Grint Daniel, Alisjhabana Bachti, Ugarte-Gil Cesar, Riza Anca-Leila, Walzl Gerhard, Pearson Fiona, Ruslami Rovina, Moore David A J, Ioana Mihai, McAllister Susan, Ronacher Katharina, Koeseomadinata Raspati C, Kerry-Barnard Sarah R, Coronel Jorge, Malherbe Stephanus T, Dockrell Hazel M, Hill Philip C, Van Crevel Reinout, Critchley Julia A
Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, England.
Infectious Disease Research Centre, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia.
Bull World Health Organ. 2018 Nov 1;96(11):738-749. doi: 10.2471/BLT.17.206227. Epub 2018 Aug 27.
To evaluate the performance of diagnostic tools for diabetes mellitus, including laboratory methods and clinical risk scores, in newly-diagnosed pulmonary tuberculosis patients from four middle-income countries.
In a multicentre, prospective study, we recruited 2185 patients with pulmonary tuberculosis from sites in Indonesia, Peru, Romania and South Africa from January 2014 to September 2016. Using laboratory-measured glycated haemoglobin (HbA1c) as the gold standard, we measured the diagnostic accuracy of random plasma glucose, point-of-care HbA1c, fasting blood glucose, urine dipstick, published and newly derived diabetes mellitus risk scores and anthropometric measurements. We also analysed combinations of tests, including a two-step test using point-of-care HbA1cwhen initial random plasma glucose was ≥ 6.1 mmol/L.
The overall crude prevalence of diabetes mellitus among newly diagnosed tuberculosis patients was 283/2185 (13.0%; 95% confidence interval, CI: 11.6-14.4). The marker with the best diagnostic accuracy was point-of-care HbA1c (area under receiver operating characteristic curve: 0.81; 95% CI: 0.75-0.86). A risk score derived using age, point-of-care HbA1c and random plasma glucose had the best overall diagnostic accuracy (area under curve: 0.85; 95% CI: 0.81-0.90). There was substantial heterogeneity between sites for all markers, but the two-step combination test performed well in Indonesia and Peru.
Random plasma glucose followed by point-of-care HbA1c testing can accurately diagnose diabetes in tuberculosis patients, particularly those with substantial hyperglycaemia, while reducing the need for more expensive point-of-care HbA1c testing. Risk scores with or without biochemical data may be useful but require validation.
评估糖尿病诊断工具(包括实验室方法和临床风险评分)在四个中等收入国家新诊断的肺结核患者中的表现。
在一项多中心前瞻性研究中,我们于2014年1月至2016年9月从印度尼西亚、秘鲁、罗马尼亚和南非的研究地点招募了2185例肺结核患者。以实验室测量的糖化血红蛋白(HbA1c)作为金标准,我们测量了随机血糖、即时检测HbA1c、空腹血糖、尿试纸检测、已发表和新推导的糖尿病风险评分以及人体测量指标的诊断准确性。我们还分析了检测组合,包括当初始随机血糖≥6.1 mmol/L时使用即时检测HbA1c的两步检测法。
新诊断的肺结核患者中糖尿病的总体粗患病率为283/2185(13.0%;95%置信区间,CI:11.6 - 14.4)。诊断准确性最佳的标志物是即时检测HbA1c(受试者操作特征曲线下面积:0.81;95%CI:0.75 - 0.86)。使用年龄、即时检测HbA1c和随机血糖推导的风险评分总体诊断准确性最佳(曲线下面积:0.85;95%CI:0.81 - 0.90)。所有标志物在各研究地点之间存在显著异质性,但两步组合检测法在印度尼西亚和秘鲁表现良好。
先进行随机血糖检测,然后进行即时检测HbA1c,可准确诊断肺结核患者中的糖尿病,尤其是那些血糖显著升高的患者,同时减少对更昂贵的即时检测HbA1c的需求。有或没有生化数据的风险评分可能有用,但需要验证。