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<p>美国食品药品监督管理局推出了一项计划，以加快针对严重心理健康问题的迷幻治疗的发展，这标志着美国医疗政策的重大变化。</p>
<p>此举是响应唐纳德·特朗普的行政命令，该命令敦促联邦卫生机构扩大对新疗法的获取。重点是难以治疗的疾病，如耐药性抑郁症、创伤后应激障碍（PTSD）和物质使用障碍。</p>
<p>罗伯特·F·肯尼迪提到，政府正在关注获得 “突破性疗法” 认证的治疗方法，这意味着有早期临床证据显示患者有实际改善。作为该倡议的一部分，FDA 将向研究用于抑郁症的迷幻蘑菇和用于 PTSD 的甲基酮的公司发放国家优先券。</p>
<p>此外，该机构已批准对氮苯丙胺盐酸盐进行早期临床试验，这是一种来自于伊波加因的化合物，作为可能的酒精使用障碍治疗。这是一个重要的步骤，因为这是美国首次批准此类物质进行人体试验。</p>
<p>FDA 专员马蒂·马卡里强调，尽管这些疗法看起来很有前景，但仍在审查中。他表示：“这些药物可能真的有助于解决我们的心理健康危机。” 同时指出，任何批准都将附带严格的指导方针，并不会像常规处方药那样使用。</p>
<p>FDA 指出，仅仅因为试验被允许推进并不意味着它们已获批准。随着研究的继续，他们将密切关注安全性和有效性。马卡里暗示，某些治疗的决定可能会在今夏或秋季作出。</p>
<p>该倡议符合政府加快药物批准的更大努力，包括对众多临床试验的长期要求进行变更。然而，一些专家对更快的时间表可能带来的风险表示担忧。</p>
<p>官员们还提到，在推动某些疗法向前发展的过程中，负担能力的重要性，强调如果获得批准，目标是使治疗更加可及。</p>
<p>这一公告与其他放宽对州许可医疗大麻运营商限制的举措相吻合，展示了美国在替代心理健康治疗方面政策的更广泛转变。</p>
<p>如有意见和反馈，请联系：editorial@rttnews.com</p>
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<p>美国食品药品监督管理局（FDA）已启动一项计划，以加快针对严重心理健康问题的迷幻疗法的开发，此举源于唐纳德·特朗普的行政命令。该计划重点关注难治性抑郁症、创伤后应激障碍（PTSD）和物质使用障碍。FDA 将为研究裸盖菇素和甲基酮的公司发放国家优先券，并已批准针对酒精使用障碍的氮苯戊胺盐酸盐的临床试验。尽管前景可期，这些疗法仍在审查中，安全性和有效性将受到密切监测。该倡议旨在提升药物审批效率并改善治疗可及性</p>

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</div><p>The U.S. Food and Drug Administration has rolled out a plan to speed up the development of psychedelic treatments for serious mental health issues, marking a significant change in U.S. healthcare policy.</p>
<div class="lb-trans"><p>美国食品药品监督管理局推出了一项计划，以加快针对严重心理健康问题的迷幻治疗的发展，这标志着美国医疗政策的重大变化。</p>
</div><p>This move follows an executive order from Donald Trump, which urged federal health agencies to broaden access to new therapies. The focus is on tough-to-treat conditions like treatment-resistant depression, PTSD, and substance use disorders.</p>
<div class="lb-trans"><p>此举是响应唐纳德·特朗普的行政命令，该命令敦促联邦卫生机构扩大对新疗法的获取。重点是难以治疗的疾病，如耐药性抑郁症、创伤后应激障碍（PTSD）和物质使用障碍。</p>
</div><p>Robert F. Kennedy Jr. mentioned that the administration is putting a spotlight on therapies that get the &#34;Breakthrough Therapy&#34; designation, which means there's early clinical evidence showing real improvements for patients. As part of the initiative, the FDA will be giving out national priority vouchers to companies looking into psilocybin for depression and methylone for PTSD.</p>
<div class="lb-trans"><p>罗伯特·F·肯尼迪提到，政府正在关注获得 “突破性疗法” 认证的治疗方法，这意味着有早期临床证据显示患者有实际改善。作为该倡议的一部分，FDA 将向研究用于抑郁症的迷幻蘑菇和用于 PTSD 的甲基酮的公司发放国家优先券。</p>
</div><p>Additionally, the agency has given the green light for an early-stage clinical trial of noribogaine hydrochloride, a compound from ibogaine, as a possible treatment for alcohol use disorder. This is a big step as it's the first time a substance like this has been approved for human trials in the U.S.</p>
<div class="lb-trans"><p>此外，该机构已批准对氮苯丙胺盐酸盐进行早期临床试验，这是一种来自于伊波加因的化合物，作为可能的酒精使用障碍治疗。这是一个重要的步骤，因为这是美国首次批准此类物质进行人体试验。</p>
</div><p>FDA Commissioner Marty Makary stressed that, while these therapies look promising, they're still under review. &#34;These medications could really help solve our mental health crisis,&#34; he said, while also noting that any approvals would come with strict guidelines and wouldn't work like regular prescription drugs.</p>
<div class="lb-trans"><p>FDA 专员马蒂·马卡里强调，尽管这些疗法看起来很有前景，但仍在审查中。他表示：“这些药物可能真的有助于解决我们的心理健康危机。” 同时指出，任何批准都将附带严格的指导方针，并不会像常规处方药那样使用。</p>
</div><p>The FDA pointed out that just because trials are allowed to move forward doesn't mean they're approved. They'll be keeping a close eye on safety and effectiveness as research continues. Makary hinted that decisions on some treatments might come as soon as this summer or fall.</p>
<div class="lb-trans"><p>FDA 指出，仅仅因为试验被允许推进并不意味着它们已获批准。随着研究的继续，他们将密切关注安全性和有效性。马卡里暗示，某些治疗的决定可能会在今夏或秋季作出。</p>
</div><p>This initiative fits into a larger effort by the administration to speed up drug approvals, including changes to longstanding requirements for numerous clinical trials. However, some experts have expressed concerns about the risks that faster timelines might bring.</p>
<div class="lb-trans"><p>该倡议符合政府加快药物批准的更大努力，包括对众多临床试验的长期要求进行变更。然而，一些专家对更快的时间表可能带来的风险表示担忧。</p>
</div><p>Officials also brought up the importance of affordability in pushing certain therapies forward, emphasizing the goal of making treatments more accessible if they get the green light.</p>
<div class="lb-trans"><p>官员们还提到，在推动某些疗法向前发展的过程中，负担能力的重要性，强调如果获得批准，目标是使治疗更加可及。</p>
</div><p>This announcement coincides with other moves to loosen restrictions on state-licensed medical cannabis operators, showcasing a broader shift in U.S. policy towards alternative mental health treatments.</p>
<div class="lb-trans"><p>这一公告与其他放宽对州许可医疗大麻运营商限制的举措相吻合，展示了美国在替代心理健康治疗方面政策的更广泛转变。</p>
</div><p>For comments and feedback contact: editorial@rttnews.com</p>
<div class="lb-trans"><p>如有意见和反馈，请联系：editorial@rttnews.com</p>
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FDA 加速推进用于心理健康的迷幻疗法