舒必利治疗胃内胆汁反流伴消化不良症状的临床研究

Clinical Study of Sulpiride in Treating Patients with Gastric Bile Reflux and Dyspeptic Symptoms

背景：胃内胆汁反流可能是引起消化不良症状的原因之一.有研究显示小剂量舒必利能减少胃食管反流事件并改善反流症状.目的：评价小剂量舒必利对胃内胆汁反流伴消化不良症状的疗效和安全性.方法：连续纳入2013年l～7月于上海交通大学医学院附属仁济医院消化内科就诊,以消化不良症状为主诉,内镜检查提示存在胃内胆汁反流的患者,随机分配入治疗组和对照组,分别接受质子泵抑制剂（PPI）＋舒必利100 mg/d和单用PPI治疗4周.治疗前后应用Leeds消化不良问卷（LDQ）、胆汁反流指数（BRI）和汉密尔顿焦虑、抑郁量表（HAMA、HAMD）对患者进行评估.记录治疗期间和治疗后不良反应发生情况.结果：治疗组3例女性患者因泌乳而停药,共125例患者完成研究.治疗4周后,两组LDQ、BRI评分均较治疗前显著降低,治疗组改善幅度优于对照组（P＜0.05）.治疗组合并精神心理障碍者的LDQ、BRI、HAMA、HAMD评分改善幅度亦均优于对照组（P＜0.05）.结论：小剂量舒必利与PPI联合可有效改善胃内胆汁反流伴消化不良症状患者的临床症状、胆汁反流严重程度以及部分患者合并的精神心理障碍,但个别女性可能出现促乳素升高.

Background： Gastric bile reflux might be one of the causes of dyspeptic symptoms. Clinical trial revealed that low- dose sulpiride could reduce gastroesophageal reflux events and improve related symptoms. Aims： To evaluate the efficacy and safety of low-dose sulpiride in treating patients with gastric bile reflux and dyspeptic symptoms. Methods： From Jan. 2013 to Jul. 2013, consecutive patients suffering from dyspeptic symptoms and accompanied by endoscopy-proved gastric bile reflux at the Division of Gastroenterology and Hepatology, Renji Hospital, Shanghai Jiaotong University School of Medicine were recruited in this study. Patients were randomly assigned into treatment group and control group, and received proton pump inhibitor （PPI） plus sulpiride （100 mg/d ） or PPI alone, respectively, for 4 weeks. Leeds Dyspepsia Questionnaire （LDQ）, bile reflux index （BRI） and Hamilton Anxiety and Depression Scales （HAMA and HAMD） were used to assess the efficacy of sulpiride. Adverse reactions were recorded during and after the treatment course. Results： Three females in treatment group manifested lactation and sulpiride was ceased. One hundred and twenty- five cases accomplished the trial. At the end of the trial, LDQ and BRI scores were decreased in both groups, and the improvement was more significant in treatment group than in control group （ P 〈 0.05 ）. In patients complicated with psychological disorders （ anxiety and depression）, the improvement in LDQ, BRI, HAMA and HAMD scores was also more significant in treatment group than in control group （P 〈 0.05）. Conclusions ： Combination of low-dose sulpiride with PPI can effectively improve the clinical symptoms and severity of bile reflux in patients with gastric bile reflux and dyspeptic symptoms, while in patients complicated with psychological disorders also improving the mental status. Prolactin-related reactions may occur in individual females.