Evaluation of Convalescent Plasma for Ebola Virus Disease in Guinea.
Evaluation of Convalescent Plasma for Ebola Virus Disease in Guinea.
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DOI：
10.1056/nejmoa1511812
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发表时间：
2016-01-07
期刊：
影响因子：
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通讯作者：
Ebola-Tx Consortium
中科院分区：
文献类型：
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作者：
van Griensven J;Edwards T;de Lamballerie X;Semple MG;Gallian P;Baize S;Horby PW;Raoul H;Magassouba N;Antierens A;Lomas C;Faye O;Sall AA;Fransen K;Buyze J;Ravinetto R;Tiberghien P;Claeys Y;De Crop M;Lynen L;Bah EI;Smith PG;Delamou A;De Weggheleire A;Haba N;Ebola-Tx Consortium
在最近几个非洲国家爆发埃博拉病毒病（EVD）之后，世界卫生组织优先评估从疾病康复患者中提取的恢复期血浆的治疗。我们评价了恢复期血浆治疗几内亚EVD的安全性和有效性。在这项非随机对照研究中，99例不同年龄的确诊EVD患者（包括孕妇）连续输注了两次200至250 ml ABO相容性恢复期血浆，每单位血浆均来自单独的恢复期供体。在诊断当天或最多2天后开始输血。给药时血浆中埃博拉病毒中和抗体水平未知。对照组为418例患者，他们在过去5个月内在同一中心接受治疗。主要结局是诊断后3 - 16天内的死亡风险，并根据年龄和聚合酶链反应测定的基线周期阈值进行调整;排除在第3天前死亡的患者。临床上重要的差异被定义为与对照组相比，恢复期血浆组的死亡率绝对降低20个百分点。共84例接受血浆治疗的患者被纳入主要分析。在基线时，恢复期血浆组比对照组有略高的周期阈值和较短的症状持续时间，沿着更高频率的眼睛发红和吞咽困难。从诊断后第3天到第16天，恢复期血浆组的死亡风险为31%，对照组为38%（风险差异，-7个百分点; 95%置信区间[CI]，-18至4）。在调整年龄和周期阈值后，差异减小（调整后的风险差异，-3个百分点; 95%CI，-13至8）。未观察到与使用恢复期血浆相关的严重不良反应。在84例确诊为EVD的患者中，输注高达500 ml的恢复期血浆（中和抗体水平未知）与生存率的显著改善无关。（由欧盟地平线2020研究和创新计划等资助; ClinicalTrials.gov编号，NCT 02342171。
In the wake of the recent outbreak of Ebola virus disease (EVD) in several African countries, the World Health Organization prioritized the evaluation of treatment with convalescent plasma derived from patients who have recovered from the disease. We evaluated the safety and efficacy of convalescent plasma for the treatment of EVD in Guinea. In this nonrandomized, comparative study, 99 patients of various ages (including pregnant women) with confirmed EVD received two consecutive transfusions of 200 to 250 ml of ABO-compatible convalescent plasma, with each unit of plasma obtained from a separate convalescent donor. The transfusions were initiated on the day of diagnosis or up to 2 days later. The level of neutralizing antibodies against Ebola virus in the plasma was unknown at the time of administration. The control group was 418 patients who had been treated at the same center during the previous 5 months. The primary outcome was the risk of death during the period from 3 to 16 days after diagnosis with adjustments for age and the baseline cycle-threshold value on polymerase-chain-reaction assay; patients who had died before day 3 were excluded. The clinically important difference was defined as an absolute reduction in mortality of 20 percentage points in the convalescent-plasma group as compared with the control group. A total of 84 patients who were treated with plasma were included in the primary analysis. At baseline, the convalescent-plasma group had slightly higher cycle-threshold values and a shorter duration of symptoms than did the control group, along with a higher frequency of eye redness and difficulty in swallowing. From day 3 to day 16 after diagnosis, the risk of death was 31% in the convalescent-plasma group and 38% in the control group (risk difference, −7 percentage points; 95% confidence interval [CI], −18 to 4). The difference was reduced after adjustment for age and cycle-threshold value (adjusted risk difference, −3 percentage points; 95% CI, −13 to 8). No serious adverse reactions associated with the use of convalescent plasma were observed. The transfusion of up to 500 ml of convalescent plasma with unknown levels of neutralizing antibodies in 84 patients with confirmed EVD was not associated with a significant improvement in survival. (Funded by the European Union’s Horizon 2020 Research and Innovation Program and others; ClinicalTrials.gov number, NCT02342171.)