Dencker S J, Giös I, Mårtensson E, Nordén T, Nyberg G, Persson R, Roman G, Stockman O, Svärd K O
Department of Clinical Neuroscience, University of Göteborg, Sweden.
Psychopharmacology (Berl). 1994 Feb;114(1):24-30. doi: 10.1007/BF02245440.
The purpose of the study was to investigate clinical and pharmacokinetic parameters concerning perphenazine decanoate (PD) and haloperidol decanoate (HD) with an interval of 3 weeks during a study period of 51 weeks. This was done by using the available drug preparations in chronic schizophrenic patients in a randomised, double-blind, cross-over, multicentre study. In addition, an elimination phase of 6 weeks was added, when no IM injections of the depot drugs were given. Twenty-nine patients in a stable neuroleptic maintenance phase entered the study. The patients were rated during the trial according to the CPRS-SCHZ and CGI scales, the UKU side effect scale and serum concentrations of the drugs and prolactin were monitored. There was no significant difference between the drugs in antipsychotic efficacy or side effects. Thus, the doses were equipotent with regard to the CPRS-SCHZ scores. However, the patients' global improvement rating was higher for PD (52%) than for HD (39%) (P > 0.05). The elimination of both drugs was very slow. No interaction effects between PD and HD were observed. The serum levels of HD were in most patients lower than those recommended for acute-subacute treatment. The mean doses were 117 mg (0.29 mmol), range 20-313 mg PD and 120 mg (0.32 mmol), range 20-350 mg HD. The serum concentrations in nmol/L of perphenazine and haloperidol (week 24) were 0.8-15.9 and 2.3-46.7, respectively.
本研究的目的是在51周的研究期间，以3周为间隔，调查癸酸奋乃静（PD）和癸酸氟哌啶醇（HD）的临床和药代动力学参数。这是通过在慢性精神分裂症患者中使用现有的药物制剂进行随机、双盲、交叉、多中心研究来完成的。此外，增加了一个6周的消除期，在此期间不进行长效药物的肌肉注射。29名处于稳定抗精神病药物维持期的患者进入了研究。在试验期间，根据CPRS-SCHZ和CGI量表对患者进行评分，监测UKU副作用量表以及药物的血清浓度和催乳素。两种药物在抗精神病疗效或副作用方面没有显著差异。因此，就CPRS-SCHZ评分而言，剂量是等效的。然而，PD组患者的整体改善评分（52%）高于HD组（39%）（P>0.05）。两种药物的消除都非常缓慢。未观察到PD和HD之间的相互作用。大多数患者的HD血清水平低于急性-亚急性治疗推荐水平。平均剂量分别为117 mg（0.29 mmol），范围为20-313 mg PD和120 mg（0.32 mmol），范围为20-350 mg HD。在第24周时，奋乃静和氟哌啶醇的血清浓度（nmol/L）分别为0.8-15.9和2.3-46.7。
