Long-Acting Risperidone and Oral Antipsychotics in Unstable Schizophrenia
Long-Acting Risperidone and Oral Antipsychotics in Unstable Schizophrenia
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DOI：
10.1056/nejmoa1005987
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发表时间：
2011-03-03
影响因子：
158.5
通讯作者：
Liang, Matthew H.
中科院分区：
文献类型：
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作者：
Rosenheck, Robert A.;Krystal, John H.;Liang, Matthew H.
背景长效注射用利培酮是第二代抗精神病药物，可以改善精神分裂症的治疗依从性和结果，但尚未在涉及不稳定疾病患者的长期随机试验中进行测试。方法我们将退伍军人事务部 (VA) 系统中患有精神分裂症或分裂情感性障碍且在过去 2 年内住院过或面临即将住院风险的患者随机分配至每两周注射 25 至 50 毫克长效注射用利培酮，或根据精神科医生选择的口服抗精神病药进行治疗。所有患者均接受长达 2 年的随访。主要终点是在退伍军人管理局或非退伍军人管理局精神病医院住院。通过盲态视频会议访谈评估症状、生活质量和功能。 结果 在 369 名参与者中，40% 随机住院，55% 在过去 2 年内住院，5% 有住院风险。接受长效注射利培酮治疗的患者随机分组后的住院率并不显着低于接受口服抗精神病药物治疗的患者（10.8 个月后为 39%，11.3 个月后为 45%；风险比为 0.87；95% 置信区间为 0.63 至 1.20）。与对照治疗相比，长效注射利培酮的精神症状、生活质量、整体功能的个人和社会表现量表得分以及神经系统副作用没有显着改善。接受长效利培酮注射剂的患者报告了更多的注射部位不良事件和更多锥体外系症状。结论对于住院或住院高风险的精神分裂症和分裂情感障碍患者，长效注射剂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。
BACKGROUNDLong-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.METHODSWe 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.RESULTSOf 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.CONCLUSIONSLong-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.