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导引出缓解期精神病患者最低有效剂量的抗精神病药(GARMED):一项具有自然队列的 2 年随机对照试验。

Guided antipsychotic reduction to reach minimum effective dose (GARMED) in patients with remitted psychosis: a 2-year randomized controlled trial with a naturalistic cohort.

机构信息

Department of Psychiatry, National Taiwan University Hospital, Taipei, 10002, Taiwan.

Department of Psychiatry, College of Medicine, National Taiwan University, Taipei, Taiwan.

出版信息

Psychol Med. 2023 Nov;53(15):7078-7086. doi: 10.1017/S0033291723000429. Epub 2023 Mar 10.

Abstract

BACKGROUND

Patients with remitted psychosis face a dilemma between the wish to discontinue antipsychotics and the risk of relapse. We test if an operationalized guided-dose-reduction algorithm can help reach a lower effective dose without increased risks of relapse.

METHODS

A 2-year open-label randomized prospective comparative cohort trial from Aug 2017 to Sep 2022. Patients with a history of schizophrenia-related psychotic disorders under stable medications and symptoms were eligible, randomized 2:1 into guided dose reduction group (GDR) maintenance treatment group (MT1), together with a group of naturalistic maintenance controls (MT2). We observed if the relapse rates would be different between 3 groups, to what extent the dose could be reduced, and if GDR patients could have improved functioning and quality of life.

RESULTS

A total of 96 patients, comprised 51, 24, and 21 patients in GDR, MT1, and MT2 groups, respectively. During follow-up, 14 patients (14.6%) relapsed, including 6, 4, and 4 from GDR, MT1, and MT2, statistically no difference between groups. In total, 74.5% of GDR patients could stay well under a lower dose, including 18 patients (35.3%) conducting 4 consecutive dose-tapering and staying well after reducing 58.5% of their baseline dose. The GDR group exhibited improved clinical outcomes and endorsed better quality of life.

CONCLUSIONS

GDR is a feasible approach as the majority of patients had a chance to taper antipsychotics to certain extents. Still, 25.5% of GDR patients could not successfully decrease any dose, including 11.8% experienced relapse, a risk comparable to their maintenance counterparts.

摘要

背景

缓解期精神病患者面临着停止使用抗精神病药物和复发风险之间的困境。我们测试了一种可操作的引导剂量减少算法,看是否可以在不增加复发风险的情况下达到更低的有效剂量。

方法

这是一项从 2017 年 8 月至 2022 年 9 月进行的为期 2 年的开放性、随机、前瞻性对照队列试验。符合条件的患者为处于稳定药物和症状的精神分裂症相关精神病障碍史的患者,按 2:1 的比例随机分为引导剂量减少组(GDR)维持治疗组(MT1),以及一组自然维持对照组(MT2)。我们观察 3 组之间的复发率是否不同,剂量可以减少多少,以及 GDR 患者的功能和生活质量是否可以改善。

结果

共有 96 名患者,GDR、MT1 和 MT2 组分别有 51、24 和 21 名患者。在随访期间,14 名患者(14.6%)复发,其中 GDR、MT1 和 MT2 组各有 6、4 和 4 名患者。各组之间无统计学差异。GDR 组中有 74.5%的患者能够在较低剂量下保持良好状态,其中 18 名患者(35.3%)连续进行 4 次剂量减少,在减少基线剂量的 58.5%后保持良好状态。GDR 组表现出更好的临床结果和更高的生活质量。

结论

GDR 是一种可行的方法,因为大多数患者都有机会在一定程度上减少抗精神病药物的剂量。尽管如此,GDR 组仍有 25.5%的患者无法成功减少任何剂量,其中 11.8%的患者出现复发,这一风险与他们的维持治疗组相当。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b0e3/10719630/7b2143c92fd2/S0033291723000429_fig1.jpg

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