Bubner Tanya K, Laurence Caroline O, Gialamas Angela, Yelland Lisa N, Ryan Philip, Willson Kristyn J, Tideman Philip, Worley Paul, Beilby Justin J
Discipline of General Practice, University of Adelaide, Adelaide, SA.
Med J Aust. 2009 Jun 1;190(11):624-6. doi: 10.5694/j.1326-5377.2009.tb02590.x.
To compare the clinical effectiveness of point-of-care testing (PoCT) and that of pathology laboratory testing, as measured by therapeutic control in chronic conditions.
Multicentre, cluster randomised controlled trial using non-inferiority analysis.
53 Australian general practices in urban, rural and remote areas across three Australian states, September 2005 to February 2007.
4968 patients with established type 1 or type 2 diabetes, established hyperlipidaemia, or taking anticoagulant therapy.
The intervention group (3010 patients in 30 practices) had blood and urine samples tested by PoCT devices in their general practices, and the control group (1958 patients in 23 practices) had samples tested by their usual pathology laboratories.
The proportion of patients and of tests with results in the target range, and change in test results from baseline.
For the proportion of patients with results in the target range, PoCT was found to be non-inferior to pathology laboratory testing for measuring glycated haemoglobin (HbA(1c)), urine albumin, albumin-creatinine ratio (ACR), total cholesterol and triglyceride levels but not for high-density lipoprotein (HDL) cholesterol level and international normalised ratio (INR). For the proportion of tests with results in the target range, PoCT was found to be non-inferior to pathology laboratory testing for measuring all variables except HDL cholesterol. For the proportion of patients showing an improvement in their test result from baseline, PoCT was non-inferior to pathology laboratory testing for HbA(1c), total cholesterol and triglyceride levels, but not for HDL cholesterol level.
This study provides important evidence for those considering the introduction of PoCT into general practice. For all tests except INR and HDL cholesterol, the PoCT approach demonstrated the same or better clinical effectiveness than pathology laboratory testing.
Australian Clinical Trials Registry ACTRN12612607000628448.
通过慢性病治疗控制情况来比较即时检验（PoCT）与病理实验室检验的临床效果。
采用非劣效性分析的多中心、整群随机对照试验。
2005年9月至2007年2月期间，澳大利亚三个州城市、农村和偏远地区的53家全科诊所。
4968例确诊为1型或2型糖尿病、确诊为高脂血症或正在接受抗凝治疗的患者。
干预组（30家诊所的3010例患者）在其全科诊所使用PoCT设备对血液和尿液样本进行检测，对照组（23家诊所的1958例患者）的样本由其常规病理实验室检测。
检测结果处于目标范围内的患者比例和检测比例，以及检测结果相对于基线的变化。
对于检测结果处于目标范围内的患者比例，发现PoCT在测量糖化血红蛋白（HbA(1c)）、尿白蛋白、白蛋白-肌酐比值（ACR）、总胆固醇和甘油三酯水平方面不劣于病理实验室检验，但在测量高密度脂蛋白（HDL）胆固醇水平和国际标准化比值（INR）方面并非如此。对于检测结果处于目标范围内的检测比例，发现PoCT在测量除HDL胆固醇外的所有变量方面不劣于病理实验室检验。对于检测结果相对于基线有所改善的患者比例，PoCT在HbA(1c)、总胆固醇和甘油三酯水平方面不劣于病理实验室检验，但在HDL胆固醇水平方面并非如此。
本研究为那些考虑在全科医疗中引入PoCT的人提供了重要证据。对于除INR和HDL胆固醇外的所有检测，PoCT方法显示出与病理实验室检验相同或更好的临床效果。
澳大利亚临床试验注册中心ACTRN12612607000628448 。
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