利用单病种数据库对非糜烂性胃食管反流病的临床研究

发布时间：2018-08-22 12:08

【摘要】：研究背景和目的胃食管反流病(Gastroesophageal reflux disease, GERD)指胃和(或)十二指肠内容物反流入食管引起不适症状和(或)并发症的一种疾病,以反流和烧心为典型症状,包括非糜烂性胃食管反流病(Non-erosive gastroesophageal reflux disease, NERD)、糜烂性食管炎(Erosive esophagitis, EE)、Barrett食管三种亚型,国内以NERD最为常见,约占GERD的60%-70%。在西方国家,每周至少一次出现反流或者烧心症状的成年人最高可达20%,亚洲国家为2.5%-7.1%。国内关于GERD大规模的流行病学研究报告较少,各研究结果报道的国内不同区域GERD的患病率均较西方国家低,但近年的研究显示其患病率在逐年增高,尤其是亚洲地区,部分原因可能与人们生活方式及饮食结构的改变有关,也有研究显示GERD的患病率随着年龄的增长而增加,30-60岁为高发人群。GERD是由多种因素造成的消化道动力障碍性疾病,主要的发病机制与抗反流防御机制功能减弱以及反流物对食管粘膜攻击作用有关,目前大多数学者认为精神心理状态异常及食管动力功能下降在NERD的发病中占有重要地位,而一些不良生活饮食习惯、社会状态等各方面的因素也起到部分促进作用,但具体机制仍不明确。虽然质子泵抑制剂(Prop pump inhibitor, PPI)的出现使得食管粘膜损伤得到快速愈合,缓解了大部分GERD患者的症状,但仍有10%-40%的患者在标准PPI治疗后症状缓解不理想,特别是NERD患者,且目前大部分NERD患者对该病不甚了解,治疗费用居高不下,不仅浪费医疗资源且患者的健康相关生活质量也受到严重影响。随着医学模式的发展,目前认为NERD患者的生活、饮食方式、精神心理状态与临床特征的评估在NERD的个体化综合治疗上非常重要。但目前国内还没有大样本临床数据库可以综合探讨NERD患者的发病相关因素、临床特点、治疗方案、治疗效果等,因此我们根据既往对NERD发病相关因素的认识及其临床特征制定了病例报告表(Case report form, CRF)并前期建立了规范化的功能性胃肠疾病(Functional gastrointestinal disease, FGID)临床研究数据库,利用该病例报告表及临床数据库收集和管理NERD病例,对NERD患者的基本信息、生活饮食习惯、心理临床特征、不同药物组合的疗效及影响PPI治疗的因素进行统计分析,具有重要的实际临床意义。第一章利用数据库分析非糜烂性胃食管反流病发病因素与临床特点研究方法根据既往对NERD研究所认识的发病相关因素、临床表现、临床特点、临床检查、饮食与起居习惯等信息制作完整的病例报告表,按照该表收集完整的个人信息和临床资料,随后将各项信息与资料录入到网络在线功能性胃肠病数据管理系统,并进行检索和分析,导出数据库中NERD单病种和对照组的各项检索分析结果,利用SPSS19.0软件进行进一步的统计学处理,探讨NERD患者的一般信息、发病相关因素、临床特征、食管功能等。研究结果一. NERD患者基本信息统计结果：在数据库中录入了504例NERD及152例对照组的临床资料,利用数据库的检索统计功能对NERD患者的基本信息进行统计显示：女性266例(52.8%)、男性238例(47.2%)：年龄分布为：20岁-(16.5%)、30岁-(57.3%)、50岁～(26.2%)：主要症状：反流(66.5%)、烧心(58.1%)、嗳气(41.5%)、胸骨后不适(37.3%)；夜间发作比例：反流51.6%,烧心56.2%；主要职业分布：商人(23.1%)、公务员(19.6%)、无业(19.2%)、工人(17.1%)；城市病源(67.3%)、农村病源(32.7%)；平均病程：27.88±16.33月。二.与NERD发病相关的多因素Logistic回顾分析结果：不良生活事件(P=-0.045,OR=I.954)、长期频繁饮酒(P=0.040,OR=3.957)、打鼾(P=0.002,OR=2.334)、进食夜宵(P=-0.002,OR=2.752)、合并焦虑抑郁(P=0.003,OR=2.723)等是NERD的独立危险因素。三.食管高分辨测压及24小时阻抗-pH监测结果：273例NERD患者完成高分辨率食管测压,结果显示60.81%NERD患者存在不同程度的食管体部无效收缩。24小时阻抗-pH监测结果显示,总液体反流次数正常但症状相关概率阳性在NERD组及合并食管裂孔疝(Hiatus hernia, HH)组分别为45.45%、28.57%(P0.05)；NERD并HH组总液体反流事件次数异常所占比例及近端反流占总反流的比均较NERD组患者多(P0.05),存在食管体部无效收缩的患者所占比例也较NERD组患者多(P0.05)。研究结论不良生活与饮食习惯、焦虑抑郁与不良事件、打鼾、食管运动功能差、HH等与NERD的发病具有重要相关性,30～50岁为高发人群,并与职业和生活区域有一定相关。第二章利用数据库分析非糜烂性胃食管反流病的疗效及相关影响因素研究方法对前期工作收集的504例NERD病例进行治疗方案及治疗效果的随访。所有病例均由消化科专家诊断并按照指南给予8周为基础的治疗方案,部分根据病情酌情给予抗焦虑药(Antianxietic)和(或)促动力药(Prokinetics)等措施。疗效评判按照临床治愈、显效、好转、无效进行分析。随后将用药情况、疗效等结果逐一录入到网络在线功能性胃肠病数据管理系统,并进行初步统计与分析,导出数据库中NERD单病种数据,利用SPSS19.0软件进行相应统计学处理,探讨不同治疗方案的治疗效果及影响治疗效果的相关因素。研究结果一.各治疗方案的总有效率(Overall response rate, ORR):单用PPI组72例,8周总有效率66.67%；PPI+Prokinetics组228例,8周总有效率81.58%;PPI+Prokinetics+Antianxietic组115例,8周总有效率90.43%。第8周时各组间总有效率比较有统计学差异(P0.05)。二.影响PPI疗效的多因素Logistic回顾分析：用药依从性差(P=0.040,OR=2.111)、不良饮食习惯(P=0.018,OR=I.408)、焦虑抑郁(P=0.027,OR=3.022)、病程时间长(P=0.043,OR=2.735)、伴随有功能性胃肠疾病(P=0.000,OR=2.782)、存在食管裂孔疝(P=0.012,OR=2.852)为治疗效果差的独立危险因素。研究结论联合用药较单用PPI能提高NERD治疗的总有效率,加用动力药和(或)抗焦虑抑郁药能显著改善NERD患者的症状并提高有效率,提示动力障碍及精神心理状态在NERD的发病中可能发挥了重要作用,如患者在治疗过程中存在有药依从性差、不良饮食习惯、焦虑抑郁、病程时间长、存在食管裂孔疝、合并有功能性胃肠病等因素将会影响治疗效果。
[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.
【学位授予单位】：南方医科大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R571

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