2020年，宫颈癌是女性中第四常见的癌症类型，许多女性还患有宫颈癌前病变鳞状上皮内病变（SIL）。及早治疗宫颈SIL以逆转或延缓其发展是减少宫颈癌发病率的重要方法。基于腺病毒载体表达胸腺嘧啶激酶基因（AdV-tk）对多种癌症的疗效和安全性显示出前景，因此在妇科使用上非常有希望。通过这项前瞻性研究，我们旨在首次介绍AdV-tk用于宫颈SIL治疗的相关临床疗效和安全数据。我们于2015年8月至2018年4月招募了23名患有宫颈低级别/高级别SIL（LSIL/HSIL）的患者（平均年龄：35岁），最多进行了6次AdV-tk基因疗法治疗，并分析了临床特征和随访结果（平均随访期：7.3个月）。本研究包括17名患有宫颈HSIL（73.9%）和6名经阴道镜引导下活检证实为LSIL的患者。我们观察到AdV-tk基因疗法后的总体组织学消退和退缩率为87.0%（20/23，95%置信区间[95%CI]：73.2-100%，P<0.001）。八名患者（34.8%）检测到人乳头瘤病毒（HPV）16/18亚型，13名患者被发现至少阳性感染其他13种高危HPV（HR-HPV）亚型之一，而两名患者则没有任何15种HR-HPV亚型。AdV-tk基因疗法后HR-HPV的总清除率为76.2%（16/21，95%CI：58.0-94.4%，P=0.016）。对于安全性评价，23名患者中没有报告任何严重并发症。最常报告的症状是发热，占患者总数的52.2%（12/23），而所有症状在对症治疗后完全消失。我们的数据表明，AdV-tk基因疗法在妇科患者的宫颈SIL治疗中具有高效和安全性。我们的研究结果为推广和应用AdV-tk在妇科患者的宫颈SIL以及潜在的宫颈癌治疗方面提供了临床证据。

Cervical cancer is the fourth most common type of cancer for women in 2020, and many more women have cervical pre-cancerous lesion-squamous intraepithelial lesion (SIL). Early treatment of cervical SIL to reverse or delay its progression is an important approach to reduce the incidence of cervical cancer. The efficacy and safety of adenovirus-based vectors expressing the thymidine kinase gene (AdV-tk) in the treatment of multiple types of cancers shows promise for its use in gynecology. We aim to provide relevant clinical efficacy and safety data after introducing AdV-tk for the treatment of cervical SIL for the first time through this prospective study. We conducted a maximum of 6-sessions to administer AdV-tk gene therapy to 23 patients (mean age: 35 years old) with cervical low-/high-grade SIL (LSIL/HSIL) who were enrolled from August 2015 to April 2018 and analyzed the clinical characteristics and follow-up outcomes (mean follow-up period: 7.3 months). The present study consisted of 17 patients (73.9%) with cervical HSIL and six patients with LSIL confirmed by colposcopy-directed biopsy. We observed an overall histological remission and regression rate of 87.0% (20/23, 95% confidence interval [95%CI]: 73.2-100%, P<0.001) after AdV-tk gene therapy. Eight patients (34.8%) were detected with human papillomavirus (HPV) 16/18 subtypes and 13 patients were found to be positive with at least one of the other 13 high-risk HPV (HR-HPV) subtypes, while two patients did not have any of the 15 HR-HPV subtypes. The overall clearance rate of HR-HPV was 76.2% (16/21, 95%CI: 58.0-94.4%, P=0.016) after AdV-tk gene therapy. For safety evaluation, no severe complications were reported in any of the 23 patients. The most commonly reported symptom was fever in 52.2% (12/23) of patients and all symptoms were fully resolved after symptomatic treatment. Our data indicates that AdV-tk gene therapy has high efficacy and safety in the treatment of cervical SIL among gynecological patients. Our findings provide clinical evidence on the potential promotion and application of AdV-tk in the treatment of cervical SIL, and potentially for cervical cancer, among gynecological patients.