近日，美国阿拉巴马大学伯明翰分校Edward W. Hook团队研究了1剂与3剂苄星青霉素G治疗早期梅毒的疗效。这一研究成果于2025年9月4日发表在《新英格兰医学杂志》上。

关于早期（即原发性、继发性或早期潜伏性）梅毒（梅毒螺旋体感染）患者用苄星青霉素G治疗的适当时间仍有争议。

在一项多中心、随机、对照、非效性试验中，研究组将感染或不感染人类免疫缺陷病毒（HIV）的早期梅毒患者分配给肌肉注射苄星青霉素G，一次性剂量为240万单位，或连续三周注射240万单位。主要终点是血清恢复到无反应状态，或6个月时快速血浆反应素滴度降低两次或更多次，此处称为血清学反应（非劣效性界限，10个百分点）。一个关键的次要终点是根据HIV状态定义的亚组内的血清学反应，也在非劣效性分析中进行评估。

共有249名早期梅毒患者被纳入研究。大多数参与者是男性（97%），62%是黑人，153人（61%）感染了艾滋病毒。按梅毒分期分布：原发性梅毒占19%，继发性梅毒占47%，早期潜伏性梅毒占33%。单剂量组6个月时血清学反应的参与者百分比为76%(95%可信区间，68 - 82)，三剂量组为70% (95% CI, 61 - 77)(差异，6个百分点；90% CI 15到3，表示非劣效性)。两组均无临床复发或治疗失败。在单剂量组中，76%的HIV感染者和76%的未感染者在6个月时出现血清学反应，而在三剂量组中，71%的HIV感染者和70%的未感染者在6个月时出现血清学反应。每一组的大多数参与者在治疗过程中都出现局部注射部位疼痛和压痛（单次给药76%，三次给药85%）。

研究结果表明，在治疗6个月后的血清学反应方面，1剂240万单位苄星青霉素G治疗不低于3剂治疗。

附：英文原文

Title: One Dose versus Three Doses of Benzathine Penicillin G in Early Syphilis

Author: Edward W. HookIII, Jodie A. Dionne, Kimberly Workowski, Candice J. McNeil, Stephanie N. Taylor, Teresa A. Batteiger, Julia C. Dombrowski, Kenneth H. Mayer, Arlene C. Sea, Matthew M. Hamill, Harold C. Wiesenfeld, Chunming Zhu, Charlotte Perlowski, Jorge E. Mejia-Galvis, Lori M. Newman

Issue&Volume: 2025-09-04

Abstract:

BACKGROUND

Controversy persists regarding the appropriate duration of therapy with benzathine penicillin G in persons with early (i.e., primary, secondary, or early latent) syphilis (Treponema pallidum infection).

METHODS

In a multicenter, randomized, controlled, noninferiority trial, we assigned persons who had early syphilis, with or without human immunodeficiency virus (HIV) infection, to receive intramuscular injections of benzathine penicillin G in a one-time dose of 2.4 million units or in doses of 2.4 million units administered at three successive weekly intervals. The primary end point was seroreversion to nonreactive status or a decrease in the rapid plasma reagin titer by two or more dilutions at 6 months, referred to here as a serologic response (noninferiority margin, 10 percentage points). A key secondary end point was a serologic response within subgroups defined according to HIV status, also assessed in a noninferiority analysis.

RESULTS

A total of 249 persons with early syphilis were enrolled. Most participants were men (97%), 62% were Black, and 153 (61%) were living with HIV infection. The distribution according to syphilis stage was 19% with primary syphilis, 47% with secondary syphilis, and 33% with early latent syphilis. The percentage of participants with a serologic response at 6 months was 76% (95% confidence interval [CI], 68 to 82) in the single-dose group and 70% (95% CI, 61 to 77) in the three-dose group (difference, 6 percentage points; 90% CI, 15 to 3, indicating noninferiority). No clinical relapse or treatment failure occurred in either group. In the one-dose group, a serologic response at 6 months was observed in 76% of participants who had HIV infection and 76% of those who did not, and in the three-dose group, a serologic response at 6 months was observed in 71% of participants who had HIV infection and 70% of those who did not. Most participants in each group had local injection-site pain and tenderness with treatment (76% with a single dose and 85% with three doses).

CONCLUSIONS

Treatment with one dose of 2.4 million units of benzathine penicillin G was noninferior to treatment with three doses with regard to serologic response 6 months after treatment.

DOI: NJ202509043930907

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2401802