FarGALS

1. FarGALS Efficiency of the new home-developed preparation FarGALS when treating patients with festering-necrotic processes on the skin and mucous membranes

2. ФарГАЛС FarGALS FarGALS Topicality of the problem • Treatment of festering wounds and mucous membranes represents one of the most burning problems in modern medicine. • The problem’s spectrum covers almost all fields of public health. • A persistently growing resistance of microflora to modern antibiotics and antiseptic preparations. • The need of prolonged treatment with a high rate of unsatisfactory results. • Economic expenditure. That’s why the search of novel, more efficient antimicrobial preparations and approaches to their application seems quite topical.

3. ФарГАЛС FarGALS Composition: The preparation is an aqueous extract from the medium of cultivated iron-oxygenating autotrophic bacteria.

4. ФарГАЛС FarGALS Properties: By its pharmaceutical characteristics, the preparation is classified as an antiseptic and wound-healing preparation. FarGALS enjoys a broad spectrum of antimicrobial effect: it is active in respect of Gram-positive and Gram-negative, aerobic and anaerobic, sporogenic and non-sporogenic bacteria: (Escherichia coli, Staphylocoсcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Clostridium perfringens, Citrobacter freundii, Enterobacter agglomerans, Serratia marcescens, Morganella morganii, Acinetobacter calcoaceticus, Bacteroides fragilis, Salmonella typhi murium, Salmonella typhi, Shigella sonnei, Proteus mirabilis and the like , Candida-type fungi, as well as Helicobacter pylori) FarGALS facilitates the improvement of vascularization processes in ischemic areas. FarGALS has a wound-healing and anti-inflammatory effect.

5. ФарГАЛС FarGALS Areas of application: • Surgery • Gynecology • Proctology • Dermatology • Combustiology • Otorhinolaryngology • Stomatology

6. ФарГАЛС FarGALS Indications for application: • In surgery: treatment of purulent and inflammatory diseases of soft tissues, postoperative and burn-related wounds, trophic ulcers and bedsores. • In gynecology: treatment of cervix erosion, cervicitis, colpitis and vulvovaginitis of the bacterial and mycotic etiology. • In proctology: proctitis, hemorrhoids. • In stomatology: treatment of purulent stomatitis, gingivitis etc. • In otorhinolaryngology: treatment of rhinitis, tonsillitis and otitis. • In dermatology: treatment of cutaneous leishmaniosis in the sharp-sphacelating form at different stages.

7. ФарГАЛС FarGALS Investigation of efficiency The investigation was carried on the basis of the following medical centers and clinics: • 1. Republican Center for Purulent Surgery and Surgical Complications of Diabetes. • 2. Republican Specialized Center for Surgery named after Academician V. Vakhidov. • 3. Department of obstetrics and gynecology at the TashGosMI polyclinic. • 4. Surkhandarya Province Dermato-Venerologic Clinic.

8. ФарГАЛС FarGALS Aims of investigation: • To assess the antibacterial and wound-healing efficiency of the novel home-developed preparation FarGALS. • To estimate the preparation’s tolerability when treating patients with festering wounds of different etiology and locality.

9. ФарГАЛС FarGALS Investigation of efficiency Distribution of patients by group 90 patients Control group 30 patients Complex therapy of festering-necrotic wounds was carried out in a traditional way (the local application of the Laevomecolum ointment). Main group60 patientsThe preparation FarGALS is used as part of complex therapy.

10. Surgical treatment: Opening of abscesses, dissection of non-viable tissues, extensive necrectomy within the limits of healthy tissue, exarticulation of toes, amputation on the level of foot and thigh. • Complex therapy: • Correction of carbohydrate metabolism (insulin, sugar-reducing preparations); • Antibacterial therapy, taking into account the sensitivity of microflora (cephalosporins, amino-glucosides, metronidazole); • Vasodilating and spasmolytic preparations (rheopolyglucinum, trental, actovegin, solcoseryl, vasoprastan, nicotinic acid); • Disintoxication therapy; • Correction of the acid-alkali medium; • Direct and indirect anti-coagulants; • Antimycotic systemic therapy (fluconazole preparations), transfusion of blood and its components (albumin and plasma).

11. WOUND AREA cm2 Wound-cicatrization rate: Main group– 3,7 ± 0,71 cm2/day (Р<0.01); Control group– 1,45 ± 0,76 cm2/day

12. Control group Main group Dynamics of clinical developments Hypostasis Purulent discharge Hyperemia

13. DYNAMICS OF MICROBIAL DISSEMINATION 5,0*108 5,0*107 4,9*107 2,6*107 3,7*106 5,0*106 5,0*105 5,0*104 4,2*103 5,0*103 5,0*102 5,0*101 P<0,001 P>0,05

14. Anaerobic phlegmon of humeral girdle on the right

16. Post-operation condition by Sharp

17. Carbuncle on the back of the head

18. ФарГАЛС FarGALS Investigation of efficiency CONCLUSIONS • The preparation FarGALS has a broad spectrum of antimicrobial effect in respect of aerobic and anaerobic bacteria and Candida-type fungi, and can therefore be used as an antimicrobial agent outwardly to treat festering-necrotic wounds. • The preparation FarGALS has a pronounced necrolytic effect, accelerating the cleaning of festering wounds and emergence of granulation tissues. • The preparation FarGALS has a proved wound-healing activity. Comparison of results by wound-healing duration showed that in patients treated with this preparation the wounds closed up 7-8 days earlier than in those, whose wounds were treated in a traditional way. • The preparation FarGALS has a pronounced local anti-inflammatory effect. • As compared with conventional treatment, the preparation FarGALS positively better diminishes the dissemination of a wound, ensuring a higher rate of its cicatrization, as well as positively better reduces the intensity of purulent discharge from a wound, its puffiness and hyperemia.

19. ФарГАЛС FarGALS Investigation of efficiency GYNECOLOGY Type of trial: Open, lengthwise trial involving 2 parallel groups: 1st group(a 30-strong main group of patients, where the preparation is used for local treatment); 2nd group(a 15-strong control group of patients, where conventional traditional local treatment is used, including antiseptics, ointments and vaginal pills). Total number of patients – 45.

20. Distribution of patients in trial groups by pathology Main group Control group

21. Prescription scheme for the preparation FarGALS Locally in the form of applications or tampons, 2 ml of the preparation diluted with distilled water 1:2 once a day, within 3-7 days, depending on the area of affection on mucous tissues or postoperative suture. Main group Prescription scheme for concomitant medicines: cephalosporins, amino-glycosides and disintoxication non-steroid anti-inflammatory preparations. Control group Scheme of traditional treatment: Sanitation using the antiseptic preparation Cyteal, application or tamponment with the Vishnevsky ointment, Solcovagyn and the erythromycin ointment.

22. THERAPY EFFICIENCY DEPENDING ON THE METHOD OF TREATMENT APPLIED Main group Control group

23. DYNAMICS OF BACTERIUM-CULTURE INDICATORS

24. WOUND AREA scores Р<0,05

25. DURATION OF TREATMENT day Р<0,05 Wound cicatrization rate: Main group– 0,72 ± 0,04 Control group– 0,17 ± 0,004

26. DYNAMICS OF COLPOSCOPICAL DATA: (Main group) After treatment(5 days) Before treatment

27. DYNAMICS OF COLPOSCOPICAL DATA:(Main group)

28. DYNAMICS OF COLPOSCOPICAL DATA:(Main group)Cervix erosionBefore treatment and on the 5th day after the beginning of treatment

29. ФарГАЛС FarGALS Investigation of efficiency CONCLUSIONS • The preparation FarGALS has a broad spectrum of antimicrobial effect, covering Gram-positive and Gram-negative, aerobic and anaerobic, sporogenic and non-sporogenic bacteria, as well as Candida-type fungi, that’s why a given preparation can be used as an antimicrobial agent when treating and preventing purulent-inflammatory processes. • The preparation FarGALS accelerates the cicatrization of postoperative wounds and enjoys a good local anti-inflammatory effect and wound-cicatrization activity. Comparison of the results by wound-cicatrization rate showed that in patients with purulent-inflammatory processes treated with the preparation FarGALS, wounds closed up 6-8 days earlier than in those, whose purulent-inflammatory processes were treated conventionally. • The results of clinical trial of the preparation FarGALS showed that antimicrobial therapy with the local application of a given preparation had a positive effect on the majority of patients suffering from inflammatory diseases in cervix and vagina. At the same time, a high antimicrobial, anesthetic and regenerative effect was recorded, with the duration of treatment being shortened and the bacterial smear indicators being improved.

30. ФарГАЛС FarGALS Method of application: • Locally 2-4 times a day in the form of applications • On the skin: in the native form or diluted 1:1 • On the mucous membranes: diluted with boiled water 1:1 or 1:2

31. ФарГАЛС FarGALS Special instructions: Counter-indicators: - individual intolerance of iron-based preparations Side effects: - the burning sensation in the place of application is possible.

32. ФарГАЛС FarGALS Investigation of efficiency DERMATOLOGY TYPE OF TRIAL: Open, lengthwise trial involving two parallel groups: 1st group – a 30-strong main group of patients treated with the preparation FarGALS, which is applied locally; 2nd group – a 15-strong control group of patients treated in a traditional way with the application of antiseptics and ointments. Total number of patients - 45

33. Clinical trial of the preparation FarGALS was carried out on the basis of the Surkhandarya Province Dermato-Venerologic Center • Head of trial: Deputy Director of the CPKOON of the Ministry of Health (Republic of Uzbekistan) for research and epidemiology issues, doctor of medical sciences A.N. Mustanov • Executives: S. Kholmuradova, B.T. Shukurov.

34. DISTRIBUTION OF PATIENTS BY GROUP 45 patients: Control group: 15 patients: Complex treatment of leishmaniosis wounds was accomplished using traditional methods (5 % boric ointment, Vishnevsky ointment, alternated with the potassium permanganate solution and rivanol lotions). Main group: 30 patients Treatment was accomplished with the preparation FarGALS only.

35. Prescription scheme for the preparation FarGALS: Locally in the form of applications, diluted with distilled water 1:1 twice a day, within 10-12 days. Main group Control group Scheme of conventional treatment: Sanitation using the potassium permanganate solution, alternated with the Vishnevsky ointment and 5% boric ointment.

36. ФарГАЛС FarGALS Efficiency criteria for the preparation FarGALS Objective: • Rejection of papillae • Epithelium formation • Secondary cicatrix formation • Wound area • Duration of treatment Subjective: Complaints from patients (pain, discomfort)

37. Control group Main group ФарГАЛС FarGALS DYNAMICS OF CLINICAL DEVELOPMENTS Rejection of papillae 140 120 125,4 100 80 60 40 20 9,80 0

38. ФарГАЛС FarGALS EPITHELIUM FORMATION IN THE WOUND 160 140 148,4 120 100 80 60 40 20 17,73 0 Main group Control group

39. 25 23 20 15 10 5 4,4 4,47 4,4 0 Main group Before treatment During treatment and after treatment Control group FarGALS ФарГАЛС WOUND AREA cm2

40. ФарГАЛС FarGALS DURATION OF TREATMENT(in days)

41. ФарГАЛС FarGALS CONCLUSIONS • The preparation FarGALS has a pronounced antimicrobial effect on the growth and fissiparity of L. major, an infecting agent of zoonotic dermal leishmaniosis. • The preparation FarGALS has a pronounced necrotic effect, speeding up the cleaning of wounds and emergence of epithelial tissues. • The preparation FarGALS has a proved wound-cicatrization activity. Comparison of results by wound-cicatrization rate showed that in patients treated with the preparation FarGALS, wounds closed up and cicatrized 120-150 days earlier than in those treated in a traditional way.

42. THANKS FOR ATTENTION!