Femina Gynecology Center, Rue Emile-Yung 1, 1205, Geneva, Switzerland.
Department of Obstetrics and Gynecology, Cantonal Hospital, University of Fribourg, Fribourg, Switzerland.
Arch Gynecol Obstet. 2021 Feb;303(2):501-511. doi: 10.1007/s00404-020-05816-8. Epub 2020 Nov 20.
The effect of SAM vaginal gel, a medical device containing adsorptive silicon dioxide and antioxidative sodium selenite and citric acid, on histologically-proven cervical intraepithelial neoplasia type 2 (CIN2) as well as p16 positive CIN1, and on the presence of the onco-marker p16 was investigated.
216 women aged 25-60 years were randomized to either receive an intravaginal daily dose of SAM gel for three 28-day periods, or be followed-up without intervention. The primary endpoint was efficacy, defined as a combined histological and cytological regression. At baseline and after 3 months participants had: a guided biopsy including p16 immunohistochemical (IHC) staining, only if a lesion was visible at colposcopy; a cervical smear for cytology, high-risk human papillomavirus (hr-HPV) and a p16/Ki-67 test. At 6 months a further cytology and p16/Ki-67 test was performed.
Regression of CIN lesions was observed in 78 out of 108 patients (72.2%) in the SAM gel arm and in 27 out of 108 patients (25.0%) in the control arm. Similarly, the change in the p16/Ki-67 cytological test status was significantly in favor of the treatment arm. The prevalence of hr-HPV decreased significantly (p < 0.001) in the treatment arm, from 87.0% to 39.8%, while it slightly increased in the control arm, from 78.7% to 83.3%. At 6 months the cytological regression in the treatment group and the highly significant effect on p16/Ki-67 was still present.
SAM vaginal gel enhances the regression of cervical lesions and clears hr-HPV and p16/Ki-67 in smears significantly, thus offering an active non-destructive management to prevent cervical cancer.
ISRCTN11009040, date of registration: 10/12/2019; https://doi.org/10.1186/ISRCTN11009040 ; retrospectively registered.
研究含有吸附性二氧化硅和抗氧化剂亚硒酸钠与柠檬酸的阴道用 SAM 凝胶对组织学证实的宫颈上皮内瘤变 2 级（CIN2）以及 p16 阳性的 CIN1 的影响，并研究其对致癌标志物 p16 的影响。
将 216 名 25-60 岁的女性随机分为两组，一组接受阴道内每日一次的 SAM 凝胶治疗，共三个 28 天疗程，另一组不进行干预。主要终点为疗效，定义为组织学和细胞学的联合缓解。在基线和 3 个月时，参与者进行了以下操作：如果阴道镜检查发现有病变，则进行引导活检，包括 p16 免疫组化（IHC）染色；进行宫颈涂片细胞学检查、高危型人乳头瘤病毒（hr-HPV）和 p16/Ki-67 检测；6 个月时进行进一步的细胞学和 p16/Ki-67 检测。
在 SAM 凝胶组中，108 名患者中有 78 名（72.2%）患者的 CIN 病变得到缓解，而在对照组中，108 名患者中有 27 名（25.0%）患者的 CIN 病变得到缓解。同样，p16/Ki-67 细胞学检测状态的变化也明显有利于治疗组。治疗组中高危型 HPV 的患病率显著下降（p<0.001），从 87.0%降至 39.8%，而对照组中则略有上升，从 78.7%升至 83.3%。6 个月时，治疗组的细胞学缓解和对 p16/Ki-67 的显著作用仍然存在。
SAM 阴道凝胶可显著促进宫颈病变的消退，显著清除 hr-HPV 和 p16/Ki-67 涂片，从而为预防宫颈癌提供一种积极的非破坏性治疗方法。
ISRCTN11009040，注册日期：2019 年 12 月 10 日；https://doi.org/10.1186/ISRCTN11009040；回溯性注册。
