调肝理脾方对胃食管反流病随机双盲对照研究  

A randomized double-blind controlled study of Tiaoganlipi recipe on gastroesophageal reflux disease

作　　者：沈晨[1] 陶琳[1] 张声生[1] 孙晓红[2] 陈苏宁[3] 吴静[4] SHEN Chen;TAO Lin;ZHANG Sheng-sheng;SUN Xiao-hong;CHEN Su-ning;WU Jing(Department of Gastroenterology,Beijing Hospital of TCM Affiliated to Capital Medical University,Beijing 100010,China;Department of Gastroenterology,Peking Union Medical College Hospital,Beijing 100730,China;Department of Gastroenterology,Shengjing Hospital of CMU,Shenyang 110004,China;Department of Gastroenterology,Beijing Shijitan Hospital Affiliated to Capital Medical University,Beijing 100038,China)

机构地区：[1]首都医科大学附属北京中医医院消化科,北京100010 [2]北京协和医院消化科,北京100730 [3]中国医科大学盛京医院消化科,沈阳110004 [4]首都医科大学附属世纪坛医院消化科,北京100038

出　　处：《中国中西医结合消化杂志》2019年第11期806-810,共5页Chinese Journal of Integrated Traditional and Western Medicine on Digestion

基　　金：北京市科学技术委员会首都临床特色应用研究(No:Z141107002514176);首都卫生发展科研专项项目(No:首发2018-2-2231)

摘　　要：[目的]评价调肝理脾方治疗胃食管反流病(GERD)的临床疗效。[方法]采取随机、双盲、阳性药物平行对照、多中心研究试验设计,将288例受试者随机分为试验组和对照组,每组144例。于治疗前及治疗后分别对2组患者进行反流性疾病问卷(Gerd-Q)评分、中医单项症状疗效评分、中医症状综合疗效评价,分别随访1个月、3个月。记录2组患者未再服药、维持服药、间歇服药、按需服药的人数并计算维持缓解的比例。[结果]研究共计脱落42例,试验组完成研究116例、对照组130例。试验组及对照组Gerd-Q评分在治疗2周、治疗4周均较本组治疗前降低(P<0.01)。2组间Gerd-Q评分在治疗2周、治疗4周差异无统计学意义(P>0.05)。2组在单项症状:烧心、反酸、上腹胀、情绪变化则加重、吐稀水、大便不成形、喜长出气、呃逆、上腹不适、咽部异物感、倦怠乏力、食欲不振、口干口苦等方面治疗4周后均有显著改善(P<0.01)。其中试验组在治疗喜长出气、呃逆、食欲不振方面优于对照组(P<0.05)。在中医症状综合疗效方面,试验组与对照组差异无统计学意义(P>0.05)。停药1个月、3个月2组间未再服药人数比例试验组分别优于对照组(P<0.01,P<0.05)。[结论]调肝理脾方治疗胃食管反流病可以明显改善患者临床症状,其短期疗效相当于奥美拉唑,在缓解患者喜长出气、呃逆、食欲不振方面优于西药,根据随访1个月及3个月的数据,调肝理脾方维持缓解更好,更少复发。[Objective]To evaluate the efficacy of Tiaogan Lipi Prescription on gastroesophageal reflux disease(GERD).[Methods]A randomized,double-blind,multi-center study of parallel-control of positive drugs was conducted,288 patients with gastroesophageal reflux were divided into treatment group and control group with 144 cases each.Before and after treatment,patients in the two groups were evaluated by Gerd-Q,single symptoms of traditional Chinese medicine and comprehensive symptoms of traditional Chinese medicine.The patients in the two groups were followed up for 1 month and 3 months without taking,maintaining,intermittent,on-demand medication and maintaining remission rate.[Results]116 cases in the treatment group and 130 cases in the control group completed the experiment.Gerd-Q scores of treatment group and control group were lower than those before treatment in 2 and 4 weeks of treatment(P<0.01).There was no significant difference in Gerd-Q score between the two groups in 2 weeks and 4 weeks of treatment(P>0.05).The symptoms such as heartburn,acid reflux,upper abdominal distension,aggravation of emotional changes,vomiting water,incomplete stool,sigh,hiccup,upper abdominal discomfort,foreign body sensation in pharynx,fatigue,loss of appetite,dry mouth and bitter mouth were significantly improved in both groups after 4 weeks of treatment(P<0.01).Among them,the treatment group is superior to the control group in the treatment of sigh,hiccup and loss of appetite(P<0.05).There was no significant difference between the treatment group and the control group in the comprehensive effect of TCM symptoms(P>0.05).The proportion of patients who did not take medicine again in the treatment group was better than that in the control group(P<0.01,P<0.05).[Conclusion]Tiaogan Lipi Prescription can significantly improve the clinical symptoms of patients with gastroesophageal reflux disease.It’s short-term efficacy is equivalent to that of proton pump inhibitor.It is superior to western medicine in alleviating the symptoms of patient

关 键 词：调肝理脾方 胃食管反流病 随机对照 盲法 临床疗效 

分 类 号：R571[医药卫生—消化系统]