心理干预治疗妊娠期糖尿病的疗效观察研究

发布时间：2018-06-29 15:55

本文选题：妊娠期糖尿病 + 疗效观察　；参考：《南方医科大学》2014年硕士论文

【摘要】：[研究背景]妊娠期糖尿病是指妊娠期发生或首次发现的不同程度的糖耐量异常,不包括妊娠前已诊断的糖尿病。妊娠期糖尿病的定义和诊断标准,在不断的争议讨论中发展、完善。据世界各地流行病学调查显示,妊娠期糖尿病的发病率种族间存在着明显差异,由于国际上尚无统一的诊断标准,国内亦无推荐使用的统一标准,再加上诊断标准的不断变化,因此,各国报道的发病率相差悬殊,为1%-14%,我国内发病率为1%-4%,且呈逐年上升的趋势。鉴于妊娠期糖尿病发病率不断增加和严重的危害性,故及时有效的治疗就显得格外重要。目前,对妊娠期糖尿病的发病机制尚未完全明确,根据最新的研究进展,其发病可能与遗传易感性、脂肪因子、慢性炎症反应、肥胖、运动量、饮食、孕妇年龄及心理社会应激等有关。因妊娠期糖尿病会导致一系列母、儿孕期并发症发生率增加,包括：巨大胎儿、宫内慢性缺氧、胎儿心脏发育异常、羊水过多、胎膜早破、早产、新生儿低血糖等情况。只有在整个妊娠期中,控制母体血糖至正常范围,才能改善妊娠期糖尿病孕妇母、儿的结局。目前临床治疗方法包括饮食疗法、运动疗法、胰岛素使用等,需要指出的是,胰岛素治疗必须在饮食治疗的基础上进行,否则效果不满意。饮食、运动等非药物治疗是妊娠期糖尿病不可替代的、有效的,也是主要的治疗方法,其在控制血糖,减少围产期母婴并发症和减少胰岛素用量等方面都有确切的临床疗效；口服降糖药因其可能导致畸胎、巨大儿、新生儿低血糖,甚至死亡等故在妊娠期糖尿病的使用存在着较大争议,我国目前仍以胰岛素作为妊娠期糖尿病唯一药物治疗,但是胰岛素最佳治疗剂量尚无统一标准,国内外学者普遍认为胰岛素用量应个体化,并充分考虑胎盘激素随着妊娠的进展而对胰岛素敏感性的影响,及时调整胰岛素用量。临床上,对妊娠期糖尿病患者目前以饮食运动为主,当饮食运动干预后,血糖仍无法达标者,需要尽快使用胰岛素控制血糖。不可否认,也取得了一定效果。现有的治疗手段往往忽略了孕妇最常见的心理应激产生的影响。妊娠期糖尿病血糖升高特点为：餐后血糖升高较快,空腹及夜间容易出现低血糖。所以妊娠期糖尿病血糖控制治疗方案选择,应保证和提供妊娠期间母体、胎儿发育正常所需热量和营养需要,避免餐后高血糖或饥饿性酮症出现,血糖控制在正常方案。考虑到妊娠是妇女特殊的生理阶段,孕妇易情绪紧张,血糖水平波动大,因此增加了控制血糖的难度,心理调节有助于改善孕妇情绪,减少忧郁,使其积极配合饮食控制及其他治疗,有利于血糖的调节。从而达到平稳控制血糖,预防低血糖发生。但目前心理治疗的研究尚处于发展阶段,还需要大量的队列性临床研究来证实其治疗作用。上述每种因素都与妊娠期糖尿病的发生有相关性,但目前为止,用上述任何一种病因都无法单独解释妊娠期糖尿病的发生机制,可能是上述各因素相互作用的结果。多数学者认为该病发生是综合因素作用的结果,而在妊娠期糖尿病的发病机制研究中,心理社会应激方面的研究明显不足,近年来发现5-羟色胺(5-HT)直接或间接参与了心理调节,研究发现在妊娠期糖尿病患者中,SCL-90积分与血清5-HT水平呈正相关,提示在妊娠期糖尿病的患者中,5-HT含量的改变同样是该病患者心理状况不良的一个重要环节,在心理干预的评估中其重要作用。在治疗上,考虑到妊娠期的特殊性,确诊妊娠期糖尿病后,均应以生活方式干预为主,药物在生活方式干预下血糖仍控制不佳时使用。而对心理干预治疗的效果评价研究相对不足,现有这方面的研究也存在疾病诊断标准不统一、样本含量偏少、症状缺乏统一公认的分级量化指标与疗效评定标准、观察时间有限,缺乏长期随访、无基础研究作为支持等,故无法明确其治疗机理。本研究根据2011年我国颁布实施的妊娠期糖尿病诊断行业标准,并参照美国糖尿病学会2013年的妊娠期糖尿病诊治标准的相关规定,以此作为研究参考,对比三组治疗妊娠期糖尿病情况,观察心理干预方式治疗疗效。[目的]1、观察三种方式治疗妊娠期糖尿病患者在降低空腹血糖、OGTT后1h、2h血糖、糖化血红蛋白及血清5-HT含量,改善患者病情、提高远期疗效等方面的作用,客观评价其临床疗效；2、观察心理干预治疗对妊娠期糖尿病的疗效,从而为临床应用提供一种有效的治疗方案。[方法]1、试验设计方案本项研究所有病例均来自2013年1月至2013年12月南方医科大学附属广东省第二人民医院内分泌科门诊及住院病房。纳入标准：参照2011年我国颁布实施的妊娠期糖尿病诊断行业标准而制定如下：诊断一步法：不必行50g葡萄糖负荷试验(GCT),而妊娠24周-28周直接行75g葡萄糖耐量试验(OGTT)。75gOGTT的正常值：空腹、服葡萄糖后1h、2h血糖值分别小于5.1mmol/L、10.0mmol/L、8.5mmol/L。任意一点血糖值异常者应诊断为妊娠期糖尿病。将所有确诊娠期糖尿病入选病例作为受试对象,以就诊时间顺序编号,根据随机数字表法均分成4组。分别为对照组：单纯生活方式干预37例,试验A组：生活方式干预+胰岛素37例,试验B组：生活方式干预+心理干预37例,试验C组：生活方式干预+心理干预+胰岛素组37例。2、治疗方法对照组：单纯生活方式干预患者采取健康宣传、运动、饮食指导联合干预治疗。运动以家庭上肢运动(每天30min,每天3次)和散步(每天40min,餐后1h后进行)相结合为主,饮食方面有营养师专门指导,碳水化合物、蛋白质、脂肪能量比大约为4：3：3。试验A组：生活方式干预+胰岛素,患者在生活方式干预的基础上加用门冬胰岛素注射液诺和锐,NovoRapidPenfill,生产批号：CVG0519),每天三餐前皮下注射,小剂量1-2单位开始,然后根据血糖监测,调整剂量。如空腹血糖仍不达标,≥5.3mmol/L时,给予加用诺和灵N睡前皮下注射治疗,小剂量开始,根据血糖调整剂量。试验B组：生活方式干预+心理干预,患者在生活方式干预基础上配合心理干预治疗,心理干预的具体方法为：由心理治疗师专人负责对妊娠期糖尿病患者进行宣教、解释病因、后果及预防措施,让患者充分认识到妊娠期糖尿病对孕产妇及围产儿均有较大危害,应予以重视。对一些伴有烦躁易怒,心情郁闷等情绪障碍的妊娠期糖尿病患者进行沟通开导,缓解或消除患者不当情绪,心理障碍严重者适当行为认知治疗。试验C组：生活方式干预+心理干预+胰岛素,患者在生活方式干预下加用胰岛素与心理干预治疗。四组患者治疗,2周为一个观察和检测疗程,共4个疗程,并在疗程结束后对四组患者进行回访至生产。3、观察指标对比三试验组与对照组及三试验组间患者空腹血糖、餐后2小时血糖,4个疗程结束后的空腹血糖、OGTT试验1h、2h血糖水平、糖化血红蛋白、血清5-HT含量的变化,以及治疗过程中低血糖发生、孕期母婴不良情况发生,把收集的数据进行统计学处理,比较三种方式对妊娠期糖尿病的治疗效果。4、统计学处理及CRF表的制作向所有受试者详细说明参加临床试验可能得到的利益与承担的风险,让患者及家属充分知情,征得患者同意并书面签署知情同意书；按设计要求,统一表格,详细记录；认真写好病例观察表；各种数据均做统计学处理。调查表数据编码量化后输入计算机,用SPSS13.0统计分析软件处理,患病率以百分率表示,先对样本资料进行正态性检验和方差齐性检验。所有数据均用以(x±s)表示,检验以P0.05为有统计学意义。对于正态分布,且方差齐同的计数资料采用R×C表卡方(χ2)检验,Ridit分析。计量资料采用t检验；对于偏态资料或未知分布类型的资料可用非参数检验法,比如秩和检验等。最后按设计要求,统一制作CRF表：患者签署知情同意书,详细记录,认真书写病例,注意观察不良反应或未预料的不良反应。[结果]1、基线资料以就诊时间顺序编号,根据随机数字表法分成对照组、试验A组、试验B组、试验C组各37例,因在治疗过程中试验A组脱落2例,试验B组脱落1例,试验C组脱落2例,实际例数对照组37例,试验A组35例,试验B组36例,试验C组35例。对照组身高(1.64±0.21)m,孕前体重(52.17±11.17) kg, BMI (20.67±10.05) kg/m2,平均年龄(28.53±8.49)岁；试验A组身高(1.66±0.27)m,孕前体重(53.65±12.05) kg, BMI (21.09±9.39) kg/m2,平均年龄(28.25±9.63)岁；试验B组身高(1.65±0.31)m,孕前体重(52.88±11.93) kg, BMI (20.93±9.57) kg/m2,平均年龄(29.13±8.67)岁；试验C组身高(1.66±0.19)m,孕前体重(53.97±12.41) kg, BMI (20.75±9.51) kg/m2,平均年龄(28.45±9.01)岁。2.治疗前纳入各组的空腹血糖,OGTT1h血糖、2h血糖,糖化血红蛋白分别进行成组t检验,各血糖和糖化血红蛋白水平组问比较,均是P0.05,差异无统计学意义。治疗后各组患者血糖水平经方差分析LSD-t检验,三试验组与对照组相比,各血糖水平差异有统计学意义(P0.05)；试验A组与试验B组相比,各血糖水平与之差异不明显(P0.05)、试验A组与试验C组相比,各血糖水平差异有统计学意义(☆P0.05)；试验C组患者在空腹血糖,OGTT1h、2h,糖化血红蛋白方面与其余三组相比,差异有统计学意义(P0.05)3、经过4个疗程的治疗,与对照组相比,三试验组在降低5-羟色胺水平方面有明显差异,差异有统计学意义(P0.05)；三试验组之间相比,也有统计学差异(P0.05)；4、三组试验组与对照组各项妊娠结局相比,除剖宫产几率相似外,其余几项都有明显差异,有统计学意义(P0.05)；5、四组患者治疗对血、尿、粪常规及肝、肾功能等方面均无明显影响；6、使用胰岛素治疗的试验C组有4例患者出现水肿、荨麻疹等不良反应。[结论]胰岛素对妊娠期糖尿病控制血糖方面疗效确切,而心理干预治疗也是效果显著的治疗方式之一；心理干预治疗可使妊娠期糖尿病患者情绪稳定,积极配合治疗,从而改善患者血清5-羟色胺(5-HT)水平,达到协助控制血糖的治疗目的；生活方式干预配合心理、胰岛素的综合治疗,在血糖控制水平、降低糖化血红蛋白水平,改善患者心理状态、减少母婴并发症方面综合效果最为显著；心理干预治疗方式的发生低血糖情况较少,无明显不良反应发生。心理干预治疗方法或成为第三种辅助控制妊娠期糖尿病血糖的有效方法。
[Abstract]:[background] gestational diabetes refers to different levels of impaired glucose tolerance occurring during pregnancy or first found, excluding pre pregnancy diagnosed diabetes. The definition and diagnostic criteria for gestational diabetes are developed and perfected in the ongoing debate. According to epidemiological studies around the world, the incidence of gestational diabetes is shown. There are obvious differences among ethnic groups. Because there is no unified standard of diagnosis in the world, there is no unified standard of recommendation in China, and the constant changes of diagnostic standards. Therefore, the incidence of reports in various countries is very different. As 1%-14%, our domestic incidence is 1%-4% and the trend of increasing year by year. In view of the increasing incidence of gestational diabetes mellitus At present, the pathogenesis of gestational diabetes is not completely clear. According to the latest research progress, the pathogenesis of gestational diabetes may be related to genetic susceptibility, fat factor, chronic inflammatory reaction, obesity, transport of momentum, diet, pregnant women's age and psychosocial stress. Gestational diabetes can lead to a series of maternal and pregnancy complications, including: fetal macrosomia, chronic hypoxia in the uterus, abnormal fetal heart development, excessive amniotic fluid, premature rupture of membranes, premature birth, hypoglycemia, and so on. Only during the whole pregnancy, the control of maternal blood glucose to the normal range can improve pregnant women with gestational diabetes. The clinical treatment methods include diet therapy, exercise therapy, insulin use and so on. It is necessary to point out that insulin therapy must be based on dietary therapy, otherwise the effect is not satisfactory. Non drug therapy, such as diet and exercise, is an irreplaceable, effective, and major treatment method for gestational diabetes. There is a definite clinical effect in controlling blood sugar, reducing maternal and infant complications in perinatal period and reducing the dosage of insulin; oral hypoglycemic agents are controversial in the use of gestational diabetes because they may lead to teratoma, gigantic infants, neonatal hypoglycemia, and even death, and insulin is still used as gestational diabetes in our country. The only drug treatment, but the best treatment dose of insulin has no unified standard, the domestic and foreign scholars generally think that the dosage of insulin should be individualized, and the effect of placental hormone on insulin sensitivity with the progress of pregnancy is fully considered, and the dosage of insulin is adjusted in time. There is no denying that the most common effects of psychological stress on pregnant women are often overlooked. The high blood glucose level in gestational diabetes mellitus is characterized by higher postprandial hyperglycemia, fasting and nocturnal volume. It is easy to have hypoglycemia. Therefore, the choice of glycemic control regimen for gestational diabetes should ensure and provide the maternal body during pregnancy, the calorie and nutritional needs of the normal fetal development, avoid postprandial hyperglycemia or starvation ketosis, and control the blood sugar in normal programs. The level of blood sugar fluctuates greatly, thus increasing the difficulty of controlling blood sugar. Psychological adjustment helps to improve the mood of the pregnant women and reduce the melancholy. It is beneficial to the diet control and other treatment, which is beneficial to the regulation of blood sugar. Thus, the blood glucose control can be smoothly controlled and the hypoglycemia is prevented. A large number of cohort clinical studies have confirmed their therapeutic effects. Each of these factors is associated with the occurrence of gestational diabetes, but so far, any of these causes can not explain the pathogenesis of gestational diabetes alone. It may be the result of the interaction of these factors. Most scholars believe that the occurrence of the disease is a comprehensive analysis. In the study of the pathogenesis of gestational diabetes, the study of the pathogenesis of gestational diabetes, the study of psychosocial stress is obviously insufficient. In recent years, 5- hydroxytryptamine (5-HT) has been found to be directly or indirectly involved in psychological regulation. The study found that in the patients with gestational diabetes, the SCL-90 score is positively correlated with the level of serum 5-HT, suggesting that in pregnancy sugar In the patients with urinary disease, the change of 5-HT content is also an important link in the mental state of the patient, and it plays an important role in the assessment of psychological intervention. In the treatment, considering the particularity of the pregnancy period, after the diagnosis of gestational diabetes, the lifestyle intervention should be the main intervention, and the drug is still in poor control of blood sugar under the lifestyle intervention. The evaluation of the effect of psychological intervention is relatively inadequate. The existing research also has a lack of uniform diagnostic criteria, less sample content, a lack of unified and recognized symptoms of symptoms and evaluation criteria, limited observation time, lack of long-term follow-up, and no basic research as support, so it can not be clear. This study was based on the standards of pregnancy diabetes diagnosis promulgated and implemented in 2011 in China, and referring to the relevant provisions of the standard of diagnosis and treatment of gestational diabetes in 2013 of the American Diabetes Society, as a reference, comparing the three groups in the treatment of gestational diabetes, and observing the therapeutic effect of psychological intervention. [Objective]1, Observation of three methods of treatment of gestational diabetes in the treatment of gestational diabetes in reducing fasting blood glucose, OGTT 1H, 2h blood sugar, glycated hemoglobin and serum 5-HT content, improving the patient's condition, improving the long-term effect and so on, objectively evaluating its clinical effect, and 2, observing the effect of psychological intervention therapy on gestational diabetes, thus providing the clinical application. An effective treatment scheme. [method]1, all cases of this study were derived from the Department of Endocrinology, Department of Endocrinology, affiliated to Guangdong No.2 People's Hospital, Southern Medical University, from January 2013 to December 2013. Lower: diagnostic one step method: no need for 50g glucose load test (GCT), and the normal value of 75g glucose tolerance test (OGTT).75gOGTT at 24 weeks of pregnancy (OGTT): 1H, 2h, 2h, 2h,.75gOGTT, 2h, 1H, 2h, 1H, 2h, and 8.5mmol/L. of any abnormal glucose value should be diagnosed as gestational diabetes. The selected cases of diabetes were selected as subjects and were divided into 4 groups according to the sequence number of visiting time and according to the random digital table method. The control group was divided into 4 groups: the simple lifestyle intervention 37 cases, the test group A, the lifestyle intervention + insulin 37 cases, the test group B: the lifestyle intervention + psychological intervention 37 cases, the test C group: lifestyle intervention + heart group. Intervention + insulin group 37 cases of.2, treatment control group: simple lifestyle intervention patients take healthy publicity, exercise, diet guidance combined intervention treatment. Exercise with family upper limb exercise (30min daily, 3 times a day) and walk (every day 40min, after the meal after the 1H) combination, diet has a nutritionist special guidance, carbon hydration Material, protein, fat energy ratio is about 4:3:3. test A group: lifestyle intervention + insulin, patients on the basis of lifestyle intervention, add Insulin Aspart Injection Nohe, NovoRapidPenfill, produce batch number: CVG0519), subcutaneous injection before three meals a day, small dose of 1-2 units start, and then according to blood glucose monitoring, regulator Quantity. If the fasting blood sugar still does not reach the standard, when it is more than 5.3mmol/L, it is given a subcutaneous injection before bedtime with the addition of N, and the small dose begins with the blood glucose adjustment dose. Test B group: lifestyle intervention + psychological intervention and psychological intervention on the basis of lifestyle intervention. The specific method of psychological intervention is: a psychotherapist special person. It is responsible for the preaching of gestational diabetes, the explanation of the causes, the consequences and the preventive measures to make the patients fully aware of the great harm to pregnant and parturient women and perinatal infants. Patients with improper emotion and serious mental disorder were treated with appropriate behavioral cognitive therapy. Group C: lifestyle intervention + psychological intervention + insulin, patients were treated with insulin and psychological intervention under the intervention of lifestyle. Four groups of patients were treated, 2 weeks were observed and tested for a total of 4 courses, and four groups were carried out after the end of the course of treatment. To return to production.3, the observation indexes were compared between the three test group and the control group and the control group and the three test group, the fasting blood glucose, the 2 hour postprandial blood sugar, the fasting blood glucose after the end of the 4 course of treatment, the OGTT test 1H, the 2H blood sugar level, the change of glycated hemoglobin, the serum 5-HT content, the occurrence of hypoglycemia in the treatment process, the bad situation of mother and baby during the pregnancy, and receiving the bad situation of mother and baby during pregnancy, and taking the harvest. The data of the collection were statistically processed to compare the therapeutic effect of three ways of treating gestational diabetes.4. Statistical processing and the production of the CRF table were given to all the subjects to specify the possible benefits and risks involved in the clinical trials, to make the patients and their families fully informed and to sign the patients' consent and to sign the informed consent in writing; Design requirements, unified form, detailed record; carefully write the case observation table; all kinds of data are statistically processed. The questionnaire data are encoded and quantized into the computer, and the SPSS13.0 statistical analysis software is used. The prevalence rate is expressed as a percentage, the sample data is first normal test and variance homogeneity test. All data are used (x The test of P0.05 is statistically significant. For the normal distribution and the counting data of the same variance, the R x C table chi square (x 2) test, Ridit analysis, and the t test are used, and the data of the partial or unknown distribution can be used nonparametric test, such as the rank sum test, etc. Finally, according to the design requirements, the CRF is made to make the CRF unified. Table: patients signed informed consent, detailed records, carefully written cases, observed adverse reactions or unanticipated adverse reactions. [results]1, baseline data were numbered in order of time, divided into control group according to random digital table, test A, test B, group C, 37 cases each, because in the treatment process, the A group shedding 2 cases, test B 1 cases were shedding, 2 cases in group C, 37 cases in control group, 35 in group A, 36 in group B and 35 in group C. The control group was (1.64 +. 0.21) m, pre pregnancy weight (52.17 + 11.17) kg, BMI (20.67 + 10.05) kg/m2, and the average age was (28.53 +) m, before pregnancy weight (35) kg, BMI (+ + +) kg, BMI (+ + + +) 9.39) kg/m2, the average age (28.25 + 9.63) years, B group height (1.65 + 0.31) m, pre pregnancy weight (52.88 + 11.93) kg, BMI (20.93 + 9.57) kg/m2, average age (29.13 + 8.67) years; test C group height (1.66 + 0.19) m, pre pregnancy weight (53.97 + excluded) kg, BMI (52.88) kg/m2, average age (mean +) years of.2. before the treatment into each group before the treatment Fasting blood glucose, OGTT1h blood sugar, 2h blood sugar and glycated hemoglobin were divided into groups of t tests respectively. All blood sugar and glycated hemoglobin levels were compared, all were P0.05, and the difference was not statistically significant. After the treatment, the blood glucose level was analyzed by LSD-t test, and the difference of blood sugar levels between the three test group and the control group was statistically significant (P0. 05): compared with the test B group, the difference of blood glucose level was not obvious (P0.05), and the blood sugar levels of group A and C group were statistically significant (P0.05), and the difference in fasting blood glucose, OGTT1h, 2h and glycated hemoglobin in the C group was statistically significant (P0.05) 3, after 4 courses of treatment (P0.05) 3. Compared with the control group, compared with the control group, there was a significant difference in the level of 5- serotonin in the three test group, and the difference was statistically significant (P0.05). Compared with the three test groups, there were also statistical differences (P0.05); 4, the three groups were significantly different from the control group, except for the cesarean section. P0.05; 5, four groups of patients had no significant effect on blood, urine, faecal routine and liver and kidney function; 6, using insulin.
【学位授予单位】：南方医科大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R714.256

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