机构地区:[1]河南省中医院/河南中医药大学第二附属医院,郑州450002 [2]河南中医药大学第二临床医学院,郑州450046 [3]郑州颐和医院,郑州450018 [4]河南中医药大学研究生院,郑州450046
出 处:《中国实验方剂学杂志》2024年第20期111-119,共9页Chinese Journal of Experimental Traditional Medical Formulae
基 金:河南省中医药科学研究专项课题计划(2019ZY2025)。
摘 要:目的:评价结肠补虚丸治疗慢性复发型溃疡性结肠炎(脾肾阳虚证)的临床疗效及对黏膜屏障损伤的修复作用。方法:将108例患者随机分为观察组和对照组,每组各54例。两组均给予美沙拉嗪肠溶片,0.5 g/次,3次/d;观察组口服结肠补虚丸,10 g/次,3次/d,对照组口服结肠补虚丸模拟药,10 g/次,3次/d。两组均连续服用3个月。每月随访,比较临床应答、临床缓解率、C反应蛋白(CRP)达标率、粪钙卫蛋白(FC)达标率和内镜黏膜愈合率,治疗结束后随访3个月,记录早期复发率。比较治疗前后改良Mayo评分、黏膜组织学评分、肠镜下黏膜评分、炎症性肠病患者生活质量问卷(IBDQ)和脾肾阳虚证评分。检测治疗前后缺氧诱导因子-1α(HIF-1α)、二胺氧化酶(DAO)、D-乳酸(D-LA)、白细胞介素(IL)-1β、IL-6、IL-17A、IL-22、肿瘤坏死因子-α(TNF-α)、辅助性T细胞17(Th17)、调节性T细胞(Treg)水平,计算Th17/Treg。结果:在治疗后1、2、3个月,观察组临床应答率、临床缓解率、CRP达标率均高于对照组(P<0.05,P<0.01);在治疗后2、3个月,观察组FC达标率高于对照组(P<0.05);治疗后观察组内镜黏膜愈合率高于对照组(P<0.01),早期复发率低于对照组(P<0.05)。与对照组治疗后比较,观察组Mayo、黏膜组织学、肠镜下黏膜和脾肾阳虚证评分更低(P<0.01),IBDQ评分更高(P<0.01),观察组HIF-1α、DAO和D-LA更低(P<0.01),观察组IL-1β、IL-6、IL-17A和TNF-α水平更低(P<0.01),IL-22水平更高(P<0.01),观察组Th17、Th17/Treg更低(P<0.01),Treg更高(P<0.01)。结论:结肠补虚丸联合美沙拉嗪肠溶片慢性复发型溃疡性结肠炎脾肾阳虚证患者,可提高临床应答率、临床缓解率、CRP达标率、FC达标率和内镜黏膜愈合率,并降低早期复发率,减轻疾病活动度,促进组织学缓解,提高生活质量,其作用机制可能与抑制炎症反应,诱导肠道黏膜免疫耐受,从而保护肠黏膜屏障功能有关。Objective:To evaluate the clinical effect of Jiechang Buxu pills on chronic relapsing ulcerative colitis(syndrome of spleen-kidney Yang deficiency)and the repair effect on mucosal barrier injury.Method:A total of 108 patients were randomly assigned into observation(54 cases)and control(54 cases)groups.Both groups were treated with mesalazine enteric-coated tablets,0.5 g/time,3 times/d.In addition,the observation group received Jiechang Buxu pills,10 g/time,3 times/d,and the control group received simulant of Jiechang Buxu pills,10 g/time,3 times/d.Both groups were treated for 3 consecutive months.During monthly follow-up,clinical response,clinical remission rate,C-reactive protein(CRP)compliance rate,fecal calprotectin(FC)compliance rate,and endoscopic mucosal healing rate were compared.The early recurrence rate was recorded after 3 months of follow-up.The modified Mayo score,mucosal histological score,colonoscopic mucosal score,inflammatory bowel disease questionnaire(IBDQ)score,and syndrome score of spleen-kidney Yang deficiency were compared before and after treatment.The levels of hypoxia-inducible factor-1α(HIF-1α),diamine oxidase(DAO),D-lactic acid(D-LA),interleukin(IL)-1β,IL-6,IL-17A,IL-22,tumor necrosis factor-α(TNF-α),T helper 17(Th17),and regulatory T cells(Treg),and Th17/Treg ratio were measured and calculated before and after treatment.Result:The clinical response rate,clinical remission rate,and CRP compliance rate in the observation group were higher than those in the control group(P<0.05,P<0.01)1,2 and 3 months after treatment.The FC compliance rate in the observation group was higher than that in the control group(P<0.05)2 and 3 months after treatment.After treatment,the observation group had higher endoscopic mucosal healing rate(P<0.01)and lower early recurrence rate(P<0.05)than the control group.In addition,the observation group had lower Mayo score,mucosal histological score,colonoscopic mucosal score,and syndrome score of spleen-kidney Yang deficiency(P<0.01),higher IBDQ score(P<0.01),lo
关 键 词:溃疡性结肠炎 慢性复发型 脾肾阳虚证 结肠补虚丸 辅助性T细胞17 调节性T细胞 炎症因子 黏膜屏障
分 类 号:R856.2[医药卫生—航空、航天与航海医学] R969.4[医药卫生—临床医学] R242R574.62R286R574.1
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