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宫颈锥切术后人乳头瘤病毒预防性疫苗接种对预防宫颈上皮内瘤变复发的疗效:中国的前瞻性观察研究。

The efficacy of human papillomavirus prophylactic vaccination after conization in preventing cervical intraepithelial neoplasia recurrence: A prospective observational study in China.

机构信息

Department of Gynecology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China; Guangdong Provincial Clinical Research Center for Obstetrical and Gynecological Diseases, China.

Department of Clinical Laboratory, Department of Laboratory Medicine, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.

出版信息

Eur J Obstet Gynecol Reprod Biol. 2023 Jul;286:10-15. doi: 10.1016/j.ejogrb.2023.04.014. Epub 2023 Apr 19.

DOI:10.1016/j.ejogrb.2023.04.014
PMID:37159990
Abstract

High-risk human papillomavirus (hrHPV) infection is the cause of most cervical cancers. Since therapeutic vaccines are not yet available for clinical practice, the administration of HPV prophylactic vaccines in patients with cervical intraepithelial neoplasia (CIN) arouses great interest and its value after excisional treatment of CIN remains unclear. We conducted this prospective cohort study to evaluate the impact of HPV prophylactic vaccination on preventing women from subsequent infection and cervical lesions after excision treatment. 148 patients after loop electrosurgical excision procedure (LEEP) for CIN2+ disease received HPV prophylactic vaccination (6/11/16/18 vaccine, Gardasil®, Merck) after surgery (V-group) and 273 didn't get vaccination (NV-group). The HPV infection rates at the first and second year after LEEP were significantly lower in the V-group than that in NV-group (P = 0.049 and P = 0.026). CIN2+ recurrence was observed in 29 cases (10.62 %) in the NV-group and 2 cases (2.03 %) in the V-group. Logistic regression analysis showed that the HPV16/18 infection, the CIN3 pathology after LEEP and no vaccination after LEEP were significant risk factors of recurrence. Patients without HPV vaccination had a higher CIN2+ recurrence rate (OR = 12.35, 95 % CI 1.919-79.492, P = 0.008). Our study showed the quadrivalent prophylactic HPV vaccination after LEEP had a significantly protective role in the prevention of high-grade squamous intraepithelial lesion recurrence. Further randomized, controlled trials are required in elucidating the efficacy of the prophylactic HPV vaccines using shortly after LEEP in patients with CIN disease.

摘要

高危型人乳头瘤病毒(hrHPV)感染是大多数宫颈癌的病因。由于治疗性疫苗尚未应用于临床实践,因此对患有宫颈上皮内瘤变(CIN)的患者进行 HPV 预防性疫苗接种引起了极大的兴趣,但其在 CIN 切除治疗后的价值尚不清楚。我们进行了这项前瞻性队列研究,以评估 HPV 预防性疫苗接种对预防 CIN 切除治疗后女性再次感染和宫颈病变的影响。148 例 CIN2+疾病行环形电切术(LEEP)后的患者术后接受 HPV 预防性疫苗接种(6/11/16/18 疫苗,佳达修,默克)(V 组),273 例未接种疫苗(NV 组)。LEEP 后第 1 年和第 2 年 V 组 HPV 感染率明显低于 NV 组(P=0.049 和 P=0.026)。NV 组中观察到 29 例(10.62%)CIN2+复发,V 组中观察到 2 例(2.03%)复发。Logistic 回归分析显示,HPV16/18 感染、LEEP 后 CIN3 病理和 LEEP 后未接种疫苗是复发的显著危险因素。未接种 HPV 疫苗的患者 CIN2+复发率较高(OR=12.35,95%CI 1.919-79.492,P=0.008)。本研究表明,LEEP 后接种四价预防性 HPV 疫苗在预防高级别鳞状上皮内病变复发方面具有显著的保护作用。需要进一步的随机、对照试验来阐明在 CIN 疾病患者 LEEP 后短期内使用预防性 HPV 疫苗的疗效。

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