Ngonzi Joseph, Bajunirwe Francis, Wistrand Charlotte, Mayanja Ronald, Altman Daniel, Thorsell Malin, Wikström Shemer Elisabeth Andrea
Departments of 1Obstetrics and Gynecology, and 2Community Health Mbarara University of Science and Technology, Mbarara, Uganda; and Departments of 3Obstetrics and Gynecology, and 4Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden.
J Low Genit Tract Dis. 2013 Oct;17(4):372-7. doi: 10.1097/LGT.0b013e31827ba7c5.
This study aimed to determine if criterion standard colposcopy could be provided by a pocket-sized battery-driven colposcope, the Gynocular.
The study was a randomized, crossover, pilot clinical trial for evaluating agreement of diagnosis of cervical lesions by colposcopy using a standard colposcope and a pocket-sized battery-driven colposcope, the Gynocular, in 69 women positive for visual inspection with acetic acid. Swede scores were used at the time of colposcopy and compared with the final histological diagnosis after directed cervical biopsy. To test the level of agreement between the colposcopy and Gynocular, we calculated the percentage agreement and the κ statistic. We calculated the detection rates of cervical lesions of the Gynocular and a standard colposcope using biopsy results as criterion standards. All included patients also underwent a Pap smear.
The level of agreement of Swede score between the Gynocular and colposcope was 70.1% and the κ statistic was 0.65 (p < .001). Biopsy identified 4 women (6.7%) with cervical intraepithelial neoplasia 1 (CIN 1) and 1 woman (1.7%) with CIN 2; 2 women (3.4%) had CIN 3, and 2 women had invasive cervical cancer (CIN 3+). Pap smear detected 2 women (3.1%) with CIN 1 but did not identify any high-grade cervical lesion. Cervicitis was present in 17 (27.4%) of the Pap smears and in 34 (57.6%) of the biopsies.
The study shows that in visual inspection with acetic acid-positive women, a battery-driven, pocket-sized colposcope has a significant level of agreement with stationary colposcopy in assessing cervical lesions.
本研究旨在确定口袋大小的电池驱动阴道镜Gynocular是否能提供标准的阴道镜检查。
本研究是一项随机、交叉、试点临床试验，用于评估在69例醋酸目视检查呈阳性的女性中，使用标准阴道镜和口袋大小的电池驱动阴道镜Gynocular通过阴道镜检查诊断宫颈病变的一致性。在阴道镜检查时使用瑞典评分，并与直接宫颈活检后的最终组织学诊断进行比较。为了测试阴道镜检查和Gynocular之间的一致性水平，我们计算了一致性百分比和κ统计量。我们以活检结果作为标准，计算了Gynocular和标准阴道镜对宫颈病变的检出率。所有纳入的患者还接受了巴氏涂片检查。
Gynocular和阴道镜检查之间瑞典评分的一致性水平为70.1%，κ统计量为0.65（p < 0.001）。活检发现4名女性（6.7%）患有宫颈上皮内瘤变1级（CIN 1），1名女性（1.7%）患有CIN 2；2名女性（3.4%）患有CIN 3，2名女性患有浸润性宫颈癌（CIN 3+）。巴氏涂片检查发现2名女性（3.1%）患有CIN 1，但未发现任何高级别宫颈病变。巴氏涂片检查中有17例（27.4%）存在宫颈炎，活检中有34例（57.6%）存在宫颈炎。
研究表明，在醋酸目视检查呈阳性的女性中，电池驱动的口袋大小的阴道镜在评估宫颈病变方面与固定式阴道镜有显著的一致性。
