AstraZeneca Greece, Athens 15125, Greece.
Ann Gen Psychiatry. 2013 Dec 20;12(1):42. doi: 10.1186/1744-859X-12-42.
Patients under antipsychotic treatment for schizophrenia commonly exhibit poor adherence to treatment, high rates of treatment discontinuation, and frequent treatment changes. The ETOS study aimed to identify the reasons leading physicians to decide to switch antipsychotic treatment in outpatients with schizophrenia and to evaluate the outcome of this switch.
ETOS was an observational 18-week (four visits) study in outpatients 18 to 65 years old, diagnosed with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders - 4th edition criteria at least 6 months prior to enrolment, who were initiated on a new antipsychotic monotherapy treatment within the 2 weeks prior to enrollment. A total of 574 patients were recruited by 87 hospital- and office-based physicians. Ethical approval was obtained prior to study initiation (NCT00999895).
The final analysis included 568 patients, 39.0 ± 11.2 years old with mean disease duration of 11.7 years. The male-to-female ratio was 53:47. The main reason for switching antipsychotic treatment was lack of tolerability (n = 369, 65.0%), followed by lack of efficacy (n = 249, 43.8%). Following treatment switch, 87.9% of patients (n = 499) showed meaningful clinical benefit by achieving a Clinical Global Impression-Clinical Benefit score of ≤4 at the final visit. By the end of the study, total Positive and Negative Syndrome Scale, Clinical Global Impression-Improvement, Clinical Global Impression-Severity, and Simpson-Angus Scale scores demonstrated significant mean decreases of 31.69, 0.70, 1.14, and 11.30, respectively (all p < 0.0001). Treatment adherence remarkably improved.
In the ETOS study, switch of antipsychotic monotherapy for reasons relating to lack of efficacy and/or tolerability was associated with significantly improved clinical benefit and significant increase of patients' adherence to treatment.
接受抗精神病药物治疗的精神分裂症患者通常表现出较差的治疗依从性、较高的停药率和频繁的治疗改变。ETOS 研究旨在确定导致医生决定为门诊精神分裂症患者更换抗精神病药物治疗的原因，并评估这种转换的结果。
ETOS 是一项观察性的 18 周（4 次就诊）研究，纳入了 18 至 65 岁的门诊患者，他们在入组前至少 6 个月根据精神障碍诊断与统计手册第 4 版标准被诊断为精神分裂症，并且在入组前 2 周内开始使用新的抗精神病单药治疗。共有 87 名医院和诊所医生招募了 574 名患者。在研究开始前获得了伦理批准（NCT00999895）。
最终分析包括 568 名患者，年龄 39.0±11.2 岁，平均病程 11.7 年。男女比例为 53:47。更换抗精神病药物治疗的主要原因是不耐受（n=369，65.0%），其次是疗效不佳（n=249，43.8%）。治疗转换后，87.9%的患者（n=499）在最后一次就诊时达到临床总体印象-临床获益评分≤4，表现出有意义的临床获益。研究结束时，阳性和阴性症状量表总分、临床总体印象-改善、临床总体印象-严重程度和辛普森-安格斯量表评分分别显著下降 31.69、0.70、1.14 和 11.30（均 p<0.0001）。治疗依从性显著提高。
在 ETOS 研究中，由于疗效和/或耐受性差而更换抗精神病药物单药治疗与显著改善的临床获益和显著提高的患者治疗依从性相关。
