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乳腺癌腋窝清扫术后的伤口引流

Wound drainage after axillary dissection for carcinoma of the breast.

作者信息

Thomson David R, Sadideen Hazim, Furniss Dominic

机构信息

Oxford University Clinical Academic Graduate School, University of Oxford, John Radcliffe Hospital, Medical Sciences Division, Level 3, John Radcliffe Hospital., Oxford, Oxfordshire, UK, OX3 9DU.

出版信息

Cochrane Database Syst Rev. 2013 Oct 20;2013(10):CD006823. doi: 10.1002/14651858.CD006823.pub2.

Abstract

BACKGROUND

Axillary dissection is commonly performed for breast carcinoma. It is uncertain whether insertion of a drain reduces complication rates.

OBJECTIVES

To assess the effects of wound drainage after axillary dissection for breast carcinoma on the incidence of postoperative seroma formation. Secondary outcome measures include the incidence of infection and length of hospital stay.

SEARCH METHODS

We searched the Cochrane Wound and Breast Cancer Group's Specialised Registers (22 February 2013), MEDLINE (1950 to 22 February 2013), EMBASE (1966 to 22 February 2013), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov (22 February 2013) for all prospectively registered and ongoing trials (22 February 2013). Reference lists of included studies were handsearched by two independent review authors to look for additional eligible trials.

SELECTION CRITERIA

All randomised controlled trials (RCTs) comparing wound drainage versus no wound drainage in individuals after axillary dissection for the treatment of breast carcinoma were included. All disease stages were considered. Breast-conserving surgery and mastectomy were considered. Patients undergoing sentinel node biopsy without axillary dissection were not included. No limits were applied to language or study location. Two review authors independently determined the eligibility of each study.

DATA COLLECTION AND ANALYSIS

Two review authors independently extracted data for each included study using a predesigned data extraction proforma and assessed risk of bias using The Cochrane Collaboration's 'Risk of bias' tool. Discrepancies were resolved by consensus discussion with a third review author. Dichotomous variables were analysed using a Mantel-Haenszel model to produce odds ratios (ORs). Continuous variables were analysed using an inverse variance model to produce a mean difference (MD).

MAIN RESULTS

Seven RCTs including 960 participants were identified. The quality of trials was generally low, with several studies at risk of selection bias, and no studies used blinding during treatment or outcome assessment. There was a high level of statistical variation between the studies, which therefore reduces the reliability of the evidence. The OR for seroma formation was 0.46 (95% confidence interval (CI) 0.23 to 0.91, P = 0.03) in favour of a reduced incidence of seroma in participants with drains inserted. There was no significant difference in infection rates between drainage and no drainage groups (OR = 0.70; 95% CI 0.44 to 1.12, P = 0.14). The mean difference in length of hospital stay, reported in four trials consisting of 600 participants, was 1.47 days greater in the drained population (95% CI 0.67 to 2.28, P = 0.0003). A mean difference of 0.79 fewer postoperative seroma aspirations was found in the drained population (95% CI 1.23 to 0.35 fewer, P = 0.0004) in two trials including 212 participants. No significant difference in volume of seroma aspirations was reported (MD -19.44, 95% CI -59.45 to 20.57, P = 0.34) in three trials including 519 participants. No significant difference in the incidence of lymphoedema was noted (OR 2.31 favouring no drainage, 95% CI 0.47 to 11.37, P = 0.30), with only six instances reported in three trials of 360 participants, nor was any significant difference in the incidence of haematoma observed (OR 1.68, 95% CI 0.33 to 8.51, P = 0.53), with only five instances reported in two trials of 314 participants.

AUTHORS' CONCLUSIONS: There is limited quality evidence that insertion of a drain following axillary lymphadenectomy reduced the odds of developing a seroma and reduced the number of post-operative seroma aspirations. These benefits should be balanced against an increased length of hospital stay in the drained population.

摘要

背景

腋窝清扫术常用于乳腺癌治疗。插入引流管是否能降低并发症发生率尚不确定。

目的

评估乳腺癌腋窝清扫术后伤口引流对术后血清肿形成发生率的影响。次要结局指标包括感染发生率和住院时间。

检索方法

我们检索了Cochrane伤口与乳腺癌小组专业注册库(2013年2月22日)、MEDLINE(1950年至2013年2月22日)、EMBASE(1966年至2013年2月22日)、世界卫生组织(WHO)国际临床试验注册平台(ICTRP)和ClinicalTrials.gov(2013年2月22日),以查找所有前瞻性注册和正在进行的试验(2013年2月22日)。两名独立的综述作者对纳入研究的参考文献列表进行手工检索,以寻找其他符合条件的试验。

入选标准

纳入所有比较腋窝清扫术后伤口引流与不引流治疗乳腺癌患者的随机对照试验(RCT)。考虑所有疾病分期。考虑保乳手术和乳房切除术。未进行腋窝清扫仅接受前哨淋巴结活检的患者不纳入。对语言或研究地点不设限制。两名综述作者独立确定每项研究的合格性。

数据收集与分析

两名综述作者使用预先设计的数据提取表格为每项纳入研究独立提取数据,并使用Cochrane协作网的“偏倚风险”工具评估偏倚风险。通过与第三位综述作者进行共识讨论解决分歧。二分变量使用Mantel-Haenszel模型进行分析以产生比值比(OR)。连续变量使用逆方差模型进行分析以产生平均差(MD)。

主要结果

共识别出7项RCT,包括960名参与者。试验质量普遍较低,多项研究存在选择偏倚风险,且没有研究在治疗或结局评估中使用盲法。研究之间存在高度的统计异质性,因此降低了证据的可靠性。插入引流管的参与者血清肿形成的OR为0.46(95%置信区间(CI)0.23至0.91,P = 0.03),表明血清肿发生率降低。引流组和不引流组的感染率无显著差异(OR = 0.70;95% CI 0.44至1.12,P = 0.14)。在由600名参与者组成的4项试验中报告的住院时间平均差为,引流人群长1.47天(95% CI 0.67至2.28,P = 0.0003)。在包括212名参与者的2项试验中,引流人群术后血清肿抽吸次数平均少0.79次(95% CI少1.23至0.35次,P = 0.0004)。在包括519名参与者的3项试验中,报告的血清肿抽吸量无显著差异(MD -19.44,95% CI -59.45至20.57,P = 0.34)。未观察到淋巴水肿发生率的显著差异(OR 2.31支持不引流,95% CI 0.47至11.37,P = 0.30),在3项共360名参与者的试验中仅报告了6例,也未观察到血肿发生率的显著差异(OR 1.68,95% CI 0.33至8.51,P =

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