过氧化物酶法测定sdLDL-C的分析性能评价及与冠心病相关研究

发布时间：2018-08-25 08:36

【摘要】：研究目的:低密度脂蛋白胆固醇(LDL)存在一种密度大而颗粒直径小亚型即为小而密低密度脂蛋白胆固醇(sdLDL-C)。近年来研究发现较LDL,sdLDL-C与动脉粥样硬化的发生发展关系尤为密切,是不良心血管事件新型的有利预测指标,有望成为冠心病临床治疗的新靶点。长期以来受限于检测手段难以在临床开展,随着sdLDL-C的检测方法不断发展,过氧化物酶法检测试剂盒的问世为临床检测sdLDL-C实现其临床价值提供了可能。1.对过氧化物酶法测定血清sdLDL-C试剂盒初步进行分析性能评价,建立本实验室参考范围,为实现临床常规检测sdLDL-C提供可靠的实验数据。2.探讨冠心病人群的的血清sdLDL-C水平,分析sdLDL-C与冠心病脂质危险因素和与冠心病严重程度的相关性,评价sdLDL-C对冠心病的风险评估价值。研究方法:1.选择健康体检者的标本、sdLDL-C检测试剂盒提供的的室内质控血清和标准品,性能评价试验包括精密度评估、检测灵敏度、线性范围、参考区间、干扰试验、回收试验。然后通过统计学方法,对所有测定结果进行t检验或方差分析,线性回归。2.收集2016年3月-2016年10月在中山市中医院心内科住院并经冠脉造影(DSA)确诊为冠心病的120例患者的空腹血清标本作为冠心病组,选取我院健康体检者120例血清标本作为对照组。根据收集的冠心病组患者临床资料,将其分为不稳定型心绞痛(UA)组(50例)、稳定型心绞痛(SA)组(28例)、急性心肌梗死(AMI)组(42例);根据DSA结果分为单支病变组、两支病变组、三支病变组。使用过氧化物酶法试剂盒检测其血清sdLDL-C水平,冠心病组的冠脉病变程度选用Gensini评分系统作为评判标准。所得数据经过合适的统计学方法,分析血清冠心病人群的sdLDL-C水平与冠心病相关脂质危险因素以及Gensini评分的相关性。研究结果:1.分析性能评价结果:过氧化物酶法试剂盒测定sdLDL-C精密度试验结果显示,低值标本(浓度为0.05mmol/L)的批内不精密度为2.9%,批间不精密度为1.5%,高值标本(浓度为2.2mmol/L)的批内不精密度为1.4%,批间不精密度为1.8%,说明精密度良好;检测灵敏度为0.025mmol/L;线性范围为0.35～3.80mmol/L;正常人的sdLDL-C水平存在性别和年龄差异,参考区间结果为男性 0.66±0.36mmol/L(20-44 岁)、0.86±0.51mmol/L(45-79 岁),女性 0.58±0.27mmol/L(20-54 岁)、0.89±0.55mmol/L(55-79 岁);回收试验结果表明:sdLDL-C的平均回收率为99.54%;干扰试验结果示:血红蛋白浓度小于500mg/dL,胆红素浓度小于35mg/dL,乳糜微粒浓度小于600mg/dL对标本的检测结果无影响。2.与冠心病严重程度相关性研究::(1)、冠心病组的血清sdLDL-C水平呈偏态分布,其血清sdLDL-C水平无明显性别差异(p0.05),冠心病各分组的sdLDL-C水平无明显差异(p0.05);(2)、冠心病组的血清sdLDL-C水平高于对照组,差异有统计学意义(t=3.774,p0.05);(3)、在冠心病人群中,血清sdLDL-C与LDL-C、TG等冠心病危险因素呈正相关(p0.05)(4)、在冠心病组中,血清sdLDL-C水平与Gensini评分呈正相关(r=0.41);三支病变组血清sdLDL-C水平明显高于单支病变组(q=4.06,p0.05)。研究结论:1.本实验表明过氧化物酶法试剂盒在日立全自动生化分析仪上精密度好,线性范围宽、抗干扰能力强、回收率较高,是目前临床实验室值得推广的一种常规检测方法。2.冠心病患者血清sdLDL-C水平高于对照组,与冠心病常见的脂质危险因素及严重程度正相关。
[Abstract]:OBJECTIVE: Low density lipoprotein cholesterol (LDL) has a subtype with large density and small particle diameter, i.e. small and dense low density lipoprotein cholesterol (sdLDL-C). New targets for clinical treatment of heart disease. It has been difficult to carry out clinical detection for a long time. With the development of detection methods of sdLDL-C, the appearance of peroxidase assay kit provides a possibility for clinical detection of sdLDL-C to realize its clinical value. 1. Preliminary analysis of the peroxidase assay kit for serum sdLDL-C Objective: To investigate the serum levels of sdLDL-C in patients with coronary heart disease, analyze the relationship between sdLDL-C and coronary heart disease lipid risk factors and severity of coronary heart disease, and evaluate the value of sdLDL-C in risk assessment of coronary heart disease. Choose the samples of healthy people and the laboratory quality control serum and standard materials provided by the sdLDL-C test kit. The performance evaluation test includes precision evaluation, detection sensitivity, linear range, reference interval, interference test, recovery test. Then, through statistical methods, all the results were tested by t-test or variance analysis, linear regression.2. The fasting serum samples of 120 patients with coronary heart disease diagnosed by coronary angiography (DSA) were collected from March 2016 to October 2016 in the Department of Cardiology of Zhongshan Hospital of Traditional Chinese Medicine as the coronary heart disease group, and 120 serum samples from healthy people in our hospital as the control group. Pain (UA) group (50 cases), stable angina (SA) group (28 cases), acute myocardial infarction (AMI) group (42 cases), according to the results of DSA were divided into single lesion group, two lesions group, three lesions group. Results: 1. Analytical performance evaluation results: Peroxidase assay kit sdLDL-C precision test results showed that low-value samples (concentration 0.05 mmol/L) within the batch. The precision was 2.9%, 1.5%, 1.4% for high-value samples (2.2 mmol/L) and 1.8% for inter-batch samples, indicating that the precision was good; the sensitivity was 0.025 mmol/L; the linear range was 0.35-3.80 mmol/L; the sdLDL-C level of normal people was different in sex and age, and the reference range was male. The average recovery of SDLDL-C was 99.54%. Interference test showed that hemoglobin concentration was less than 500 mg/dL, bilirubin concentration was less than 35 mg/dL, chyle particle concentration was less than 600 mg/dL and chyle particle concentration was less than 600 mg/dL. The correlation between the level of serum SDLDL-C and the severity of CHD was studied: (1) The level of serum SDLDL-C in CHD group was skewed distribution, and there was no significant gender difference (p0.05). There was no significant difference in the level of serum SDLDL-C between different groups of CHD (p0.05); (2) The level of serum SDLDL-C in CHD group was higher than that in control group, the difference was significant. Statistical significance (t = 3.774, p0.05); (3) In patients with coronary heart disease, serum sdLDL-C and LDL-C, TG and other risk factors of coronary heart disease were positively correlated (p0.05) (4), in patients with coronary heart disease, serum sdLDL-C levels and Gensini score were positively correlated (r = 0.41); three vessel disease group serum sdLDL-C levels were significantly higher than single vessel disease group (q = 4.06, p0.05). Research conclusions: 1. The results show that the peroxidase assay kit has good precision, wide linear range, strong anti-interference ability and high recovery rate on Hitachi automatic biochemical analyzer. It is a routine method worth popularizing in clinical laboratory. 2. The level of serum sdLDL-C in patients with coronary heart disease is higher than that in control group, and the common lipid risk factors and coronary heart disease. Severity is positively correlated.
【学位授予单位】：广州中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R446.1;R541.4

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