Efficacy and safety of compound Qingdai enema in rapidly alleviating inflammatory activity in ulcerative colitis: a prospective study.

Aim of the Study: To observe the efficacy and safety of CQE in rapidly alleviating inflammatory activity in UC. Materials and Methods: CQE extracts were analyzed by UHPLC-Q Exactive Orbitrap-HRMS. This study used a self-controlled design before and after treatment. A total of 114 UC patients were included and treated with traditional rectal enema administration of CQE. Among them, 107 patients completed the treatment, and 101 patients with complete clinical and laboratory data were included in the final analysis. The primary clinical intestinal symptoms, mucosal endoscopic and pathological changes, laboratory indicators, quality of life scores, and adverse reactions were compared before and after 14 days of enema treatment. A historical comparison was made with previous studies. The expression of intestinal tight junction proteins in the colons of UC patients during active periods was detected using Quantitative Real-time PCR (RT-qPCR) and Western blot (WB). Results: The main compounds in CQE were identified, including Gallic acid, Matrine, Oxysophocarpine, Ellagic acid, Prim-O-glucosylcimifugin, Cytisinicline, Danshensu, Protocatechuic acid, Cimifugin, Salvianolic acid A Cytisinicline, Indigo, Indirubin, Tryptanthrin and others. The primary endpoint, defined as the change in modified Mayo score, showed a significant improvement after 14 days of CQE treatment ( Conclusion: CQE can rapidly alleviate inflammatory activity in UC within 14 days and improve patients' quality of life, with a low incidence of adverse events.