Fiona Stanley Fremantle Hospital Group, Murdoch, WA, Australia.
Australian Red Cross Blood Service, Perth, WA, Australia.
Vox Sang. 2020 May;115(4):288-292. doi: 10.1111/vox.12900. Epub 2020 Feb 20.
Therapeutic phlebotomy is the cornerstone of treatment for HFE haemochromatosis (HH). Current Australian Red Cross LifeBlood Service guidelines mandate measuring haemoglobin (Hb) levels prior to phlebotomy and if below 130 g/l in men or 120 g/l in women, donors are deferred from donating whole blood. Therapeutic donation below these levels may take place where both the treating doctor and a blood service medical officer approve. The aim of the current study was to determine whether adverse events are more frequent in those who undergo therapeutic phlebotomy below current Hb thresholds applied to volunteer therapeutic donors. A retrospective review of all therapeutic donations was undertaken for the financial year 2016-2017. The data were obtained through the Australian Red Cross Blood Service. Inclusion criteria were any donor between 16 and 70 years of age, weighing more than 50 kg and meeting blood service guidelines for donation. All adverse events recorded in an electronic quality system were obtained and associated with donor haemoglobin level. Statistical analyses were performed using analysis of variance or Fisher's exact test (GraphPad Prism). About 34 886 therapeutic phlebotomy donations occurred during 2016-2017, of whom the majority were referred for HH (34 089). In total, 365 of 34 886 donations (0·0105%) were complicated by an adverse event. A total of 305 (0·0087%) therapeutic donations occurred while below the lower limit of blood service Hb threshold for their respective genders. Of the donations that occurred below the blood service threshold, 3 of 305 (0·0098%) had an adverse event compared with 362 of 34 581 donations above the lower limit threshold (0·0105%, P = 0·99). The incidence of adverse events was not increased in the group which underwent therapeutic phlebotomy below the current Australian Red Cross Blood Service Hb threshold compared with those above threshold, indicating safety of treatment at Hb levels lower than currently recommended.
治疗性放血是治疗 HFE 血色病（HH）的基石。目前，澳大利亚红十字会生命血服务指南规定，在放血前测量血红蛋白（Hb）水平，如果男性低于 130g/l 或女性低于 120g/l，则推迟献血者献血。在治疗医生和血液服务医务人员批准的情况下，可在低于这些水平的情况下进行治疗性捐献。目前的研究目的是确定在目前应用于志愿治疗性献血者的 Hb 阈值以下进行治疗性放血时，是否会出现更频繁的不良事件。对 2016-2017 年财政年度的所有治疗性献血进行了回顾性审查。数据通过澳大利亚红十字会血液服务获得。纳入标准为年龄在 16-70 岁之间、体重超过 50kg 且符合血液服务献血标准的任何献血者。从电子质量系统中获得并与供体血红蛋白水平相关的所有记录的不良事件。使用方差分析或 Fisher 确切检验（GraphPad Prism）进行统计分析。在 2016-2017 年期间，约有 34886 次治疗性放血，其中大多数是 HH （34089 次）。共有 365 次/34886 次（0·0105%）献血出现不良事件。共有 305 次/34886 次（0·0087%）献血发生在各自性别血液服务 Hb 阈值下限以下。在低于血液服务阈值的献血中，有 3 例/305 例（0·0098%）发生不良事件，而高于下限阈值的 34581 例/34581 例（0·0105%，P=0·99）发生不良事件。与高于阈值的献血者相比，在低于当前澳大利亚红十字会血液服务 Hb 阈值的情况下进行治疗性放血的献血者不良事件发生率并未增加，表明在低于目前推荐水平的 Hb 水平下进行治疗是安全的。
