Veterans Affairs (VA) New England Mental Illness, Research Education and Clinical Center, VA Connecticut Healthcare System, West Haven, CT 06516, USA.
N Engl J Med. 2011 Mar 3;364(9):842-51. doi: 10.1056/NEJMoa1005987.
Long-acting injectable risperidone, a second-generation antipsychotic agent, may improve adherence to treatment and outcomes in schizophrenia, but it has not been tested in a long-term randomized trial involving patients with unstable disease.
We randomly assigned patients in the Veterans Affairs (VA) system who had schizophrenia or schizoaffective disorder and who had been hospitalized within the previous 2 years or were at imminent risk for hospitalization to 25 to 50 mg of long-acting injectable risperidone every two weeks or to a psychiatrist's choice of an oral antipsychotic. All patients were followed for up to 2 years. The primary end point was hospitalization in a VA or non-VA psychiatric hospital. Symptoms, quality of life, and functioning were assessed in blinded videoconference interviews.
Of 369 participants, 40% were hospitalized at randomization, 55% were hospitalized within the previous 2 years, and 5% were at risk for hospitalization. The rate of hospitalization after randomization was not significantly lower among patients who received long-acting injectable risperidone than among those who received oral antipsychotics (39% after 10.8 months vs. 45% after 11.3 months; hazard ratio, 0.87; 95% confidence interval, 0.63 to 1.20). Psychiatric symptoms, quality of life, scores on the Personal and Social Performance scale of global functioning, and neurologic side effects were not significantly improved with long-acting injectable risperidone as compared with control treatments. Patients who received long-acting injectable risperidone reported more adverse events at the injection site and more extrapyramidal symptoms.
Long-acting injectable risperidone was not superior to a psychiatrist's choice of oral treatment in patients with schizophrenia and schizoaffective disorder who were hospitalized or at high risk for hospitalization, and it was associated with more local injection-site and extrapyramidal adverse effects. (Supported by the VA Cooperative Studies Program and Ortho-McNeil Janssen Scientific Affairs; ClinicalTrials.gov number, NCT00132314.).
长效注射用利培酮是一种第二代抗精神病药物，可能会提高精神分裂症患者的治疗依从性和治疗效果，但尚未在涉及病情不稳定的患者的长期随机试验中进行测试。
我们在退伍军人事务部（VA）系统中随机分配了在过去 2 年内住院或有住院风险的精神分裂症或分裂情感障碍患者，他们被分配到每两周接受 25 至 50 毫克长效注射用利培酮或接受精神科医生选择的口服抗精神病药物治疗。所有患者均随访 2 年。主要终点是在 VA 或非 VA 精神病医院住院。通过视频会议访谈评估症状、生活质量和功能。
在 369 名参与者中，40%在随机分组时住院，55%在过去 2 年内住院，5%有住院风险。与接受口服抗精神病药物治疗的患者相比，接受长效注射用利培酮治疗的患者随机分组后住院的比例没有显著降低（10.8 个月后为 39%，11.3 个月后为 45%；风险比，0.87；95%置信区间，0.63 至 1.20）。长效注射用利培酮与对照治疗相比，并未显著改善精神病症状、生活质量、总体功能的个人和社会表现量表评分以及神经副作用。接受长效注射用利培酮治疗的患者报告更多的注射部位不良反应和更多的锥体外系症状。
在住院或有住院风险的精神分裂症和分裂情感障碍患者中，长效注射用利培酮并不优于精神科医生选择的口服治疗，并且与更多的局部注射部位和锥体外系不良反应相关。（由 VA 合作研究计划和 Ortho-McNeil Janssen 科学事务部支持；ClinicalTrials.gov 编号，NCT00132314。）
