Efficacy and Safety of Risperidone Microspheres for Injection (Ⅱ) in the Treatment of Patients with Acute Schizophrenia
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, ther...
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| Format: | Article |
| Language: | zho |
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Chinese General Practice Publishing House Co., Ltd
2023-11-01
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| Series: | Zhongguo quanke yixue |
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| Online Access: | https://www.chinagp.net/fileup/1007-9572/PDF/20230224.pdf |
| _version_ | 1797216575708725248 |
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| author | LI Qian, ZHANG Yunshu, YAN Baoping, WANG Jian, MA Yanjuan, WANG Yuan, QIN Yingjie, NA Long, REN Zhiyong, SUN Junwei, DENG Huaili, MA Hongjun, QU Xuehui, ZHOU Nan, SI Tianmei |
| author_facet | LI Qian, ZHANG Yunshu, YAN Baoping, WANG Jian, MA Yanjuan, WANG Yuan, QIN Yingjie, NA Long, REN Zhiyong, SUN Junwei, DENG Huaili, MA Hongjun, QU Xuehui, ZHOU Nan, SI Tianmei |
| author_sort | LI Qian, ZHANG Yunshu, YAN Baoping, WANG Jian, MA Yanjuan, WANG Yuan, QIN Yingjie, NA Long, REN Zhiyong, SUN Junwei, DENG Huaili, MA Hongjun, QU Xuehui, ZHOU Nan, SI Tianmei |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-24T11:48:09Z |
| format | Article |
| id | doaj.art-87ae968f92cb4b24956fd2f50a8b87c9 |
| institution | Directory Open Access Journal |
| issn | 1007-9572 |
| language | zho |
| last_indexed | 2024-04-24T11:48:09Z |
| publishDate | 2023-11-01 |
| publisher | Chinese General Practice Publishing House Co., Ltd |
| record_format | Article |
| series | Zhongguo quanke yixue |
| spelling | doaj.art-87ae968f92cb4b24956fd2f50a8b87c92024-04-09T08:51:00ZzhoChinese General Practice Publishing House Co., LtdZhongguo quanke yixue1007-95722023-11-0126324007401210.12114/j.issn.1007-9572.2023.0224Efficacy and Safety of Risperidone Microspheres for Injection (Ⅱ) in the Treatment of Patients with Acute SchizophreniaLI Qian, ZHANG Yunshu, YAN Baoping, WANG Jian, MA Yanjuan, WANG Yuan, QIN Yingjie, NA Long, REN Zhiyong, SUN Junwei, DENG Huaili, MA Hongjun, QU Xuehui, ZHOU Nan, SI Tianmei01. Peking University Sixth Hospital/Peking University Institute of Mental Health/NHC Key Laboratory of Mental Health (Peking University) /National Clinical Research Center for Mental Disorders, Beijing 100191, China;2. Hebei Provincial Mental Health Center/Hebei Key Laboratory of Major Mental and Behavioral Disorders/the Sixth Clinical Medical College of Hebei University, Baoding 071000, China;3. The Fourth People's Hospital in Urumqi, Urumqi 830002, China;4. Taiyuan Psychiatric Hospital, Taiyuan 030045, China;5. Tianjin Anding Hospital, Tianjin 300222, ChinaBackground 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.https://www.chinagp.net/fileup/1007-9572/PDF/20230224.pdfschizophrenia|antipsychotic agents|long-acting antipsychotics|risperidone microspheres for injection (ⅱ)|treatment outcome|drug-related side effects and adverse reactions |
| spellingShingle | LI Qian, ZHANG Yunshu, YAN Baoping, WANG Jian, MA Yanjuan, WANG Yuan, QIN Yingjie, NA Long, REN Zhiyong, SUN Junwei, DENG Huaili, MA Hongjun, QU Xuehui, ZHOU Nan, SI Tianmei Efficacy and Safety of Risperidone Microspheres for Injection (Ⅱ) in the Treatment of Patients with Acute Schizophrenia Zhongguo quanke yixue schizophrenia|antipsychotic agents|long-acting antipsychotics|risperidone microspheres for injection (ⅱ)|treatment outcome|drug-related side effects and adverse reactions |
| title | Efficacy and Safety of Risperidone Microspheres for Injection (Ⅱ) in the Treatment of Patients with Acute Schizophrenia |
| title_full | Efficacy and Safety of Risperidone Microspheres for Injection (Ⅱ) in the Treatment of Patients with Acute Schizophrenia |
| title_fullStr | Efficacy and Safety of Risperidone Microspheres for Injection (Ⅱ) in the Treatment of Patients with Acute Schizophrenia |
| title_full_unstemmed | Efficacy and Safety of Risperidone Microspheres for Injection (Ⅱ) in the Treatment of Patients with Acute Schizophrenia |
| title_short | Efficacy and Safety of Risperidone Microspheres for Injection (Ⅱ) in the Treatment of Patients with Acute Schizophrenia |
| title_sort | efficacy and safety of risperidone microspheres for injection ii in the treatment of patients with acute schizophrenia |
| topic | schizophrenia|antipsychotic agents|long-acting antipsychotics|risperidone microspheres for injection (ⅱ)|treatment outcome|drug-related side effects and adverse reactions |
| url | https://www.chinagp.net/fileup/1007-9572/PDF/20230224.pdf |
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