Ratner Yael, Gibel Anatoly, Yorkov Vladimir, Ritsner Michael S
Acute Department, Sha'ar Menashe Mental Health Center, Mobile Post Hefer 38814, Hadera, Israel.
Prog Neuropsychopharmacol Biol Psychiatry. 2007 Oct 1;31(7):1401-9. doi: 10.1016/j.pnpbp.2007.06.008. Epub 2007 Jun 21.
This is a first report from a long-term study aimed to evaluate efficacy, safety, tolerability, cognitive functioning, and quality of life outcomes during ziprasidone treatment of chronic schizophrenia patients in the "real-world".
Seventy clinically unstable schizophrenia patients with persistent symptoms or troublesome side effects were assigned to a 12-month, open-label, flexible-dose (40-160 mg/day), large-scale, naturalistic trial. Outcome measures were taken at baseline, 6, and 12 months, and included the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression (CGI-S) scale, the Global Assessment of Functioning Scale (GAF) scores, treatment-emergent adverse events, body weight, and drug attitude.
Thirty-two patients fully completed the study protocol. A discontinuation of treatment for any cause occurred in 54.3% of patients; the mean time until discontinuation was 4.4 +/- 2.7 months. A discontinuation due to lack of clinical efficacy was more predominantly linked to patient perception (25.7%) than to physicians' conclusions alone (8.6%), adverse events (11.4%), and other reasons (8.6%). After controlling daily dose of ziprasidone, concomitant medications and sex, ANCOVA revealed improvement in PANSS factors, and global functioning among patients who had completed the study. Improvement in PANSS and GAF dimensions was evident at a 6-month visit, and it continued until the endpoint. When a cutoff of 20% improvement of PANSS total scores was used, the response rate among completers was 43.8%. Most common side effects were: fatigue, sleep disturbances, and headache. Ziprasidone did not appear to be linked to weight gain.
This study suggests that ziprasidone may be beneficial for long-term treatment of schizophrenia patients in terms of severity of symptoms, and general functioning. Ziprasidone is well tolerated during the long-term treatment of chronic schizophrenia patients undergoing usual care.
这是一项长期研究的首份报告，旨在评估齐拉西酮在“现实世界”中治疗慢性精神分裂症患者期间的疗效、安全性、耐受性、认知功能及生活质量结果。
70名临床症状不稳定、有持续症状或出现令人困扰副作用的精神分裂症患者被纳入一项为期12个月的开放标签、灵活剂量（40 - 160毫克/天）、大规模、自然主义试验。在基线、6个月和12个月时进行结果测量，包括阳性和阴性症状量表（PANSS）、临床总体印象（CGI - S）量表、功能总体评定量表（GAF）评分、治疗中出现的不良事件、体重及药物态度。
32名患者完全完成了研究方案。54.3%的患者因任何原因中断治疗；中断治疗的平均时间为4.4±2.7个月。因缺乏临床疗效而中断治疗更多是与患者的认知（25.7%）相关，而非仅与医生的结论（8.6%）、不良事件（11.4%）及其他原因（8.6%）有关。在控制齐拉西酮的每日剂量、合并用药及性别后，协方差分析显示完成研究的患者在PANSS因子及总体功能方面有所改善。在6个月的访视时，PANSS和GAF维度的改善就已明显，并持续至终点。当使用PANSS总分改善20%的临界值时，完成者的缓解率为43.8%。最常见的副作用为：疲劳、睡眠障碍及头痛。齐拉西酮似乎与体重增加无关。
本研究表明，就症状严重程度和总体功能而言，齐拉西酮可能对精神分裂症患者的长期治疗有益。在接受常规护理的慢性精神分裂症患者的长期治疗中，齐拉西酮耐受性良好。
