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2012 版儿童严重脓毒症与脓毒性休克治疗国际指南解读 2012版指南采用GRADE分级系统 GRADE分级系统由推荐等级与证据强度两部分构成 推荐等级 1级——推荐(recomment):指该措施有着良好的预期效果和经济效益。 2级——建议(suggest):指该措施可能有不可预知的不良反应和较低的经济效益 证据强度分级 A级(强) 高质量随机对照研究 B级(中等) 中等质量随机对照或高质量观察性及队列研究 C级(弱) 完成良好、设对照的观察性及队列研究 D级(极弱) 病例总结或专家意见 Part G Protein C and activated protein concentrate G. Protein C and activated protein concentrate. 蛋白C和活化蛋白浓缩物 指南中在儿童及成人均不推荐使用(已退市) See “History of recommendations regarding use of recombinant activated protein C” . 参照“关于重组活化蛋白C(rhAPC)使用的旧版推荐” Recombinant human activated protein C (rhAPC) was approved for use in adult patients in a number of countries in 2001 following the Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) trial, which enrolled 1,690 severe sepsis patients and showed a significant reduction in mortality (24.7 %) with rhAPC compared with placebo (30.8 %, P = 0.005) . Part G Protein C and activated protein concentrate 2001年一些国家根据PROWESS研究结果开始批准重组活化蛋白(rhAPC)应用于成人。 PROWESS研究一共收集了1690例严重脓毒症病例,证实rhAPC相对安慰剂可以明显降低严重脓毒症患者死亡率(24.7 %vs. 30.8 %, P = 0.005)。 Part G Protein C and activated protein concentrate The 2004 SSC guidelines recommended use of rhAPC in line with the product labeling instructions required by the US and European regulatory authorities with a grade B quality of evidence [ 7, 8]. 2004版SSC指南将rhAPC使用等级定为1B。 Part G Protein C and activated protein concentrate By the time of publication of the 2008 SSC guidelines, additional studies of rhAPC in severe sepsis (as required by regulatory agencies) had shown it ineffective in less severely ill patients with severe sepsis as well as in children [229, 230]. 到了2008年,又有一些新的研究表明rhAPC对一些疾病引起的严重脓毒症中是无效的(包括儿童)。 Part G Protein C and activated protein concentrate The 2008 SSC recommendations reflected these findings, and the strength of the rhAPC recommendation was downgraded to a suggestion for use in adult patients with a clinical assessment of high risk of death, most of whom will have Ac
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