American journal of translational research · 2026
Kangfuxin liquid enema plus adalimumab for ulcerative colitis: a retrospective cohort study.
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Zhao Meimei, Yu Tao
Аннотация
OBJECTIVES: Ulcerative colitis (UC) is a chronic inflammatory bowel disease requiring effective treatment. This study aimed to evaluate the efficacy and safety of Kangfuxin liquid enema combined with adalimumab compared to adalimumab monotherapy in patients with UC.
METHODS: This retrospective cohort study included 240 UC patients treated between June 2022 and January 2024. Patients were divided into a combination therapy group (CT, adalimumab + Kangfuxin enema, n = 123) and a monotherapy group (MT, adalimumab alone, n = 117). We assessed clinical efficacy, adverse reactions, quality of life, serum inflammatory cytokines (interleukin-1 beta [IL-1β], interleukin-8 [IL-8], tumor necrosis factor-alpha [TNF-α]), endoscopic scores (Mayo, Baron), histologic score (Geboes), oxidative stress indicators (superoxide dismutase [SOD], malondialdehyde [MDA]), and intestinal barrier indicators (diamine oxidase [DAO], D-lactate) before and after 8 weeks of treatment.
RESULTS: Overall response rate observed in the CT cohort (88.62%) significantly exceeded that of the MT cohort (73.50%, P = 0.003). Mucosal healing rates were 56.10% vs. 32.48% (P < 0.001). Endoscopic remission rates were 65.04% vs. 47.01% (P = 0.005). Post-treatment inflammatory factor levels were decreased in the CT group (all P < 0.001). Oxidative stress and intestinal barrier markers also improved more in the CT group (all P < 0.001). Moreover, patient-reported quality of life (assessed by IBDQ-32) improved significantly more in the CT group (P < 0.001). Adverse reaction incidence (8.94% vs. 23.94%, P = 0.002) was decreased in the CT group.
CONCLUSION: Combining Kangfuxin liquid enema and adalimumab was more effective and safer than adalimumab alone in the treatment of ulcerative colitis.
METHODS: This retrospective cohort study included 240 UC patients treated between June 2022 and January 2024. Patients were divided into a combination therapy group (CT, adalimumab + Kangfuxin enema, n = 123) and a monotherapy group (MT, adalimumab alone, n = 117). We assessed clinical efficacy, adverse reactions, quality of life, serum inflammatory cytokines (interleukin-1 beta [IL-1β], interleukin-8 [IL-8], tumor necrosis factor-alpha [TNF-α]), endoscopic scores (Mayo, Baron), histologic score (Geboes), oxidative stress indicators (superoxide dismutase [SOD], malondialdehyde [MDA]), and intestinal barrier indicators (diamine oxidase [DAO], D-lactate) before and after 8 weeks of treatment.
RESULTS: Overall response rate observed in the CT cohort (88.62%) significantly exceeded that of the MT cohort (73.50%, P = 0.003). Mucosal healing rates were 56.10% vs. 32.48% (P < 0.001). Endoscopic remission rates were 65.04% vs. 47.01% (P = 0.005). Post-treatment inflammatory factor levels were decreased in the CT group (all P < 0.001). Oxidative stress and intestinal barrier markers also improved more in the CT group (all P < 0.001). Moreover, patient-reported quality of life (assessed by IBDQ-32) improved significantly more in the CT group (P < 0.001). Adverse reaction incidence (8.94% vs. 23.94%, P = 0.002) was decreased in the CT group.
CONCLUSION: Combining Kangfuxin liquid enema and adalimumab was more effective and safer than adalimumab alone in the treatment of ulcerative colitis.