Tuyển tập báo cáo các nghiên cứu khoa học quốc tế ngành y học dành cho các bạn tham khảo đề tài: Dose-associated changes in safety and efficacy parameters observed in a 24-week maintenance trial of olanzapine long-acting injection in patients with schizophrenia | Hill et al. BMC Psychiatry 2011 11 28 http 1471-244X 11 28 BMC Psychiatry RESEARCH ARTICLE Open Access Dose-associated changes in safety and efficacy parameters observed in a 24-week maintenance trial of olanzapine long-acting injection in patients with schizophrenia 1 1 2 1 1 Angela L Hill Bin Sun Jamie L Karagianis Susan B Watson David P McDonnell Abstract Background In a recently published 24-week maintenance study of olanzapine long-acting injection LAI in schizophrenia Kane et al. 2010 apparent dose-associated changes were noted in both efficacy and safety parameters. To help clinicians balance safety and efficacy when choosing a dose of olanzapine LAI we further studied these changes. Methods Outpatients with schizophrenia who had maintained stability on open-label oral olanzapine for 4 to 8 weeks were randomly assigned to low 150 mg 2 weeks N 140 medium 405 mg 4 weeks N 318 or high 300 mg 2 weeks N 141 dosages of olanzapine LAI for 24 weeks. Potential relationships between dose and several safety or efficacy measures were examined via regression analysis the Jonckheere-Terpstra test continuous data or the Cochran-Armitage test categorical data . Results Safety parameters statistically significantly related to dose were mean weight change low SD medium SD high SD kg p .024 effect size ES high vs. low dose mean change in prolactin low SD medium SD high SD gg L p .001 ES high vs. low dose fasting triglycerides change from normal at baseline to high low medium high p .001 NNT 7 high vs. low dose and fasting high-density lipoprotein cholesterol change from normal at baseline to low low medium high p .019 NNT 6 high vs. low dose . Efficacy measures significantly related to dose included Positive and Negative Syndrome Scale total score mean change low SD medium SD high SD p .01 ES high vs. low dose .
