Dioxidin, 1%, solution for intracavitary administration and external use, 10 ml, 10 pcs.

What does Dioxidin help with?

A solution for intravenous administration is prescribed for:

• sepsis;
• purulent-inflammatory processes in the brain.

The medicine for intracavitary use is effective for:

• inflammation of the bladder;
• purulent pleurisy;
• purulent processes in the gallbladder.

The product for local and external application can be used for the following problems:

• burns, wounds, ulcers;
• deep purulent cavities.

Compound

How to use Dioxidin for gargling

The active substance of the drug can kill infections in the throat and takes part in the restoration of the mucous membrane. The solution is used to rinse the mouth for diseases such as sore throat and pharyngitis. It is necessary to mix the contents of the ampoule with 200 ml of purified water. After this, you can gargle for a few seconds. The solution must be used completely. 3-4 procedures can be performed per day. The duration of the therapeutic course is up to 5 days. Only a specialist can extend the appointment or prescribe a repeat course after examination.

Trophic ulcers, according to the combined classification of skin and soft tissue infections, are classified as secondary complicated infections [3], i.e. they are not an independent disease, but arise during the progression of another disease (diabetes mellitus, obliterating atherosclerosis of the lower extremities, chronic venous diseases, etc.). Trophic ulcers of venous etiology are a defect of the skin and underlying tissues of the leg, resulting from a chronic disorder of the venous outflow. They complicate the course of chronic venous insufficiency (CVI) in 15-18% of cases and occur in 1-2% of the adult working population and in 4-5% of elderly patients. Generally accepted methods of treating trophic disorders caused by chronic venous disease (CVD) are aimed at the main links of pathogenesis in order to eliminate one of the main causes of the development of CVI - venous hypertension, the long-term existence of which leads to changes at the tissue, cellular and microcirculatory levels and ultimately to tissue destruction. To correct these disorders, a set of measures is used: compression treatment, systemic pharmacotherapy, and surgery [4].

Local treatment of the ulcer and periulcerous tissues with various topical medications and/or wound dressings is a key step in treatment. The choice of specific therapeutic agents depends on the characteristics of the wound process, the condition of the tissues surrounding the trophic ulcer, and the limb as a whole. In our country, the most common and accessible method for its simplicity and economic costs, despite its inherent disadvantages, is the use of various topical medications (drainage sorbents; proteolytic enzymes; antiseptics) in the practice of a Russian surgeon. - solutions, pastes, powders; ointments; aerosols; regeneration stimulants). Recently, publications have appeared in domestic and foreign literature on the use of a new generation of antiseptic drugs that have a combined effect. Over the past half century, the number of such drugs has increased significantly, but the healing time for ulcers in most patients averages about 2-3 months, in some patients they do not heal for years, and the relapse rate with conservative treatment reaches 60-70%.

The microbiological structure of the surface of venous ulcers almost always has a wide range in the form of associative aerobic-anaerobic microflora with a level of microbial contamination of 107-108 per 1 g of tissue. Gram-positive microorganisms predominate (60.8%). In most cases, the development of purulent-inflammatory complications is caused by Staphylococcus aureus

(58.4%),
Pseudomonas aeruginosa
(17.2%),
Proteus mirabilis
(12.9%). Along with this, in patients with CVI, almost 75% are diagnosed with a mycotic infection, which sensitizes the body and aggravates the severity of the wound process. Symbiotic microorganisms present in venous ulcers, as a rule, do not cause signs of inflammation and do not have a significant effect on the rate of healing.

It has been established that the use of local antibacterial drugs in patients with venous ulcers should not be routine, as this leads to the emergence of resistant strains of microorganisms, prolongation of the inflammation phase, suppression of protective immune mechanisms and, as a consequence, inhibition of regeneration, the appearance of signs of the process becoming chronic state. Regular use of antiseptic solutions (miramistin, chlorhexidine, hydrogen peroxide) for the purpose of sanitation of ulcers during dressing or treatment has a cytotoxic effect on granulation tissue and inhibits proliferation [2, 5], increasing the risk of contact dermatitis. Only in the case of the addition of an infection, clinically manifested in the form of a systemic and/or pronounced local inflammatory reaction both in the ulcer itself and in the surrounding tissues (acute indurative cellulitis), signs of paratraumatic microbial eczema and pyoderma, does the need arise for local use of antiseptic and antibacterial drugs independently or as an adjunct to the administration of systemic antibacterial therapy [1, 6]. In these cases, accelerating the ulcer healing process can be more effective due to a more rapid transition from stage I of the wound process to stage III-III, granulation and epithelization due to a decrease in microbial contamination, relief of signs of inflammation, cleansing the ulcer surface from purulent-necrotic masses, fibrin, removal excess exudate.

It has been proven that the use of modern wound coverings, which create and maintain conditions in the wound that are optimal for autolytic cleansing and regeneration, close to physiological (hydrogels, alginates, hydrocolloids, etc.) actually accelerates the healing time. However, due to the low availability in the pharmacy chain and the relatively high cost, lack of experience, their widespread use in the daily practice of a surgeon is problematic. In this regard, it deserves attention and targeted study of the possibilities of using “old” antiseptic drugs in phlebological practice for the local treatment of purulent wounds.

We conducted a clinical study, the purpose of which was to study the effectiveness of the drug dioxidin, 1% solution, and dioxidin, 5% ointment (MIR-PHARM LLC, Russia), in patients with trophic ulcers of venous origin in the first stage of the wound process.

Material and methods

Dioxidin is a synthetic broad-spectrum antibacterial drug that is used to treat various forms of purulent infection. It has a bactericidal effect, causes structural changes in the cell wall and nucleotide of bacteria, selectively inhibits DNA synthesis in the microbial cell without affecting the synthesis of RNA and protein. Dioxidin is active against gram-negative, gram-positive pathogenic and opportunistic aerobic and anaerobic microorganisms of spore-forming and non-spore-forming species. It remains active against strains resistant to other antimicrobials, including antibiotics. Cross-resistance between dioxidin and other antimicrobial drugs has not been established.

We carried out outpatient treatment of venous ulcers in 30 patients (stage I of the wound process) for 2 weeks with bandages with a 1% dioxidine solution or 5% dioxidine ointment. Among them there were 11 men and 19 women. The age of the patients ranged from 36 years to 71 years (mean age 59.7 ± 9.4 years). The history of CVI was documented in the range from 5 to 40 years and averaged 17.87±8.7 years. The area of ​​the ulcerative defect ranged from 5.1 to 19.32 cm2 (average 7.91±5.3 cm2). The duration of ulcer history varied from 2 to 54 months. In 18 (60%) patients, the ulcer was recurrent, of which in 4 it did not heal for several years.

Throughout the study, along with local treatment, all patients mandatory used elastic compression of the lower extremities in the form of bandaging and systemic pharmacotherapy (micronized purified flavonoid fraction of diosmin 1000 mg per day). The main clinical characteristics of the patients are presented in Table. 1

.

In 18 (60%) patients, ulcers were a complication of varicose veins of the lower extremities, and in 12 (40%) - postthrombophlebitic syndrome.

In all patients, the ulcers were located on the medial surface of the lower third of the leg. At the start of treatment, the clinical picture of the ulcer in 16 patients was characterized by the presence of fibrinous and fibrinous-purulent deposits, intense or moderate serous-purulent discharge, single granulations and lack of epithelization. In 4 patients, the bottom of the ulcerative defect was represented by necrotic masses with pronounced perifocal inflammation and profuse fibrinous-purulent discharge; in 10 patients, there was an overlay of loose fibrin on flaccid granulations, there was initial marginal epithelization, and varying degrees of serous-purulent discharge. Along with this, at the initial stage of the study, 26 patients complained of pain, a feeling of heaviness and discomfort in the area of ​​the trophic ulcer.

Clinical monitoring of the wound was carried out every 4-5 days for 2 weeks: they examined and measured the area of ​​the ulcerative defect, noted the presence of fibrin, the severity of granulation, epithelialization, the nature and amount of wound discharge, the condition of surrounding tissues, and the presence of local adverse events. Along with this, subjective data were assessed: the degree of discomfort in the patient’s daily life (using a 10-cm visual analogue scale), pain syndrome in points. All patients underwent microbiological and cytological examinations at the beginning and end of treatment, and ultrasound examination of the veins of the lower extremities.

The dressing regulations depended on the intensity of exudation, the presence of pain and the degree of discomfort in the ulcer area. In case of severe exudation, dressings were carried out 2-3 times a day, in case of moderate or scanty exudation, the appearance of granulation tissue and areas of marginal epithelialization - 1 time a day.

Inclusion criteria:

men and women aged 18-75 years, undergoing outpatient treatment and having trophic ulcers of the lower leg of one or both extremities with a diameter of 5-20 cm2, at least 2 months old, ready to follow the doctor’s instructions regarding the prescribed therapy.

Exclusion criteria:

patients whose general serious condition due to somatic diseases did not allow them to comply with the recommended regimen; the patient has diabetes mellitus, obliterating atherosclerosis of the lower extremities (ABI <0.8), hypersensitivity to dioxidin, lack of willingness to cooperate on the part of the patient.

results

All patients completed the study. After 2 weeks of treatment of venous trophic ulcers with a 1% solution of dioxidine and 5% dioxidine ointment, complete cleansing of the ulcerative defect from purulent-necrotic ulcers and fibrin occurred in 21 (70%) patients. The course of the wound process in patients in this group was the most favorable. Along with cleansing, a significant decrease in pain was noted (on average from 2.13 to 1.0 points), a decrease in the degree of discomfort (on average from 7.0 to 3.0 cm on a 10-cm scale). Against the background of cleansing, activation of reparative processes was documented in the form of growth of granulation tissue and the appearance of marginal epithelialization, which led to a reduction in the area of ​​the ulcerative defect from an average of 7.9 to 6.8 cm2 (Table 2)

.

In 7 (23%) patients, the area of ​​the ulcer defect remained the same. The cleansing process did not proceed as quickly as in the previous group. Initially, in these cases there were pronounced changes in the periulcerous tissues in the form of dermatitis, lipodermatosclerosis, which supported inflammation and provoked pain and discomfort. At the same time, patients in this group also documented cleansing of the ulcer surface from pus, necrotic tissue, a decrease in the degree of compaction of surrounding tissues, and a zone of hyperemia around the wound. It should be noted that by the beginning of the 2nd week of treatment with the drug, despite minor changes in the area of ​​the ulcer, all patients noted a decrease in pain and discomfort in the ulcer area; by the end of the 2nd week of treatment with dioxidine, the nature of the wound discharge noticeably changed (from fibrinous-purulent to serous), pain decreased, active succulent granulations appeared.

The rate of cleansing of the ulcer surface was uneven and depended mainly on the area of ​​the defect and the condition of the surrounding skin. More rapid cleansing of purulent-necrotic tissue, the appearance of granulations, and marginal epithelization were observed in small ulcers (from 5 to 8 cm2) with unchanged surrounding tissues (two of which were superficial and by the end of treatment were almost completely covered with a thin layer of epithelium).

We compared the effectiveness of dioxidin in the local treatment of venous trophic ulcers in the inflammation stage with the effectiveness of modern antiseptic drugs based on the results of our previously conducted clinical studies (Table 3)

.

It turned out that in terms of the timing of cleansing and transition from the inflammation stage to the regeneration stage, the effectiveness of dioxidine is comparable to that of modern antiseptic drugs and is almost 2 times higher than the results of treatment in the control group, in which traditional solutions of chlorhexidine, miramistin, levomekol or levosin ointments were used.

Staphylococcus aureus in 60% of cases

, in 16% -
Proteus mirabilis
, in 10% -
Pseudomonas aeroginoza
(both in the form of a monoculture and in association with other microorganisms), the remaining 14% of patients have different associations of gram-positive and gram-negative microflora. At the end of treatment, all patients showed positive dynamics, non-pathogenic and opportunistic microflora were identified, not exceeding the critical level of contamination.

During cytological examination before treatment, the degenerative-inflammatory type of cytogram was determined in 70% of cases, inflammatory - in 20%, inflammatory-regenerative - in 10%. At the final visit, patients had a predominantly inflammatory-regenerative (57%) and regenerative-inflammatory (20%) type of cytogram.

There were no adverse events or complications during the treatment process. Only one patient experienced an allergic reaction in the form of local dermatitis during treatment, which was relieved with the use of local corticosteroid ointments.

All patients noted the ease of applying and removing bandages with dioxidine. Only 3 patients, due to old age, obesity, spinal osteochondrosis, and acute cerebrovascular accident, were forced to resort to the help of relatives during dressing changes. 3 patients, during dressings, noted a short-term burning sensation in the area of ​​the ulcer, which disappeared within 0.5-1 hour and did not require discontinuation of treatment.

Thus, dioxidin is a broad-spectrum antibacterial drug that provides rapid cleansing of the wound surface from fibrin and pus, moisturizes the wound, reduces pain at the site of application, promotes rapid cleansing of the wound surface, stimulates regeneration and marginal epithelization. Its use in stage I of the wound process helps to reduce treatment time and transition to the granulation stage 3-4 days earlier compared to standard treatment. Along with this, due to the ease of use and low cost of the drug, patient adherence to this type of treatment was noted. This is extremely important, since many patients with venous trophic ulcers are treated on an outpatient basis and the simplicity-price-effectiveness ratio is one of the priorities in choosing a particular treatment method. The results of the study allow us to consider dioxidin, along with modern local antiseptic drugs, as an effective treatment for venous trophic ulcers in the first stage of the wound process and recommend it for wider implementation in the daily practice of phlebologists.

Release form

Ointment for external use, 5%. 30 and 40 g in aluminum tubes or cans. Each tube or jar is placed in a cardboard pack.

1000 and 2000 g in glass jars.

Solution for infusion and external use, 5 mg/mg

5 or 10 ml in neutral glass ampoules. 3, 5 or 10 amps. placed in a blister packaging made of PVC film or polyethylene terephthalate tape and aluminum foil or paper with PE coating or without foil, or without paper.

1 or 2 blister packs with a knife for opening ampoules or an ampoule scarifier are placed in a cardboard pack. When packaging ampoules with a break ring or break point, do not insert a knife for opening ampoules or an ampoule scarifier.

Solution for intracavitary administration and external use, 10 mg/ml

During production at OJSC "Novosibkhimpharm"

Solution for intracavitary and external use 10 mg/ml. 5 or 10 ml in neutral glass ampoules. 3, 5 or 10 amps. in blister packs made of PVC film or polyethylene terephthalate tape and aluminum foil or PE-coated paper, or without foil, or without paper. 1 or 2 blister packs with a knife for opening ampoules or an ampoule scarifier are placed in a cardboard pack. When packaging ampoules with a break ring or break point, do not insert a knife for opening ampoules or an ampoule scarifier.

When producing at an LLC

Solution for intracavitary and external use 10 mg/ml. 10 or 70 ml in bottles of neutral transparent or dark glass. 1 fl. 10 ml along with a dropper cap are placed in a cardboard pack.

1 fl. 70 ml are placed in a cardboard pack. 6, 8, 10 fl. 70 ml are placed in a cardboard box (for hospitals).

Manufacturer

Ointment for external use

JSC "Biosintez", Russia, Penza.

Legal address and address for accepting claims: JSC Biosintez, 440033, Russia, Penza, st. Friendship, 4.

Tel/fax

Solution for infusion and external use, 5 mg/mg

Name and address of the legal entity in whose name the registration certificate was issued/Organization receiving consumer complaints: OJSC “Valenta Pharmaceuticals”, 141101, Russia, Shchelkovo, st. Factory, 2.

Tel.; Fax.

Solution for intracavitary administration and external use, 10 mg/ml

Name and address of the legal entity in whose name the registration certificate was issued/Organization receiving consumer complaints: OJSC “Valenta Pharmaceuticals”, 141101, Russia, Shchelkovo, st. Factory, 2.

Tel., fax.

Company-. 630028, Russia, Novosibirsk, st. Dekabristov, 275.

Tel.; Fax.

2. LLC, 143422, Russia, Moscow region, Krasnogorsk district, village. Petrovo-Dalneye, “Biomed” named after. Mechnikov.

Tel/fax.