過氧化物酶法測定sdLDL-C的分析性能評價及與冠心病相關(guān)研究
發(fā)布時間：2018-08-25 08:36
【摘要】：研究目的:低密度脂蛋白膽固醇(LDL)存在一種密度大而顆粒直徑小亞型即為小而密低密度脂蛋白膽固醇(sdLDL-C)。近年來研究發(fā)現(xiàn)較LDL,sdLDL-C與動脈粥樣硬化的發(fā)生發(fā)展關(guān)系尤為密切,是不良心血管事件新型的有利預(yù)測指標(biāo),有望成為冠心病臨床治療的新靶點(diǎn)。長期以來受限于檢測手段難以在臨床開展,隨著sdLDL-C的檢測方法不斷發(fā)展,過氧化物酶法檢測試劑盒的問世為臨床檢測sdLDL-C實(shí)現(xiàn)其臨床價值提供了可能。1.對過氧化物酶法測定血清sdLDL-C試劑盒初步進(jìn)行分析性能評價,建立本實(shí)驗(yàn)室參考范圍,為實(shí)現(xiàn)臨床常規(guī)檢測sdLDL-C提供可靠的實(shí)驗(yàn)數(shù)據(jù)。2.探討冠心病人群的的血清sdLDL-C水平,分析sdLDL-C與冠心病脂質(zhì)危險因素和與冠心病嚴(yán)重程度的相關(guān)性,評價sdLDL-C對冠心病的風(fēng)險評估價值。研究方法:1.選擇健康體檢者的標(biāo)本、sdLDL-C檢測試劑盒提供的的室內(nèi)質(zhì)控血清和標(biāo)準(zhǔn)品,性能評價試驗(yàn)包括精密度評估、檢測靈敏度、線性范圍、參考區(qū)間、干擾試驗(yàn)、回收試驗(yàn)。然后通過統(tǒng)計(jì)學(xué)方法,對所有測定結(jié)果進(jìn)行t檢驗(yàn)或方差分析,線性回歸。2.收集2016年3月-2016年10月在中山市中醫(yī)院心內(nèi)科住院并經(jīng)冠脈造影(DSA)確診為冠心病的120例患者的空腹血清標(biāo)本作為冠心病組,選取我院健康體檢者120例血清標(biāo)本作為對照組。根據(jù)收集的冠心病組患者臨床資料,將其分為不穩(wěn)定型心絞痛(UA)組(50例)、穩(wěn)定型心絞痛(SA)組(28例)、急性心肌梗死(AMI)組(42例);根據(jù)DSA結(jié)果分為單支病變組、兩支病變組、三支病變組。使用過氧化物酶法試劑盒檢測其血清sdLDL-C水平,冠心病組的冠脈病變程度選用Gensini評分系統(tǒng)作為評判標(biāo)準(zhǔn)。所得數(shù)據(jù)經(jīng)過合適的統(tǒng)計(jì)學(xué)方法,分析血清冠心病人群的sdLDL-C水平與冠心病相關(guān)脂質(zhì)危險因素以及Gensini評分的相關(guān)性。研究結(jié)果:1.分析性能評價結(jié)果:過氧化物酶法試劑盒測定sdLDL-C精密度試驗(yàn)結(jié)果顯示,低值標(biāo)本(濃度為0.05mmol/L)的批內(nèi)不精密度為2.9%,批間不精密度為1.5%,高值標(biāo)本(濃度為2.2mmol/L)的批內(nèi)不精密度為1.4%,批間不精密度為1.8%,說明精密度良好;檢測靈敏度為0.025mmol/L;線性范圍為0.35～3.80mmol/L;正常人的sdLDL-C水平存在性別和年齡差異,參考區(qū)間結(jié)果為男性 0.66±0.36mmol/L(20-44 歲)、0.86±0.51mmol/L(45-79 歲),女性 0.58±0.27mmol/L(20-54 歲)、0.89±0.55mmol/L(55-79 歲);回收試驗(yàn)結(jié)果表明:sdLDL-C的平均回收率為99.54%;干擾試驗(yàn)結(jié)果示:血紅蛋白濃度小于500mg/dL,膽紅素濃度小于35mg/dL,乳糜微粒濃度小于600mg/dL對標(biāo)本的檢測結(jié)果無影響。2.與冠心病嚴(yán)重程度相關(guān)性研究::(1)、冠心病組的血清sdLDL-C水平呈偏態(tài)分布,其血清sdLDL-C水平無明顯性別差異(p0.05),冠心病各分組的sdLDL-C水平無明顯差異(p0.05);(2)、冠心病組的血清sdLDL-C水平高于對照組,差異有統(tǒng)計(jì)學(xué)意義(t=3.774,p0.05);(3)、在冠心病人群中,血清sdLDL-C與LDL-C、TG等冠心病危險因素呈正相關(guān)(p0.05)(4)、在冠心病組中,血清sdLDL-C水平與Gensini評分呈正相關(guān)(r=0.41);三支病變組血清sdLDL-C水平明顯高于單支病變組(q=4.06,p0.05)。研究結(jié)論:1.本實(shí)驗(yàn)表明過氧化物酶法試劑盒在日立全自動生化分析儀上精密度好,線性范圍寬、抗干擾能力強(qiáng)、回收率較高,是目前臨床實(shí)驗(yàn)室值得推廣的一種常規(guī)檢測方法。2.冠心病患者血清sdLDL-C水平高于對照組,與冠心病常見的脂質(zhì)危險因素及嚴(yán)重程度正相關(guān)。
[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.
【學(xué)位授予單位】：廣州中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R446.1;R541.4
本文編號：2202345
[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.
【學(xué)位授予單位】：廣州中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R446.1;R541.4
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