Altern Ther Health Med. 2024 Jan;30(1):6-12.
This study aims to assess the safety and efficacy of Thymosin Alpha 1 (Tα1) through a comprehensive narrative review of clinical studies involving over 11 000 human subjects in more than 30 trials. The focus was on Tα1's application in COVID-19, autoimmune conditions, and cancer treatment, with implications for future considerations.
We systematically searched articles relevant to critical studies on COVID-19, infectious diseases, cancer, and autoimmune diseases indexed on Pubmed, Google Scholar, and Cochrane Library. Our focus was on evaluating the safety and efficacy of Tα1 in human subjects. Clinical trials conducted worldwide involving diverse populations were analyzed to assess the safety and effectiveness of Tα1. The review examines explicit outcomes in over 11 000 human subjects, emphasizing its role in addressing COVID-19, autoimmune conditions, and cancer treatment.
Contrary to the FDA's restriction on Tα1 and 21 additional peptides in 2023, our analysis reveals consistent evidence of Tα1's safety and efficacy. The peptide has demonstrated significant effectiveness in treating various conditions, including COVID-19, autoimmune disorders, and cancer. This review summarizes conclusions drawn from a comprehensive examination of clinical trials worldwide.
Based on substantial evidence from clinical trials, Tα1 emerges as a well-tolerated and effective immune modulator. The FDA›s restriction appears unfounded, as Tα1 has shown safety and efficacy beyond the initially specified conditions. Urgent attention and intervention are warranted to ensure the continued availability of this life-saving peptide through prescription. Therefore, it is recommended that the FDA permits 503A compounding pharmacies to compound Tα1, considering its potential to treat a variety of conditions effectively.
通过对超过 30 项试验中涉及 11000 多名人类受试者的临床研究进行全面叙述性综述，评估胸腺肽α1（Tα1）的安全性和有效性。重点关注 Tα1 在 COVID-19、自身免疫性疾病和癌症治疗中的应用，以及对未来的考虑。
我们系统地搜索了与 COVID-19、传染病、癌症和自身免疫性疾病相关的关键研究的文章，这些文章在 Pubmed、Google Scholar 和 Cochrane Library 上进行了索引。我们的重点是评估 Tα1 在人类受试者中的安全性和有效性。分析了全球范围内进行的涉及不同人群的临床试验，以评估 Tα1 的安全性和有效性。该综述考察了超过 11000 名人类受试者的明确结果，强调了其在解决 COVID-19、自身免疫性疾病和癌症治疗方面的作用。
与 2023 年 FDA 对 Tα1 和 21 种其他肽的限制相反，我们的分析显示了 Tα1 的安全性和有效性的一致证据。该肽在治疗各种疾病方面表现出显著的效果，包括 COVID-19、自身免疫性疾病和癌症。本综述总结了对全球临床试验进行全面检查得出的结论。
基于临床试验的大量证据，Tα1 是一种耐受性良好且有效的免疫调节剂。FDA 的限制似乎没有依据，因为 Tα1 已显示出超出最初规定条件的安全性和有效性。迫切需要关注和干预，以确保通过处方继续提供这种救命肽。因此，建议 FDA 允许 503A 化合物配药药房配制 Tα1，考虑到它有效治疗多种疾病的潜力。
