背景:2级宫颈上皮内瘤变的治疗是一个临床难题。宫颈上皮内瘤变3级被认为是癌症的前体,并且总是通过切除治疗。多数宫颈上皮内瘤变1级自发消退,它在国际上主要由预期管理进行监控。宫颈上皮内瘤变的手术治疗会增加将来怀孕中早产的风险。对25岁以下女性的宫颈上皮内瘤变2级进行了充分研究;消退率高,宫颈癌风险低。25岁及以上女性宫颈上皮内瘤变2级,隐匿性癌症的风险更高,研究较少。
目的:本研究旨在评估自然病程,超过2年,25至30岁女性未经治疗的宫颈上皮内瘤变2级及其与人乳头瘤病毒16的关系。
方法:该研究是作为一项前瞻性纵向多中心临床研究,于2017年2月至2021年6月在VästraGötaland地区的5家阴道镜诊所管理异常宫颈筛查后转诊,瑞典。每个方案组由127名妇女组成,年龄25至30岁,具有完全可见的鳞状umnar交界处和组织学证实的宫颈上皮内瘤变2级。患者经阴道镜随访2年,细胞学,人乳头瘤病毒检测,和至少2个宫颈活检每6个月,直到进展或消退。主要结果指标是在人乳头瘤病毒16和没有人乳头瘤病毒16的病例中,宫颈上皮内瘤变2级在6、12、18和24个月的消退率。次要结果是持续和进展。
结果:在每个方案分析中,在72%的患者中发现了2年期间的部分或全部回归(95%置信区间,63-79).在人乳头瘤病毒16的患者中,回归率为51%(95%置信区间,36-66),进展率为47%(95%置信区间,32-62).在人乳头瘤病毒非16组中,83%(95%置信区间,73-90)和16%(95%置信区间,9-26)进展。两组的大部分消退和进展都发生在15个月内。人乳头瘤病毒16例和人乳头瘤病毒非16例之间的回归差异具有统计学意义(P值=0.0001),进展差异也是如此(P=.0002)。
结论:宫颈上皮内瘤变2级消退率高,人乳头瘤病毒16是自然病程的重要决定因素。年龄在25至30岁的患者,完全可见的鳞茎结且没有人乳头瘤病毒16,通常应建议积极监测15个月。而在患有人乳头瘤病毒16的病例中,应考虑立即治疗。
BACKGROUND: The management of cervical intraepithelial neoplasia grade 2 is a clinical dilemma. Cervical intraepithelial neoplasia grade 3 is considered a cancer precursor and is always treated with excision. Most of the cervical intraepithelial neoplasia grade 1 cases regress spontaneously, and it is internationally mostly monitored with expectant management. Surgical treatment of cervical intraepithelial neoplasia entails increased risk of preterm birth in future pregnancies. Cervical intraepithelial neoplasia grade 2 in women aged under 25 years is quite well-studied; the regression rate is high and the cervical cancer risk is low. Cervical intraepithelial neoplasia grade 2 in women aged 25 years and above, in whom the risk of occult cancer is higher, has been less studied.
OBJECTIVE: This
study aimed to evaluate the natural course, over 2 years, of untreated cervical intraepithelial neoplasia grade 2 in women aged 25 to 30 years and its association with human papillomavirus 16.
METHODS: The
study was conducted as a prospective longitudinal multicenter clinical
study during February 2017 to June 2021 at 5 colposcopy clinics managing referrals after abnormal cervical screening in Region Västra Götaland, Sweden. The per protocol group comprised 127 women, aged 25 to 30 years, with fully visible squamocolumnar junction and histologically verified cervical intraepithelial neoplasia grade 2. The patients were followed up for 2 years with colposcopy, cytology, human papillomavirus tests, and at least 2 cervical biopsies every 6 months until progression or regression. The main outcome measures were the rates of regression of cervical intraepithelial neoplasia grade 2 at 6, 12, 18, and 24 months in cases with human papillomavirus 16 and those without human papillomavirus 16. The secondary outcomes were persistence and progression.
RESULTS: In the per protocol analysis, partial or total regression during the 2-year period was found in 72% of patients (95% confidence interval, 63-79). In patients with human papillomavirus 16, the regression rate was 51% (95% confidence interval, 36-66) and the progression rate was 47% (95% confidence interval, 32-62). In the human papillomavirus-non-16 group, 83% (95% confidence interval, 73-90) regressed and 16% (95% confidence interval, 9-26) progressed. Most of the regression and progression in both the groups occurred within 15 months. The difference in regression between human papillomavirus 16 and human papillomavirus-non-16 cases was statistically significant (P value=.0001), as was the difference in progression (P=.0002).
CONCLUSIONS: The regression rate of cervical intraepithelial neoplasia grade 2 is high, and human papillomavirus 16 is a strong determinant of the natural course. Patients aged 25 to 30 years with a fully visible squamocolumnar junction and without human papillomavirus 16 should generally be recommended active surveillance for 15 months, whereas immediate treatment should be considered in cases with human papillomavirus 16.