Efficiency of the new home-developed preparation FarGALS when treating patients with...

Efficiency of the new home-developed preparation FarGALS when treating

patients with festering-necrotic processes on the skin and mucous

membranes

FarGALS

• 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.

Topicality of the problemФарГАЛСFarGALSFarGALS

Composition:

The preparation is an aqueous extract from the medium of cultivated iron-oxygenating autotrophic bacteria.

ФарГАЛСFarGALS

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. In addition, the laboratory of the National Collection of Bacteria and Agents for I-II Infection Groups studied the effect of the preparation FarGALS on the representatives of Vibrio cholerae, Iersinia pestis, Brucella abortus bovis, Bacillus anthracis cultures and revealed its pathogenic effect on these cultures.


Areas of application:

• Surgery

• Gynecology

• Proctology

• Dermatology

• Combustiology

• Otorhinolaryngology

• Stomatology


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.


Investigation of efficiency ФарГАЛС

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.

FarGALS

• 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.

Aims of investigation:ФарГАЛСFarGALS

Main group60 patients

The preparation FarGALS is used as part of complex

therapy.

Distribution of patients by group

Control group30 patients

Complex therapy of festering-necrotic wounds was carried out in a traditional way (the local application of the Laevomecolum ointment).

90 patients

Investigation of efficiencyФарГАЛСFarGALS

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).

41,6

36,3

16,0

30,7

0

5

10

15

20

25

30

35

40

45

Before treatment After treatment

Main group Control group

Wound-cicatrization rate:Main group – 3,7 ± 0,71 cm2/day (Р<0.01);

Control group– 1,45 ± 0,76 cm2/day

cm2

WOUND AREA

2,352,06

0,130,87

0

0,5

1

1,5

2

2,5


Purulent discharge

1,43

1,70

0,11

0,93

0,00

0,60

1,20

1,80


Hypostasis

1,38 1,30

0,13 0,60

0,00

0,60

1,20

1,80


Hyperemia

Control groupMain group

Dynamics of clinical developments

0,00

1,00

2,00

3,00

4,00

5,00

6,00

7,00



5,0*107 4,9*107

2,6*107

5,0*106

5,0*105

5,0*104

5,0*103

5,0*102

5,0*101

4,2*103

3,7*106

5,0*108

DYNAMICS OF MICROBIAL DISSEMINATION

P<0,001 P>0,05

Anaerobic phlegmon of humeral girdle on the right

Post-operation condition by Sharp

Carbuncle on the back of the head

1. 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.

2. The preparation FarGALS has a pronounced necrolytic effect, accelerating the cleaning of festering wounds and emergence of granulation tissues.

3. 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.

4. The preparation FarGALS has a pronounced local anti-inflammatory effect.5. 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.

CONCLUSIONS


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.

GYNECOLOGYType of trial:


Distribution of patients in trial groups by pathology

20%

26,70% 30%

23,30%

Cervix erosion Cervicitis

Colpitis Postoperative wound

26,70%

20% 33,30%

20%


Prescription scheme for concomitant medicines: cephalosporins, amino-glycosides and disintoxication non-steroid

anti-inflammatory preparations.

Prescription schemefor 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

Control group

Scheme of traditional treatment: Sanitation using the antiseptic preparation Cyteal, application or tamponment with the Vishnevsky ointment, Solcovagyn and the

erythromycin ointment.

THERAPY EFFICIENCYDEPENDING ON THE METHOD

OF TREATMENT APPLIED

13,4%

86,6%

Very good Good Satisfactory Negligible

30,0%

6,7%

53,3%

10,0%

Control group Main group

№ Pathogenic organism

Main group (n=30) Control group (n=15)

Before treatment

After treatment Before

treatmentAfter treatment

%Incidence of

recovery%

Incidence of recovery

1. St. Epidermidis 33,3 100% 36,6 66,7%

2. St. Aureus 26,6 100% 20,0 0%

3. E. Coli 30,0 100% 33,3 60%

4. St. Haemoliticus 13,3 100% 16,6 100%

5. Candida 26,6 100% 23,3 50%

6. Yeast 16,6 100% 13,3 100%

DYNAMICS OF BACTERIUM-CULTURE INDICATORS

3,64 3,58

0,0

0,33

0

0,5

1

1,5

2

2,5

3

3,5

4


Main groupControl group

scoresWOUND AREA

Р<0,05

DURATION OF TREATMENT

4,53

11,33

0

2

4

6

8

10

12


day

Wound cicatrization rate:Main group – 0,72 ± 0,04 Control group – 0,17 ± 0,004

Р<0,05

DYNAMICS OF COLPOSCOPICAL DATA:(Main group )

Before treatment After treatment (5 days)

DYNAMICS OF COLPOSCOPICAL DATA:(Main group )

DYNAMICS OF COLPOSCOPICAL DATA: (Main group)

Cervix erosion

Before treatment and on the 5th day after the beginning of treatment

•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.

CONCLUSIONS

Investigation of efficiency ФарГАЛСFarGALS

• 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

Method of application: ФарГАЛСFarGALS

Counter-indicators:

Side effects:

- individual intolerance of iron-based preparations

- the burning sensation in the place of application is possible.

Special instructions: ФарГАЛСFarGALS

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

DERMATOLOGYTYPE OF TRIAL:

Investigation of efficiency ФарГАЛСFarGALS

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.

Main group: 30 patients

Treatment was accomplished with the preparation FarGALS

only.

DISTRIBUTION OF PATIENTS BY GROUP

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).

45 patients:

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.

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)


Rejection of papillae

Control group

Main group

DYNAMICS OF CLINICAL DEVELOPMENTS

9,80

125,4

0

20

40

60

80

100

120

140


EPITHELIUM FORMATION IN THE WOUND

17,73

148,4

0

20

40

60

80

100

120

140

160

Main group

Control group


cm2

WOUND AREA

4,4 4,47 4,4

23

0

5

10

15

20

25

Before treatment During treatment

and after treatment

Main group

Control group


DURATION OF TREATMENT

(in days)

26,63

175,26

0

50

100

150

200



1. The preparation FarGALS has a pronounced antimicrobial effect on the growth and fissiparity of L. major, an infecting agent of zoonotic dermal leishmaniosis.

2. The preparation FarGALS has a pronounced necrotic effect, speeding up the cleaning of wounds and emergence of epithelial tissues.

3. 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.

CONCLUSIONS


THANKS FOR ATTENTION !

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