Efficacy of Kangfuxin Liquid Retention Enema in Preventing and Treating Radiation-Induced Proctitis in Cervical Cancer Patients: A Randomized, Open-Label, Phase III Study

Abstract

Purpose/Objective(s)

Kangfuxin liquid is derived from the desiccated bodies of American cockroaches and is recognized for its notable anti-ulcerative properties. This study aimed to elucidate the therapeutic efficacy and underlying mechanism of action of Kangfuxin liquid retention enema in mitigating radiation-induced proctitis (RP) in cervical cancer patients.

Materials/Methods

A cohort of 86 cervical cancer patients, undergoing radiotherapy between June 2021 and January 2023, were enrolled. These participants were stratified into two groups based on their treatment modalities, each comprising 43 patients. Those in the control group did not receive any prophylactic Kangfuxin solution during the onset of their treatment. Conversely, the observation group underwent daily retention enemas containing the Kangfuxin solution from the commencement of their radiotherapy. Parameters, such as the incidence, onset, categorization of both acute and chronic RP, were meticulously documented for each group. Additionally, using flow cytometry, the expression levels of neutrophils, CD3, CD4, and CD8 were gauged pre- and post-treatment. Concurrently, C-reactive protein (CRP) levels were assessed before and after treatment via fluorescence assay.

Results

The observation group exhibited a markedly reduced incidence of acute RP post-radiotherapy, at 20.93%, in contrast to the control group, which presented a 41.86% incidence. Furthermore, the mean time to onset of RP in the observation group was significantly protracted relative to the control group, with the differences attaining statistical significance (P < 0.05). The incidence of moderate to severe radiation enteritis was considerably diminished in the observation group at 2.33%, as compared to 18.60% in the control group. Additionally, the incidences of grade 1-2 and grade 3-4 RP, as well as the cumulative incidence of both acute and chronic RP, were substantially lower in the observation group, demonstrating statistical significance (P < 0.05). Post-radiotherapy, the observation group displayed elevated levels of CD3 and CD4, and a reduction in CD8 levels, relative to the control group. Concurrently, the levels of neutrophils and CRP in the observation group were found to be lower than those in the control group, with the differences being statistically significant (P < 0.05).

Conclusion

The administration of Kangfuxin liquid retention enema demonstrates efficacy in both delaying the onset and diminishing the prevalence of radiation proctitis, subsequently ameliorating the clinical manifestations observed in cervical cancer patients post-radiotherapy. This therapeutic efficacy may be attributed to the enhancement of immune functionality coupled with a reduction in pro-inflammatory mediators (ChiCTR2200055355).