清热祛湿、凉血化瘀法治疗中度活动期溃疡性结肠炎大肠湿热证多中心、随机对照、双盲的临床研究  

A multi-center,randomized controlled,double-blind clinical study on treatment of moderately active ulcerative colitis with intestinal damp-heat syndrome by the methods of Qingre Qushi and Liangxue Huayu Principles

作　　者：朱磊[1] 沈洪[1] 张声生[2] 赵文霞[3] 任顺平 柯晓[5] 顾庆华[6] 唐志鹏[7] 谢晶日[8] 陈苏宁[9] 陈延[10] 邹建东[11] 沈照峰 张露[1] 刘亚军[1] ZHU Lei;SHEN Hong;ZHANG Shengsheng;ZHAO Wenxia;REN Shun ping;KE Xiao;GUQinghua;TANG Zhipeng;XIEJingri;CHEN Suning;CHEN Yan;ZOU Jiandong;SHEN Zhaofeng;ZHANG Lu;LIU Yajun(Department of Gastroenterology,Affiliated Hospital of Nanjing University of Chinese Medi-cine,Nanjing,210029,China;zDepartment of Gastroenterology,Beijing Hospital of Traditional Chinese Medicine;Department of Gastroenterology,the First Affiliated Hospital of Henan University of Chinese Medicine;Department of Gastroenterology,the Hospital of Shanxi University of Chinese Medicine;Department of Gastroenterology,the Second Affiliated Hospital of Fu-jian Traditional Chinese Medical University;Department of Gastroenterology,Nantong Hospital of Traditional Chinese Medicine;Department of Gastroenterology,LongHua Hospital Shanghai University of Traditional Chinese Medicine;Department of Gastroenterology,the First Affiliated Hospital,Heilongjiang University of Chinese Medicine;Department of Gastroenterology,Shengjing Hospital of China Medicine University;Department of Gastroenterology,Guangdong Province Hospital of Chinese Medicine;Department of Clinical Pharmacology,Affiliated Hospital of Nanjing University of Chinese Medicine;Department of Technology,Affiliated Hospital of Nanjing University of Chinese Medicine)

机构地区：[1]南京中医药大学附属医院消化科,南京210029 [2]首都医科大学附属北京中医医院消化科 [3]河南中医药大学第一附属医院消化科 [4]山西中医药大学附属医院消化科 [5]福建中医药大学附属第二人民医院消化科 [6]南通市中医院消化科 [7]上海中医药大学附属龙华医院消化科 [8]黑龙江中医药大学附属第一医院消化科 [9]中国医科大学附属盛京医院消化科 [10]广东省中医院消化科 [11]南京中医药大学附属医院临床药理科 [12]南京中医药大学附属医院科技处

出　　处：《中国中西医结合消化杂志》2021年第10期681-685,690,共6页Chinese Journal of Integrated Traditional and Western Medicine on Digestion

基　　金：国家中医药管理局中医药行业科研专项项目(No:201407001)。

摘　　要：目的:评价清热祛湿、凉血化瘀法对中度活动期溃疡性结肠炎(UC)大肠湿热证患者的临床症状及对生存质量的影响。方法:按照多中心、随机对照、双盲临床研究设计,纳入5-氨基水杨酸治疗至少4周后仍为中度活动期UC(mayo评分6~10分)且中医辨证为大肠湿热证患者,随机分为试验组和对照组,2组以美沙拉嗪缓释颗粒(4 g/d)作为基础治疗,试验组给予清肠化湿颗粒口服,对照组给予清肠化湿颗粒(低剂量)口服,疗程12周。比较治疗前后的中医证候积分、单项症状积分和生存质量积分变化。结果:纳入的119例患者中,共脱落10例,剔除7例,符合方案有效病例102例,其中试验组54例,对照组48例。治疗12周后,试验组中医证候疗效为96.3%(52/54),优于对照组(87.5%,42/48),差异有统计学意义(P<0.05);2组症状总积分和主要症状(脓血便、腹泻和腹痛)总积分治疗前后比较,试验组均优于对照组(P<0.05),其中试验组脓血便在第8周、10周和12周优于对照组,且改善患者生存质量方面试验组优于对照组(P<0.05)。结论:清热祛湿、凉血化瘀法能够改善中度活动期UC的临床症状,提高生存质量,特别在改善脓血便方面作用明显。Objective:To observe the effect of Qingre Qushi and Liangxue Huayu Principles on the clinical symptoms and quality of life of patients with moderately active ulcerative colitis(UC)with intestinal damp-heat syndrome.Methods:According to multi-center,randomized,double-blind,controlled clinical research design,patients who met the inclusion criteria with a diagnosis of moderately active UC after received 5-aminosalicylic acid treatment at least 4 weeks and belonged to intestinal damp-heat syndrome,were randomly divided into treatment group and control group.Both groups were given mesalazine sustained-release granules 4 g/d as the basic treatment,while the treatment group was followed by oral administration of Qingchang Huashifang granules,the control group was given Qingchang Huashifang granules of Low dose.After 12 weeks of treatment,the scores of TCM syndromes,individual symptom scores and quality of life scores of the two groups were compared before and after treatment.Results:Among 119 patients enrolled,10 patients fell off,7 patients were excluded,and 102 patients met the protocol set(54 patients in the treatment group and 48 patients in the control group).The therapeutic effect of TCM syndromes in the treatment group was better than that of the control group(P<0.05);the total scores of symptoms and the total score of main symptoms in the two groups were better than the control group(P<0.05);Pus-blood stool at the 8 th,10 th and 12 th week after treatment,the treatment group is better than the control group,and the treatment group is better than the control group in terms of improving the quality of life(P<0.05).Conclusion:Qingre qushi and liangxue huayu can improve the clinical efficacy and quality of life with moderately active ulcerative colitis,especially in the aspect of pus-blood stool.

关 键 词：溃疡性结肠炎 中医药 大肠湿热证 脓血便 生存质量 

分 类 号：R574.[医药卫生—消化系统]