中华中医药学刊2025，Vol.43Issue(3)：13-18,6.DOI:10.13193/j.issn.1673-7717.2025.03.003
评价四磨汤口服液治疗功能性腹胀临床疗效的多中心、随机、安慰剂对照临床研究
A Multicenter,Randomized,Placebo-Controlled Clinical Study on Clinical Efficacy of Simo Decoction(四磨汤口服液)Oral Liquid in Treatment of Functional Bloating
摘要
Abstract
Objective To evaluate the clinical efficacy of Simo Decoction Oral Liquid(四磨汤口服液)in the treatment of functional bloating(FB).Method Sixty cases of FB patients included in four hospitals from March 2022 to May 2023 were ran-domly divided into two groups,30 cases in the treatment group were given oral administration of Simo Decoction Oral Liquid,and the other 30 cases in the control group were treated with Simo Decoction Oral Liquid simulant for a period of 8 weeks.The re-sponse rate of visual analogue scale(VAS),gastrointestinal symptoms rating scales(GSRS),each individual symptom score,over-all disease effectiveness rate,hospital anxiety and depression scale(HAD)score and adverse reactions were observed in the two groups.Result The bloat VAS response rate[Full Analysis Set(FAS):80.00％;Per Protocol Set(PPS):82.10％]and GSRS ef-fective rate(FAS:96.67％;PPS:96.40％)in the treatment group were higher than those of the control group[the bloat VAS re-sponse rate(FAS:23.33％;PPS:24.1％)and GSRS effective rate(FAS:86.67％;PPS:86.20％),and the difference was statis-tically significant(P＜0.05).The change value of abdominal distension VAS score in the treatment group(FAS:-4.37±2.08;PPS:-4.27±2.07)was greater than that in the control group(FAS:-1.34±1.32;PPS:-1.34±1.32),and the difference was statistically significant(P＜0.05).The GSRS scores and change values of the treatment group before and after treatment,the scores and change values of each single symptom of FB(severity and frequency of episodes of bowel sounds,bowel irregularity,bloating,nausea,and flatulences),the effective rate of overall evaluation of the disease,as well as the change values of the anxiety of the HAD scores(FAS and PPS)were better than those of the control group,and the differences were statistically significant(P＜0.05).No adverse reactions related to the study drug occurred in either group.Conclusion Simo Decoction Oral Liquid can improve the symptoms of abdominal distension and other symptoms of FB patients,the efficacy is exact,and the medication is safe.At the same time,to a certain extent,it can relieve the patients anxiety and depression,and improve the patients quality of life.关键词
四磨汤口服液/功能性腹胀/临床随机对照试验/疗效评价Key words
Simo Decoction Oral Liquid(四磨汤口服液)/functional bloating/clinical randomized controlled trial/efficacy evaluation分类
医药卫生引用本文复制引用
王萍,唐旭东,杨倩,霍永利,梁海清,李一然,贺涛,孔伟光,杨华,吕红霞..评价四磨汤口服液治疗功能性腹胀临床疗效的多中心、随机、安慰剂对照临床研究[J].中华中医药学刊,2025,43(3):13-18,6.基金项目
中国中医科学院科技创新工程创新团队项目(CI2021B005) （CI2021B005）
中国中医科学院科技创新工程项目(CI2021A009) （CI2021A009）
