Chartier F, Rouillon F, Berggren L, Jamonneau I, Falissard B, Llorca P M
Health Outcomes/RWE Research Unit France, Lilly France, 24, boulevard Vital-Bouhot, 92521 Neuilly-sur-Seine cedex, France.
CMME, Sainte Anne University Hospital, 75014 Paris, France.
Encephale. 2017 Aug;43(4):303-310. doi: 10.1016/j.encep.2017.05.004. Epub 2017 Jul 11.
To characterize patients treated with olanzapine pamoate in French centers and investigate the conditions of use of olanzapine pamoate in real-life treatment situation.
Data came from French sites participating in an international post-authorization safety study. In this observational study, patients diagnosed with schizophrenia were receiving commercially available olanzapine pamoate, in accordance with their physician's usual standard of care. Data were collected during routine visits within the standard course of patient care.
One hundred and thirty eight patients (male, 73.9%; mean age, 39.4 years; mean duration of disease, 12.7years) received olanzapine pamoate and were included in the study by 32 investigative psychiatrists distributed across 20 different sites (psychiatric hospitals). During the period of analysis, a total of 2975 injections of olanzapine pamoate was administered to the patients. The mean duration of olanzapine pamoate exposure was 475 days (1.3years). During follow-up, 13.8% of all patients had at least one psychiatric hospitalization, 15.9% had at least one same-day psychiatric hospitalization (information documented for 116patients), and 44.2% received at least one concomitant drug. Three cases of post-injection delirium/sedation syndrome were reported during the analysis period. Treatment emergent adverse events (incidence, 20.3%) were in line with the known profile of olanzapine.
Patients were administered olanzapine pamoate and monitored in compliance with label recommendations. The safety profile assessment of olanzapine pamoate in actual conditions was consistent with that described in clinical studies.
对法国各中心接受棕榈酸奥氮平治疗的患者进行特征描述，并调查棕榈酸奥氮平在实际治疗情况下的使用条件。
数据来自参与一项国际上市后安全性研究的法国研究点。在这项观察性研究中，被诊断为精神分裂症的患者按照其医生的常规治疗标准接受市售棕榈酸奥氮平治疗。数据在患者常规护理过程中的随访期间收集。
138例患者（男性占73.9%；平均年龄39.4岁；平均病程12.7年）接受了棕榈酸奥氮平治疗，并由分布在20个不同地点（精神病医院）的32名调查精神科医生纳入研究。在分析期间，共向患者注射了2975次棕榈酸奥氮平。棕榈酸奥氮平暴露的平均持续时间为475天（1.3年）。在随访期间，所有患者中有13.8%至少有一次精神科住院治疗，15.9%至少有一次当日精神科住院治疗（116例患者有记录信息），44.2%接受了至少一种伴随药物治疗。在分析期间报告了3例注射后谵妄/镇静综合征病例。治疗中出现的不良事件（发生率为20.3%）与奥氮平已知的情况相符。
患者接受了棕榈酸奥氮平治疗，并按照标签建议进行监测。棕榈酸奥氮平在实际情况下的安全性评估与临床研究中描述的一致。
