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With the rising of investigational new drugs in clinical trials, the risk of adverse events is increasing as many aspects of the innovation medicine need to be explored. The first-in-human clinical trial (FIH) was retrieved in PubMed from January 1, 2009 to October 31, 2022. The types of drugs and the proportion of adverse drug reactions (ADRs) were analyzed. The number of innovative drugs in FIH during 2021-2022 was 37.4% of the number during 2009-2020. In terms of large molecule drugs, the proportion of ADRs reported in the period 2021-2022 is higher than the proportion in 2009-2020 (15.63% vs 12.66%). Importantly, the proportion of monoclonal antibodies with ADRs in 2021-2022 was also higher than that in 2009-2020 (27.59% vs 11.32%). Strengthen risk awareness and the risk of acute insight play significant important role in early warning and prevention of adverse events in FIH. At the same time, the key elements of emergency management and principles of emergency treatment are the essential cores of the entire emergency management strategy. It is crucial to formulate a feasible emergency management strategy which is worth exploring. The potential risk factors in FIH, the common adverse events of innovative drugs, the key elements of first aid management and the principles of first aid management are expounded on how to realize emergency management strategies.

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在整个试验过程中，创新药在很多方面是未知的、探索性的，不良事件风险也随之增加，本文通过在Pubmed数据库，以“首次人体试验”为关键词进行检索分析，检索时间选择为2009年1月1日—2022年10月30日，对创新药首次人体试验（first-in-human clinical trial, FIH）的药物类型和出现药物不良反应（adverse drug reaction, ADR）的比例进行汇总分析，2021—2022年创新药首次人体试验的数量占2009—2020年数量的37.4%，就大分子药物而言，2021—2022年期间出现ADR的比例高于2009—2020年（15.63% vs 12.66%），其中单克隆抗体出现ADR的比例也有升高（27.59% vs 11.32%）。在创新药的FIH中，加强风险意识以及具有敏锐的风险洞察力是预警和预防不良反应发生的关键，急救管理关键要素与急救处理原则是整个急救管理策略的核心，制定切实可行的急救管理策略是至关重要的部分。因此，本文从人体试验中的潜在风险因素、创新药的常见不良事件、急救管理关键要素以及急救处理原则等方面对于如何实现急救管理策略进行阐述。

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方莹莹，女，主治医师，主要从事创新药早期临床试验研究，曾在从事急诊急救工作。联系电话：(010)63926402，E-mail: fangyingying@bjsjth.cn。

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方莹莹，女，主治医师，主要从事创新药早期临床试验研究，曾在从事急诊急救工作。联系电话：(010)63926402，E-mail: fangyingying@bjsjth.cn。

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