Department of Obstetrics and Gynaecology, St Marys Imperial College NHS Trust, London W2, United Kingdom.
Eur J Obstet Gynecol Reprod Biol. 2010 Jul;151(1):91-5. doi: 10.1016/j.ejogrb.2010.02.042. Epub 2010 Mar 19.
To determine whether the proportion of incomplete resection of cervical intraepithelial neoplasia (CIN 1-3) may be reduced by CIN Excisor compared with loop excision of the transformation zone (LLETZ).
A prospective trial during a 2-year period at a district general hospital in London, United Kingdom, including 420 women scheduled for treatment due to CIN, after colposcopy guided biopsy results. This study was expected to demonstrate a statistically significant difference (p<0.05) in the proportion of women with clear histopathological resection margins after treatment with CIN Excisor compared with LLETZ. Chi-square or Fisher's exact test were used to compare histopathological resection margins in the CIN Excisor and LLETZ groups.
Overall, there is strong evidence of a difference in the proportion of histopathological specimens with clear resection margins for the CIN Excisor group, compared with the LLETZ group (201/210, 95.7% versus 180/210, 85.7%: p<0.001). Sub-analysis within the two groups, of the proportion of histopathological specimens with clear resection margins in relation to CIN grades, revealed a statistically significant difference in favour of the CIN Excisor group for CIN 1 (99/103, 96.1% versus 82/95, 86.3%: p=0.01), and CIN 2 (73/77, 94.8% versus 68/80, 85%: p=0.04). There is a numerical difference in the proportion of clear resection margins in favour of the CIN Excisor for CIN 3 (29/30, 96.7% versus 30/35, 85.7%), but this difference was not statistically significant (p=0.21). Perioperative complications were similar between the two groups.
CIN Excisor achieved better results than LLETZ for treatment of CIN 1-3 with respect to clear histopathological resection margins. However, further studies including a larger number of women treated for CIN 3 are needed before firm conclusions are drawn.
比较宫颈上皮内瘤变（CIN 1-3）切除术和环形电切术（LLETZ）治疗后，CIN 切除术是否能降低 CIN 不彻底切除的比例。
这是一项在英国伦敦的地区综合医院进行的为期 2 年的前瞻性试验，共纳入 420 名因 CIN 而接受治疗的女性，入组标准为阴道镜引导下活检后。本研究预计可以证明 CIN 切除术治疗后，在有明确组织病理学切缘的患者比例方面，CIN 切除术与 LLETZ 相比有统计学上的显著差异（p<0.05）。采用卡方检验或 Fisher 精确检验比较 CIN 切除术和 LLETZ 组的组织病理学切缘。
总体而言，CIN 切除术组有明确切缘的组织病理学标本比例明显高于 LLETZ 组（201/210，95.7%比 180/210，85.7%：p<0.001）。在两组内，根据 CIN 分级分析有明确切缘的组织病理学标本比例，CIN 切除术组在 CIN 1（99/103，96.1%比 82/95，86.3%：p=0.01）和 CIN 2（73/77，94.8%比 68/80，85%：p=0.04）方面具有统计学显著优势。CIN 切除术组在 CIN 3（29/30，96.7%比 30/35，85.7%）方面有明确切缘的比例更高，但差异无统计学意义（p=0.21）。两组的围手术期并发症相似。
CIN 切除术在 CIN 1-3 的治疗中与 LLETZ 相比，可获得更好的组织学切缘，然而，在得出明确结论之前，还需要进行包括更多 CIN 3 患者的研究。
