| Background Agitated behaviour in men with schizophrenia has serious individual and social consequences. Non-invasive formulations of drug delivery may help to rapidly control agitation and may improve the overall patient experience, but there are limited studies of olanzapine orally dissolved film for the treatment of agitated behaviour. Objective To compare the efficacy and safety of 10 mg/d olanzapine orally dissolved film with 8 mg/d haloperidol on the improvement of agitated behaviours in male patients with schizophrenia, with a view to providing a reference for the treatment of agitated behaviours. Methods From May 2022 to July 2023, schizophrenic patients (n=44) with agitated behaviour who met the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) were recruited in the male closed ward of the Third People's Hospital of Fuyang City, Anhui Province, China. They were divided into 22 cases each in the study group and the control group using the random number table method, and the study group was treated with olanzapine orally dissolved membrane 10 mg/d, while the control group was treated with intramuscular haloperidol 8 mg/d. The severity of agitated behaviour was assessed using the Excited Component of Positive and Negative Syndrome Scale (PANSS-EC) and the Agitation Calmness Evaluation Scale (ACES) pre-treatment and 6 h after administration of the drug. Drug side effects were assessed using the Rating Scale for Extrapyramidal Side Effects (RSESE) and the Barnes Akathisia Rating Scale (BARS) before and 6 hours after treatment. Results After 6h of drug administration, the difference between the PANSS-EC score and ACES score of the two groups was not statistically significant (F=0.039, P=0.844; F=0.082, P=0.776), the difference between the rates of therapeutic response of the two groups was not statistically significant (χ2=0.419, P=0.517), and the incidence rate of adverse reactions was lower than that of the control group in the study group, and the difference was statistically significant (χ2=4.659, P=0.031), there was no statistically significant difference between the BARS scores of the two groups (F=0.907, P=0.347), and the RSESE scores of the study group were lower than those of the control group, with a statistically significant difference (F=55.503, P<0.01). No serious adverse reactions were reported in either group. Conclusions: In the treatment of agitation in patients with schizophrenia, olanzapine orally dissolved film and intramuscular haloperidol are antipsychotics with similar effects, both safe and well tolerated, while olanzapine orally dissolved film performs better in terms of side effects. |