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1 硕士学位论文论文题目糖化血清白蛋白在正常及妊娠期糖尿病孕妇中的临床研究研究生姓名指导教师姓名专业名称研究方向论文提交日期王凤环李华萍妇产科学围产医学 2014 年 4 月

7 糖化血清白蛋白在正常及妊娠期糖尿病孕妇中的临床研究中文摘要糖化血清白蛋白在正常及妊娠期糖尿病孕妇中的临床研究中文摘要第一部分糖化血清白蛋白在正常孕妇中的临床研究目的通过对正常孕妇糖化血清白蛋白 (Serum Glycated Albumin, GA) 的研究, 探讨其影响因素变化趋势, 初步建立妊娠期 GA 的正常参考值范围方法选择 2010 年 12 月 1 日至 2014 年 2 月 28 日在上海交通大学附属第六人民医院产科门诊产前检查并分娩的孕妇, 采用前瞻性研究, 以 1479 例血糖正常, 无合并症的孕妇为研究对象, 采用 t 检验多元线性回归分析等方法研究孕期 GA 的影响因素和变动趋势对孕前体重指数 (BMI) 正常及孕期体重增长在正常范围的孕妇采用百分位数方法初步制定 GA 医学参考值范围结果 (1)1479 例正常孕妇在孕 12~16W 24~28W 36~38W GA 值与相应孕周的血糖均有良好的相关性 ; 与孕前 BMI 均成负相关关系 (P<0.05); 在孕 24~28 周孕 36~38 周 GA 与相应孕周体重增长呈负相关关系 (P<0.05) 各期 GA 与年龄孕产次新生儿体重之间无明显相关性 (P>0.05) 多元线性回归分析显示孕前 BMI 及空腹血糖 (FPG) 是影响各孕期 GA 的主要因素 (2) 根据 BMI 水平, 将正常孕妇分为低 BMI 组, 正常 BMI 组, 超重及肥胖组 3 组, 在孕 12~16 孕 24~28 孕 36~38 周各组间 GA 水平差异均有统计学意义 (P<0.05) GA 值在各孕期均具有统计学差异 (P<0.05) (3) 正常孕妇 1479 例, 其中正常 BMI 及孕期体重增长在正常范围的孕妇 769 例, 以百分位数法取 2.5%~97.5% 作为孕期 GA 正常参考值, 其范围为 9.20%~14.70% 孕 12~16 周 GA 参考值范围为 10.53%~15.30%; 孕 24~28 周为 10.00%~13.98%; 孕 36~38 周 GA 为 9.03%~13.50% 结论随孕前 BMI 增长及孕期的进展 GA 水平逐渐降低, 且 GA 值受孕期体重增长的影响 GA 与血糖有良好的相关性, 能够反映出血糖水平, 可作为孕期血糖监测的一个良好指标 9.20%~14.70% 可初步作为妊娠期 GA 的正常参考值范围关键词糖化血清白蛋白 ; 妊娠 ; 正常 I

8 中文摘要糖化血清白蛋白在正常及妊娠期糖尿病孕妇中的临床研究第二部分糖化血清白蛋白在妊娠期糖尿病孕妇中的临床应用研究目的分析妊娠期糖尿病 (gestational diabetes mellitus, GDM) 孕妇 GA 水平与常用代谢参数新生儿体重等妊娠结局的相关性, 探讨 GDM 患者 GA 监测的临床意义方法 2010 年 12 月至 2014 年 2 月上海交通大学附属第六人民医院正规产检孕妇 2118 例进行前瞻性研究, 诊断为 GDM 孕妇 639 例, 选取血糖正常孕妇 1479 例作为对照组分别于孕 12~14W 孕 24~28W 孕 36~38W 采用液态酶法测定 GA 水平, 并计算相关指标及进行统计学分析结果 (1) 与正常组孕妇比较,GDM 组孕妇在 24~28W 36~38W,GA 水平明显升高, 差异具有统计学差异 (2)Pearson 相关分析显示 : 孕 12~16W GA 与孕前 BMI 均呈负相关 (r=-0.231,p=0.000), 与空腹血糖呈正相关 (r=0.135,p=0.011) 与年龄孕产次无明显相关性,P 值均 >0.05 孕 24~ 28W GA 与 OGTT FPG 1PG 2PG 血糖异常情况新生儿体重呈正相关, P 值均 <0.05; 而与 HOMA-β I30/ G30 体重增长呈负相关, 但与孕前 BMI HOMA -IR 无明显相关性孕 36~38W GA 与 FPG 新生儿体重血糖控制情况呈正相关 ; 与孕期体重增长分娩时 BMI 呈负相关 P 均 <0.05 经多元逐步回归分析结果显示孕前 BMI FPG 是影响孕 12~16W GA 的的独立影响因素 ;FPG OGTT2hPG 及 130/ G30 为孕 24~28W GA 的主要影响因素 ; 而孕 FPG 分娩 BMI 孕期体重增长血糖控制情况新生儿体重为影响孕 36~38W GA 的主要危险因素 (3) 以 OGTT 为 GDM 诊断标准, 绘制受试者特征工作曲线 (ROC), GA 对 GDM 诊断的曲线下面积为 0.581(95%C.I:0.545~0.618),p=0.000 以 GA 12.30% 为切点诊断 GDM 的敏感度为 39.26%; 以 GA 14.00% 为切点诊断 GDM 的敏感度为 9.13% 而通过 ROC 曲线评估孕晚期血糖控制不满意的 GA 切点为 11.60%, 敏感度 76.54%, 特异度为 87.15% (4) GDM 患者孕 24~28W 孕 36~38WGA 水平与新生儿体重成正相关关系 ; 孕 24~28W GA 水平 13.00%, 超重儿的发生率明显升高 ; 孕 24~28W GA 水平 14.00% 孕 36~38W GA 水平 12.00%, 巨大儿的发生率明显升高同时孕 36~ 38W 高 GA 组的 GDM 孕妇中, 剖宫产胎膜早破产后出血发生率均高于低 GA 组结论 : GA 可准确反映 GDM 患者短期内平均血糖水平及变化, 孕晚期 GA 11.60% II

9 糖化血清白蛋白在正常及妊娠期糖尿病孕妇中的临床研究中文摘要可作为一个优良且检测方便的血糖控制不佳的指标 GDM 患者孕中晚期 GA 与巨大儿的发生密切相关, 可为临床处理提供依据但不推荐孕中期 GA 作为 GDM 诊断指标关键词 : 妊娠期糖尿病 ; 糖化血清白蛋白 ; 巨大儿作者 : 王凤环指导老师 : 李华萍 III

10 英文摘要糖化血清白蛋白在正常及妊娠期糖尿病孕妇中的临床研究 The Clinical Study of Serum Glycated Albumin in Normal Pregnant Women and Patients with Gestational Diabetes Mellitus Abstract Part I. The clinical study of serum glycated albumin in normal pregnancy women Objective To set up the reference value of serum glycated albumin(ga)in pregnancy for using in clinical practice through a clinical trial of normal pregnant women, and to discuss the influencing factors and trends.methods 1479 normal pregnant women who presented to obstetric clinics of Shanghai Jiao Tong University Affiliated Sixth People's Hospital between December 1, 2010 and February 28, 2014 were studied with prospective study, using the method of percentiles to establish the reference range of GA for normal prepregnancy body mass index (BMI) and weight gain within the normal range of 769 cases and using t test, multiple linear regression analysis method to study the influential factors and change trend. Results (1)GA value was negative correlation with prepregnancy BMI and positive correlation with glucose in the 1479 normal pregnant women((p<0.05); there is no obvious correlation between GA and age,birth weight and gravidity and parity (P>0.05),but GA is negative correlation with weight gain during pregnancy; Multiples stepwise regression analysis showed that prepregnancy BMI and FPG were the main influential factors of GA in 12~16, 24~28 and 36~38 weeks of gestation.(2)when dividing 1479 subjects by prepregnancy BMI into 3 groups, low body mass index group,normal body mass index group, and overweight and obesity group, respectively,we came to the following results:there was significant difference in the GA levels among the 3 groups(p<0.05) in 12~16, 24~28 and 36~38 weeks of gestation.in addition, GA values were statistically difference during pregnancy (P < 0.05).(3)The level of GA in the 2.5th to 97.5th percentile was 9.20%~14.70% of the 769 normal pregnant women with normal body mass index and weight gain within the normal range; 10.53%~ IV

11 糖化血清白蛋白在正常及妊娠期糖尿病孕妇中的临床应用研究英文摘要 15.46% in 12~16 weeks of gestation; 9.84%~13.96% in 24~28 weeks of gestation and 8.94%~13.26% in 36~38 weeks of gestation, respectively. Conclusion With the growth of progestational body mass index and the progress of the pregnancy, GA gradually reduced, and is affected by weight gain during pregnancy. GA has good correlation with glucose, it can reflect the blood glucose levels and be used as a good indicator of the blood glucose monitoring during pregnancy. The normal range of GA for the pregnant women could be suggested at 9.20%~14.70%. Keywords Gestational; Glycated albumin; Reference values; V

12 英文摘要 Part Ⅱ 糖化血清白蛋白在正常及妊娠期糖尿病孕妇中的临床研究 The Clinical Study of Serum Glycated Albumin in Patients with Gestational Diabetes Mellitus Aim To explore the clinical significance in gestational diabetes mellitus and analyse the correlation between GA and metabolic parameters, neonatal weight and others. Methods Using the liquid enzymatic method to determine the GA value of the 639 gestational diabetes mellitus women and 1479 normal pregnant women in 12~14, 24 ~ 28 and 36~38 weeks of gestation, and then calculating the interrelated indexes, who presented to obstetric clinics of Shanghai Jiao Tong University Affiliated Sixth People's Hospital between December 1, 2010 and February 28, 2014 through the prospective study. Results (1) Compared with normal group, the GA levels of GDM group increased significantly at 24 to 28 weeks of gestation and 36 to 38 weeks of gestation in GDM group, the difference has statistical difference (p < 0.05). (2) Pearson correlation analysis showed that GA value,in 12~16 weeks of gestation, was negative correlation with prepregnancy BMI ( r=-0.231, P=0.000 ) and positive correlation with FPG (r=0.135,p=0.011). There was no obvious correlation between GA and age, gravidity and parity (P>0.05). In 24~28 weeks of gestation GA was positive correlation with OGTT FPG, 1hPG, 2hPG, glucose abnormalities condition and birth weight (P<0.05), GA was negative correlation with HOMA-β, I30/ G30, weight gain in 24~28 weeks of gestation, but there was no correlation between GA and propregnancy BMI, HOMA-IR. GA was positive correlation with FPG, birth weight and blood glucose controlled situation, and was negative correlation with weight gain in 36~38 weeks of gestation and BMI before delivery. Multiples stepwise regression analysis showed that prepregnancy BMI and FPG is the main influential factors of GA in 12~16 weeks of gestation, OGTT FPG 2hPG and 130/ G30 in 24~28 weeks of gestation, FPG, birth weight, blood glucose controlled situation,weight gain and BMI before delivery in 36~38 weeks of gestation. (3) Based on OGTT diagnosis standard of GDM, we plotted the participants work characteristic curve (ROC). The area under curve of the GA to GDM diagnosis was VI

13 糖化血清白蛋白在正常及妊娠期糖尿病孕妇中的临床应用研究英文摘要 (95% C.I; ~ 0.618), p = 0.000). When GA 12.30% was set as the tangent point of GDM diagnosis the sensitivit was 39.26%, and the specificity was 73.68%; GA 14.00% the sensitivity is 9.13%, and the specificity was 96.87%. (4) In gestational diabetes mellitus patients, GA showed a significant positive correlation with neonatal weight in 24 ~28 and 35~38 weeks of gestation. When GA 13.00% had a higher risk for overweight baby ( 3500g) in 24 ~28 weeks, GA 14.00% and GA 12.00% for macrosomia ( 4000g) in 24 ~28 and 36~38 weeks of gestation respectively. While, in the high GA group of GDM patients, the incidence of caesarean section, premature rupture of membranes, postpartum hemorrhage was higher than that in the low GA group. Conclusion In GDM patients, GA can accurately reflect the average blood glucose levels and changes in the short term. GA 11.60% can be used as a adequate and convenient detection indicator for judgeing the poor blood glucose control in third trimester. But GA can not be recommended for a diagnosis index of GDM. GA is closely related to the occurrence of macrosomia in second and third trimester of GDM patients, and it can provide a basis for clinical treatment. Keywords Gestational diabetes mellitus; Glycated albumin; Macrosomia Written by: Wang feng-huan Supervised by: Li hua-ping VII

15 目录序言...1 第一部分糖化血清白蛋白在正常孕妇中的临床研究对象与方法对象诊断标准及分组测量方法统计学方法结果研究对象的临床特征正常孕妇 GA 与各指标的相关性分析 GA 水平与孕前 BMI 的关系孕期糖化白蛋白正常参考值范围的初步制定讨论 GA 与血糖的关系孕前 BMI 与 GA 水平的关系 GA 水平与孕期的关系孕期 GA 正常参考值的初步确立...12 第二部分糖化血清白蛋白在妊娠期糖尿病孕妇中的临床应用研究研究对象与方法研究对象诊断标准及分组测定方法资料处理与分析结果 GDM 孕妇的临床特征两组孕妇人口学资料比较...14

16 2.3 两组孕妇 GA 值的比较 GDM 组中 GA 与各指标的相关性分析影响 GDM 组 GA 的多元逐步回归 GA 在 GDM 诊断及血糖控制中的应用价值 GDM 组孕中晚期 GA 水平与新生体重相关性分析孕 36~38 周 GDM 组 GA 与妊娠结局的关系讨论孕期 CA 的变化及影响因素 GA 在 GDM 诊断及血糖控制方面的临床价值...25 结论...28 参考文献...29 攻读硕士学位期间发表论文...35 附录 1 中英文词汇缩写...36 附录 2 综述...38 附录 3 论著...42 致谢...47

2014年1月A 1期排版.FIT)

2014年1月A 1期排版.FIT) 第 26 卷第 15 期中国现代医学杂志 Vol. 26 No.15 2016 年 8 月 China Journal of Modern Medicine Aug. 2016 DOI: 10.3969/j.issn.1005-8982.2016.15.022 文章编号 : 1005-8982(2016)15-0114-05 声检查对产前出血病因诊断的