本文選題：妊娠期糖尿病 + 療效觀察　； 參考：《南方醫(yī)科大學》2014年碩士論文

【摘要】：[研究背景]妊娠期糖尿病是指妊娠期發(fā)生或首次發(fā)現的不同程度的糖耐量異常,不包括妊娠前已診斷的糖尿病。妊娠期糖尿病的定義和診斷標準,在不斷的爭議討論中發(fā)展、完善。據世界各地流行病學調查顯示,妊娠期糖尿病的發(fā)病率種族間存在著明顯差異,由于國際上尚無統(tǒng)一的診斷標準,國內亦無推薦使用的統(tǒng)一標準,再加上診斷標準的不斷變化,因此,各國報道的發(fā)病率相差懸殊,為1%-14%,我國內發(fā)病率為1%-4%,且呈逐年上升的趨勢。鑒于妊娠期糖尿病發(fā)病率不斷增加和嚴重的危害性,故及時有效的治療就顯得格外重要。目前,對妊娠期糖尿病的發(fā)病機制尚未完全明確,根據最新的研究進展,其發(fā)病可能與遺傳易感性、脂肪因子、慢性炎癥反應、肥胖、運動量、飲食、孕婦年齡及心理社會應激等有關。因妊娠期糖尿病會導致一系列母、兒孕期并發(fā)癥發(fā)生率增加,包括：巨大胎兒、宮內慢性缺氧、胎兒心臟發(fā)育異常、羊水過多、胎膜早破、早產、新生兒低血糖等情況。只有在整個妊娠期中,控制母體血糖至正常范圍,才能改善妊娠期糖尿病孕婦母、兒的結局。目前臨床治療方法包括飲食療法、運動療法、胰島素使用等,需要指出的是,胰島素治療必須在飲食治療的基礎上進行,否則效果不滿意。飲食、運動等非藥物治療是妊娠期糖尿病不可替代的、有效的,也是主要的治療方法,其在控制血糖,減少圍產期母嬰并發(fā)癥和減少胰島素用量等方面都有確切的臨床療效；口服降糖藥因其可能導致畸胎、巨大兒、新生兒低血糖,甚至死亡等故在妊娠期糖尿病的使用存在著較大爭議,我國目前仍以胰島素作為妊娠期糖尿病唯一藥物治療,但是胰島素最佳治療劑量尚無統(tǒng)一標準,國內外學者普遍認為胰島素用量應個體化,并充分考慮胎盤激素隨著妊娠的進展而對胰島素敏感性的影響,及時調整胰島素用量。臨床上,對妊娠期糖尿病患者目前以飲食運動為主,當飲食運動干預后,血糖仍無法達標者,需要盡快使用胰島素控制血糖。不可否認,也取得了一定效果。現有的治療手段往往忽略了孕婦最常見的心理應激產生的影響。妊娠期糖尿病血糖升高特點為：餐后血糖升高較快,空腹及夜間容易出現低血糖。所以妊娠期糖尿病血糖控制治療方案選擇,應保證和提供妊娠期間母體、胎兒發(fā)育正常所需熱量和營養(yǎng)需要,避免餐后高血糖或饑餓性酮癥出現,血糖控制在正常方案�？紤]到妊娠是婦女特殊的生理階段,孕婦易情緒緊張,血糖水平波動大,因此增加了控制血糖的難度,心理調節(jié)有助于改善孕婦情緒,減少憂郁,使其積極配合飲食控制及其他治療,有利于血糖的調節(jié)。從而達到平穩(wěn)控制血糖,預防低血糖發(fā)生。但目前心理治療的研究尚處于發(fā)展階段,還需要大量的隊列性臨床研究來證實其治療作用。上述每種因素都與妊娠期糖尿病的發(fā)生有相關性,但目前為止,用上述任何一種病因都無法單獨解釋妊娠期糖尿病的發(fā)生機制,可能是上述各因素相互作用的結果。多數學者認為該病發(fā)生是綜合因素作用的結果,而在妊娠期糖尿病的發(fā)病機制研究中,心理社會應激方面的研究明顯不足,近年來發(fā)現5-羥色胺(5-HT)直接或間接參與了心理調節(jié),研究發(fā)現在妊娠期糖尿病患者中,SCL-90積分與血清5-HT水平呈正相關,提示在妊娠期糖尿病的患者中,5-HT含量的改變同樣是該病患者心理狀況不良的一個重要環(huán)節(jié),在心理干預的評估中其重要作用。在治療上,考慮到妊娠期的特殊性,確診妊娠期糖尿病后,均應以生活方式干預為主,藥物在生活方式干預下血糖仍控制不佳時使用。而對心理干預治療的效果評價研究相對不足,現有這方面的研究也存在疾病診斷標準不統(tǒng)一、樣本含量偏少、癥狀缺乏統(tǒng)一公認的分級量化指標與療效評定標準、觀察時間有限,缺乏長期隨訪、無基礎研究作為支持等,故無法明確其治療機理。本研究根據2011年我國頒布實施的妊娠期糖尿病診斷行業(yè)標準,并參照美國糖尿病學會2013年的妊娠期糖尿病診治標準的相關規(guī)定,以此作為研究參考,對比三組治療妊娠期糖尿病情況,觀察心理干預方式治療療效。[目的]1、觀察三種方式治療妊娠期糖尿病患者在降低空腹血糖、OGTT后1h、2h血糖、糖化血紅蛋白及血清5-HT含量,改善患者病情、提高遠期療效等方面的作用,客觀評價其臨床療效；2、觀察心理干預治療對妊娠期糖尿病的療效,從而為臨床應用提供一種有效的治療方案。[方法]1、試驗設計方案本項研究所有病例均來自2013年1月至2013年12月南方醫(yī)科大學附屬廣東省第二人民醫(yī)院內分泌科門診及住院病房。納入標準：參照2011年我國頒布實施的妊娠期糖尿病診斷行業(yè)標準而制定如下：診斷一步法：不必行50g葡萄糖負荷試驗(GCT),而妊娠24周-28周直接行75g葡萄糖耐量試驗(OGTT)。75gOGTT的正常值：空腹、服葡萄糖后1h、2h血糖值分別小于5.1mmol/L、10.0mmol/L、8.5mmol/L。任意一點血糖值異常者應診斷為妊娠期糖尿病。將所有確診娠期糖尿病入選病例作為受試對象,以就診時間順序編號,根據隨機數字表法均分成4組。分別為對照組：單純生活方式干預37例,試驗A組：生活方式干預+胰島素37例,試驗B組：生活方式干預+心理干預37例,試驗C組：生活方式干預+心理干預+胰島素組37例。2、治療方法對照組：單純生活方式干預患者采取健康宣傳、運動、飲食指導聯(lián)合干預治療。運動以家庭上肢運動(每天30min,每天3次)和散步(每天40min,餐后1h后進行)相結合為主,飲食方面有營養(yǎng)師專門指導,碳水化合物、蛋白質、脂肪能量比大約為4：3：3。試驗A組：生活方式干預+胰島素,患者在生活方式干預的基礎上加用門冬胰島素注射液諾和銳,NovoRapidPenfill,生產批號：CVG0519),每天三餐前皮下注射,小劑量1-2單位開始,然后根據血糖監(jiān)測,調整劑量。如空腹血糖仍不達標,≥5.3mmol/L時,給予加用諾和靈N睡前皮下注射治療,小劑量開始,根據血糖調整劑量。試驗B組：生活方式干預+心理干預,患者在生活方式干預基礎上配合心理干預治療,心理干預的具體方法為：由心理治療師專人負責對妊娠期糖尿病患者進行宣教、解釋病因、后果及預防措施,讓患者充分認識到妊娠期糖尿病對孕產婦及圍產兒均有較大危害,應予以重視。對一些伴有煩躁易怒,心情郁悶等情緒障礙的妊娠期糖尿病患者進行溝通開導,緩解或消除患者不當情緒,心理障礙嚴重者適當行為認知治療。試驗C組：生活方式干預+心理干預+胰島素,患者在生活方式干預下加用胰島素與心理干預治療。四組患者治療,2周為一個觀察和檢測療程,共4個療程,并在療程結束后對四組患者進行回訪至生產。3、觀察指標對比三試驗組與對照組及三試驗組間患者空腹血糖、餐后2小時血糖,4個療程結束后的空腹血糖、OGTT試驗1h、2h血糖水平、糖化血紅蛋白、血清5-HT含量的變化,以及治療過程中低血糖發(fā)生、孕期母嬰不良情況發(fā)生,把收集的數據進行統(tǒng)計學處理,比較三種方式對妊娠期糖尿病的治療效果。4、統(tǒng)計學處理及CRF表的制作向所有受試者詳細說明參加臨床試驗可能得到的利益與承擔的風險,讓患者及家屬充分知情,征得患者同意并書面簽署知情同意書；按設計要求,統(tǒng)一表格,詳細記錄；認真寫好病例觀察表；各種數據均做統(tǒng)計學處理。調查表數據編碼量化后輸入計算機,用SPSS13.0統(tǒng)計分析軟件處理,患病率以百分率表示,先對樣本資料進行正態(tài)性檢驗和方差齊性檢驗。所有數據均用以(x±s)表示,檢驗以P0.05為有統(tǒng)計學意義。對于正態(tài)分布,且方差齊同的計數資料采用R×C表卡方(χ2)檢驗,Ridit分析。計量資料采用t檢驗；對于偏態(tài)資料或未知分布類型的資料可用非參數檢驗法,比如秩和檢驗等。最后按設計要求,統(tǒng)一制作CRF表：患者簽署知情同意書,詳細記錄,認真書寫病例,注意觀察不良反應或未預料的不良反應。[結果]1、基線資料以就診時間順序編號,根據隨機數字表法分成對照組、試驗A組、試驗B組、試驗C組各37例,因在治療過程中試驗A組脫落2例,試驗B組脫落1例,試驗C組脫落2例,實際例數對照組37例,試驗A組35例,試驗B組36例,試驗C組35例。對照組身高(1.64±0.21)m,孕前體重(52.17±11.17) kg, BMI (20.67±10.05) kg/m2,平均年齡(28.53±8.49)歲；試驗A組身高(1.66±0.27)m,孕前體重(53.65±12.05) kg, BMI (21.09±9.39) kg/m2,平均年齡(28.25±9.63)歲；試驗B組身高(1.65±0.31)m,孕前體重(52.88±11.93) kg, BMI (20.93±9.57) kg/m2,平均年齡(29.13±8.67)歲；試驗C組身高(1.66±0.19)m,孕前體重(53.97±12.41) kg, BMI (20.75±9.51) kg/m2,平均年齡(28.45±9.01)歲。2.治療前納入各組的空腹血糖,OGTT1h血糖、2h血糖,糖化血紅蛋白分別進行成組t檢驗,各血糖和糖化血紅蛋白水平組問比較,均是P0.05,差異無統(tǒng)計學意義。治療后各組患者血糖水平經方差分析LSD-t檢驗,三試驗組與對照組相比,各血糖水平差異有統(tǒng)計學意義(P0.05)；試驗A組與試驗B組相比,各血糖水平與之差異不明顯(P0.05)、試驗A組與試驗C組相比,各血糖水平差異有統(tǒng)計學意義(☆P0.05)；試驗C組患者在空腹血糖,OGTT1h、2h,糖化血紅蛋白方面與其余三組相比,差異有統(tǒng)計學意義(P0.05)3、經過4個療程的治療,與對照組相比,三試驗組在降低5-羥色胺水平方面有明顯差異,差異有統(tǒng)計學意義(P0.05)；三試驗組之間相比,也有統(tǒng)計學差異(P0.05)；4、三組試驗組與對照組各項妊娠結局相比,除剖宮產幾率相似外,其余幾項都有明顯差異,有統(tǒng)計學意義(P0.05)；5、四組患者治療對血、尿、糞常規(guī)及肝、腎功能等方面均無明顯影響；6、使用胰島素治療的試驗C組有4例患者出現水腫、蕁麻疹等不良反應。[結論]胰島素對妊娠期糖尿病控制血糖方面療效確切,而心理干預治療也是效果顯著的治療方式之一；心理干預治療可使妊娠期糖尿病患者情緒穩(wěn)定,積極配合治療,從而改善患者血清5-羥色胺(5-HT)水平,達到協(xié)助控制血糖的治療目的；生活方式干預配合心理、胰島素的綜合治療,在血糖控制水平、降低糖化血紅蛋白水平,改善患者心理狀態(tài)、減少母嬰并發(fā)癥方面綜合效果最為顯著；心理干預治療方式的發(fā)生低血糖情況較少,無明顯不良反應發(fā)生。心理干預治療方法或成為第三種輔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.
【學位授予單位】：南方醫(yī)科大學
【學位級別】：碩士
【學位授予年份】：2014
【分類號】：R714.256

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