Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh 160012, India.
Respir Care. 2010 Jul;55(7):901-10.
Activated protein C reduces 28-day mortality in patients with severe sepsis, but its anticoagulant properties entail a risk of bleeding.
The aim of this systematic review was to evaluate the prevalence of serious bleeding events in patients receiving activated protein C.
We searched the MEDLINE and EMBASE databases for studies that described the prevalence of serious bleeding events and intracranial hemorrhage in patients receiving activated protein C. We calculated the bleeding rates by calculating proportions and 95% CIs for each study, and then pooled the data to derive a pooled proportion and 95% CI.
Our search yielded 17 studies, which included 10,679 patients. The occurrence of serious bleeding events in patients receiving activated protein C ranged from 0.5% to 9.6%, and the pooled prevalence was 3.3% (95% CI 2.4-4.4%) by the random effects model. The occurrence of intracranial hemorrhage ranged from 0% to 1.4%, and the pooled prevalence was 0.44% (95% CI 0.31-0.6%). Sensitivity analysis showed a higher prevalence of bleeding in the observational studies than in the randomized controlled trials. There was substantial clinical and statistical heterogeneity, but no evidence of publication bias.
Activated protein C is associated with significant risk of bleeding, so strict inclusion and exclusion criteria should be set prior to administering activated protein C.
活化蛋白 C 可降低严重脓毒症患者的 28 天死亡率，但它的抗凝特性会带来出血风险。
本系统评价旨在评估接受活化蛋白 C 治疗的患者发生严重出血事件的发生率。
我们检索了 MEDLINE 和 EMBASE 数据库，以获取描述接受活化蛋白 C 治疗的患者严重出血事件和颅内出血发生率的研究。我们通过计算每个研究的比例和 95%置信区间来计算出血率，然后汇总数据得出合并比例和 95%置信区间。
我们的检索结果共 17 项研究，纳入了 10679 名患者。接受活化蛋白 C 治疗的患者发生严重出血事件的发生率为 0.5%至 9.6%，随机效应模型得出的合并发生率为 3.3%（95%CI 2.4-4.4%）。颅内出血的发生率为 0%至 1.4%，合并发生率为 0.44%（95%CI 0.31-0.6%）。敏感性分析显示，观察性研究中的出血发生率高于随机对照试验。存在较大的临床和统计学异质性，但无发表偏倚的证据。
活化蛋白 C 与出血风险显著相关，因此在给予活化蛋白 C 之前应制定严格的纳入和排除标准。
