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精神分裂症患者停用氟哌啶醇。

Haloperidol discontinuation for people with schizophrenia.

作者信息

Essali Adib, Turkmani Khaled, Aboudamaah Shaimaa, AbouDamaah Alaa, Diaa Aldeen Mohammad Reyad, Marwa Mohamad Essam, AlMounayer Nawar

机构信息

Community Mental Health, Counties Manukau Health, Building 6, 17 Lambie Drive,, Manukau, Auckland, New Zealand, 2241.

出版信息

Cochrane Database Syst Rev. 2019 Apr 21;4(4):CD011408. doi: 10.1002/14651858.CD011408.pub2.


DOI:10.1002/14651858.CD011408.pub2
PMID:31006114
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6475523/
Abstract

BACKGROUND: Schizophrenia is a disabling serious mental illness that can be chronic. Haloperidol, one of the first generation of antipsychotic drugs, is effective in the treatment of schizophrenia but can have adverse side effects. The effects of stopping haloperidol in people with schizophrenia who are stable on their prescription are not well researched in the context of systematic reviews. OBJECTIVES: To review the effects of haloperidol discontinuation in people with schizophrenia who are stable on haloperidol. SEARCH METHODS: On 20 February 2015, 24 May 2017, and 12 January 2019, we searched the Cochrane Schizophrenia Group's Study-Based Register of Trials including trial registers. SELECTION CRITERIA: We included clinical trials randomising adults with schizophrenia or related disorders who were receiving haloperidol, and were stable. We included trials that randomised such participants to either continue their current treatment with haloperidol or discontinue their haloperidol treatment. We included trials that met our selection criteria and reported usable data. DATA COLLECTION AND ANALYSIS: We independently checked all records retrieved from the search and obtained full reports of relevant records for closer inspection. We extracted data from included studies independently. All usable data were dichotomous, and we calculated relative risks (RR) and their 95% confidence intervals (95% CI) using a fixed-effect model. We assessed risk of bias within the included studies and used GRADE to create a 'Summary of findings' table. MAIN RESULTS: We included five randomised controlled trials (RCTs) with 232 participants comparing haloperidol discontinuation with haloperidol continuation. Discontinuation was achieved in all five studies by replacing haloperidol with placebo. The trials' size ranged between 23 and 87 participants. The methods of randomisation, allocation concealment and blinding were poorly reported.Participants allocated to discontinuing haloperidol treatment were more likely to show no improvement in global state compared with those in the haloperidol continuation group (n = 49; 1 RCT; RR 2.06, 95% CI 1.33 to 3.20; very low quality evidence: our confidence in the effect estimate is limited due to relevant methodological shortcomings of included trials). Those who continued haloperidol treatment were less likely to experience a relapse compared to people who discontinued taking haloperidol (n = 165; 4 RCTs; RR 1.80, 95% CI 1.18 to 2.74; very low quality evidence). Satisfaction with treatment (measured as numbers leaving the study early) was similar between groups (n = 43; 1 RCT; RR 0.13, 95% CI 0.01 to 2.28; very low quality evidence).No usable mental state, general functioning, general behaviour or adverse effect data were reported by any of the trials. AUTHORS' CONCLUSIONS: This review provides limited evidence derived from small, short-term studies. The longest study was for one year, making it difficult to generalise the results to a life-long disorder. Very low quality evidence shows that discontinuation of haloperidol is associated with an increased risk of relapse and a reduction in the risk of 'global state improvement'. However, participant satisfaction with haloperidol treatment was not different from participant satisfaction with haloperidol discontinuation as measured by leaving the studies early. Due to the very low quality of these results, firm conclusions cannot be made. In addition, the available studies did not report usable data regarding the adverse effects of haloperidol treatment.Considering that haloperidol is one of the most widely used antipsychotic drugs, it was surprising that only a small number of studies into the benefit and harm of haloperidol discontinuation were available. Moreover, the available studies did not report on outcomes that are important to clinicians and to people with schizophrenia, particularly adverse effects and social outcomes. Better designed trials are warranted.

摘要

背景:精神分裂症是一种致残性严重精神疾病,可能呈慢性病程。氟哌啶醇是第一代抗精神病药物之一,对精神分裂症治疗有效,但可能产生不良副作用。在系统评价的背景下,关于稳定服用氟哌啶醇的精神分裂症患者停用该药的影响,研究尚不充分。 目的:回顾稳定服用氟哌啶醇的精神分裂症患者停用该药的影响。 检索方法:2015年2月20日、2017年5月24日和2019年1月12日,我们检索了Cochrane精神分裂症研究组基于研究的试验注册库,包括试验登记册。 入选标准:我们纳入了将正在接受氟哌啶醇治疗且病情稳定的成年精神分裂症或相关障碍患者随机分组的临床试验。我们纳入了将此类参与者随机分为继续接受当前氟哌啶醇治疗或停用氟哌啶醇治疗的试验。我们纳入了符合我们入选标准并报告了可用数据的试验。 数据收集与分析:我们独立检查了检索到的所有记录,并获取了相关记录的完整报告以进行更仔细的检查。我们独立从纳入研究中提取数据。所有可用数据均为二分法,我们使用固定效应模型计算相对风险(RR)及其95%置信区间(95%CI)。我们评估了纳入研究中的偏倚风险,并使用GRADE创建了一个“结果总结”表。 主要结果:我们纳入了5项随机对照试验(RCT),共232名参与者,比较停用氟哌啶醇与继续使用氟哌啶醇的情况。在所有5项研究中,通过用安慰剂替代氟哌啶醇实现了停药。试验规模在23至87名参与者之间。随机化、分配隐藏和盲法的方法报告不佳。与继续使用氟哌啶醇组相比,分配到停用氟哌啶醇治疗的参与者在整体状态上更有可能无改善(n = 49;1项RCT;RR 2.06,95%CI 1.33至3.20;极低质量证据:由于纳入试验相关的方法学缺陷,我们对效应估计的信心有限)。与停用氟哌啶醇的人相比,继续使用氟哌啶醇治疗的人复发的可能性较小(n = 165;4项RCT;RR 1.80,95%CI 1.18至2.74;极低质量证据)。两组之间对治疗的满意度(以提前退出研究的人数衡量)相似(n = 43;1项RCT;RR 0.13,95%CI 0.01至2.28;极低质量证据)。任何试验均未报告可用的精神状态、总体功能、一般行为或不良反应数据。 作者结论:本综述提供的证据有限,来自小型短期研究。最长的研究为期一年,因此难以将结果推广到一种终身疾病。极低质量证据表明,停用氟哌啶醇与复发风险增加和“整体状态改善”风险降低有关。然而,通过提前退出研究衡量,参与者对氟哌啶醇治疗的满意度与对停用氟哌啶醇的满意度没有差异。由于这些结果质量极低,无法得出确凿结论。此外,现有研究未报告关于氟哌啶醇治疗不良反应的可用数据。考虑到氟哌啶醇是使用最广泛的抗精神病药物之一,令人惊讶的是,关于停用氟哌啶醇利弊的研究数量很少。此外,现有研究未报告对临床医生和精神分裂症患者重要的结果,特别是不良反应和社会结果。需要设计更好的试验。

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