【摘要】

摘要 目的：观察齐拉西酮联合喹硫平治疗精神分裂症患者急性期兴奋激越的临床疗效。
方法：将120例精神分裂症急性期兴奋激越患者随机分为对照组和观察组，每组60例。对照组给予富马酸喹硫平片口服治疗，观察组在对照组基础上加服盐酸齐拉西酮胶囊，两组均持续治疗4周。分别于不同时间点行阳性与阴性症状量表（PANSS）评分、疗效总评量表-病情严重程度（CGI-SI）评分、PANSS兴奋激越因子（PANSS-EC）评分、认知功能成套测验（MCCB）量表评分、个人与社会功能量表（PSP）评分、SF-36生活质量量表评分以评价治疗效果，检测血清脑源性神经营养因子（BDNF）、胶质源性神经营养因子（GDNF）、神经生长因子（NGF）及白细胞介素-1β（IL-1β）、肿瘤坏死因子-α（TNF-α）水平；并采用不良反应症状量表（TESS）评分及血常规、心电图、肝功能定期监测以评价安全性。
结果：治疗4周后，观察组较对照组PANSS总分、CGI-SI评分、PANSS-EC评分、MCCB评分均明显降低（P<0.05），PSP评分、SF-36生活质量量表评分显著升高（P<0.05）。治疗4周后，观察组血清BDNF、GDNF、NGF水平明显升高（P<0.05），IL-1β、TNF-α水平明显降低（P<0.05）。两组不良反应症状均较轻微，治疗4周后，组间TESS评分及不良反应总发生率比较均无显著差异（P>0.05），且未见严重血常规、心电图、肝功能异常。
结论：齐拉西酮联合喹硫平治疗伴兴奋激越症状的精神分裂症，明显改善血清BDNF、GDNF、NGF水平，有效缓解精神分裂症状及兴奋激越症状，提高患者认知功能、社会功能及生活质量，且未明显增加不良反应。

【Abstract】

Abstract Objective: To observe the clinical efficacy of ziprasidone combined with quetiapine in the treatment of excitement and agitation in acute phase of schizophrenia.
Methods: 120 cases of patients with excitement and agitation in acute phase of schizophrenia were randomly divided into the control group and the observation group, 60 cases in each group. The control group was treated with Quetiapine Fumarate Tablets orally, and the observation group was additionally treated with Ziprasidone Hydrochloride Capsules on the basis of the treatment in control group. The two groups were treated continuously for 4 weeks. The Positive and Negative Syndrome Scale (PANSS) score, the clinical global impression-severity of illness (CGI-SI) score, the Excited Component of PANSS (PANSS-EC) score, The MATRICS Consensus Cognitive Battery (MCCB) score, personal and social performance (PSP) score and SF-36 quality of life score were used to evaluate the curative effect. Levels of serum brain-derived neurotrophic factor (BDNF), glial derived neurotrophic factor (GDNF), nerve growth factor (NGF), interleukin -1 β (IL-1β) and tumor necrosis factor α (TNF- α) were detected, and the safety was evaluated by the Treatment Emergent Symptom Scale (TESS) and regular monitoring of blood routine, electrocardiogram and liver function.
Results: After 4 weeks of treatment, the total PANSS score, CGI-SI score, PANSS-EC score and MCCB score of the observation group were significantly lower than those of the control group (P<0.05), while PSP score and SF-36 quality of life score were significantly higher than those of the control group (P<0.05). After 4 weeks of treatment, the serum levels of BDNF, GDNF and NGF in the observation group were significantly increased, and the levels of IL-1β and TNF-α were significantly decreased (P<0.05). Adverse reactions in the two groups were mild, and after 4 weeks of treatment, there was no significant difference in the TESS score and the total incidence of adverse reactions between the two groups (P>0.05). There were no abnormalities of blood routine, electrocardiogram and liver function.
Conclusion  : The application of ziprasidone combined with quetiapine in the treatment of patients with excitement and agitation in acute phase of schizophrenia can improve the levels of serum BDNF, GDNF and NGF, effectively alleviate the symptoms of schizophrenia, excitement and agitation, and improve the cognitive function, social function and quality of life, without significantly increasing the adverse reactions.