MODERN APPROACHES TO THE CHOICE OF LOCALLY APPLIED DRUG IN THE THERAPY OF BACTERIAL VAGINOSIS

Objective. To study the efficacy and safety of lactic acid (femilex) alone and in combination with chlorhexidine (hexicon) versus ascorbic acid (vaginorm—C) and clindamycin (dalacin) in the therapy of bacterial vaginosis. Subjects and methods. In the period May 2010 to July 2011, the N.I. Pirogov National Medical and Surgical Center, Ministry of Health and Social Development of Russia (Moscow), and the Academician V.I. Kulakov Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health and Social Development of Russia (Moscow) conducted a randomized, multicenter, comparative trial of the efficacy and safety of vaginal suppositories containing lactic acid and its combination with vaginal suppositories with chlorhexidine versus vaginal tablets with ascorbic acid and vaginal suppositories with clindamycin in 114 patients diagnosed as having bacterial vaginosis (BV). All the patients were divided into 4 groups according to the therapy used: 1) 33 women patients who were treated for BV with monotherapy with femilex as a vaginal suppository daily for 10 days; 2) 26 women who received daily monotherapy with vaginorm-C as a vaginal tablet for 6 days; 3) 28 patients who were daily treated with hexicone as a vaginal suppository in combination with femilex as a vaginal suppository for 10 days; 4) 27 patients who daily received dalacin as a vaginal suppository for 7 days. All the women underwent a set of clinical and laboratory studies including collection of their complaints, an objective gynecological examination, evaluation of vaginal biocenosis, PCR diagnosis of sexually transmitted infections. Results. The total recovery and improvement rates regarded by the patients as a positive treatment result were 93.9% in the femilex group, 73% in the vaginorm group, 96.5% in the femilex+hexicon group, and 59.2% in the dalacin group (Fisher’s exact test, p<0.01). It was the investigators’ opinion that the effectiveness rates in the groups were 90.9, 69.2, 96.4, and 55.5%, respectively. Evaluation of the safety and tolerability of the drugs in all the study groups showed no serious adverse reactions due to their use, which would worsen the patients’ health. However, undesirable events were recorded in the vaginorm-C (in 6(23.1%) of the 26 cases) and dalacin (in 4 (14.8%) of the 27 cases) groups. Conclusion. The given results of BV therapy with femilex alone and in combination with hexicon indicated the high efficiency and safety of both therapy regimens, which was comparable and even superior to conventional clindamycin therapy. Ascorbic acid (vaginorm-C) versus femilex, femilex + hexicon, and dalacin proved to be ineffective as an independent treatment option for BV. The findings suggest that femilex alone and in combination with hexicon may be recommended to treat BV and concomitant infectious and inflammatory diseases of the vagina.

bacterial vaginosis, femilex, lactic acid, hexicon, vaginorm-C, dalacin