醒脾胶囊治疗腹泻型肠易激综合征的临床观察  

Observation of clinical effect of Xingpi capsule on irritable bowel syndrome with predominant diarrhea

作　　者：张琪 张迪 秦宇宁 王鑫[1] 艾艳珂[1] 吕晓颖[1] 盛煜栋 赵天易 李洪皎[1] ZHANG Qi;ZHANG Di;QIN Yuning;WANG Xin;AI Yanke;LV Xiaoying;SHENG Yudong;ZHAO Tianyi;LI Hongjiao(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;School of Traditional Chinese Medicine,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]天津中医药大学中医学院,天津301617

出　　处：《科技导报》2024年第21期122-131,共10页Science & Technology Review

基　　金：中国中医科学院国家自然科学基金重点项目经费结余项目(2022029);中国中医科学院科技创新工程中医临床基础学科创新团队项目(CI2021B003)。

摘　　要：腹泻型肠易激综合征(IBS-D)以慢性及反复发作的腹泻以及伴有与排便相关的腹痛为主要症状,是中国常见的肠易激综合征(IBS)亚型,严重影响患者生活质量。前期调研提示,醒脾胶囊临床用于治疗IBS效果较好,但尚无临床研究证据为合理用药提供参考,本研究采用前瞻性设计,以患者为中心,系统采集和分析2021年10月至2022年10月期间的临床应用醒脾胶囊治疗的326例IBS-D患者服药情况、胃肠道症状等28项症状总积分、主要症状群积分和胃肠道症状评定量表(GSRS)评分变化情况及不良事件。结果显示,IBS-D患者女性多于男性(约为1.35倍),青年患者占比较高(52.76%),单独服用醒脾胶囊治疗IBS-D患者占比90.80%,患者在用药第2天,症状总积分、主要症状群积分以及失眠症状积分即有显著改善(P<0.001),GSRS评分在第3天有明显改善(P<0.001)。326名患者中,99.08%的患者对醒脾胶囊治疗效果表示满意,有6人(1.84%)出现了不良事件,其中恶心1例,胃部不适2例,便秘1例,口干1例,上腹部不适1例。6名患者的不适均在服用胶囊前3天内出现,继续服药2~3 d后,不适感消失。经过14 d的观察,醒脾胶囊可以用于治疗青年、中年和老年人IBS-D;临床单独用药效果良好;可以改善IBS-D患者腹泻、腹痛、食道反流、大便异常等胃肠道症状,治疗IBS-D主要症状2 d起效,安全性较好,患者满意度较高。可为临床医师合理用药提供真实世界证据,同时也在无临床证据情况下,开展醒脾胶囊治疗IBS-D验证性研究提供临床研究要素设计的参考。Irritable bowel syndrome with predominant diarrhea(IBS-D),characterized by chronic and recurrent diarrhea and abdominal pain associated with defecation,is a common subtype of irritable bowel syndrome(IBS)in China,which seriously affects the quality of patient life.Previous investigation showed that Xingpi capsule is effective in the treatment of IBS but lacks clinical research evidence to provide reference for rational drug use.This study adopted a patient-centered prospective design,and systematically collected and analyzed population characteristics,disease improvement after taking Xingpi capsule in a real clinical diagnosis and treatment environment,as well as patient satisfaction and other information.The aim is to provide realworld evidence for rational drug use by clinicians and to provide reference for the design of clinical research elements for validation study of Xingpi capsule for IBS-D treatment in the absence of clinical evidence.This study observed and analyzed 28 symptom scores,major symptom group scores,gastrointestinal symptom rating scale(GSRS)scores and adverse events of 326 patients treated with Xipi capsule from Oct 2021 to Oct 2022.The results were as follows.Patients with IBS-D were more female than male(about 1.35 times),the proportion of young patients was relatively high(52.76%),and 90.80%of the patients were treated with Xingpi capsule alone.On the first day of treatment,the total symptom score,the major symptom cluster score and the insomnia symptom score were significantly improved(P<0.001),the GSRS score was significantly improved on the third day(P<0.001).Among the 326 patients,99.08%were satisfied with the therapeutic effect of Xingpi capsule,and 6(1.84%)had adverse events,including 1 case of nausea,2 cases of stomach discomfort,1 case of constipation,1 case of dry mouth,and 1 case of upper abdominal discomfort.All six patients experienced discomfort within three days of taking the capsule,and discomfort disappeared after two to three days of continuing taking the pill.After 14 day

关 键 词：肠易激综合征 醒脾胶囊 真实世界研究 中成药 

分 类 号：R259[医药卫生—中西医结合]