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术前静脉补铁对结直肠癌手术后生活质量的影响:来自结直肠癌相关贫血静脉补铁(IVICA)试验的结果。

The impact of pre-operative intravenous iron on quality of life after colorectal cancer surgery: outcomes from the intravenous iron in colorectal cancer-associated anaemia (IVICA) trial.

机构信息

Milton Keynes University Hospital NHS Foundation Trust, Eaglestone, UK.

NIHR Biomedical Research Unit in Gastrointestinal and Liver Diseases at Nottingham, University Hospitals NHS Trust and the University of Nottingham, UK.

出版信息

Anaesthesia. 2019 Jun;74(6):714-725. doi: 10.1111/anae.14659. Epub 2019 Apr 8.

DOI:10.1111/anae.14659
PMID:30963552
Abstract

Anaemia is associated with a reduction in quality of life, and is common in patients with colorectal cancer . We recently reported the findings of the intravenous iron in colorectal cancer-associated anaemia (IVICA) trial comparing haemoglobin levels and transfusion requirements following intravenous or oral iron replacement in anaemic colorectal cancer patients undergoing elective surgery. In this follow-up study, we compared the efficacy of intravenous and oral iron at improving quality of life in this patient group. We conducted a multicentre, open-label randomised controlled trial. Anaemic colorectal cancer patients were randomly allocated at least two weeks pre-operatively, to receive either oral (ferrous sulphate) or intravenous (ferric carboxymaltose) iron. We assessed haemoglobin and quality of life scores at recruitment, immediately before surgery and at outpatient review approximately three months postoperatively, using the Short Form 36, EuroQoL 5-dimension 5-level and Functional Assessment of Cancer Therapy - Anaemia questionnaires. We recruited 116 anaemic patients across seven UK centres (oral iron n = 61 (53%), and intravenous iron n = 55 (47%)). Eleven quality of life components increased by a clinically significant margin in the intravenous iron group between recruitment and surgery compared with one component for oral iron. Median (IQR [range]) visual analogue scores were significantly higher with intravenous iron at a three month outpatient review (oral iron 70, (60-85 [20-95]); intravenous iron 90 (80-90 [50-100]), p = 0.001). The Functional Assessment of Cancer Therapy - Anaemia score comprises of subscales related to cancer, fatigue and non-fatigue items relevant to anaemia. Median outpatient scores were higher, and hence favourable, for intravenous iron on the Functional Assessment of Cancer Therapy - Anaemia subscale (oral iron 66 (55-72 [23-80]); intravenous iron 71 (66-77 [46-80]); p = 0.002), Functional Assessment of Cancer Therapy - Anaemia trial outcome index (oral iron 108 (90-123 [35-135]); intravenous iron 121 (113-124 [81-135]); p = 0.003) and Functional Assessment of Cancer Therapy - Anaemia total score (oral iron 151 (132-170 [69-183]); intravenous iron 168 (160-174 [125-186]); p = 0.005). These findings indicate that intravenous iron is more efficacious at improving quality of life scores than oral iron in anaemic colorectal cancer patients.

摘要

贫血与生活质量下降有关,在结直肠癌患者中很常见。我们最近报告了静脉铁在结直肠癌相关贫血(IVICA)试验中的发现,该试验比较了接受择期手术的贫血结直肠癌患者静脉或口服铁替代后血红蛋白水平和输血需求。在这项随访研究中,我们比较了静脉和口服铁在改善该患者群体生活质量方面的疗效。我们进行了一项多中心、开放标签的随机对照试验。至少在术前两周,将贫血结直肠癌患者随机分配接受口服(硫酸亚铁)或静脉(羧基麦芽糖铁)铁治疗。我们使用简短表格 36、欧洲五维健康量表 5 级和癌症治疗功能评估-贫血问卷,在招募时、手术前立即以及术后约三个月的门诊复查时评估血红蛋白和生活质量评分。我们在英国的七个中心招募了 116 名贫血患者(口服铁 61 名(53%),静脉铁 55 名(47%))。在静脉铁组中,与口服铁相比,有 11 个生活质量成分在招募和手术之间增加了临床显著幅度。在三个月的门诊复查时,静脉铁的视觉模拟评分中位数(IQR[范围])明显更高(口服铁 70(60-85[20-95]);静脉铁 90(80-90[50-100]),p=0.001)。癌症治疗功能评估-贫血量表包含与癌症、疲劳和与贫血相关的非疲劳项目相关的亚量表。静脉铁在癌症治疗功能评估-贫血量表的亚量表上的得分更高,因此更有利(口服铁 66(55-72[23-80]);静脉铁 71(66-77[46-80]);p=0.002),癌症治疗功能评估-贫血试验结局指数(口服铁 108(90-123[35-135]);静脉铁 121(113-124[81-135]);p=0.003)和癌症治疗功能评估-贫血总分(口服铁 151(132-170[69-183]);静脉铁 168(160-174[125-186]);p=0.005)。这些发现表明,与口服铁相比,静脉铁在改善贫血结直肠癌患者的生活质量评分方面更有效。

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