肠炎清合剂联合美沙拉嗪肠溶片维持治疗缓解期溃疡性结肠炎的临床疗效  

Clinical Effect of Changyanqing Mixture Combined with Mesalazine Enteric-coated Tablets for Maintenance Treatment of Ulcerative Colitis in Remission Period

作　　者：丛龙玲 姚嘉茵[2] 吴宇金 吕永慧 CONG Long-ling;YAO Jia-yin;WU Yu-jin;LYU Yong-hui(Affiliated Traditional Chinese Medicine Hospital of Guangzhou Medical University,Guangzhou 510130,China;The Sixth Affiliated Hospital,Sun Yat Sen University,Guangzhou 510011,China)

机构地区：[1]广州医科大学附属中医医院,广州510130 [2]中山大学附属第六医院,广州510011

出　　处：《中国实验方剂学杂志》2021年第3期99-104,共6页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：广东省中医药局科研项目(20173029);广州市中医药和中西医结合科技项目(20172a01004)。

摘　　要：目的:评价肠炎清合剂联合美沙拉嗪肠溶片维持治疗缓解期溃疡性结肠炎(UC)的临床疗效。方法:将140例符合要求的缓解期UC患者按照随机数字表法分为观察组和对照组,各70例。对照组脱落、失访6例,剔除3例,完成61例;观察组脱落、失访5例,剔除2例,完成63例。两组均给予生活方式调整,并内服美沙拉嗪肠溶片,0.5 g/次,3次/d,维持治疗。观察组,肠炎清合剂,150 mL/次,每日早、晚2次服用,连续1个月;然后改为150 mL/次,1次/d,连续3个月;然后为隔日1次,连续8个月。对照组,口服肠炎清合剂模拟药,方法同观察组。两组连续治疗12个月,若治疗期间UC复发,采用美沙拉嗪肠溶片,1 g/次,3次/d,口服,直到病情缓解后继续采用以上干预方案。记录12个月内的复发率、首次复发时间(本次研究中病情缓期后至Mayo评分系统≥3分的时间)和复发时疾病活动程度;中医证评分和炎症性肠病问卷(IBDQ)每2个月评价1次;治疗前、治疗后6个月和12个月各进行1次肠镜和黏膜组织学检查,进行肠镜下黏膜评分,黏膜组织学Geboes指数评价,并检测粪便钙卫蛋白(FC)水平。进行安全性评价。结果:在12个月期间,观察组复发率20.63%(13/63),低于对照组的39.34%(24/61)(χ^(2)=4.369,P<0.05);观察组平均复发次数少于对照组和首次复发时间长于对照组(P<0.01);观察组患者在复发时疾病活动情况轻于对照组(χ^(2)=5.947,P<0.05);在12个月期间两组患者的中医证候评分,肠镜下黏膜评分,Geboes指数和FC水平逐渐升高(P<0.05),IBDQ评分逐渐下降(P<0.05),在治疗后2,4,6,8,10,12个月各时间点,观察组患者中医证候评分均低于对照组(P<0.01),IBDQ评分高于对照组(P<0.01);在治疗后6,12个月,观察组患者肠镜下黏膜评分,Geboes指数和FC水平均低于对照组(P<0.01)。未发现与肠炎清合剂相关不良反应。结论:肠炎清合剂联合美沙拉嗪肠溶片维持治疗缓解期UC患者,可控制FC水平Objective:This study aims to evaluate the clinical effect of Changyanqing mixture combined with mesalazine enteric-coated tablets in the maintenance treatment of ulcerative colitis(UC)in remission period.Method: The 140 patients with UC in remission period were randomly divided into control group(70 cases)and observation group(70 cases). The 61 patients in control group completed the therapy(6 cases lost or lost to follow-up and 3 were eliminated),63 patients in observation group completed the therapy(5 cases lost or lost to follow-up and 2 were eliminated). Both groups ′patients got treatment of lifestyle adjustment,and they also took mesalazine enteric-coated tablets orally, 0.5 g/time, 3 times/day. Patients in observation group took Changyanqing mixture orally for a month in the morning and evening every day,150 mL/time,and then changed to 150 mL/time,1 time/day,for 3 consecutive months,finally changed to once every other day for 8 months. Patients in control group took simulated medicine of Changyanqing mixture orally in the same way as observation group. The treatment was continued for 12 months. When UC recurred during the treatment,patients took mesalazine enteric-coated tablets orally at 1 g/time, 3 times/day until remission, when the above intervention plan was continued to be adopted. The recurrence rate,first recurrence time within 12 months(duration from remission to Mayo≥3)and the degree of disease activity at recurrence were recorded. Scores of traditional Chinese medicine(TCM)syndrome and inflammatory bowel disease questionnaire(IBDQ)were evaluated once every 2 months. Before treatment,and at the 6 thand 12 thmonth after treatment,colonoscopy and mucosal histology were performed once,enteroscopic mucosal scores,Geboes index of mucosal histology were evaluated,and fecal calprotectin(FC)levels were detected. Also,safety evaluation was conducted. Result:During 12 months,the recurrence rate in observation group was 20.63%(13/63),lower than 39.34%(24/61)in control group(P<0.05),the frequency of recu

关 键 词：溃疡性结肠炎 缓解期 维持治疗 肠炎清合剂 美沙拉嗪肠溶片 粪便钙卫蛋白 复发 

分 类 号：R22[医药卫生—中医基础理论] R242[医药卫生—中医学]