导语：
在临床实践中，药品短缺问题日益严重，尤其是某些无可替代的药品，如鱼精蛋白。本文将为您介绍一项关于心肺旁路（CPB）术后肝素逆转的新型固定剂量鱼精蛋白方案的研究，探讨其在节省药品资源的同时，是否具有与传统比例剂量方案相似的效果。
一、研究背景
鱼精蛋白是一种用于逆转肝素抗凝作用的药物，但在临床实践中，其供应不足的问题时有发生。传统的鱼精蛋白剂量计算方法是基于肝素比例的，这可能导致鱼精蛋白的过量使用，从而增加潜在的危害。本研究旨在探讨一种固定剂量（250mg）的鱼精蛋白方案是否与传统1:1（1mg鱼精蛋白对应100U肝素）比例剂量方案在肝素逆转效果上具有可比性，并实现鱼精蛋白的节约。
二、研究方法
本研究为一项单中心、双盲的随机对照试验。纳入符合条件的成年心脏手术患者，分为固定剂量组（250mg鱼精蛋白）和比例剂量组（1mg:100U肝素）。主要观察指标为首次鱼精蛋白给药后的活化凝血时间（ACT），次要观察指标包括总鱼精蛋白用量、额外鱼精蛋白需求量以及术后24小时胸腔引流管累计引流量。
三、研究结果
共有125例患者参与研究，其中固定剂量组62例，比例剂量组63例。两组患者给药后的平均ACT值差异无统计学意义。固定剂量组每例患者的总鱼精蛋白用量较比例剂量组显著降低（2.1个50mg安瓿，P<0.0001）。两组患者术后24小时胸腔引流管累计引流量差异无统计学意义。
四、研究结论
与传统1:1肝素比例剂量方案相比，固定250mg鱼精蛋白剂量方案在肝素逆转效果上并无显著差异，且能显著降低鱼精蛋白的总用量，对术后胸腔引流管引流量无影响。这为临床实践中节省鱼精蛋白资源提供了一种可行的方案。
总结：
在药品短缺的背景下，本研究为心肺旁路术后肝素逆转提供了一种新型固定剂量鱼精蛋白（250mg）方案。该方案在确保疗效的同时，有助于节约宝贵药品资源，具有一定的临床推广价值。
原文摘要
Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass: A Double-Blinded Prospective Randomized Control Trial Comparing Two Strategies
Background: Drug shortages are a frequent challenge in current clinical practice. Certain drugs, (e.g., protamine) lack alternatives and inadequate supplies can limit access to services. Conventional protamine dosing uses heparin ratio-based calculations for heparin reversal following CPB and may result in excess protamine utilization, and potential harm due to its intrinsic anticoagulation. We hypothesized that a fixed 250-mg protamine dose would be comparable, as measured by the activated clotting time, to a 1:1 (1 mg for every 100 U) protamine to heparin ratio-based strategy for heparin reversal and that protamine would be conserved.
Methods: In a single-center, double-blinded trial, consenting elective adult cardiac surgical patients without pre-existing coagulopathy or ongoing anticoagulation, and a calculated initial heparin dose of ≥ 27500 U were randomized to receive, following CPB, protamine as a fixed dose (250 mg) or a ratio-based dose (1 mg:100 U heparin). The primary outcome was the activated clotting time following initial protamine administration, assessed by Student's t-test. Secondary outcomes included total protamine, the need for additional protamine, and the cumulative 24-h chest tube output.
Results: There were 62 and 63 patients in the fixed- and ratio-based dose groups, respectively. The mean post-protamine ACT was not different between groups (-2.0 s, 95% CI -7.2 to 3.3 s, P = 0.47). Less total protamine per case was administered in the fixed-dose group (2.1 50-mg vials, 95% CI -2.4 to -1.8, P < 0.0001). There was no difference in the cumulative 24-h chest tube output (difference = -77 ml, 95% CI 220 to 65 ml, P = 0.28).
Conclusions: A 1: 1 heparin ratio-based protamine dosing strategy compared to a fixed 250-mg dose resulted in the administration of a larger total dose of protamine no difference in either the initial ACT or the amount postoperative chest-tube bleeding.
注意：
上述内容仅供参考，如有错误欢迎批评指正，以临床医疗实际为准！
