Smith R C, Chua J W, Lipetsker B, Bhattacharyya A
Department of Psychiatry, New York University School of Medicine, USA.
J Clin Psychiatry. 1996 Oct;57(10):460-6. doi: 10.4088/jcp.v57n1004.
Although risperidone has been shown to be an effective antipsychotic medication in schizophrenia, the clinical studies performed for the Food and Drug Administration's approval process focused on only a mixed group of schizophrenic patients. Most of these studies did not directly address the efficacy of risperidone in chronic nonresponding schizophrenics. To better evaluate whether risperidone has a substantial degree of efficacy in schizophrenic non-responders, we conducted an open prospective study of risperidone in a sample of chronically hospitalized schizophrenic patients.
Twenty-five patients who met DSM-III-R criteria for schizophrenia or schizoaffective psychosis, who were chronically hospitalized at a tertiary care state facility, and who had not responded to conventional neuroleptics were evaluated before and during treatment with risperidone by using several standard rating scales and adjunctive assessments.
Endpoint analysis showed that 36% (N = 9) of the patients were classified as responders on the basis of at least a 20% decrease in total Brief Psychiatric Rating Scale score at final evaluation. A higher percentage of patients were classified as responders when other rating scale criteria were used. Reductions in psychopathology scores were seen in scales reflecting positive symptoms but not in scores of negative symptoms. High baseline negative symptom scores were correlated with poorer response to risperidone as indicated by the decrease in positive symptom scores.
This study offers evidence that risperidone may reduce positive symptoms of schizophrenia for a subgroup of chronically hospitalized schizophrenic patients who have not responded to conventional neuroleptics. The comparative evaluation of the efficacy of risperidone versus that of clozapine in these types of patients requires further study.
尽管利培酮已被证明是治疗精神分裂症的一种有效抗精神病药物，但为获得美国食品药品监督管理局（FDA）批准而开展的临床研究仅聚焦于一组混合型精神分裂症患者。这些研究大多未直接探讨利培酮对慢性无反应性精神分裂症患者的疗效。为了更好地评估利培酮对精神分裂症无反应者是否具有显著疗效，我们对一组长期住院的精神分裂症患者进行了一项关于利培酮的开放性前瞻性研究。
25名符合精神分裂症或分裂情感性精神病DSM-III-R标准、在三级护理州立机构长期住院且对传统抗精神病药物无反应的患者，在使用利培酮治疗前及治疗期间，通过几种标准评定量表和辅助评估进行了评估。
终点分析显示，在最终评估时，根据简明精神病评定量表总分至少降低20%，36%（N = 9）的患者被归类为有反应者。使用其他评定量表标准时，被归类为有反应者的患者比例更高。反映阳性症状的量表上精神病理学得分有所降低，但阴性症状得分未降低。如阳性症状得分的降低所示，高基线阴性症状得分与对利培酮的反应较差相关。
本研究提供了证据表明，利培酮可能会减轻一组对传统抗精神病药物无反应的长期住院精神分裂症患者的阳性症状。在这类患者中，对利培酮与氯氮平疗效的比较评估需要进一步研究。
