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结直肠癌患者术前口服补充剂的非盲随机对照试验。

An unblinded randomised controlled trial of preoperative oral supplements in colorectal cancer patients.

机构信息

Dietetic Service, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK.

出版信息

J Hum Nutr Diet. 2011 Oct;24(5):441-8. doi: 10.1111/j.1365-277X.2011.01188.x. Epub 2011 Jun 23.

DOI:10.1111/j.1365-277X.2011.01188.x
PMID:21699587
Abstract

BACKGROUND

Perioperative oral supplementation has been shown to reduce post-operative complications. However, the use of preoperative standard oral supplements in a cohort of colorectal cancer patients has not been evaluated. The present study examined whether preoperative supplements are beneficial in this group.

METHODS

In a randomised controlled trial, patients were assigned to receive 400 mL of oral supplement and dietary advice or dietary advice alone. Primary outcome was the number of post-operative complications. One hundred and twenty-five patients were recruited (59 randomised to the intervention group and 66 to the control group) and nine were excluded.

RESULTS

In the intervention group, 24 (44%) patients had a complication compared to 26 (42%) in the control group (P = 0.780). In the intervention and control groups, there were eight (15%) and 16 (25%) surgical site infections, respectively (P = 0.140) and seven (13%) and 11 (17%) chest infections, respectively (P = 0.470). Subgroup analysis for hypothesis generation included 83 (71%) weight-losing patients, where there was a significant reduction in surgical site infections using the Buzby definition (P = 0.034), although this was not the case for the Centre for Disease Control definition (P = 0.052).

CONCLUSIONS

There was no evidence that preoperative supplements were beneficial in reducing the number of complications, although there may be some benefit for surgical site infections in selected weight-losing preoperative patients.

摘要

背景

围手术期口服补充剂已被证明可减少术后并发症。然而,尚未评估在结直肠癌患者队列中使用术前标准口服补充剂的情况。本研究旨在探讨术前补充剂在此类患者中的益处。

方法

在一项随机对照试验中,患者被分配接受 400 毫升口服补充剂和饮食建议或仅接受饮食建议。主要结局是术后并发症的数量。共招募了 125 名患者(59 名随机分配至干预组,66 名分配至对照组),其中 9 名被排除。

结果

在干预组中,24 名(44%)患者发生并发症,而对照组中则有 26 名(42%)患者发生并发症(P=0.780)。在干预组和对照组中,分别有 8 名(15%)和 16 名(25%)患者发生手术部位感染(P=0.140),分别有 7 名(13%)和 11 名(17%)患者发生肺部感染(P=0.470)。针对假设生成的亚组分析包括 83 名(71%)体重减轻的患者,使用 Buzby 定义时,手术部位感染的发生率显著降低(P=0.034),而使用疾病控制中心定义时则没有显著差异(P=0.052)。

结论

没有证据表明术前补充剂有助于减少并发症的数量,但对于某些术前体重减轻的患者,手术部位感染可能会有一定的益处。

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