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N-乙酰半胱氨酸(NAC)治疗氯氮平抵抗的精神分裂症:一项针对阴性症状的双盲、随机、安慰剂对照试验。

N-Acetylcysteine (NAC) in Schizophrenia Resistant to Clozapine: A Double-Blind, Randomized, Placebo-Controlled Trial Targeting Negative Symptoms.

机构信息

Centre for Mental Health, Faculty of Health, Arts & Design, Swinburne University of Technology, Melbourne, Australia.

Department of Mental Health, St Vincent's Hospital, Melbourne, Australia.

出版信息

Schizophr Bull. 2022 Nov 18;48(6):1263-1272. doi: 10.1093/schbul/sbac065.

DOI:10.1093/schbul/sbac065
PMID:35857752
原文链接:
https://pmc.ncbi.nlm.nih.gov/articles/PMC9673271/
Abstract

BACKGROUND AND HYPOTHESIS

Clozapine is the most effective antipsychotic for treatment-resistant schizophrenia, yet a significant proportion of individuals on clozapine continue to experience disabling symptoms, despite being treated with an adequate dose. There is a need for adjunct treatments to augment clozapine, notably for negative and cognitive symptoms. One such potential agent is the glutathione precursor N-acetylcysteine (NAC).

STUDY DESIGN

A randomized double-blind, multi-center, placebo-controlled trial for clozapine patients with enduring psychotic symptoms (n = 84) was undertaken to investigate the efficacy of adjunctive NAC (2 g daily) for negative symptoms, cognition and quality of life (QoL). Efficacy was assessed at 8, 24, and 52 weeks.

STUDY RESULTS

NAC did not significantly improve negative symptoms (P = .62), overall cognition (P = .71) or quality of life (Manchester quality of life: P = .11; Assessment of quality of life: P = .57) at any time point over a 1-year period of treatment. There were no differences in reported side effects between the groups (P = .26).

CONCLUSIONS

NAC did not significantly improve schizophrenia symptoms, cognition, or quality of life in treatment-resistant patients taking clozapine. This trial was registered with "Australian and New Zealand Clinical Trials" on the 30 May, 2016 (Registration Number: ACTRN12615001273572).

摘要

背景与假设

氯氮平是治疗难治性精神分裂症最有效的抗精神病药物,但尽管使用了适当剂量的氯氮平,仍有相当一部分患者继续出现致残症状。需要辅助治疗来增强氯氮平的疗效,尤其是针对阴性和认知症状。一种潜在的药物是谷胱甘肽前体 N-乙酰半胱氨酸(NAC)。

研究设计

对持续存在精神病症状的氯氮平患者(n = 84)进行了一项随机、双盲、多中心、安慰剂对照试验,以研究辅助 NAC(每日 2 克)对阴性症状、认知和生活质量(QoL)的疗效。在第 8、24 和 52 周评估疗效。

研究结果

NAC 治疗 1 年期间,在任何时间点均未显著改善阴性症状(P =.62)、整体认知(P =.71)或生活质量(曼彻斯特生活质量:P =.11;生活质量评估:P =.57)。两组之间报告的副作用没有差异(P =.26)。

结论

NAC 不能显著改善服用氯氮平的难治性患者的精神分裂症症状、认知或生活质量。该试验于 2016 年 5 月 30 日在“澳大利亚和新西兰临床试验”注册(注册号:ACTRN12615001273572)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e90/9673271/585c8301b405/sbac065f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e90/9673271/0a14c58ca478/sbac065f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e90/9673271/585c8301b405/sbac065f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e90/9673271/0a14c58ca478/sbac065f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e90/9673271/585c8301b405/sbac065f0002.jpg

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