脂蛋白残粒检测方法的评价及在冠心病中的初步应用

The evaluation on method of remnant lipoprotein detection and its primary application in coronary heart disease

目的对免疫分离法测定血清脂蛋白残粒(RLP)进行方法学评价,分析该方法在冠心病患者血清RLP临床检测中的应用。方法评价免疫分离法测定血浆RLP的精密度、稳定性试验、回收试验、干扰试验、线性范围。用该法测定100名体检健康者、59名冠心病患者空腹血清RLP水平,同时测定三酰甘油(TG)、总胆固醇(TC)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)、载脂蛋白A1(apo A1)和载脂蛋白B(apo B),比较7个项目的临床符合率。结果免疫分离法测定高(0.48 mmol/L)、低浓度(0.12 mmol/L)血清RLP的批内变异系数(CV)分别为4.6%、4.2%,平均为4.4%;批间CV分别为5.8%、6.0%,平均为5.9%。平均回收率为98.7%。血清样本4℃可保存4 d以上,-20℃可稳定保存1个月以上。血红蛋白(Hb)<5 g/L、胆红素<300μmol/L、TG<14.1 mmol/L时对RLP测定无明显干扰;RLP在2.0 mmol/L范围内线性良好。体检健康人群RLP参考范围为(0.18±0.04)mmol/L。冠心病患者空腹血清RLP浓度为(0.31±0.072)mmol/L,明显高于正常对照组(P<0.01);其临床符合率为79.7%,高于TG(44.0%)、TC(30.5%)、LDL-C(28.8%)、apo B(27.1%)、apo A1(25.4%)和HDL-C(18.6%)。结论免疫分离法测定RLP操作简单,结果准确、可靠,符合临床质控要求,适用于基础研究和临床检验。RLP可作为冠心病的致病因子应用于临床。

Objective To evaluate immunoseparation assay for remnant lipoprotein（RLP） detection and its clinical application significance in patients with coronary heart disease.Methods The precision,stability,recycling,interference and linearity were analyzed for RLP by immunoseparation assay.The fasting serum RLP,triglyceride（TG）,total cholesterol（TC）,high density lipoprotein cholesterol（HDL-C）,low density lipoprotein cholesterol（LDL-C）,apolipoprotein A1（apo A1） and apolipoprotein B（apo B）were assayed for 100 healthy subjects and 59 patients with coronary heart disease.The coincidence was analyzed.Results The within-run coefficients of variation（CV） of the assay from high levels（0.48 mmol/L） and low level（0.12 mmol/L） of RLP were 4.6% and 4.2% respectively,and the between-run CV were 5.8% and 6.0%.The average within-run and between-run CV were 4.4% and 5.9%.The mean recovery rate was 98.7%.The serum samples could be preserved for 4 d at 40 ℃ and 1 month at-20℃.Hemoglobin（Hb5 g/L）,bilirubin（300 μmol/L） and TG（14.1 mmol/L） did not interfere in the immunoseparation assay for RLP.There was an excellent linearitty with RLP within 2.0 mmol/L.The levels of RLP in patients with coronary heart disease[（0.31±0.072） mmol/L] were significantly higher than those in normal controls [（0.18±0.04）mmol/L]（P0.01）.The clinical conformity rate of RLP（79.9%） was higher than that of TG（44.0%）,TC（30.5%）,LDL-C（28.8%）,apo B（27.1%）,apo A1（25.4%）and HDL-C（18.6%）.Conclusions The immnoseparation assay for RLP is a simple method with reliable accuracy and meets the clinical quality control demand,so it is suitable for clinical and basic research.RLP could be considered as a risk factor of coronary heart disease.