醒脾胶囊临床适宜病症的横断面调查研究  

A Cross-sectional Study on Clinically Appropriate Diseases and Symptoms of Xingpi Capsule(醒脾胶囊)

作　　者：李洪皎[1] 李凌香 王渊 葛志闪 艾艳珂[1] 赵天易 吕晓颖[1] 何丽云[1] LI Hongjiao;LI Lingxiang;WANG Yuan;GE Zhishan;AI Yanke;ZHAO Tianyi;LYU Xiaoying;HE Liyun(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing,100700;Affiliated Hospital of Inner Mongolia University for Nationalities;School of Acupuncture,Moxibustion and Tuina,Shaanxi University of Chinese Medicine;Tianjin University of Traditional Chinese Medicine)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京市100700 [2]内蒙古民族大学附属医院 [3]陕西中医药大学针灸推拿学院 [4]天津中医药大学

出　　处：《中医杂志》2022年第18期1753-1759,共7页Journal of Traditional Chinese Medicine

基　　金：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);中国中医科学院自选课题(ZZ13-026);醒脾胶囊临床价值定位的真实世界研究(H0205)。

摘　　要：目的总结临床实践中醒脾胶囊治疗的病症、使用方法和安全性等情况,为临床合理用药和上市后再评价提供参考。方法采用横断面调查,围绕临床医师用药关注的重点问题设计问卷,包含醒脾胶囊治疗病症、服用剂量、服用时间、联合用药和服药后不良反应等内容,在醒脾胶囊临床应用的8个省及直辖市,抽取62家医院,每家医院调查2名医师,共计调查124名医师。通过问卷星收集问卷,并辅以质量控制人员进行数据质量核查和跟踪。结果发放问卷124份,回收有效问卷111份。100名医师(90.1%)根据医师临床使用经验认为患者服用醒脾胶囊有效,76.6%的医师应用醒脾胶囊治疗慢性肠炎,此外还用于治疗慢性胃炎(64.0%)、肠易激综合征(56.8%)、失眠(40.5%)、胃溃疡(39.6%)。中医与西医医师使用醒脾胶囊治疗病症基本相似,但中医师与西医师认为醒脾胶囊能明显改善的症状不完全相同,相比西医师,中医师更倾向于认为醒脾胶囊对头晕(P=0.028)和心慌(P=0.028)有改善作用。受调查医师在治疗慢性肠炎(P=0.032)、肠易激综合征(P=0.006)、溃疡性结肠炎(P=0.042)时倾向于单独使用醒脾胶囊,仅在用于治疗慢性肠炎时服药次数推荐更倾向每日2次(P=0.014)。中医师推荐治疗不同病症的服药次数和服药量差异无统计学意义(P>0.05),92.8%医师表示未发现患者服药后不适,7.2%医师表示患者服用醒脾胶囊后有胃肠道反应、皮肤瘙痒和药疹。结论医师应用醒脾胶囊主要治疗慢性肠炎、慢性胃炎、肠易激综合征、失眠、胃溃疡等病症,中医师与西医师使用醒脾胶囊治疗病症基本相同。ObjectiveTo summarize the applications,usage and safety of Xingpi Capsule(醒脾胶囊)in clinical practice,thereby providing reference for its rational use and post-marketing evaluation.Methods A cross-sectional survey was conducted,and questionnaires were designed involving the key issues that clinicians paid attention to when using Xingpi Capsules,involving treated diseases and symptoms,dosage,medication time,combined medication and adverse reactions.Sixty-two hospitals were sampled from 8 provinces and municipalities where Xingpi Capsule have been clinically used,and two physicians were selected in each hospital.Totally,124 physicians were surveyed.Questionnaires were collected through Wenjuanxing software,and quality control personnel were set for data quality verification and tracking.Results The response rate of total 124 questionnaires was 91.7%,and there were111 valid questionnaires.Totally,100 physicians(90.1%)believed that Xingpi Capsule was effective(the judgement was based on the clinical experience of physicians).Most physicians have used Xingpi Capsule to treat chronic enteritis(76.6%),as well as chronic gastritis(64.0%),irritable bowel Syndrome(56.8%),insomnia(40.5%),and gastric ulcer(39.6%).Traditional Chinese medicine(TCM)and Western medicine physicians treated similar diseases with Xingpi Capsule,but were different for treating clinical symptoms,where TCM physicians were more inclined to believe that Xingpi Capsule can significantly improve dizziness(P=0.028)and palpitation(P=0.028).Physicians were more inclined to use Xingpi Capsule alone when treating chronic enteritis(P=0.032),irritable bowel syndrome(P=0.006),and ulcerative colitis(P=0.042),and took Xingpi Capsule twice daily only for the treatment of chronic enteritis(P=0.014).In addition,there was no significant difference in the frequency and dosage of Xingpi Capsule recommended by practitioners for the treatment of different diseases and symptoms(P>0.05).For safety issue,92.8%of the physicians said that they did not find uncomfortable c

关 键 词：醒脾胶囊 临床适宜病症 真实世界研究 中成药上市后再评价 

分 类 号：R286[医药卫生—中药学]