Gitlin M J, Midha K K, Fogelson D, Nuechterlein K
Department of Psychiatry and Biobehavioral Science, University of California, Los Angeles 90024.
J Clin Psychopharmacol. 1988 Feb;8(1):53-6.
We discontinued fluphenazine decanoate using a double-blind, crossover random order design, in 12 recent onset clinically stable schizophrenics who had been given fluphenazine decanoate 12.5 mg intramuscularly every 2 weeks for at least 1 year prior to drug withdrawal. Each condition (drug or placebo) lasted 12 weeks. Using a radioimmunoassay verified by comparison to a gas chromatographic-mass spectrometric method, plasma fluphenazine levels were measured every 2 weeks during drug continuation and drug withdrawal conditions. No patient relapsed over the 24-week period of the study. Mean fluphenazine levels between drug continuation and withdrawal conditions showed a progressively larger difference over time, although significant differences were not seen until week 8. By week 12 after drug withdrawal, 33% of subjects still showed notable plasma fluphenazine levels. On the basis of our preliminary findings, we suggest that 2-week intervals between injections may be too short and that wider intervals may achieve similar clinical results.
我们采用双盲、交叉随机顺序设计,对12例近期发病且临床症状稳定的精神分裂症患者停用癸酸氟奋乃静。这些患者在停药前至少1年,每2周接受12.5mg癸酸氟奋乃静肌肉注射。每种情况(用药或安慰剂)持续12周。通过与气相色谱 - 质谱法比较验证的放射免疫分析法,在持续用药和停药期间每2周测量血浆氟奋乃静水平。在研究的24周期间,没有患者复发。尽管直到第8周才出现显著差异,但持续用药和停药状态下的平均氟奋乃静水平随时间推移差异逐渐增大。停药后第12周,33%的受试者血浆氟奋乃静水平仍显著。基于我们的初步研究结果,我们认为每2周的注射间隔可能过短,更大的间隔可能会取得相似的临床效果。