Klinik für Psychiatrie und Psychotherapie, Zentrum für Psychosoziale Medizin, Universitätsklinikum Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.
Lundbeck GmbH, Ericusspitze 2, 20457, Hamburg, Germany.
BMC Psychiatry. 2020 Feb 22;20(1):77. doi: 10.1186/s12888-020-02488-1.
In this non-interventional study, the functionality and well-being of patients with schizophrenia with aripiprazole once-monthly (AOM) was evaluated under real-life conditions in a naturalistic population.
This non-interventional, prospective, multicenter 6-month study included 242 predominantly symptomatically stable patients (mean age 43.1 ± 15.1 years, 55% male) who switched their treatment to AOM after 9.7 (± 22.3) months of oral treatment. Outcome parameters included functionality (Global Assessment of Functioning, GAF), patient's wellbeing (WHO-5 Well-Being Index, WHO-5), and both patient's and clinician's assessment of efficacy and tolerability of AOM. Treatment emergent adverse events (TRAE) were also recorded.
At baseline, the mean GAF score was 47.0 (±13.9), indicating that patients experienced serious impairment in functioning. A continuous increase to 60.2 (±17.0) during treatment was found, with a robust and significant increase already after 4 weeks. At study start, patients reported diminished wellbeing, with a mean score of 10.6 (±5.6) on the WHO-5 scale. During treatment, patient wellbeing increased continuously with strong and significant improvements even after 4 weeks and an overall improvement of 4.8 (±6.9) over the course of 6 months with an endpoint of 15.4 (±5.5). Stratification of these results showed that more pronounced effects were achieved in younger patients ≤35 years (p<0.05 for GAF). The effectiveness and tolerability of AOM was rated good/very good by most patients (89.2 and 93.7%) and physicians (91.4 and 96.8%). Only few TRAEs occurred.
Our results show a significant positive effect after initiation of AOM treatment in predominantly stable patients with schizophrenia on their functioning and wellbeing, which was even more pronounced in patients aged ≤35 years, thereby supporting previous randomized controlled findings under routine conditions in clinical practice.
在这项非干预性研究中，在真实环境下，对接受阿立哌唑一月一次（AOM）治疗的精神分裂症患者的功能和健康状况进行了评估。
这是一项非干预性、前瞻性、多中心 6 个月研究，共纳入 242 名主要症状稳定的患者（平均年龄 43.1±15.1 岁，55%为男性），他们在接受奥氮平治疗 9.7（±22.3）个月后改用 AOM 治疗。主要结局参数包括功能（总体功能评定量表，GAF）、患者的健康状况（世界卫生组织幸福度量表，WHO-5）、以及患者和临床医生对 AOM 的疗效和耐受性的评估。还记录了治疗中出现的不良事件（TRAE）。
基线时，GAF 评分平均为 47.0（±13.9），表明患者的功能严重受损。在治疗过程中发现，GAF 评分持续增加，治疗 4 周后即出现显著增加。在研究开始时，患者的健康状况较差，WHO-5 评分平均为 10.6（±5.6）。在治疗过程中，患者的健康状况持续改善，治疗 4 周后即出现显著改善，6 个月时总体改善 4.8（±6.9），终点时为 15.4（±5.5）。这些结果的分层分析表明，在≤35 岁的年轻患者中，效果更为显著（GAF 评分，p<0.05）。大多数患者（89.2%和 93.7%）和医生（91.4%和 96.8%）认为 AOM 的有效性和耐受性好/非常好。只有少数患者出现 TRAE。
我们的研究结果显示，在精神分裂症稳定患者中，起始 AOM 治疗后，患者的功能和健康状况显著改善，在≤35 岁的患者中更为显著，从而支持了在常规条件下，在临床实践中的随机对照研究结果。
