Рецепт. 2018; : 834-842
Исследование эффективности вагинальных суппозиториевс противовоспалительной и противомикробной активностью на модели экспериментального вагинита
Аннотация
The study has been carried out in 35 female Vistar rats weighing 200-220 g. The animals were divided into 5 groups: 1 - intact animals, control; 2 - animals with modeled experimental vaginitis (EV); 3 - ЕV + base (B); 4 - ЕV + new combined investigated medicinal product with anti-inflammatory and antimicrobial effect in the form of vaginal suppositories (ID); 5 - ЕV + reference medicinal product neo-penotran in the form of vaginal suppositories (RP). The investigated medicinal product contained ibuprofen, clotrimazol and metronidazol in the form of suppositories. neo-penotran contained miconazol and metronidazol. Both medicinal products included the identical base: witepsol. 5 days after modeling EB a histological examination of rats’ vagina was carried out.While modeling EB in 2 group of animals an evident atrophy of vaginal mucosa epithelium, desquamation of the areas of dead mucosa and an evident inflammatory reaction (macrophage and neutrophil infiltration). In groups 4 and 5 the drugs’ effect was manifested as rejection of a dead layer into the organ lumen. A statistically significant reduction of structural changes in the vaginal wall (total index, epithelial thickness) was detected in group 4 and there was no true difference in group 5.The investigated medicinal product’s effect consisted in a faster rejection and elimination of the damaged epithelium and a formation of favorable conditions for the reconstructive process. A conclusion about the absence of the drug influence in group 5 was made, because an increase of the average epithelial thickness resulted from a mucosal edema, but not from an activation of reconstructive processes.
Список литературы
1. Lester J.L., Bernhart L., Ryan-Wenger N. (2012) A self-report instrument that describes urogenital atrophy in breast cancer survivors. West. J. Nurs. Res, no 34, pp. 72-96. doi: 10.1177/0193945910391483
2. Castelo-Branco C., Cancelo M.J., Villero J., Nohales F., Juliá M.D. (2005) Management of post- menopausal vaginal atrophy and atrophic vaginitis. Maturitas, no 52, pp.46-52. doi: 10.1016/j. maturitas.2005.06.01
3. Reiter S. (2013) Barriers to effective treatment of vaginal atrophy with local estrogen therapy.
4. Int J Gen Med. no 6, pp. 153-8. doi: 10.2147/IJGM.S43192
5. Lee A., Kim T. H., Lee H. H., Kim Y. S., Enkhbold T., Lee B., Song K. (2018) Therapeutic Approaches to Atrophic Vaginitis in Postmenopausal Women: A Systematic Review with a Network Meta- analysis of Randomized Controlled Trials. Journal of Menopausal Medicine, no 24 (1), pp. 1-10. doi: org/10.6118/jmm.2018.24.1.1
6. Shen J., Song N., Williams C. J., Brown C. J., Yan Z., Xu. C. & Forney, L. J. (2016) Effects of low dose estrogen therapy in the vaginal microbiomes of women with atrophic vaginitis. Scientific Reports, no 6, 24380. doi: org/10.1038/srep24380
7. Kaur J., Kalsy J. (2017) Study of pruritus vulvae in geriatric age group in tertiary hospital. Indian Journal of Sexually Transmitted Diseases, no 38 (1), pp. 15-21. doi: org/10.4103/0253-7184.192632
8. De Bernardis F.D., Lucciarini R., Boccanera M., Amantini C., Arancia S., Morrone S., Mosca M., Cassone A., Santoni, G. (2006) Vaginitis Candida albicans of Vaginal Dendritic Cells in a Rat Model of Phenotypic and Functional Characterization. Infect. Immun, no 74 (7): 4282. doi: 10.1128/ IAI.01714-05
9. De Bernardis F., Boccanera M., Adriani D., Spreghini E., Santoni G., Cassone A. (1997) Protective role of antimannan and anti-aspartyl proteinase antibodies in an experimental model of Candida albicans vaginitis in rats. Infection and Immunity, no 65 (8), pp. 3399-3405.
10. Dolzhykova O.V., Maloshtan L.M. (2016) Pathomorpological research of vaginal suppositories “klimedeks” in rats with the irrytative vaginitis. Ukrainian biopharmaceutical journal, no. 6 (47), pp. 30-36.
11. Mendling W., Weissenbacher E. R., Gerber S., Prasauskas V., Grob P. (2016) Use of locally delivered dequalinium chloride in the treatment of vaginal infections: a review. Archives of Gynecology and Obstetrics, no 293, pp. 469-484. do: iorg/10.1007/s00404-015-3914-8
12. Gülmezoglu A.M., Azhar M. (2011) Interventions for trichomoniasis in pregnancy. Cochrane Data base Syst Rev., 11 (5): CD000220. doi: 10.1002/14651858.CD000220.pub2
13. Bradshaw C.S., Sobel J.D. (2016) Current Treatment of Bacterial Vaginosis -Limitations and Need for Innovation. The Journal of Infectious Diseases, no 214 (Suppl. 1), pp. 14-20. doi: org/10.1093/ infdis/jiw159
14. Milani M., Iacobelli P. (2012) Vaginal Use of Ibuprofen Isobutanol ammonium (Ginenorm): Efficacy, Tolerability, and Pharmacokinetic Data: A Review of Available Data. ISRN Obstetrics and Gynecology, 673131. doi: org/10.5402/2012/673131
15. Schnitzer T.J., Burmester G.R., Mysler E. (2004) Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), reduction in ulcer complications: randomised controlled trial. Lancet, no 364 (9435), pp. 665-674.
16. Stepanova K.O., Dolzhykova O.V., Maloshtan L.M., Maloshtan A.V. Patent 62115, UA, G 09 В 23/28, А 61 К 33/38. Simulation method for aseptic inflammation of vagina mucosa. National Pharmaceutical University is the applicant and the owner of the patent № u201101356; appl. 07.02.2011; publ. 10.08.2011, bullet. № 15.
17. Pullè C., Sturlese E. (2002) Clinical trial comparing the activity and efficacy of Ibuprofen isobutanol ammonium vs Benzydamine hydrochloride, applied as vaginal irrigations, in patients with vaginitis. Clinical and Experimental Obstetrics and Gynecology, no 29 (3), pp. 173-179.
18. Zinchenko L.V. Nizhenkovska I.V. (2017) Acute toxicity studies of the new complex drug with anti-inflammatory activity. Current Topics in Pharmacology, no 21, pp. 71-74.
19. Ornelas-Aguirre J.M., Gómez-Meda B.C., Zamora-Perez A.L., Ramos-Ibarra M.L., Batista-González C.M., Zúñiga-González G.M. (2006) Micronucleus induction by metronidazole in rat vaginal mucosa. Environ. Mol. Mutagen, no 47 (5), pp. 352-6.
20. Himmat Singh Johal, Tarun Garg, Goutam Rath, Amit Kumar Goyal (2016) Advanced topical drug delivery system for the management of vaginal candidiasis. Drug Delivery, no 23 (2), pp. 550-563. doi: 10.3109/10717544.2014.928760
21. Carr P.L., Felsenstein D., Friedman R.H. (1998) Evaluation and Management of Vaginitis. Journal of General Internal Medicine, no 13 (5), pp. 335-346. doi: org/10.1046/j.1525-1497.1998.00101
22. Schwebke J.R., Lensing S.Y., Sobel J. (2013) Intravaginal metronidazole/miconazole for the treatment of vaginal trichomoniasis. Sex Transm Dis., no 40 (9), pp.710-4. doi: 10.1097/01.olq. 0000431069.38601.d5
Recipe. 2018; : 834-842
Efficacy study of vaginal suppositorieswith anti-inflammatory and antimicrobial effect on a model of experimental vaginitis
Abstract
References
1. Lester J.L., Bernhart L., Ryan-Wenger N. (2012) A self-report instrument that describes urogenital atrophy in breast cancer survivors. West. J. Nurs. Res, no 34, pp. 72-96. doi: 10.1177/0193945910391483
2. Castelo-Branco C., Cancelo M.J., Villero J., Nohales F., Juliá M.D. (2005) Management of post- menopausal vaginal atrophy and atrophic vaginitis. Maturitas, no 52, pp.46-52. doi: 10.1016/j. maturitas.2005.06.01
3. Reiter S. (2013) Barriers to effective treatment of vaginal atrophy with local estrogen therapy.
4. Int J Gen Med. no 6, pp. 153-8. doi: 10.2147/IJGM.S43192
5. Lee A., Kim T. H., Lee H. H., Kim Y. S., Enkhbold T., Lee B., Song K. (2018) Therapeutic Approaches to Atrophic Vaginitis in Postmenopausal Women: A Systematic Review with a Network Meta- analysis of Randomized Controlled Trials. Journal of Menopausal Medicine, no 24 (1), pp. 1-10. doi: org/10.6118/jmm.2018.24.1.1
6. Shen J., Song N., Williams C. J., Brown C. J., Yan Z., Xu. C. & Forney, L. J. (2016) Effects of low dose estrogen therapy in the vaginal microbiomes of women with atrophic vaginitis. Scientific Reports, no 6, 24380. doi: org/10.1038/srep24380
7. Kaur J., Kalsy J. (2017) Study of pruritus vulvae in geriatric age group in tertiary hospital. Indian Journal of Sexually Transmitted Diseases, no 38 (1), pp. 15-21. doi: org/10.4103/0253-7184.192632
8. De Bernardis F.D., Lucciarini R., Boccanera M., Amantini C., Arancia S., Morrone S., Mosca M., Cassone A., Santoni, G. (2006) Vaginitis Candida albicans of Vaginal Dendritic Cells in a Rat Model of Phenotypic and Functional Characterization. Infect. Immun, no 74 (7): 4282. doi: 10.1128/ IAI.01714-05
9. De Bernardis F., Boccanera M., Adriani D., Spreghini E., Santoni G., Cassone A. (1997) Protective role of antimannan and anti-aspartyl proteinase antibodies in an experimental model of Candida albicans vaginitis in rats. Infection and Immunity, no 65 (8), pp. 3399-3405.
10. Dolzhykova O.V., Maloshtan L.M. (2016) Pathomorpological research of vaginal suppositories “klimedeks” in rats with the irrytative vaginitis. Ukrainian biopharmaceutical journal, no. 6 (47), pp. 30-36.
11. Mendling W., Weissenbacher E. R., Gerber S., Prasauskas V., Grob P. (2016) Use of locally delivered dequalinium chloride in the treatment of vaginal infections: a review. Archives of Gynecology and Obstetrics, no 293, pp. 469-484. do: iorg/10.1007/s00404-015-3914-8
12. Gülmezoglu A.M., Azhar M. (2011) Interventions for trichomoniasis in pregnancy. Cochrane Data base Syst Rev., 11 (5): CD000220. doi: 10.1002/14651858.CD000220.pub2
13. Bradshaw C.S., Sobel J.D. (2016) Current Treatment of Bacterial Vaginosis -Limitations and Need for Innovation. The Journal of Infectious Diseases, no 214 (Suppl. 1), pp. 14-20. doi: org/10.1093/ infdis/jiw159
14. Milani M., Iacobelli P. (2012) Vaginal Use of Ibuprofen Isobutanol ammonium (Ginenorm): Efficacy, Tolerability, and Pharmacokinetic Data: A Review of Available Data. ISRN Obstetrics and Gynecology, 673131. doi: org/10.5402/2012/673131
15. Schnitzer T.J., Burmester G.R., Mysler E. (2004) Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), reduction in ulcer complications: randomised controlled trial. Lancet, no 364 (9435), pp. 665-674.
16. Stepanova K.O., Dolzhykova O.V., Maloshtan L.M., Maloshtan A.V. Patent 62115, UA, G 09 V 23/28, A 61 K 33/38. Simulation method for aseptic inflammation of vagina mucosa. National Pharmaceutical University is the applicant and the owner of the patent № u201101356; appl. 07.02.2011; publ. 10.08.2011, bullet. № 15.
17. Pullè C., Sturlese E. (2002) Clinical trial comparing the activity and efficacy of Ibuprofen isobutanol ammonium vs Benzydamine hydrochloride, applied as vaginal irrigations, in patients with vaginitis. Clinical and Experimental Obstetrics and Gynecology, no 29 (3), pp. 173-179.
18. Zinchenko L.V. Nizhenkovska I.V. (2017) Acute toxicity studies of the new complex drug with anti-inflammatory activity. Current Topics in Pharmacology, no 21, pp. 71-74.
19. Ornelas-Aguirre J.M., Gómez-Meda B.C., Zamora-Perez A.L., Ramos-Ibarra M.L., Batista-González C.M., Zúñiga-González G.M. (2006) Micronucleus induction by metronidazole in rat vaginal mucosa. Environ. Mol. Mutagen, no 47 (5), pp. 352-6.
20. Himmat Singh Johal, Tarun Garg, Goutam Rath, Amit Kumar Goyal (2016) Advanced topical drug delivery system for the management of vaginal candidiasis. Drug Delivery, no 23 (2), pp. 550-563. doi: 10.3109/10717544.2014.928760
21. Carr P.L., Felsenstein D., Friedman R.H. (1998) Evaluation and Management of Vaginitis. Journal of General Internal Medicine, no 13 (5), pp. 335-346. doi: org/10.1046/j.1525-1497.1998.00101
22. Schwebke J.R., Lensing S.Y., Sobel J. (2013) Intravaginal metronidazole/miconazole for the treatment of vaginal trichomoniasis. Sex Transm Dis., no 40 (9), pp.710-4. doi: 10.1097/01.olq. 0000431069.38601.d5
