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精神分裂症长期药物治疗的起始:口服氟奋乃静与长效氟奋乃静的剂量及副作用比较

The initiation of long-term pharmacotherapy in schizophrenia: dosage and side effect comparisons between oral and depot fluphenazine.

作者信息

Schooler N R, Levine J

出版信息

Pharmakopsychiatr Neuropsychopharmakol. 1976 Jul;9(4):159-69.

PMID:790413
Abstract

This report focuses on two comparisons between oral and depot fluphenazine specifically FPZ decanoate: 1) can equivalent dosages for the two drugs be established and do these equivalencies change over six months of treatment; 2) what are the side effects seen with the two drugs during the early weeks of administration. Patients in the study receive either oral or depot FPZ as the active treatment but in order to preserve double blind conditions, they are also given the other treatment in placebo form. No dosage equivalence is established by the protocol, however, if dosage is adjusted, both forms must be changed and in the same direction. During the first weeks of treatment there is a linear relationship between the two dosage forms but a range of relatively low dosages of the oral compound (5-20 mg) is associated with a single dose (25 mg/q 3 weeks) of FPZ decanoate. At higher dosages of the oral drug the relationship is linear. Side effects of some kind are noted in over 60 percent of patients in both treatment groups after four weeks of treatment, while symptoms of at least moderate severity occur in almost 40 percent. Only symptoms involving the extrapyramidal system and sleep disturbance are observed in more than 20 percent of the patients. Benztropine was prescribed only if needed and was administered to 65% of patients. In general, those receiving benztropine had more side effects than those who did not. These differences reached significance for extrapyramidal symptoms and depression. Based on these data, we conclude that at the dosages used in this study there are no side effect differences between these two forms of fluphenazine in the early weeks of administration. Dosage equivalence between the two drugs can be set within the range of 5-60 mg/day oral and 12.5-100 mg/three weeks depot.

摘要

本报告重点关注口服氟奋乃静和长效氟奋乃静(特别是癸酸氟奋乃静)之间的两项比较:1)能否确定两种药物的等效剂量,以及这些等效剂量在六个月的治疗过程中是否会发生变化;2)在给药的最初几周内,两种药物会出现哪些副作用。该研究中的患者接受口服或长效氟奋乃静作为活性治疗药物,但为了保持双盲条件,他们还会以安慰剂形式接受另一种治疗。研究方案未确定剂量等效性,然而,如果调整剂量,两种形式都必须改变且方向相同。在治疗的最初几周内,两种剂型之间存在线性关系,但口服化合物的一系列相对低剂量(5 - 20毫克)与单次剂量(25毫克/每三周)的癸酸氟奋乃静相关。口服药物剂量较高时,关系呈线性。治疗四周后,两个治疗组中超过60%的患者出现了某种副作用,而至少中度严重程度的症状在近40%的患者中出现。只有超过20%的患者出现涉及锥体外系和睡眠障碍的症状。仅在必要时开具苯海索,65%的患者使用了该药。一般来说,接受苯海索治疗的患者比未接受治疗的患者有更多副作用。这些差异在锥体外系症状和抑郁方面具有统计学意义。基于这些数据,我们得出结论,在本研究使用的剂量下,这两种形式的氟奋乃静在给药的最初几周内没有副作用差异。两种药物的剂量等效性可设定在口服5 - 60毫克/天和长效注射12.5 - 100毫克/每三周的范围内。

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