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齐拉西酮治疗精神分裂症患者生活质量受损的有效性:一项针对接受常规护理患者的为期12个月的开放标签、灵活剂量、自然观察性研究。

The effectiveness of ziprasidone in treating impaired quality of life in schizophrenia: a 12-month, open-label, flexible-dose, naturalistic observational study of patients undergoing usual care.

作者信息

Ritsner Michael S, Yorkov Vladimir, Ratner Yael, Soifer Peter, Gibel Anatoly

机构信息

Sha'ar Menashe Mental Health Center, Mobile Post Hefer 38814, Israel.

出版信息

Prog Neuropsychopharmacol Biol Psychiatry. 2007 Oct 1;31(7):1470-7. doi: 10.1016/j.pnpbp.2007.06.029. Epub 2007 Jul 4.

DOI:10.1016/j.pnpbp.2007.06.029
PMID:17669573
Abstract

OBJECTIVE

Health related quality of life (HRQL) has become an important outcome measure in the treatment of psychiatric disorders. This long-term observational study examined ziprasidone-induced improvement in satisfaction with HRQL in schizophrenia patients treated under real-world conditions.

METHOD

Seventy schizophrenia patients with persistent symptoms or troublesome side effects were assigned to a 12-month, open-label, flexible-dose (40-160 mg/d), large-scale, naturalistic trial. Outcome measures were taken at baseline, 6, and 12 months, and included the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), severity of symptoms, distress, and side effects.

RESULTS

Thirty-two patients fully completed the study protocol. Patients reported poorer general HRQL compared with healthy subjects. At the end of the study, significant improvement in general activity, and satisfaction with life was observed. The effect sizes for these changes were moderate (0.55, and 0.72, respectively). After Bonferroni correction for multiple comparisons improvement in satisfaction with general activity remained significant. No significant changes were noted in other Q-LES-Q dimensions. Improvement in general activity was associated with a reduction in the severity of symptoms and emotional distress, but was unrelated to the ziprasidone daily dose, side effect scores, and concomitantly prescribed antidepressants, anxiolytics, mood stabilizers, or antiparkinson drugs.

CONCLUSION

This study indicates that ziprasidone treatment resulted in the improvement of the satisfaction with general activity that tended to increase over time, from month 6 onwards. This effect was associated with reduction in the severity of clinical symptoms, and emotional distress.

摘要

目的

健康相关生活质量(HRQL)已成为精神疾病治疗中的一项重要疗效指标。这项长期观察性研究考察了在现实世界条件下接受治疗的精神分裂症患者中,齐拉西酮治疗对HRQL满意度的改善情况。

方法

70例有持续症状或严重副作用的精神分裂症患者被纳入一项为期12个月、开放标签、灵活剂量(40 - 160毫克/天)的大规模自然试验。在基线、6个月和12个月时进行疗效评估,评估指标包括生活质量享受与满意度问卷(Q - LES - Q)、症状严重程度、痛苦程度和副作用。

结果

32例患者完全完成了研究方案。与健康受试者相比,患者报告的总体HRQL较差。在研究结束时,观察到总体活动和生活满意度有显著改善。这些变化的效应大小为中等(分别为0.55和0.72)。经Bonferroni多重比较校正后,总体活动满意度的改善仍然显著。在其他Q - LES - Q维度上未观察到显著变化。总体活动的改善与症状严重程度和情绪痛苦的减轻相关,但与齐拉西酮每日剂量、副作用评分以及同时开具的抗抑郁药、抗焦虑药、心境稳定剂或抗帕金森药物无关。

结论

本研究表明,齐拉西酮治疗可改善总体活动满意度,从第6个月起,这种满意度随时间推移有上升趋势。这种效应与临床症状严重程度和情绪痛苦的减轻相关。

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