Zhongguo quanke yixue (Nov 2023)
Efficacy and Safety of Risperidone Microspheres for Injection (Ⅱ) in the Treatment of Patients with Acute Schizophrenia
Abstract
Background Long-acting antipsychotics are currently important therapeutic options for the long-term treatment of schizophrenia. Risperidone microspheres for injection (Ⅱ) has been modified in dosage form to ensure fast acting without oral antipsychotic supplementation during treatment, however, there is a lack of studies on the efficacy and safety of it. Objective To evaluate the efficacy and safety of risperidone microspheres for injection (Ⅱ) in patients with acute schizophrenia. Methods This is a single-arm multicenter prospective study. The patients aged 18-55 years with acute schizophrenia from August 2021 to April 2022 at five study centers including Peking University Sixth Hospital, Hebei Provincial Mental Health Center, the Fourth People's Hospital in Urumqi, Taiyuan Psychiatric Hospital and Tianjin Anding Hospital were included and given variable dose of risperidone microspheres for injection (Ⅱ) of 25.0 mg/2 weeks, 37.5 mg/2 weeks or 50.0 mg/2 weeks and followed up for 8 weeks. The Positive and Negative Symptom Scale (PANSS), Clinical Global Impression Scale (CGI-S) and the Udvalg for Kliniske Undersogelser (UKU) Side Effects Rating Scale were used for evaluation at baseline and the end of week 2, 4, 6 and 8. In addition, Personal and Social Performance (PSP) Scale were evaluated and laboratory tests were collected at baseline and the end of week 8. Results A total of 58 patients were included in the study. PANSS total score, PANSS-positive score, PANSS-negative score, PANSS-general psychopathology score and CGI-S score were significantly reduced at the end of week 2, 4, 6 and 8 compared to baseline (P<0.001). The effective rates of PANSS total score reduction were 37.9% (22/58), 70.7% (41/58), 89.7% (52/58) and 89.7% (52/58) at the end of week 2, 4, 6 and 8, respectively. The PSP score at the end of week 8 (71.00±14.99) was higher than at baseline (46.28±15.43) (P<0.001). The average plasma concentration was (12.94±8.47), (13.23±10.86), (21.09±13.04), (23.64±14.23) and (29.08±19.51) μg/L at the end of week 1, 2, 4, 6 and 8, respectively. Common adverse reactions included tremor, dystonia, and constipation, all of which ranged from mild to moderate, with no serious adverse reactions or discontinuations due to no adverse reactions. Plasma prolactin (PRL) level was increased at the end of week 8 compared with baseline (P<0.05) . Conclusion Risperidone microspheres for injection (Ⅱ) can act fast without oral antipsychotic supplementation and effectively improve the multi-dimensional symptoms of acute schizophrenia with acceptable tolerance.
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