肥胖和非肥胖的危及生命出血或需要紧急手术患者中4F-PCC的比较。
Comparison of 4F-PCC in obese and nonobese patients with life-threatening bleeding or requiring emergent surgery.
作者信息
Rimsans Jessica, Berger Karen, Culbreth Sarah, Hood Christopher, Chester Katleen, Connors Jean M, Omert Laurel
机构信息
Department of Pharmacy Services Brigham and Women's Hospital Boston Massachusetts USA.
Department of Pharmacy NewYork-Presbyterian Hospital/Weill Cornell Medical Center New York New York USA.
出版信息
Res Pract Thromb Haemost. 2021 Nov 26;5(8):e12624. doi: 10.1002/rth2.12624. eCollection 2021 Dec.
BACKGROUND
Four-factor prothrombin complex concentrate (4F-PCC) dosing is based on INR and actual body weight (ABW), with maximum doses not to exceed the dose used in patients weighing >100 kg (Kcentra PI). There are limited data comparing the efficacy of 4F-PCC between patients with low body weight ≤100 kg (LoWT) and high body weight >100 kg (HiWT).
METHODS
We conducted a retrospective cohort study of patients on warfarin who received 4F-PCC for life-threatening major bleeding or requiring emergent surgery between January 2015 to June 2018 at three academic medical centers. These data were combined with a dataset from 2 randomized Phase 3b clinical trials.
RESULTS
We included 388 patients who received 4F-PCC, 318 (82%) were LoWT, and 70 (18%) were HiWT. Indication for 4F-PCC for life-threatening bleeding and emergent surgery was 266 (69%) and 122 (31%) patients, respectively. The most common bleeding type was intracranial hemorrhage (41%), followed by gastrointestinal (36%). The median dose was 2283 units (25 units/kg), and 2.1% of patients required a repeat dose.
CONCLUSION
In those >100 kg, we found no difference in achieving international normalized ratio (INR) ≤1.3, hemostasis in intracranial hemorrhage, or thrombosis. In-hospital mortality occurred 15% in LoWt versus 6% in HiWT (CI 1.8%-17%, = 0.034). Achievement of INR ≤ 1.5 was significantly lower in the LoWT group compared to the HiWT group (80% versus 91%, CI -20% to -2.5%, = 0.03).
背景
四因子凝血酶原复合物浓缩剂（4F-PCC）的剂量是基于国际标准化比值（INR）和实际体重（ABW）来确定的，最大剂量不得超过体重>100 kg患者所使用的剂量（Kcentra药品说明书）。关于体重≤100 kg的低体重（LoWT）患者和体重>100 kg的高体重（HiWT）患者使用4F-PCC的疗效对比数据有限。
方法
我们对2015年1月至2018年6月期间在三家学术医疗中心接受4F-PCC治疗的华法林治疗患者进行了一项回顾性队列研究，这些患者因危及生命的严重出血或需要紧急手术而接受治疗。这些数据与来自2项随机3b期临床试验的数据集相结合。
结果
我们纳入了388例接受4F-PCC治疗的患者，其中318例（82%）为低体重患者，70例（18%）为高体重患者。因危及生命的出血和紧急手术而使用4F-PCC的患者分别为266例（69%）和122例（31%）。最常见的出血类型是颅内出血（41%），其次是胃肠道出血（36%）。中位剂量为2283单位（25单位/千克），2.1%的患者需要重复给药。
结论
在体重>100 kg的患者中，我们发现在使国际标准化比值（INR）≤1.3、颅内出血止血或血栓形成方面没有差异。低体重患者的院内死亡率为15%，而高体重患者为6%（可信区间1.8%-17%，P = 0.034）。与高体重组相比，低体重组达到INR≤1.5的比例显著更低（80%对91%，可信区间-20%至-2.5%，P = 0.03）。
Zotero 插件