柔肝健脾法联合美沙拉嗪灌肠液治疗远端型溃疡性结肠炎肝郁脾虚证的临床研究  

Clinical study on the treatment of distal ulcerative colitis with Ganyu-Pixu by the therapeutic method of Rougan Jianpi and mesalazine enema

作　　者：黄华[1] 马俊杰[2] 华秋雯 金超 季利江[1] Huang Hua;Ma Junjie;Hua Qiuwen;Jin Chao;Ji Lijiang(Department of Anorectal,Changshu Hospital Affiliated to Nanjing University of Chinese Medicine,Changshu 215500,China;College of Traditional Chinese Medicine/College of Integrated Chinese and Western Medicine,Nanjing University of Chinese Medicine,Nanjing 210046,China;Department of Gastroenterology,Changshu Hospital Affiliated to Nanjing University of Chinese Medicine,Changshu 215500,China;Department of Endocrine,Changshu Hospital Affiliated to Nanjing University of Chinese Medicine,Changshu 215500,China)

机构地区：[1]南京中医药大学附属常熟医院肛肠科,常熟215500 [2]南京中医药大学中医学院•中西医结合学院,南京210046 [3]南京中医药大学附属常熟医院消化内科,常熟215500 [4]南京中医药大学附属常熟医院内分泌科,常熟215500

出　　处：《国际中医中药杂志》2024年第4期444-450,共7页International Journal of Traditional Chinese Medicine

基　　金：江苏省中医药科技发展计划项目(MS2021007、MS2023099);南京中医药大学自然科学基金资助项目(XZR2023076);苏州市科技局“科教兴卫”青年科技项目(KJXW2023069);苏州市科协软科学课题项目(2023年);常熟市科技局医学应用基础研究项目(CY202340);常熟市医药科技计划青年项目(CAWSQ202207)。

摘　　要：目的评价柔肝健脾法联合美沙拉嗪灌肠液治疗远端型溃疡性结肠炎(DUC)肝郁脾虚证的临床疗效。方法本研究为前瞻性平行随机对照研究。选择2021年11月-2022年5月南京中医药大学附属常熟医院115例DUC患者作为观察对象,采用随机数字表法分为对照组58例和研究组57例。对照组给予美沙拉嗪灌肠液灌肠治疗,研究组在对照组基础上服用柔肝健脾方。2组均治疗8周。分别于治疗前后采用改良Mayo量表评估疾病严重程度,依据其治疗前后的评分变化评估临床疗效与内镜疗效;从腹痛腹泻、黏液脓血便、里急后重、肛门灼热4个方面进行中医证候评分;采用IBD生活质量量表(IBDQ)评价患者生活质量;采用ELISA法检测血清TNF-α、IL-10水平。观察记录治疗期间的不良反应,评价临床疗效。结果研究组总有效率为91.23%(52/57)、对照组为79.31%(46/58),2组比较差异无统计学意义(Z=1.47,P=0.143)。研究组临床疗效中临床应答[40.35%(23/57)比51.72%(30/58)]及临床缓解[59.65%(34/57)比43.11%(25/58)]患者总占比[100.00%(57/57)比94.83%(55/58)]高于对照组(Z=1.97,P=0.049);内镜疗效中内镜应答[52.63%(30/57)比56.90%(33/58)]及黏膜愈合[33.33%(19/57)比17.24%(10/58)]患者总占比[85.96%(49/57)比74.14%(43/58)]高于对照组(Z=2.23,P=0.026)。治疗后,研究组IBDQ评分[(194.3±15.1)分比(172.6±18.4)分,t=6.90]高于对照组(P<0.01);中医证候积分中黏液脓血便[(1.7±0.8)分比(2.0±0.6)分,t=2.03]、里急后重[(1.5±0.6)分比(1.8±0.6)分,t=2.32]、肛门灼热[(1.3±0.6)分比(1.6±0.7)分,t=2.38]积分低于对照组(P<0.05)。研究组治疗后血清IL-10水平[(53.3±8.0)ng/L比(49.0±6.7)ng/L,t=3.10]高于对照组(P<0.01),TNF-α水平[(28.3±7.9)ng/L比(36.8±8.1)ng/L,t=3.58]低于对照组(P<0.01)。2组治疗过程中未见明显不良反应。结论柔肝健脾法联合美沙拉秦灌肠液可有效改善DUC患者的临床症状,提高临床疗效,且安全性好。Objective To evaluate the clinical efficacy of Rougan Jianpi therapy combined with Mesalazine enema in the treatment of distal ulcerative colitis(DUC)with Ganyu-Pixu syndrome.Methods This study is a prospective parallel randomized controlled study.From November 2021 to May 2022,115 patients with DUC in Changshu Hospital Affiliated to Nanjing University of Chinese Medicine were selected and randomly divided into a control group of 58 patients and a study group of 57 patients.The control group was treated with Mesalazine enema,and the study group was treated with Rougan Jianpi Decoction on the basis of the control group.Both groups were treated for 8 weeks.The severity of the disease was evaluated by using the Modified Mayo Scale,and the clinical and endoscopic efficacy was evaluated based on the changes in the score before and after treatment.TCM syndromes were scored from four aspects:abdominal pain,diarrhea,mucopurulent bloody stool,Rectal tenesmus,and anal burning.The quality of life was evaluated by using the IBD Quality of Life Scale(IBDQ).The serum TNF-αand IL-10 level were detected by using ELISA method.The adverse reactions during treatment were observed and recorded.Results The total effective rate of the study group was 91.23%(52/57),while that of the control group was 79.31%(46/58).The difference between the two groups was no statistically significant(Z=1.47,P=0.143).The proportion of patients in the study group who achieved clinical response[40.35%(23/57)vs.51.72%(30/58)]and clinical relief[59.65%(34/57)vs.43.11%(25/58)]the total proportion were significantly higher than those in the control group[100.00%(57/57)vs.94.83%(55/58);Z=1.97,P=0.049].The proportion of patients with endoscopic response[52.63%(30/57)vs.56.90%(33/58)]and mucosal healing[33.33%(19/57)vs.17.24%(10/58)]the total proportion in the study group were significantly higher than those in the control group[85.96%(49/57)vs.74.14%(43/58);Z=2.23,P=0.026].after treatment,the IBDQ score[(194.3±15.1)vs.(172.6±18.4),t=6.90]in the study group w

关 键 词：结肠炎 溃疡性 柔肝健脾方 灌肠疗法 肝郁脾虚证 

分 类 号：R574.62[医药卫生—消化系统]