|Esomeprazole regimens for reflux symptoms in Chinese patients with chronic gastritis|
|Sun, Jing1; Yuan, Yao-Zong1; Hou, Xiao-Hua2; Zou, Duo-Wu3; Lu, Bin4; Chen, Min-Hu5; Liu, Fei6; Wu, Kai-Chun7; Zou, Xiao-Ping8; Li, Yan-Qing9; Zhou, Li-Ya10|
|关键词||Esomeprazole Non-erosive Reflux Disease Regimen Chronic Gastritis Regimen Symptom Control Rate|
|刊名||WORLD JOURNAL OF GASTROENTEROLOGY|
|WOS标题词||Science & Technology|
|类目[WOS]||Gastroenterology & Hepatology|
|资助者||AstraZeneca ; AstraZeneca|
|研究领域[WOS]||Gastroenterology & Hepatology|
|关键词[WOS]||ON-DEMAND THERAPY ; CONTROLLED TRIAL ; 20 MG ; PRIMARY-CARE ; DISEASE ; MANAGEMENT ; OMEPRAZOLE ; EPIDEMIOLOGY ; DIAGNOSIS ; ASIA|
AIM: To compare symptom control with esomeprazole regimens for non-erosive reflux disease and chronic gastritis in patients with a negative endoscopy.
METHODS: This randomized, open-label study was designed in line with clinical practice in China. Patients with typical reflux symptoms for >= 3 mo and a negative endoscopy who had a Gastroesophageal Reflux Disease Questionnaire score >= 8 were randomized to initial treatment with esomeprazole 20 mg once daily either for 8 wk or for 2 wk. Patients with symptom relief could enter another 24 wk of maintenance/on-demand treatment, where further courses of esomeprazole 20 mg once daily were given if symptoms recurred. The primary endpoint was the symptom control rate at week 24 of the maintenance/on-demand treatment period. Secondary endpoints were symptom relief rate, success rate (defined as patients who had symptom relief after initial treatment and after 24 wk of maintenance treatment), time-to-first-relapse and satisfaction rate.
RESULTS: Based on the data collected in the modified intention-to-treat population (MITT; patients in the ITT population with symptom relief after initial esomeprazole treatment, n = 262), the symptom control rate showed a small but statistically significant difference in favor of the 8-wk regimen (94.9% vs 87.3%, P = 0.0473). Among the secondary endpoints, based on the data collected in the ITT population (n = 305), the 8-wk group presented marginally better results in symptom relief after initial esomeprazole treatment (88.3% vs 83.4%, P = 0.2513) and success rate over the whole study (83.8% vs 72.8%, P = 0.0258). The 8-wk regimen was found to provide a 46% reduction in risk of relapse vs the 2-wk regimen (HR = 0.543; 95% CI: 0.388-0.761). In addition, fewer unscheduled visits and higher patient satisfaction supported the therapeutic benefits of the 8-wk regimen over the 2-wk regimen. Safety was comparable between the two groups, with both regimens being well tolerated.
CONCLUSION: Chinese patients diagnosed with chronic gastritis achieved marginally better control of reflux symptoms with an 8-wk vs a 2-wk esomeprazole regimen, with a similar safety profile.
|资助者||AstraZeneca ; AstraZeneca|
|作者单位||1.Shanghai Jiao Tong Univ, Sch Med, Ruijin Hosp, Dept Gastroenterol, Shanghai 200025, Peoples R China|
2.Huazhong Univ Sci & Technol, Union Hosp Med Coll, Dept Gastroenterol, Wuhan 430074, Hunan, Peoples R China
3.Second Mil Med Univ, Changhai Hosp, Dept Gastroenterol, Shanghai 200433, Peoples R China
4.Zhejiang Tradit Chinese Med Hosp, Dept Gastroenterol, Hangzhou 310006, Zhejiang, Peoples R China
5.Sun Yat Sen Univ, Affiliated Hosp 1, Dept Gastroenterol, Guangzhou 510080, Guangdong, Peoples R China
6.Shanghai East Hosp, Dept Gastroenterol, Shanghai 200120, Peoples R China
7.Xijing Hosp, Mil Med Coll 4, Dept Gastroenterol, Xian 710032, Shaanxi, Peoples R China
8.Nanjing Univ, Sch Med, Affiliated Hosp, Dept Gastroenterol,Nanjing Drum Tower Hosp, Nanjing 210093, Jiangsu, Peoples R China
9.Shandong Univ, Qilu Hosp, Dept Gastroenterol, Jinan 250012, Shandong, Peoples R China
10.Peking Univ, Hosp 3, Dept Gastroenterol, Beijing 100191, Peoples R China
|Sun, Jing,Yuan, Yao-Zong,Hou, Xiao-Hua,et al. Esomeprazole regimens for reflux symptoms in Chinese patients with chronic gastritis[J]. WORLD JOURNAL OF GASTROENTEROLOGY,2015,21(22):6965-6973.|
|APA||Sun, Jing.,Yuan, Yao-Zong.,Hou, Xiao-Hua.,Zou, Duo-Wu.,Lu, Bin.,...&Zhou, Li-Ya.(2015).Esomeprazole regimens for reflux symptoms in Chinese patients with chronic gastritis.WORLD JOURNAL OF GASTROENTEROLOGY,21(22),6965-6973.|
|MLA||Sun, Jing,et al."Esomeprazole regimens for reflux symptoms in Chinese patients with chronic gastritis".WORLD JOURNAL OF GASTROENTEROLOGY 21.22(2015):6965-6973.|