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
-
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。Abstract: 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.
-
[1] Ungaro R,Mehandru S,Allen PB,et al.Ulcerative colitis[J].Lancet,2017,389(10080):1756-1770.
[2] Feuerstein JD,Isaacs KL,Schneider Y,et al.AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis[J].Gastroenterology,2020,158(5):1450-1461.
[3] 张天涵,沈洪.炎症性肠病的中医辨治思路[J].中医杂志,2019,60(14):1191-1193,1236.
[4] 中华医学会消化病学分会炎症性肠病学组.炎症性肠病诊断与治疗的共识意见(2012年,广州)[J].中华消化杂志,2012(12):796-813.
[5] Dignass A,Eliakim R,Magro F,et al.Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 1:definitions and diagnosis[J].J Crohns Colitis,2012,6(10):965-990.
[6] 中华中医药学会脾胃病分会.溃疡性结肠炎中医诊疗共识(2009)[J].中国中西医结合杂志,2010,30(5):527-532.
[7] 陈治水,王新月.溃疡性结肠炎中西医结合诊疗共识[J].中国中西医结合消化杂志,2010,18(6):416-419.
[8] 郑筱萸.中药新药临床研究指导原则(试行)[M].北京:中国医药科技出版社,2002:124-129.
[9] Guyatt G,Mitchell A,Irvine EJ,et al.A new measure of health status for clinical trials in inflammatory bowel disease[J].Gastroenterology,1989,96(3):804-810.
[10] Prideaux L,Kamm MA,De Cruz PP,et al.Inflammatory bowel disease in Asia:a systematic review[J].J Gastroenterol Hepatol,2012,27(8):1266-1280.
[11] 戴慧敏,成园,刘苏,等.88例溃疡性结肠炎患者首发临床症状分析[J].胃肠病学和肝病学杂志,2015,24(10):1220-1222.
[12] 中国炎症性肠病协作组.3100例溃疡性结肠炎住院病例回顾分析[J].中华消化杂志,2006,26(6):368-372.
[13] 沈洪,朱磊,邹建东.500例溃疡性结肠炎住院患者临床特征回顾分析[J].北京中医药,2018,37(7):598-601.
[14] 李孝镇,唐志鹏,谢建群.溃疡性结肠炎患者的生存质量分析176例[J].世界华人消化杂志,2013,21(32):3486-3492.
[15] 中华医学会消化病学分会炎症性肠病学组.炎症性肠病诊断与治疗的共识意见(2018年,北京)[J].中华消化杂志,2018,38(5):292-311.
[16] Ooi CJ,Fock KM,Makharia GK,et al.The Asia-Pacific consensus on ulcerative colitis[J].J Gastroenterol Hepatol,2010,25(3):453-468.
[17] Magro F,Cordeiro G,Dias AM,et al.Inflammatory Bowel Disease-Non-biological treatment[J].Pharmacol Res,2020,160:105075.
[18] Sandborn WJ,Kamm MA,Lichtenstein GR,et al.MMX Multi Matrix System mesalazine for the induction of remission in patients with mild-to-moderate ulcerative colitis:a combined analysis of two randomized,double-blind,placebo-controlled trials[J].Aliment Pharmacol Ther,2007,26(2):205-215.
[19] Ko CW,Singh S,Feuerstein JD,et al.AGA Clinical Practice Guidelines on the Management of Mild-to-Moderate Ulcerative Colitis[J].Gastroenterology,2019,156(3):748-764.
[20] 顾思臻,薛艳,张玉丽,等.口服中药复方治疗溃疡性结肠炎临床疗效Meta分析[J].中国中西医结合消化杂志,2018,26(12):981-986.
[21] 王琦.沈洪运用凉血化瘀法治疗溃疡性结肠炎经验撷粹[J].江苏中医药,2019,51(5):17-19.
[22] 沈洪,张声生,王垂杰,等.中药分期序贯治疗轻中度溃疡性结肠炎临床观察[J].中华中医药杂志,2012,27(7):1788-1791.
[23] 中国中西医结合学会消化系统疾病专业委员会.溃疡性结肠炎中西医结合诊疗共识意见(2017年)[J].中国中西医结合消化杂志,2018,26(2):105-111,120.
[24] Shen H,Zhang S,Zhao W,et al.Randomised clinical trial:Efficacy and safety of Qing-Chang-Hua-Shi granules in a multicenter,randomized,and double-blind clinical trial of patients with moderately active ulcerative colitis[J].Biomed Pharmacother,2021,139:111580.
[25] 韩啸,李军祥.从撰写《中药新药用于溃疡性结肠炎的临床研究技术指导原则》看中医药治疗的关键问题与优势环节[J].中国中西医结合消化杂志,2019,27(7):541-545.
计量
- 文章访问数: 515
- PDF下载数: 234
- 施引文献: 0