2021-09-07-世界卫生组织-Phenibut_pre-review_report_36页_1mb
报告摘要
- Phenibut Overview: Phenibut is a psychotropic drug developed in Russia for treating conditions like anxiety and insomnia, but its use is limited outside a few countries. It is widely misused recreationally due to effects similar to anxiolytics, available as supplements or powders online with varying purity.
- Chemical Structure: Phenibut has a racemic mixture as a common form; it is a GABA B receptor agonist and α2–δ subunit binder at voltage-dependent calcium channels, sharing structural similarity with baclofen and gabapentin.
- Pharmacology: Administered orally, it has a plasma half-life of 5.3 hours. As a GABA B agonist, it reduces neuronal firing and may act on calcium channels. Human studies show dose-dependent effects, with a therapeutic index of 90 (LD50 not verified).
- Toxicology and Adverse Effects: Overdose can lead to severe agitation, seizures, respiratory depression, and delirium, often requiring hospitalization. Withdrawal syndrome includes anxiety, agitation, hallucinations, and seizures. Human case studies report 21-14 adverse drug reactions in WHO VigiAccess, with high incidences in young males.
- Dependence Potential: Proven through human studies; continuous use leads to rapid tolerance, escalating dosing, and withdrawal symptoms that may necessitate mediceinal intervention. Withdrawal was managed with baclofen in several cases.
- Abuse Potential: No human or animal studies directly examine abuse potential, but recreational use is common, with users seeking high or nootropic effects. It is non-medical use prevalent on social media and forums.
- Therapeutic Use: Clinically used in Russia for anxiety and other conditions, but limited evidence outside. No FDA approval in Western countries, and no standardized trials exist; internet sources promote nootropic properties.
- Regulation and Public Health: Not internationally controlled under UN conventions but restricted by some countries like Australia, Hungary, and Italy. Public health concerns include increasing misuse and emergency room visits; no reported deaths but seizures are documented.
- Current Status: Under WHO ECDD pre-review for potential scheduling due to emerging abuse and dependence issues, but currently lacks international control and is legally sold online in many regions.
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