Novel blood derived hemostatic agents for bleeding therapy and prophylaxis.
Novel blood derived hemostatic agents for bleeding therapy and prophylaxis.
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DOI：
10.1097/moh.0000000000000737
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发表时间：
2022-11-01
影响因子：
3.2
通讯作者：
Cancelas, Jose A.
中科院分区：
文献类型：
--
作者：
Hegde, Shailaja;Zheng, Yi;Cancelas, Jose A.
出血是创伤和癌症中可预防死亡的主要原因。创伤诱导的凝血病和癌症相关的内皮病仍然是主要的治疗挑战。已经提出了早期、积极地给予血液衍生产品，假设其具有增加的凝血效力。一系列早期和晚期临床试验测试了冻干血浆和新型血小板产品在人体中的安全性和/或有效性，为替代血液成分疗法的未来提供了光明。本综述旨在对这些试验提供的信息进行背景分析和批判性综述。在随机、多中心临床试验中进行测试时，现有冻干血浆产品的有益效果可能没有最初预期的那么高。下一代冻干血浆产品已在早期临床试验中显示出安全性，其他具有良好临床前特征的冻干血浆和喷雾干燥血浆正在进行首次人体试验。新的血小板添加剂溶液和具有长期保质期的血小板冷冻保存或冻干形式已经证明了可行性和后勤优势。最近的试验证实了改良血浆和血小板产品在治疗或预防出血方面的后勤优势。然而，其假定的效价增加特征仍未得到证实。
Hemorrhage is a major cause of preventable death in trauma and cancer. Trauma induced coagulopathy and cancer associated endotheliopathy remain major therapeutic challenges. Early, aggressive administration of blood-derived products with hypothesized increased clotting potency have been proposed. A series of early- and late-phase clinical trials testing the safety and/or efficacy of lyophilized plasma and new forms of platelet products in humans have provided light on the future of alternative blood component therapies. This review intends to contextualize and provide a critical review of the information provided by these trials. The beneficial effect of existing freeze-dried plasma products may not be as high as initially anticipated when tested in randomized, multicenter clinical trials. A next-generation freeze dried plasma product has shown safety in an early phase clinical trial and other freeze-dried plasma and spray-dried plasma with promising pre-clinical profiles are embarking in first-in-human trials. New platelet additive solutions and forms of cryopreservation or lyophilization of platelets with long-term shelf-life have demonstrated feasibility and logistical advantages. Recent trials have confirmed logistical advantages of modified plasma and platelet products in the treatment or prophylaxis of bleeding. However, their postulated increased potency profile remains unconfirmed.
影响因子：
2.9
作者：
Booth GS;Lozier JN;Nghiem K;Clibourn D;Klein HG;Flegel WA
通讯作者：
Flegel WA