Clinical study of Modified Ermiao Granules activating AIM2 inflammasome-mediated pyroptosis to clear HR-HPV and ameliorate LSIL

This study aimed to examine the efficacy and safety of Modified Ermiao Granules in clearing high-risk human papillomavirus (HR-HPV) and reversing low-grade squamous intraepithelial lesions (LSIL), as well as to examine cervical tissues before and after drug treatment for absent in melanoma (AIM2) inflammasome-mediated pyroptosis. A total of 60 patients with persistent HR-HPV infection and cervical histopathology of the LSIL were randomly divided into control group and observation groups (n = 30 each). Observation group participants received Modified Ermiao Granules orally, whereas the control group received recombinant human interferon α2b vaginal effervescent tablets. After treatment, the observation group had a significantly lower HPV DNA loads than the control group (p < 0.05). Compared with the control group, the observation group had a significantly higher HR-HPV clearance rate (χ2 = 4.267, p = 0.039). Accordingly, the LSIL reversal rates were 33.33% and 60.00% in the control and observation groups, respectively (χ2 = 4.286, p = 0.038). Both treatments reduced clinical symptoms in patients with HR-HPV with LSIL, but the observation group showed greater improvement (p < 0.05). Control and observation groups expressed AIM2 protein positively at 36.67% and 66.37%, respectively (χ2 = 5.406, p < 0.05). Caspase-1, gasdermin D (GSDMD), and interleukin (IL)-1β levels in vaginal douche were significantly higher in the observation group than in the control group (p < 0.05). There was a significant negative correlation between HPV DNA load and AIM2 expression in cervical tissues (rho = −0.493, p < 0.05), with caspase-1 (r = −0.439, p < 0.05), GSDMD (r = −0.508, p < 0.05) and IL-1β levels (r = −0.347, p = 0.007) in vaginal douche. In conclusion, the Modified Ermiao Granules effectively cleared persistent HR-HPV infections and reversed LSIL, which may be associated with its activating effect on AIM2 inflammasome-mediated pyroptosis.

Modified Ermiao Granules; HPV; Pyroptosis; Inflammasome; AIM2

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