Method of treating glial brain tumours of supratentorial localisation

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to neurosurgery, neurooncology, and can be used for the treatment of glial brain tumours of a supratentorial localisation. For this purpose photodithazine in a dose of 1 mg/kg of body weight is introduced to a patient 2 hours before the tumour ablation. After that, surgical access to the tumour is performed. The operation wound is illuminated by blue colour with a wavelength of 400 nm, and the tumour boundaries are determined by means of fluorescence of photodithazine, selectively accumulated in the tumour tissue. The tumour is ablated under control of the tumour luminescence in blue colour with the application of an operation microscope. After that, a flexible light guide from a radiation source with a wavelength of 662 nm and power of 2.0 W with a light dispersing nozzle is placed into the tumour bed and the perifocal zone of the tumour is irradiated. The dose of irradiation is determined by the disappearance of fluorescence.

EFFECT: method provides an increase of the treatment efficiency due to the reliable clear determination of the tumour tissue boundaries with the normal brain substance independent on the malignancy degree and character of the tumour growth, with an increase of its ablation radicality, as well as due to the destruction of cells, located in the perifocal zone.

2 cl, 1 ex

 

The invention relates to medicine, namely neurosurgery, neuro-Oncology, and can be used in the treatment of glial brain tumors of different malignancy grade.

Surgical treatment of glial brain tumors always presents considerable difficulties for the surgeon, due to the infiltrative nature of their growth, difficulties, intraoperative differentiation of healthy brain matter and tumor tissue.

The known method of surgical treatment of glial brain tumors of supratentorial localization (Sun H, Zhao JZ. Application of intraoperative ultrasound in neurological surgery. Minim Invasive Neurosurg. 2007; 50:155-159). After the introduction of the patient in anaesthesia perform osteoplastic craniotomy in the projection of the planned surgical access to the tumor. After raising the bone flap to expose the Dura, through which using sterile ULTRASOUND probe and ULTRASONIC equipment, ultrasound examination, which allows to determine the size and localization of tumor tissue, the relationship between tumor site and adjacent to it the structures of the brain. Then the Dura is opened, repeat ultrasound study, conduct corticotomy in functionally eloquent area and begin a phased removal of the tumor. Such ultra�vukovo the study is repeated many times during the procedure. Thus, it is possible to visualize the fragments of tumor tissue not visible to the surgeon, with the aid of a standard magnifying equipment (operating microscope, headlamp bulb), used during the surgical intervention, and, consequently, to increase the radicality of tumor removal. After removal of the tumor is carried out control ULTRASOUND study confirming the efficacy of the operation. The Dura is sutured, the bone flap is set up and fixed, and then sutured in layers of soft fabric.

The disadvantages of the method:

1) the difficulties associated with the diagnosis of small fragments of the tumor, reduce the radicality of tumor removal;

2) objective of the difficulty of obtaining reliable ULTRASOUND information for removal of tumors of large size, associated with the presence in the wound channel of the air;

3) difficulties in the differential diagnosis of perifocal zone of the tumor and edema of the cerebral substance;

4) inability to conduct adequate cytoreduction cells perifocal region;

5) the lack of opportunity for the surgeon to simultaneously remove the tumor and perform ultrasonography;

6) need for involvement during the surgery specialist in ultrasound diagnostics.

The closest to the claimed method is x�rulechecker treatment of glial brain tumors of supratentorial localization, adopted as a prototype (Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006; 7:392-401). Patient within 4 hours prior to estimated time of tumor removal orally administered drug 5-aminolevulinic acid in the dosage calculated on body weight. The drug has the ability to selectively accumulate in tissue glial tumor in significant concentrations, while the concentration of the drug in the tissue of normal brain matter is minimal. During the surgery after the introduction of the patient to the anesthesia produce bone-plastic trepanation of the skull, the bone fragment during surgery are removed, dissect the Dura, perform the corticotomy in the projection of the location of the tumor tissue with light of a nearby eloquent areas of the brain, followed by access to tumor tissue. Visualization of the surgical wound during the manipulation of brain tissue and tumor tissue is performed using a Pentero surgical microscope, equipped with diagnostic color filter blue color (wavelength 400 nm). During surgery, the surgeon has the option to switch the illuminator, built-in operating microscope, with normal white light to blue. When rendering OPE�make sure the wounds in the blue light 5-aminolevulinate acid, accumulated in tumor tissue, begins to fluorochromate red-violet spectrum that differ in brightness from normal brain tissue, not the accumulated 5-aminolevulinate acid. Thus, the boundary between normal brain tissue and tissue of the tumor becomes more obvious, which enables the surgeon to conduct a more complete removal of tumor tissue. After tumor removal, conduct a thorough hemostasis, sutured the Dura, set in place and fix the bone flap. Operation complete subcutaneous drainage and suturing of soft tissues.

However, the prototype is not sufficiently effective, because:

1) not all glial tumors accumulate equally 5-aminolevulinate acid. Stockpiling her the worse, the lower the degree of malignancy of the tumor. Therefore, the definition of fluorescence in a relatively benign glial tumors is often impossible and ineffective method;

2) the accumulation of the drug in benign glial tumors (Grade I-II), except tuckaleechee astrocytomas, very low, or absent, making it difficult intraoperative determination of the boundaries of the tumor by using fluorescence, or makes it impossible.

3) the difficulty of determining the boundary between tumor tissue and normal tissue of the cerebral substance occur when�present during the removal of the tumor bleeding, because the blood that's shed abroad in the wound channel, hindered the determination of fluorescence;

4) inability to conduct adequate cytoreduction cells perifocal region;

5) low quality of images obtained with the aid of an operating microscope, when used in mode blue;

6) the need for special expensive surgical microscope (Pentero or Leyca), has a built-in diagnostic filter with a wavelength of 400 nm.

The invention is directed to a method for the treatment of glial brain tumors of supratentorial localization, providing increase of efficiency of the method due to the accurate and clear definition of the boundaries of the tumor tissue from normal brain substance, regardless of the degree of malignancy and the nature of tumor growth to increase the radicality of its removal, and also by the destruction of the cells located in the perifocal area.

Said technical result of the invention is achieved in that in the known method of treatment of glial brain tumors of supratentorial localization, comprising administering a photosensitizer, surgical access to the tumor, the lighting of the surgical wound blue wavelengths of 400 nm, the definition of the boundaries of the tumor by using fluoric�entii selectively accumulated in tumor tissue photosensitizer, removal of the tumor under the control of the illumination of the tumor in the blue light using an operating microscope, the peculiarity lies in the fact that, as a photosensitizer, using the drug of the group of chlorine E6 - fotoditazin, which is administered to the patient for 2 hours before removal of the tumor at a dose of 1 mg/kg of body weight, and after removal in the tumor bed is placed the optical fiber and irradiated perifocal zone of the tumor, the radiation dose is determined by the disappearance of the fluorescent glow. In addition, surgical wound light blue light from the radiation source is a mercury short-arc lamps with elliptical reflector 120W, spectral range of the exciting radiation is 387-447 nm, power density of the exciting radiation is 50 mW/cm2the radiation receiver - digital TV camera with interlaced scan 1/2", PAL 752×582, maximum frame rate is 25 Hz, the integration time - 40...160 MS, read noise of 10 electrons, the wavelength is 400 nm.

The method is carried out as follows. While the patient is on the operating table, after induction of anesthesia, for 1.5-2 hours before anticipated removal of the tumor tissue to the patient intravenously administered drug of the group of chlorine E6 - fotoditazin, diluted with 200 ml of physiological solution, at the rate of 1 mg per 1 kg body weight of the patient. The bottle of physiolo�algebraic solution dissolved in photoditazin wrapped in opaque material. The drug fotoditazin selectively accumulate in the tumor tissue, while its concentration in normal brain tissue is minimal. After the introduction of the patient to the anesthesia head is treated with a sterile antiseptic solution. An incision of the skin, odseparowana skin-aponeurotic flap and stellerovaya bones. Using high-speed boron form a sufficient size trepanation window in the projection of the location of the tumor tissue. Formed bone flap during surgery are removed. An incision of the Dura mater. Access to the tumor is carried out outside the functionally important areas of the brain. To determine fluorescence of fotoditazin illuminate the surgical wound, and blue, using a microscope (e.g., Leyca OHS - 1), combined with blue light illuminator. The radiation source is a mercury short-arc lamp with an elliptical reflector with a capacity of 120 watts. The spectral range of the exciting radiation is 387-447 nm. The power density of the exciting radiation is 50 mW/cm2. The radiation receiver: digital TV camera with interlaced scanning (1/2", PAL 752×582), maximum frame rate is 25 Hz, the integration time - 40...160 MS, read noise of 10 electrons, the wavelength is 400 nm. Fluorescence of fotoditazin in tumor tissue in the form of a bright red glow in the district�the bench real time you can watch with a laptop screen or computer monitor.

To determine fluorescence through the eyepieces of a surgical microscope, they are additionally set yellow filters. The resulting image is high definition to define the fabric, nikopoulou photosensitizer, and, therefore, which is the tumor, and the tissue in which the photosensitizer is not penetrated (unmodified medulla). Fabric, nikopoulou photosensitizer, in stages, parametern remove the physiological permissibility. After removal of tumor tissue perifocal zone perform a careful hemostasis. Then, in a tumor bed is placed a flexible optical waveguide from the source of radiation and a wavelength of 662 nm and irradiated perifocal area containing tumor cells. For this purpose, the laser power with a wavelength of 662 nm set at 2.0 W and using light-scattering nozzle on the optical fiber is irradiated with a tumor bed within 5 min. When this is achieved the decomposition of fotoditazin in the tumor cells located in the peritumoral zone, with the formation of singlet oxygen, which is a strong oxidizer and providing a striking effect on tumor cells that have accumulated photosensitizer. The duration of exposure determine the effect of fotovytsvetaniya drug fotoditazin. Thereafter, the fiber is removed from the wound and hold counter�Sal lighting perifocal area using a light with a blue light wavelength of about 400 nm and television reception. Upon detection of residual luminescence irradiation perifocal zone again. In the absence of illumination in the perifocal area it is no longer irradiated. Thus, the exposure time is determined by the actual result, i.e. to achieve the effect of fotovytsvetaniya. After irradiation perifocal region the Dura continuously tightly sutured. The bone flap is set in place and fix. The soft tissue is sutured in layers. In the immediate postoperative period during the day the patient is wearing sunglasses to prevent exposure to direct sun rays onto the retina, which, as well as tumor tissue, is capable of accumulating fotoditazin, to prevent deterioration of vision.

The claimed method was developed and clinically tested at the research center of the Polenov research neurosurgical Institute them Professor A. L. Polenov.

Here is an example, an extract from the medical history.

Patient M., age 37, IB No. 3213 was treated in the Department of surgery of tumors of the brain and the spinal cord research center of the Polenov research neurosurgical Institute them. A. L. Polenov with 15.12.11 on 08.01.12.

From April 2011 the patient was bothered by headaches hypertensive nature. 10 July 2011 the patient developed a single generalizovanny a seizure. When performing MRI of the brain 14.07.2011 G. in the basal parts of the left temporal lobe revealed a maximum tumor size of up to 28×30×8 mm, with a zone of perifocal edema compressing the left temporal horn, causing no displacement of midline structures.

In the Polenov research neurosurgical Institute named after A. L. Polenov, the patient in a compensated state. Rating on a scale the Karnofsky scale of 80 points. Upon receipt of consciousness is clear, the clinical picture was predominantly cerebral symptoms, intellectual - mnestic disorders, epileptic syndrome. During the inspection and related professionals gross pathology was identified. EEG data indicated a pronounced diffuse changes, focal pathological in the left temporal region, the dysfunction of diencephalic structures.

The patient 26.12.2011 surgery performed: CPTC in the left temporal region, microsurgical removal of the tumor under ultrasound navigation, photodiagnostic with photoditazine, photodynamic therapy. A light dose of 120 j/cm2The ECOG.

Access to the tumor was performed via anterior middle temporal gyrus of the brain. To determine fluorescence of fotoditazin used a fluorescent microscope, built on the base of the microscope Leyca OHS - 1, which was upgraded with a lighter blue color system and TV reception. The radiation source is a mercury short-arc lamp with an elliptical reflector with a capacity of 120 watts. The spectral range of the exciting radiation is 387-447 n�. The power density of the exciting radiation is 50 mW/cm2. The radiation receiver: digital TV camera with interlaced scanning (1/2”, PAL 752×582), maximum frame rate is 25 Hz, the integration time - 40...160 MS, read noise of 10 electrons, the wavelength is 400 Nm. Fluorescence of fotoditazin in tumor tissue in the form of a bright red fluorescence in real-time observed from the laptop screen.

To determine fluorescence through the eyepieces of the surgical microscope were installed on these yellow filters. When high definition was determined in tumor tissue, accumulated photosensitizer, unlike unmodified medulla, in which the photosensitizer is not penetrated. The fabric has accumulated photosensitizer, in stages, parametern was removed, leaving a fragment of the tumor, situated in the area of the zone of Wernicke. Was made a careful hemostasis. Then, in a tumor bed was placed a flexible optical waveguide from the source of radiation and a wavelength of 662 nm and spent photodynamic therapy, a total light dose of 120 j/cm2. The required light dose was determined by the disappearance of fluorescent glow fotoditazin in the perifocal zone of the tumor, defined with a control light perifocal zone blue light of wavelength 400 nm and registered using si�themes video. After conducting photodynamic therapy Dura was tightly sutured, the bone graft is in place and fixed to craniotomy, and then sutured in layers of soft fabric.

A pathology report dated 26.12.2011 No. 12633-40/11: "Fibrillar-protoplasmic astrocytoma CT. the anaplasia. II.

The postoperative period proceeded calmly, was conducted antibacterial, decongestant, antispasmodic, symptomatic therapy. Postoperative wound healed by primary intention, the sutures were removed on 10th day.

In the control CT brain data for the presence of tumor tissue was not. The control of radical removal of the tumor was performed using MRI, which confirmed the data obtained during the operation.

The patient was discharged in stable, stoppage of vital functions. Rating on a scale the Karnofsky scale of 80 points. In the neurological status was observed regression of General cerebral symptoms. Her seizures were not.

1. A method for the treatment of glial brain tumors of supratentorial localization, comprising administering a photosensitizer, surgical access to the tumor, the lighting of the surgical wound blue wavelength of 400 nm, defining the boundaries of tumours using fluorescence selectively accumulated in tumor tissue Photosens�of beliator, removal of the tumor under the control of the illumination of the tumor in the blue light using a surgical microscope, characterized in that the photosensitizer is used, the drug of the group of chlorine E6 - fotoditazin, which is administered to the patient for 2 hours before removal of the tumor at a dose of 1 mg/kg of body weight, and after removal in the tumor bed is placed a flexible optical waveguide from the source of radiation and a wavelength of 662 nm, with a capacity of 2.0 W with light-scattering nozzle and irradiated perifocal zone of the tumor, the radiation dose is determined by the disappearance of fluorescent light effect.

2. A method according to claim 1, characterized in that the surgical wound light blue light from the radiation source is a mercury short-arc lamps with elliptical reflector 120W, spectral range of the exciting radiation is 387-447 nm, power density of the exciting radiation is 50 mW/cm2the radiation receiver - digital TV camera with interlaced scan 1/2", PAL 752×582, maximum frame rate is 25 Hz, the integration time - 40...160 MS, read noise of 10 electrons, the wavelength is 400 nm.



 

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12 cl, 1 dwg, 14 tbl, 55 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to organic chemistry, namely to compounds of formula (I), wherein R1 and R2 independently represent C6-C10 aryl optionally substituted by -OH, halogen, -OC1-C3 alkyl, -NO2, -CF3 or C1-C3 alkyl, or 5- or 6-merous heteroaryl containing one heteroatom specified in N, S and O; A and M independently represent a methylene group or a single bond; an adjacent aromatic cycle is attached directly to an amide group; the group Y=Z represents together and irregularly oxygen atom (-O-), cis-vinylidene group (-CH=CH-), iminogroup (-N=CH- or -CH=N-) or methylene group with sp2-hybridised carbon atom (=CH-); X irregularly represents methine group (=CH-), cis-vinylidene group (-CH=CH-) or carbon atom (=N-), and W represents hydroxyl group (-OH), C1-C6 alkyl optionally substituted by -SH, 5- or 6-merous heteroaryl containing 1 to 2 nitrogen heteroatoms, or C6-C10 aryl, optionally substituted by -SH, -NH2, and their pharmaceutically acceptable salts.

EFFECT: described are the methods for preparing the compounds, using as a drug for treating cancer and the based pharmaceutical composition.

14 cl, 6 tbl, 49 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: present invention refers to immunology. What is presented is a completely human monoclonal antibody, which binds insulin-like growth factor-II (IGF-II) and has a cross responsiveness to IGF-I, as well as its antigen-binding fragment. There are disclosed a nucleic acid molecule coding an antibody according to the invention, a vector and a host cell for the expression of the antibody according the invention. There are described a pharmaceutical composition, as well as conjugates for treating and diagnosing malignant tumour, using the antibody according to the invention in preparing the therapeutic agent and a method for determining IGF-II and IGF-I levels in a patient's sample.

EFFECT: present invention can find further application in cancer therapy.

16 cl, 27 ex, 18 tbl

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to biotechnology, more specifically to a method for producing a mixture of mono- and di-pegylated IL-10, and can be used in medicine. The above method consists in carrying out a reaction of IL-10 protein in the concentration of 1 to 12 mg/ml with activated PEG-linker, wherein the relation of IL-10 and PEG-linker makes 1:1 to 1:7.7 in the presence of 25 to 35 mM of the reducing agent. The appropriate cases may require purifying the produced mixture of IL-10. The invention also refers to a pharmaceutical composition for treating a proliferative condition or disorder, containing a therapeutically effective amount of the mixture of mono- and di-pegylated IL-10 produced as described above, and a pharmaceutically acceptable carrier.

EFFECT: invention enables producing the mixture of mono- and di-pegylated IL-10 accompanied by no side products produced and keeping the protein dimer structure non-destructive.

16 cl, 2 dwg, 1 ex

FIELD: medicine.

SUBSTANCE: septoplasty is followed by postoperative stable-contact pulsed magnetic laser infrared exposure on the patient's skin at wavelength 890-904 nm, power 7 Wt, frequency 80 Hz for 1.5 minutes. The exposure covers four points successively two of which adjoin wings of nose, whereas the other two are found on the lateral nasal walls. The treatment is performed for 3 days daily, 1 procedure a day. After swabs are taken off from the nasal cavity, the procedure is added with endonasal low-intensity red laser exposure for another 3 days at wavelength 635 nm in a continuous mode of power 5 Wt for 1.5 minutes in each half of the nasal cavity.

EFFECT: method enables reducing the length of re-convalescence and recovery of the nasal mucosa, particularly mucociliary clearance, reducing the signs of injury-induced aseptic inflammation, eliminating an oedema, reducing the risk of postoperative haemorrhages following the septoplasty by the combined use of low-intensity red and infrared laser light.

1 ex

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