Jørgensen Christoffer Calov, Kehlet Henrik
Departement of Anaesthesia and Intensive Care, Hospital of Northern Zeeland, Hillerød, Denmark and The Center for Fast-track Hip and Knee Replacement, Rigshospitalet, Copenhagen, Denmark.
Section for Surgical Pathophysiology, Copenhagen, Denmark and The Centre for Fast-Track Hip and Knee Replacement, Rigshospitalet, Copenhagen University, Copenhagen, Denmark.
Perioper Med (Lond). 2024 Jun 21;13(1):60. doi: 10.1186/s13741-024-00426-3.
Preoperative anaemia including iron deficiency anaemia (IDA) is a well-established perioperative risk factor. However, most studies on iron therapy to treat IDA have been negative and few have been conducted within an enhanced recovery after surgery (ERAS) protocol. Furthermore, patients with IDA often have comorbidities not necessarily influenced by iron, but potentially influencing traditional study endpoints such as length of stay (LOS), morbidity, etc. The aim of this paper is to discuss patient-related challenges when planning outcome studies on the potential benefits of iron therapy in patients with IDA, based upon a large detailed prospective database in ERAS total hip (THA) and knee arthroplasty (TKA).
A prospective observational cohort study in ERAS THA and TKA from 2022 to 2023. Detailed complete follow-up through questionnaires and electronic medical records.
Of 3655 included patients, 276 (7.6%) had IDA defined as a haemoglobin (Hb) of < 13.0 g/dL and transferrin saturation of 0.20, while 3379 had a Hb of ≥ 13.0. Patients with IDA were a median 5 years older than non-anaemics, with an increased fraction living alone (38.4% vs. 28.8%), using walking aids (54.3% vs 26.4%) and receiving home care (16.2% vs 4.7%). Fewer IDA patients were working (12.7% vs. 29.6%) and a median number of prescribed drugs was higher (10 vs. 6). Median LOS was 1 day in both IDA and non-anaemic patients, but a LOS of > 2 days occurred in 11.6% of patients with IDA vs. 4.3% in non-anaemics. The proportion with 30- or 90-day readmissions was 6.5% vs. 4.1% and. 13.4% vs6.0%, in patients with IDA and non-anaemics, respectively. However, potentially anaemia or iron deficiency-related causes of LOS > 2 days or 90-day readmissions were only 5.4% and 2.2% in patients with IDA and 1.9% and 1.0% in non-anaemics.
Conventional randomised trials with single or composite "hard" endpoints are at risk of being inconclusive or underpowered due to a considerable burden of other patient-related risk factors and with postoperative complications which may not be modifiable by correction of IDA per se. We will propose to gain further insights from detailed observational and mechanistic studies prior to initiating extensive randomised studies.
术前贫血，包括缺铁性贫血（IDA），是公认的围手术期风险因素。然而，大多数关于铁剂治疗IDA的研究结果均为阴性，且很少有研究是在术后加速康复（ERAS）方案下进行的。此外，IDA患者常伴有其他合并症，这些合并症不一定受铁缺乏影响，但可能会影响传统的研究终点，如住院时间（LOS）、发病率等。本文旨在基于一个关于ERAS全髋关节置换术（THA）和膝关节置换术（TKA）的大型详细前瞻性数据库，探讨在规划关于铁剂治疗IDA患者潜在益处的结局研究时与患者相关的挑战。
对2022年至2023年期间接受ERAS THA和TKA手术的患者进行前瞻性观察队列研究。通过问卷调查和电子病历进行详细的完整随访。
在纳入的3655例患者中，276例（7.6%）被诊断为IDA，定义为血红蛋白（Hb）<13.0 g/dL且转铁蛋白饱和度<0.20，而3379例患者的Hb≥13.0。IDA患者的年龄中位数比非贫血患者大5岁，独居比例更高（38.4%对28.8%），使用助行器的比例更高（54.3%对26.4%），接受家庭护理的比例更高（16.2%对4.7%）。IDA患者中工作的人数较少（12.7%对29.6%），且处方药物的中位数数量更多（10对6）。IDA患者和非贫血患者的中位住院时间均为1天，但IDA患者中有11.6%的患者住院时间>2天，而非贫血患者中这一比例为4.3%。IDA患者和非贫血患者30天或90天再入院的比例分别为6.5%对4.1%和13.4%对6.0%。然而，IDA患者中因潜在贫血或缺铁相关原因导致住院时间>2天或90天再入院的比例仅为5.4%和2.2%，非贫血患者中这一比例分别为1.9%和1.0%。
由于存在大量其他与患者相关的风险因素以及术后并发症，而这些并发症可能无法通过纠正IDA本身来改善，因此采用单一或复合“硬”终点的传统随机试验可能会得出不确定的结果或效力不足。我们建议在开展广泛的随机研究之前，先从详细的观察性研究和机制性研究中获取更多见解。
