95% CI.

RESULTS

Seven studies were eligible for inclusion with a total of 21 898 participants that were incorporated into the meta-analysis. Five studies were retrospective. Clopidogrel monotherapy was not significantly associated with an increase in risk of tICH compared with no antithrombotic controls (OR 0.97, 95% CI 0.54 to 1.75). Heterogeneity was high with an I of 75%. Sensitivity analysis produced an I of 21% and did not show a significant association between clopidogrel monotherapy and risk of tICH (OR 1.16, 95% CI 0.87 to 1.55). All studies scored for moderate to serious ROB on categories in the ROBINS-I tool.

CONCLUSION

Included studies were vulnerable to confounding and several were small-scale studies. The results should be interpreted with caution given the ROB identified. This study does not provide statistically significant evidence that clopidogrel monotherapy patients are at increased risk of tICH after head injury compared with no antithrombotic controls.

PROSPERO REGISTRATION NUMBER

CRD42020223541.

摘要

背景

目前的多项指南未将抗血小板药物的使用明确列为头部受伤后进行头颅CT扫描的指征。单独使用抗血小板药物对颅内出血发生率的影响尚不清楚。本系统评价的主要目的是评估与未使用抗血栓药物的对照组相比,在头部外伤后24小时内接受氯吡格雷单药治疗的患者,其头颅CT上的创伤性颅内出血(tICH)情况。

方法

符合条件的研究为非随机研究,研究对象为年龄≥18岁的头部受伤患者。研究必须在就诊后24小时内进行头颅CT检查,且包含未使用抗血栓药物的对照组和氯吡格雷单药治疗组。检索了从数据库建立至2020年12月的8个数据库。两位作者独立且重复地根据纳入标准对已识别的研究进行评估和数据提取。使用纽卡斯尔-渥太华质量评估工具和干预性非随机研究中的偏倚风险(ROBINS-I)工具进行质量评估和偏倚风险评估。采用随机效应模型进行荟萃分析,并报告为比值比(OR)和95%置信区间(CI)。

结果

七项研究符合纳入标准,共21898名参与者被纳入荟萃分析。五项研究为回顾性研究。与未使用抗血栓药物的对照组相比,氯吡格雷单药治疗与tICH风险增加无显著相关性(OR 0.97,95%CI 0.54至1.75)。异质性较高,I²为75%。敏感性分析得出I²为21%,且未显示氯吡格雷单药治疗与tICH风险之间存在显著相关性(OR 1.16,95%CI 0.87至1.55)。所有研究在ROBINS-I工具的类别中评分为中度至严重偏倚风险。

结论

纳入的研究容易受到混杂因素的影响,且有几项是小规模研究。鉴于已识别的偏倚风险,对结果的解释应谨慎。本研究未提供具有统计学意义的证据表明,与未使用抗血栓药物的对照组相比,氯吡格雷单药治疗的患者在头部受伤后发生tICH的风险增加。

国际前瞻性系统评价注册库注册号

CRD42020223541。

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引用本文的文献

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