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氯氮平对国立医院患者的疗效:一项随机试验的结果。

Clozapine's effectiveness for patients in state hospitals: results from a randomized trial.

作者信息

Essock S M, Hargreaves W A, Covell N H, Goethe J

机构信息

Connecticut Department of Mental Health and Addiction Services (DMHAS), Hartford 06134, USA.

出版信息

Psychopharmacol Bull. 1996;32(4):683-97.

PMID:8993092
Abstract

In our study, we examined the effectiveness of clozapine and compared it to the array of medication alternatives typically used in the public sector. Long-term patients in Connecticut's state hospitals who met Food and Drug Administration criteria for clozapine use were invited to participate in this randomized open-label study. Participants (N = 227) were followed for 2 years. Compared with usual care, clozapine was associated with significantly greater reductions in side effects, disruptiveness, and hospitalization, but was not more effective in reducing symptoms or improving quality of life. The groups did not differ in likelihood of being discharged; however, once discharged, clozapine patients were less likely to be readmitted. The results of our study suggest that, compared with the flexible range of medication alternatives available, clozapine is an effective agent. However, at least with this patient population, clozapine did not produce the dramatic improvements is symptomatology or hospital utilization reported in clinical efficacy trials or suggested by mirror-image studies.

摘要

在我们的研究中,我们检验了氯氮平的有效性,并将其与公共部门通常使用的一系列替代药物进行了比较。康涅狄格州立医院中符合美国食品药品监督管理局氯氮平使用标准的长期患者被邀请参与这项随机开放标签研究。对参与者(N = 227)进行了为期2年的随访。与常规治疗相比,氯氮平与副作用、破坏性行为及住院率的显著降低相关,但在减轻症状或改善生活质量方面并无更显著效果。两组在出院可能性上并无差异;然而,一旦出院,服用氯氮平的患者再次入院的可能性较小。我们的研究结果表明,与现有的多种灵活的替代药物相比,氯氮平是一种有效的药物。然而,至少在这一患者群体中,氯氮平并未像临床疗效试验中所报告的或镜像研究中所暗示的那样,在症状学或医院利用率方面产生显著改善。

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