Dolzhykova O. The experimental substantiation of the treatment optimization of nonspecific vaginitis with combined vaginal suppositories containing plant oils

Українська версія

Thesis for the degree of Doctor of Science (DSc)

State registration number

0521U100378

Applicant for

Specialization

  • 14.03.05 - Фармакологія

02-04-2021

Specialized Academic Board

Д 64.605.03

National University of Pharmacy

Essay

The thesis is devoted to generalization of the treatment optimization of nonspecific vaginitis of acute and chronic course. An increase in the effectiveness and safety of vaginal suppositories (pessaries) by adding such plant oils as sea buckthorn and tea tree oil to their composition has been substantiated. It has been found that the combination of tea tree oil with metronidazole in “Melanizol” pessaries allows to expand the range of their activity against museum and clinical strains of both aerobic and anaerobic and C. albicans that can provoke nonspecific vaginitis (NV) under certain conditions. For the first time, on the model of vaginal inflammation caused by different phlogogens (carrageenan and zymosan), the anti-inflammatory activity of “Melanizol” pessaries in the dose of 21 mg/kg (44.92 % for carrageenan and 20 % for zymosan, p<0.05) has been proven to be significantly (p<0.05) superior to “Gravagin” pessaries in the dose of 30 mg/kg. The effectiveness of “Melanizol” on the background of “mechanical” and “chemical” vaginitis in rats has been proven. It has been confirmed by planimetric, physicochemical, clinical and biochemical studies of the blood and vaginal discharge. In our model of “chemical” vaginitis the effectiveness of “Melanizol” pessaries was confirmed histologically. By its efficiency “Melanizol” exceeded the “Gravagin” (p<0.05). The advantage of the effectiveness of “Klimedeks” (33.31 mg/kg) over “Melanizol” (21 mg/kg) on the background of acute “irritative” vaginitis in rats has been confirmed by physicochemical (decrease in the pH level by 1.13 and 0.63 in the vagina, respectively; р<0.05), hematological (decrease in the number of leukocytes, ESR), and biochemical indicators. “Klimedeks” pessaries (33.31 mg/kg) showed a significantly (p<0.05) more pronounced local effect on “Melanizol” confirmed biochemically. The restoration of the native microflora has been also observed against the background of the treatment with the pessaries studied by increasing gram-positive rods, which is facilitated by the increase in the amount of glycogen in the vaginal tissue. The advantage of “Melanizol” (21 mg/kg) over “Klimedeks” (33.31 mg/kg) on the background of subchronic vaginitis in ratshas been proven by the hematological and biochemical studies. Proved in the experience in vitro on the culture of HepG2, that “Melanizol” detected active cytotoxic effect compared to “Klimedeks” and “Melanizol” has developed cytotoxic influence on the culture of SiHa. Safety studies of “Klimedeks” and “Melanizol” showed safe for use in vivo. The results obtained substantiate the expediency of using combined vaginal pessaries “Melanizol” and “Klimedeks” for the treatment of NV. “Klimedeks” is more promising in acute vaginitis, both infectious and non-infectious etiology as an agent with the antimicrobial, antifungal, anti-inflammatory, reparative, antioxidant and immunostimulatory effects. “Melanizol” is a more promising agent for chronic vaginitis and vaginitis with a recurrent course, as an agent with the anti-inflammatory, antimicrobial, antifungal, moderate wound healing, antioxidant, immunostimulatory effect, and does not have toxic effects on organs and systems under conditions of its subchronic use. Both drugs can also be used as preventive drugs in preparation for surgical intervention, which requires confirmation in clinical trials.

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