摘要
目的:观察结肠清热丸治疗活动期溃疡性结肠炎(UC)大肠湿热证的临床疗效及对炎症因子的影响。方法:将108例符合要求的活动期UC患者,按随机数字表法分为观察组和对照组。两组患者均口服美沙拉嗪肠溶片,2 g/次,2次/d,连续服用2周,若症状控制不佳,则改为醋酸泼尼松片,0.75 mg·kg^(-1)·d^(-1),分3次口服。观察组口服结肠清热丸,10 g/次,3次/d,饭前服用。对照组口服结肠清热丸模拟药,10 g/次,3次/d,饭前服用。两组疗程均为12周,并进行3个月随访。以改良Mayo评分评价疾病活动情况,进行治疗前后大肠湿热证评分、炎症性肠病问卷(IBDQ),黏膜组织学评估和主要症状及肠黏膜病变轻重分级与评分;记录治疗后2周治疗无反应性发生率、激素无效、激素依赖、早期复发情况,检测治疗前后肿瘤坏死因子-α(TNF-α),白细胞介素-6(IL-6)和IL-17水平。结果:观察组临床有效率为94.00%(47/50),高于对照组的77.55%(38/49)(χ^(2)=5.514,P<0.05);观察组临床缓解率为82.00%(41/50),高于对照组的61.22%(30/49)(χ^(2)=5.266,P<0.05);观察组内镜应答率为96.00%(48/50),高于对照组的79.59%(39/49)(χ^(2)=6.251,P<0.05);观察组黏膜愈合率为90.00%(45/50),高于对照组的79.59%(35/49)(χ^(2)=5.503,P<0.05);治疗后观察组患者腹泻、脓血便、腹痛、里急后重、充血水肿、糜烂、溃疡评分均低于对照组(P<0.01);观察组治疗无反应性发生率为16.00%(8/50),低于对照组的34.69%(17/49)(χ^(2)=4.581,P<0.05);观察组激素无效率为37.50%(3/8),低于对照组的64.71%(11/17),但差异无统计学意义(经确切概率法检验);观察组激素依赖率为12.50%(1/8),低于对照组的23.53%(4/18),但差异无统计学意义(经确切概率法检验);观察组早期复发率为14.00%(7/50),低于对照组的32.65%(16/49)(χ^(2)=4.827,P<0.05);观察组患者Mayo评分、大肠湿热证评分和Geboes指数均低于对照组(P<0.01),IBDQ评分高于对照组(P<0.01);观察组患者TNF-α,IL-6及IL-17均低于对照组(P<0.01)。结论:在西医常规治疗的基础上,采用结肠清热丸治疗活动期UC大肠湿热证患者,可有效诱导临床缓解,减轻了炎症反应,促进了肠黏膜愈合,改善了临床症状,提高了生活质量,并提高治疗的应答情况,临床疗效和肠镜疗效均优于单纯西医治疗,值得临床使用。
Objective: To observe the clinical efficacy of Jiechang Qingre pills for dampness-heat syndrome of large intestine at active stage of ulcerative colitis(UC)and investigate its effect on inflammatory factors. Method: One hundred and eight patients with active UC were divided into observation group and control group. Both groups were treated with Mesalazine enteric-coated tablets,2 g/times,2 times/day,for 2 weeks. If symptoms were poorly controlled,prednisone acetate tablets would be used instead,0.75 mg·kg^(-1)·d^(-1) in 3 times by oral administration. Patients in the observation group took Jiechang Qingre pills,10 g/time,3 times/day before meals. Patients in the control group took Jiechang Qingre pills simulated drug,10 g/time,3 times/day before meals. The course of treatment was 12 weeks in both groups and the patients were followed up for 3 months. The modified Mayo score was used to evaluate disease activity. Before and after treatment,large intestine dampness-heat syndrome score,inflammatory bowel disease questionnaire(IBDQ),mucosal histology assessment and scores of major symptoms and intestinal mucosal lesion severity were graded. The incidence of non-reactivity, hormone failure, hormone dependence, and early recurrence were recorded 2 weeks after treatment. Tumor necrosis factor-α(TNF-α),interleukin-6(IL-6)and IL-17 levels were measured before and after treatment. Result: The clinical effective rate in the observation group was 94.00%(47/50),higher than77.55%(38/49)in the control group(χ^(2)=5.514,P<0.05). The clinical remission rate was 82.00%(41/50)in the observation group,higher than 61.22%(30/49)in the control group(χ^(2)=5.266,P<0.05). The endoscopic response rate was 96.00%(48/50)in the observation group,higher than 79.59%(39/49)in the control group(χ^(2)=6.251,P<0.05). The rate of mucosal healing in the observation group was 90.00%(45/50),higher than79.59%(35/49)in the control group(χ^(2)=5.503,P<0.05). The scores of diarrhea,purulent stool,abdominal pain,tenesmus,hyperemia,edema,erosion and ulcer in the observation group were lower than those in the control group(P<0.01). The rate of non-reactivity in the observation group was 16.00%(8/50),lower than34.69%(17/49)in the control group(χ^(2)=4.581,P<0.05). The hormone failure rate in the observation group was37.50%(3/8),lower than 64.71%(11/17)in the control group,but the difference was not statistically significant(tested by the exact probaility method). The hormone dependence rate in the observation group was 12.50%(1/8),lower than 23.53%(4/17)in the control group,but the difference was not statistically significant(tested by the exact probaility method). The early recurrence rate in the observation group was 14.00%(7/50),lower than 32.65%(16/49)in the control group(χ^(2)=4.827,P<0.05). The scores of Mayo,dampness and heat syndrome and Geboes index in the observation group were lower than those in the control group(P<0.01),and the IBDQ scores were significantly higher than those in the control group(P<0.01). The TNF-α,IL-6 and IL-17 levels of the patients in the observation group were lower than those in the control group(P<0.01). Conclusion: Based on the routine treatment of western medicine,Jiechang Qingre pills treatment for the patients with active UC can effectively induce clinical remission, alleviate inflammatory reaction, promote intestinal mucosal healing,improve clinical symptoms,quality of life and the response of treatment. Its clinical efficacy and enteroscopy efficacy are better than western medicine treatment alone,so it is worthy of clinical use.
作者
杨娅娟
王凯
席作武
高宗跃
YANG Ya-juan;WANG Kai;XI Zuo-wu;GAO Zong-yue(Second Clinical Medical College,Henan University of Chinese Medicine,Zhengzhou 450002,China;Henan Province Hospital of TCM The Second Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450002,China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2021年第9期112-117,共6页
Chinese Journal of Experimental Traditional Medical Formulae
基金
河南省中医药科学研究专项课题(2019JDZX082)。
关键词
溃疡性结肠炎
活动期
大肠湿热证
肠清热丸
炎症因子
生活质量
复发
ulcerative colitis
active stage
large intestine dampness and heat syndrome
Jiechang Qingre pills
inflammatory factors
quality of life
recurrence
