Wang Gang, Ding Fan, Chawarski Marek Cezary, Hao Wei, Liu Xuebing, Deng Qijian, Ouyang Xuan
Affiliated Wuhan Mental Health Center, Tongji Medical College of Huazhong University of Science & Technology, Wuhan, China.
Wuhan Wudong Hospital, The Second Mental Hospital of Wuhan, Wuhan, China.
Front Psychiatry. 2020 Apr 1;11:237. doi: 10.3389/fpsyt.2020.00237. eCollection 2020.
The efficacy or tolerability of paliperidone extended release (ER) in the treatment of methamphetamine (METH)-associated psychosis (MAP) is unknown. This study was designed to assess the tolerability and efficacy of paliperidone ER and risperidone for the treatment of MAP in China.
This 25-day randomized clinical trial involved 120 patients with acute MAP symptoms who were randomized to receive either paliperidone ER or risperidone from baseline to day 25 of an inpatient hospital stay. The primary outcome was changes in the severity of psychosis, which were assessed using the Positive and Negative Syndrome Scale (PANSS) total score changes from baseline to endpoint.
Overall, 84% of the patients completed the entire study protocol. The PANSS total score, the Clinical Global Impressions-Severity of Illness scale (CGI-S) score, and a METH craving score assessed by a visual analog scale (VAS) showed statistically significant improvements from baseline for the patients in both groups ( < 0.01). The Simpson-Angus Scale (SAS) and the Barnes Akathisia Rating Scale (BARS) scores increased from baseline during treatment in both groups ( < 0.01); there were statistically significant differences between the treatment groups in the SAS scores ( < 0.01). Measures of hypermyotonia, salivation, and dizziness were significantly higher in the risperidone-treated patients than in the paliperidone ER-treated patients (all < 0.05).
Paliperidone ER and risperidone had similar efficacy and were generally tolerable in the treatment of MAP; however, paliperidone ER had a more favorable adverse event profile than risperidone, particularly regarding extrapyramidal and prolactin-increasing effects.
ClinicalTrials.gov, identifier NCT01822730. Full date of first registration:03/28/2013.
帕利哌酮缓释剂（ER）治疗甲基苯丙胺（METH）所致精神病（MAP）的疗效或耐受性尚不清楚。本研究旨在评估帕利哌酮ER和利培酮在中国治疗MAP的耐受性和疗效。
这项为期25天的随机临床试验纳入了120例急性MAP症状患者，他们在住院期间从基线到第25天被随机分配接受帕利哌酮ER或利培酮治疗。主要结局是精神病严重程度的变化，使用阳性和阴性症状量表（PANSS）从基线到终点的总分变化进行评估。
总体而言，84%的患者完成了整个研究方案。两组患者的PANSS总分、临床总体印象-疾病严重程度量表（CGI-S）评分以及通过视觉模拟量表（VAS）评估的METH渴求评分均较基线有统计学意义的改善（<0.01）。两组患者治疗期间的辛普森-安格斯量表（SAS）和巴恩斯静坐不能评定量表（BARS）评分均较基线升高（<0.01）；治疗组间SAS评分有统计学意义的差异（<0.01）。利培酮治疗的患者肌张力亢进、流涎和头晕的测量值显著高于帕利哌酮ER治疗的患者（均<0.05）。
帕利哌酮ER和利培酮在治疗MAP方面疗效相似且总体耐受性良好；然而，帕利哌酮ER的不良事件谱比利培酮更有利，尤其是在外锥体外系和催乳素升高效应方面。
ClinicalTrials.gov，标识符NCT01822730。首次注册的完整日期：2013年3月28日。
