目的:探讨咪喹莫特对宫颈上皮内瘤变(rrCIN)患者的疗效。与大环形切除转化区(LLETZ)相比。
方法:随机对照非劣效性试验。
方法:荷兰一家学术医院和一家地区医院。
方法:2016年5月至2021年5月,35名rrCIN患者被纳入研究。
方法:女性随机接受5%咪喹莫特乳膏(12.5mg)阴道内治疗(每周3次,持续16周)或LLETZ程序(标准治疗)。
方法:主要结果是在开始治疗后6个月时降低至正常细胞学。次要结果是两组的高危型人乳头瘤病毒(hr-HPV)清除,咪喹莫特组降低至≤CIN1。监测副作用。
结果:咪喹莫特组治疗成功率为33%(6/18),而LLETZ组治疗成功率为100%(16/16)(P<0.001),而HPV清除率在咪喹莫特组为22%(4/18),在LLETZ组为88%(14/16)(P<0.001).在对35名女性进行随机分组后,咪喹莫特治疗无效,试验提前结束.在后续阶段,三名患者仍未接受额外治疗,而所有其他患者都接受了LLETZ,锥切术或子宫切除术。在LLETZ组中,在2年的随访期间,没有患者接受额外的治疗。
结论:这是第一个随机对照试验,表明局部用咪喹莫特在降低细胞学和hr-HPV清除率方面的成功率明显较低,与LLETZ相比,在有rrCIN的女性中。此外,咪喹莫特有许多副作用,使用咪喹莫特后,大多数患有rrCIN的女性仍需要额外的手术治疗。
OBJECTIVE: To investigate the efficacy of imiquimod in women with residual or recurrent cervical intraepithelial neoplasia (rrCIN), compared with large loop excision of the transformation zone (LLETZ).
METHODS: Randomised controlled non-inferiority
trial.
METHODS: One academic and one regional hospital in the Netherlands.
METHODS: Thirty-five women with rrCIN were included in the
study between May 2016 and May 2021.
METHODS: Women were randomised to receive treatment with 5% imiquimod cream (12.5 mg) intravaginally (three times a week for a duration of 16 weeks) or a LLETZ procedure (standard treatment).
METHODS: The primary outcome was reduction to normal cytology at 6 months after starting treatment. Secondary outcomes were clearance of high-risk human papilloma virus (hr-HPV) in both groups and reduction to ≤CIN1 in the imiquimod group. Side effects were monitored.
RESULTS: Treatment success was 33% (6/18) in the imiquimod group versus 100% (16/16) in the LLETZ group (P < 0.001), whereas HPV clearance was 22% (4/18) in the imiquimod group versus 88% (14/16) in the LLETZ group (P < 0.001). After the randomisation of 35 women, the futility of treatment with
imiquimod was proven and the
trial was prematurely finished. In the follow-up period, three patients remained without additional treatment, whereas all other patients underwent LLETZ, conisation or hysterectomy. In the LLETZ group none of the patients received additional treatment during 2 years of follow-up.
CONCLUSIONS: This is the first randomised controlled
trial to show that topical
imiquimod has a significantly lower success rate in terms of reduction to normal cytology and hr-HPV clearance, compared with LLETZ, in women with rrCIN. Additionally,
imiquimod has numerous side effects and after using
imiquimod most women with rrCIN still required additional surgical treatment.