罗卡西林的效益风险评价  

Evaluating the Benefit-Risk of Lorcaserin

作　　者：周殿友[1] 马医杰[1] 刘妍[1] 李青[2] 

机构地区：[1]山西医科大学,山西太原030001 [2]山西医科大学第一附属医院

出　　处：《中国医学创新》2013年第15期127-129,共3页Medical Innovation of China

摘　　要：目的:评价罗卡西林治疗肥胖症的效益风险,为临床用药提供指导。方法:根据罗卡西林的两个Ⅲ期临床试验的数据,采用多准则决策分析计算罗卡西林10mg/次QD、罗卡西林10mg/次BID和安慰剂的效益值、风险值和效益风险总和,运行蒙特卡洛模拟处理多准则决策分析的不确定性,观察罗卡西林与安慰剂各项值的差异大于0的概率。结果:罗卡西林10mg/次QD、罗卡西林10mg/次BID和安慰剂的效益值分别为41、49和26,罗卡西林10mg/次BID的效益最优,其效益优于罗卡西林QD和安慰剂的概率分别为77.2%和99.2%;风险值分别等于83、79和82,罗卡西林QD的风险最小,其风险小于罗卡西林BID和安慰剂的概率分别是60%和52.3%;效益风险总和分别等于62、64和53,可见采用罗卡西林10mg/次BID是最好的,好于安慰剂和罗卡西林10mgQD概率分别等于91.7%和62.8%。结论:罗卡西林10mg/次BID是最好的治疗选择,但是其风险在三者中最大,因此当患者对于风险的可接受性较低时,可以采用罗卡西林10mg/次QD。Objective： To evaluate the benefit-risk of lorcaserin and placebo for weight loss, so as to provide guidance for clinical use. Method： According to the data from two phase III clinical trials of loreaserin, we performed multi-criteria decision analysis （ MCDA ） to evaluate the benefit value, risk value and total value of lorcaserin 10 mg QD, BID and placebo. Then running the Monte Carlo simulation to analysis the uncertainty of the MCDA results and observe the probability of greater than zero about between the options difference. Result： The benefit value of lorcaserin QD, lorcaserin BID and placebo respectively were 41,49 and 26, suggesting that lorcaserin BID was the most preferred. The Monte Carlo simulation results showed that for the probability Iorcaserin BID was superior to lorcaserin QD and placebo were 77.2% and 99.2%. Similary, the risk value respectively was 83, 79, and 82. It cleared that lorcaserin QD was the safest, its risk was less than lorcaserin BID and placebo for the probability was 60% and 52.3% respectively. The total benefit-risk value suggested that lorcaserin BID was overall the most preferred, it scored 64. Lorcaserin QD and placebo scored 62 and 53. The simulation results showed that lorcaserin BID was superior to loreaserin QD and placebo for the probability was 91.7% and 62.8%. Condusion： Lorcaserin BID is the best choice, but the risk of lorcaserin BID is the greatest in the three options, so patients can choose loreaserin QD when they risk acceptability is low.

关 键 词：罗卡西林 效益风险 多准则决策分析 蒙特卡洛模拟 

分 类 号：R98[医药卫生—药品]