A Post Hoc Analysis of Negative Symptoms and Psychosocial Function in Patients With Schizophrenia: A 40-Week Randomized, Double-Blind Study of Ziprasidone Versus Haloperidol Followed by a 3-Year Double-Blind Extension Trial
A Post Hoc Analysis of Negative Symptoms and Psychosocial Function in Patients With Schizophrenia: A 40-Week Randomized, Double-Blind Study of Ziprasidone Versus Haloperidol Followed by a 3-Year Double-Blind Extension Trial
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精神分裂症患者阴性症状和心理社会功能的事后分析：齐拉西酮与氟哌啶醇的 40 周随机双盲研究，随后进行 3 年双盲延伸试验
DOI：
10.1097/jcp.0b013e3181e69042
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发表时间：
2010
影响因子：
2.9
通讯作者：
S. Romano
中科院分区：
文献类型：
--
作者：
S. Stahl;A. Malla;J. Newcomer;S. Potkin;P. Weiden;Philip D. Harvey;A. Loebel;E. Watsky;C. Siu;S. Romano
精神分裂症是一种持续的、终生的疾病，因此持久的功能改善可能只会在几年的过程中发生。在一项为期40周的随机双盲研究中，对稳定的门诊精神分裂症患者进行了一项事后分析，调查了齐拉西酮(每天两次给药80-160 mg，平均模式剂量112 mg/d；每天给药80-120 mg/d，平均模式剂量96 mg/d)与氟哌啶醇(5-20 mg/d，平均模式剂量12 mg/d)的阴性症状疗效和治疗结果。当受试者根据生活质量的4个子量表(工具角色、人际关系、对社区的参与和心理基础)获得阴性症状缓解和良好的心理社会功能时，症状和功能恢复标准得到满足。在196周的双盲研究期间，齐拉西酮80~160 mg组的阴性症状缓解(P=0.005)、在辅助作用(P=0.04)和参与社区(P=0.02)方面持续良好的功能(6个月)与缓解时间显著缩短，症状和功能恢复的结合也是如此。齐拉西酮80至120 mg组也观察到了类似的模式，在阴性症状缓解和辅助作用功能方面与氟哌啶醇有显著差异(但其他生活质量子量表测量结果除外)。在这项特别的探索性分析中发现的临床相关结果差异支持了在使用非典型药物的长期治疗期间，阴性症状的增强缓解和心理社会恢复的可能性，并增加了我们对维持阶段阴性症状缓解程度的理解。
Schizophrenia is a persistent, lifelong illness such that enduring functional improvements may only occur over the course of years. This post hoc analysis in stable outpatients with schizophrenia investigated the negative symptom efficacy and treatment outcomes of ziprasidone (80-160 mg/d given twice a day, mean modal dose of 112 mg/d; and 80-120 mg/d given every day, mean modal dose of 96 mg/d) versus haloperidol (5-20 mg/d, mean modal dose of 12 mg/d) in a randomized, 40-week, double-blind study, followed by a double-blind continuation trial that extended up to 156 additional weeks. Symptomatic and functional recovery criteria were met when subjects attained both negative symptom remission and adequate psychosocial functioning based on the 4 Quality-of-Life subscales (instrumental role, interpersonal relations, participation in community, and intrapsychic foundations). Negative symptom remission (P = 0.005), as well as sustained adequate functioning (6 months) in instrumental role (P = 0.04) and participation in community (P = 0.02), was associated with significantly shorter time to remission in the ziprasidone 80 to 160 mg group than in the haloperidol group, as was the combination of symptomatic and functional recovery during the 196-week double-blind study period. A similar pattern was observed for the ziprasidone 80 to 120 mg group, which showed significant differences versus haloperidol in negative symptom remission and instrumental role functioning (but not other Quality-of-Life subscale measures). The clinically relevant outcome differences detected in this post hoc exploratory analysis support the potential for both enhanced remission in negative symptoms and psychosocial recovery during long-term treatment with an atypical agent and add to our understanding regarding the degree to which negative symptom remission can be attained in the maintenance phase.
影响因子：
17.7
作者：
Milev, P;Ho, BC;Andreasen, NC
通讯作者：
Andreasen, NC
影响因子：
17.7
作者：
Robinson, DG;Woerner, MG;McMeniman, M
通讯作者：
McMeniman, M
影响因子：
158.5
作者：
Lieberman, JA;Stroup, TS;Hsiao, JK
通讯作者：
Hsiao, JK