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[在一项针对高血压患者进行的综合内科随访的IMMEDIAT研究中,对内膜中层厚度进行集中解读的贡献]

[Contribution of centralized reading of intima media thickness in an IMMEDIAT study conducted in hypertensive patients followed up in general medicine].

作者信息

Poncelet P, Danchin N, Baulac C, Eychenne J L, Girerd X

机构信息

Polyclinique de Hénin Beaumont, 62110 Hénin-Beaumont.

出版信息

Arch Mal Coeur Vaiss. 2003 Jul-Aug;96(7-8):719-24.

PMID:12945210
Abstract

OBJECTIVE

To compare the results of two readings of Intima Media thickness (EIM): one performed during measurement by the cardiologist, the other by a technician in a reading unit. To evaluate the consequences of these readings on the principal criterion of a study conducted into cardiovascular risk (RCV) for hypertensives followed up in ordinary medical practice.

METHODS

The EIM was measured in 991 hypertensives with the aid of the M'Ath program by cardiologists specially trained in the technique, within the framework of a study aimed at evaluating the RCV according to the WHO/ISH classification. The re-reading of source data by a reference centre was performed with the same program.

RESULTS

The analysis was performed in 973 patients after eliminating duplicates and missing values (2%). The average cardiologist value of EIM was 0.761 +/- 0.168 mm, after centralised reading it was 0.743 +/- 0.128 mm. The difference between the measurements was -0.020 +/- 0.150 (p < 0.0001). According to the OMS/ISH classification, the presence of a vascular condition categorizes a hypertensive as being at "high risk" of a cardiovascular complication occurring. The calculation of RCV was performed by taking a value of EIM > 0.7 mm and/or presence of a plaque to define a vascular condition. The appreciation of risk was identical for the subjects at low risk and at very high risk. There was a shift from medium risk towards high risk: General Medicine 15%, Cardio 49%, after re-reading 68%.

CONCLUSION

Despite the simplicity and the good inter observer reproducibility of the measurement of EIM by the M'Ath program, centralization of the reading is recommended during clinical trials.

摘要

目的

比较内膜中层厚度(EIM)的两次读数结果:一次由心脏病专家在测量过程中进行,另一次由读数室的技术人员进行。评估这些读数对普通医疗实践中随访的高血压患者心血管风险(RCV)研究的主要标准的影响。

方法

在一项旨在根据世界卫生组织/国际高血压学会(WHO/ISH)分类评估RCV的研究框架内,由经过该技术专门培训的心脏病专家借助M'Ath程序对991名高血压患者进行EIM测量。参考中心使用相同程序对源数据进行重新读数。

结果

在消除重复数据和缺失值(2%)后,对973名患者进行了分析。心脏病专家测得的EIM平均数值为0.761±0.168毫米,集中读数后为0.743±0.128毫米。两次测量的差值为-0.020±0.150(p<0.0001)。根据WHO/ISH分类,血管状况的存在将高血压患者归类为发生心血管并发症的“高风险”人群。通过采用EIM>0.7毫米和/或存在斑块的值来定义血管状况,进而计算RCV。低风险和极高风险受试者的风险评估相同。从中等风险向高风险有一个转变:普通内科为15%,心脏病科为49%,重新读数后为68%。

结论

尽管M'Ath程序测量EIM简单且观察者间重复性良好,但在临床试验期间建议进行读数集中化。

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