莫沙必利片联合奥美拉唑镁肠溶片治疗质子泵抑制药-难治性胃食管反流病患者的临床研究  

Clinical trial of mosapride tablets combined with omeprazole magnesium enteric-coated tablets in the treatment of patients with proton pump inhibitor-refractory gastroesophageal reflux disease

作　　者：杨艳 张艇[1] 张芳旭 张哲铭 孔帅 YANG Yan;ZHANG Ting;ZHANG Fang-xu;ZHANG Zhe-ming;KONG Shuai(Department of Gastroenterology,Ningguo People's Hospital,Ningguo 242300,Anhui Province,China;Department of Gastrointestinal Surgery,Shandong Provincial Hospital,Jinan 250000,Shandong Province,China)

机构地区：[1]宁国市人民医院消化内科,安徽宁国242300 [2]山东省立医院胃肠外科,山东济南250000

出　　处：《中国临床药理学杂志》2021年第21期2875-2877,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：目的观察莫沙必利片联合奥美拉唑镁肠溶片治疗质子泵抑制药(PPI)-难治性胃食管反流病(GERD)患者的临床疗效及安全性。方法将57例PPI-难治性GERD患者随机分为对照组29例和试验组28例。对照组给予奥美拉唑镁肠溶片每次20 mg,qd,口服;试验组在对照组治疗的基础上,给予枸橼酸莫沙必利片每次5 mg,tid,口服。2组患者均治疗4周。比较2组患者的临床疗效,症状频率量表(FSSG)和Demeester评分,以及药物不良反应的发生情况。结果试验过程中共脱落7例。治疗后,试验组和对照组的治愈率分别为72.00%(18例/25例)和24.00%(6例/25例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的FSSG评分分别为(15.24±0.97)和(18.96±1.51)分,Demeester评分分别为(7.22±1.62)和(9.72±1.34)分,差异均有统计学意义(均P<0.05)。试验组和对照组的总药物不良反应发生率分别为16.00%和8.00%,差异无统计学意义(P>0.05)。结论莫沙必利片联合奥美拉唑肠溶片治疗PPI-难治性GERD患者的临床疗效确切,且不增加药物不良反应的发生率。Objective To observe the clinical efficacy and safety of mosapride tablets combined with omeprazole magnesium enteric-coated tablets in the treatment of patients with proton pump inhibitor(PPI)-refractory gastroesophageal reflux disease(GERD).Methods Fifty-seven patients with PPI-refractory GERD were randomly divided into control group(n=29 cases)and treatment group(n=28 cases).The control group was given omeprazole magnesium enteric-coated tablets 20 mg each time,qd,orally.The treatment group was given mosapride citrate tablets 5 mg each time,tid,orally on the basis of control group.Two groups were treated for 4 weeks.The clinical efficacy,frequency of symptoms scale(FSSG)and Demeester score,and adverse drug reactions were compared between two groups.Results Seven cases were lost during the trial process.After treatment,the cure rates of treatment and control groups were 72.00%(18 cases/25 cases)and 24.00%(6 cases/25 cases)with significant difference(P<0.05).After treatment,the FSSG scores of treatment and control groups were(15.24±0.97)and(18.96±1.51),the Demeester scores were(7.22±1.62)and(9.72±1.34),respectively,the differences were statistically significant(all P<0.05).The total incidences of adverse drug reactions in the treatment and control groups were 16.00%and 8.00%without significant difference(P>0.05).Conclusion Mosapride tablets combined with omeprazole enteric soluble tablets have a definitive clinical efficacy in the treatment of patients with PPI-refractory GERD,without increasing the incidence of adverse drug reactions.

关 键 词：莫沙必利片 奥美拉唑肠溶片 质子泵抑制药-难治性胃食管反流病 安全性评价 

分 类 号：R975[医药卫生—药品]