注射用甲磺酸齐拉西酮治疗精神分裂症急性激越症状疗效观察

发布时间：2018-02-16 09:10

本文关键词： 精神分裂症精神运动性激动齐拉西酮氟哌啶醇临床对照试验　出处：《中国新药与临床杂志》2014年01期 　论文类型：期刊论文

【摘要】：目的评价注射用甲磺酸齐拉西酮治疗精神分裂症急性激越症状的疗效和安全性。方法伴急性激越症状的精神分裂症住院患者86例,分为齐拉西酮组(n=43)和氟哌啶醇组(n=43)进行单盲临床对照研究。齐拉西酮组肌内注射甲磺酸齐拉西酮10~20 mg·次~(-1),总量不超过40 mg·d~(-1);氟哌啶醇组肌内注射氟哌啶醇5~10 mg·次~(-1),总量不超过30 mg·d~(-1)。两组药物根据病情4~6h后可重复使用,注射不超过3次·d~(-1),观察疗程3 d。于治疗前及治疗后2、6、24、48、72 h,采用阳性和阴性症状量表(PANSS)、临床疗效总评量表一病情严重程度(CGI-SI)、副反应量表(TESS)及有关实验室检查评价疗效和安全性。结果与基线比较,齐拉西酮组在治疗后2 h PANSS兴奋因子(PANSS-EC)评分即显著降低,其他各观察点PANSS总分、PANSS-EC评分及CGI-SI评分均显著下降(P0.01),但组间无显著差异(P0.05)。两组临床总有效率无显著差异(P0.05)。两组均未出现严重不良事件,齐拉西酮组锥体外系不良反应少,药物不良反应发生率为37%,显著低于氟哌啶醇组的53%(X~2=2.30,P0.05)。结论注射用甲磺酸齐拉西酮对伴激越症状精神分裂症的治疗起效快、疗效肯定、不良反应发生率低,值得临床推广使用。
[Abstract]:Objective to evaluate the efficacy and safety of ziprasidone mesylate in the treatment of acute agitation symptoms of schizophrenia. Ziprasidone group was divided into ziprasidone group (n = 43) and haloperidol group (n = 43) for a single blind clinical control study. The intramuscular injection of ziprasidone mesylate 1020 mg / time with a total amount of no more than 40 mg 路dlO-1 in the ziprasidone group, haloperidol 510 mg / time intramuscular injection of haloperidol in haloperidol group. The total amount is not more than 30 mg 路dl ~ (-1). The two groups can be reused after 6 hours according to the condition of the disease. No more than 3 times per day of injection. Observe the course of treatment for 3 days. Before and after treatment, use the positive and negative symptom scale (PANSSN) to evaluate the curative effect before and after treatment. The severity of the disease is CGI-SIN, the side effects scale (TESS) and related laboratory tests are used to evaluate the efficacy of the therapeutic effect by using the positive and negative symptom scale (PANSSI), the severity of the disease (CGI-SIQ), the side effects scale (TESS), and the related laboratory tests. And safety. Results compared with baselines, In the ziprasidone group, the PANSS-ECS score of PANSS was significantly decreased 2 hours after treatment. PANSS-EC score and CGI-SI score of other observation points decreased significantly (P 0.01), but there was no significant difference between the two groups (P 0.05). There was no significant difference in total effective rate between the two groups (P 0.05). There were no serious adverse events in both groups, and there were few adverse reactions in extrapyramidal system in ziprasidone group. The incidence of adverse drug reactions was 37, which was significantly lower than that in haloperidol group. Conclusion Ziprasidone mesylate for injection is effective and effective in the treatment of schizophrenia with agitation symptoms, and the incidence of adverse reactions is low, which is worthy of clinical popularization.
【作者单位】：中国人民解放军第324医院精神卫生中心;
【基金】：军队心理卫生科研课题(12XLZ324) 成都军区“十二五”医学科研重点课题(B12009)
【分类号】：R749.3

【参考文献】