Department of Obstetrics and Gynecology, University Hospital of Bordeaux, Laboratory of Virology, University of Bordeaux, Bordeaux, France.
Am J Obstet Gynecol. 2011 Feb;204(2):169.e1-8. doi: 10.1016/j.ajog.2010.09.020.
We sought to evaluate the safety and efficacy of TG4001 in patients with human papillomavirus (HPV) 16-related cervical intraepithelial neoplasia (CIN) 2/3 at 6 and 12 months.
In all, 21 patients with HPV 16-related CIN 2/3 received 3 weekly subcutaneous injections of TG4001. Regression of the CIN 2/3 lesion and the clearance of HPV 16 infection were monitored by cytology, colposcopy, and HPV DNA/messenger RNA (mRNA) detection. A clinical response was defined by no CIN 2/3 found on conization, or no conization performed because not suspected at cytology or colposcopy.
Ten patients (48%) were evaluated as clinical responders at month 6. Nine patients experienced an improvement of their HPV 16 infection, by mRNA ± DNA eradication. HPV 16 mRNA clearance was associated with CIN 2/3 cytologic and colposcopic regression in 7 of 10 patients. At month 12, 7 of 8 patients without conization reported neither suspicion of CIN 2/3 relapse nor HPV 16 infection. The remaining patient was lost to follow-up.
These promising data warrant further development of TG4001 in CIN 2/3 treatment.
我们旨在评估 TG4001 在人乳头瘤病毒（HPV）16 相关宫颈上皮内瘤变（CIN）2/3 患者中的安全性和疗效，随访时间为 6 个月和 12 个月。
共 21 例 HPV 16 相关 CIN 2/3 患者接受 TG4001 每周皮下注射 3 次。通过细胞学、阴道镜和 HPV DNA/信使 RNA（mRNA）检测监测 CIN 2/3 病变的消退和 HPV 16 感染的清除情况。临床应答定义为宫颈锥切术未发现 CIN 2/3，或细胞学或阴道镜检查未怀疑 CIN 2/3 而未行宫颈锥切术。
10 例患者（48%）在 6 个月时评估为临床应答者。9 例患者的 HPV 16 感染得到改善，表现为 mRNA±DNA 清除。在 10 例患者中，有 7 例 HPV 16 mRNA 清除与 CIN 2/3 细胞学和阴道镜下消退相关。在 12 个月时，8 例未行宫颈锥切术的患者均未报告 CIN 2/3 复发或 HPV 16 感染的可疑症状。其余患者失访。
这些有前景的数据支持进一步开发 TG4001 用于治疗 CIN 2/3。
