【摘要】：研究背景和目的胃食管反流病(Gastroesophageal reflux disease, GERD)指胃和(或)十二指腸內(nèi)容物反流入食管引起不適癥狀和(或)并發(fā)癥的一種疾病,以反流和燒心為典型癥狀,包括非糜爛性胃食管反流病(Non-erosive gastroesophageal reflux disease, NERD)、糜爛性食管炎(Erosive esophagitis, EE)、Barrett食管三種亞型,國(guó)內(nèi)以NERD最為常見(jiàn),約占GERD的60%-70%。在西方國(guó)家,每周至少一次出現(xiàn)反流或者燒心癥狀的成年人最高可達(dá)20%,亞洲國(guó)家為2.5%-7.1%。國(guó)內(nèi)關(guān)于GERD大規(guī)模的流行病學(xué)研究報(bào)告較少,各研究結(jié)果報(bào)道的國(guó)內(nèi)不同區(qū)域GERD的患病率均較西方國(guó)家低,但近年的研究顯示其患病率在逐年增高,尤其是亞洲地區(qū),部分原因可能與人們生活方式及飲食結(jié)構(gòu)的改變有關(guān),也有研究顯示GERD的患病率隨著年齡的增長(zhǎng)而增加,30-60歲為高發(fā)人群。GERD是由多種因素造成的消化道動(dòng)力障礙性疾病,主要的發(fā)病機(jī)制與抗反流防御機(jī)制功能減弱以及反流物對(duì)食管粘膜攻擊作用有關(guān),目前大多數(shù)學(xué)者認(rèn)為精神心理狀態(tài)異常及食管動(dòng)力功能下降在NERD的發(fā)病中占有重要地位,而一些不良生活飲食習(xí)慣、社會(huì)狀態(tài)等各方面的因素也起到部分促進(jìn)作用,但具體機(jī)制仍不明確。雖然質(zhì)子泵抑制劑(Prop pump inhibitor, PPI)的出現(xiàn)使得食管粘膜損傷得到快速愈合,緩解了大部分GERD患者的癥狀,但仍有10%-40%的患者在標(biāo)準(zhǔn)PPI治療后癥狀緩解不理想,特別是NERD患者,且目前大部分NERD患者對(duì)該病不甚了解,治療費(fèi)用居高不下,不僅浪費(fèi)醫(yī)療資源且患者的健康相關(guān)生活質(zhì)量也受到嚴(yán)重影響。隨著醫(yī)學(xué)模式的發(fā)展,目前認(rèn)為NERD患者的生活、飲食方式、精神心理狀態(tài)與臨床特征的評(píng)估在NERD的個(gè)體化綜合治療上非常重要。但目前國(guó)內(nèi)還沒(méi)有大樣本臨床數(shù)據(jù)庫(kù)可以綜合探討NERD患者的發(fā)病相關(guān)因素、臨床特點(diǎn)、治療方案、治療效果等,因此我們根據(jù)既往對(duì)NERD發(fā)病相關(guān)因素的認(rèn)識(shí)及其臨床特征制定了病例報(bào)告表(Case report form, CRF)并前期建立了規(guī)范化的功能性胃腸疾病(Functional gastrointestinal disease, FGID)臨床研究數(shù)據(jù)庫(kù),利用該病例報(bào)告表及臨床數(shù)據(jù)庫(kù)收集和管理NERD病例,對(duì)NERD患者的基本信息、生活飲食習(xí)慣、心理臨床特征、不同藥物組合的療效及影響PPI治療的因素進(jìn)行統(tǒng)計(jì)分析,具有重要的實(shí)際臨床意義。第一章利用數(shù)據(jù)庫(kù)分析非糜爛性胃食管反流病發(fā)病因素與臨床特點(diǎn)研究方法根據(jù)既往對(duì)NERD研究所認(rèn)識(shí)的發(fā)病相關(guān)因素、臨床表現(xiàn)、臨床特點(diǎn)、臨床檢查、飲食與起居習(xí)慣等信息制作完整的病例報(bào)告表,按照該表收集完整的個(gè)人信息和臨床資料,隨后將各項(xiàng)信息與資料錄入到網(wǎng)絡(luò)在線功能性胃腸病數(shù)據(jù)管理系統(tǒng),并進(jìn)行檢索和分析,導(dǎo)出數(shù)據(jù)庫(kù)中NERD單病種和對(duì)照組的各項(xiàng)檢索分析結(jié)果,利用SPSS19.0軟件進(jìn)行進(jìn)一步的統(tǒng)計(jì)學(xué)處理,探討NERD患者的一般信息、發(fā)病相關(guān)因素、臨床特征、食管功能等。研究結(jié)果一. NERD患者基本信息統(tǒng)計(jì)結(jié)果：在數(shù)據(jù)庫(kù)中錄入了504例NERD及152例對(duì)照組的臨床資料,利用數(shù)據(jù)庫(kù)的檢索統(tǒng)計(jì)功能對(duì)NERD患者的基本信息進(jìn)行統(tǒng)計(jì)顯示：女性266例(52.8%)、男性238例(47.2%)：年齡分布為：20歲-(16.5%)、30歲-(57.3%)、50歲～(26.2%)：主要癥狀：反流(66.5%)、燒心(58.1%)、噯氣(41.5%)、胸骨后不適(37.3%)；夜間發(fā)作比例：反流51.6%,燒心56.2%；主要職業(yè)分布：商人(23.1%)、公務(wù)員(19.6%)、無(wú)業(yè)(19.2%)、工人(17.1%)；城市病源(67.3%)、農(nóng)村病源(32.7%)；平均病程：27.88±16.33月。二.與NERD發(fā)病相關(guān)的多因素Logistic回顧分析結(jié)果：不良生活事件(P=-0.045,OR=I.954)、長(zhǎng)期頻繁飲酒(P=0.040,OR=3.957)、打鼾(P=0.002,OR=2.334)、進(jìn)食夜宵(P=-0.002,OR=2.752)、合并焦慮抑郁(P=0.003,OR=2.723)等是NERD的獨(dú)立危險(xiǎn)因素。三.食管高分辨測(cè)壓及24小時(shí)阻抗-pH監(jiān)測(cè)結(jié)果：273例NERD患者完成高分辨率食管測(cè)壓,結(jié)果顯示60.81%NERD患者存在不同程度的食管體部無(wú)效收縮。24小時(shí)阻抗-pH監(jiān)測(cè)結(jié)果顯示,總液體反流次數(shù)正常但癥狀相關(guān)概率陽(yáng)性在NERD組及合并食管裂孔疝(Hiatus hernia, HH)組分別為45.45%、28.57%(P0.05)；NERD并HH組總液體反流事件次數(shù)異常所占比例及近端反流占總反流的比均較NERD組患者多(P0.05),存在食管體部無(wú)效收縮的患者所占比例也較NERD組患者多(P0.05)。研究結(jié)論不良生活與飲食習(xí)慣、焦慮抑郁與不良事件、打鼾、食管運(yùn)動(dòng)功能差、HH等與NERD的發(fā)病具有重要相關(guān)性,30～50歲為高發(fā)人群,并與職業(yè)和生活區(qū)域有一定相關(guān)。第二章利用數(shù)據(jù)庫(kù)分析非糜爛性胃食管反流病的療效及相關(guān)影響因素研究方法對(duì)前期工作收集的504例NERD病例進(jìn)行治療方案及治療效果的隨訪。所有病例均由消化科專家診斷并按照指南給予8周為基礎(chǔ)的治療方案,部分根據(jù)病情酌情給予抗焦慮藥(Antianxietic)和(或)促動(dòng)力藥(Prokinetics)等措施。療效評(píng)判按照臨床治愈、顯效、好轉(zhuǎn)、無(wú)效進(jìn)行分析。隨后將用藥情況、療效等結(jié)果逐一錄入到網(wǎng)絡(luò)在線功能性胃腸病數(shù)據(jù)管理系統(tǒng),并進(jìn)行初步統(tǒng)計(jì)與分析,導(dǎo)出數(shù)據(jù)庫(kù)中NERD單病種數(shù)據(jù),利用SPSS19.0軟件進(jìn)行相應(yīng)統(tǒng)計(jì)學(xué)處理,探討不同治療方案的治療效果及影響治療效果的相關(guān)因素。研究結(jié)果一.各治療方案的總有效率(Overall response rate, ORR):單用PPI組72例,8周總有效率66.67%；PPI+Prokinetics組228例,8周總有效率81.58%;PPI+Prokinetics+Antianxietic組115例,8周總有效率90.43%。第8周時(shí)各組間總有效率比較有統(tǒng)計(jì)學(xué)差異(P0.05)。二.影響PPI療效的多因素Logistic回顧分析：用藥依從性差(P=0.040,OR=2.111)、不良飲食習(xí)慣(P=0.018,OR=I.408)、焦慮抑郁(P=0.027,OR=3.022)、病程時(shí)間長(zhǎng)(P=0.043,OR=2.735)、伴隨有功能性胃腸疾病(P=0.000,OR=2.782)、存在食管裂孔疝(P=0.012,OR=2.852)為治療效果差的獨(dú)立危險(xiǎn)因素。研究結(jié)論聯(lián)合用藥較單用PPI能提高NERD治療的總有效率,加用動(dòng)力藥和(或)抗焦慮抑郁藥能顯著改善NERD患者的癥狀并提高有效率,提示動(dòng)力障礙及精神心理狀態(tài)在NERD的發(fā)病中可能發(fā)揮了重要作用,如患者在治療過(guò)程中存在有藥依從性差、不良飲食習(xí)慣、焦慮抑郁、病程時(shí)間長(zhǎng)、存在食管裂孔疝、合并有功能性胃腸病等因素將會(huì)影響治療效果。
[Abstract]:BACKGROUND AND OBJECTIVE Gastroesophageal reflux disease (GERD) is a disease characterized by discomfort and/or complications caused by reflux of gastric and/or duodenal contents into the esophagus, with reflux and heartburn as typical symptoms, including non-erosive gastroesophageal reflux disease (NERD). NERD is the most common subtype in China, accounting for 60% - 70% of GERD. In western countries, 20% of adults have reflux or heartburn symptoms at least once a week, and 2.5% - 7.1% in Asian countries. The prevalence of GERD in different regions of China is lower than that in Western countries. However, recent studies have shown that the prevalence of GERD is increasing year by year, especially in Asia, partly because of changes in people's lifestyle and dietary structure. Some studies have shown that the prevalence of GERD increases with age, ranging from 30 to 60 years old. GERD is a gastrointestinal motility disorder caused by a variety of factors. The main pathogenesis is related to the weakening of anti-reflux defense mechanism and the attack of reflux food on esophageal mucosa. Most scholars believe that abnormal mental state and decreased esophageal motility play an important role in the pathogenesis of NERD. Although the appearance of PPI makes esophageal mucosal injury heal quickly and alleviates the symptoms of most patients with GERD, 10% - 40% of patients still have standard PP. The symptoms of patients with NERD are not well relieved after I treatment, especially those with NERD. At present, most of the patients with NERD do not know much about NERD, and the treatment costs remain high. It is not only a waste of medical resources but also a serious impact on the health-related quality of life of patients. Assessment of state and clinical characteristics is very important in the individualized comprehensive treatment of NERD. However, there is no large sample clinical database in China which can comprehensively explore the related factors, clinical characteristics, treatment options, therapeutic effects of NERD patients. Therefore, we have formulated the relevant factors and clinical characteristics of NERD. Case report form (CRF) and a standardized clinical research database of functional gastrointestinal disease (FGID) were established in the early stage. The case report form and clinical database were used to collect and manage NERD cases. The basic information of NERD patients, dietary habits, psychological and clinical characteristics, and different drugs were collected and managed. Statistical analysis of the efficacy of the combination of substances and the factors affecting PPI treatment is of great practical significance. Chapter 1: Analysis of etiological factors and clinical characteristics of non-erosive gastroesophageal reflux disease by database. Methods: According to the past knowledge of NERD, the related factors, clinical manifestations, clinical features, clinical examinations, diet were studied. Make a complete case report form with living habits and other information, collect complete personal information and clinical data according to the form, then input the information and data into the network online functional gastrointestinal disease data management system, and carry on the retrieval and analysis, derive the retrieval analysis results of the single disease and the control group of NERD in the database. SPSS19.0 software was used for further statistical processing to explore the general information, pathogenesis-related factors, clinical features, esophageal function of NERD patients. Results 1. Statistical results of basic information of NERD patients: Clinical data of 504 cases of NERD and 152 cases of control group were recorded in the database, and the retrieving statistical function of the database was used to analyze NERD patients. Statistical data showed that 266 women (52.8%) and 238 men (47.2%) were aged 20 -(16.5%), 30 -(57.3%) and 50 -(26.2%). The main symptoms were reflux (66.5%), heartburn (58.1%), belching (41.5%) and poststernal discomfort (37.3%), nocturnal reflux (51.6%) and heartburn (56.2%) and major occupational distribution (quotient). Persons (23.1%), civil servants (19.6%), unemployed (19.2%) and workers (17.1%); urban (67.3%) and rural (32.7%); average course of disease: 27.88 [16.33] months. 2. Logistic retrospective analysis of multiple factors associated with NERD: adverse life events (P = - 0.045, OR = I.954), frequent long-term drinking (P = 0.040, OR = 3.957), snoring (P = 0.002, OR = 2.334), progressing Eating supper at night (P = - 0.002, OR = 2.752), anxiety and depression (P = 0.003, OR = 2.723) were independent risk factors for NERD. 3. High-resolution esophageal manometry and 24-hour impedance-pH monitoring results: 273 NERD patients completed high-resolution esophageal manometry, the results showed that 60.81% of NERD patients had varying degrees of ineffective contraction of the esophagus body. 24-hour impedance-pH monitoring. The results showed that the frequency of total fluid reflux was normal but the probability of symptom correlation was positive in NERD group and Hiatus hernia (HH) group, which were 45.45% and 28.57% (P 0.05), respectively. The proportion of patients with effective contraction was also higher than that in NERD group (P 0.05). Conclusion The incidence of NERD was significantly correlated with unhealthy living and eating habits, anxiety and depression, adverse events, snoring, poor esophageal motor function, HH, etc. The age of 30-50 was a high risk group, and was related to occupation and living area. Methods A total of 504 cases of NERD were followed up. All cases were diagnosed by gastroenterologists and given 8-week-based treatment according to the guidelines. Antianxietics were given as appropriate according to the condition of the disease. Therapeutic effect evaluation was analyzed according to clinical cure, marked effect, improvement and ineffectiveness. Then the results of drug use and efficacy were input into the network online functional gastrointestinal disease data management system one by one, and preliminary statistics and analysis were carried out. The single disease data of NERD in the database was derived using SPSS19.0 software. Results 1. Overall response rate (ORR) of each treatment regimen: 72 cases in PPI group, the total effective rate of 8 weeks was 66.67%; 228 cases in PPI + Prokinetics group, the total effective rate of 8 weeks was 81.58%; The total effective rate was 90.43% at the 8th week in 115 patients. There was significant difference between the groups at the 8th week (P 0.05). 2. Logistic retrospective analysis of multiple factors influencing the efficacy of PPI: poor drug compliance (P = 0.040, OR = 2.111), bad dietary habits (P = 0.018, OR = I.408), anxiety and depression (P = 0.027, OR = 3.022), long course of disease (P = 0.043, OR = 2.735), accompanied by adverse eating habits (P = 0.018, OR = I.408), anxiety and depression (P = 0.027, OR = 3.02 Functional gastrointestinal disorders (P = 0.000, OR = 2.782) and esophageal hiatal hernia (P = 0.012, OR = 2.852) were independent risk factors for poor therapeutic efficacy. Mental disorders may play an important role in the pathogenesis of NERD, such as poor drug compliance, poor dietary habits, anxiety and depression, long course of disease, esophageal hiatal hernia, and functional gastrointestinal diseases.
【學(xué)位授予單位】：南方醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2016
【分類號(hào)】：R571

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