Long-acting antipsychotics are one of the important choices in the maintenance treatment of patients with schizophrenia, which can effectively prevent relapse. Risperidone microspheres for injection (Ⅱ) has been improved in dosage form to maintain steady-state concentration, however there is currently a lack of study for efficacy on maintenance phase treatment.

To evaluate the efficacy and safety of risperidone microspheres for injection (Ⅱ) in the maintenance treatment for schizophrenia.

This was a single-arm, self-controlled, multicenter study. From May 2021 to May 2022, patients with schizophrenia, aged 18-65 years, were enrolled from 3 centers: Shanghai Mental Health Center, Hangzhou Seventh People's Hospital, and Suzhou Guangji Hospital. All patients switched from oral risperidone to risperidone microspheres for injection (Ⅱ) for maintenance treatment. During the treatment period, 25.0 mg, 37.5 mg or 50.0 mg were injected every two weeks, followed up for 12 weeks. At baseline, and at the end of 2, 4, 8, and 12 weeks, the social functioning was assessed using the Personal and Social Functioning Scale (PSP) ; the clinical symptoms and overall changes were assessed using the Positive and Negative Symptoms Scale (PANSS) and the Clinical Global Impression Scale (CGI) ; the health status was assessed using the European Five-Dimensional Survival Quality Inventory (EQ-5D) ; The Simpson-Angus Scale (SAS), Barnes Akathisia Rating Scale (BARS), and Abnormal Involuntary Movement Rating Scale (AIMS) were used to assess the extrapyramidal symptoms (EPS), and the laboratory indices were also collected.

A total of 71 patients were included in the study. The total PSP scores of patients at the end of the 2, 4, 8 and 12 weeks of treatment were (48.20±24.65), (49.07±25.81), (50.46±26.96), and (51.85±28.16), respectively, which were higher than the baseline (43.89±22.32) (P<0.05). The PANSS total score, positive symptom scale, negative symptom scale, and general psychopathology scale scores were reduced at the end of 12 weeks of treatment compared with baseline (P<0.05). CGI-S scores were lower than baseline (P<0.05), CGI-I scores were significantly reduced at the end of 12 weeks compared with the end of 4 weeks after treatment (P<0.01), and EQ-5D scores were higher than baseline (P<0.05). Common adverse reactions were increased prolactin, EPS, and dizziness, and no serious adverse reactions (SAE) or drop-out patients due to AE were observed.

Risperidone microspheres for injection (Ⅱ) can effectively improve the clinical symptoms of schizophrenia in the maintenance period, and it is well tolerated.

长效抗精神病药是精神分裂症患者维持治疗中的重要选择之一，能有效预防复发。注射用利培酮微球（Ⅱ）在剂型上进行了改良，能够保持血药浓度平稳，但目前尚缺乏维持期临床疗效的相关研究。

评价注射用利培酮微球（Ⅱ）在维持期精神分裂症患者中的疗效和安全性。

本研究为单臂、自身对照的多中心研究。纳入2021年5月—2022年5月上海市精神卫生中心、杭州市第七人民医院、苏州市广济医院3个中心，以18~65岁维持期精神分裂症患者为研究对象，由口服利培酮制剂换成注射用利培酮微球（Ⅱ）维持治疗，治疗期间每2周注射25.0 mg、37.5 mg或50.0 mg，随访12周，分别在基线及治疗2、4、8、12周末使用个人与社会功能量表（PSP）评定患者社会功能；使用阳性和阴性症状量表（PANSS）、临床总体印象量表（CGI）评定患者临床症状及总体病情变化；使用欧洲五维生存质量量表（EQ-5D）评定患者健康状况；使用辛普森-安格斯量表（SAS）、巴恩斯静坐不能评定量表（BARS）、不自主运动评定量表（AIMS）评定患者锥体外系反应，并采集患者实验室指标。

共纳入71例患者。治疗第2、4、8、12周末患者PSP总分分别为（48.20±24.65）、（49.07±25.81）、（50.46±26.96）、（51.85±28.16）分，均高于基线[（43.89±22.32）分]（P<0.05）。治疗12周末患者PANSS总分、阳性症状量表、阴性症状量表和一般精神病理量表评分均较基线降低（P<0.05）。CGI-S评分较基线下降（P<0.05），CGI-I评分12周末较4周末下降（P<0.01），EQ-5D评分较基线提高（P<0.05）。常见不良反应为泌乳素升高、锥体外系反应（EPS）、头晕等，无严重不良反应及因不良反应脱落者。

注射用利培酮微球（Ⅱ）可有效改善精神分裂症患者维持期的临床症状，耐受性良好。