2025-09-03 アメリカ国立衛生研究所(NIH)
<関連情報>
- https://www.nih.gov/news-events/news-releases/one-dose-antibiotic-treats-early-syphilis-well-three-doses
- https://www.nejm.org/doi/full/10.1056/NEJMoa2401802
初期梅毒治療におけるベンザチンペニシリンGの単回投与と3回投与の比較 One Dose versus Three Doses of Benzathine Penicillin G in Early Syphilis
Edward W. Hook III, M.D., Jodie A. Dionne, M.D., M.S.P.H., Kimberly Workowski, M.D., Candice J. McNeil, M.D., M.P.H., Stephanie N. Taylor, M.D., Teresa A. Batteiger, M.D., Julia C. Dombrowski, M.D., M.P.H., +7 , and Lori M. Newman, M.D.
New England Journal of Medicine Published: September 3, 2025
DOI: 10.1056/NEJMoa2401802
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. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT03637660.)
