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目的 美国食品和药品管理局 (FDA)近期批准一项政策 ,即在安全试验基础上 ,加强新的治疗方法在儿童中的使用。本研究讨论这项政策对PICU随机对照试验(RCTs)的潜在影响。方法 回顾RCTs、FDA和这一政策产生的历史经过。结果 一项最新的FDA政策确保了加强儿童药物试验 ;然而 ,它同时也增加了未用RCTs方法在儿童中验证该药物疗效 ,就批准将药物用于患儿的可能性。结论因为PICU具有高度不稳定性 ;经常同时给予多种药物 ,而药物之间存在相互作用 ;药物代谢受损的危重婴儿和儿童存在药物中毒危险性及不同年龄儿童生理状况不同等 ,所以 ,必须告知内科医生哪种药物获得FDA批准可用于儿童 ,哪种药物未获FDA批准而不准用于儿童
Purpose The U.S. Food and Drug Administration (FDA) recently approved a policy to strengthen the use of new treatments in children based on safety trials. This study discusses the potential impact of this policy on PICU randomized controlled trials (RCTs). Methods Review RCTs, the FDA, and the history of this policy. Results A recent FDA policy to ensure enhanced pediatric drug trials; however, it also added the possibility of approving the use of drugs in children without validating the efficacy of the drug in children without RCTs. Conclusion Because of the high instability of PICU, multiple drugs are frequently administered simultaneously with the interaction of drugs. The risk of drug poisoning in critically ill infants and children with different drug metabolism and the physiological status of children of different ages are different. Therefore, Inform the physician of which drug is FDA approved for use in children and which drug is not approved for use in children without FDA approval