血凝酶对老年髋部骨折半关节置换术患者凝血功能改善及出血减少的影响：一项前瞻性、单盲、随机对照研究。

The impact of hemocoagulase for improvement of coagulation and reduction of bleeding in fracture-related hip hemiarthroplasty geriatric patients: A prospective, single-blinded, randomized, controlled study.

作者信息

Qiu Meiguang, Zhang Xuming, Cai Hongru, Xu Zhixian, Lin Hao

机构信息

Department of Surgery, Fujian Provincial Hospital Emergency Center; Provincial Clinical College of Fujian Medical University; Fujian Provincial Emergency Medicine Institute, Fuzhou, China.

出版信息

Injury. 2017 Apr;48(4):914-919. doi: 10.1016/j.injury.2016.11.028. Epub 2016 Nov 27.

DOI:10.1016/j.injury.2016.11.028

PMID:28238301

Abstract

BACKGROUND

Uncontrolled bleeding is associated with poor outcomes and mortality in geriatric patients undergoing hemiarthroplasty. Hemocoagulase agkistrodon is a hemocoagulative, anti-hemorrhagic enzyme complex from Deinagkistrodon acutus snake venom. This study aimed to investigate the efficacy of hemocoagulase agkistrodon on coagulation and bleeding outcomes in fracture-related hemiarthroplasty.

PATIENTS AND METHODS

This was a prospective, single-blinded, randomized controlled trial carried out between October 2013 and September 2014 in 96 geriatric patients undergoing hemiarthroplasty for unilateral femoral neck fracture. Patients were administrated hemocoagulase agkistrodon (n=48) or normal saline (n=48). Intraoperative blood loss, transfusion volume and rate, and drainage were assessed. Hemoglobin (Hb) and coagulation parameters (prothrombin time [PT], thrombin time [TT], plasma fibrinogen [FIB], and activated partial thromboplastin time [aPTT]) were recorded preoperatively and 30min and 1, 3, and 5days after surgery. Complications were followed up for 4 weeks.

RESULTS

Compared to controls, hemocoagulase patients exhibited lower intraoperative blood loss (P<0.01) and postoperative blood loss, total drainage, mean transfusion volume, and transfusion rates (all P<0.05), with lower aPTT at 30min (P<0.05). No significant differences in postoperative FIB were observed. Controls exhibited significantly higher PP and TT on day 1, and Hb on days 1, 3, and 5 (P<0.05). No serious complications were reported.

CONCLUSIONS

Hemocoagulase reduced blood loss and transfusion in fracture-related hip hemiarthroplasty without increasing short-term adverse event rates. In geriatric populations, hemocoagulase could be used for limiting bleeding and related complications.

TRIAL REGISTRATION

This trial is registered in the Chinese Clinical Trial Register (no. ChiCTR-TRC-14004379).

摘要

背景

在接受半髋关节置换术的老年患者中，出血控制不佳与不良预后和死亡率相关。尖吻蝮蛇血凝酶是一种从尖吻蝮蛇毒中提取的促凝血、抗出血酶复合物。本研究旨在探讨尖吻蝮蛇血凝酶在骨折相关半髋关节置换术中对凝血和出血结局的疗效。

患者与方法

这是一项前瞻性、单盲、随机对照试验，于2013年10月至2014年9月对96例因单侧股骨颈骨折接受半髋关节置换术的老年患者进行。患者被给予尖吻蝮蛇血凝酶（n = 48）或生理盐水（n = 48）。评估术中失血量、输血量和输血率以及引流量。记录术前、术后30分钟以及术后1、3和5天的血红蛋白（Hb）和凝血参数（凝血酶原时间[PT]、凝血酶时间[TT]、血浆纤维蛋白原[FIB]和活化部分凝血活酶时间[aPTT]）。对并发症进行4周的随访。

结果

与对照组相比，使用尖吻蝮蛇血凝酶的患者术中失血量更低（P < 0.01），术后失血量、总引流量、平均输血量和输血率也更低（均P < 0.05），术后30分钟时aPTT更低（P < 0.05）。术后FIB未观察到显著差异。对照组在术后第1天的PT和TT以及术后第1、3和5天的Hb显著更高（P < 0.05）。未报告严重并发症。