Kaushik Sonali, Pepas Litha, Nordin Andy, Bryant Andrew, Dickinson Heather O
Obstetrics and Gynaecology, Queen Elizabeth The Queen Mother Hospital, St Peter's Road, Margate, Kent, UK, CT9 4AN.
Cochrane Database Syst Rev. 2011 Jan 19(1):CD007928. doi: 10.1002/14651858.CD007928.pub2.
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 surgical treatment of VIN has been to treat symptoms and exclude underlying malignancy with the continued aim of preservation of vulval anatomy and function. Repeated treatments affect local cosmesis and cause psychosexual morbidity thus impacting on the patients' quality of life.
To evaluate the effectiveness and safety of surgical interventions for high grade VIN.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 3, 2010, Cochrane Gynaecological Cancer Group Trials Register, MEDLINE and EMBASE up to September 2010. We also searched registers of clinical trials, abstracts of scientific meetings, 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 vulval intraepithelial neoplasia.
Two review authors independently abstracted data and assessed risk of bias.
We found only one RCT which included 30 women that met our inclusion criteria and this trial reported data on carbon dioxide laser (CO(2) laser) versus ultrasonic surgical aspiration (USA).There was no statistically significant difference in the risk of disease recurrence after one year follow-up, pain, presence of scarring, dysuria or burning, adhesions, infection, abnormal discharge and eschar between women who received CO(2) laser and those who received USA. 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. Therefore in the absence of reliable evidence regarding the effectiveness and safety of the two surgical techniques for the management of vulval intraepithelial neoplasia precludes any definitive guidance or recommendations for clinical practice.
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,尤其是在年轻人群体中。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潜在恶性肿瘤,同时持续致力于保留外阴的解剖结构和功能。反复治疗会影响局部美观,并导致性心理问题,从而影响患者的生活质量。
评估手术干预治疗高级别VIN的有效性和安全性。
我们检索了Cochrane对照试验中心注册库(CENTRAL,2010年第3期)、Cochrane妇科癌症小组试验注册库、截至2010年9月的MEDLINE和EMBASE。我们还检索了临床试验注册库、科学会议摘要、纳入研究的参考文献列表,并联系了该领域的专家。
比较手术干预措施的随机对照试验(RCT),研究对象为诊断为高级别外阴上皮内瘤变的成年女性。
两位综述作者独立提取数据并评估偏倚风险。
我们仅找到一项RCT,该研究纳入了30名符合我们纳入标准的女性,该试验报告了二氧化碳激光(CO₂激光)与超声手术抽吸(USA)的数据。在一年的随访后,接受CO₂激光治疗的女性与接受USA治疗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、异常分泌物和焦痂方面,没有统计学上的显著差异。由于每组女性数量较少且观察到的事件数量较低,该试验缺乏统计学效力,但偏倚风险较低。
由于每组女性数量较少且观察到的事件数量较低,纳入的试验缺乏统计学效力。因此,在缺乏关于这两种手术技术治疗外阴上皮内瘤变有效性和安全性的可靠证据的情况下,无法为临床实践提供任何明确的指导或建议。