重症领域哪些干预是有害的？

意大利人2013年组织专家对2013年7月以前发表的重症领域多中心临床干预试验（mRCT）进行了系统分析。

纳入与排除标准

纳入：研究发表在同行评阅杂志的文章；mRCT设计；运用在成人患者上的非外科干预；死亡率增加或降低在统计学上有意义。

排除：半随机或非随机设计；外科干预；儿童人群；仅涉及围术期；院外；死亡率差异的统计学意义仅限于亚组分析或校正后；认可度低于问卷调查者的50%。

结果

共计24项mRCT研究探寻15项临床干预。

七项治疗降低危重患者的死亡率。

伴有急性呼吸衰竭的特殊人群（如COPD急性加重，呼吸性酸中毒，低氧性呼吸衰竭，有创机械通气撤机）进行无创通气（共计8项mRCT）；心脏骤停后给予亚低温治疗；ARDS患者给予俯卧位和低潮气量通气；存在或有创伤失血性休克风险人群给予氨甲环酸治疗（盲）；机械通气患者实施每日唤醒计划；肝硬化伴原发性细菌性腹膜炎患者给予白蛋白治疗（盲）。这其中仅有两项研究为盲法。

八项治疗增加危重患者的死亡率。

创伤失血性休克给予琥珀酰水杨酸交联血红蛋白（非盲）；脓毒性休克给予羟乙基淀粉；高频振荡通气（非盲）；ARDS给予沙丁胺醇（iv）；超正常范围给予全身性氧输送；强化胰岛素治疗（非盲，血糖控制在81-108mg/dL）。这其中有五项研究为盲法。

这些研究结果认同度如何？为了探索这个问题，意大利人随后开展了一项问卷调查，结果并不乐观。61个国家的555位临床医师参与了问卷调查，大多数为美国、澳大利亚及意大利人，80%的为ICU工作者。总的来说，这些人对上述研究的认可度达到81%，但只有71%的参与者将研究结果运用在临床。其中，保护性通气有85%的受访者进行了临床应用，氨甲环酸只有56%，俯卧位只有55%。应用及认可度不高主要受制于部分研究的样本量、研究质量、中心数量不多的原因。

附1：24项mRCT

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附2：24项mRCT的基本数据

原文：Landoni et al. Mortality in Multicenter Critical Care Trials: AnAnalysis of Interventions With a Significant Effect. Crit Care Med. 2015 Aug;43(8):1559-68. doi:10.1097/CCM.0000000000000974.

附3：24项mRCT的样本量等数据

附4：8项增加死亡率的mRCT相关数据

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