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已发表论文
黄葵连肠汤灌肠液与美沙拉嗪灌肠剂治疗轻中度活动期远端溃疡性结肠炎有效性的比较：一项多中心、前瞻性、随机对照试验方案
Authors Zhu Y, Wang R , Ding H, Li H, Zhao Y, Chen K, Zeng T, Ma Y, Chen C, Bu Z, Zhang J, Yang Y , Chen Y
Received 13 October 2025
Accepted for publication 13 January 2026
Published 5 February 2026 Volume 2026:19 574028
DOI https://doi.org/10.2147/JPR.S574028
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Houman Danesh
Yijia Zhu,1,2,* Rong Wang,3,* Haoyu Ding,1,2 Hong Li,4 Yang Zhao,1,2 Kailan Chen,1,2 Tian Zeng,1,2 Yimeng Ma,1 Chen Chen,1 Zhijun Bu,1,2 Jianghai Zhang,4 Ye Yang,5 Yugen Chen6– 8
1The Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing, 210029, People’s Republic of China; 2No. 1 Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing, 210023, People’s Republic of China; 3School of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, 210029, People’s Republic of China; 4Jiangsu Jiuxu Pharmaceutical Co. Ltd., Huai’an, 223002, People’s Republic of China; 5School of Medicine, Nanjing University of Chinese Medicine, Nanjing, 210023, People’s Republic of China; 6Department of Colorectal Surgery, The Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing, 210029, People’s Republic of China; 7Jiangsu Province Key Laboratory of Tumor Systems Biology and Chinese Medicine, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, 210029, People’s Republic of China; 8Jiangsu Collaborative Innovation Center of Chinese Medicine in Prevention and Treatment of Tumor, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, 210029, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Ye Yang, School of Medicine, Nanjing University of Chinese Medicine, Nanjing, 210023, People’s Republic of China, Email yangye876@sina.com Yugen Chen, Department of Colorectal Surgery, The Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing, 210029, People’s Republic of China, Email yugen.chen@njucm.edu.cn
Introduction: Traditional Chinese medicine enemas have been widely utilized in clinical practice due to their rapid and effective relief of symptoms such as bloody stools and abdominal pain in ulcerative colitis (UC), sustained therapeutic effectiveness, and low cost. The objective of this multicenter, unblinded randomized controlled trial (RCT) is to evaluate whether the effectiveness and safety of HKE are comparable to those of Mesalazine enemas. Evidence from observational studies is of insufficient quality, underscoring the need for randomized controlled trials to strengthen the reliability and validity of the findings.
Methods and Analysis: Eight hospitals in Jiangsu Province with Good Clinical Practice (GCP) certification will recruit patients with mild to moderate active rectal or left-sided colonic UC and randomly assign them in a 1:1 ratio to the Huangkui Lianchang decoction Enema (HKE) treatment group and the mesalazine enema treatment group. All participants received oral Mesalazine enteric-coated tablets. Enema treatment is administered for 8 weeks. Eighty-six patients are recruited for each group. Clinical events are monitored throughout the treatment and follow-up periods. The primary outcome is the modified Mayo score, assessed at baseline and post-treatment (on Day 56 ± 7). This score is used to evaluate both clinical outcomes (clinical remission and response rates) and endoscopic outcomes (endoscopic response and mucosal healing rates). Secondary outcomes include improvements in traditional Chinese medicine symptom scores, resolution rates of individual symptoms, endoscopic mucosal healing rates, and changes in C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and fecal calprotectin levels.
Discussion: The outcomes of this research aim to provide evidence supporting the efficacy and safety of HKE enemas for treating ulcerative colitis, and generate high-quality evidence on the treatment of UC with Chinese herbal medicine retention enemas through rigorous clinical investigation. The findings are intended to inform the optimization of therapeutic strategies in clinical guidelines. As this study is a protocol, no results are available at this stage.
Trial Registration Number: International Traditional Medicine Clinical Trial Registry ITMCTR2024000702 (https://itmctr.ccebtcm.org.cn/mgt/project/view/-7877458543771072185).
Keywords: Huangkui Lianchang decoction enema, complementary medicine, abdominal pain, ulcerative colitis
1The Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing, 210029, People’s Republic of China; 2No. 1 Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing, 210023, People’s Republic of China; 3School of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, 210029, People’s Republic of China; 4Jiangsu Jiuxu Pharmaceutical Co. Ltd., Huai’an, 223002, People’s Republic of China; 5School of Medicine, Nanjing University of Chinese Medicine, Nanjing, 210023, People’s Republic of China; 6Department of Colorectal Surgery, The Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing, 210029, People’s Republic of China; 7Jiangsu Province Key Laboratory of Tumor Systems Biology and Chinese Medicine, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, 210029, People’s Republic of China; 8Jiangsu Collaborative Innovation Center of Chinese Medicine in Prevention and Treatment of Tumor, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, 210029, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Ye Yang, School of Medicine, Nanjing University of Chinese Medicine, Nanjing, 210023, People’s Republic of China, Email yangye876@sina.com Yugen Chen, Department of Colorectal Surgery, The Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing, 210029, People’s Republic of China, Email yugen.chen@njucm.edu.cn
Introduction: Traditional Chinese medicine enemas have been widely utilized in clinical practice due to their rapid and effective relief of symptoms such as bloody stools and abdominal pain in ulcerative colitis (UC), sustained therapeutic effectiveness, and low cost. The objective of this multicenter, unblinded randomized controlled trial (RCT) is to evaluate whether the effectiveness and safety of HKE are comparable to those of Mesalazine enemas. Evidence from observational studies is of insufficient quality, underscoring the need for randomized controlled trials to strengthen the reliability and validity of the findings.
Methods and Analysis: Eight hospitals in Jiangsu Province with Good Clinical Practice (GCP) certification will recruit patients with mild to moderate active rectal or left-sided colonic UC and randomly assign them in a 1:1 ratio to the Huangkui Lianchang decoction Enema (HKE) treatment group and the mesalazine enema treatment group. All participants received oral Mesalazine enteric-coated tablets. Enema treatment is administered for 8 weeks. Eighty-six patients are recruited for each group. Clinical events are monitored throughout the treatment and follow-up periods. The primary outcome is the modified Mayo score, assessed at baseline and post-treatment (on Day 56 ± 7). This score is used to evaluate both clinical outcomes (clinical remission and response rates) and endoscopic outcomes (endoscopic response and mucosal healing rates). Secondary outcomes include improvements in traditional Chinese medicine symptom scores, resolution rates of individual symptoms, endoscopic mucosal healing rates, and changes in C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and fecal calprotectin levels.
Discussion: The outcomes of this research aim to provide evidence supporting the efficacy and safety of HKE enemas for treating ulcerative colitis, and generate high-quality evidence on the treatment of UC with Chinese herbal medicine retention enemas through rigorous clinical investigation. The findings are intended to inform the optimization of therapeutic strategies in clinical guidelines. As this study is a protocol, no results are available at this stage.
Trial Registration Number: International Traditional Medicine Clinical Trial Registry ITMCTR2024000702 (https://itmctr.ccebtcm.org.cn/mgt/project/view/-7877458543771072185).
Keywords: Huangkui Lianchang decoction enema, complementary medicine, abdominal pain, ulcerative colitis