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(P<0.01),但组间无显著差异(P>0.05)。两组临床总有效率无显著差异(P>0.05)。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,P<0.05)。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。
AIM To verify the efficacy and safety acute agitation of schizophrenia. METHODS Totally 86 of ziprasidone mesylate injection in the treatment of hospitalized patients who met ICD- 10 criteria of schizophrenia were divided into ziprasidone group （n = 43） and haloperidol group （n = 43） in the single blind clinical trail. The ziprasidone group was given ziprasidone mesylate 10 - 20 mg by intramuscular injection and the amount was less than 40 mg ＂d-1. The haloperidol group were given haloperidol 5 - 10 mg by intramuscular injection and the amount was less than 30 mg-d-~. Drugs in the two groups could be repeated according to the state of illness 4 - 6 h after the administration, and the daily injections were no more than 3 times and the course of treatment was 3 d. Before the treatment and 2, 6, 24, 48, 72 h after the treatment, the Positive and Negative Symptoms Scale （PANSS）, Clinical Global Impression scale-the severity of the disease （CGI-SI）, Adverse Reactions Scale （TESS） and the related lab tests were employed for assessing the efficacy and safety of the treatment. RESULTS Compared with the baseline, PANSS Excited Component （PANSS-EC） scores of the ziprasidone group decreased significantly at 2 h after the treatment. At other observation time- points, PANSS scores, PANSS-EC scores and CGI-SI scores in the two groups both decreased significantly （P 〈 0.01） with no significant difference between the two groups （P 〉 0.05）. There were no significant difference between the total effective rates in the two groups （P 〉 0.05）. There were no serious adverse events in the two groups. The ziprasidone group had fewer extrapyramidal adverse reactions, and its incidence of adverse reactions （37%） were lower than that of the haloperidol group （53%） （X2 = 2.30, P 〈 0.05）. CONCLUSION The mesylate ziprasidone injection is effective and safe in the treatment of of adverse reactions, and worth spreading clinically. acute agitation in schizophrenia with lower incidence
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2014年第1期57-60,共4页
Chinese Journal of New Drugs and Clinical Remedies
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)
