Jostell K G, Lapierre Y D
Astra Research Centre, Södertälje, Sweden.
Acta Psychiatr Scand Suppl. 1990;358:48-50. doi: 10.1111/j.1600-0447.1990.tb05286.x.
The possible relationship between plasma concentration of remoxipride and antipsychotic effect/adverse symptoms has been evaluated in a 6-week double-blind dose-finding study in schizophrenic patients. The study comprised 3 parallel groups with fixed daily doses of 30-90 mg, 120-240 mg or 300-600 mg, divided in order to be given three times a day. A total of 79 patients from the three groups, who were treated with the maximum dose for 4 weeks or more, were included in the analysis. All patients had reached steady-state at week 2 and the intra-individual trough remoxipride plasma levels remained stable over the study period. The mean steady-state trough concentrations were found to be linearly related to the dose. Responders to remoxipride treatment were observed over the total concentration range of 0.24-13.50 mumols/l. Reductions of dose or discontinuations of treatment due to adverse symptoms were not associated with elevated remoxipride concentrations. In conclusion, no obvious relationship between plasma concentration of remoxipride and its antipsychotic effect or adverse symptoms was established.
在一项针对精神分裂症患者的为期6周的双盲剂量探索研究中,已对瑞莫必利的血浆浓度与抗精神病作用/不良症状之间的可能关系进行了评估。该研究包括3个平行组,固定日剂量分别为30 - 90毫克、120 - 240毫克或300 - 600毫克,分三次给药。分析纳入了来自这三组的共79例患者,他们接受最大剂量治疗4周或更长时间。所有患者在第2周时达到稳态,且在研究期间个体内瑞莫必利血浆谷浓度保持稳定。发现平均稳态谷浓度与剂量呈线性相关。在0.24 - 13.50微摩尔/升的总浓度范围内均观察到了对瑞莫必利治疗有反应的患者。因不良症状而减少剂量或停药与瑞莫必利浓度升高无关。总之,未确立瑞莫必利血浆浓度与其抗精神病作用或不良症状之间的明显关系。