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

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Abstract

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.

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About the authors

Inna A. Apolikhina

Academician V.I. Kulakov National Medical Research Centre for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia

Author for correspondence.
Email: apolikhina@inbox.ru
ORCID iD: 0000-0002-4581-6295

Dr. Med. Sci., Professor, Head of the Department of Aesthetic Gynecology and Rehabilitation, Professor of the Department of Obstetrics, Gynecology, Perinatology, and Reproductology

Russian Federation, 117997, Moscow, Ac. Oparin str., 4

Margarita R. Rakhmatulina

State Scientific Center for Dermatovenereology and Cosmetology, Ministry of Health of Russia

Email: apolikhina@inbox.ru
ORCID iD: 0000-0003-3039-7769

Dr. Med. Sci., Professor, Deputy Director for Organizational and Analytical Work, State Scientific Center for Dermatovenereology and Cosmetology

Russian Federation, 107076, Moscow, Korolenko str., 3-6

Tatyana V. Priputnevich

Academician V.I. Kulakov National Medical Research Centre for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia

Email: apolikhina@inbox.ru
ORCID iD: 0000-0002-4126-9730

Dr. Med. Sci., Corresponding Member of the Russian Academy of Sciences, Director of the Institute of Microbiology, Antimicrobial Therapy and Epidemiology

Russian Federation, 117997, Moscow, Ac. Oparin str., 4

Elena A. Gorbunova

Academician V.I. Kulakov National Medical Research Centre for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia

Email: el_gorbunova@oparina4.ru
ORCID iD: 0000-0002-4723-4299

obstetrician-gynecologist, Researchrer at the Department of Aesthetic Gynecology and Rehabilitation

Russian Federation, 117997, Moscow, Ac. Oparin str., 4

Alexander E. Guschin

Moscow Scientific and Practical Center for Dermatovenereology and Cosmetology, Moscow Healthcare Department

Email: aguschin1965@mail.ru
ORCID iD: 0000-0002-0399-1167

PhD, Leading Researcher, Moscow Scientific and Practical Center of Dermatovenerology and Cosmetology

Russian Federation, 119071, Moscow, Leninsky Ave., 17

Nikolai N. Potekaev

Moscow Scientific and Practical Center for Dermatovenereology and Cosmetology, Moscow Healthcare Department

Email: apolikhina@inbox.ru
ORCID iD: 0000-0002-9578-5490

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

Russian Federation, 119071, Moscow, Leninsky Ave., 17

Igor I. Baranov

Academician V.I. Kulakov National Medical Research Centre for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia

Email: apolikhina@inbox.ru
ORCID iD: 0000-0002-9813-2823

Dr. Med. Sci., Professor, Vice-President of the Russian Society of Obstetricians and Gynecologists, Head of the Organizational and Methodological Department

Russian Federation, 117997, Moscow, Ac. Oparin str., 4

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