Imputabilité d’une mise en jeu du pronostic vital à un inhibiteur spécifique de la thrombine

We present the case of a 73-year-old man, operated on for paralyzing sciatica, who displayed acute postoperative respiratory distress and intra-alveolar haemorrhage following the administration of dabigatran etexilate, a new oral antithrombin used in the prevention of venous thromboembolism. This serious incident occurred in a patient who had a 20-year history of chronic thrombocytopenia (platelet level at 100 G/l) and a heparin-induced thrombocytopenia and in whom no other aetiology was found (tuberculosis, pneumorenal syndrome, etc.). The postoperative prevention of thromboembolic events in a patient with high risk bleeding requires intensive monitoring, notably, when prescribing new drugs such as new anticoagulant agents.     

达比加群酯对非瓣膜性房颤患者抗凝治疗效果及安全性的Meta分析

目的评价达比加群酯对非瓣膜性房颤患者抗凝治疗的效果及安全性。方法检索有关达比加群酯对非瓣膜性房颤患者抗凝治疗的随机对照试验及多中心对照研究等文献,并进行质量评估,采用RevMan 5.2对符合条件的研究进行Meta分析,评价达比加群酯对非瓣膜性房颤患者的抗凝效果及安全性。结果符合纳入标准的文献共7篇(中文1篇,英文6篇),总样本量为33 502例。Meta分析显示,与华法林比较,达比加群酯明显降低房颤患者脑卒中发生率(OR=0.82,95%CI 0.73⁰.93,P=0.001)、全因出血率(OR=0.86,95%CI 0.790.93,P=0.001)、全因出血率(OR=0.86,95%CI 0.79⁰.95,P=0.003)及颅内出血发生率(OR=0.42,95%CI 0.290.95,P=0.003)及颅内出血发生率(OR=0.42,95%CI 0.29⁰.62,P=0.001);而动脉栓塞率(OR=0.75,95%CI 0.450.62,P=0.001);而动脉栓塞率(OR=0.75,95%CI 0.45¹.25,P=0.28)及全因死亡率(OR=0.91,95%CI 0.821.25,P=0.28)及全因死亡率(OR=0.91,95%CI 0.82¹.00,P=0.06)无明显差异。结论达比加群酯可有效降低房颤患者脑卒中、全因出血及颅内出血的风险,疗效优于传统药物华法林且安全性高。     

甲磺酸达比加群酯胶囊微生物限度检查方法的建立

目的探讨建立甲磺酸达比加群酯胶囊的微生物限度检查的方法。方法依据《中国药典》2010年版(二部)收载的微生物限度检查法应用指导原则进行方法学验证试验。结果试验表明甲磺酸达比加群酯胶囊对枯草芽孢杆菌和金黄色葡萄球菌具有较强的抑制作用。结论推荐采用薄膜过滤法进行本品的细菌计数;采用常规检验方法进行真菌及酵母菌计数和控制菌检查。     

Italian intersociety consensus statement on antithrombotic prophylaxis in hip and knee replacement and in femoral neck fracture surgery

Anticoagulant prophylaxis for preventing venous thromboembolism (VTE) is a worldwide established procedure in hip and knee replacement surgery, as well as in the treatment of femoral neck fractures (FNF). Different guidelines are available in the literature, with quite different recommendations. None of them is a multidisciplinary effort as the one presented. The Italian Society for Studies on Haemostasis and Thrombosis (SISET), the Italian Society of Orthopaedics and Traumatology (SIOT), the association of Orthopaedists and Traumatologists of Italian Hospitals (OTODI), together with the Italian Society of Anesthesia, Analgesia, Resuscitation, and Intensive Care (SIAARTI) have set down easy and quick suggestions for VTE prophylaxis in hip and knee surgery as well as in FNF treatment. This inter-society consensus statement aims at simplifying the grading system reported in the literature, and its goal is to benefit its clinical application. Special focus is given to fragile patients, those with high bleeding risk, and those receiving chronic antiplatelet (APT) and vitamin K antagonists treatment. A special chapter is dedicated to regional anaesthesia and VTE prophylaxis.     

80岁以上非瓣膜性心房颤动患者抗凝方案的调查研究

背景　目前80岁以上非瓣膜性心房颤动患者的抗凝治疗比例普遍偏低,这类人群的抗凝实际情况与指南存在较大差距,抗凝方案的选择缺乏临床证据。目的　调查80岁以上非瓣膜性心房颤动住院患者抗凝方案的选择及预后情况。方法　从HIS系统筛选2016年9月-2018年9月浙江中医药大学附属第二医院首次诊断非瓣膜性心房颤动或既往诊断但未进行抗凝治疗的80岁以上患者516例为研究对象,根据出院时抗凝治疗方案不同将患者分为华法林组、利伐沙班组、达比加群酯组、不抗凝组。收集患者性别、年龄、吸烟史、合并疾病〔高血压、糖尿病、冠状动脉疾病、心肌病、心力衰竭、慢性阻塞性肺疾病（COPD）〕、心房颤动类型（持续性心房颤动、阵发性心房颤动、永久性心房颤动）、缺血性脑卒中史、出血史、估算肾小球滤过率（eGFR）、卒中风险评分（CHA2DS2-VASc评分）、出血风险评分（HAS-BLED评分）、抗凝治疗时间、抗血小板药物应用情况、不良反应（出血事件、缺血性脑卒中、出血性脑卒中、死亡）等情况。采用二元Logistic回归分析探讨患者出现死亡、缺血性脑卒中、出血事件的影响因素。结果　516例患者中接受抗凝治疗137例（26.6%）,其中口服华法林21例（4.1%）、口服利伐沙班67例（13.0%）、口服达比加群酯49例（9.5%）;不抗凝治疗患者379例（73.5%）,其中应用单药抗血小板266例（51.6%）、应用双联抗血小板药物53例（10.3%）、未应用抗血小板药物60例（11.6%）。4组患者性别、年龄、吸烟史、合并疾病（高血压、糖尿病、冠状动脉疾病、心肌病、心力衰竭、COPD）、缺血性脑卒中史、出血史、eGFR、CHA2DS2-VASc评分、HAS-BLED评分、出血（轻度、中度、严重）、出血性脑卒中发生率比较,差异均无统计学意义（P>0.05）。4组患者缺血性脑卒中发生率及死亡率比较,差异均有统计学意义（P<0.05）。华法林组、利伐沙班组、达比加群酯组抗凝治疗时间比较,差异无统计学意义（P>0.05）。二元Logistic回归分析结果显示,CHA2DS2-VASc评分、抗凝治疗方案是缺血性脑卒中的影响因素（P<0.05）,抗凝治疗方案是患者发生死亡事件的影响因素（P<0.05）,HAS-BLED评分是患者发生出血事件的影响因素（P<0.05）。结论　80岁以上非瓣膜性心房颤动患者抗凝治疗比例较低。不抗凝治疗（包括口服抗血小板药物）增加了患者死亡、缺血性卒中风险,而华法林与新型口服抗凝药相比同样安全有效,未增加出血及死亡风险。