Rodgers R P, Levin J
Department of Laboratory Medicine, School of Medicine, University of California, San Francisco.
Semin Thromb Hemost. 1990 Jan;16(1):1-20. doi: 10.1055/s-2007-1002658.
Since its initial invention by the French worker Milian in 1901, the bleeding time has been put forward as a clinically useful test in three contexts: diagnosis (particularly of platelet disorders), prediction of clinically important bleeding, and assessment of the adequacy of various forms of therapy. Attempting a complete review of the published experience with this test, we assessed 862 articles. Original bleeding time data appeared in 664 of these articles, from which we tabulated 1083 distinct studies in humans. ROC analysis, which characterizes the sensitivity and specificity of the test, was applied in every instance in which published data were adequate (34 studies). ROCs from 27 studies of the bleeding time in association with aspirin ingestion reveal high variability in the ability of the bleeding time to detect aspirin intake, and provide evidence against claims that recently devised bleeding time methods have improved discriminatory ability based on improved reproducibility. Two ROCs from surgical studies, in which the bleeding time was used to try to predict abnormal bleeding, were statistically indistinguishable from that of a completely noninformative test. In ROCs from five studies of abnormal bleeding in uremia, the test performed approximately the same as the platelet count or hematocrit (taken singly); in one of these studies, prothrombin consumption was determined and was a better predictor of bleeding than bleeding time, hematocrit, or platelet count. In the settings of renal biopsy (one study) and massive transfusion (one study), data allowed estimation of predictive value: in no instance was there evidence that the bleeding time significantly altered a priori estimates (based on prevalence) of the risk of bleeding. Linear regression analysis was applied to data from 23 studies relating platelet count to bleeding time, to assess published claims that the bleeding time and platelet count follow a predictively useful linear relationship. In 22 of 23 instances, the inverse relationship between bleeding time and platelet count was associated with broad statistical scatter, making it impossible to predict precisely one variable given the other. The pathophysiology of an abnormal bleeding time remains poorly understood. The bleeding time is affected by a large number of diseases, drugs, physiologic factors, test conditions, and therapeutic actions, not all of them platelet-related. The test is likely to remain widely used for the diagnosis of inherited disorders of platelet function, such as von Willebrand's syndrome, despite the lack of clear criteria for its use in this context.(ABSTRACT TRUNCATED AT 400 WORDS)
自1901年法国工人米利安首次发明出血时间以来，它已在三种情况下被提出作为一种临床有用的检测方法：诊断（特别是血小板疾病的诊断）、预测临床上重要的出血以及评估各种治疗形式的充分性。为了全面回顾关于该检测方法已发表的经验，我们评估了862篇文章。其中664篇文章出现了原始出血时间数据，我们从中整理出了1083项针对人类的不同研究。在已发表数据充足的每一个实例（34项研究）中，都应用了表征该检测方法敏感性和特异性的ROC分析。来自27项关于出血时间与阿司匹林摄入相关研究的ROC曲线显示，出血时间检测阿司匹林摄入的能力存在很大差异，并提供证据反驳了近期设计的出血时间方法基于提高的可重复性而改善了区分能力的说法。两项来自外科手术研究的ROC曲线，其中出血时间被用于尝试预测异常出血，在统计学上与完全无信息的检测方法的ROC曲线没有区别。在五项关于尿毒症异常出血研究的ROC曲线中，该检测方法的表现与血小板计数或血细胞比容（单独来看）大致相同；在其中一项研究中，测定了凝血酶原消耗情况，它比出血时间、血细胞比容或血小板计数是更好的出血预测指标。在肾活检（一项研究）和大量输血（一项研究）的情况下，数据允许估计预测价值：在任何情况下都没有证据表明出血时间显著改变了基于患病率的出血风险的先验估计。对来自23项将血小板计数与出血时间相关联研究的数据进行了线性回归分析，以评估已发表的关于出血时间和血小板计数遵循预测性有用的线性关系的说法。在23个实例中的22个实例中，出血时间与血小板计数之间的反比关系伴随着广泛的统计离散，使得给定另一个变量时无法精确预测其中一个变量。异常出血时间的病理生理学仍知之甚少。出血时间受到大量疾病、药物、生理因素、检测条件和治疗措施的影响，并非所有这些都与血小板相关。尽管在这种情况下缺乏明确的使用标准，但该检测方法可能仍会广泛用于诊断遗传性血小板功能障碍，如血管性血友病。（摘要截选至400字）
