Institute of Dermatology and Skin Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing.
Department of Dermatology, Northern Jiangsu People's Hospital, Yangzhou.
Clin Infect Dis. 2017 Oct 30;65(10):1683-1688. doi: 10.1093/cid/cix611.
The aim of this study was to assess the efficacy of ceftriaxone and benzathine penicillin G (BPG) in nonpregnant, immunocompetent adults with early syphilis because there is a lack of clinical evidence supporting ceftriaxone as an alternative treatment for early syphilis without an human immunodeficiency virus coinfection.
A randomized, open-label controlled study evaluating the efficacy of ceftriaxone and BPG was conducted in 4 hospitals in Jiangsu Province. Treatment comprised either ceftriaxone (1.0 g, given intravenously, once daily for 10 days) or BPG (2.4 million units, given intramuscularly, once weekly for 2 weeks). A serological response was defined as a ≥4-fold decline in the rapid plasma reagin (RPR) titer.
In all, 301 patients with early syphilis were enrolled in this study; 230 subjects completed the follow-ups. The serological response at 6 months of follow up was observed in 90.2% in ceftriaxone group and 78.0% in BPG group (P = .01). There was no significant difference between treatment groups in patients with primary or early latent syphilis, but among patients with secondary syphilis the difference was highly significant (95.8% vs 76.2%; P < .01). Moreover, patients exhibiting a Jarisch-Herxheimer reaction after treatment might have a shorter period before a serological response (P = .03).
In this study, ceftriaxone regimen was noninferior to the BPG regimen in nonpregnant, immunocompetent patients with early syphilis.
ChiCTR-TQR-13003624.
本研究旨在评估头孢曲松和苄星青霉素 G（BPG）在非妊娠、免疫功能正常的早期梅毒患者中的疗效，因为缺乏临床证据支持头孢曲松可作为无人类免疫缺陷病毒合并感染的早期梅毒替代治疗方法。
在江苏省的 4 家医院进行了一项随机、开放标签对照研究，评估头孢曲松和 BPG 的疗效。治疗方案包括头孢曲松（1.0 g，静脉注射，每日 1 次，共 10 天）或 BPG（240 万单位，肌肉注射，每周 1 次，共 2 周）。血清学反应定义为快速血浆反应素（RPR）滴度至少下降 4 倍。
本研究共纳入 301 例早期梅毒患者，230 例完成随访。头孢曲松组 6 个月随访时血清学反应率为 90.2%，BPG 组为 78.0%（P =.01）。在原发性或早期潜伏性梅毒患者中，两组间无显著差异，但在二期梅毒患者中差异具有高度显著性（95.8%比 76.2%；P <.01）。此外，治疗后出现贾尔森-赫克斯海默反应的患者血清学反应时间可能更短（P =.03）。
在本研究中，头孢曲松方案在非妊娠、免疫功能正常的早期梅毒患者中的疗效不劣于 BPG 方案。
ChiCTR-TQR-13003624。
