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    注射用甲磺酸齐拉西酮治疗酒精所致精神障碍患者激越症状疗效及安全性的随机对照研究

    Randomized controlled study of the efficacy and safety of ziprasidone mesylate for injection in the treatment of agitation symptoms in patients with alcohol-induced mental disorders

      摘要
    • 摘要: 目的：探讨注射用甲磺酸齐拉西酮治疗酒精所致精神障碍患者激越症状的有效性和安全性。方法：选取广西南宁市第五人民医院物质依赖科住院治疗的91例酒精所致精神障碍患者作为研究对象，根据随机数字表法将所有患者分为实验组（n=46）和对照组（n=45），分别给予注射用甲磺酸齐拉西酮、氟哌啶醇治疗；在基线（用药前）及用药后第1天、第2天和第3天，均采用阳性和阴性精神症状评定量表（PANSS）、阳性和阴性症状量表兴奋因子（PANSS-EC）、药物副作用量表（TESS）对研究对象进行有效性和安全性的评估；有效性和安全性的主要结局指标是治疗激越症状有效率与TESS 得分改变。结果：实验组与对照组治疗激越症状有效率分别为73.9%、73.3%，两组比较差异无统计学意义（χ2=0.04，P=0.95）；经重复测量方差分析，两组PANSS 得分时间主效应（F=451.12，P< 0.001，偏η2=0.911）、PANSS-EC 得分时间主效应均有显著差异（F=186.42，P< 0.001，偏η2=0.809），用药后，两组PANSS 得分、PANSS-EC 得分均较用药前显著降低（均P< 0.05）；两组PANSS 得分、PANSS-EC 得分组别和组别×时间主效应差异均无统计学意义（均P> 0.05）；两组TESS得分组别主效应（F=5.43，P=0.024，偏η2=0.110）、时间主效应（F=75.39，P< 0.001，偏η2=0.631）和组间×时间交互作用（F=4.27，P=0.026，偏η2=0.089）均有显著差异；简单效应分析表明实验组TESS 得分低于对照组（P< 0.05）。结论：注射用甲磺酸齐拉西酮能改善酒精所致精神障碍患者激越症状，安全性较注射氟哌啶醇注射液高。

       

      Abstract: Objective: To investigate the efficacy and safety of ziprasidone mesylate for injection in the treat-ment of agitation symptoms in patients with alcohol-induced mental disorders.Methods: A total of 91 patients with alcohol-induced mental disorders hospitalized in the Department of Substance Dependence of the Fifth Peo-ple’s Hospital of Nanning City in Guangxi were selected as the study subjects, and all the patients were divided into experimental group (n=46) and control group (n=45) according to the method of randomized table, and were given injectable ziprasidone mesylate and haloperidol treatment respectively.The efficacy and safety of the study subjects were assessed using the Positive and Negative Assessment of Psychiatric Symptoms Scale(PANSS), Positive and Negative Symptom Scale Excitability Factor (PANSS-EC), and the Drug Side Effects Scale (TESS) at baseline (pre-dose), and on day 1, day 2, and day 3 of post-dose.The primary outcome measures of efficacy and safety were the rate of treatment of agitation symptoms and the change in TESS score.Results: The effective rates of treatment of agitation symptoms in the experimental group (n=46) and the control group (n=45) were 73.9% and 73.3%, respectively, which were not sta-tistically different (χ2=0.04, P=0.95).After repeated measures analysis of variance (ANOVA), there was significant difference between the two groups in the time main effect of PANSS score (F=451.12, P< 0.001, bi-ased η2=0.911), and the time main effect of PANSS-EC score (F=186.42, P< 0.001, biased η2=0.809), and after the medication was administered, both groups had a significant decrease in the total PANSS score and the PANSSEC score compared to the before medication(all P< 0.05).There were no significant differences in PANSS score, PANSS-EC score group and group x time main effect between the two groups (all P> 0.05).There were signifi-cant differences between the two groups for the TESS score group main effect (F=5.43, P=0.024, biased η2=0.110), time main effect(F=75.39, P< 0.001, biased η2=0.631), and group x time interaction(F=4.27, P=0.026, bi-ased η2=0.089).Simple effects analysis indicated that the experimental group had lower TESS score than the con-trol group(all P< 0.05).Conclusion: Ziprasidone mesylate for injection improves agitation symptoms in patients with alcohol-induced mental disorders and has higher security than haloperidol injection.

       

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