Knudsen P, Hansen L B, Højholdt K, Larsen N E
Acta Psychiatr Scand Suppl. 1985;322:29-40.
In an open, prospective 12 month study of perphenazine decanoate (PD), 42 psychotic patients diagnosed according to DSM-III were treated with a fixed depot interval and an individual dose, guided by gas chromatographic perphenazine plasma concentration monitoring combined with clinical evaluation. Degree of illness was rated using a social-psychiatric CGI-scale and extrapyramidal side effects were evaluated by means of a modified Simpson and Angus rating scale. After six months of treatment, a statistically significant improvement was found (p less than 0.001). During the last six months a further slight reduction in mean CGI-scores was observed. Mild to moderate extrapyramidal side effects occurred in 9 patients (21%) principally during the initial phase of therapy. No other side effects or changes in blood chemistry were found during the study. Plasma concentrations of perphenazine increased during the initial 3 months and stabilized hereafter. There were however, large intra- and inter-individual variations in the perphenazine plasma concentration/dose ratio. In addition, it was observed that plasma concentrations of perphenazine were significantly higher in patients who had been treated with neuroleptics for more than 10 years compared to those who had been treated 5 years or less. This observation indicates gradual development of tolerance to neuroleptic treatment. This study demonstrates that PD is a safe and effective remedy for maintenance therapy in psychotic patients.
在一项为期12个月的奋乃静癸酸酯(PD)开放性前瞻性研究中,42名根据《精神疾病诊断与统计手册》第三版(DSM-III)诊断的精神病患者,在气相色谱法监测奋乃静血浆浓度并结合临床评估的指导下,采用固定的长效注射间隔和个体化剂量进行治疗。使用社会精神病学临床总体印象量表(CGI量表)对疾病严重程度进行评分,并通过改良的辛普森和安格斯评定量表评估锥体外系副作用。治疗6个月后,发现有统计学显著改善(p<0.001)。在最后6个月中,观察到平均CGI评分进一步略有下降。9名患者(21%)出现轻度至中度锥体外系副作用,主要发生在治疗初期。研究期间未发现其他副作用或血液生化指标变化。奋乃静血浆浓度在最初3个月内升高,此后趋于稳定。然而,奋乃静血浆浓度/剂量比在个体内和个体间存在很大差异。此外,观察到与接受治疗5年或更短时间的患者相比,接受抗精神病药物治疗超过10年的患者奋乃静血浆浓度显著更高。这一观察结果表明对抗精神病药物治疗的耐受性逐渐发展。本研究表明,PD是精神病患者维持治疗的一种安全有效的药物。