阴道镜：比双瓣窥器更舒适，且在细胞学检查方面效果相当。

Department of Obstetrics and Gynaecology, Werribee Mercy Hospital, Werribee, Victoria, Australia.

Aust N Z J Obstet Gynaecol. 2004 Apr;44(2):140-5. doi: 10.1111/j.1479-828X.2004.00180.x.

OBJECTIVE

The aim of the present study was to confirm that the Veda-scope is equivalent to the bivalve speculum in the collection of endocervical cells, as confirmation of adequate cervical sampling for Pap smear testing. The study also aimed to assess the comfort level of the Veda-scope compared to the traditional bivalve speculum and the patient preference of the Veda-scope compared to the bivalve speculum.

METHODOLOGY

Multicentre, randomised, controlled crossover, cytologist blinded study.

POPULATION

The total number of subjects enrolled in the study were 250. The number of evaluable subjects were 210.

RESULTS

In primary efficacy analysis, no significant difference was seen between the presence or absence of endocervical cells in the smears using either the Veda-scope or the bivalve speculum. There was a high concordance level between the diagnosis assigned to each specimen of a paired sample, the diagnosis agreeing in 97.6% cases. The primary reason given by many women for avoidance of regular Pap smear examinations is the discomfort or pain experienced with sample collection with the bivalve speculum. In the present study, 92% of subjects indicated a preference for the Veda-scope for Pap smear collection, while only 8.4% preferred the bivalve speculum. Subject preference was also assessed with respect to how the subject rated the comfort level of her previous Pap smear. In subjects who rated their previous Pap smear as very comfortable or comfortable, 86% expressed a preference for the Veda-scope. This rose to 93% in subjects who rated their previous Pap smear as only tolerable.

CONCLUSION

The results of the present study show that Pap smear collections with the Veda-scope are of equal quality to those collected with the bivalve speculum, with an equivalent diagnostic outcome. A very strong preference for the Veda-scope was shown by the women enrolled in the present study based on the comfort levels experienced with the two devices.

目的

本研究的目的是确认阴道镜在宫颈管细胞采集方面与双瓣窥器等效，以此证实巴氏涂片检测中宫颈取样充分。该研究还旨在评估阴道镜与传统双瓣窥器相比的舒适度，以及患者对阴道镜与双瓣窥器的偏好。

方法

多中心、随机、对照交叉、细胞学专家盲法研究。

研究对象

本研究共纳入250名受试者。可评估的受试者有210名。

结果

在主要疗效分析中，使用阴道镜或双瓣窥器采集的涂片内宫颈管细胞的有无无显著差异。配对样本中每个标本的诊断之间具有高度一致性，诊断一致率为97.6%。许多女性避免定期进行巴氏涂片检查的主要原因是使用双瓣窥器采集样本时感到不适或疼痛。在本研究中，92%的受试者表示更喜欢使用阴道镜进行巴氏涂片采集，而只有8.4%的人更喜欢双瓣窥器。还根据受试者对其之前巴氏涂片舒适度的评分来评估受试者偏好。在将其之前的巴氏涂片评为非常舒适或舒适的受试者中，86%表示更喜欢阴道镜。在将其之前的巴氏涂片评为仅可忍受的受试者中，这一比例升至93%。