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To improve and refine the relevant regulations and guiding principles of warnings on drug instructions and labels in China.
This paper sorted out the drug instructions of small molecule anti-tumor drugs listed by the U.S. Food and Drug Administration (FDA) from 2005 to 2022, included the drugs mentioned in the QT interval prolongation risk, analyzed the clinical research and QT research results, and sorted out the identification and warning rules of the instructions.
A total of 35 drugs were included, 4 drugs wrote the risk of QT interval prolongation in the black box warning, 21 drugs were wrote in the warning and precautions position, 6 drugs were wrote in the adverse reaction section, and 2 drugs were only described under clinical pharmacology section. According to the severity of the QT interval prolongation caused by the drug and whether there were serious clinical consequences, they were displayed in the warnings (black box warnings), precautions (warnings and precautions) and adverse reactions in the instructions.
The aim of this article is to provide a reference for the writing of QT risk warning information of the instructions of domestic drug production enterprises and regulatory departments. It is recommended to clarify the severity of drug safety and the location of the instructions in clinical research, and continue to carry out safety monitoring and update the instructions in time after listing.
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| 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 |
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