2026年9月15日 晚上9:50 UTC / 2小时前更新 / 来源:路透社
美国卫生与公众服务部部长小罗伯特·F·肯尼迪2026年9月1日在华盛顿特区美国卫生与公众服务部举办的儿童屏幕时间危害活动上发表讲话。路透社/埃文·武奇/档案照片 购买授权许可,将在新标签页中打开
摘要
一项新研究显示,尽管缺乏人体研究证据,未获批准的肽类药物BPC-157仍被用于治疗多种疾病
- 无法通过标准电子健康档案追踪BPC-157的使用情况
- 分析师估计,若合法化,BPC-157及其他肽类药物市场规模可达20亿至30亿美元
9月15日(路透社)——一项最新分析发现,获美国卫生部长小罗伯特·F·肯尼迪支持、在网上宣传可用于止痛、康复和提升运动表现的实验性肽类药物,尽管人体研究几乎未提供其安全性和有效性证据,仍被用于治疗多种疾病。
这种名为BPC-157的肽类药物尚未获得美国批准使用,但已在灰色市场吸引了消费者,社交媒体上声称其有助于肌肉增长和损伤恢复的帖子为其造势,但这些说法并未经过科学验证。人们常将其与另一种肽类药物TB-500联合使用,这种组合被俗称为“金刚狼组合”。
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今年7月,在美国食品药品监督管理局(FDA)的一个顾问小组投票允许药房配制BPC-157,这一决定得到了肯尼迪的鼓励。此前,FDA曾以存在重大安全风险且人体数据不足为由,限制BPC-157的配制。
分析师估计,若合法化,BPC-157及其他肽类药物市场规模可迅速达到20亿至30亿美元。
由于缺乏国家药品代码,无法通过电子健康档案追踪BPC-157的实际使用情况。为此,数据分析公司nference审查了超过1500万份医疗记录,确认了1039名患者,其医生在书面临床笔记中手动记录了患者使用该肽类药物的情况。
该研究负责人文基·桑达拉贾恩表示,这项分析进一步揭示了BPC-157使用量的上升趋势,但由于实际使用规模未知,研究仍不完整。
“大多数医生可能甚至都不会询问患者:‘你在服用BPC-157吗?’”他说。
研究人员发现,2020年至2026年间,新确认的使用者数量增长了33倍。
分析显示,在644名记录了用药原因的患者中,他们使用这种未获批准的化合物治疗的病症包括运动损伤、慢性疼痛以及胃肠道疾病等。
BPC-157最初最常用于缓解疼痛或胃肠道症状,通常从配药房或灰色市场肽类药物供应商处购买。
新使用者中男性占比从2020年的57%升至2026年的70%,平均年龄从2020年的55岁降至2026年的49岁。在972名记录了种族信息的BPC-157使用者中,96%为白人。
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该研究仅记录了三分之一患者的治疗反应。尽管部分医生的笔记中提到了症状改善,但有限的数据凸显了该肽类药物效果的不确定性,也突显了其安全性和有效性数据的缺乏,这份在同行评议前发表的报告称。
患者停止使用BPC-157的最常见原因是医生建议停药。其他原因包括不良反应,涉及神经精神、皮肤和胃肠道症状。
犹他大学的弗林·麦奎尔博士曾研究过BPC-157,但未参与此次研究,他指出,nference记录的使用者中约有一半同时服用其他药物,包括睾酮、非甾体抗炎药、TB-500和皮质类固醇,以及物理治疗和手术等干预措施。
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“这项研究没有设置安慰剂组或未治疗对照组,也没有标准化的适应症、剂型、剂量、给药途径、治疗时长或结局评估标准,”他说。
因此,麦奎尔和该论文的作者强调,无法得知症状改善中有多少可归因于BPC-157,又有多少来自自然恢复、其他治疗、安慰剂效应或选择性记录。
麦奎尔表示,该论文“让我们充分了解了谁在使用BPC-157、如何使用,以及临床实践中记录了哪些情况”。但他表示,仍需要随机对照试验来证实BPC-157是否确实能带来具有临床意义的改善。
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Use of untested ‘Wolverine’ peptide backed by US Health Secretary Kennedy on the rise, study finds
September 15, 2026 9:50 PM UTC / Updated 2 hours ago / Source: Reuters
U.S. Health and Human Services Secretary Robert F. Kennedy Jr. speaks during an event on screen time harm in children at the Department of Health and Human Services in Washington, D.C., U.S., September 1, 2026. REUTERS/Evan Vucci/File Photo Purchase Licensing Rights, opens new tab
Summary
The unapproved peptide BPC-157 is being used for a wide range of ailments despite scant human evidence, a new study suggests
- Use of BPC-157 cannot be tracked through standard electronic health records
- Analysts estimate BPC-157 and other peptides could become a $2 billion to $3 billion market if legitimized
Sept 15 (Reuters) – An experimental peptide backed by U.S. Health Secretary Robert F. Kennedy Jr. and marketed online for pain, healing and performance enhancement is being used for a wide range of ailments despite little safety and efficacy evidence from human studies, a new analysis found.
The peptide, BPC-157, has not been approved for use in the United States but has attracted consumers in a gray market, bolstered by social media posts that claim benefits for muscle growth and injury recovery not backed by scientific testing. It is often taken together with a second peptide, TB-500, in a combination popularly known as the “Wolverine stack.”
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In July, a panel of U.S. Food and Drug Administration advisers voted to allow pharmacy compounding of BPC-157, encouraged by Kennedy. Previously, the FDA had restricted BPC-157 compounding due to what it said were significant safety risks and insufficient human data.
Analysts have estimated that BPC-157 and other peptides could quickly become a $2 billion to $3 billion market if legitimized.
Real-world use of BPC-157 is hard to track using electronic health records because it lacks a National Drug Code. Instead, data analytics firm nference reviewed more than 15 million medical records and identified 1,039 patients whose doctors had manually documented use of the peptide in written clinical notes.
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The analysis sheds more light on the rise of BPC-157, but is still incomplete since the actual scale of its use is unknown, said study leader Venky Soundararajan.
“Most likely, very few doctors are even asking their patients, ‘Are you taking BPC-157?’” he said.
The number of new confirmed users increased 33-fold between 2020 and 2026, the researchers found.
Reasons for use were documented in 644 patients, who took the unapproved compound for conditions ranging from sports injuries and chronic pain to gastrointestinal disorders, the analysis found.
BPC-157 was most often initiated to help manage pain or gastrointestinal symptoms and most commonly obtained from a compounding pharmacy or gray-market peptide vendor.
The proportion of new users who were male increased from 57% in 2020 to 70% in 2026, while the average age decreased from 55 in 2020 to 49 in 2026. Among 972 BPC-157 users with recorded race, 96% were white.
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Responses to treatment were only recorded for one-third of the patients in the study. While some doctors’ notes described symptom improvement, the limited data highlighted uncertainty about the peptide’s effects and underscored a lack of data on its safety and effectiveness, according to a report published ahead of peer review, opens new tab.
When patients discontinued BPC-157, it was most often because their doctors advised them to stop. Others cited adverse effects, including neuropsychiatric, dermatologic, and gastrointestinal symptoms.
Dr. Flynn McGuire of the University of Utah, who has researched BPC-157, opens new tab but was not involved in the study, noted that about half of patients with documented use by nference were taking other drugs as well, including testosterone, NSAIDs, TB-500, and corticosteroids, plus interventions such as physical therapy and surgery.
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“There was no placebo or untreated comparator, and there was no standardized indication, formulation, dose, route, treatment duration, or outcome assessment,” he said.
Therefore, it’s impossible to know how much of any improvement was attributable to BPC-157 versus natural recovery, other treatments, placebo effects, or selective documentation, McGuire and the paper’s authors emphasized.
The paper “tells us a lot about who is using BPC-157, how they are using it, and what is being reported in practice,” McGuire said. But randomized controlled trials are needed to answer whether BPC-157 actually causes clinically meaningful improvement, he said.
Reporting by Nancy Lapid; editing by Michele Gershberg and Bill Berkrot
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