摘要
目的:评价青玉散胶囊长期治疗轻中度活动期溃疡性结肠炎(UC)大肠湿热证的临床疗效及安全性。方法:采用随机、对照研究设计,将88例轻中度UC大肠湿热证患者分为青玉散组和对照组(每组各44例)。对照组41例(脱落3例)予美沙拉嗪颗粒4 g·d^(-1)治疗,青玉散组43例(脱落1例)予青玉散胶囊0.8 g·d^(-1)治疗,2组均持续治疗32周。比较2组的临床缓解率、黏膜愈合率、治疗前后改良Mayo评分、中医证候评分及简化炎症性肠病生存质量评分(SIBDQ),观察肠镜及病理变化,并比较2组患者的临床安全性。结果:治疗后,青玉散组临床缓解率为72.1%(31/43),对照组临床缓解率为26.8%(11/41),青玉散组高于对照组(χ^(2)=17.200,P<0.01);青玉散组黏膜愈合率为74.4%(32/43),对照组黏膜愈合率为41.5%(17/41),青玉散组临床疗效高于对照组(χ^(2)=10.843,P<0.01)。与本组治疗前比较,2组患者的改良Mayo评分、部分Mayo评分、中医证候评分均明显降低(P<0.05),与对照组治疗后比较,青玉散组下降更显著(P<0.01)。与本组治疗前比较,2组患者的SIBDQ评分明显升高(P<0.05),与对照组治疗后比较,青玉散组升高更明显(P<0.01)。两组不良事件发生率差异无统计学意义。结论:青玉散长期治疗UC大肠湿热证的临床疗效显著,在诱导并维持临床缓解、促进黏膜愈合、改善中医证候和提高生存质量上具有优势,且安全性较好。
Objective:To evaluate the efficacy and safety of Qingyusan capsules in the long-term treatment of mild to moderate active ulcerative colitis(UC)with the syndrome of large intestine dampness-heat.Method:A randomized,controlled design was adopted,and 88 patients with mild to moderate UC and syndrome of large intestine dampness-heat were randomized into a Qingyusan(Qingyusan capsules,0.8 g·d^(-1))group and a control(mesalazine,0.4 g·d^(-1))group,with 44 patients in each group.Three and one patients dropped out in the control and Qingyusan groups,respectively,during the 32 weeks of treatment.The clinical remission rate,mucosal healing rate,and modified Mayo score,TCM symptom score,and short inflammatory bowel disease questionnaire(SIBDQ)score before and after treatment were compared between the two groups.The colonoscopic and pathological changes were observed,and the clinical safety was compared between the two groups.Result:After treatment,the clinical remission rate and mucosal healing rate in the Qingyusan group were 72.1%(31/43)and 74.4%(32/43),respectively,which were higher than those[26.8%(11/41)and 41.5%(17/41),respectively]in the control group(χ^(2)=17.200,χ^(2)=10.843,respectively,both P<0.01).The treatment in both groups decreased the modified Mayo score,partial Mayo score,and TCM symptom score(P<0.05),and the decreases in the Qingyusan group were higher than those in the control group(P<0.01).After treatment,the SIBDQ scores in both groups increased(P<0.05),and the increase was more pronounced in the Qingyusan group than in the control group(P<0.01).There was no difference in the incidence of adverse events between the two groups.Conclusion:The clinical efficacy of Qingyusan capsules is remarkable in the long-term treatment of UC with the syndrome of large intestine dampness-heat.Particularly,Qingyusan capsules demonstrates advantages in inducing and maintaining clinical remission,promoting mucosal healing,alleviating TCM symptoms,and enhancing the survival quality of patients,with high safety.
作者
刘晓雯
顾思臻
窦丹波
薛仕贵
唐旖旎
蔡淦
LIU Xiaowen;GU Sizhen;DOU Danbo;XUE Shigui;TANG Yini;CAI Gan(Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2024年第14期114-121,共8页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家自然科学基金项目(82174288)
上海市科技创新行动计划医学创新研究专项(20Y21901900)
上海市科技创新行动计划生物医药科技支撑专项(22S21903500)
上海中医药大学“杏林学者”项目(上中医人字[2020]23号)。
关键词
青玉散
溃疡性结肠炎
大肠湿热证
临床研究
Qingyusan capsules
ulcerative colitis
syndrome of large intestine dampness-heat
clinical study
