Al Khabori Murtadha K, Al-Riyami Arwa Z, Al-Farsi Khalil, Al-Huneini Mohammed, Al-Hashim Abdulhakeem, Al-Kemyani Nasser, Al-Qarshoubi Issa, Khan Hammad, Al-Amrani Khalfan, Daar Shahina
Departments of Haematology, Sultan Qaboos University Hospital;
Medicine, Sultan Qaboos University Hospital;
Sultan Qaboos Univ Med J. 2014 Nov;14(4):e468-72. Epub 2014 Oct 14.
This study aimed to validate pulse CO-oximetry-based haemoglobin (Hb) estimation in children and adults with thalassaemia major (TM) and to determine the impact of different baseline variables on the accuracy of the estimation.
This observational study was conducted over a five-week period from March to April 2012. A total of 108 patients with TM attending the daycare thalassaemia centre of a tertiary care hospital in Muscat, Oman, were enrolled. Spot (Sp) Hb measurements were estimated using a Pronto-7(®) pulse CO-oximetry device (Masimo Corp., Irvine, California, USA). These were compared to venous samples of Hb using the CELL-DYN Sapphire Hematology Analyzer (Abbott Diagnostics, Abbott Park, Illinois, USA) to determine the reference (Ref) Hb levels. A multivariable linear regression model was used to assess the impact of baseline variables such as age, gender, weight, height, Ref Hb and blood pressure on the Hb estimations.
Of the 108 enrolled patients, there were 54 males and 54 females with a mean age of 21.6 years (standard deviation [SD] = 7.3 years; range: 2.5-38 years). The mean Ref Hb and Sp Hb were 9.4 g/dL (SD = 0.9 g/dL; range: 7.5-12.3 g/dL) and 11.1 g/dL (SD = 1.2 g/dL; range: 7.5-14.7 g/dL), respectively. The coefficient of determination (R(2)) was 21% with a mean difference of 1.7 g/dL (SD = 1.1 g/dL; range: -0.9-4.3 g/dL). In the multivariable model, the Ref Hb level (P = 0.001) was the only statistically significant predictor.
The Pronto-7(®) pulse CO-oximetry device was found to overestimate Hb levels in patients with TM and therefore cannot be recommended. Further larger studies are needed to confirm these results.
本研究旨在验证基于脉搏碳氧血红蛋白法对重型地中海贫血（TM）儿童和成人血红蛋白（Hb）的估计，并确定不同基线变量对估计准确性的影响。
本观察性研究于2012年3月至4月进行，为期五周。共有108例TM患者纳入研究，这些患者来自阿曼马斯喀特一家三级护理医院的日间地中海贫血中心。使用Pronto-7（®）脉搏碳氧血红蛋白测定仪（美国加利福尼亚州尔湾市Masimo公司）估计即时（Sp）Hb测量值。将这些测量值与使用CELL-DYN Sapphire血液分析仪（美国伊利诺伊州雅培公园市雅培诊断公司）检测的静脉血Hb样本进行比较，以确定参考（Ref）Hb水平。使用多变量线性回归模型评估年龄、性别、体重、身高、Ref Hb和血压等基线变量对Hb估计值的影响。
在108例纳入研究的患者中，男性54例，女性54例，平均年龄21.6岁（标准差[SD]=7.3岁；范围：2.5 - 38岁）。平均Ref Hb和Sp Hb分别为9.4 g/dL（SD = 0.9 g/dL；范围：7.5 - 12.3 g/dL）和11.1 g/dL（SD = 1.2 g/dL；范围：7.5 - 14.7 g/dL）。决定系数（R²）为21%，平均差异为1.7 g/dL（SD = 1.1 g/dL；范围：-0.9 - 4.3 g/dL）。在多变量模型中，Ref Hb水平（P = 0.001）是唯一具有统计学意义的预测因素。
发现Pronto-7（®）脉搏碳氧血红蛋白测定仪高估了TM患者的Hb水平，因此不推荐使用。需要进一步开展更大规模的研究来证实这些结果。
