Fariborz Farsad Bahram, Golpira Reza, Najafi Hamideh, Totonchi Ziae, Salajegheh Shirin, Bakhshandeh Hooman, Hashemian Farshad
Rajaie Cardiovascular, Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran.
Department of Clinical Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University.
Iran J Pharm Res. 2015 Summer;14(3):877-85.
Fresh frozen plasma (FFP) and prothrombin complex concentrate (PCC) reverse oral anticoagulants such as Warfarin. We compared the standard dosage of FFP and PCC in terms of efficacy and safety for patients with mechanical heart valves undergoing interventional procedures while receiving Warfarin. Fifty patients were randomized (25 for each group) with mechanical heart valves [international normalized ratio (INR) >2.5]. FFP dosage was administered based on body weight (10-15 mL/Kg), while PCC dosage was administered based on both body weight and target INR. INR measurements were obtained at different time after PCC and FFP infusion. The mean ± SD of INR pre treatment was not significantly different between the PCC and FFP groups. However, over a 48-hour period following the administration of PCC and FFP, 76% of the patients in the PCC group and only 20% of the patients in the FFP group reached the INR target. Five (20%) patients in the PCC group received an additional dose of PCC, whereas 17 (68%) patients in the FFP group received a further dose of FFP (P=0.001). There was no significant difference between the two groups in Hb and Hct before and during a 48-hour period after PCC and FFP infusion. As regards safety monitoring and adverse drug reaction screening in the FFP group, the INR was high (INR > 2.5) in 86% of the patients. There was no report of hemorrhage in both groups. PCC reverses anticoagulation both effectively and safely while having the advantage of obviating the need to extra doses.
新鲜冰冻血浆（FFP）和凝血酶原复合物浓缩剂（PCC）可逆转华法林等口服抗凝剂的作用。我们比较了FFP和PCC的标准剂量对接受华法林治疗的机械心脏瓣膜患者进行介入手术时的有效性和安全性。50例机械心脏瓣膜患者[国际标准化比值（INR）>2.5]被随机分组（每组25例）。FFP剂量根据体重（10 - 15 mL/Kg）给药，而PCC剂量根据体重和目标INR给药。在输注PCC和FFP后的不同时间测量INR。PCC组和FFP组治疗前INR的平均值±标准差无显著差异。然而，在给予PCC和FFP后的48小时内，PCC组76%的患者达到INR目标，而FFP组只有20%的患者达到该目标。PCC组有5例（20%）患者接受了额外剂量的PCC，而FFP组有17例（68%）患者接受了额外剂量的FFP（P = 0.001）。在输注PCC和FFP后的48小时内，两组的血红蛋白（Hb）和血细胞比容（Hct）在治疗前后无显著差异。关于FFP组的安全监测和药物不良反应筛查，86%的患者INR较高（INR > 2.5）。两组均未报告出血情况。PCC既能有效又安全地逆转抗凝作用，同时具有无需额外给药的优势。
