围手术期缺铁性贫血患者术前静脉注射异麦芽糖铁对血红蛋白和铁蛋白浓度的影响：一项初步随机对照试验。
Perioperative changes in haemoglobin and ferritin concentrations from preoperative intravenous iron isomaltoside for iron deficiency anaemia in patients with colorectal cancer: A pilot randomised controlled trial.
机构信息
Department of Anaesthesia and Intensive Care, Prince of Wales Hospital, Shatin, New Territories, Hong Kong SAR, China.
Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong SAR, China.
出版信息
PLoS One. 2022 Jun 30;17(6):e0270640. doi: 10.1371/journal.pone.0270640. eCollection 2022.
BACKGROUND
Patients with colorectal cancer have a high risk of iron deficiency anaemia (IDA) due to chronic tumour induced blood loss, a reduced dietary iron intake from poor nutrition or gastrointestinal malabsorption. This pilot, double blinded, randomised controlled trial (RCT) examined the effect and feasibility of using preoperative iron isomaltoside for treating iron deficiency anaemia.
METHODS
Forty eligible adults with IDA were randomised to receive either intravenous iron isomaltoside (20 mg.kg-1 up to 1000 mg over 30 minutes) or usual preoperative care (control) three weeks before scheduled colorectal surgery. The primary outcomes were perioperative changes in haemoglobin and ferritin concentrations.
RESULTS
The recruitment rate was 78% of all eligible referred patients (1.9 patients/month). The haemoglobin and ferritin concentrations were higher in the iron isomaltoside group than the control group over the perioperative period (group*time interaction P = 0.042 and P < 0.001 respectively). Mean haemoglobin change from baseline to before surgery was higher in the iron isomaltoside group (7.8, 95% CI: 3.2 to 12.3 g.l-1) than the control group (1.7, 95% CI: -1.9 to 5.3 g.l-1) [mean difference 6.1, 95% CI: 0.3 to 11.8 g.l-1; P = 0.040]. The ferritin change from baseline to before surgery between groups was large in favour of the iron isomaltoside group (mean difference 296.9, 95% CI: 200.6 to 393.2 μg.l-1; P < 0.001]. There were no differences between groups in packed red blood cell transfusions needed, surgical complications, quality of recovery and days (alive and) at home within 30 days after surgery.
CONCLUSION
Iron isomaltoside therapy was safe and had a minimal effect on perioperative changes in haemoglobin concentration. Given the slow recruitment and new evidence emerging during the conduct of this study, conducting a multi-centre RCT based on the current pilot trial protocol is unlikely to be feasible.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03565354.
背景
由于慢性肿瘤诱导性失血、营养不良或胃肠道吸收不良导致的铁摄入减少，结直肠癌患者铁缺乏性贫血（IDA）的风险很高。这项先导、双盲、随机对照试验（RCT）研究了术前使用异麦芽糖铁治疗缺铁性贫血的效果和可行性。
方法
40 名符合条件的 IDA 成年患者被随机分为两组，分别接受静脉注射异麦芽糖铁（20mg/kg，最高剂量 1000mg，30 分钟内输注完毕）或常规术前护理（对照组），在计划行结直肠手术前 3 周进行治疗。主要结局为围手术期血红蛋白和铁蛋白浓度的变化。
结果
招募率为所有符合条件的转诊患者的 78%（每月 1.9 例）。与对照组相比，铁异麦芽糖组在围手术期内血红蛋白和铁蛋白浓度均较高（组间*时间交互作用 P=0.042 和 P<0.001）。铁异麦芽糖组从基线到术前的血红蛋白变化平均值高于对照组（7.8，95%CI：3.2 至 12.3g/l-1），而对照组为 1.7，95%CI：-1.9 至 5.3g/l-1）[平均差值 6.1，95%CI：0.3 至 11.8g/l-1；P=0.040]。两组间从基线到术前的铁蛋白变化差异较大，铁异麦芽糖组更有利（平均差值 296.9，95%CI：200.6 至 393.2μg/l-1；P<0.001）。两组间需要输红细胞悬液、手术并发症、恢复质量以及术后 30 天内（存活和）在家天数均无差异。
结论
铁异麦芽糖治疗安全，对血红蛋白浓度的围手术期变化影响较小。鉴于本次研究过程中缓慢的招募和新出现的证据，基于当前先导试验方案开展多中心 RCT 不太可行。
试验注册
ClinicalTrials.gov NCT03565354。
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