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用于治疗精神分裂症的癸酸氟奋乃静长效注射剂和庚酸氟奋乃静长效注射剂

Depot perphenazine decanoate and enanthate for schizophrenia.

作者信息

David A, Quraishi S, Rathbone J

机构信息

Institute of Psychiatry and GKT School of Medicine, King's College School of Medicine and Dentistry, 103 Denmark Hill, London, UK, SE5 8AF.

出版信息

Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD001717. doi: 10.1002/14651858.CD001717.pub2.

Abstract

BACKGROUND

Antipsychotic drugs are usually given orally but compliance with medication given by this route may be difficult to quantify. The development of depot injections in the 1960s gave rise to extensive use of depots as a means of long-term maintenance treatment. Perphenazine decanoate and enanthate are depot antipsychotics that belong to the phenothiazine family and have a piperazine ethanol side chain.

OBJECTIVES

To assess the effects of depot perphenazine decanoate and enanthate versus placebo, oral antipsychotics and other depot antipsychotic preparations for people with schizophrenia in terms of clinical, social and economic outcomes.

SEARCH STRATEGY

We updated previous searches of the Cochrane Schizophrenia Group Register (June 1998), Biological Abstracts (1982-1998), the Cochrane Library (Issue 2, 1998), EMBASE (1980-1998), MEDLINE (1966-1998), and PsycLIT (1974-1998) by searching the Cochrane Schizophrenia Group Register (March 2004). References of all identified trials were also inspected for more studies and industry contacted.

SELECTION CRITERIA

We compared randomised clinical trials focusing on people with schizophrenia where depot perphenazine decanoate and enanthate, oral antipsychotics or other depot preparations.

DATA COLLECTION AND ANALYSIS

We reliably selected studies, quality rated them and extracted data. For dichotomous data we estimated the Relative Risk (RR) with the 95% confidence intervals (CI). Where possible, we calculated the number needed to treat statistic (NNT). Analysis was by intention-to-treat.

MAIN RESULTS

Only four studies (Ahlfors 1980, Eufe 1979, Knudsen 1985c, Tegeler 1979), randomising a total 313 people could be included in this review and this combined with an overall lack of usable data limits any interpretation of results. Perphenazine enanthate was not significantly any better or worse than other depot antipsychotics in most of the main outcomes such as global state, relapse or leaving the study early. We found some differences favouring the control groups for adverse effects. One study (Ahlfors 1980) of six months' duration (n=172), compared perphenazine enanthate to clopenthixol decanoate. There were no differences between the two groups for outcomes of global improvement, relapse and leaving the study early. More people in the perphenazine enanthate group, however, required anticholinergic drugs than those allocated to clopenthixol decanoate (RR 1.12 CI 1.0 to 1.2, NNT 10).A single study (n=64, duration six weeks) compared perphenazine enanthate and its longer acting decanoate ester. Data on relapse and leaving the study early failed to show convincing differences. The enanthate group, however, experienced more movement disorders (RR 1.36, CI 1.1 to 1.8 NNT 5) than those allocated the decanoate ester of the same drug and required more anticholinergic drugs (RR 1.47 CI 1.1 to 2.0, NNT 4).

AUTHORS' CONCLUSIONS: Depot perphenazine is in clinical use in the Nordic countries, Belgium, Portugal and the Netherlands. At a conservative estimate, a quarter of a million people suffer from schizophrenia in those countries and could be treated with depot perphenazine. The total number of participants in the four trials with useful data is 313. None of the studies observed the effects of oral versus depot antipsychotic drugs. Until well conducted and reported randomised trials are undertaken clinicians will be in doubt as to the effects of perphenazine depots and people with schizophrenia should exercise their own judgement or ask to be randomised.

摘要

背景

抗精神病药物通常通过口服给药,但这种给药途径的服药依从性可能难以量化。20世纪60年代长效注射剂的研制使得长效注射剂作为长期维持治疗手段得到广泛应用。癸酸奋乃静和庚酸奋乃静是属于吩噻嗪类且具有哌嗪乙醇侧链的长效抗精神病药物。

目的

评估癸酸奋乃静和庚酸奋乃静长效注射剂与安慰剂、口服抗精神病药物及其他长效抗精神病制剂相比,对精神分裂症患者在临床、社会和经济结局方面的影响。

检索策略

我们通过检索Cochrane精神分裂症研究组注册库(2004年3月)更新了之前对Cochrane精神分裂症研究组注册库(1998年6月)、生物学文摘数据库(1982 - 1998年)、Cochrane图书馆(1998年第2期)、EMBASE数据库(1980 - 1998年)、MEDLINE数据库(1966 - 1998年)和PsycLIT数据库(1974 - 1998年)的检索。还检查了所有已识别试验的参考文献以寻找更多研究,并与制药行业联系。

选择标准

我们比较了针对精神分裂症患者的随机临床试验,这些试验聚焦于癸酸奋乃静和庚酸奋乃静长效注射剂、口服抗精神病药物或其他长效制剂。

数据收集与分析

我们可靠地选择研究、对其质量进行评分并提取数据。对于二分法数据,我们估计相对风险(RR)及其95%置信区间(CI)。在可能的情况下,我们计算治疗所需人数统计量(NNT)。分析采用意向性分析。

主要结果

本综述仅纳入了四项研究(阿尔福斯1980年、欧费1979年、克努森1985c年、特格勒1979年),共随机分配313人,并且总体缺乏可用数据限制了对结果的任何解读。在大多数主要结局如整体状态、复发或提前退出研究方面,庚酸奋乃静并不比其他长效抗精神病药物显著更好或更差。我们发现对照组在不良反应方面有一些优势。一项为期六个月(n = 172)将庚酸奋乃静与癸酸氯哌噻吨进行比较的研究(阿尔福斯1980年)发现,两组在整体改善、复发和提前退出研究的结局方面没有差异。然而,庚酸奋乃静组中需要抗胆碱能药物的人数比分配到癸酸氯哌噻吨组的更多(RR 1.12,CI为1.0至1.2,NNT为 10)。一项单一研究(n = 64,为期六周)比较了庚酸奋乃静及其长效癸酸酯。关于复发和提前退出研究的数据未能显示出令人信服的差异。然而,庚酸奋乃静组比分配到同一药物癸酸酯组的人出现更多运动障碍(RR 1.36,CI为1.1至1.8,NNT为5),且需要更多抗胆碱能药物(RR 1.47,CI为1.1至2.0,NNT为4)。

作者结论

长效癸酸奋乃静在北欧国家、比利时、葡萄牙和荷兰临床使用。据保守估计,这些国家有25万人患有精神分裂症,可用长效癸酸奋乃静进行治疗。四项有可用数据的试验中的参与者总数为313人。没有研究观察到口服与长效抗精神病药物的效果差异。在进行良好且报告规范的随机试验之前,临床医生将对奋乃静长效注射剂的效果存疑,精神分裂症患者应自行判断或要求参与随机试验。

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