College of Pharmacy, University of Arizona, Phoenix, AZ, USA.
Ann Pharmacother. 2011 Jul;45(7-8):990-9. doi: 10.1345/aph.1Q096. Epub 2011 Jul 5.
To review the evidence supporting the use of prothrombin complex concentrate (PCC) as a hemostatic agent in individuals without hemophilia.
Articles were identified through a search of Ovid/MEDLINE (up to April 2011) and Cochrane Central Register of Controlled Trials (up to April 2011). The search terms used were prothrombin complex concentrate, hemorrhage, and bleeding.
The search was limited to comparative studies. Bibliographies of retrieved articles were reviewed to obtain additional articles. The intent of the search was to identify original research comparing PCC to fresh frozen plasma (FFP) or recombinant factor VIIa for the management of bleeding in patients without hemophilia.
PCCs are recommended as an alternative to FFP and recombinant factor VIIa for the treatment of serious or life-threatening bleeding related to vitamin K antagonist therapy. Studies in this setting have shown that PCCs are safe and effective and provide prompt reduction of international normalized ratio (INR) compared to FFP. However, most trials are uncontrolled, and the primary outcomes in these studies have been INR reduction rather than hemostatic effect. Other common off-label uses include coagulopathy due to hepatic failure and traumatic hemorrhage; however, there is insufficient evidence to support use of PCC in these settings. Advantages of PCC include the low drug volume required compared to FFP. The use of PCC may be associated with thromboembolic complications.
PCC is a safe and effective alternative to FFP and provides rapid reversal of INR in patients on vitamin K antagonist therapy. These agents may be advantageous compared to FFP in patients with volume restrictions. Comparative trials are needed to compare the various PCC products, FPP, and recombinant factor VIIa with regard to clinically significant outcomes such as hemostatic effect.
综述促凝血酶原复合物浓缩物（PCC）作为非血友病患者止血剂的应用证据。
通过在 Ovid/MEDLINE（截至 2011 年 4 月）和 Cochrane 对照试验中心注册库（截至 2011 年 4 月）进行检索，确定相关文章。检索词为促凝血酶原复合物浓缩物、出血和出血。
检索仅限于比较性研究。对检索到的文章的参考文献进行了综述，以获取更多的文章。检索的目的是确定比较 PCC 与新鲜冷冻血浆（FFP）或重组因子 VIIa 治疗非血友病患者出血的原始研究。
推荐 PCC 替代 FFP 和重组因子 VIIa 治疗与维生素 K 拮抗剂治疗相关的严重或危及生命的出血。该治疗方案的研究表明，PCC 安全有效，与 FFP 相比，可迅速降低国际标准化比值（INR）。然而，大多数试验为非对照研究，这些研究的主要终点为 INR 降低，而非止血效果。其他常见的适应证还包括肝衰竭和创伤性出血引起的凝血功能障碍；然而，目前尚缺乏支持在这些情况下应用 PCC 的证据。与 FFP 相比，PCC 的优势在于所需药物剂量低。使用 PCC 可能与血栓栓塞并发症相关。
PCC 是维生素 K 拮抗剂治疗患者安全有效的 FFP 替代物，可迅速逆转 INR。与 FFP 相比，这些药物在有容量限制的患者中可能具有优势。需要开展比较性试验，比较不同 PCC 产品、FFP 和重组因子 VIIa 对有临床意义的结局（如止血效果）的影响。
