Department of Pharmacy Services, University Medical Center, Tucson, AZ, USA.
Ann Pharmacother. 2012 Jan;46(1):51-6. doi: 10.1345/aph.1Q588. Epub 2011 Dec 20.
Three-factor prothrombin complex concentrate (PCC) is commonly used for reversal of international normalized ratio (INR) in patients who are bleeding or require emergency surgery. However, there is little information regarding the optimal dosing strategy for achieving adequate INR reversal.
To determine whether patients with higher initial INR levels are less likely to achieve adequate INR reversal after receiving 3-factor PCC.
A retrospective cohort study was conducted in a tertiary care medical center in the US. Patients who received 3-factor PCC were grouped into 2 categories based on degree of INR reversal after PCC infusion: (1) adequate reversal (final INR ≤1.5) or (2) inadequate reversal (final INR >1.5). Initial INR was compared between the 2 groups using the Wilcoxon rank-sum test. A multivariate logistic regression analysis was used to adjust for confounders and determine predictors of adequate INR reversal.
Fifty patients met criteria for inclusion in the final analyses. Of these, 58% achieved adequate reversal after PCC. There were no significant differences in patient demographics or in vitamin K or fresh frozen plasma (FFP) use between the 2 groups. Median PCC dose was also similar between the adequate and inadequate reversal groups (25.2 vs 24.5 units/kg, respectively; p = 0.2). The group that did not achieve adequate reversal had a significantly higher initial INR (3.5 vs 2.5, p = 0.012) prior to PCC administration. In the multivariate logistic regression analysis, initial INR was a significant predictor of adequate INR reversal (ie, reversal less likely as INR increases) after adjusting for PCC dose and concurrent use of vitamin K or FFP (OR = 0.38; 95% CI 0.17 to 0.87; p = 0.02).
Patients with a higher initial INR are less likely to achieve adequate INR reversal after receiving 3-factor PCC and may require higher doses than were used in the study.
三因子凝血酶原复合物浓缩物（PCC）常用于逆转国际标准化比值（INR）在出血或需要紧急手术的患者。然而，关于达到足够 INR 逆转的最佳剂量策略的信息很少。
确定初始 INR 水平较高的患者在接受三因子 PCC 后是否不太可能达到足够的 INR 逆转。
在美国的一家三级护理医疗中心进行了回顾性队列研究。根据 PCC 输注后 INR 的逆转程度，将接受三因子 PCC 的患者分为 2 组：（1）充分逆转（最终 INR≤1.5）或（2）不充分逆转（最终 INR>1.5）。使用 Wilcoxon 秩和检验比较两组之间的初始 INR。使用多变量逻辑回归分析调整混杂因素并确定充分 INR 逆转的预测因素。
50 名患者符合最终分析标准。其中，58%在接受 PCC 后实现了充分的逆转。两组患者的人口统计学特征或维生素 K 或新鲜冷冻血浆（FFP）的使用无显著差异。充分和不充分逆转组的 PCC 剂量中位数也相似（分别为 25.2 和 24.5 单位/公斤，p=0.2）。在接受 PCC 治疗前，未达到充分逆转的组初始 INR 显著更高（3.5 与 2.5，p=0.012）。在多变量逻辑回归分析中，调整 PCC 剂量和同时使用维生素 K 或 FFP 后，初始 INR 是充分 INR 逆转的显著预测因素（即 INR 升高时逆转可能性降低）（OR=0.38；95%CI 0.17 至 0.87；p=0.02）。
接受三因子 PCC 后，初始 INR 较高的患者不太可能达到充分的 INR 逆转，并且可能需要比研究中使用的更高剂量。
