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糖尿病门诊中三种筛查试验及一种风险评估模型用于诊断周围神经病变的评估

Evaluation of three screening tests and a risk assessment model for diagnosing peripheral neuropathy in the diabetes clinic.

作者信息

Olaleye D, Perkins B A, Bril V

机构信息

iBiomatics LLC (a SAS Company), 11000 Weston Parkway, Suite 100, Cary, NC 27513, USA.

出版信息

Diabetes Res Clin Pract. 2001 Nov;54(2):115-28. doi: 10.1016/s0168-8227(01)00278-9.

DOI:10.1016/s0168-8227(01)00278-9
PMID:11640995
Abstract

OBJECTIVE

with the aim of evaluating predictive power, three simple screening tests as alternates to nerve conduction tests for diagnosing diabetic peripheral neuropathy (DPN) were investigated. Results of the screening tests, along with the subjects' demographic and clinical characteristics, were planned as the variables for the development of a risk assessment tool for predicting DPN.

DESIGN

this is a cross-sectional multi-group comparison study. The study utilized a predictive model derived from one subset of the study population, and prospectively tested in the other subset to predict the presence of neuropathy.

SETTING

Diabetic Neuropathy Research Clinic of the Toronto General Hospital and University Health Network in Toronto, Ontario, Canada from June 1998 to August 1999.

SAMPLE POPULATION

data come from 478 subjects consisting of non-diabetic reference subjects, and patients with type 1 and type 2 diabetes mellitus.

OUTCOMES MEASURES

nerve conduction studies (NCS) comprised the primary defined outcome. The three screening sensory tests examined in the study were the Semmes-Weinstein 10 g monofilament examination (SWME), superficial pain sensation, and vibration by the on-off method.

RESULTS

the three screening tests are significantly and positively correlated with NCS. An increase in the number of insensate responses in the screening test is associated with an increase in the abnormal NCS score. The strength of the association between NCS and each sensory test was greater when the neuropathy severity stage of the subject was added to the model. Both the SWME and vibration by the on-off method tests demonstrated sufficient statistical power to differentiate non-diabetic control subjects from subjects with diabetes, as well as to differentiate subjects with diabetes with and without neuropathy. These two tests, when compared with NCS, also demonstrated acceptable diagnostic performance characteristics in terms of high sensitivity and specificity, total number of correctly predicted cases, and receiver-operating characteristic curves.

CONCLUSION

this data, through the development of a model involving training and validation sets, demonstrates that the knowledge of clinical risk factors alters the interpretation of sensory tests for DPN. This finding lends further support to the validity of simple sensory testing maneuvers in the conditional diagnosis of DPN. We recommend annual screening with either the SWME or vibration by the on-off method in the primary care and diabetes clinics.

摘要

目的

为评估预测能力,研究了三种简单的筛查试验,作为诊断糖尿病周围神经病变(DPN)时神经传导测试的替代方法。筛查试验的结果,连同受试者的人口统计学和临床特征,被规划为开发预测DPN风险评估工具的变量。

设计

这是一项横断面多组比较研究。该研究利用从研究人群的一个子集得出的预测模型,并在前瞻性地在另一个子集中进行测试,以预测神经病变的存在。

地点

1998年6月至1999年8月,加拿大安大略省多伦多市多伦多综合医院和大学健康网络的糖尿病神经病变研究诊所。

样本人群

数据来自478名受试者,包括非糖尿病对照受试者以及1型和2型糖尿病患者。

观察指标

神经传导研究(NCS)构成主要的既定观察指标。该研究中检测的三项筛查感觉试验为Semmes-Weinstein 10克单丝检查(SWME)、浅感觉和开-关法振动觉。

结果

三项筛查试验与NCS显著正相关。筛查试验中无感觉反应数量的增加与异常NCS评分的增加相关。当将受试者的神经病变严重程度阶段添加到模型中时,NCS与每项感觉试验之间的关联强度更大。SWME和开-关法振动觉试验均显示出足够的统计效力,可区分非糖尿病对照受试者与糖尿病受试者,以及区分有和无神经病变的糖尿病受试者。与NCS相比,这两项试验在高敏感性和特异性、正确预测病例总数以及受试者工作特征曲线方面也显示出可接受的诊断性能特征。

结论

这些数据通过开发一个涉及训练集和验证集的模型表明,临床风险因素的知识改变了对DPN感觉试验的解释。这一发现进一步支持了简单感觉测试方法在DPN条件诊断中的有效性。我们建议在初级保健和糖尿病诊所每年使用SWME或开-关法振动觉进行筛查。

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