两种商业性病原体灭活技术处理的添加溶液中血小板的临床有效性。
Clinical effectiveness of platelets in additive solution treated with two commercial pathogen-reduction technologies.
作者信息
Rebulla Paolo, Vaglio Stefania, Beccaria Francesco, Bonfichi Maurizio, Carella Angelo, Chiurazzi Federico, Coluzzi Serelina, Cortelezzi Agostino, Gandini Giorgio, Girelli Gabriella, Graf Maria, Isernia Paola, Marano Giuseppe, Marconi Maurizio, Montemezzi Rachele, Olivero Barbara, Rinaldi Marianna, Salvaneschi Laura, Scarpato Nicola, Strada Paolo, Milani Silvano, Grazzini Giuliano
机构信息
Blood Transfusion Service, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Italian National Blood Center, National Institute of Health, Rome, Italy.
出版信息
Transfusion. 2017 May;57(5):1171-1183. doi: 10.1111/trf.14042. Epub 2017 Feb 24.
BACKGROUND
Two noninferiority, randomized, controlled trials were conducted in parallel comparing the safety and efficacy of platelets treated with Intercept or Mirasol pathogen-reduction technologies versus standard platelets.
STUDY DESIGN AND METHODS
The primary endpoint was the percentage of hematology patients who developed World Health Organization Grade 2 or greater bleeding. A noninferiority margin of 11% was chosen based on expected Grade 2 or greater bleeding in 20% of controls. The study was closed for financial restrictions before reaching the planned sample size of 828 patients, and an intention-to-treat analysis was conducted on 424 evaluable patients.
RESULTS
In the Intercept trial (113 treated vs. 115 control patients), the absolute risk difference in Grade 2 or greater bleeding was 6.1%, with an upper one-sided 97.5% confidence limit of 19.2%. The absolute risk difference in the Mirasol trial (99 treated vs. 97 control patients) was 4.1%, and the upper one-sided 97.5% confidence limit was 18.4%. Neither absolute risk difference was statistically significant. In both trials, posttransfusion platelet count increments were significantly lower in treated versus control patients. Mean blood component use in treated patients versus controls was 54% higher (95% confidence interval, 36%-74%; Intercept) and 34% higher (95% confidence interval, 16%-54%; Mirasol) for platelets and 23% higher (95% confidence interval, 8%-39%; Intercept) and 32% higher (95% confidence interval, 10%-57%; Mirasol) for red blood cells. Unexpected reactions and adverse events were not reported. Mortality did not differ significantly between treated and control patients.
CONCLUSION
Although conclusions on noninferiority could not be drawn due to low statistical power, the study provides additional information on the safety and efficacy of pathogen-reduced platelets treated with two commercial pathogen-reduction technologies.
背景
两项非劣效性随机对照试验同时进行，比较采用Intercept或Mirasol病原体灭活技术处理的血小板与标准血小板的安全性和有效性。
研究设计与方法
主要终点是出现世界卫生组织2级或更严重出血的血液学患者百分比。基于预计20%的对照患者会出现2级或更严重出血，选择了11%的非劣效性界值。该研究在达到计划的828例患者样本量之前因财务限制而提前结束，并对424例可评估患者进行了意向性分析。
结果
在Intercept试验中（113例接受治疗患者与115例对照患者），2级或更严重出血的绝对风险差异为6.1%，单侧97.5%置信上限为19.2%。Mirasol试验中（99例接受治疗患者与97例对照患者）的绝对风险差异为4.1%，单侧97.5%置信上限为18.4%。两个绝对风险差异均无统计学意义。在两项试验中，接受治疗患者输血后的血小板计数增量均显著低于对照患者。与对照患者相比，接受治疗患者的平均血液成分使用量，血小板高出54%（95%置信区间，36% - 74%；Intercept）和34%（95%置信区间，16% - 54%；Mirasol），红细胞高出23%（95%置信区间，8% - 39%；Intercept）和32%（95%置信区间，10% - 57%；Mirasol）。未报告意外反应和不良事件。接受治疗患者与对照患者的死亡率无显著差异。
结论
尽管由于统计效能低无法得出非劣效性结论，但该研究为采用两种商业病原体灭活技术处理的病原体灭活血小板的安全性和有效性提供了更多信息。
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