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

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.