2019 Chinese Expert Consensus Statement on Diagnosis and Treatment of Syphilis
Syphilis, a chronic systemic disease caused by Treponema pallidum subsp. pallidum (T. pallidum), remains a significant public health concern in China due to its high incidence and prevalence. The disease is primarily transmitted through sexual contact, and its management requires a comprehensive understanding of its clinical manifestations, diagnostic criteria, and treatment protocols. This consensus statement provides updated guidelines for the diagnosis and treatment of syphilis, aiming to standardize clinical practices and improve patient outcomes.
Clinical Manifestations and Diagnosis
Syphilis is a multi-stage disease with distinct clinical features at each stage. The diagnosis of syphilis is based on a combination of epidemiological history, clinical manifestations, and laboratory tests. The disease is classified into primary, secondary, tertiary (late), neurosyphilis, latent, and congenital syphilis, each with unique diagnostic criteria.
Primary Syphilis
Primary syphilis is characterized by the presence of a chancre, typically a painless ulcer, and indolent enlargement of regional lymph nodes. A probable case is defined by epidemiological history, clinical features, and a positive non-treponemal serological test (NTT) or treponemal test (TT). A confirmed case requires positive darkfield microscopy examination (DFME) or both positive NTT and TT.
Secondary Syphilis
Secondary syphilis presents with cutaneous or mucosal lesions and generalized lymphadenopathy. Similar to primary syphilis, a probable case is identified through epidemiological history, clinical features, and positive NTT or TT. Confirmation requires positive DFME or both positive NTT and TT.
Tertiary (Late) Syphilis
Tertiary syphilis includes “benign” late syphilis, cutaneous or mucosal lesions, bone syphilis, syphilis of other viscera, and cardiovascular syphilis. Probable cases are diagnosed based on epidemiological history, clinical features, and positive NTT or TT. Confirmed cases require both positive NTT and TT.
Neurosyphilis
Neurosyphilis encompasses asymptomatic neurosyphilis, syphilitic meningitis, meningovascular syphilis, parenchymatous neurosyphilis, ocular syphilis, and auricular syphilis. Probable cases are identified through epidemiological history, clinical features, and positive NTT or TT. Confirmation requires both positive NTT and TT.
Latent Syphilis
Latent syphilis is defined by the absence of clinical manifestations, with diagnosis relying solely on serological tests. A probable case is indicated by positive NTT or TT, while a confirmed case requires both positive NTT and TT.
Congenital Syphilis
Congenital syphilis is divided into early, late, and latent forms. Early congenital syphilis presents with rhinitis, laryngitis, osteomyelitis, osteochondritis, and ossitis. Late congenital syphilis is characterized by saddle-nose deformity, Hutchinson teeth, and skin lesions around the mouth. Latent congenital syphilis shows no clinical manifestations. All infants born to untreated mothers with syphilis are considered probable cases. Confirmation requires positive DFME, positive sera IgM test, NTT titer fourfold or greater than the mother’s serum, negative NTT at birth, or TT remaining positive at 18 months.
Management and Treatment
The treatment of syphilis varies depending on the stage of the disease and the patient’s medical history, particularly penicillin allergy. The primary treatment for syphilis is penicillin, with alternative regimens available for penicillin-allergic patients.
Early Syphilis
For early syphilis, the recommended regimen is benzathine penicillin G 2.4 million units intramuscularly (IM) in both buttocks, either as a single dose or two doses at one-week intervals. Alternatively, procaine penicillin 800,000 units IM daily for 15 days can be used. For penicillin-allergic patients, doxycycline 100 mg twice daily orally for 15 days is recommended. An alternative regimen is ceftriaxone 500 mg to 1 g IM or intravenously daily for 10 days.
Late Syphilis
Late syphilis is treated with benzathine penicillin G 2.4 million units IM in both buttocks separately, administered once weekly for three doses. Alternatively, procaine penicillin 800,000 units IM daily for 20 days is used, with the option to repeat the course after a two-week interval if necessary. Penicillin-allergic patients are treated with doxycycline 100 mg twice daily orally for 30 days.
Cardiovascular Syphilis
Cardiovascular syphilis requires aqueous crystalline penicillin G 100,000 units IM on the first day, followed by 100,000 units IM twice on the second day, and 200,000 units IM twice on the third day. From the fourth day, procaine penicillin 800,000 units IM daily for 20 days is administered, with the option to repeat the course after a two-week interval. Alternatively, benzathine penicillin G 1.2 million units IM in each buttock, once weekly for three doses, can be used. Penicillin-allergic patients are treated with doxycycline 100 mg twice daily orally for 30 days.
Neurosyphilis, Ocular, and Auricular Syphilis
Neurosyphilis, ocular syphilis, and auricular syphilis are treated with aqueous crystalline penicillin G 18 to 24 million units daily intravenously (IV) for 10 to 14 days, followed by benzathine penicillin G 2.4 million units IM weekly for three doses if necessary. Alternatively, procaine penicillin 2.4 million units IM once daily with probenecid 500 mg orally four times a day for 10 to 14 days can be used, followed by benzathine penicillin G 2.4 million units IM weekly for three doses if necessary. Penicillin-allergic patients are treated with doxycycline 100 mg twice daily orally for 30 days.
Congenital Syphilis
Early congenital syphilis is treated with aqueous crystalline penicillin G 100,000–150,000 units/kg IV daily, administered as 50,000 units/kg per dose IV every 12 hours during the first seven days of life and every eight hours thereafter for 10 to 14 days. Alternatively, procaine penicillin G 50,000 units/kg IM in a single daily dose for 10 to 14 days can be used. Late congenital syphilis is treated with procaine penicillin 50,000 units/kg IM daily for 10 days, with the dose adjusted to be less than that of adults in the same stage of syphilis. For penicillin-allergic patients, ceftriaxone (125 mg for normal cerebrospinal fluid examination or 250 mg for abnormal examination) IM daily for 10 to 14 days is recommended, with caution for possible cross-allergic reactions with penicillin.
Follow-Up and Serological Evaluation
After treatment, regular follow-up is essential to monitor the effectiveness of therapy and detect any signs of reactivation. The criteria for effective treatment include the disappearance of skin lesions and clinical symptoms, along with a fourfold or greater decline in NTT titer within three to six months after treatment. Serological reactivation is defined by a reversion of NTT from negative to positive or a fourfold increase in titer. Clinical reactivation involves the reappearance of clinical symptoms, usually accompanied by an increased NTT titer. Patients with serological or clinical reactivation should receive retreatment. In some cases, the NTT titer may decline but remain positive, a condition known as serofast, which does not necessarily indicate treatment failure.
Conclusion
The 2019 Chinese Expert Consensus Statement on Diagnosis and Treatment of Syphilis provides comprehensive guidelines for the management of syphilis across all stages of the disease. By standardizing diagnostic criteria and treatment protocols, the consensus aims to improve the quality of care for patients with syphilis and reduce the burden of the disease in China. Regular follow-up and serological evaluation are critical components of syphilis management, ensuring the effectiveness of treatment and early detection of reactivation.
doi.org/10.1097/CM9.0000000000001035
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