Abbas Mohamed Sayed
Department of Anesthesia, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Indian J Crit Care Med. 2017 Jul;21(7):419-423. doi: 10.4103/ijccm.IJCCM_23_17.
Critically ill patients are considered a high-risk group for developing venous thromboembolism (VTE). Due to their impaired cardiopulmonary reserve, these VTEs may result in significant morbidity and mortality. In this study, we compared two types of low molecular weight heparin, enoxaparin, and bemiparin, as regards to their efficacy and safety in VTE prevention among Intensive Care Unit (ICU) patients.
This study was a prospective, randomized trial of 100 critically ill patients who are at high risk for developing VTE were included in this study and assigned to receive subcutaneous injections of either 3500 international units (IU) anti-factor Xa of bemiparin sodium or 40 mg of enoxaparin given once a day and patient were followed for 60 days after initiation of anticoagulant therapy for the development of documented deep venous thrombosis (DVT) using bilateral lower limb venous duplex, documented pulmonary embolism using computed tomography pulmonary angiography, and complications related to injectant anticoagulant.
Confirmed DVT was observed in two patients (4%) in the bemiparin group compared with 10 patients (20%) in the enoxaparin group with < 0.05. Confirmed pulmonary embolism (PE) was observed in seven patients (14%) in the enoxaparin group with no recorded cases of confirmed PE in the bemiparin group ( < 0.05). No deaths were recorded in either group. Adverse events such as ecchymosis or hematoma at the injection site were observed in one patient (2%) in the bemiparin group and eight patients (16%) in the enoxaparin group ( < 0.05). There was no significant statistical difference between both groups as regards other adverse effects and complications related to the injectant anticoagulant.
Bemiparin was superior to enoxaparin as a prophylactic anticoagulant for VTE in critically ill patients with less adverse local complications at the injection site. The study was registered on www.clinicaltrials.gov. Registration ID: NCT02795065. Registered June 8, 2016.
重症患者被视为发生静脉血栓栓塞症(VTE)的高危人群。由于他们心肺储备功能受损,这些VTE可能导致显著的发病率和死亡率。在本研究中,我们比较了两种低分子量肝素,依诺肝素和贝米肝素,在重症监护病房(ICU)患者预防VTE方面的疗效和安全性。
本研究是一项前瞻性随机试验,纳入了100名发生VTE高危的重症患者,将其分配接受皮下注射3500国际单位(IU)抗Xa因子的贝米肝素钠或40毫克依诺肝素,每天一次,并在开始抗凝治疗后对患者随访60天,使用双侧下肢静脉超声检查记录深静脉血栓形成(DVT),使用计算机断层扫描肺动脉造影记录肺栓塞,以及记录与注射用抗凝剂相关的并发症。
贝米肝素组有2例患者(4%)确诊为DVT,依诺肝素组有10例患者(20%)确诊为DVT,差异<0.05。依诺肝素组有7例患者(14%)确诊为肺栓塞(PE),贝米肝素组无确诊PE病例记录(差异<0.05)。两组均无死亡记录。贝米肝素组有1例患者(2%)出现注射部位瘀斑或血肿等不良事件,依诺肝素组有8例患者(16%)出现此类不良事件(差异<0.05)。两组在与注射用抗凝剂相关的其他不良反应和并发症方面无显著统计学差异。
作为重症患者VTE的预防性抗凝剂,贝米肝素优于依诺肝素,且注射部位局部不良并发症较少。本研究已在www.clinicaltrials.gov上注册。注册号:NCT02795065。注册日期:2016年6月8日。