中华中医药学刊2025，Vol.43Issue(2)：6-11,6.DOI:10.13193/j.issn.1673-7717.2025.02.002
四磨汤口服液治疗功能性消化不良餐后不适综合征的多中心临床研究
Efficacy and Safety of Simo Decoction Oral Liquid(四磨汤口服液)for Post-prandial Distress Syndrome of Functional Dyspepsia:A Multicenter Trial
摘要
Abstract
Objective To evaluate the safety and efficacy of Simo Decoction Oral Liquid(四磨汤口服液)for post-prandial distress syndrome(PDS)of functional dyspepsia(FD).Methods Randomized,controlled and placebo-controlled parallel trial design was adopted,the observation was conducted in 12 parallel centers,and 240 cases were randomly divided into trial group and control group,with 120 cases in each group.The trial group was administered with Simo Decoction Oral Liquid,while the control group was given Simo Decoction Oral Liquid simulation agent.The treatment course was 4 weeks.The PDS symptom im-provement rate,other individual symptom scores of FD,overall treatment evaluation scale(OTE),hospital anxiety and scale(HAD),functional dyspepsia quality of live(FDDQL)and safety were compared.Full analysis set(FAS)and per protocol set(PPS)were used for effectiveness analysis,while safety set(SS)was used for safety analysis.Results There were 237 cases in the FAS(with 118 in the trial group and 119 in the control group),220 cases in the PPS(with 112 in the trial group and 108 in the control group),and 239 cases in the SS(with 120 in the trial group and 119 in the control group).FAS and PPS analyses showed that after treatment,postprandial distress syndrome,postprandial fullness and discomfort and early satiety in the trial group were higher;the decrease of postprandial discomfort symptoms and postprandial fullness and discomfort VAS scores were larger and the symptom improvement rates of OTE were higher than those in the control group(P＜0.05).FAS analyses showed that af-ter treatment,the response rates of stomach burning sensation,acid reflux and poor bowel movement in the trial group were high-er;the decrease of stomach burning sensation VAS score was larger than those in the control group(P＜0.05).PPS analyses showed that after treatment,the response rates of stomach burning sensation and poor bowel movement in the trial group were higher;the decrease of stomachache,stomach burning sensation and poor bowel movement VAS scores were larger than those in the control group(P＜0.05).There was 1 adverse event occurred in the trial group,and 2 adverse events occurred in the control group,and there were no statistical difference between groups(P＞0.05).Conclusion Simo Decoction Oral Liquid is effective and safe in treating post-prandial distress syndrome of functional dyspepsia.关键词
四磨汤口服液/功能性消化不良/餐后不适综合征/安全性/有效性Key words
Simo Decoction Oral Liquid(四磨汤口服液)/functional dyspepsia/post prandial distress syndrome/safety/ef-fectiveness分类
医药卫生引用本文复制引用
王凤云,符佳,任顺平,李宝乐,李娜,贺涛,陈伟红,李延萍,杨小军,杨倩,白海燕,陆芳,徐进康,张昕琰,钱陈洁,周正华,冀建斌,高会斌,王晓静,梁丹红,袁瑞兴,柯晓,肖英莲,黄铭涵,陈旻湖,唐旭东,王捷虹,穆恒,张志杰,丁少华,朱莹,徐寅..四磨汤口服液治疗功能性消化不良餐后不适综合征的多中心临床研究[J].中华中医药学刊,2025,43(2):6-11,6.基金项目
中国中医科学院科技创新工程项目(C12021A01003) （C12021A01003）
中国中医科学院中医药科技重大成果引导项目(ZZ13-ZD-02) （ZZ13-ZD-02）
