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用于治疗精神分裂症的长效氟奋乃静

Depot fluphenazine for schizophrenia.

作者信息

Adams C E, Eisenbruch M

机构信息

Cochrane Schizophrenia Group, Summertown Pavilion, Middle Way, Summertown, Oxford, UK, OX2 7LG.

出版信息

Cochrane Database Syst Rev. 2000(2):CD000307. doi: 10.1002/14651858.CD000307.

Abstract

BACKGROUND

In the years after the discovery of oral antipsychotic medications, it became clear that there was a link between stopping medication and relapse of psychotic symptoms. A series of long-acting preparations was developed. These depot preparations, are frequently used for those who find taking oral medication on a regular basis difficult or unacceptable. However, it has been a consistent concern that any reduction in relapse rate afforded by the depot preparations may be offset by an increase in undesirable side effects. There is one oral preparation and two depot forms (enanthate (Moditen) and decanoate (Modecate)). The decanoate form is more frequently used but both versions were reviewed in this work.

OBJECTIVES

To compare depot fluphenazine medication to oral fluphenazine for treatment of schizophrenia.

SEARCH STRATEGY

Electronic searches of Biological Abstracts, CSG's Register, EMBASE, LILACS, MEDLINE, PsycLIT, SCISEARCH, hand searching the references of all identified studies and contacting the manufacturers of the compounds.

SELECTION CRITERIA

All randomised clinical trials that compared fluphenazine enanthate or fluphenazine decanoate to oral fluphenazine for people with schizophrenia or other psychoses were included.

DATA COLLECTION AND ANALYSIS

One reviewer (CEA) inspected study citations and then the second reviewer (ME) independently inspected 20% of citations to ensure reliability. Full reports of the studies of agreed relevance were obtained and data extracted in the same manner by the authors. Trials were allocated to three quality categories, as described in the Cochrane Collaboration Handbook. Data were analysed on an intention-to-treat basis, and, where possible, parametric continuous data were presented. Tests for heterogeneity were undertaken.

MAIN RESULTS

Data were very limited. There was no difference between fluphenazine hydrochloride and its depot form for outcomes such as global impression of functioning, relapse/re-hospitalisation, poor initial response to treatment, leaving the study early, depressed mood / suicide and side effects such as movement disorders, uncomfortable dry mouth, sleep problems and weight gain were equally common in both groups. Direct measures of mental state, social functioning and satisfaction with care were either not measured or presented in such as way as to make any analysis impossible.

REVIEWER'S CONCLUSIONS: All six included studies relate to people with schizophrenia who are already stable on oral fluphenazine or seem contented to stay in the studies. How the data from this review relate to everyday psychiatric practices, where compliance with medication is more problematic, is debatable. The use of depot fluphenazine continues to be based on clinical judgement rather than evidence from methodical evaluation within trials. A large pragmatic randomized controlled trial is long overdue.

摘要

背景

在发现口服抗精神病药物后的数年里,逐渐明确停药与精神病症状复发之间存在关联。一系列长效制剂应运而生。这些长效制剂常用于那些难以定期服用口服药物或对此无法接受的患者。然而,一直令人担忧的是,长效制剂所带来的复发率降低可能会被不良副作用的增加所抵消。有1种口服制剂和2种长效剂型(庚酸酯(氟奋乃静庚酸酯)和癸酸酯(氟奋乃静癸酸酯))。癸酸酯剂型使用更为频繁,但本研究对两种剂型都进行了综述。

目的

比较长效氟奋乃静与口服氟奋乃静治疗精神分裂症的效果。

检索策略

对《生物学文摘》、CSG登记册、EMBASE、LILACS、MEDLINE、《心理学文摘》、SCISEARCH进行电子检索,人工查阅所有已识别研究的参考文献,并联系化合物制造商。

入选标准

纳入所有比较氟奋乃静庚酸酯或氟奋乃静癸酸酯与口服氟奋乃静治疗精神分裂症或其他精神病患者的随机临床试验。

数据收集与分析

一位评审员(CEA)检查研究文献,然后第二位评审员(ME)独立检查20%的文献以确保可靠性。获取符合相关性的研究的完整报告,作者以相同方式提取数据。按照Cochrane协作手册中的描述,将试验分为三个质量类别。数据按意向性分析原则进行分析,尽可能呈现参数连续性数据。进行异质性检验。

主要结果

数据非常有限。盐酸氟奋乃静与其长效剂型在功能的总体印象、复发/再次住院、对治疗的初始反应不佳、提前退出研究、情绪低落/自杀以及运动障碍、口干不适、睡眠问题和体重增加等副作用方面没有差异。精神状态、社会功能和对护理的满意度的直接测量指标要么未进行测量,要么呈现方式使得无法进行任何分析。

评审员结论

纳入的6项研究均涉及已在口服氟奋乃静治疗下病情稳定或似乎愿意留在研究中的精神分裂症患者。本综述的数据与日常精神病学实践(其中药物依从性问题更大)的相关性存在争议。长效氟奋乃静的使用仍基于临床判断,而非来自试验中系统评估的证据。早就应该进行一项大型实用随机对照试验了。

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