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肝素诱导的血小板减少症:基于前瞻性国际多中心数据库分析构建的预测试诊断评分,内部验证。

Heparin-induced thrombocytopenia: Construction of a pretest diagnostic score derived from the analysis of a prospective multinational database, with internal validation.

机构信息

CIC 1408, Inserm U1059 SAINBIOSE, F-Crin INNOVTE, Université de Lyon, Saint-Etienne, France.

Hemostasis Unit, CHU Dijon, Dijon, France.

出版信息

J Thromb Haemost. 2021 Aug;19(8):1959-1972. doi: 10.1111/jth.15344. Epub 2021 Jun 14.

DOI:10.1111/jth.15344
PMID:33872452
Abstract

BACKGROUND

Diagnosis of heparin-induced thrombocytopenia (HIT) requires pretest probability assessment and dedicated laboratory assays.

OBJECTIVE

To develop a pretest score for HIT.

DESIGN

Observational; analysis of prospectively collected data of hospitalized patients suspected with HIT (ClinicalTrials.gov NCT00748839).

SETTING

Thirty-one tertiary hospitals in France, Switzerland, and Belgium.

PATIENTS

Patients tested for HIT antibodies (2280 evaluable), randomly allocated to derivation and validation cohorts.

MEASUREMENTS

Independent adjudicators diagnosed HIT based on the prospectively collected data and serotonin release assay results.

RESULTS

Heparin-induced thrombocytopenia was diagnosed in 234 (14.7%) and 99 (14.5%) patients in the two cohorts. Eight features were associated with HIT (in brackets, points assigned for score calculation of the score): unfractionated heparin (1); therapeutic-dose heparin (1); cardiopulmonary bypass (cardiac surgery) (2); major trauma (3); 5- to 21-day interval from anticoagulation initiation to suspicion of HIT (4); ≥40% decrease in platelet count over ≤6 days (3); thrombotic event, arterial (3) or venous (3). The C-statistic was 0.79 (95% CI, 0.76-0.82). In the validation cohort, the area under the receiver operating characteristic curve was 0.77 (95% CI, 0.74-0.80). Three groups of scores were defined; HIT prevalence reached almost 30% in the high-probability group.

LIMITATION

The performance of the score may depend on settings and practices.

CONCLUSION

The objective, easy-to-collect, clinical features of HIT we evidenced were incorporated into a pretest score, which may guide clinical decisions regarding diagnostic testing and anticoagulation.

摘要

背景

肝素诱导的血小板减少症(HIT)的诊断需要进行术前概率评估和专用实验室检测。

目的

开发一种用于 HIT 的术前评分。

设计

观察性;对疑似 HIT 的住院患者前瞻性收集数据的分析(ClinicalTrials.gov NCT00748839)。

地点

法国、瑞士和比利时的 31 家三级医院。

患者

接受 HIT 抗体检测的患者(2280 例可评估),随机分配到推导和验证队列。

测量方法

独立裁判根据前瞻性收集的数据和血清素释放试验结果诊断 HIT。

结果

在两个队列中,234 例(14.7%)和 99 例(14.5%)患者被诊断为 HIT。有 8 个特征与 HIT 相关(括号内为评分计算的分数):未分级肝素(1);治疗剂量肝素(1);体外循环(心脏手术)(2);重大创伤(3);从抗凝开始到怀疑 HIT 的 5-21 天间隔(4);血小板计数在≤6 天内下降≥40%(3);血栓形成事件,动脉(3)或静脉(3)。C 统计量为 0.79(95%CI,0.76-0.82)。在验证队列中,受试者工作特征曲线下面积为 0.77(95%CI,0.74-0.80)。定义了三个评分组;高概率组的 HIT 患病率接近 30%。

局限性

评分的性能可能取决于环境和实践。

结论

我们证实的 HIT 的客观、易于收集的临床特征被纳入术前评分中,这可能有助于指导关于诊断检测和抗凝的临床决策。

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