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首页> 外文期刊>Clinical drug investigation >Switching patients with stable schizophrenia or schizoaffective disorder from olanzapine to risperidone long-acting injectable
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Switching patients with stable schizophrenia or schizoaffective disorder from olanzapine to risperidone long-acting injectable

机译:将稳定的精神分裂症或精神分裂症患者从奥氮平改为利培酮长效注射剂

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Background: Patients with schizophrenia or related disorders often switch antipsychotic therapy, most commonly due to lack of efficacy and side effects. The differences in anticipated efficacy and tolerability among atypical antipsychotics may drive switching behaviours. Switching to long-acting antipsychotics may improve adherence. Improving adherence is essential as relatively short medication gaps significantly increase the risk of schizophrenia hospitalizations. Long-term treatment with risperidone long-acting injectable (RLAI), the first available long-acting atypical antipsychotic, versus oral atypical antipsychotics showed better adherence with RLAI. Stable patients with schizophrenia or related disorders treated with a stable dose of antipsychotic showed improved efficacy when switched to flexible doses of RLAI. The most common reason for patients to switch from olanzapine to another antipsychotic is excessive weight gain. Metabolic dysfunction also occurs more commonly with olanzapine than with risperidone. Patients switching from olanzapine to risperidone experienced significant decreases in body weight, body mass index and triglyceride levels, whereas patients switching from risperidone to olanzapine experienced significant increases in body weight and triglyceride levels. The efficacy, tolerability and safety of RLAI in non-acute patients with schizophrenia or schizoaffective disorder previously treated with oral olanzapine needs to be explored. Objective: The objective of this study was to evaluate the efficacy, tolerability and safety of switching from oral olanzapine to RLAI. Methods: This was a six-month, prospective, multicentre, non-randomized, single-arm, open-label trial. The trial evaluated non-acute adult patients with psychotic disorders treated with a stable olanzapine dose who required a treatment change. Three weeks after RLAI initiation, olanzapine was tapered off over 1 week or 3 weeks. Efficacy and safety measures included the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression-Severity (CGI-S), Global Assessment of Functioning (GAF) and treatment-emergent adverse events (TEAEs). Results: Among 96 patients analysed, significant endpoint efficacy changes versus baseline were observed for PANSS, CGI-S and GAF (all p < 0.0001). PANSS total score improvement was ≥20% for 65.6% of patients and ≥50% for 31.3%. TEAEs were similar in the 1- and 3-week taper groups (40.0% and 46.5%, respectively). TEAEs were generally mild (34.5%) or moderate (49.0%) in intensity. Conclusion: Switching non-acute patients with schizophrenia or schizoaffective disorder requiring a treatment change from a stable dose of oral olanzapine to RLAI improved psychiatric symptom control, functioning andpatient treatment satisfaction. RLAI was generally well tolerated. Clinical Trial Registration: Clinicaltrials.gov identifier: NCT00216632.
机译:背景:患有精神分裂症或相关疾病的患者通常会改用抗精神病药物治疗,最常见的原因是缺乏疗效和副作用。非典型抗精神病药在预期疗效和耐受性方面的差异可能会导致转换行为。改用长效抗精神病药可能会改善依从性。改善依从性至关重要,因为相对较短的用药间隔会显着增加精神分裂症住院的风险。利培酮长效注射剂(RLAI)的长期治疗是首个可用的长效非典型抗精神病药,相对于口服非典型抗精神病药,其对RLAI的依从性更好。稳定剂量的抗精神病药治疗的精神分裂症或相关疾病的稳定患者在改用灵活剂量的RLAI后显示出更高的疗效。患者从奥氮平转用另一种抗精神病药的最常见原因是体重增加过多。相比于利培酮,奥氮平更常发生代谢功能障碍。从奥氮平转变为利培酮的患者的体重,体重指数和甘油三酸酯水平显着降低,而从利培酮转变为奥氮平的患者的体重和甘油三酸酯水平显着增加。 RLAI在先前口服奥氮平治疗的非急性精神分裂症或精神分裂症患者中的疗效,耐受性和安全性需要探索。目的:本研究的目的是评估从口服奥氮平改为RLAI的疗效,耐受性和安全性。方法:这是一个为期六个月的前瞻性,多中心,非随机,单组,开放标签的试验。该试验评估了需要稳定治疗的稳定剂量奥氮平治疗的非急性成年精神病患者。 RLAI开始三周后,奥氮平在1周或3周内逐渐减少。疗效和安全性措施包括阳性和阴性综合征量表(PANSS),临床总体印象严重度(CGI-S),功能总体评估(GAF)和治疗紧急不良事件(TEAE)。结果:在分析的96位患者中,观察到PANSS,CGI-S和GAF的终点疗效相对于基线有显着变化(所有p <0.0001)。 PANSS总评分改善率为65.6%的患者≥20%,≥31.3%的≥50%。 1周和3周锥度组的TEAE相似(分别为40.0%和46.5%)。 TEAE的强度一般为轻度(34.5%)或中度(49.0%)。结论:将需要治疗的非急性精神分裂症或精神分裂症患者从稳定剂量的口服奥氮平改为RLAI,可以改善精神症状控制,功能和患者治疗满意度。 RLAI一般耐受良好。临床试验注册:Clinicaltrials.gov标识符:NCT00216632。

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