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

作　　者：王萍[1] 杨倩[2] 霍永利[2] 梁海清[3] 李一然 贺涛 孔伟光 杨华 吕红霞 唐旭东[1] WANG Ping;YANG Qian;HUO Yongli;LIANG Haiqing;LI Yiran;HE Tao;KONG Weiguang;YANG Hua;LYU Hongxia;TANG Xudong(Institute of Spleen and Stomach Diseases,Xiyuan Hospital,Chinese Academy of Traditional Chinese Medicine,Beijing 100091,China;Hebei Provincial Hospital of Traditional Chinese Medicine,Shijiazhuang 050013,Hebei,China;Dezhou Hospital,Qilu Hospital of Shandong University,Dezhou 253075,Shandong,China;Inner Mongolia Hospital of Traditional Chinese Medicine,Hohhot 010020,Inner Mongolia,China;Hunan Hansen Pharmaceutical Co.,Ltd.,Yiyang 413000,Hunan,China;Beijing Kangzhong Times Medical Technology Group Co.,Ltd.,Beijing 100071,China)

机构地区：[1]中国中医科学院西苑医院脾胃病研究所,北京100091 [2]河北省中医院,河北石家庄050013 [3]山东大学齐鲁医院德州医院,山东德州253075 [4]内蒙古自治区中医医院,内蒙古呼和浩特010020 [5]湖南汉森制药股份有限公司,湖南益阳413000 [6]北京康众时代医药科技集团有限公司,北京100071

出　　处：《中华中医药学刊》2025年第3期13-18,共6页Chinese Archives of Traditional Chinese Medicine

基　　金：中国中医科学院科技创新工程创新团队项目(CI2021B005);中国中医科学院科技创新工程项目(CI2021A009)。

摘　　要：目的评价四磨汤口服液治疗功能性腹胀(Functional Bloating,FB)的临床疗效。方法将2022年3月—2023年5月在4家医院纳入的FB患者60例随机分为两组,治疗组30例给予四磨汤口服液口服,对照组30例服用四磨汤口服液模拟剂治疗,疗程8周。观察两组腹胀视觉模拟评分量表(visual analogue scale,VAS)应答率、胃肠道症状评定量表(gastrointestinal symptoms rating scales,GSRS)评分、FB各单项症状评分、疾病总体评价有效率、医院焦虑抑郁量表(hospital anxiety and depression scale,HAD)评分以及不良反应情况。结果治疗组的腹胀VAS应答率[全分析数据集(full analysis set,FAS):80.00%;符合方案数据集(per protocol set,PPS):82.10%]和GSRS有效率(FAS:96.67%;PPS:96.40%)高于对照组腹胀VAS应答率(FAS:23.33%;PPS:24.1%)和GSRS有效率(FAS:86.67%;PPS:86.20%),差异有统计学意义(P<0.05);治疗组腹胀VAS评分变化值(FAS:-4.37±2.08;PPS:-4.27±2.07)大于对照组(FAS:-1.34±1.32;PPS:-1.34±1.32),差异有统计学意义(P<0.05)。治疗组治疗前后GSRS评分及变化值、FB各单项症状评分(肠鸣、大便不调、腹胀、纳差、矢气的严重程度和发作频率)及变化值、疾病总体评价有效率以及HAD评分的焦虑变化值(FAS、PPS)均优于对照组,差异有统计学意义(P<0.05)。两组均无与研究药物相关的不良反应发生。结论四磨汤口服液可改善FB患者腹胀等症状,疗效确切,且用药安全。同时在一定程度上可改善焦虑抑郁情况,提高患者生活质量。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 response 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 me

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 

分 类 号：R256.3[医药卫生—中医内科学]