Department of Psychiatry, Bezirkskrankenhaus Augsburg, Germany.
Pharmacopsychiatry. 2010 Mar;43(2):73-80. doi: 10.1055/s-0029-1239592. Epub 2010 Feb 3.
The objective of this open-label study was to evaluate treatment benefits of risperidone long-acting injectable (RLAI) in patients with schizophrenia following direct transition from oral risperidone (RIS) compared with transition from other oral second generation antipsychotics.
Stable in- or outpatients (n=206) receiving RIS or OQAZ (olanzapine, quetiapine, amisulpride, ziprasidone) were transitioned to RLAI for 12 weeks. The primary outcome was the between-group treatment difference in change in PANSS total score from baseline to endpoint. Secondary outcomes included health-related quality-of-life and therapeutic alliance.
Mean between-group difference in the change in PANSS total score from baseline to endpoint was -6.1 (CI: -17.6, 5.4), suggesting greater improvement in OQAZ than RIS patients. Due to the pre-specified non-inferiority margin of 5.1, it could not be concluded that OQAZ pre-treatment results in an at least non-inferior PANSS reduction versus RIS pre-treatment. Patient satisfaction with medication and change in quality-of-life subscores showed advantages for OQAZ patients.
Compared to RIS pre-treatment, clinically stable patients with schizophrenia who are pre-treated with OQAZ might draw a stronger clinical benefit from direct transition to RLAI.
本开放性标签研究旨在评估精神分裂症患者从口服利培酮（RIS）直接转换为利培酮长效注射剂（RLAI）与从其他口服第二代抗精神病药物转换相比，RLAI 的治疗获益。
稳定的门诊或住院患者（n=206）正在接受 RIS 或 OQAZ（奥氮平、喹硫平、氨磺必利、齐拉西酮）治疗，将其转换为 RLAI 治疗 12 周。主要结局是从基线到终点时，PANSS 总分变化的组间治疗差异。次要结局包括健康相关的生活质量和治疗联盟。
从基线到终点时 PANSS 总分变化的组间平均差异为-6.1（CI：-17.6，5.4），表明 OQAZ 组比 RIS 组的改善更大。由于预先指定的非劣效性边界为 5.1，因此不能得出 OQAZ 预处理相对于 RIS 预处理导致至少非劣效的 PANSS 降低的结论。患者对药物的满意度和生活质量子评分的变化表明 OQAZ 患者具有优势。
与 RIS 预处理相比，预先接受 OQAZ 治疗的临床稳定精神分裂症患者可能从直接转换为 RLAI 中获得更强的临床获益。
