Jiang Libing, Jiang Shouyin, Feng Xia, Ma Yuefeng, Zhang Mao
Department of Emergency Medicine, Second Affiliated Hospital, School of Medicine & Institute of emergency Medicine, Zhejiang University, Hangzhou, China.
The Second Department of Respiration, Affiliated Hospital of Zunyi Medical College, Zunyi, Guizhou, China.
BMJ Open. 2014 Dec 22;4(12):e006770. doi: 10.1136/bmjopen-2014-006770.
Sepsis is the leading cause of mortality in non-cardiological critically ill patients. There are as many as 20 million cases of sepsis annually worldwide, with a mortality rate of around 35%. It has been reported that the dysregulation of haemostatic system due to the interaction between coagulation system and inflammatory response is a strong predictor of mortality in patients with severe sepsis. In this context, several anticoagulants have been evaluated in recent years. However, the results of these studies were inconsistent and even contradictory. In addition, there is insufficient evidence comparing the efficacy and safety of different anticoagulants. The purpose of our study is to carry out a systematic review and network meta-analysis comparing the efficacy and safety of different anticoagulants for severe sepsis based on existing randomised controlled trials (RCTs) and ranking these anticoagulants for practical consideration.
PubMed, EMBASE and Cochrane Library databases will be systematically searched for eligible studies. Randomised controlled trials (RCT) on anticoagulant therapy for severe sepsis with multiple outcome measures will be included. The Cochrane Risk of Bias Tool will be used to assess the quality of included studies. The primary outcomes are mortality and bleeding events. The secondary outcomes include the length of intensive care stay, the length of hospital stay and duration of mechanical ventilation. Direct pairwise meta-analysis (DMA), indirect treatment comparison meta-analysis (ITC) and network meta-analysis (NMA) will be conducted to compare different anticoagulants.
Ethical approval is not required given that this is a protocol for a systematic review. The protocol of this systematic review will be disseminated in a peer-reviewed journal and presented at a relevant conference.
This protocol has been registered in PROSPERO (http://www.crd.york.ac.uk/PROSPERO/) under registration number CRD42014013886.
脓毒症是非心脏科重症患者死亡的主要原因。全球每年有多达2000万例脓毒症病例，死亡率约为35%。据报道，凝血系统与炎症反应相互作用导致的止血系统失调是严重脓毒症患者死亡的有力预测指标。在此背景下，近年来对几种抗凝剂进行了评估。然而，这些研究结果并不一致，甚至相互矛盾。此外，比较不同抗凝剂疗效和安全性的证据不足。我们研究的目的是基于现有的随机对照试验（RCT），对不同抗凝剂治疗严重脓毒症的疗效和安全性进行系统评价和网状Meta分析，并对这些抗凝剂进行排序以供实际参考。
将系统检索PubMed、EMBASE和Cochrane图书馆数据库以获取符合条件的研究。纳入关于多种结局指标的严重脓毒症抗凝治疗的随机对照试验（RCT）。将使用Cochrane偏倚风险工具评估纳入研究的质量。主要结局是死亡率和出血事件。次要结局包括重症监护住院时间、住院时间和机械通气持续时间。将进行直接成对Meta分析（DMA）、间接治疗比较Meta分析（ITC）和网状Meta分析（NMA）以比较不同的抗凝剂。
鉴于这是一项系统评价方案，无需伦理批准。本系统评价方案将在同行评审期刊上发表，并在相关会议上展示。
本方案已在PROSPERO（http://www.crd.york.ac.uk/PROSPERO/）注册，注册号为CRD42014013886。
