Diamond George A
Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, California; David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California.
Am J Cardiol. 2014 Nov 1;114(9):1456-63. doi: 10.1016/j.amjcard.2014.07.080. Epub 2014 Aug 13.
Regulatory agencies, professional societies, and clinical trialists commonly base judgments of treatment benefit on separate assessments of efficacy and safety. When separate assessments were compared with an integrated assessment using a kinetic model of a hypothetical randomized trial of antiplatelet agents in patients with acute coronary syndrome, the former showed treatment A to be superior to treatment B, whereas the latter showed treatment B to be superior to treatment A. In conclusion, comparative judgments regarding the balance between efficacy and safety depend on the model chosen for analysis; kinetic models are particularly suited to the integrated assessment of efficacy and safety relative to regulatory decisions, public policy, guideline development, and clinical care.
监管机构、专业学会和临床试验人员通常依据对疗效和安全性的单独评估来判断治疗效果。在一项针对急性冠脉综合征患者的抗血小板药物假设性随机试验中，将单独评估与使用动力学模型的综合评估进行比较时，前者显示治疗A优于治疗B，而后者显示治疗B优于治疗A。总之，关于疗效和安全性平衡的比较判断取决于所选择的分析模型；动力学模型特别适合于相对于监管决策、公共政策、指南制定和临床护理的疗效和安全性综合评估。
