Starks David, Arriba Lucybeth Nieves, Enerson Christine L, Brainard Jennifer, Nagore Norma, Chiesa-Vottero Andres, Uribe Jesús Villagran, Belinson Jerome
1Cleveland Clinic Women's Health Institute, Cleveland, OH; 2Prueba Para La Vida A.C., Morelia, Mexico; 3Preventive Oncology International Inc., Cleveland Heights, OH; 4Department of Pathology, Cleveland Clinic, Cleveland, OH; 5Department of Pathology, Hospital de la Mujer; and 6Department of Pathology, Hospital Civil, Morelia, Mexico.
J Low Genit Tract Dis. 2014 Oct;18(4):333-7. doi: 10.1097/LGT.0000000000000029.
To determine the efficacy and tolerance of cryotherapy in a visual inspection with acetic acid (VIA) triage protocol after primary human papillomavirus (HPV) screening in a low-resource setting.
This continuous series conducted over 2 years enrolled nonpregnant, high-risk HPV (HR-HPV)-positive women between the ages of 30 and 50 years, who resided in the state of Michoacán, Mexico, and had a history of no Pap smear screening or knowledge of Pap smear results within the last 3 years. These women were initially enrolled in the Mexican Cervical Cancer Screening Study II (MECCS II) trial and were treated with cryotherapy after VIA triage. They subsequently followed up at 6 months and 2 years for repeat VIA, colposcopy, and biopsy.
A total of 291 women were treated with cryotherapy, of whom 226 (78%) followed up at 6 months. Of these 226 women, 153 (68%) were HR-HPV-negative; there were no findings of cervical intraepithelial neoplasia grade 2 (CIN2) or worse. The remaining 73 women (32%) were HR-HPV-positive; of these women, 2 had CIN2 and 3 had CIN3. Only 137 women followed up at 2 years. Of these 137 women, 116 were HR-HPV-negative and 21 were HR-HPV-positive. Of the 21 women positive for HR-HPV, 9 had negative biopsy results, 11 had CIN1, and 1 had no biopsy. The clearance rate of HR-HPV was 83% (95% confidence interval: 0.78-0.87). There were no biopsy findings of CIN2 or worse at 2 years. Before cryotherapy, of the 226 women, 15 (6.6%) were positive for endocervical curettage (ECC) and 5 (2.2%) were referred for surgical management. Of these 15 ECC-positive women, 10 (67%) followed up at 6 months and it was shown that no patient was ECC positive at that time point. Moreover, of the 15 ECC-positive women, 11 (73%) followed up at 2 years and it was shown that no patient was ECC positive at that time point. In our study, VIA had a false-positive rate of 5%.
Cryotherapy was an effective, acceptable, and well-tolerated means of treating cervical dysplasia in a low-resource setting.
在资源匮乏地区，确定冷冻疗法在醋酸肉眼观察（VIA）分流方案中用于原发性人乳头瘤病毒（HPV）筛查后的疗效及耐受性。
本连续系列研究历时2年，纳入了年龄在30至50岁之间、居住在墨西哥米却肯州、过去3年内未进行过巴氏涂片筛查或不知晓巴氏涂片结果的非妊娠高危HPV（HR-HPV）阳性女性。这些女性最初参加了墨西哥宫颈癌筛查研究II（MECCS II）试验，并在VIA分流后接受冷冻疗法治疗。随后，她们在6个月和2年时接受随访，进行重复VIA、阴道镜检查和活检。
共有291名女性接受了冷冻疗法治疗，其中226名（78%）在6个月时进行了随访。在这226名女性中，153名（68%）HR-HPV呈阴性，未发现宫颈上皮内瘤变2级（CIN2）或更严重病变。其余73名女性（32%）HR-HPV呈阳性，其中2名患有CIN2，3名患有CIN3。只有137名女性在2年时进行了随访。在这137名女性中，116名HR-HPV呈阴性，21名HR-HPV呈阳性。在21名HR-HPV阳性女性中，9名活检结果为阴性，11名患有CIN1，1名未进行活检。HR-HPV清除率为83%（95%置信区间：0.78 - 0.87）。2年时未发现CIN2或更严重病变的活检结果。在冷冻疗法前，226名女性中，15名（6.6%）宫颈管刮术（ECC）呈阳性，5名（2.2%）被转诊接受手术治疗。在这15名ECC阳性女性中，10名（67%）在6个月时进行了随访，结果显示该时间点无患者ECC呈阳性。此外，在这15名ECC阳性女性中，11名（73%）在2年时进行了随访，结果显示该时间点无患者ECC呈阳性。在我们的研究中，VIA的假阳性率为5%。
在资源匮乏地区，冷冻疗法是治疗宫颈发育异常的一种有效、可接受且耐受性良好的方法。
