Marder S R, Van Putten T, Mintz J, Lebell M, McKenzie J, May P R
Arch Gen Psychiatry. 1987 Jun;44(6):518-21. doi: 10.1001/archpsyc.1987.01800180028005.
We evaluated the effectiveness and the side effects of what we defined as low (5-mg) and conventional (25-mg) doses of fluphenazine decanoate administered every two weeks in a double-blind comparison. Subjects were 66 patients who fulfilled DSM-III criteria for schizophrenic disorder. Evaluation of the survival with each dose revealed no significant difference at one year, but significantly better survival was seen with the 25-mg dose (64%) than the 5-mg dose (31%) at two years. There was no significant difference in survival when the clinician was permitted to make a dosage adjustment up to 10 mg in the low-dose group and 50 mg in the higher-dose group when the patient demonstrated evidence of a symptomatic exacerbation. Patients assigned to the higher dose appeared to feel more uncomfortable during the early months of the study, as indicated by significantly higher scores on subscales of the Hopkins Symptom Checklist-90R and higher side effect scores for retardation and akathisia. Implications for clinical practice are discussed.
我们进行了一项双盲对照研究，评估了每两周注射一次我们定义的低剂量（5毫克）和常规剂量（25毫克）癸酸氟奋乃静的有效性和副作用。研究对象为66名符合精神分裂症障碍DSM-III标准的患者。对每种剂量下患者留存情况的评估显示，一年时无显著差异，但两年时，25毫克剂量组的留存情况（64%）显著优于5毫克剂量组（31%）。当患者出现症状加重迹象时，如果允许临床医生在低剂量组中将剂量调整至最高10毫克、在高剂量组中将剂量调整至最高50毫克，两组患者的留存情况无显著差异。在研究的最初几个月，分配到高剂量组的患者似乎感觉更不舒服，这体现在霍普金斯症状清单90项修订版（Hopkins Symptom Checklist-90R）分量表得分显著更高，以及迟滞和静坐不能的副作用得分更高。本文讨论了该研究结果对临床实践的意义。
