江苏省中医院/南京中医药大学附属医院,江苏省南京市秦淮区汉中路155号,210029
zhulei5100@njucm.edu.cn
收稿:2025-09-30,
修回:2026-02-06,
录用:2026-01-13,
纸质出版:2026-04-17
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刘怡婧,张梦媛,沈洪等.参榆灌肠方联合美沙拉嗪缓释颗粒治疗左半结肠型溃疡性结肠炎大肠湿热证患者的临床疗效及网络药理学研究[J].中医杂志,2026,67(08):881-887.
LIU Yijing,ZHANG Mengyuan,SHEN Hong,et al.Clinical Efficacy of Shenyu Guanchang Formula (参榆灌肠方) Enema Combined with Oral Mesalazine in the Treatment of Left-Sided Ulcerative Colitis with Large Intestine Damp-Heat Syndrome and Network Pharmacology Research[J].Journal of Traditional Chinese Medicine,2026,67(08):881-887.
刘怡婧,张梦媛,沈洪等.参榆灌肠方联合美沙拉嗪缓释颗粒治疗左半结肠型溃疡性结肠炎大肠湿热证患者的临床疗效及网络药理学研究[J].中医杂志,2026,67(08):881-887. DOI: 10.13288/j.11-2166/r.2026.08.013.
LIU Yijing,ZHANG Mengyuan,SHEN Hong,et al.Clinical Efficacy of Shenyu Guanchang Formula (参榆灌肠方) Enema Combined with Oral Mesalazine in the Treatment of Left-Sided Ulcerative Colitis with Large Intestine Damp-Heat Syndrome and Network Pharmacology Research[J].Journal of Traditional Chinese Medicine,2026,67(08):881-887. DOI: 10.13288/j.11-2166/r.2026.08.013.
目的
2
评估在口服美沙拉嗪缓释颗粒基础上应用参榆灌肠方灌肠治疗左半结肠型溃疡性结肠炎(UC)大肠湿热证患者的临床疗效,并应用网络药理学方法探讨其可能作用机制。
方法
2
采用前瞻性队列研究,纳入轻中度活动期左半结肠型大肠湿热证UC患者,根据患者意愿分为观察组和对照组各30例。两组均予美沙拉嗪缓释颗粒口服,每日3 g;观察组联合参榆灌肠方灌肠(每日1次);对照组联合美沙拉嗪栓塞肛(每日1枚);两组疗程均为8周。主要疗效指标为临床缓解率,次要疗效指标包括部分改良Mayo评分、中医单项症状评分、炎症性肠病生存质量量表(IBDQ)评分和炎症性肠病残疾指数(IBD-DI)评分,并记录不良事件及不良反应的发生情况。采用网络药理学方法分析参榆灌肠方活性成分和关键靶点,探究其潜在作用机制,并应用分子对接预测参榆灌肠方核心活性成分与关键靶点间结合活性。
结果
2
治疗8周后,观察组临床缓解率为86.7%(26/30),对照组76.7%(23/30),两组差异无统计学意义(
P
>0.05)。观察组治疗后部分改良Mayo评分、脓血便症状评分及IBD-DI评分均低于对照组(
P
<0.05)。两组患者治疗期间均未出现严重不良事件和不良反应。结合网络药理学筛选得到参榆灌肠方治疗UC的核心药物活性成分前5位为槲皮素、山柰酚、木犀草素、β-谷甾醇、豆甾醇,关键蛋白靶点前5位为肿瘤蛋白p53(TP53)、白细胞介素-6(IL-6)、丝氨酸/苏氨酸激酶1(AKT1)、白细胞介素-1β(IL-1β)、表皮生长因子受体(EGFR)。
结论
2
在口服美沙拉嗪基础上应用参榆灌肠方灌肠能够较好地改善左半结肠型UC大肠湿热证患者的临床症状,提高患者生存质量,降低残疾指数,且安全性较好。参榆灌肠方治疗UC可能与癌症通路和炎症通路相关,槲皮素、山柰酚等可能是其治疗UC的核心活性化合物。
Objective
2
To evaluate the clinical efficacy of
Shenyu Guanchang Formula
(参榆灌肠方, SGF) enema combined with oral mesalazine in the treatment of left-sided ulcerative colitis (UC) with large intestine damp-heat syndrome, and to explore its possible mechanism of action through network pharmacology.
Methods
2
In a prospective cohort design, a total of 60 patients diagnosed with left-sided UC in the mild-moderate active stage were enrolled and were divided into an observation group and a control group according to patients' willingness, with 30 participants in each arm. Both groups received oral mesalazine sustained-release granules at 3 g daily. The observation group was additionally treated with SGF by enema once daily, while the control group received mesalazine suppositories per rectum one suppository daily. The treatment course lasted 8 weeks. The primary efficacy endpoint was the clinical remission rate, and the secondary endpoints included the Mayo score, the scores of individual symptoms in traditional Chinese medicine (TCM), the inflammatory bowel disease questionnaire (IBDQ) score, and the inflammatory bowel disease disability index (IBD-DI) score. Adverse events and adverse reactions were recorded throughout the study. Network pharmaco-logy was used to analyze the active components and key targets of SGF, exploring its potential mechanisms of action, and applying molecular docking to predict the binding activity between the core active components of SGF and the key targets.
Results
2
After 8 weeks of treatment, the clinical remission rate was 86.7% (26/30) in the observation group, higher than 76.7% (23/30) in the control group, while the difference was not significant (
P
>0. 05). The observation group had lower partial modified Mayo scores, bloody stool symptom score, and IBD-DI scores than the control group (
P
<0.05). No seve
re adverse events or reactions were observed during the treatment of both groups. Based on network pharmacology screening, the top five core active components of SGF for UC treatment were quercetin, kaempferol, luteolin, β-sitosterol, and stigmasterol; and the top five key protein targets were tumor protein p53 (TP53), interleukin-6 (IL-6), serine/ threonine kinase 1 (AKT1), interleukin-1β (IL-1β), and epidermal growth factor receptor (EGFR).
Conclusion
2
SGF enema combined with oral mesalazine can effectively alleviate clinical symptoms, improve quality of life and reduce the disability index in left-sided UC patients with large intestine damp-heat syndrome, with favorable safety. SGF may exert its function through cancer pathways and inflammatory pathways, and quercetin, kaempferol, and other compounds may be the core active ingredients for treating UC.
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