【目的】观察致康胶囊联合复方黄柏液涂剂保留灌肠治疗大肠湿热型轻中度结肠远端溃疡性结肠炎 （UC） 患者的临床疗 效及其对血清促炎细胞因子肿瘤坏死因子α （TNF-α） 、白细胞介素6 （IL-6） 和C反应蛋白 （CRP） 水平的影响。 【方法】将2022年 10月至2023年12月在河南中医药大学第三附属医院门诊及病房接受治疗的110例大肠湿热型轻中度结肠远端UC患者按随机 数字表法随机分为观察组和对照组，每组各55例。对照组给予每晚临睡前锡类散1 g联合复方黄柏液涂剂50 mL保留灌肠治 疗，观察组给予每晚临睡前致康胶囊2.4 g联合复方黄柏液涂剂50 mL保留灌肠治疗，疗程为14 d。观察2组患者治疗前后血 清炎症因子指标、凝血功能指标、中医证候评分、炎症性肠病生活质量问卷 （IBDQ） 评分的变化情况，并评价2组患者的临床 疗效和用药安全性。 【结果】（1） 疗效方面，治疗14 d后，观察组的总有效率为90.91% （50/55） ，对照组为80.00% （44/55） ，组间比 较 （秩和检验） ，观察组的疗效明显优于对照组 （P < 0.01） 。 （2） 炎症因子方面，治疗后，2组患者的血清TNF-α、IL-6、CRP 水平均较治疗前降低 （P < 0.05） ，且观察组的降低幅度均明显优于对照组 （P < 0.05或P < 0.01） 。 （3） 凝血功能方面，治疗后， 2组患者的凝血酶原时间 （PT） 、纤维蛋白原 （FIB） 均较治疗前改善 （P < 0.05） ，而凝血酶时间 （TT） 与活化部分凝血活酶时间 （APTT） 均较治疗前无明显改善 （P > 0.05） ；组间比较，观察组对PT、FIB的改善幅度均明显优于对照组 （P < 0.05或P < 0.01） 。 （4） 中医证候方面，治疗后，2组患者的腹泻、便下黏液脓血、里急后重、肛门灼热等各项中医证候评分均较治疗前降低 （P < 0.05） ，且观察组的降低幅度均明显优于对照组 （P < 0.05或P < 0.01） 。 （5） 生活质量方面，治疗后，2组患者IBDQ的全身 症状、肠道症状、社会能力、情感能力等各项评分均较治疗前升高 （P < 0.05） ，且观察组的升高幅度均明显优于对照组 （P < 0.01） 。 （6） 安全性方面，治疗过程中，2组患者均未出现明显不良反应，具有较高的安全性。 【结论】致康胶囊联合复方黄柏液涂剂 保留灌肠治疗大肠湿热型轻中度结肠远端UC患者的安全性及疗效性均较为显著，能有效控制UC病情，缓解临床症状与 负面情绪，改善炎症反应及凝血功能，提高患者生活质量。

Objective To investigate the clinical efficacy of Zhikang Capsules plus Compound Huangbai Lotion for retention enema in the treatment of patients with mild to moderate distal ulcerative colitis（UC）of damp-heat in large intestine type， and to observe their effects on the serum levels of pro-inflammatory cytokines of tumor necrosis factor α（TNF-α），interleukin 6（IL-6）and C-reactive protein（CRP）. Methods A total of 110 patients with mild to moderate distal UC of damp-heat in large intestine type who were treated in the Outpatient Clinics and Wards of the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine from October 2022 to December 2023 were randomly divided into an observation group and a control group according to random number table method，with 55 patients in each group. The control group was given retention enema with 1 g of Xilei Powder and 50 mL of Compound Huangbai Lotion before going to bed every night，while the observation group was given retention enema with 2.4 g of Zhikang Capsules and 50 mL of Compound Huangbai Lotion before going to bed every night The course of treatment for the two groups covered 14 days. The changes in the serum inflammation factors， coagulation function indicators， traditional Chinese medicine（TCM）syndrome scores， and the Inflammatory Bowel Disease Quality of Life Questionnaire（IBDQ）scores in the two groups were observed before and after treatment. After treatment，the clinical efficacy and drug safety in the two groups were evaluated. Results（1）After 14 days of treatment，the total effective rate of the observation group was 90.91%（50/55）and that of the control group was 80.00%（44/55），and the intergroup comparison（tested by rank sum test）showed that the therapeutic efficacy of the observation group was significantly superior to that of the control group（P < 0.01）.（2）After treatment，the serum levels of inflammation factors of TNF-α，IL-6，and CRP patients in the two groups were decreased compared with those before treatment（P < 0.05）， and the decrease in the observation group was significantly superior to that in the control group（P < 0.05 or P < 0.01）.（3）After treatment，the prothrombin time（PT）and fibrinogen（FIB）of the two groups of patients were improved compared with those before treatment （P < 0.05），while the improvement of thrombin time（TT）and activated partial thromboplastin time（APTT）were not obvious when compared with those before treatment（P > 0.05）； the comparison between the two groups showed that the improvement of PT and FIB in the observation group was significantly superior to that in the control group（P < 0.05 or P < 0.01）.（4）After treatment，the scores of TCM symptoms of diarrhea，mucous-purulent and bloody stool，tenesmus，scorching sensation of the anus in the two groups were decreased compared with those before treatment（P < 0.05），and the decrease in the observation group was significantly superior to that in the control group（P < 0.05 or P < 0.01）.（5）After treatment， the scores of IBDQ items of general symptoms， intestinal symptoms，social functioning，emotional role functioning in the two groups were increased compared with those before treatment（P < 0.05），and the increase in the observation group was significantly superior to that in the control group（P < 0.01）.（6）During the treatment， no obvious adverse reactions occurred in the two groups，with higher safety. Conclusion Zhikang Capsules plus Compound Huangbai Lotion for retention enema are effective and safe in treating mild to moderate distal UC of damp-heat in large intestine type. The therapy can effectively control the illness of UC， alleviate the clinical symptoms and negative emotions， improve the inflammatory response and coagulation function，and enhance the quality of life of the patients.

R259.756

国家自然科学基金资助项目 （编号：82374351） ；河南省中医药拔尖人才项目 （编号：豫卫中医函[2021]15号、2022ZYBJ16） ； 河南省中医药科学研究专项课题项目 （编号：20-21ZY2075）