Objective To explore the clinical efficacy and safety of a combined therapy by using recombinant human interferon α2b, Baofukang suppository and vaginal lactobacillus for high-risk human papillomavirus (HR-HPV) infection in postmenopausal women, and to provide a reference for the treatment of HR-HPV infection.

Methods This study was a single-center, prospective, randomized, open-label, and parallel-controlled trial. A total of 210 postmenopausal women with cervical HR-HPV infection who visited the Maternal and Child Health Care and Family Planning Service Center of Deqing County from January 2022 to December 2023 were consecutively selected. They were randomly divided into study group (112 cases) and control group (98 cases) using a random number table. The control group was treated with recombinant human interferon α2b vaginal effervescent capsules and Baofukang suppositories. The study group received vaginal lactobacillus capsules in addition to the treatment given to the control group. The primary outcome measure was the HPV clearance rate at 6 and 12 months after treatment. The secondary outcomes included the rate of cervical cytology improvement, symptom relief rate, vaginal microecological indicators (vaginal pH value, proportion of lactobacillus), and the incidence of adverse reactions.

Results A total of 196 patients (112 in the study group and 84 in the control group) completed the 12-month follow-up. At 6 months after treatment, there was no significant difference in the negative rate of HR-HPV between the two groups (χ²=3.36, P=0.072). At 12 months after treatment, the negative rate of HPV in the study group (78.57%, 88/112) was higher than that in the control group (52.38%, 44/84) (χ²=3.98, P=0.046). At 6 months after treatment, there was no significant difference in the improvement rate of cervical cytology between the two groups (χ²=0.12, P=0.063). At 12 months after treatment, the improvement rate of cervical cytology in the study group (73.21%, 82/112) was higher than that in the control group (47.62%, 40/84) (χ²=4.26, P=0.039).In terms of vaginal microecology, at 6 months after treatment, the median vaginal pH value of the study group 4.17 (4.03,4.26) was lower than that of the control group 4.60 (4.31,4.85) (U=386.52, P=0.004), and the average proportion of lactic acid bacteria (82.36±5.12)% was higher than that of the control group (68.57±6.34)% (t=7.56, P=0.002). At 12 months after treatment, the median vaginal pH value of the study group 4.04 (3.81,4.12) was lower than that of the control group 4.06 (3.83,4.19) (U=352.04, P=0.006), and the average proportion of lactic acid bacteria (91.25±4.36)% was higher than that of the control group (78.63±5.72)% (t=6.73, P=0.001). At 6 months after treatment, the remission rate of symptoms in the study group (64.29%, 72/112) was higher than that in the control group (40.48%, 34/84) (χ²=10.957, P=0.001). At 12 months after treatment, the remission rate of symptoms in the study group (87.50%, 98/112) was higher than that in the control group (64.29%, 54/84) (χ²=56.81, P<0.001). Regarding side effects, during the treatment period and within one month after the completion of treatment, only three types of mild local side effects, including increased vaginal discharge, vaginal burning sensation, and vulvar pruritus, were observed in both groups. All adverse reactions were alleviated after symptomatic management (such as perineal cleaning and adjusting medication posture). The total incidence of adverse reactions in the study group was 6.25%, compared to 7.14% in the control group, with no statistically significant differences between the two groups (χ²=0.09, P=0.768).

Conclusion The combined treatment of recombinant human interferon α2b vaginal effervescent capsules, Baofukang suppositories, and vaginal lactobacillus capsules in postmenopausal women with cervical HR-HPV infection could effectively increase the HPV clearance rate, improve cervical cytology, restore vaginal microbiota balance, and relieve clinical symptoms.