過氧化物酶法測定sdLDL-C的分析性能評價及與冠心病相關研究
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)現較LDL,sdLDL-C與動脈粥樣硬化的發(fā)生發(fā)展關系尤為密切,是不良心血管事件新型的有利預測指標,有望成為冠心病臨床治療的新靶點。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實現其臨床價值提供了可能。1.對過氧化物酶法測定血清sdLDL-C試劑盒初步進行分析性能評價,建立本實驗室參考范圍,為實現臨床常規(guī)檢測sdLDL-C提供可靠的實驗數據。2.探討冠心病人群的的血清sdLDL-C水平,分析sdLDL-C與冠心病脂質危險因素和與冠心病嚴重程度的相關性,評價sdLDL-C對冠心病的風險評估價值。研究方法:1.選擇健康體檢者的標本、sdLDL-C檢測試劑盒提供的的室內質控血清和標準品,性能評價試驗包括精密度評估、檢測靈敏度、線性范圍、參考區(qū)間、干擾試驗、回收試驗。然后通過統(tǒng)計學方法,對所有測定結果進行t檢驗或方差分析,線性回歸。2.收集2016年3月-2016年10月在中山市中醫(yī)院心內科住院并經冠脈造影(DSA)確診為冠心病的120例患者的空腹血清標本作為冠心病組,選取我院健康體檢者120例血清標本作為對照組。根據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DSA結果分為單支病變組、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)作為評判標準。所得數據經過合適的統(tǒng)計學方法,分析血清冠心病人群的sdLDL-C水平與冠心病相關脂質危險因素以及Gensini評分的相關性。研究結果:1.分析性能評價結果:過氧化物酶法試劑盒測定sdLDL-C精密度試驗結果顯示,低值標本(濃度為0.05mmol/L)的批內不精密度為2.9%,批間不精密度為1.5%,高值標本(濃度為2.2mmol/L)的批內不精密度為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);回收試驗結果表明:sdLDL-C的平均回收率為99.54%;干擾試驗結果示: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對標本的檢測結果無影響。2.與冠心病嚴重程度相關性研究::(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)計學意義(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(p0.05)(4)、在冠心病組中,血清sdLDL-C水平與Gensini評分呈正相關(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)。研究結論:1.本實驗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、回收率較高,是目前臨床實驗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危險因素及嚴重程度正相關。
[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.
【學位授予單位】：廣州中醫(yī)藥大學
【學位級別】：碩士
【學位授予年份】：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.
【學位授予單位】：廣州中醫(yī)藥大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R446.1;R541.4
【參考文獻】
相關期刊論文 前10條
1 戴雯;李艷;;冠心病患者小而密低密度脂蛋白/高密度脂蛋白與Gensini評分的相關性[J];微循環(huán)學雜志;2016年04期
2 朱敖;呂榮;沈昊;楊鴻林;陸潔;陸趙陽;周蕾;;血清小而密低密度脂蛋白水平對頸動脈中內膜厚度的影響[J];江蘇醫(yī)藥;2015年05期
3 于群;王惠民;季伙燕;蘇建友;叢輝;顧國浩;沈國榮;;化學沉淀法測定小而密低密度脂蛋白方法的建立[J];檢驗醫(yī)學;2014年02期
4 林杰;陳力平;孔維菊;肖立;袁俊菲;于長春;王申;;2型糖尿病患者血清小而密低密度脂蛋白膽固醇水平與脂類代謝異常及胰島素抵抗的關系[J];國際檢驗醫(yī)學雜志;2013年18期
5 閔芳;吳嘉;牛冬梅;董偉;汪俊軍;;小而密低密度脂蛋白膽固醇直接測定法與肝素鎂沉淀法的比較[J];現代檢驗醫(yī)學雜志;2012年04期
6 陳力平;林杰;孔維菊;袁俊菲;肖立;;不同血脂水平人群小而密LDL膽固醇分布及其與血脂組分的相關性[J];中華檢驗醫(yī)學雜志;2012年04期
7 張正清;王連升;莊興;張琦;范虞琪;陳福祥;;血清三酰甘油水平與小而密低密度脂蛋白膽固醇的關系[J];檢驗醫(yī)學;2011年12期
8 沈昊;沈國榮;李曉平;楊鴻林;朱同華;;腦卒中及其危險因素與小而密低密度脂蛋白關系的研究[J];臨床軍醫(yī)雜志;2011年06期
9 翟菊萍;黃惠芳;顧國浩;周滔;金曉華;邱駿;;小而密低密度脂蛋白與冠心病的相關性研究[J];中國現代醫(yī)學雜志;2011年27期
10 叢輝;王惠民;劉杰;;小而密低密度脂蛋白與動脈粥樣硬化性相關疾病[J];中華老年醫(yī)學雜志;2009年04期
，本文編號：2202345
本文鏈接：http://sikaile.net/linchuangyixuelunwen/2202345.html
最近更新
教材專著
