Mao Zhen, Dong Fang, Li Anning, Li Feng, Zhu Junhong, Du Xiangdong, Wu Gang, Deng Huaili, Yu Xueqin, Liu Jintong, Xie Shiping, Tang Xiaowei, Wang Gang
The National Clinical Research Center for Mental Disorders, Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, 100088, China.
Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, 100069, China.
BMC Psychiatry. 2024 Dec 30;24(1):959. doi: 10.1186/s12888-024-06455-y.
This study investigates the effectiveness and safety of aripiprazole oral solution in Chinese patients with schizophrenia.
This was a multicenter, single-arm phase IV study involving 134 patients in China in the acute stage of schizophrenia from May 2021 to July 2022. The patients received aripiprazole oral solution 10 - 30 mg/d for 12 weeks. The effectiveness endpoints included the Positive and Negative Symptom Scale (PANSS) and the Clinical Global Impression (CGI) scale score. The safety endpoints included adverse events, laboratory inspection indicators (including the serum prolactin level [PRL]), and waist circumferences (WC).
Ultimately, 86 patients (64.18%) completed the trial, and 21 patients (15.67%) dropped out due to poor effectiveness. From baseline to week eight, 43.28% of patients had a PANSS reduction of ≥ 50%, 82.84% of patients improved in the CGI-Improvement (CGI-I scale score of 1 - 3), and the percentage of patients with abnormal PRL and waist circumferences decreased significantly. In total, 45 patients (33.58%) experienced mild adverse drug reactions predominately manifested as extrapyramidal symptoms (EPSs; 9.70%), constipation (8.96%), and palpitations (7.46%). Upon further subgroup analysis, aripiprazole oral solution demonstrated significantly improved effectiveness in first-episode schizophrenia patients and those with symptoms of agitation.
Aripiprazole oral solution displayed positive clinical effectiveness and favorable tolerability in Chinese patients in the acute stage of schizophrenia.
Clinical trial registration number: ChiCTR2100044653. Name of trial registration: A real-world study of Aripiprazole Oral Solution in the treatment of schizophrenia (Registration date: 25/03/2021). The full trial protocol can be accessed at the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/ ).
本研究旨在调查阿立哌唑口服溶液在中国精神分裂症患者中的有效性和安全性。
这是一项多中心、单臂IV期研究，于2021年5月至2022年7月在中国纳入了134例处于精神分裂症急性期的患者。患者接受10 - 30mg/d的阿立哌唑口服溶液治疗，为期12周。有效性终点包括阳性与阴性症状量表（PANSS）和临床总体印象（CGI）量表评分。安全性终点包括不良事件、实验室检查指标（包括血清催乳素水平[PRL]）和腰围（WC）。
最终，86例患者（64.18%）完成试验，21例患者（15.67%）因疗效不佳退出。从基线至第8周，43.28%的患者PANSS降低≥50%，82.84%的患者在CGI改善量表（CGI - I量表评分为1 - 3）上有所改善，PRL和腰围异常的患者百分比显著下降。共有45例患者（33.58%）发生轻度药物不良反应，主要表现为锥体外系症状（EPSs；9.70%）、便秘（8.96%）和心悸（7.46%）。进一步亚组分析显示，阿立哌唑口服溶液在首发精神分裂症患者和有激越症状的患者中疗效显著改善。
阿立哌唑口服溶液在中国精神分裂症急性期患者中显示出积极的临床疗效和良好的耐受性。
临床试验注册号：ChiCTR2100044653。试验注册名称：阿立哌唑口服溶液治疗精神分裂症的真实世界研究（注册日期：2021年3月25日）。完整的试验方案可在中国临床试验注册中心（http://www.chictr.org.cn/）获取。
