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第二代抗精神病药物剂量国际共识研究(ICSAD-2)。

Second International Consensus Study of Antipsychotic Dosing (ICSAD-2).

机构信息

Department of Psychiatry, Dalhousie University, Halifax, NS, Canada.

International Consortium for Mood & Psychotic Disorders Research, Mailman Research Center, McLean Hospital, Belmont, MA, USA.

出版信息

J Psychopharmacol. 2023 Oct;37(10):982-991. doi: 10.1177/02698811231205688. Epub 2023 Oct 16.

DOI:10.1177/02698811231205688
PMID:37842908
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10612374/
Abstract

BACKGROUND

Expert consensus-based clinically equivalent dose estimates and dosing recommendations can provide valuable support for the use of drugs for psychosis in clinical practice and research.

AIMS

This second International Consensus Study of Antipsychotic Dosing provides dosing equivalencies and recommendations for newer drugs for psychosis and previously reported drugs with low consensus.

METHODS

We used a two-step Delphi survey process to establish and update consensus with a broad, international sample of clinical and research experts regarding 26 drug formulations to obtain dosing recommendations (start, target range, and maximum) and estimates of clinically equivalent doses for the treatment of schizophrenia. Reference agents for equivalent dose estimates were oral olanzapine 20 mg/day for 15 oral and 7 long-acting injectable (LAI) agents and intramuscular haloperidol 5 mg for 4 short-acting injectable (SAI) agents. We also provide a contemporary list of equivalency estimates and dosing recommendations for a total of 44 oral, 16 LAI, and 14 SAI drugs for psychosis.

RESULTS

Survey participants ( = 72) from 24 countries provided equivalency estimates and dosing recommendations for oral, LAI, and SAI formulations. Consensus improved from survey stages I to II. The final consensus was highest for LAI formulations, intermediate for oral agents, and lowest for SAI formulations of drugs for psychosis.

CONCLUSIONS

As randomized, controlled, fixed, multiple-dose trials to optimize the dosing of drugs for psychosis remain rare, expert consensus remains a useful alternative for estimating clinical dosing equivalents. The present findings can support clinical practice, guideline development, and research design and interpretation involving drugs for psychosis.

摘要

背景

基于专家共识的临床等效剂量估算和给药建议可为精神疾病药物在临床实践和研究中的应用提供有价值的支持。

目的

本次第二代抗精神病药剂量共识研究提供了精神疾病新药物和先前共识度较低药物的剂量等效性和建议。

方法

我们采用两步德尔菲调查流程,对广泛的国际临床和研究专家样本就 26 种药物制剂进行了调查,以获得给药建议(起始剂量、目标范围和最大剂量)和治疗精神分裂症的临床等效剂量估算值。等效剂量估算的参考药物为奥氮平口服 20mg/天,适用于 15 种口服制剂和 7 种长效注射剂;氟哌啶醇肌肉注射 5mg,适用于 4 种短效注射剂。我们还提供了一份当代的等效剂量估算值和给药建议列表,涵盖了总共 44 种口服、16 种长效注射和 14 种短效注射的精神疾病药物。

结果

来自 24 个国家的 72 名调查参与者提供了口服、长效和短效制剂的等效性估算值和给药建议。从调查阶段 I 到 II,共识得到了提高。最终共识度最高的是长效注射剂,其次是口服药物,最低的是精神疾病的短效注射剂。

结论

由于优化精神疾病药物剂量的随机、对照、固定、多剂量试验仍然很少,专家共识仍然是估算临床剂量等效性的有用替代方法。本研究结果可为涉及精神疾病药物的临床实践、指南制定、研究设计和解释提供支持。

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