WO2024046160A1 - 一种综合评价糖脂代谢水平的系统及其应用 - Google Patents

一种综合评价糖脂代谢水平的系统及其应用 Download PDF

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WO2024046160A1
WO2024046160A1 PCT/CN2023/114046 CN2023114046W WO2024046160A1 WO 2024046160 A1 WO2024046160 A1 WO 2024046160A1 CN 2023114046 W CN2023114046 W CN 2023114046W WO 2024046160 A1 WO2024046160 A1 WO 2024046160A1
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index
glycolipid
evaluation
glucose
treatment
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郭姣
荣向路
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广东药科大学
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    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
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    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/70—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients
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  • the invention relates to the field of disease and health status assessment, and specifically relates to a system for comprehensively evaluating glucose and lipid metabolism levels and its application.
  • Glucolipid metabolic disorders refers to a type of metabolic syndrome caused by disorders of glucose and lipid metabolism, mainly including obesity, type 2 diabetes, hypertension, hyperlipidemia, non-alcoholic fatty liver disease and atherosclerosis. Hardening etc. Research has found that the occurrence of many chronic diseases such as glycolipid metabolism is significantly related to the intake of more fats and sugars in the diet. This dietary structure significantly changes the metabolic status of the liver. A large number of reports indicate that these energy substances can increase blood sugar levels, are synthesized in the body, and accumulate into fat, further causing a series of metabolic problems.
  • Glucolipid metabolism diseases have diverse manifestations, including abnormal glucose metabolism, abnormal lipid metabolism, overweight, non-alcoholic fatty liver disease, and even atherosclerotic disease. The incidence rate remains high, leading to the syndrome The performance is complex and diverse.
  • Glucolipid metabolism is a clinically frequent and serious chronic disease. Many patients adopt Western medicine theory and medication methods for single treatment. As we all know, taking Western medicine has quick effects, but the side effects after long-term use are not small, and may cause liver disease. Major organs of the human body such as liver, kidneys, etc. have been damaged to varying degrees, and even due to severe dependence on Western medicine, it is difficult to maintain the efficacy of various Western medicines even if they are taken alternately. Therefore, simple Western medicine treatment often fails to achieve the effect of comprehensive control. Traditional Chinese medicine, from a holistic perspective, has unique advantages in treating such diseases. Whether it is syndrome differentiation and treatment guided by the theoretical system of traditional Chinese medicine, or basic experimental research based on modern pharmacology, it has been shown that traditional Chinese medicine has significant effects on lowering blood sugar and regulating lipids.
  • the hypoglycemic and lipid-lowering mechanism of traditional Chinese medicine is often multi-pathway, multi-link, multi-target and multi-effect.
  • Clinically, many patients with diabetes Some patients have achieved satisfactory blood sugar-lowering effects by taking traditional Chinese medicine, and some patients have improved various symptoms through the intervention of traditional Chinese medicine on the basis of maintaining good blood sugar by taking western medicine. It is undeniable that traditional Chinese medicine has exerted obvious advantages in treating glycolipid metabolism diseases and their complications in recent years.
  • the patent CN111297878A discloses a composition composed of at least two of the four compounds isolated from the medicinal material of bamboo ginseng, which can prepare hypoglycemic drugs or/and drugs for repairing high-sugar-induced kidney damage.
  • the patent CN108434296A discloses A traditional Chinese medicine composition for lowering blood sugar, lipids and blood viscosity, its preparation method and use.
  • the composition can be used for the prevention and treatment of pre-diabetes and diabetes, and is suitable for different syndrome types of pre-diabetes and diabetes.
  • These patents all indicate the important role of traditional Chinese medicine in the treatment of glycolipid metabolism diseases.
  • glycolipid metabolism disease is a newly defined clinical disease, and using existing indicators to evaluate efficacy cannot reflect the characteristics of the new disease. Therefore, there is an urgent need for a comprehensive evaluation index that reflects the body's glucose and lipid metabolism.
  • the present invention provides a system for comprehensively evaluating the level of glucose and lipid metabolism and its application.
  • This system is based on the characteristics of the holistic treatment of glucose and lipid metabolism diseases in traditional Chinese medicine and constructs a system that can appropriately reflect the glucose and lipid metabolism of the patient's body. , a new glycolipid index that can accurately evaluate the therapeutic effect.
  • the present invention claims a system for comprehensively evaluating glucose and lipid metabolism levels, which specifically includes an input module and a comprehensive evaluation module;
  • the input module is used to input glucose and lipid metabolism level evaluation indicators;
  • the glucose and lipid metabolism level evaluation indicators include waist circumference, fasting blood glucose, serum total cholesterol, and serum low-density lipoprotein cholesterol;
  • the comprehensive evaluation module is used to calculate the glycolipid index and output the evaluation results.
  • the body's glycolipid metabolism is disordered, and it can be used for early diagnosis and clinical screening of glycolipid metabolism diseases, and by comparing the GLI of patients with glycolipid metabolism diseases before and after treatment, the clinical treatment effect can be comprehensively evaluated.
  • the cut point is calculated as follows: using the receiver operating characteristic curve and the Youden index to obtain the optimal critical value.
  • the maximum Youden index is 0.96
  • glycolipid index is:
  • GLI glycolipid index
  • WC waist circumference
  • FPG fasting blood glucose
  • TG serum total cholesterol
  • LDL-C serum low-density lipoprotein cholesterol
  • a system for comprehensively evaluating the level of glucose and lipid metabolism includes the following steps:
  • the glucose and lipid metabolism level evaluation indicators described in step S1 are WC, FPG, TG and LDL-C.
  • the sample database described in step S1 is constructed by searching the Chinese biomedical literature database for clinical trial articles on the treatment of glycolipid metabolism diseases with traditional Chinese medicine, using "type 2 diabetes", “dyslipidemia” , “non-alcoholic steatohepatitis” and “TCM” as search terms, screen the literature for inclusion criteria, read the included literature, and select information: title, first author, author affiliation, publication journal, publication year, Western medicine diagnosis, traditional Chinese medicine Syndrome types, intervention measures in the control group, intervention measures in the experimental group, intervention time, evaluation indicators, adverse reactions and remarks are added to the table to establish a literature research database; the evaluation indicators include the total effective rate of treatment, total points of TCM syndromes, and physical examination indicators. , blood sugar evaluation indexes, blood lipid evaluation indexes, liver function evaluation indexes, hemorrheology indexes, pancreatic islet function evaluation indexes, inflammation indicators, oxidative stress indicators, neuroendocrine disorder indicators and scale scores.
  • the inclusion criteria are: (1) the research subjects meet the diagnostic standards in the "Technical Standards for Diagnosis and Treatment of Glucolipid Metabolism Diseases (Zhuo) Integrated Traditional Chinese and Western Medicine"; (2) Intervention measures: divided into a control group and an experimental group , the control group includes lifestyle change intervention, Western medicine treatment, and taking placebo.
  • the experimental group is comprehensive treatment with traditional Chinese medicine, including traditional Chinese medicine treatment.
  • traditional Chinese medicine treatment, acupuncture treatment, and massage treatment are added;
  • Literature The type is clinical research literature.
  • the modeling method described in step S2 is to perform binary logistic regression on the glucose and lipid metabolism level evaluation index, take the regression equation index and round the coefficient.
  • the present invention also provides the application of the above system for comprehensively evaluating the glucose and lipid metabolism level in the body's glucose and lipid metabolism.
  • the indicators used in the glycolipid formula are all commonly used clinical indicators, which are available in various hospitals and grassroots units and have good generalizability.
  • the index covers the basic information of glucose and lipid metabolism and is scientific.
  • the present invention retrieves clinical trial articles on the treatment of glycolipid metabolism diseases with traditional Chinese medicine, extracts key information, and establishes a sample database; performs statistical analysis on the sample database, and screens to obtain evaluation indicators for glucose and lipid metabolism levels; and performs evaluation on the evaluation indicators. Modeling was carried out to finally obtain the glycolipid index model.
  • the system using this glycolipid index model can comprehensively analyze the body's glucose and lipid metabolism, evaluate the overall condition of glucose and lipid metabolism diseases, fill the gap in the evaluation system of glucose and lipid metabolism diseases, and make a huge contribution to the modern development of traditional Chinese medicine.
  • Figure 1 is the ROC curve of glycolipid index for detecting glycolipid metabolism diseases.
  • CBM China Biology Medicine disc
  • the search terms were “type 2 diabetes”, “dyslipidemia”, “non-alcoholic steatohepatitis” and “traditional Chinese medicine”.
  • the inclusion criteria are: 1
  • the research subjects meet the diagnostic standards in the "Technical Standards for the Diagnosis and Treatment of Glucolipid Metabolism Diseases (Zhuo) Integrated Traditional Chinese and Western Medicine"; 2 Intervention measures:
  • the intervention measures in the control group include lifestyle modification intervention, Western medicine drug treatment, and taking placebo.
  • agent, the intervention method of the experimental group was comprehensive treatment of traditional Chinese medicine, including traditional Chinese medicine treatment.
  • the main information in the literature sample database includes: title, first author, author unit, publication journal, publication year, Western medicine diagnosis, TCM syndrome type, intervention measures in the control group, intervention measures in the experimental group, intervention time, evaluation indicators, adverse reactions and remarks .
  • the evaluation indicators include: total treatment effectiveness, total TCM syndrome score, physical examination indicators, blood sugar evaluation indicators, blood lipid evaluation indicators, liver function evaluation indicators, hemorrheology indicators, pancreatic islet function evaluation indicators, inflammation indicators, oxidative stress indicators, neuroendocrine disorders indicators and scale scores.
  • the first category is the overall evaluation category, which includes the total effective rate and the total score of TCM syndromes;
  • the second category is the clinical significance category, including physical examination indicators, glucose metabolism indicators, lipid metabolism indicators, liver function indicators and blood flow Metabolic indicators;
  • the third category is pathogenesis, which can be divided into 5 subcategories: insulin resistance indicators, inflammatory response indicators, oxidative stress indicators, neuroendocrine disorders indicators and intestinal flora indicators.
  • the fourth category is the prognostic evaluation category, including two subcategories: quality of life evaluation indicators and safety evaluation indicators, as shown in Table 1:
  • Indicators with better effects include WC among physical examination indexes, FPG among glucose metabolism evaluation indexes, TG and LDL-C among lipid metabolism evaluation indexes, and PV among blood rheology indexes.
  • Example 1 and Example 2 candidate indicators that can be incorporated into the formula were screened out, and then 100 clinical data were collected at the Guangdong Provincial Research Center for Integrated Traditional Chinese and Western Medicine in Metabolic Diseases, including 50 healthy people and 10 patients with glucose and lipid metabolism diseases. 50 cases.
  • the collected indicators include gender, age, BMI, WC, SBP, DBP, FPG, TC, TG, LDL-C, ALT, AST, plasma viscosity, and hematocrit.
  • SPSS26 statistical software was used, and independent sample t was used for normally distributed data.
  • the normality test showed that BMI, WC, SBP, DBP, TC, PCV and PV are normally distributed, and independent sample t test can be used; age, gender, FPG, TG, LDL-C, ALT and AST were non-normally distributed, and non-parametric rank sum test was used.
  • the results showed that there were significant differences in BMI, WC, SBP, DBP, FPG, TC, TG, and LDL-C between the healthy group and the glycolipid metabolism disease group, P ⁇ 0.05. There was no significant difference in PCV, PV, ALT and AST.
  • WC has the best sensitivity. WC also reflects the body's insulin resistance and is related to cardiovascular events. It is more clinically significant and can be given priority; Among the glucose metabolism indicators, the most common and widely used are the three included indicators, FPG, 2hPBG and HbA1c. The sensitivities of these three indicators are basically the same.
  • FPG which is used most frequently, naturally becomes the first choice indicator to evaluate the level of glucose metabolism
  • the lipid metabolism evaluation indicators can be divided into two categories, one is those with high frequency of use. , indicators with better sensitivity, they are TC, TG, HDL-C and LDL-C commonly used in clinical practice.
  • the focus should be on the first category of indicators.
  • TG is the most frequently used and most sensitive indicator, so TG can be used as the first choice indicator to evaluate lipid metabolism function
  • LDL-C levels are related to cardiovascular events. A linear correlation occurs, so LDL-C is considered to be included in the formula as an indicator of prognostic level. Therefore, the inclusion indicators of the formula were finally determined as WC, FPG, TG and LDL-C, as shown in Table 2:
  • GLI glycolipid index
  • WC waist circumference
  • FPG fasting blood glucose
  • TG serum total cholesterol
  • LDL-C serum low-density lipoprotein cholesterol.
  • the unit of WC is cm, and the unit of FPG, TG, and LDL-C is mmol/L.
  • the test result variable GLI has at least one binding value between the positive actual state group and the negative actual state group.
  • the minimum dividing value is the minimum measured test value minus 1
  • the maximum dividing value is the maximum measured test value plus 1
  • all other dividing values are Both are the average of two consecutive ordered measured test values.
  • the cut-off point can be set to 11.5, that is, when GLI > cut-off point, glycolipid metabolism disease can be diagnosed.
  • GLI can reflect the body's glucose and lipid metabolism. The larger the GLI value, the worse the body's glucose and lipid metabolism. In clinical practice, GLI can also be used to evaluate the patient's therapeutic effect. A reduced GLI value indicates that the patient's comprehensive treatment effect is better.

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Abstract

本发明公开了一种综合评价糖脂代谢水平的系统及其应用，属于疾病健康状态评估领域。本发明提供了一种综合评价糖脂代谢水平的系统，包括输入模块和综合评价模块，输入模块用于输入糖脂代谢水平评价指标，糖脂代谢水平评价指标包括腰围、空腹血糖、血清总胆固醇、血清低密度脂蛋白胆固醇，综合评价模块用于计算糖脂指数，并输出评价结果。该系统可以综合分析机体糖脂代谢情况，评价糖脂代谢病整体病情，填补了糖脂代谢病评价系统的空白，为中医药的现代化发展做出巨大贡献。

Description

一种综合评价糖脂代谢水平的系统及其应用
本发明要求于2022年09月02日提交中国专利局、申请号为202211075990.6、发明名称为“一种综合评价糖脂代谢水平的系统及其应用”的中国专利申请的优先权，其全部内容通过引用结合在申请中。
技术领域
本发明涉及疾病健康状态评估领域，具体涉及一种综合评价糖脂代谢水平的系统及其应用。
背景技术
糖脂代谢病(Glucolipid metabolic disorders,GLMD)是指糖脂代谢紊乱所引起的一类代谢综合征，主要包括肥胖、2型糖尿病、高血压、高血脂、非酒精性脂肪性肝病和动脉粥样硬化等。研究发现，许多像糖脂代谢病这种慢病的发生与饮食中较多的油脂和糖类等摄入显著相关，这种饮食结构显著改变了肝脏的代谢状况。大量报道表明，这些能量物质能够提高血糖水平，并在身体内合成，堆积为脂肪，进一步引发一系列的代谢问题。例如，血液中游离脂肪酸水平和血糖水平提高，可诱导肌肉、肝脏、脂肪细胞出现胰岛素抵抗(Insulin resistance,IR)、氧化应激等，进一步导致细胞脂肪合成和代谢异常，内分泌紊乱，形成恶性循环，最终使机体糖脂代谢出现紊乱。糖脂代谢病表现多样,既可出现糖代谢异常、脂质代谢异常,又可出现超重、非酒精性脂肪性肝病,甚至动脉粥样硬化性疾病,其发病率居高不下，以致其证候表现复杂多样。它们的共同特征是糖脂代谢紊乱,引起全身多系统损害,导致眼、肾、神经、心脏和血管等组织器官慢性进行性病变、功能减退甚至衰竭,严重危害人类健康,其综合防治是世界难题。
糖脂代谢病作为一种临床多发且重大的慢性疾病，不少病人采纳西医西药理论和用药方法进行单一治疗，众所周知，服用西药见效快，但是长期服用后的副作用也不小，可能会导致肝、肾等人体主要器官受到不同程度的损坏，甚至由于对西药产生严重的依赖，就算调换地服用各种西药也难以维持药效。所以采用单纯的西医治疗，往往达不到综合调控的效果。而中医从整体观的角度出发，在治疗此类疾病上有得天独厚的优势。无论是通过中医的理论体系来指导的辨证论治，还是从现代药理学出发而开展的基础实验研究，都显示出了中医药具有显著的降糖调脂的作用。
中药的降糖调脂机制常为多途径、多环节、多靶点、多效应的。临床上有许多糖尿病患 者通过服用中药获得了满意的降糖效果,也有一些患者在服用西药治疗保持良好血糖的基础上,通过中医药的干预改善了各方面的症状。不可否认，近年来中医药在治疗糖脂代谢病及其并发症上发挥了明显的优势。如专利CN111297878A公开了从竹节参药材中分离得到的4种化合物中的至少两种组成的组合物，能够制备降糖药物或/和用于修复高糖诱导的肾损伤药物、专利CN108434296A公开了一种降糖降脂降血粘的中药组合物及其制备方法与用途，该组合物可用于糖尿病前期和糖尿病的防治，适用于糖尿病前期和糖尿病期不同证型。这些专利都表明中药在治疗糖脂代谢病中的重要作用。
但是糖脂代谢病是一个全新定义的临床病种，用既有的指标来做疗效评价并不能体现新病种的特点，因此，目前急需要一种反映机体糖脂代谢情况的综合评价指数。
发明内容
本发明为实现上述目的，提供了一种综合评价糖脂代谢水平的系统及其应用，该系统基于中医整体论治糖脂代谢病的特点，构建了一个既能恰当反映病人身体糖脂代谢情况，又可以准确评价治疗效果的全新糖脂指标。
本发明请求保护一种综合评价糖脂代谢水平的系统，具体的包括输入模块和综合评价模块；
所述的输入模块，用于输入糖脂代谢水平评价指标；所述的糖脂代谢水平评价指标包括腰围、空腹血糖、血清总胆固醇、血清低密度脂蛋白胆固醇；
所述的综合评价模块，用于计算糖脂指数，并输出评价结果。
所述糖脂指数大于切点时，机体糖脂代谢紊乱，可用于糖脂代谢病的早期诊断和临床筛查,并且通过比较糖脂代谢病患者治疗前后的GLI，综合评价其临床治疗效果。
优选地，所述切点的计算方式为：利用受试者工作特征曲线和约登指数得到最佳临界值，当约登指数最大为0.96时，敏感度为100％，特异度为96％，对应的受试者工作特征曲线上的GLI结果即为切点；所述约登指数的计算公式为：约登指数＝敏感度+特异度-1。
所述糖脂指数的公式为：
其中，GLI为糖脂指数、WC为腰围、FPG为空腹血糖、TG为血清总胆固醇、LDL-C为血清低密度脂蛋白胆固醇。
一种综合评价糖脂代谢水平的系统，其糖脂指数的获得方法，包括以下步骤：
S1、对样本数据库进行统计学分析，筛选得到糖脂代谢水平评价指标；
S2、将步骤S1得到的糖脂代谢水平评价指标进行建模，得到所述糖脂指数公式。
优选地，步骤S1中所述的糖脂代谢水平评价指标为WC、FPG、TG和LDL-C。
优选地，步骤S1中所述的样本数据库的构建方式为：通过在中国生物医学文献数据库中检索有关中医药治疗糖脂代谢病的临床试验类文章，以“2型糖尿病”、“血脂异常”、“非酒精性脂肪性肝炎”和“中医”为检索词，筛选纳入标准的文献，阅读纳入的文献，选取信息：题目、第一作者、作者单位、发表期刊、发表年份、西医诊断、中医证型、对照组干预措施、实验组干预措施、干预时间、评价指标、不良反应和备注到表格中，建立文献研究数据库；其中评价指标包括治疗总有效率、中医证候总积分、体格检查指标、血糖评价指标、血脂评价指标、肝脏功能评价指标、血液流变学指标、胰岛功能评价指标、炎症指标、氧化应激指标、神经内分泌失调指标和量表评分。
优选地，所述的纳入标准为：(1)研究对象符合《糖脂代谢病(瘅浊)中西医结合诊疗技术规范》中的诊断标准；(2)干预措施：分为对照组和实验组，对照组包括改变生活方式干预，西医药物治疗，服用安慰剂，实验组为中医综合治疗，包括中药治疗，在对照组干预措施的基础上加入中药治疗，针灸治疗，推拿治疗；(3)文献类型为临床研究文献。
优选地，步骤S2中所述的建模方法为将所述的糖脂代谢水平评价指标作二元logistic回归，取回归方程指数并将系数取整。
本发明还提供了上述综合评价糖脂代谢水平的系统在机体糖脂代谢情况中的应用。
本发明具有以下有益效果：
(1)糖脂公式所采纳的指标皆是临床上常用指标，在各个医院及基层单位都可得到，具有良好的推广性。
(2)指标涵盖了糖脂代谢的基本信息，具有科学性。
(3)通过Logistic回归分析和受试者工作曲线下面积(AUROC)验证其具有较好的诊断性。
(4)本发明通过检索有关中医药治疗糖脂代谢病的临床试验类文章，提取关键信息，建立样本数据库；对样本数据库进行统计学分析，筛选得到糖脂代谢水平评价指标；对评价指标进行建模，最终得到糖脂指数模型。利用该糖脂指数模型的系统，可以综合分析机体糖脂代谢情况，评价糖脂代谢病整体病情，填补了糖脂代谢病评价系统的空白，为中医药的现代化发展做出巨大贡献。
附图说明
图1为检测糖脂代谢病的糖脂指数的ROC曲线。
具体实施方式
以下结合具体实施例对本发明上述的和另外的技术特征和优点作更详细的说明。
实施例1
建立文献样本数据库。
两名研究者相互独立地在中国生物医学文献数据库(China Biology Medicine disc，CBM)检索从2016年1月1日至2021年8月31日有关中医药治疗糖脂代谢病的临床试验类文章，以“2型糖尿病”、“血脂异常”、“非酒精性脂肪性肝炎”和“中医”为检索词。纳入标准为：①研究对象符合《糖脂代谢病(瘅浊)中西医结合诊疗技术规范》中的诊断标准；②干预措施：对照组的干预措施包括改变生活方式干预，西医药物治疗，服用安慰剂，实验组的干预方式为中医综合治疗，包括中药治疗，在对照组干预措施的基础上加入中药治疗，针灸治疗，推拿治疗；③文献类型为临床研究文献。筛选符合条件的文献。阅读纳入的文献，摘取以下信息到Excel表格中，建立文献样本数据库。
文献样本数据库中主要信息包括：题目、第一作者、作者单位、发表期刊、发表年份、西医诊断、中医证型、对照组干预措施、实验组干预措施、干预时间、评价指标、不良反应和备注。其中评价指标包括：治疗总有效率、中医证候总积分、体格检查指标、血糖评价指标、血脂评价指标、肝脏功能评价指标、血液流变学指标、胰岛功能评价指标、炎症指标、氧化应激指标、神经内分泌失调指标和量表评分。
实施例2
筛选糖脂指数的构成指标。
建立样本数据库采用频数统计法进行统计分析，得到了4大类13小类43种评价指标。第1大类为总体评价类，其中包括有总有效率和中医证候总积分；第2大类为临床意义类，包括体格检查指标、糖代谢指标、脂代谢指标、肝脏功能指标和血液流变学指标；第3大类为发病机制类，可分为胰岛素抵抗指标、炎症反应指标、氧化应激指标、神经内分泌失调指标以及肠道菌群指标5小类，但因肠道菌群指标使用频率低于1％，故仅纳入前4小类；第4大类为预后评价类，包括生存质量评价指标和安全性评价指标2个小类，具体如表1所示：
表1疗效评价指标的分类及使用情况
通过对这4大类指标的分析，可以得出临床意义类指标、最适合作为糖脂指数构成指标的结论，并通过对指标的使用频率和敏感性的分析，得到每个小类中，评价效果较好的指标，如体格检查类指标中的WC、糖代谢评价指标中的FPG、脂代谢评价指标中的TG和LDL-C、血液流变学指标中的PV。
实施例3
确定糖脂指数的公式。
根据实施例1和实施例2，筛选出了可纳入公式的候选指标，然后在广东省代谢病中西医结合研究中心搜集了100例临床数据，其中健康人有50例，糖脂代谢病患者有50例。采集的指标包括性别、年龄、BMI、WC、SBP、DBP、FPG、TC、TG、LDL-C、ALT、AST、血浆黏度、红细胞压积，采用SPSS26统计软件，正态分布数据采用独立样本t检验，非正态分布数据采用非参数秩和检验，多因素方差分析采用logistic回归法，受试者工作曲线下面积(AUROC)评价模型敏感性的指标，约登指数用作确定公式的最佳切点。
通过对受试者的基本资料进行分析，经正态性检验，BMI、WC、SBP、DBP、TC、PCV和PV是正态性分布，可用独立样本t检验；年龄、性别、FPG、TG、LDL-C、ALT和AST是非正态分布，采用非参数秩和检验。结果显示，健康组和糖脂代谢病组的BMI、WC、SBP、DBP、FPG、TC、TG、LDL-C有显著差异，P＜0.05。而PCV、PV、ALT和AST均无显著性差异。
对各类指标组合应用情况的研究发现，使用3类或4类评价指标的文献最多，使用8类的最少，所以选择的变量不宜过多，以3-4个为宜。通过对指标的使用频率及敏感性进行分析，发现体格检查指标中，WC的敏感性最好，WC还反映了人体胰岛素抵抗的情况，与心血管发生事件相关，更具有临床意义可优先考虑；在糖代谢指标中，最常见的也是应用最广泛的就是纳入的这三个指标，FPG、2hPBG和HbA1c。而这三个指标的敏感性基本相同，在这种情况下，使用频次最多的FPG自然成为评价糖代谢水平的首选指标；在脂代谢评价指标中可分为两类，一类是使用频率高，敏感性也较好的指标，他们就是临床上常用到的TC、TG、HDL-C和LDL-C。还有一类是使用频率较低，敏感性也较低的指标，即载脂蛋白A和B。应该将重点放在第一类指标中，这其中，使用次数最多和敏感性最好的都是TG，所以可以将TG作为评价脂代谢功能的首选指标；LDL-C的水平与心血管事件的发生成线性相关，所以，考虑将LDL-C纳入公式中作为衡量预后水平的指标。因此，将公式的纳入指标最终确定为WC、FPG、TG和LDL-C，如表2所示:
表2研究对象基本资料统计

将健康组和糖脂代谢病组的WC、FPG、TG和LDL-C四类指标(具体数据如表3所示)做二元logistic回归分析，得到回归方程：
利用该回归方程的指数，将系数近似为整数后，可得到修正后的糖脂指数计算公式：
其中，GLI为糖脂指数、WC为腰围、FPG为空腹血糖、TG为血清总胆固醇、LDL-C为血清低密度脂蛋白胆固醇。WC的单位是cm，FPG、TG、LDL-C的单位是mmol/L。
表3研究对象具体数据



在临床上纳入的100例研究对象，将具体数据(表3)带入到GLI的公式中，仅有1例的误判，误判率为2％。用得到的结果计算受试者工作曲线，得到AUROC为0.998(95％CI:0.993-1.000)，说明通过GLI来预测糖脂代谢病的发病具有很高的准确性，如图1所示。
约登指数，也称正确指数，是评价筛查试验真实性的方法，指数越大说明筛查实验的效果越好，真实性越大。利用公式：约登指数＝敏感度+特异度-1，计算GLI的约登指数，检验已得到的GLI，将得到的GLI数值，按照组别，在spss26.0里做受试者工作曲线，检验结果变量GLI至少有一个在正实际状态组与负实际状态组之间的绑定值，最小分界值为最小实测检验值减1，最大分界值为最大实测检验值加1，所有其他分界值均为两个连续的有序实测检验值的平均值。得到当约登指数最大为0.96时，敏感度为100％，特异度为96％，对应的GLI结果为11.474。为了在临床上方便应用，可将切点设置为11.5，即当GLI＞切点时，可诊断为糖脂代谢病。
GLI可反映机体的糖脂代谢情况，GLI值越大，说明机体的糖脂代谢情况越差。在临床上还可用GLI来评价患者的治疗效果，GLI值降低，说明患者的综合治疗效果较好。
本发明方案不仅限于上述技术手段所公开的技术手段，还包括由以上技术特征任意组合所组成的技术方案。以上所述是本发明的具体实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也视为本发明的保护范围。

Claims (10)

  1. 一种综合评价糖脂代谢水平的系统，其特征在于，包括输入模块和综合评价模块；
    所述的输入模块，用于输入糖脂代谢水平评价指标；所述的糖脂代谢水平评价指标包括腰围、空腹血糖、血清总胆固醇、血清低密度脂蛋白胆固醇；
    所述的综合评价模块，用于计算糖脂指数，并输出评价结果。
  2. 根据权利要求1所述的系统，其特征在于，当所述糖脂指数大于切点时，机体糖脂代谢紊乱。
  3. 根据权利要求2所述的系统，其特征在于，所述切点的计算方法为：利用受试者工作特征曲线和约登指数得到最佳临界值，当约登指数最大为0.96时，敏感度为100％，特异度为96％，对应的受试者工作特征曲线上的GLI结果即为切点；所述约登指数的计算公式为：约登指数＝敏感度+特异度-1。
  4. 根据权利要求1所述的系统，其特征在于，所述的糖脂指数的公式为：
    其中，GLI为糖脂指数、WC为腰围、FPG为空腹血糖、TG为血清总胆固醇、LDL-C为血清低密度脂蛋白胆固醇。
  5. 根据权利要求1所述的系统，其特征在于，所述糖脂指数的获得方法，包括以下步骤：
    S1、对样本数据库进行统计学分析，筛选得到糖脂代谢水平评价指标；
    S2、将步骤S1得到的糖脂代谢水平评价指标进行建模，得到所述糖脂指数公式。
  6. 根据权利要求5所述的系统，其特征在于，步骤S1中所述的糖脂代谢水平评价指标为WC、FPG、TG和LDL-C。
  7. 根据权利要求5所述的系统，其特征在于，步骤S1中所述的样本数据库的构建方式为：通过在中国生物医学文献数据库中检索有关中医药治疗糖脂代谢病的临床试验类文章，以“2型糖尿病”、“血脂异常”、“非酒精性脂肪性肝炎”和“中医”为检索词，筛选纳入标准的文献，阅读纳入的文献，选取信息：题目、第一作者、作者单位、发表期刊、发表年份、西医诊断、中医证型、对照组干预措施、实验组干预措施、干预时间、评价指标、不良反应和备注到表格中，建立文献研究数据库；其中评价指标包括治疗总有效率、中医证候总积分、体格检查指标、血糖评价指标、血脂评价指标、肝脏功能评价指标、血液流变学指标、胰岛功能评价指标、炎症指标、氧化应激指标、神经内分泌失调指标和量表评分。
  8. 根据权利要求7所述的系统，其特征在于，所述的纳入标准为：(1)研究对象符合《糖脂代谢病(瘅浊)中西医结合诊疗技术规范》中的诊断标准；(2)干预措施：分为对照组和实验组，对照组包括改变生活方式干预，西医药物治疗，服用安慰剂，实验组为中医综合治疗，包括中药治疗，在对照组干预措施的基础上加入中药治疗，针灸治疗，推拿治疗；(3)文献类型为临床研究文献。
  9. 根据权利要求5所述的系统，其特征在于，步骤S2中所述的建模的方法为：将所述的糖脂代谢水平评价指标作二元logistic回归，取回归方程指数并将系数取整。
  10. 根据权利要求1-9任一项所述的综合评价糖脂代谢水平的系统在机体糖脂代谢情况中的应用。
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CN115547495A (zh) * 2022-09-02 2022-12-30 广东药科大学 一种综合评价糖脂代谢水平的系统及其应用

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