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Quantitative Efficacy of 3 Kinds of Antipsychotic drugs with Schizophrenia:Based on a Real-world Study in China

Lei Zhang  Yange Li  Yan Zhang  Shen He  Yi-min Yu  Yan Li  Hui Wen  Ying Qiao  Yifeng Shen  Hua-fang Li  
【摘要】:Aim The long-term efficacy especially the personal and social function of the schizophrenia with atypical antipsychotics is remarkable.This study established pharmacodynamic models to quantitatively describe the time effect of each antipsychotics in order to identify relevant impacting factors and to use pharmacodynamic parameters to directly reflect the characteristics of the therapeutic efficacy of each drug in order to provide quantitative information for schizophrenia individual treatment in China.Methods373 schizophrenia patients,who were treated with an antipsychotic monotherapy of olanzapine,risperidone or aripiprazole were selected from a real-world clinical study of long-term outcomes for Schizophrenia by Atypical antipsychotic treatment in China(SALT-C,NCT02640911).The study was a there-year prospective,multi-center study.The following visit time was 13 weeks,26 weeks,52 weeks,78 weeks,104 weeks,130 weeks,and 156 weeks after baseline.Time-efficacy model with nonlinear mixed effect method(NONMEM) was established based on the changes of the Personal and Social Performance(PSP) rating scale score compared to baseline level and crucial pharmacodynamic parameters,such as the maximal efficacy and drug onset time were used to reflect the differences in efficacy among the three drugs.Results Based on 144 patiens treated with olanzapine,160 with rispiprazole and 69 with aripiprazole,we successfully and quantitatively described the time course for the PSP improvement effects of three antipsychotics.The results revealed a classic pharmacodynamic maximal effect(Emax)model could describe the time course of PSP score change.The Emax of olanzapine,risperidone or aripiprazole was 80.3%, 68.2%,and 44.2%,respectively.The time to achieve half of the maximal effect(ET50) of them was 56.7 weeks,29.2 weeks and 49.7 weeks,respectively.Baseline social function,general psychotic symptoms,onset frequency,and the course of the disease were significant impact factors for the efficacy of our models.Specifically the typical increase PSP score rate of olanzapine showed superior efficacy versus rispiprazole and aripiprazole.However,a time interval of 29.2 weeks was needed for rispiprazole to achieve half of its maximal effects,much shorter than olanzapine and aripiprazole.Conclusion The newly constructed models supported previous evidence for the beneficial effects of longterm maintenance therapy.In addition,the established framework is expected to be applicable to prediction and clinical decision.

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