Organ- retaining method for treating uveal melanoma cases

FIELD: medicine.

SUBSTANCE: method involves administering Wobenzyme combined with brachytherapy with radiomodification and transpupillary thermotherapy or combined with isolated transpupillary thermotherapy. When combined with brachytherapy with radiomodification, Wobenzyme is given 2 days before brachytherapy at a dose of 3 pills 3 times a day with the exception of 8 h before fixation and removal of β-applicator. Next to it, Wobenzyme is given at a dose of 4-6 pills 3 times a day during 3 months. Then, the dose is reduced by 2 pills every month at the fourth, fifth and sixth months. Adjuvant transpupillary thermotherapy is carried out 6 months later after brachytherapy. Wobenzyme is given at a dose of 2-3 pills 3 times a day 2 days before transpupillary thermotherapy. Then, the dose is 4-6 pills 3 times a day during 2 months with following dose reduction by 3 pills every month to prophylactic dose of 1 pill a day. When carrying out isolated transpupillary thermotherapy, Wobenzyme is given in the same mode that it was the case when carrying out adjuvant transpupillary thermotherapy after brachytherapy. To prevent metastasis occurrence, Wobenzyme administration is continued at a dose of 1 pill 7 days every month during the first year and at a dose of 1 pill 3 days every month during the second observation year.

EFFECT: accelerated resorption processes; reduced risk of radiation treatment complications.

 

A priority in the treatment of the most common malignant intraocular tumors, uveal melanoma is isolated or integrated use of various methods of influence on tumor: radiation therapy (brachytherapy, teletherapy protons, helium ions or γ-rays), surgery (transscleral local resection), laser treatment (photo - and laser coagulation, transpupillary thermotherapy, photodynamic therapy), cryogenic [2, 3, 4]. The use of different methods or their combination allows to achieve tumor resorption at 90-93% of patients and reduce the risk of metastasis in the first 5 years up to 7-14%, compared with the frequency of metastasis after removal of the eye - 24-50% [1].

It is well known on the high radioresistance of melanoma tissue to radiation. In addition, due to pathological changes of microcirculation in tumors the majority of cells are in a state of chronic hypoxia, as a consequence, their sensitivity to radiation influence is sharply reduced. All this requires the impact of a total focal dose for a short time. Therefore, this method of radiation exposure is associated with development of severe complications in a high enough percentage: radiation cataracts (66%), proliferative retinopathy (25%), neuropathy (24%), case (23%), torinoi neovascular glaucoma (7%); thus, the effect obtained in the conservative treatment outweighed by the need enucleation of the eye.

Among the drugs that can improve microcirculation in the tissue, a special place belongs to the drugs systemic enzyme therapy with high efficacy and safety, such as Wobenzym.

Wobenzym is a mixture of hydrolytic enzymes of plant (papain, bromeline, rutin) and animal origin (trypsin, chymotrypsin, Pancreatin, amylase, lipase), which can significantly reduce the infiltration of interstitial space plasma proteins, increase the elimination of protein debris and deposits of fibrin in the hearth. This provides improved microcirculation in the damage zone and the reduction of local edema. Research conducted in the 60's, proved radioprotective action of papain by linking free radical groups [7]. Because of the complex effects on individual components of the immunological processes through effects on cellular and humoral immunity, ability to split circulating in the blood and fixed tissues by immune complexes to exert a regulatory influence on the components of complement and adhesion molecules, as well as a pronounced anti-inflammatory effect and improve real the logical properties of blood, the change in the total proteolytic activity of blood, enzyme therapy is widely used in the treatment of various diseases, including cancer [10].

In the treatment of malignant tumors with the use of the drug in this group, Voba-Mugos E most important the following factors:

a) suppress the production of adhesion molecules that promote the metastasis of tumor cells and the development of postradiation complications;

b) increase fibrinolytic activity of blood;

C) increase the sensitivity of tumor cells to the effects of radiotherapy and cytotoxic drugs [5, 6].

The well-known scheme of the drug, Voba-Mugos E in malignant tumors [5, 6]: 6 to 12 tablets a day for 30 - 45 minutes before meals, not chewing and drinking plenty of water (200-250 ml). For the prevention of metastasis is prescribed 1 tablet daily for 7 days every month during the first year and within 7 days every second month during the second year.

When radiation therapy hydrolytic enzymes that are part of this group of drugs, allow not only to increase the radiosensitivity of the tumor, but mitigated the adverse factors of exposure, both in early and late period of observation [9]. Thus, it is of interest to use the system exclusive enzyme therapy, namely Wobenzym in the multicomponent system conservative treatment of uveal melanoma. However, data about technology use in the treatment of uveal melanoma at the present time there is no.

It is known that in order to enhance the effect of brachytherapy apply various methods of influence on tumor tissue - microwave thermotherapy, laser therapy, laser photocoagulation, system prescribing cisplatin or iron-59 [2, 4]. But none of them is aimed at preventing the development of radiation damage.

The aim of the invention is to increase the efficiency of multicomponent conservative treatment of uveal melanoma and improving the quality of life of patients by reducing radiation damage.

This goal is achieved primarily through the use of diagrams and sequence of reception of Wobenzym in multicomponent conservative treatment of uveal melanoma, which allow you to use it with radiomodification in order to accelerate the resorption processes uveal melanoma and to reduce the severity of radiation damage to the organ of vision.

This goal is solved due to the fact that when the claimed method of treatment of uveal melanoma drug administered for two days before the start of the contact transscleral irradiation (brachytherapy), while exposed the Oia 3 tablets 3 times a day for 40 minutes before a meal, squeezed 200-250 ml of water, excluding the 8 hours prior to General anesthesia when fixing or removing β-applicator, after uninstalling β-applicator dose picked individually from 4 to 6 tablets 3 times a day for 3 months (during the formation of the early postradiation complications), then reduce the dose to 2 tablets up to 6 months; after transpupillary thermotherapy, both isolated and in the adjuvant treatment after brachytherapy, the drug is administered 2-3 tablets 3 times a day for 2 days before transpupillary thermotherapy, then from 4 to 6 tablets 3 times a day for 2 months after transpupillary thermotherapy, then reduce the dose to 3 tablets every month to prophylactic dose (1 tablet per day); to prevent the development of metastatic disease after brachytherapy and/or transpupillary thermotherapy taking Wobenzym prodajut 1 pill 7 days monthly during the first year, then 1 tablet 3 days monthly during the second year of observation.

Studies on patent and scientific and technical information sources showed that the proposed method for the treatment of uveal melanoma is not known and should not be explicitly studied the level of science and technology, that is, meets the criterion of "novelty". Drug use Wobenzym is known in medical practice, however good the songs have a distinctive action on their application, the sequence of application, it is possible to draw a conclusion on the conformity of the proposed method inventive step.

The proposed method of treatment is as follows.

The patient takes the drug "Wobenzym" 3 tablets 3 times a day for 40 minutes before eating, drinking 200-250 ml of water, excluding the 8 hours prior to General anesthesia when fixing or removing β-applicator, after uninstalling β-applicator dose picked individually from 4 to 6 tablets 3 times a day for 3 months, then reduce the dose to 2 tablets up to 6 months. Treatment after transpupillary thermotherapy, both isolated and in the adjuvant treatment after brachytherapy, was as follows: the drug is administered 2-3 tablets 3 times a day for 2 days before transpupillary thermotherapy, then from 4 to 6 tablets 3 times a day for 2 months after transpupillary thermotherapy followed by reduction of the dose to 3 tablets every month to prophylactic dose of 1 tablet a day. To prevent the development of metastatic disease after brachytherapy and/or transpupillary thermotherapy taking Wobenzym continued 1 pill 7 days monthly during the first year, then 1 tablet 3 days monthly during the second year of observation.

The method used in the conservative treatment of melanoma in fact the vessel is stand membranes of the eyes in 18 patients.

Monitoring effectiveness of treatment was combined clinical and instrumental examination, which included: visiometry, tonometry, perimetry, biomicroscopy, ophthalmoscopy, intravenous fluorescein angiography, ultrasound examination with color Doppler mapping. It was estimated the degree of resorption of the tumor, change its size, colors, patterns, dynamics of blood flow, the dynamics of visual functions, for radiation reactions and complications. In addition, conducted a physical examination of the patient to detect metastases.

In 18 patients (study group) in multicomponent treatment were included: brachytherapy with radiologicaly drugs platinum, transpupillary thermotherapy and Wobenzym.

22 patients (control group) brachytherapy with radiologicaly the platinum drugs and the subsequent transpupillary thermotherapy was conducted without the use of Wobenzym. In both groups of patients were comparable stages of the process.

In the study group after 6 months of complete tumor resorption with formation of atrophic scar was observed in 4 patients (22%), partial resorption (decrease elevation of the tumor more than 50% of baseline) in 11 patients (61%), stabilization (reduction in tumor size of less than 50% of the tons of original size stabilization or increase its size by no more than 25%)and 3 patients (17%). After 12 months of complete tumor resorption was observed in 15 patients (83%), partial resorption (decrease elevation of the tumor more than 50%) in 3 patients (17%). Residual tumor in 3 patients, amounting to 15-20% of the original, was subjected to laser treatment - transpupillary thermotherapy. In Exodus 3-6 months, there was complete regression of the tumor in all patients.

In the control group after 6 months of complete tumor resorption with formation of atrophic scar was observed in 4 patients (18%), partial resorption of 12 patients (55%), stabilization of the process in 6 patients (27%). After 12 months of complete tumor resorption with formation of atrophic scar was observed in 14 patients (64%), partial resorption, 6 patients (27%), stabilization of the process in 2 patients (9%), progression of the process were observed. Residual tumor in 6 patients, representing up to 15-35% of the original, and in 2 patients, comprising 50-70% of the original, was subjected to laser treatment - transpupillary thermotherapy. In Exodus 5-10 months, there was complete regression of the tumor in 5 patients, partial regression in 3 patients, the progression of the process have been noted.

The clinical result is confirmed by ultrasonographic studies, meet eelistusena about the reduction of acoustic density of the tumor and decrease blood flow to his absence in the study group in the earlier period (up to 6 months), than in the control group. Local and systemic metastasis during the follow-up period of up to 3 years in both groups is not marked.

The study postradiation complications in both groups showed that in the group they were observed in 4 patients (18%): retinovascular -2 (11%), neuromyopathy - 1 (5,5%), neovascular glaucoma - 1 (5,5%). In the control group postradiation complications were observed in 9 (41%) patients: necrosis of the conjunctiva - 1 (4.5%), necrosis of the conjunctiva with subsequent necrosis of the sclera - 1 patient (4.5%), paresis direct muscle - 2 (9%), neuromyopathy - 2 (9%), cataract - 3(14%).

After transpupillary thermotherapy in the study group there were no complications. In the control group was observed complications in 5 patients (62,5%): occlusion of large vessels by mixed type 4 patients (40%), partial hemophthalmus in 1 patient (12.5%).

In clinical studies the effects of Wobenzym when conducting multicomponent conservative treatment of melanoma in fact the choroid installed: strengthening and accelerating the destruction of the tumor, the more rapid the rate of regression of education, fewer complications, improved vital prognosis and quality of life of patients.

All patients reported good tolerability Wobenzym, no allergic reactions, improve well-being.

Bring the clinical examples of the use of the prototype (example 1) and the proposed method (examples 2, 3).

Example 1. Patient Y., 74 years. Diagnosis: Melanoma of the choroid left eye T3N0M0. Ophthalmoscopically in the Central regions of the fundus of the optic nerve - prominere hearth yellowish-grayish color from 12 to 3 hours, with rough surface, single hemorrhages, perifocal retinal detachment. By ultrasound with color Doppler mapping juxtapapillary is determined by the formation of an inhomogeneous structure, with the width of the base of 11.1 mm, prominence 7.0 mm, color flow mapping the flow from low to high, medium and vysokonasyshchennye. Conducted brachytherapy, total focal dose amounted to 132 Gr. 3 months after treatment was noted slabopolozhitelnym dynamics, which is clinically defined as a reduction in tumor size, which was confirmed by the data of ultrasound with color Doppler mapping (education with the width of the base of 9.5 mm, prominence 5.1 mm, your own blood flow is slow, vysokonasyshchennye). 5 months after treatment, the patient developed postradiation cataract that has resulted in a dramatic reduction of vision to the right svetoproektsii and the inability Ophthalmoscope control for uveal melanoma. After 6 months after treatment according to ultra is vukovara research education to its previous size. With organoboranes order was repeated contact transscleral irradiation of uveal melanoma.

Example 2. Patient D., 59 years. Diagnosis: Melanoma of the choroid left eye T3N0M0. Ophthalmoscopically in the lower-outer segment of the eye fundus - exophytic prominere in the vitreous body formation in dark gray with 3 to 6 hours, with rough surface, above it flat retinal detachment. By ultrasound with color Doppler mapping in the lower-outer segment is determined by education moderately heterogeneous echostructure, the width of the base of not less than 11 mm, prominence 8,6 mm, color flow mapping, the blood flow average velocity, srednerazmernyj. Conducted episcleral fixation ophthalmoplegia with a preliminary introduction cisplatin 100 mg with radiomodification purpose, the total focal dose of 128 Grams. Took Wobenzym scheme: up to 2 days before fixation β-applicator 3 tablets 3 times a day for 40 minutes before a meal, during the next 3 months to 5 tablets 3 times a day and the gradual reduction of the dose to 9 tablets per day by the beginning of the 7th month. 6 months after treatment there was a strong positive trend in the reduction of tumor tissue in area and height, the formation of atrophy of the choroid around about the adequate tumor, reduction of retinal detachment. By ultrasound with color Doppler mapping was determined by the formation of a width of the base to 7.8 mm, prominence 2.7 mm, blood in the projection of the focus is on the verge of artifacts. 6 months after brachytherapy held transpupillary thermotherapy for residual tumor and extended the deadline of Wobenzym 3 tablets 3 times a day for 2 months after transpupillary thermotherapy followed by reduction of the dose to 3 tablets every month to prophylactic dose of 1 tablet a day. To prevent the development of metastases taking Wobenzym continued 1 pill 7 days monthly for the first year. 3 months after transpupillary thermotherapy clinically on the background of atrophic scar will be determined in dark gray small prominence lesion with areas of fibroplasia on its surface, retinal detachment no. According to a comprehensive ultrasound examination base width up to 6 mm, prominence 1 mm, the blood flow in the projection of the hearth is not defined. In the period of follow up to 12 months received a complete regression of the tumor, signs of early and late complications were noted. Visual acuity before and after treatment was 0.8.

Example 3. Patient 3., 50. Diagnosis: Melanoma of the choroid right eye T2N0M0. Clinically unstopper the Jarno at the upper boundary of the optic disc ophthalmoscopically gray bumpy education with single point hemorrhages on the surface, above him flat retinal detachment. By ultrasound with color Doppler mapping upwards from the optic disk is determined by education with a wide base of 8-9 mm, prominence 4 mm, height of retinal detachment is up to 1 mm; logged own vessels in the tumor, the blood flow average velocity, srednerazmernyj. Held isolated transpupillary thermotherapy with the prior 2 days taking Wobenzym 3 tablets 3 times a day, then 6 pills 3 times a day for 2 months after transpupillary thermotherapy followed by reduction of the dose to 3 tablets every month to prophylactic dose of 1 tablet a day. To prevent the development of metastases taking Wobenzym continued 1 pill 7 days monthly for the first year. At the control examination after 3 months there is positive dynamics: ophthalmoscopically reduction of tumor size in area and height, the appearance of plots brick color, retinal detachment no. The clinical picture is confirmed by ultrasound - up from the optic nerve education with the width of the base 6 mm, prominence 3.2 mm, the flow on the verge of artifacts. 6 months after transpupillary thermotherapy clinically observed light gray n is large prominence hearth with clear boundaries, according to the integrated ultrasound - prominence is 1.8 mm, the flow is not defined. After 10 months received a complete regression of the tumor. Complications were not observed. Visual acuity before treatment amounted to 0.4 after treatment 0,3.

Thus, the claimed invention is directed to improving the efficiency of multicomponent conservative treatment of uveal melanoma and improving the quality of life of patients by reducing radiation damage.

Literature:

1. Brovkin A.F., Walski V.V. Gusev, G. and others, the Risk of metastasis of malignant melanoma of the choroid after brachytherapy. // Vestnik of ophthalmology. - 2003. No. 2. - P.26-28.

2. Brovkin A.F., Zaruba GD About the effectiveness of brachytherapy in uveal melanomas.//Ophthalmological journal. - 1993. No. 1. - P.1-4.

3. Volkov V.V. Laser treatment of intraocular melanoma. // Clinical ophthalmology. - 2001. - P.3-7.

4. The Korytov LI, Alekseev, V.N., Ilyin, NV, etc. the Role of radiation therapy in combined treatment of eye diseases. // Clinical ophthalmology. - 2002. No. 4. - 164-168.

Castana the enzyme therapy. A practical guide for physicians. // SPb.: 2001 - P.24-25.

6. Systemic enzyme therapy. Modern approaches and prospects. - SPb.: Non-profit partnership of publishers, St. Petersburg, 1999. - S-156.

7. Daha M.R. Measurement and role of immune complex disease in. J. Int. Fed. Clin. Chem. 5, 5 (1993) 200-204.

8. Licastro F, DavisL.J., Morini L.C., et al. Cerebrospinal fluid of patients with senile dementia of Alzheimer's type shows an increased inhibition of α-chymotrypsin. Alzheimer's disease and Associated Disorders 8, 4 (1994), 241-249.

9. Loetscher H., Steinmetz M., Lesslauer W. Tumor necrosis factor: Receptors and inhibitors. Cancer cells. 3,6 (1991), 221-226.

10. Warshaw A.L., Femandez-Del Castill C. Pancreatic carcinoma. N. Engl. J. Med. 326 (1992), 455-465.

The way conservative treatment of uveal melanoma by multicomponent impact, characterized in that the injected Wobenzym in combination with brachytherapy with radiologicaly and transpupillary thermotherapy or in combination with isolated transpupillary thermotherapy, in the case of brachytherapy with radiologicaly Wobenzym introduce two days before brachytherapy 3 tablets 3 times per day, excluding 8 hours prior to fixing and removing β-applicator, after which the Wobenzym injected from 4 to 6 tablets 3 times a day for 3 months, then reduce the dose to 2 tablets monthly on the 4th, 5-th and 6th months, then 6 months after brachytherapy spend adjuvant transpupillary thermotherapy, and two days before transpupillary thermotherapy Wobenzym impose on 2-3 tablets 3 times a day, and after it within 2 months 4-6 tablets 3 times a day with subsequent dose reduction to 3 tablets every month to prophylactic doses of 1 tablet per day; in the case of an isolated transpupillary thermotherapy Wobenzym impose the same schema is, when adjuvant transpupillary thermotherapy after brachytherapy; to prevent the development of metastasis, as in the case after brachytherapy and transpupillary thermotherapy, and in the case of an isolated transpupillary thermotherapy, the introduction of Wobenzym continue 1 pill 7 days monthly during the first year, and 1 tablet 3 days monthly during the second year of observation.



 

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3 cl, 3 dwg

FIELD: medicine.

SUBSTANCE: method involves doing surgical intervention including gastropancreaticoduodenectomy with pancreatojejunal anastomosis being created. Small fraction radiation therapy course is preliminarily applied during 3 weeks before operation by treating pancreas projection region and lymph discharge path with gamma-radiation at total dose of 35-40 Gy. Hemcytabine is introduced into gastroduodenal artery at a dose of 0.2 g/m2 in radiopaque oil during operation before carrying out gastropancreaticoduodenectomy.

EFFECT: enhanced effectiveness of treatment.

FIELD: medicine.

SUBSTANCE: method involves administering chemotherapy in 1-5 days long courses. The treatment is accompanied with subtotal patient body irradiation with field concentrated in the area from diaphragm vault to feet everyday once a day before every chemotherapy course. Irradiation dose is equal to 0.1 Gy within total dose of 0.8 Gy. The combined treatment is repeated with 2-3 months long pauses to reach remission or total dose of 1 Sv in subtotal patient body irradiation.

EFFECT: enhanced effectiveness of treatment.

FIELD: medicine.

SUBSTANCE: method involves applying intraoperative radiation therapy with rapid electrons of 6 MeV with single dose of 8 Gray per removed tumor bed. Then, postoperative remote gamma-therapy course is applied after having healed the wound and removing sutures to postoperative suture region and regional lymph discharge zone at a dose of 2 Gray with 5 fractions per week. The number of remote gamma-therapy sessions is calculated from formula N=8.8(3.4-X-0.169), where N is the number of postoperative remote gamma-therapy sessions; X is the time interval length in days between the intraoperative radiation therapy session and remote gamma-therapy session under condition that mixed irradiation dose (intraoperative radiation therapy and remote gamma-therapy) to thyroid gland tumor region or cancer recurrence area is equal to 60 Gray in terms of isoeffect.

EFFECT: increased total course dose per tumor focus; reduced risk of relapse; accelerated treatment course.

1 tbl

FIELD: medicine, ophthalmology.

SUBSTANCE: it is necessary to conduct scanning laser impulse irradiation of newly formed corneal vessels with scattering light bundle for about 5-10 min at applying the following parameters: wave length 890-900 nm, irradiation power 1-5 W in impulse, the frequency of impulses 140-160 Hz and impulse duration 50-300 nsec. Then it is necessary to introduce 0.1-1%-aqueous solution of photosensitizer of khlorin type taken out of the group of photolon, radakhlorin or photoditasin, at the dosage of about 0.8-1.1 mg/kg. Then one should perform exposition of newly formed corneal vessels without light access for about 15-20 min. Then it is necessary to apply the gel based upon hyaluronic acid viscoelastic onto corneal surface, this gel should be chosen out of the group of chealon, viscoate or hyatulon and, moreover, it is important to locate a laser light-scattering device upon corneal surface. Laser irradiation of newly formed corneal vessels should be fulfilled with scattered laser radiation at the density of laser radiation energy being 30-60 J/sq. cm. The innovation provides high efficiency in destructing newly formed corneal vessels followed by technique of optico-reconstructive keratoplasty.

EFFECT: higher efficiency of photodynamic therapy.

1 cl, 2 ex

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