一项在乌干达癌症患者中比较白细胞减少和非白细胞减少全血输血患者死亡率的随机对照试验。

A randomized control trial to compare mortality in recipients of leucoreduced and non-leucoreduced whole blood transfusion in patients with cancer in Uganda.

机构信息

Uganda Cancer Institute, Kampala, Uganda.

Department of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.

出版信息

BMC Cancer. 2024 Jun 3;24(1):677. doi: 10.1186/s12885-024-12445-w.

DOI:10.1186/s12885-024-12445-w

PMID:38831291

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11149322/

Abstract

BACKGROUND

Mortality benefit of transfusion with leucoreduced whole blood has not been demonstrated in the sub-Saharan Africa (SSA). We compared mortality in patients with cancer transfused with leucoreduced and non-leucoreduced whole blood in a SSA setting.

METHODS

An open-label randomized controlled trial was conducted at the Uganda Cancer Institute where participants were randomized in a 1:1 ratio into the leucoreduced and non-leucoreduced whole blood transfusion arms. Leucocyte filtration of whole blood was performed within 72 h of blood collection. Patients aged ≥ 15 years who were prescribed blood transfusion by the primary physicians were eligible for study enrolment. Mortality difference was analyzed using intention-to-treat survival analysis and cox proportional hazard model was used to analyze factors associated with mortality.

RESULTS

There were 137 participants randomized to the leucoreduced and 140 to the non-leucoreduced arms. Baseline characteristics were similar between the two arms. The median number of blood transfusions received was 1 (IQR, 1-3) unit and 2 (IQR, 1-3) units in the leucoreduced and non-leucoreduced arms respectively, p = 0.07. The 30-day mortality rate in the leucoreduced arm was 4.6% (95% CI, 2.1-10) and was 6.2% (95% CI, 3.2-12.1) in the non-leucoreduced arm (p = 0.57), representing an absolute effect size of only 1.6%. Increasing age (HR = 0.92, 95% CI, 0.86-0.98, p = 0.02) and Eastern Co-operative Oncology Group (ECOG) performance score of 1 (HR = 0.03, 95% CI, 0.00-0.31, p < 0.01) were associated with reduced 30-day mortality.

CONCLUSIONS

The study failed to demonstrate mortality difference between cancer patients transfused with leucoreduced and non-leucoreduced whole blood. Although this study does not support nor refute universal leucoreduction to reduce mortality in patients with cancer in SSA, it demonstrates the feasibility of doing transfusion RCTs in Uganda, where a multi-center trial with an appropriate sample size is needed.

TRIAL REGISTRATION

Pan African Clinical Trial Registry, https://pactr.samrc.ac.za/ (PACTR202302787440132). Registered on 06/02/2023.

摘要

背景

在撒哈拉以南非洲（SSA），尚未证明输注去白细胞全血可降低死亡率。我们比较了 SSA 环境中接受去白细胞和非去白细胞全血输注的癌症患者的死亡率。

方法

乌干达癌症研究所进行了一项开放性标签随机对照试验，参与者按照 1:1 的比例随机分配到去白细胞和非去白细胞全血输血组。在采血后 72 小时内进行全血白细胞过滤。符合以下条件的 15 岁及以上的原发性医生开具输血医嘱的患者可入组本研究。采用意向治疗生存分析比较死亡率差异，并采用 Cox 比例风险模型分析与死亡率相关的因素。

结果

137 名参与者被随机分配到去白细胞组，140 名参与者被随机分配到非去白细胞组。两组的基线特征相似。去白细胞组和非去白细胞组分别接受中位数 1（IQR，1-3）单位和 2（IQR，1-3）单位的血液输注，p=0.07。去白细胞组的 30 天死亡率为 4.6%（95%CI，2.1-10），非去白细胞组为 6.2%（95%CI，3.2-12.1）（p=0.57），绝对效应大小仅为 1.6%。年龄增加（HR=0.92，95%CI，0.86-0.98，p=0.02）和东部合作肿瘤学组（ECOG）表现评分为 1（HR=0.03，95%CI，0.00-0.31，p<0.01）与降低 30 天死亡率相关。