Using Single Disease Database To Explore The Clinical Characteristics Of Non-erosive Reflux Disease

Background and purpose:GERD is a condition which develops when reflux of stomach contents causes troublesome symptoms and/or complications including non-erosive gastroesophageal reflux disease (NERD), erosive esophagitis (EE) and Barrett esophagus. Regurgitation and heartburn are the typical symptoms of GERD. NERD is the most common type and accounts for about 60%-70% of GERD in China. Defined by at least weekly heartburn and/or acid regurgitation for GERD, an approximate prevalence of 10-20% was identified in the Western world, while in Asia this was lower, about2.5%-7.1%. However fewer large-scale epidemiological study of GERD had carried out in China. The prevalence of GERD at different area in China was lower than those of western countries, but recent studies had shown that the prevalence of GERD increased year by year especially in Asia. Part of the reason may be related to lifestyle and diet habits change. Studies had showed that the prevalence of GERD increased with age increasing, with more distribution in 30-60 years old.GERD is a dynamic obstacles disorder of digestive system caused by many factors. The main pathogenesis is anti-reflux defense barrier weakened and esophageal mucosa attacked by reflux content. Most scholars believed that abnormal mental state and declined esophageal dynamic function played a crucial role in the pathogenesis of NERD, but some bad eating habits and lifestyle, social state and so on also played a role, however the specific mechanism is still not clear. Unfortunately highly cost of treatment at present and most of the NERD patients don’t understanding any knowledge of this disease not only waste of medical resources but also the health-related quality of life of patients severely affected. Since the introduction of proton pump inhibitor (PPI), clinical management of GERD has markedly changed, shifting the therapeutic challenge from mucosal healing to reduction of PPI-resistant symptoms, as 10%-40% patients don’t have satisfied symptom control mainly with patient of NERD.Along with the development of the medical model, evaluation the diet habits, lifestyle, mental state and clinical characteristics of the NERD patients is very important in the individualized comprehensive treatment of NERD. But there is no large-sample clinical database can be used to explore the pathogenesis, clinical characteristics, management and treatment effect of NERD patients in China. So we established an online database of functional gastrointestinal disease and a case report form which was made according to the previous understanding of onset factors related to NERD and its relevant clinical manifestations, clinical characteristics, clinical examination, diet habits and lifestyle previously. We used the CRF to collect personal and clinical information of NERD patient. All the information and data will be input into the database of functional gastrointestinal disease system. The database of NERD can be exported for further statistical processing using SPSS 19.0 software to explore the NERD patients’ general information, onset factors, clinical features, mental status, the curative effect of different treatment and the related factors influencing the treatment effect.Part 1 Using database to explore the onset factors and clinical characteristics of non-erosive reflux diseaseMethods:According to the previous understanding of onset factors related to NERD and relevant clinical manifestations, clinical characteristics, clinical examination, diet habits and lifestyle to make a Case report form (CRF), we use this CRF to collect personal and clinical information of NERD patients, then all the information and data will be input into online database of functional gastrointestinal disease system. The database of NERD and the control group can be exported for further statistical processing using SPSS 19.0 software to explore the NERD patient’s general information, etiology, clinical features and the function of esophagus.Results:I General information of NERD patients504 NERD patients were included in our database with 152 controls. Of 504 NERD patients:266 female(52.8%),238 male(47.2%); from rural areas (32.7%), urban areas (67.3%);main profession distribution:merchant (23.1%),civil Servant (19.6%),unemployed(19.2%),worker(17.1%); Mean disease duration:27.88±16.33 month.II Logistic regression analysis of etiology related to NERDHistory of adverse events(P=0.045, OR=1.954), frequent drinking (P=0.040, OR=3.957),snore(P=0.002, OR=2.334), late meals (P=0.002, OR=2.752),anxiety or depression(P=0.003, OR=2.723)were the independent risk factors for patients with NERD.III The results of High resolution manometry and Mltichanne intralumial impedance-pH monitoring, MII-pH)60.81% patients exist varying degrees of esophageal body ineffective contract. Obvious difference of total liquid reflux events was observed between NERD patients with or without hiatal hernia (HH) (P< 0.05). Normal total number of liquid reflux with positive symptom associated probability in the NERD group and combined hiatal hernia group were 45.45%,28.57%respectively(P<0.05).Compared with NERD group, NERD with HH have more ineffective esophageal body motility(P< 0.05).Conclusion:Unhealthy eating habits and lifestyle, history of adverse events, anxiety and depression, snore, poor esophageal motor function and hiatal hernia have significant correlation with NERD which is related with profession and living areas and mostly occurred among 30-50 years old.Part 2 using database to explore the treatment effect and influencing factors of non-erosive reflux diseaseMethods:504 NERD patients enrolled previously will give 8 weeks treatment according with the guidelines. Some patients will give antianxietic or (and) prokinetics according to their conditions. At the end, we will evaluate the effect of the treatment. All the information will be input into the online database of functional gastrointestinal disease system established previously.The database can be exported for further statistical processing using SPSS 19.0 software to explore the curative effect of different treatment and the related factors influencing the treatment effect.Results:I The overall response rate of different treatmentThe overall response rate of 8 weeks’ treatment in group with PPI only was 66.67%,for PPI with prokinetics group and PPI with prokinetics and antianxietic group was 81.58% and 90.43% respectively, the overall response rate within each groups is statistically significant(P<0.05).II Factors influence the effect of PPI using Logistic regression analysisPoor compliance(P=0.040, OR=2.111),bad eating habits(P=0.018, OR=1.408),anxiety or depression (P=0.027, OR=3.022),concomitant Fgid(P=0.000, OR=2.782),longer ill history(P=0.043, OR=2.735),hiatus hernia(P=0.012, OR=2.852)were the independent risk factors for poor treatment effect of PPI.Conclusion:PPI Combined with prokinetics or (and) antianxietic can enhance the effectiveness of NERD and significantly improve the symptom of the NERD patients when compared with PPI alone. Esophageal dynamic disorder and mental status may play an important role in the pathogenesis of NERD. Poor compliance, bad eating habits, anxiety or depression, concomitant FGID, longer ill history, hiatus hernia will decrease the effect of PPI if patients accompanied any one of them.