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Azithromycin may be an effective alternative to benzathine benzylpenicillin in the treatment of early syphilis

Syphilis remains a very common infection in many countries of the world. In our country, despite the trend of a decrease in the incidence of syphilis observed in the last 2 years, the average indicator for the United States of America (52.01 per 100,000 inhabitants in 2009) and the indicators in the individual regions remain unacceptably high.

The recommended treatment for syphilis in most countries of the world is benzylpenicillin, in the form of the usual sodium or potassium salt, or its prolonged form - benzathine benzylpenicillin. The risk of anaphylactic reactions to penicillin in patients with hypersensitivity requires the search for safe and effective alternative drugs for the treatment of syphilis. In this regard, the results of a recently completed randomized controlled clinical trial (RKKI), which showed the equal efficacy of benzathine benzylpenicillin and azithromycin in the treatment of early forms of syphilis in patients without infection with Concomitant HIV are interesting.

During the study, azithromycin at a dose of 2 g was used once in 255 patients, and benzylpenicillin at a dose of 2.4 million units was administered once per m / m to 262 patients with early syphilis without concomitant HIV infection. The study was conducted from June 2000 to May 2007 in several American centers and in Madagascar. Pregnant women did not participate in the study. The efficacy of the treatment was evaluated according to the results of the serological studies 3 and 6 months after the treatment.

According to the results of serological studies, 6 months after treatment, recovery was observed in 180 of 232 (77.6%) patients taking azithromycin and 186 of 237 (78.5%) patients receiving benzathine injections benzylpenicillin.

Adverse events (AEs) were observed in 61.5% of patients in the azithromycin group and in 46.3% of patients in the benzathine-benzylpenicillin group. In most cases, there were mild AEs from the gastrointestinal tract, which required no further treatment. The frequency of serious AEs during the 6-month follow-up was the same in the two groups (2.8% and 3.5%, respectively), including 3 deaths each. According to experts, not all cases of AE were associated with treatment with azithromycin or benzathine benzylpenicillin.

Thus, the results of this RKKI confirm the data previously obtained in a pilot study that an oral dose of 2 g of azithromycin can be considered once an effective and safe alternative to penicillin in the treatment of early forms of syphilis in patients without concomitant HIV infection.

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