依诺金AHCC®对高危和低危HPV感染患者的治疗的最新动态

• 日期：2021/4/14
• 来源：Judith Smith

 

目前还没有批准用于HPV感染患者的有效药物。在过去的五年里，我们已经完成了三个临床试验，证明依诺金AHCC补充有利于清除HPV感染。当我们继续优化依诺金AHCC补充方案治疗高危HPV感染时，我们现在也在评估其在男性和女性低风险HPV感染中的益处。本报告将回顾我们最后的NIH资助的随机第二阶段研究结果，并更新我们正在进行的低和高风险HPV感染的研究。
[Background/Aims] There is currently no approved effective medicine for patients with HPV infections. Over the past five years, we have completed three clinical trials demonstrating that AHCC supplement is beneficial for clearance of HPV infections. As we continue to optimize the AHCC supplementation regimen for high risk HPV infections, we are also now evaluating its benefits in low risk HPV infections in men and women. This presentation will review our final NIH-funded randomized phase II study results and updates on our ongoing studies in both low and high risk HPV infections.
 
[方法] 将回顾完成的第二阶段随机安慰剂对照研究的方法，评估依诺金AHCC补充，以支持根除高风险HPV。正在进行的第二阶段开放标记研究正在评估依诺金AHCC3g的益处，每天空腹一次，持续4个月，以清除男性和女性低风险HPV感染。在启动任何应计或处理研究之前，机构审查委员会对该议定书进行了审查和批准。复发的低风险HPV病变，以前失败的局部亚胺基莫德被登记后，符合所有的资格标准。患者每四周返回16周进行血样和皮肤活检，并记录皮损。每次访问，参与者都收到下个月的依诺金AHCC供应。在整个治疗过程中，每个参与者在每日补充日志中记录他们的自我依从性和不良影响。在每次复诊时未服用85%的补充剂的患者被排除在试验之外。
[Methods] The methods of the completed phase II randomized, placebo controlled study evaluating AHCC supplementation to support the eradication of high risk HPV will be reviewed. The ongoing phase II open labeled study is evaluating the benefits of AHCC 3 g supplementation by mouth once daily on an empty stomach for up to four months to clear low risk HPV infections in men and women. The protocol was reviewed and approved by the Institutional Review Board prior to initiating any study accrual or treatment. Patients with recurrent low risk HPV lesions that have previously failed topical imiquimod were enrolled after meeting all eligibility criteria. Patients returned every four weeks for 16 weeks to have blood samples and skin biopsies taken, and skin lesions were recorded. At each visit, the participant received the next month’s supply of AHCC. Throughout treatment, each participant recorded their self-compliance and adverse effects in a daily supplement log. Patients who did not take 85% of the supplement as determined at each returning visit were excluded from the trial.

[结果] 将总结第二阶段研究的最终结果。 初步结果开放标签II期研究，HPV低风险研究，也将讨论。根据临床前数据，两项试点研究，第二阶段研究以及我们的临床观察，我们证明依诺金AHCC补充将支持宿主免疫系统成功清除持续的HPV感染。
[Results] Final results of phase II study will be summarized. Preliminary results for open-label phase II study, HPV low risk study, will also be discussed. Based on the pre-clinical data, two pilot studies, phase II study as well as our clinical observations, we demonstrated that AHCC supplementation will support the host immune system to successfully clear persistent HPV infections.