D-二聚體測試在中風後靜脈血栓栓塞症診斷中的準確性:一項診斷性薈萃分析

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研究顯示,D-二聚體是一種有用的生物標誌物,用於診斷中風後患者的靜脈血栓栓塞症(VTE)。雖然D-二聚體測試在低風險中風患者中能有效排除VTE,但其假陽性率高,建議結合其他診斷工具使用,不宜單獨作為診斷依據。

Diagnostic accuracy of biomarker D-dimer in patients after stroke suspected from venous thromboembolism: A diagnostic meta-analysis

經顱血栓栓塞症疑似中風患者血清生物標記D-二聚體的診斷準確性:診斷性的荟萃分析

Zhang D, Li F, Du X, et al. Diagnostic accuracy of biomarker D-dimer in patients after stroke suspected from venous thromboembolism: A diagnostic meta-analysis. Clin Biochem. 2019;63:126-134. doi:10.1016/j.clinbiochem.2018.09.011

https://pubmed.ncbi.nlm.nih.gov/30261183/

Abstract

D-dimer is a promising biomarker for identification of venous thromboembolism (VTE) in patients with stroke. The purpose of our study is to evaluate the diagnostic value of D-dimer as a promising biomarker for VTE in patients after stroke. We performed an exhaustive search of leading databases including Pubmed, Embase, the Cochrane library, China National Knowledge Infrastructure (CNKI), and China Biology Medicine disc (CBM) from inception to Oct 13, 2017. We included studies written in English and Chinese. We included studies that appraised the diagnostic value of D-dimer with reference standard for VTE diagnosis in patients after stroke. We concurrently constructed a 2 × 2 table with data extracted from included studies. We identified 8 studies that included 1490 patients after stroke from our database searches. The pooled result from limited evidence showed a sensitivity of 0.85 (95% CI 0.76–0.90) and a specificity of 0.77 (95% CI 0.73–0.81). The area under the summary receiver operating characteristic curve was 0.85(95% CI 0.81–0.88). The positive likelihood ratio (LR+) and the negative likelihood ratio (LR-) were 3.8 (95% CI 3.1–4.4) and 0.20(95% CI 0.12–0.31), respectively. In patients after stroke suspected of venous thromboembolism, D-dimer is a beneficial biomarker for diagnosis of VTE. For stroke patients with low probability of VTE, a normal D-dimer test can be used to rule-out VTE. However, we do not recommend using D-dimer as the single definitive test for VTE diagnosis. We recommend diagnosing VTE using multi-branch diagnostic strategy.

摘要

D-二聚體是一種有前景的生物標記,用於識別中風患者中的靜脈血栓栓塞(VTE)。我們的研究目的是評估D-二聚體作為中風後患者VTE有前景的生物標記的診斷價值。我們從發表的主要數據庫中,包括Pubmed、Embase、Cochrane圖書館、中國國家知識基礎設施(CNKI)和中國生物醫學光碟(CBM),從建庫至2017年10月13日進行了詳盡的搜索。我們納入了用英文和中文撰寫的研究。我們納入了評估D-二聚體對中風後患者VTE診斷具有參考標準的診斷價值的研究。我們同時建立了一個從納入研究中提取的數據的2×2表。我們從數據庫搜索中找到了8項研究,包括1490名中風後患者。有限證據的綜合結果顯示,敏感性為0.85(95% CI 0.76–0.90),特異性為0.77(95% CI 0.73–0.81)。總結接收器操作特性曲線下面積為0.85(95% CI 0.81–0.88)。陽性可能性比(LR+)和陰性可能性比(LR-)分別為3.8(95% CI 3.1–4.4)和0.20(95% CI 0.12–0.31)。在懷疑有靜脈血栓栓塞的中風患者中,D-二聚體是一種有益的生物標記,用於診斷VTE。對於VTE可能性較低的中風患者,正常的D-二聚體檢測可以用於排除VTE。但我們不建議將D-二聚體作為VTE診斷的單一確定性測試。我們建議使用多分支診斷策略來診斷VTE。

簡介

全球范围内,静脉血栓栓塞(VTE)是急性中风后常见的并发症,也是中风后死亡的主要原因之一[1]。已经确立的是,肢体瘫痪、身体不动、年龄尤其是老年患者和房颤是与VTE风险正相关的重要因素[[2],[3],[4]]。早期诊断VTE对于预防因肺部或呼吸功能受损而导致的死亡至关重要[1]。然而,诊断怀疑有静脉血栓栓塞的患者是临床医生面临的一大挑战,因为其非特异性的体征和症状使该病被临床医生忽视[5]。在过去,静脉造影是金标准;然而,由于其具有侵入性和昂贵的特点,它已经几乎被淘汰。作为VTE的基石诊断策略,静脉超声(US)是一种安全、无创和可靠的VTE检测替代方法[1,[6],[7],[8]]。然而,US仅限于仅有15%~28%的疑似病例实际上患有血栓形成[9]。此外,进行US检查成本高昂,需要专家进行解读[1]。这促使人们寻找更有效的策略。

D-二聚体检测通常被应用于提高VTE诊断的成本效益,作为一种无创和廉价的筛查试验。D-二聚体是在纤维蛋白溶解过程中产生的纤维蛋白降解产物[10]。目前,已经确定了血浆D-二聚体水平作为VTE排除诊断的有价值的检验,但它们缺乏足够的临床敏感性或特异性,无法用于VTE的诊断。有系统性评价和荟萃分析表明,在低VTE风险的患者中,正常的D-二聚体水平可以排除VTE,无需进行额外的调查[[11],[12],[13],[14],[15],[16]]。

上述荟萃分析涵盖了各种人群,不仅限于中风患者。在健康个体中,血浆D-二聚体很少升高。然而,在包括感染、癌症、手术和中风在内的任何涉及纤维蛋白形成和降解的情况中,血浆D-二聚体可能会升高[17,18]。目前尚不清楚中风后患者血浆D-二聚体浓度随时间的变化是否可归因于VTE或中风。威廉姆斯等人进行的一项研究结果表明,中风后第一周的平均D-二聚体水平略有升高,并在中风后2周持续增加[19]。在中风患者中,血浆D-二聚体密度显着增加,导致高比例的这些患者的血浆D-二聚体水平高于常见的截断点(500ng/ml)[18]。这可能导致使用D-二聚体检测在中风患者中进行更多的假阳性VTE诊断(低特异性)。D-二聚体在中风患者的VTE诊断中是否扮演相同的角色尚不清楚。最近,有关D-二聚体的研究结果已经发表,我们对D-二聚体的理解仍在不断发展。

系统性回顾可以为这个主题提供证据,而荟萃分析可以为中风后患者VTE诊断的D-二聚体检测的准确评估提供帮助[20]。因此,我们进行了一项系统性回顾和荟萃分析,以评估D-二聚体检测在中风后患者VTE诊断中的准确性,特别关注其在中风后排除DVT(深静脉血栓)或PE(肺栓塞)的诊断中的诊断价值。

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