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.
| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |