The safety and efficacy of a novel method for treatment of HSIL

Abstract

Purpose: To investigate the efficacy and safety of Nr-CWS on treatment of cervical HSIL.

Method: In this observational study, 16 patients were treated with Nr-CWS 1 time every 2 days for 6 times as one-course group (OC group), the other 184 patients were treated with Nr-CWS 1 time every 2 days for 12 times between 2 menstruations as two-course group (TC group). The medical information including age, HPV assay, vaginal-cervical cytology, and the pathological result of biopsy before and after treatment was collected. All patients were followed up at least twice after treatment. The LEEP was performed once the patients with persistent HR-HPV infection and/or abnormal TCT after the second follow-up.

Results: The cytology remission rate of cervical HSIL in OC and TC group was 100.0% and 87.8%, respectively, which were significant higher than the control (25.0%) with the P value of 2.00 × 10^-3 and 2.06 × 10^-4. Furthermore, HPV clearance rate was 87.5% and 70.2% in OC and TC group, respectively, which were significant higher than control (32.4%) with the P value of 2.74 × 10^-4 and 2.18 × 10^-5, respectively. Moreover, the more severe of cytology, the worse effect of HPV clearance for the HPV remission was 75.4%, 68.3%, 67.4%, 65.6% and 64.3% in the negative, LSIL, ASC-US, ASC-H, and HSIL group. 12 patients underwent LEEP after Nr-CWS treatment, 9 (75%) had persistent HSIL and 44.4% cases were found HSIL lesion in the cervical canal. There was no serious adverse reaction observed during treatment and follow-up, four patients were pregnant after treatment and no adverse pregnancy outcomes were observed.

Conclusion: Nr-CWS is an effective and safe drug for treatment of cervical HSIL for Chinese women, especially for cases without lesions in cervical canal.

Keywords: Cervical cancer; Drug therapy; Effect; HSIL; Non-surgical treatment; Nr-CWS; Safety.