酶法测定游离脂肪酸的评价与研究

发布时间：2018-01-04 10:57

本文关键词：酶法测定游离脂肪酸的评价与研究　出处：《北京理工大学》2015年硕士论文　论文类型：学位论文

【摘要】：研究意义和目的由于血中游离脂肪酸FFA在糖尿病(diabetes mellitus,DM)、心血管病(angiocardiopathy,CD)等疾病的发病机理及作用方面的重要意义,对人体血清中游离脂肪酸含量进行检测,能够尽早发现患者血清中游离脂肪酸的异常情况,最终起到预防及尽早对相关疾病进行治疗的目的。因此,FFA检测对于糖尿病的诊断、预后跟踪控制、机理研究等方面具有重要的意义。尽管已有多种FFA检测试剂盒上市,尚缺乏对各种检测方法和不同试剂间的系统的方法学和诊断效能的评价,测定方法尚未统一,因此亟需对现有检测方法的快速和准确特性进行研究和评价,这将有利于临床工作的开展。本论文对市场上国产和进口的游离脂肪酸测定试剂盒(酶法)用于临床诊断检测性能的等效性,以及在Ⅱ型糖尿病和心血管病上的临床应用价值展开评价。方法选择医院检验科健康查体人员及糖尿病患者、心血管疾病、甲机能亢进、肢端肥大症、严重肝病和饥饿、甲状腺机能减退、脑垂体功能不全、阿狄森氏病等病症的血清,入选样本100例。根据NCCLS相关的EP标准,对北京九强生物技术股份有限公司、英国朗道公司和德国德赛公司的游离脂肪酸检测试剂盒进行检测限、线性、精密度、抗干扰能力来评价试剂盒的临床检测性能,并对九强、朗道、德赛三家公司的游离脂肪酸检测试剂盒进行相关性评价,评价两两间的相关性。本研究进一步选择Ⅱ型糖尿病和心血管疾病临床样本和健康对照样本共200例,对血清中游离脂肪酸在自动生化分析仪上检测。分析正常对照组与病例组是否存在显著差异。统计学分析应用SPSS17.0软件进行,计量资料以x±S表示,以P0.05为差异具有统计学意义。结果相关性分析显示,三种试剂盒两两之间均具有良好的相关性,R2均大于0.99,产品测试结果在统计学上无差异,一致性很好。精密度结果显示,九强试剂批内CV为0.44%~1.29%,系统CV为0.85%~1.89%,朗道试剂批内CV为0.50%~1.52%,系统CV为0.84%~2.18%,德赛试剂批内CV为0.40%~1.23%,系统CV为0.92%~2.51%。干扰试验结果显示德赛试剂对TG高于600mg/dl浓度的样本有影响,九强和朗道试剂对TG高于900 mg/dl浓度的样本有影响。德赛试剂盒对VC基本没有抗干扰能力,九强和朗道试剂盒对VC 50mg/dl浓度的样本没有影响。朗道试剂盒对DB的抗干扰能力很差,九强和德赛试剂盒对DB 40mg/dl浓度的样本没有影响。九强、德赛、朗道试剂盒对HB 300mg/dl浓度的样本没有影响。线性试验结果显示,三种试剂盒线性相关性良好,且差异均无统计学意义(P0.05)。检测限结果显示,九强、朗道、德赛三家试剂盒的空白检测限分别为:0.0301 mmol/L、0.0340 mmol/L、0.0484 mmol/L,检测低限分别为0.0622mmol/L、0.0836mmol/L、0.1133mmol/L,功能灵敏度分别为0.0996mmol/L、0.1037mmol/L、0.1259mmol/L。Ⅱ型糖尿病研究结果表明,正常对照组血清FFA检测结果为0.56±0.19mmol/L,病例组血清FFA检测结果为0.99±0.49 mmol/L,通过对病例组及对照组检测结果分析,Ⅱ型糖尿病患者血清FFA浓度与对照组血清FFA浓度有显著性差异,前者高于后者。心血管病研究结果表明,正常对照组血清FFA检测结果为0.56±0.13mmol/L,冠心病组血清FFA检测结果为1.06±0.22mmol/L,高血脂组血清FFA检测结果为0.68±0.31mmol/L,高血压组血清FFA检测结果为0.90±0.26mmol/L,通过对病例组及对照组检测结果分析,冠心病患者和高血压患者血清FFA浓度与对照组血清FFA浓度有显著性差异,冠心病患者和高血压患者高于正常对照组。高血脂组与正常对照组相比FFA无显著差异,结果相差不大。结论1、九强、朗道以及德赛三家公司FFA试剂盒具有良好的相关性。2、九强的试剂抗干扰能力和检测限优于朗道和德赛试剂,线性和精密度与朗道和德赛试剂基本无差异,三家试剂比较具体有等效性且临床符合性良好。3、九强公司生产的FFA检测试剂盒的临床检测性能良好,在临床上具有推广应用的潜在价值。4、通过对血清FFA在糖尿病和心血管疾病中的作用进行探讨,可以看出,临床上通过对血清FFA的监测,可以预测Ⅱ型糖尿病的发展和控制情况。血清FFA水平升高是冠心病和高血压发生的特征之一。
[Abstract]:Study on the significance and purpose of the blood free fatty acid FFA in diabetes (diabetes mellitus, DM), cardiovascular disease (angiocardiopathy, CD) important role in pathogenesis and disease, to detect the content of free fatty acid in human serum, can as early as possible abnormal free fatty acid in serum. Finally to the prevention and treatment of related diseases as soon as possible. Therefore, FFA detection for the diagnosis of diabetes, the prognosis of tracking control, has important significance in researching the mechanism. Although there are a variety of FFA detection kit market, lack of all kinds of methods of detection method and system between different agents and diagnostic efficiency the evaluation and determination method is not unified, so the research and evaluation of the urgent need for the existing detection methods of fast and accurate characteristics, which will be conducive to clinical work. In this paper The market of domestic and imported free fatty acid determination kit (enzymatic) for equivalent performance of clinical diagnostic tests, as well as in type II diabetes and cardiovascular disease on the clinical value of the evaluation methods. The hospital health examination personnel and patients with diabetes, cardiovascular disease, thyroid hyperfunction, acromegaly, serious liver disease and hunger, hypothyroidism, pituitary dysfunction, serum Addison's disease and other diseases, 100 cases of selected samples. According to the NCCLS EP standard, the Beijing nine strong biotechnology Limited by Share Ltd, the Landau company and the German company DESAY free fatty acid detection kit for detection limit, linearity, precision the performance and anti-interference ability to evaluate the clinical detection kit, and on the nine, Landau, the DESAY company's three free fatty acid detection kit for correlation evaluation, evaluation The correlation between the 22. This study further selection of type II diabetes and cardiovascular disease in clinical samples and samples of healthy control were 200 cases of detection in the automatic biochemical analyzer of free fatty acid in serum. Analysis of normal control group and the case group had significant difference. Statistical analysis was conducted using SPSS17.0 software, measurement data with x + S P0.05 said, the difference was statistically significant. The results of correlation analysis showed that between the three kit 22 has good correlation, R2 was greater than 0.99, product testing results in no statistically difference, good consistency. The precision of the results showed that the nine strong group of CV reagent for 0.44%~1.29%, CV for 0.85%~1.89% system Landau, the inside of CV 0.50%~1.52% reagent, 0.84%~2.18% reagent system CV, DESAY inside group CV 0.40%~1.23%, system CV 0.92%~2.51%. interference test showed that DESAY reagent on TG than Effect of concentration of 600mg/dl samples, nine strong influence and Landau reagent is higher than 900 mg/dl concentration of TG samples. The DESAY kit of VC basically no anti-interference ability, no effect nine and Landau kit of VC 50mg/dl concentration in the sample. The anti-interference ability of Landau kit of DB is very poor, no effect nine strong and DESAY kit of DB 40mg/dl concentration in the sample. Nine, DESAY did not affect Landau kit on HB 300mg/dl concentration samples. The results of linear test showed that three kinds of correlation kit with good linearity, and the differences were not statistically significant (P0.05). The results show that the detection limit, nine, Landau, blank test three DESAY home kit limit were 0.0301 mmol/L, 0.0340 mmol/L, 0.0484 mmol/L, lower limit of detection were 0.0622mmol/L, 0.0836mmol/L, 0.1133mmol/L, functional sensitivity were 0.0996mmol/L, 0.1037mmol/L, 0.1259mmol/L. II Diabetes research results show that the normal control group serum FFA detection results of 0.56 + 0.19mmol/L, case group serum FFA detection results of 0.99 + 0.49 mmol/L, according to the case group and the control group analysis, there was significant difference in type II diabetic serum FFA concentration and serum FFA concentration in control group, the former was higher than the latter cardiovascular disease. The results show that the normal control group serum FFA detection results of 0.56 + 0.13mmol/L, FFA serum test results for 1.06 + 0.22mmol/L, high cholesterol serum FFA detection results of 0.68 + 0.31mmol/L, hypertension group serum FFA detection results of 0.90 + 0.26mmol/L, the case group and the control group test results analysis, there was significant the difference in patients with coronary heart disease and serum FFA concentration in patients with hypertension and control group serum FFA concentration in patients with coronary heart disease in patients with hypertension, and higher than the normal control group hyperlipidemia group and the positive. Often compared to the control group FFA had no significant difference, the results are not significant. Conclusion: 1, nine, Landau and DESAY three companies FFA kit has a good correlation to.2, reagent nine strong anti-interference ability and the detection limit is better than DESAY and Landau reagent, linearity and precision and the reagent had no difference between Landau and DESAY, three an equivalent and more specific reagent have good agreement with the clinical performance of.3 clinical detection kit FFA kit nine strong company production is good,.4 has a potential value in clinical application, this paper discusses the role of FFA in the serum, diabetes and cardiovascular disease can be seen by clinical monitoring of serum FFA, can predict and control the development of type II diabetes. Elevated serum FFA level is one of the characteristics of coronary heart disease and hypertension.

【学位授予单位】：北京理工大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R446.112

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