Astra Clinical Research Unit, 10 York Place, Edinburgh EHI 3EP.
J Psychopharmacol. 1992 Jan;6(4):519-25. doi: 10.1177/026988119200600408.
An open non-comparative multicentre study was carried out to evaluate the safety and tolerability of remoxipride over a treatment period of 12 months. The efficacy of the drug in controlling psychotic symptoms was also monitored. Eighty-five men and women aged 18-69 who met the Research Diagnostic Criteria for schizophrenia were entered into the study and after withdrawal of previous antipsychotic medication, treated orally with remoxipride 75-300 mg b.i.d. The treatment was well tolerated and most of the adverse symptoms reported were reduced in incidence at the last rating compared to baseline. Sleep problems (insomnia and increased sleep) and increased thirst showed an increase in incidence during treatment. The incidence of extrapyramidal side effects was low and less than at baseline; there was no evidence that remoxipride produced an increase in abnormal involuntary movements, the median weight of the group did not alter and remoxipride produced no significant effect on cardiovascular, clinical chemistry and haematology variables. It appeared effective in controlling psychotic symptoms and produced some improvement on over one third of the patients despite the fact that the majority of patients entered were not in a productive phase of their illness. The results indicate that remoxipride will be well tolerated and effective when given for the maintenance treatment of schizophrenia.
一项为期 12 个月的开放性、非对照、多中心研究旨在评估罗美必利的安全性和耐受性。同时也监测了该药物控制精神病症状的疗效。85 名年龄在 18-69 岁之间的男性和女性,符合精神分裂症的研究诊断标准,在停用先前的抗精神病药物后,接受罗美必利 75-300mg,每日两次的口服治疗。治疗耐受性良好,与基线相比,大多数报告的不良反应在最后一次评估时发生率降低。睡眠问题(失眠和睡眠增加)和口渴增加在治疗期间的发生率增加。锥体外系副作用的发生率较低,低于基线;没有证据表明罗美必利会导致异常不自主运动增加,该组的平均体重没有改变,罗美必利对心血管、临床化学和血液学变量没有显著影响。它似乎对控制精神病症状有效,并使三分之一以上的患者得到改善,尽管大多数患者进入研究时并没有处于疾病的活跃期。结果表明,罗美必利在精神分裂症的维持治疗中具有良好的耐受性和疗效。