Kaushik Sonali, Pepas Litha, Nordin Andy, Bryant Andrew, Dickinson Heather O
Division of Gynaecological Oncology, Cheltenham General Hospital, Cheltenham, Gloucestershire, UK, GL53 7AN.
Cochrane Database Syst Rev. 2014 Mar 4;2014(3):CD007928. doi: 10.1002/14651858.CD007928.pub3.
This is an updated version of an original Cochrane review published in The Cochrane Library, 2011, Issue 1.Vulval intraepithelial neoplasia (VIN) is a pre-malignant condition of the vulval skin. This uncommon chronic skin condition of the vulva is associated with a high risk of recurrence and the potential to progress to vulval cancer. The condition is complicated by its multicentric and multifocal nature. The incidence of this condition appears to be rising, particularly in the younger age group. There is a lack of consensus on the optimal surgical treatment method. However, the rationale for the surgical treatment of VIN has been to treat the symptoms and exclude any underlying malignancy, with the continued aim of preserving the vulval anatomy and function. Repeated treatments affect local cosmesis and cause psychosexual morbidity, thus impacting he individual's quality of life.
To evaluate the effectiveness and safety of surgical interventions in women with high-grade VIN.
We searched the Cochrane Gynaecological Cancer Group Trials Register and the Cochrane Central Register of Controlled Trials (CENTRAL) Issue 11,2013 and MEDLINE and EMBASE up to December 2013. We also searched registers of clinical trials, abstracts of scientific meetings and reference lists of included studies, and contacted experts in the field.
Randomised controlled trials (RCTs) that compared surgical interventions in adult women diagnosed with high-grade VIN.
Two review authors independently abstracted data and assessed risk of bias.
We identified one RCT, including 30 women, that met our inclusion criteria; this trial reported data on carbon dioxide (CO2) laser surgery versus cavitational ultrasonic surgical aspiration (CUSA). There were no statistically significant differences in the risks of disease recurrence after one year of follow-up, pain, scarring, dysuria or burning, adhesions, infection, abnormal discharge or eschar between women who underwent CO2 laser surgery and those who received CUSA. The trial lacked statistical power due to the small number of women in each group and the low number of observed events, but was at low risk of bias.
AUTHORS' CONCLUSIONS: The included trial lacked statistical power due to the small number of women in each group and the low number of observed events. The absence of reliable evidence regarding the effectiveness and safety of the two surgical techniques for the management of VIN therefore precludes any definitive guidance or recommendations for clinical practice.
这是发表于《考科蓝系统评价》2011年第1期的一篇考科蓝原始综述的更新版本。外阴上皮内瘤变(VIN)是外阴皮肤的一种癌前病变。这种外阴部不常见的慢性皮肤疾病与高复发风险及进展为外阴癌的可能性相关。该疾病因其多中心和多灶性的特点而变得复杂。这种疾病的发病率似乎在上升,尤其是在较年轻的年龄组。对于最佳手术治疗方法缺乏共识。然而,VIN手术治疗的基本原理一直是治疗症状并排除任何潜在恶性肿瘤,其持续目标是保留外阴的解剖结构和功能。反复治疗会影响局部美观并导致心理性性功能障碍,从而影响个人生活质量。
评估手术干预对高级别VIN女性患者的有效性和安全性。
我们检索了考科蓝妇科癌症组试验注册库、截至2013年第11期的考科蓝对照试验中央注册库(CENTRAL)、MEDLINE和EMBASE。我们还检索了临床试验注册库、科学会议摘要以及纳入研究的参考文献列表,并联系了该领域的专家。
比较诊断为高级别VIN的成年女性手术干预措施的随机对照试验(RCT)。
两位综述作者独立提取数据并评估偏倚风险。
我们确定了一项符合纳入标准的RCT,包括30名女性;该试验报告了二氧化碳(CO2)激光手术与空化超声手术抽吸(CUSA)的数据。在随访一年后,接受CO2激光手术的女性与接受CUSA的女性在疾病复发风险、疼痛、瘢痕形成、排尿困难或烧灼感、粘连、感染、异常分泌物或焦痂方面无统计学显著差异。由于每组女性数量少且观察到的事件数量少,该试验缺乏统计学效力,但偏倚风险较低。
由于每组女性数量少且观察到的事件数量少,纳入的试验缺乏统计学效力。因此,缺乏关于这两种手术技术治疗VIN有效性和安全性的可靠证据,无法为临床实践提供任何明确的指导或建议。