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原发性皮肤黑色素瘤治疗中的切缘:一项比较窄切缘与宽切缘切除的随机对照试验的系统评价

Excision margins in the treatment of primary cutaneous melanoma: a systematic review of randomized controlled trials comparing narrow vs wide excision.

作者信息

Lens Marko B, Dawes Martin, Goodacre Tim, Bishop Julia A Newton

机构信息

Centre for Evidence-Based Medicine, University of Oxford, Nuffield Department of Clinical Medicine, The Oxford Radcliffe NHS Trust, Oxford, England.

出版信息

Arch Surg. 2002 Oct;137(10):1101-5. doi: 10.1001/archsurg.137.10.1101.

Abstract

BACKGROUND

The optimal excision margin for primary cutaneous melanoma remains controversial, although several clinical studies have suggested that wide local excision is unnecessary.

HYPOTHESIS

Wide excision margins do not improve survival in patients with melanoma.

OBJECTIVES

To describe the published evidence and determine the effectiveness of wide surgical margins compared with narrow surgical margins.

DESIGN

Systematic review of randomized controlled trials that compared narrow margins with wide excision margins for cutaneous melanoma.

SETTING

Randomized controlled trials available by March 2001.

SUBJECTS

The included trials comprised 2406 participants.

INTERVENTION

Surgical excision of melanoma using narrow excision margins compared with excision using wide excision margins.

MAIN OUTCOME MEASURE

Effect of width of excision margin on melanoma recurrences, disease-free survival, and overall survival.

RESULTS

We identified and analyzed 4 randomized controlled trials. All 4 trials failed to demonstrate statistically significant differences in overall survival and disease-free survival when comparing wide vs narrow excision. Peto pooled odds ratio for overall survival was 0.79 (95% confidence interval, 0.61-1.04) and for disease-free survival was 0.89 (95% confidence interval, 0.69-1.13), indicating a statistically nonsignificant improvement with wide excision.

CONCLUSIONS

Not one of the included studies showed any statistically significant difference between the 2 groups treated with narrow or wide excision margins with regard to recurrences and survival. However, current evidence is not sufficient to address the optimal surgical margins for all melanomas, and further research is required.

摘要

背景

尽管多项临床研究表明广泛局部切除并无必要,但原发性皮肤黑色素瘤的最佳切除边缘仍存在争议。

假设

广泛切除边缘并不能提高黑色素瘤患者的生存率。

目的

描述已发表的证据,并确定与窄切除边缘相比,宽手术边缘的有效性。

设计

对比较皮肤黑色素瘤窄边缘与宽切除边缘的随机对照试验进行系统评价。

设置

截至2001年3月可获得的随机对照试验。

受试者

纳入的试验包括2406名参与者。

干预

使用窄切除边缘与宽切除边缘进行黑色素瘤手术切除。

主要观察指标

切除边缘宽度对黑色素瘤复发、无病生存率和总生存率的影响。

结果

我们识别并分析了4项随机对照试验。在比较宽切除与窄切除时,所有4项试验均未显示总生存率和无病生存率有统计学显著差异。总生存率的Peto合并比值比为0.79(95%置信区间,0.61 - 1.04),无病生存率为0.89(95%置信区间,0.69 - 1.13),表明宽切除无统计学显著改善。

结论

纳入的研究中没有一项显示在复发和生存方面,窄切除边缘组与宽切除边缘组之间存在任何统计学显著差异。然而,目前的证据不足以确定所有黑色素瘤的最佳手术边缘,仍需要进一步研究。

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