富马酸伏诺拉生联合莫沙必利治疗难治非糜烂性胃食管反流患者的临床研究OA
Clinical trial of vonoprazan fumarate combined with mosapride in the treatment of patients with refractory non-erosive gastroesophageal reflux disease
目的 观察富马酸伏诺拉生片联合莫沙必利片治疗难治性非糜烂性胃食管反流病(rNERD)的临床疗效与安全性.方法 将本院收治的rNERD患者按治疗方法分为对照组(口服富马酸伏诺拉生片20 mg,qd)和试验组(加用枸橼酸莫沙必利片,餐前服用,每次5 mg,tid),疗程8周.比较2组的临床症状、食管动力学指标、胃肠激素指标、生活质量和临床疗效,并进行安全性评价.结果 共纳入120例患者,对照组59例、试验组61例.治疗后,试验组与对照组的胃食管反流病量表(Gerd Q)评分分别为(6.89±1.29)和(7.56±1.64)分,胃食管反流病症状频率量表(FSSG)评分分别为(7.95±1.71)和(9.00±2.24)分,食管下括约肌压力(LESP)分别为(22.19±4.33)和(19.67±4.38)mmHg,胃蛋白酶原 Ⅰ(PG Ⅰ)分别为(121.21±26.75)和(111.57±20.28)pg·mL-1,胃蛋白酶原Ⅱ(PG Ⅱ)分别为(13.58±3.17)和(15.12±3.57)pg·mL-1,胃泌素(GAS)分别为(72.16±11.23)和(67.97±10.94)pg·mL-1,胃食管反流病生存质量量表(GERD-QOL)评分分别为(32.82±7.24)和(29.75±5.37)分.2 组的上述指标比较,在统计学上差异均有统计学意义(P<0.05,P<0.01).试验组的临床总有效率为90.16%(55例/61例),显著高于对照组的76.27%(45例/59例)(P<0.05).对照组的药物不良反应主要包括腹泻、便秘和恶心;试验组包括腹泻、便秘和口干.试验组和对照组的药物不良反应总发生率分别为8.20%(5例/61例)和6.78%(4例/59例),在统计学上差异无统计学意义(P>0.05).结论 富马酸伏诺拉生片联合莫沙必利片治疗rNERD具有协同增效作用,能够更有效地改善rNERD的临床症状及生活质量,其作用机制可能与协同改善食管动力、调节胃肠激素水平等多重效应相关,且联合方案安全性良好.
Objective To observe the clinical efficacy and safety of fumarate furosemide tablets combined with mosapride tablets in the treatment of refractory non erosive gastroesophageal reflux disease(rNERD).Methods The rNERD patients admitted to our hospital were divided into control group(oral administration of 20 mg fumarate fumarate tablets,qd)and treatment group(addition of mosapride citrate tablets,taken before meals,5 mg each time,tid)according to the treatment method,with a treatment course of 8 weeks.Compared the clinical symptoms,esophageal motility indicators,gastrointestinal hormone indicators,quality of life and clinical efficacy of two groups,and conducted safety evaluation.Results A total of 120 patients were included,with 59 in control group and 61 in treatment group.After treatment,the gastroesophageal reflux disease scale(Gerd Q)scores of treatment group and control group were(6.89±1.29)and(7.56±1.64)points,respectively;the gastroesophageal reflux disease symptom frequency scale(FSSG)scores were(7.95±1.71)and(9.00±2.24)points,respectively;the lower esophageal sphincter pressure(LESP)were(22.19±4.33)and(19.67±4.38)mmHg,respectively;the pepsinogen Ⅰ(PG Ⅰ)levels were(121.21±26.75)and(111.57±20.28)pg·mL-1,respectively;the pepsinogen Ⅱ(PG Ⅱ)levels were(13.58±3.17)and(15.12±3.57)pg·mL-1,respectively;the gastrin(GAS)levels were(72.16±11.23)and(67.97±10.94)pg·mL-1,respectively;the scores of the gastroesophageal reflux disease quality of life scale(GERD-QOL)were(32.82±7.24)and(29.75±5.37)points,respectively.The differences in the above indicators were all statistically significant between the two groups(P<0.05,P<0.01).The total clinical effective rate of treatment group was 90.16%(55 cases/61 cases),which was significantly higher than 76.27%(45 cases/59 cases)in control group(P<0.05).The adverse drug reactions in control group mainly included diarrhea,constipation and nausea;treatment group included diarrhea,constipation and dry mouth.The total incidence of adverse drug reactions in treatment group and control group were 8.20%(5 cases/61 cases)and 6.78%(4 cases/59 cases),respectively,with no statistically significant difference(P>0.05).Conclusion The combination of vonoprazan fumarate tablets and mosapride citrate tablets has a synergistic effect in the treatment of rNERD,which can effectively improve the clinical symptoms and quality of life of rNERD.Its mechanism of action may be related to multiple effects such as synergistic improvement of esophageal motility and regulation of gastrointestinal hormone levels,and the combination regimen has good safety.
郭红烨;沈男男;陈骏寅
绍兴大学附属医院 药剂科,浙江绍兴 312000绍兴大学附属医院 药剂科,浙江绍兴 312000绍兴大学附属医院 消化内科,浙江绍兴 312000
医药卫生
富马酸伏诺拉生片枸橼酸莫沙必利片难治非糜烂性胃食管反流生活质量胃肠激素
vonoprazan fumarate tabletmosapride citrate tabletrefractory non-erosive gastroesophageal reflux diseasequality of lifegastrointestinal hormone
《中国临床药理学杂志》 2026 (9)
1221-1226,6
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