Haigh Philip I, DiFronzo L Andrew, McCready David R
Department of Health Administration, University of Toronto, Ont.
Can J Surg. 2003 Dec;46(6):419-26.
To determine in patients with localized primary melanoma of the trunk or extremities the optimal excision margin that achieves the highest disease-free survival and overall survival and the lowest local recurrence rate.
Trials comparing 2 different excision margins were identified by searching MEDLINE from 1966 to May 2002 using the term "melanoma," subheading "surgery," and limiting the search to human studies and randomized controlled trials (RCTs). Additional studies were found using the MeSH term "surgical procedures, operative," combining with "melanoma," and limiting to human studies. We searched EMBASE and the Cochrane Library in May 2002 using similar terminology. No language restriction was applied.
We selected studies for the overview using the following inclusion criteria: design--an RCT with wide excision versus narrower excision (margin width was not specified a priori); population--adult patients (> 18 yr) with cutaneous melanoma of the trunk or extremities without evidence of metastasis; intervention--surgical excision of the primary melanoma; and outcomes--at least 1 of overall survival, disease-free survival, local recurrence, wound complications and necessity for skin grafting.
Information was abstracted for each outcome reported in the studies, and results were pooled by consensus. Statistical analysis was performed using RevMan 4.1 (The Cochrane Collaboration) software program. Relative risk and risk difference were reported with 95% confidence intervals. The number needed to harm was calculated for the need for skin grafting by taking the inverse of the risk difference.
Three trials and their follow-up studies met the inclusion criteria and included 2087 adults with localized cutaneous melanoma of the trunk or extremities. No statistically significant differences were found between wide surgical excision (margins ranging from 3-5 cm) and narrower surgical excision (margins ranging from 1-2 cm) with respect to mortality, disease-free survival or local recurrence rate.
Surgical excision margins no more than 2 cm around a melanoma of the trunk or extremities are adequate; overall survival, disease-free survival and recurrence rate are not adversely affected compared with a wider excision. There is more data to support a 2-cm margin than a 1-cm margin as the minimum margin of excision. Surgical margins should be no less than 1 cm around the primary melanoma.
确定躯干或四肢局限性原发性黑色素瘤患者的最佳切除边缘,以实现最高的无病生存率和总生存率,并使局部复发率最低。
通过使用“黑色素瘤”一词、副标题“手术”,并将检索范围限制在人体研究和随机对照试验(RCT),检索1966年至2002年5月的MEDLINE,以识别比较两种不同切除边缘的试验。使用医学主题词“外科手术,手术操作”与“黑色素瘤”相结合,并限制在人体研究中,发现了其他研究。我们在2002年5月使用类似的术语检索了EMBASE和Cochrane图书馆。未应用语言限制。
我们使用以下纳入标准选择用于综述的研究:设计——一项随机对照试验,比较广泛切除与较窄切除(边缘宽度未事先指定);人群——成年患者(>18岁),躯干或四肢皮肤黑色素瘤,无转移证据;干预——原发性黑色素瘤的手术切除;结局——总生存率、无病生存率、局部复发、伤口并发症和植皮必要性中至少一项。
提取研究中报告的每个结局的信息,并通过共识汇总结果。使用RevMan 4.1(Cochrane协作网)软件程序进行统计分析。报告相对风险和风险差异,并给出95%置信区间。通过取风险差异的倒数计算植皮需求的伤害所需人数。
三项试验及其随访研究符合纳入标准,包括2087例躯干或四肢局限性皮肤黑色素瘤成年患者。在广泛手术切除(边缘范围为3 - 5厘米)和较窄手术切除(边缘范围为1 - 2厘米)之间,在死亡率、无病生存率或局部复发率方面未发现统计学显著差异。
躯干或四肢黑色素瘤周围不超过2厘米的手术切除边缘是足够的;与更广泛的切除相比,总生存率、无病生存率和复发率不会受到不利影响。有更多数据支持将2厘米边缘作为切除的最小边缘,而不是1厘米边缘。原发性黑色素瘤周围的手术边缘不应小于1厘米。