Cato Krista, Chuang Eleanore, Connolly Kristie L, Deal Carolyn, Hiltke Thomas
From the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.
Sex Transm Dis. 2025 Apr 1;52(4):201-210. doi: 10.1097/OLQ.0000000000002113. Epub 2024 Nov 29.
The dramatic increase in syphilis cases in the United States in recent years is a serious public health concern. Periodic shortages of benzathine penicillin G (BPG), the mainstay of syphilis treatment, create challenges for management of syphilis in the United States and worldwide. The National Institute of Allergy and Infectious Diseases convened working groups of experts to assess the landscape of syphilis treatments for uncomplicated adult syphilis, syphilis in pregnant women, congenital syphilis, and neurosyphilis. The working groups came together at a workshop entitled "Alternative Therapies to Penicillin for the Treatment of Syphilis" on February 13 to 14, 2024, to share their findings regarding promising alternative treatments, research gaps, and challenges. Discussions focused on using existing antibiotics, with a preference for those with favorable safety profiles and demonstrated success against syphilis or other infectious diseases. Clinical research on alternative treatments is complicated by the high effectiveness of penicillin and by differences in clinical, physiological, cultural, and socioeconomic considerations across different patient populations and geographic settings. In addition, current diagnostic tests and tests-of-cure create challenges for clinical trial design. Various potential trial designs were discussed, focusing on subjects with different types and stages of disease. This summary of the workshop is presented to inform plans for future research, including clinical trials on alternatives to penicillin for the treatment of syphilis.
近年来，美国梅毒病例急剧增加，这是一个严重的公共卫生问题。梅毒治疗的主要药物苄星青霉素G（BPG）定期短缺，给美国乃至全球的梅毒管理带来了挑战。美国国立过敏与传染病研究所召集了专家工作组，以评估非复杂性成人梅毒、孕妇梅毒、先天性梅毒和神经梅毒的治疗情况。这些工作组于2024年2月13日至14日齐聚一堂，参加了一场名为“梅毒治疗的青霉素替代疗法”的研讨会，分享他们在有前景的替代治疗方法、研究空白和挑战方面的研究结果。讨论聚焦于使用现有抗生素，优先选择那些安全性良好且已证明对梅毒或其他传染病有效的抗生素。青霉素的高效性以及不同患者群体和地理环境在临床、生理、文化和社会经济方面的差异，使得替代治疗的临床研究变得复杂。此外，当前的诊断测试和治愈测试给临床试验设计带来了挑战。会上讨论了各种潜在的试验设计，重点是患有不同疾病类型和阶段的受试者。本研讨会总结旨在为未来研究计划提供信息，包括梅毒治疗青霉素替代药物的临床试验。
