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Obstetrics and Gynegology2023№11
Systematic review of the efficacy...

Systematic review of the efficacy and safety of nifuratel for women with diseases accompanied by pathological discharge from the genital tract

DOI
https://dx.doi.org/10.18565/aig.2023.248

Apolikhina I.A., Rakhmatulina М.R., Priputnevich Т.V., Gorbunova Е.А., Guschin А.Е., Potekaev N.N., Baranov I.I.

1) Academician V.I. Kulakov National Medical Research Centre for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia, Moscow, Russia; 2) State Scientific Center for Dermatovenereology and Cosmetology, Ministry of Health of Russia, Moscow, Russia; 3) Moscow Scientific and Practical Center for Dermatovenereology and Cosmetology, Moscow Healthcare Department, Moscow, Russia

Objective: To evaluate the clinical and laboratory efficacy and safety of nifuratel for women with diseases accompanied by pathological discharge from the genital tract.
Materials and methods: This systematic review was conducted according to the PRISMA checklist. The analysis included controlled clinical studies for the period 1972–2023 which evaluated the efficacy and safety of oral and/or vaginal administration of nifuratel in women over the age of 18 with bacterial vaginosis, aerobic vaginitis, candidiasis vulvovaginitis, mixed vaginitis and trichomoniasis.
Results: After selecting the proper publications and excluding duplicates, the qualitative analysis included 14 studies (5 randomized and 9 non-randomized); totally, there were 3,337 patients including 544 pregnant women. The quantitative synthesis and meta-analysis included 9 clinical studies. According to received data, a statistically significant difference in clinical and microbiological efficacy was determined in favor of nifuratel in comparison with other drugs (odds ratio (OR)=1.03, 95% CI [1.00, 1.07], p=0.03 and OR=1.15, 95% CI [1.04, 1.27], p=0.005, respectively). There was a statistically significant difference in the frequency of relapses after a course of therapy in favor of nifuratel in comparison with other drugs (OR=0.36, 95% CI [0.19, 0.68], p=0.001). None of the included studies showed any serious side effects after the treatment with the drug.
Conclusion: The use of nifuratel both as monotherapy and in combination with nystatin surpasses other drugs in clinical and microbiological efficacy in the treatment of diseases accompanied by pathological discharge from the genital tract in women; it also shows a lower frequency of relapses. Nevertheless, additional well-planned studies with standardized criteria for evaluating results and long-term follow-up periods can allow the women with vaginitis and bacterial vaginosis to make a better choice among antimicrobial therapy options.

Authors’ contributions: Apolikhina I.A., Gorbunova E.A. – developing the concept and design of the study, search and analysis of the literature, writing the text, approving the final version of the article; Rakhmatulina M.R., Priputnevich T.V., Guschin A.E., Potekaev N.N., Baranov I.I. – text editing, approval of the final version of the article.
Conflicts of interes: Authors declare lack of the possible conflicts of interests.
Funding: The study was conducted without sponsorship.
For citation: Apolikhina I.A., Rakhmatulina М.R., Priputnevich Т.V., Gorbunova Е.А., Guschin А.Е., Potekaev N.N., Baranov I.I. Systematic review of the efficacy and safety of nifuratel for women with diseases accompanied by pathological discharge from the genital tract. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2023; (11): 48-58 (in Russian)
https://dx.doi.org/10.18565/aig.2023.248

Keywords

nifuratel
vaginal infections
bacterial vaginosis
aerobic vaginitis
infectious vaginitis
candidiasis vulvovaginitis
recurrent vulvovaginitis
pregnancy
pathological discharge
Full text (in Russian)

References

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Received 30.10.2023

Accepted 17.11.2023

About the Authors

Inna A. Apolikhina, Dr. Med. Sci., Professor, Head of the Department of Aesthetic Gynecology and Rehabilitation, Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia; Professor of the Department of Obstetrics, Gynecology, Perinatology, and Reproductology,
Institute of Professional Education, I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia, +7(495)735-10-55, apolikhina@inbox.ru,
https://orcid.org/0000-0002-4581-6295, 117997, Russia, Moscow, Ac. Oparin str., 4.
Margarita R. Rakhmatulina, Dr. Med. Sci., Professor, Deputy Director for Organizational and Analytical Work, State Scientific Center for Dermatovenereology and Cosmetology, Ministry of Health of Russia, https://orcid.org/0000-0003-3039-7769, 107076, Russia, Moscow, Korolenko str., 3-6.
Tatyana V. Priputnevich, Dr. Med. Sci., Corresponding Member of the Russian Academy of Sciences, Director of the Institute of Microbiology, Antimicrobial Therapy and Epidemiology, Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia,
https://orcid.org/0000-0002-4126-9730, 117997, Russia, Moscow, Ac. Oparin str., 4.
Elena A. Gorbunova, obstetrician-gynecologist, Researchrer at the Department of Aesthetic Gynecology and Rehabilitation, Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia, +7(495)531-44-44, el_gorbunova@oparina4.ru,
https://orcid.org/0000-0002-4723-4299, 117997, Russia, Moscow, Ac. Oparin str., 4.
Alexander E. Guschin, PhD, Leading Researcher, Moscow Scientific and Practical Center of Dermatovenerology and Cosmetology, +7(916)144-05-56, aguschin1965@mail.ru, https://orcid.org/0000-0002-0399-1167, 119071, Russia, Moscow, Leninsky Ave., 17.
Nikolai N. Potekaev, Dr. Med. Sci., Professor, Director of the Moscow Scientific and Practical Center of Dermatovenerology and Cosmetology; Chief Specialist in dermatovenerology and cosmetology of the Ministry of Health of the Russian Federation; Chief Specialist in dermatovenerology and cosmetology of the Moscow Department of Health; Head of the Department of Skin Diseases and Cosmetology FDPO, N.I. Pirogov Russian National Research Medical University, Ministry of Health of Russia,
https://orcid.org/0000-0002-9578-5490
Igor I. Baranov, Dr. Med. Sci., Professor, Vice-President of the Russian Society of Obstetricians and Gynecologists, Head of the Organizational and Methodological Department, Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia,
https://orcid.org/0000-0002-9813-2823, 117997, Russia, Moscow, Ac. Oparin str., 4.

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