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DERMATOVENEREOLOGY
INVENTION
Patent of the Russian Federation RU2147896

METHOD FOR TREATMENT OF LIMITED SCLERODERMIUM

METHOD FOR TREATMENT OF LIMITED SCLERODERMIUM

The name of the inventor: Volnukhin VA; Vybornov OV; Grebenyuk V.N .; Samsonov VA; Kovalenko Yu.Yu.
The name of the patent holder: Central Research Institute of Skin and Venereology; The production and experimental plant of the NGO "VILAR"
Address for correspondence: 107076, Moscow, Korolenko St., 3, building 4, Kozhvininstitute, Volnukhin VA
Date of commencement of the patent: 1999.06.23

The invention relates to medicine, in particular to dermatology, and is intended for physiotherapeutic treatment of limited scleroderma. Irradiated foci of ultraviolet damage with a wavelength of 320 - 400 nm, starting at a dose of 0.05 - 0.3 J / cm 2 and increasing it to a maximum value of 2.0 - 3.5 J / cm 2 . Single doses are increased every 3 to 6 sessions by 0.07-0.02 J / cm 2 . The first 15 sessions are carried out every other day, the rest 2 times a week. Total for the course 35 - 100 sessions. Before irradiation, a photosensitizer ammifurin is applied to the foci in the form of 0.3% alcohol solution. In addition, tablets of ammifurin orally may be used 2 hours prior to irradiation. The invention makes it possible to increase the effectiveness of treatment of limited scleroderma with a minor drug load.

DESCRIPTION OF THE INVENTION

The invention relates to medicine, in particular to the field of dermatology, and can be used to treat limited scleroderma.

Limited scleroderma is a severe chronic disease characterized by a specific lesion of the connective tissue and vessels of the microcirculatory bed and clinically manifested by foci of skin sclerosis.

For the treatment of this dermatosis, many different methods have been proposed, including the use of antifibrotic, vasoactive, trophic, anti-inflammatory, immunotropic, corticosteroid, detoxification, vitamin preparations, preformed physical factors (ultrasound, laser radiation, paraffin, ozocerite, etc.) and external means. Unfortunately, the treatment of scleroderma is long, complex, multi-course and often ineffective. The use of various drugs in large quantities leads to significant drug loading on the patient's body, the risk of developing side effects, intolerance or resistance to the drugs used.

A physiotherapeutic method for the treatment of limited scleroderma is known, based on irradiation of lesions with low-intensity laser radiation in the visible region of the optical spectrum ( l = 633 nm) in combination with preliminary external application of photosensitizers from the group of aniline dyes (Mandel A. Sh. "Efficiency of laser photochemotherapy in patients with chronic dermatoses "The thesis abstract for the degree of Doctor of Medical Sciences, M., 1989, pp. 8,9,10,14). However, this method is not effective enough, because visible light, used for laser therapy, has little biological activity.

The invention is aimed at increasing the effectiveness of treatment of limited scleroderma by combining the use of ultraviolet radiation of the long-wave range (320-400 nm) and the photosynitizer of ammifurin.

This result is achieved due to the fact that in the method for treating limited scleroderma, which involves irradiation of lesions after a photosensitizer has been applied to them, the irradiation is carried out by ultraviolet radiation with a wavelength of 320-400 nm starting from a dose of 0.05-0.3 J / Cm 2 and increasing subsequent single doses every 3-6 sessions by 0.07-0.2 J / cm 2 to a maximum value of 2.0-3.5 J / cm 2 , with the first 15 sessions performed every other day, the rest - 2 times a week, all for a course of 35-100 sessions; And as a photosensitizer, ammifurin is used in the form of 0.3% alcohol solution, which is applied to the affected skin 30 minutes prior to irradiation.

When treating patients with a large number of lesions and / or their expressed density, ammifurin is additionally used as tablets orally at a rate of 0.8 mg / kg of body weight 2 hours before irradiation.

In some cases, it is advisable to prescribe, after 25 minutes after application of the solution of ammifurin, 5-25% of an aqueous solution of dimethyl sulphoxide on the foci of involvement of the solution of dimethyl sulfoxide, which allows increasing the penetration of the photosensitizer into the skin.

The method is carried out as follows. Irradiation with long-wave ultraviolet is carried out on ultraviolet therapeutic devices "Waldmann UV-7001 K" (Herbert Waldmann GmbH & Co., Germany), UUD-1, UUD-1-A, OUG-1, OUK-1, (JSC VNIIMP-VITA, JSC "Zavod" EMA ", Yekaterinburg, Russia) or other physiotherapy equipment with similar radiation parameters permitted for use in medical practice .If the initial dose of irradiation is prescribed, the type of skin is taken into account (according to TB classification Fitzpatrick), the degree of sunburn and individual sensitivity of the patient to the combined use of ultraviolet and ammifurin.

During the session the patient is located at a distance of 50 - 70 cm from the ultraviolet lamps. Irradiation begins with a dose of 0.05-0.3 J / cm 2 , subsequent single doses are increased every 3-6 sessions by 0.07-0.2 J / cm 2 to a maximum value of 2.0-3.5 J / Cm 2 . The first 15 sessions are performed every other day, the rest - 2 times a week. The course consists of 35-100 sessions with a total radiation dose of 8-193 J / cm 2 . If necessary, after 1.5-12 months, the course of treatment is repeated.

A solution of ammifurin (produced by PES of the NGO "VILAR", Moscow) is applied to lesions 30 minutes prior to irradiation at the rate of 5-10 ml per procedure. To avoid irradiation of the apparently healthy skin surrounding the scleroderma foci, it is lubricated at a distance of 1-2 cm from the boundaries of the lesion with zinc paste or a photoprotective cream. After the procedure, the zinc paste or cream is removed with a cotton swab dipped in vegetable oil.

In the treatment of patients with a large number of lesions and / or their expressed density, in addition to applications of 0.3% alcohol solution of ammifurin, the latter is administered orally in the form of tablets at a rate of 0.8 mg / kg of body weight. In this case, the tablets are prescribed for 2 hours, and the applications of alcohol solution of ammifurin - 30 minutes before irradiation with ultraviolet.

To improve the penetration of ammifurin into tissues, especially in the treatment of patients with a pronounced density of scleroderma foci, dimethylsulfoxide is applied to the affected skin 25-25 minutes after irradiation, 25 minutes after the application of ammifurin, as a 5-25% aqueous solution.

Due to the selection of the optimal parameters of ultraviolet action in the long-wave range in combination with the use of ammifurin as a photosensitizer, the application of the described method of treatment of limited scleroderma leads to positive clinical results in 87.5% of patients, expressed by the therapeutic effect (clinical recovery and significant improvement) in 56.3% After treatment in scleroderma foci, the inflammation decreases or disappears, softens or completely resorbs the skin, reduces the area of ​​lesions by 50-80%, or their total resolution. The method allows not only to improve the overall outcomes of limited scleroderma in both adults and children, but also to obtain more stable results of treatment. In monitoring patients treated with this method, within 1.5 years, further progression or exacerbation of the disease was noted only in 12.5% ​​of cases. The method is effective not only in the usual course of scleroderma, but also in patients with torpid forms of the disease, resistant to other methods of therapy. The described method allows to significantly reduce the drug load, and thereby reduce the risk of developing drug allergies, gastrointestinal disorders and other adverse reactions that occur with conventional multi-course treatment.

Example 1 . Patient K., 12 years old. On admission, she complained of soreness and limited movements in her left arm. I got sick 3 years ago when, after a mechanical trauma, I first discovered a skin tightening of white and yellow color, arranged in the form of a rough strand along the flexor surface of the left arm from the upper third of the shoulder to the middle of the forearm. She received 5 courses of drug therapy, including penicillin, lidazu, vascular drugs, laser therapy, electrophotophoresis with lidase, external drugs without significant effect. When viewed on the flexor surface of the left upper limb, a scleroderma focus in the form of a strip, 32 cm in length and 3 cm in width, ivory, with indistinct borders and uneven surface, is defined above the level of healthy skin 0.5 cm and surrounded by an inflammatory whisk up to 7 cm. The skin in the region of the hearth is dense, not going into the crease; In the zone of projection of the elbow joint, a pearl-colored constriction is defined, which limits the extension of the left arm. A diagnosis was established: limited scleroderma, linear form, stage of induction. The patient is prescribed treatment according to the claimed method. Irradiation was carried out at a dose of 0.05 J / cm 2 , the single dose was increased every 4 to 6 sessions by 0.07-0.1 J / cm 2 to a maximum value of 2.0 J / cm 2 . The first 15 sessions were conducted every other day, the rest - 2 times a week. As a photosensitizer, a 0.3% alcohol solution of ammifurin was used, which was applied 30 minutes prior to irradiation. The tolerability of treatment was good. After 45 sessions of outpatient treatment, with a total radiation dose of 43.7 J / cm 2 , there was a significant improvement, manifested by a 50% decrease in the area of ​​the lesion, the disappearance of the inflammatory corolla, a significant decrease in the density of the skin in the focus, and the restoration in full of movements in the ulnar The joint. When the patient was observed for 6 months, no recurrences of the disease were detected.

Example 2. Patient M., 60 years old. At admission - complaints about common rashes on the trunk, upper and lower extremities. It is sick for half a year, when for the first time on the left mammary gland found a spot of bright pink color, the size of a five-kopeck coin. The patient associates the occurrence of the disease with the onset of menopause. In the anamnesis - intolerance of penicillin. She received 2 courses of medicamentous therapy, including erythromycin, lidaz, trental, laser therapy, external ointment agents. The disease continued to progress: the number of foci reached 15, they increased in size and compacted. Objectively: on the mammary glands 4 foci of white-yellow color, rounded in shape, measuring from 3 to 12 cm in diameter, dense to the touch, have a smooth, shiny surface, surrounded by a purple corolla. The remaining 11 foci are pink spots on the shoulders and hips, ranging in size from 1 to 6 cm. Limited scleroderma, plaque form, edematous infiltrative stage is diagnosed. Treatment was prescribed according to the claimed method with the additional application of ammofurin orally 4 tablets (0.02 g) per reception (the patient's body weight was 100 kg) 2 hours prior to irradiation. Single doses were increased from 0.3 J / cm 2 , every 3-4 sessions by 0.2 J / cm 2 to a maximum value of 2.5 J / cm 2 . The number of sessions per course was 35, the total exchange rate was 46.1 J / cm 2 . After the end of treatment, a significant improvement was noted, manifested in the cessation of disease progression, the resolution of erythematous spots and significant softening of skin density in the remaining foci of scleroderma. During the next 4 months there was no relapse of scleroderma.

Example 3 . Patient Z., 30 years old. At admission - complaints on the appearance of rashes on the right shin and skin of the abdomen. He got sick a year ago, when he first noticed the appearance of a seal on his right shin and abdomen. A diagnosis was made: limited scleroderma, plaque form. In occasion of the disease, I received outpatiently 3 courses of drug therapy with insignificant effect. When viewed on the abdomen and antero-medial surface of the right shin, there are 2 foci in the form of ivory plaques, woody density, with indistinct boundaries, rough surface and gloss, 4 x 7 cm and 6 x 20 cm, respectively. Considering the expressed density of the affected skin, the patient is prescribed therapy according to the claimed method with 0.3% alcohol solution of ammifurin with additional application of 5% of the aqueous solution of dimethylsulfoxide to the foci of applications. Doses were increased from 0.3 J / cm 2 to 0.2 J / cm 2 every 6 sessions to a maximum value of 3.5 J / cm 2 . Irradiation performed the first 15 procedures every other day, the rest - 2 times a week. A total of 100 sessions were conducted for the course at a total exchange rate of 193 J / cm 2 . At the end of treatment scleroderma plaques almost completely softened, in their place remained pigmented spots.

The state of clinical remission is established; During the next 3 months there were no relapses, the pigmentation in the outbreaks decreased.

CLAIM

1. A method for treating limited scleroderma that involves irradiation of lesions after a photosensitizer has been applied to them, characterized in that the irradiation is carried out by ultraviolet radiation with a wavelength of 320-400 nm, starting at a dose of 0.05-0.3 J / cm 2 and increasing subsequent Single doses every 3 to 6 sessions for 0.07-0.2 J / cm 2 to a maximum value of 2.0-3.5 J / cm 2 , with the first 15 sessions conducted every other day, the rest - 2 times a week , All for a course of 35 - 100 sessions, and as a photosensitizer, ammifurin is used in the form of 0.3% alcohol solution, which is applied to the lesions 30 minutes prior to irradiation.

2. The method of claim 1, wherein ammophyrin is further used as tablets orally at a rate of 0.8 mg / kg of body weight 2 hours prior to irradiation.

3. A method according to claim 1, characterized in that, before irradiation, 25 minutes after the application of ammifurin, dimethylsulfoxide is added to the lesions in the form of a 5-25% aqueous solution.

print version
Date of publication 01.04.2007гг