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INVENTION
Patent of the Russian Federation RU2284039

METHOD OF DIAGNOSTICS AND TREATMENT OF PATIENTS AFFECTING SURGERY CANCER OF A ULTIMATE BUBBLE

The name of the inventor: Popov Sergey Leonidovich (RU)
The name of the patent owner: Sergey Leonidovich Popov (RU)
Address for correspondence: 664003, Irkutsk, ul. Fourier, 15, ap. 26, S.L. Popov
Date of commencement of the patent: 2004.09.14

The invention relates to the field of medicine, namely to oncourology, and can be used in the diagnosis and treatment of patients suffering from superficial bladder cancer. The concentrations of the following carcinogens, aniline, toluene, diethylaniline, diphenyl, 1-naphtholamine in the urine and disturbance of the urodynamics, are assessed, and an evaluation of the proliferative activity of urothelium by the degree of Ki-67 expression. In the case of high carcinogen concentrations and urodynamic disturbances, in addition to tumor removal and biopsy of unchanged mucosa, transurethral resection of the prostate or resection of the neck of the bladder is performed, after which it is recommended to increase the consumed liquid in the postoperative period, to reduce contact with carcinogens. Three months later, a control study is carried out, and with a continuing high level of carcinogens and no decrease in the proliferative activity of the urothelium, the urodynamics are re-performed as a cystectomy. The method allows the diagnosis and treatment of patients suffering from superficial bladder cancer.

DESCRIPTION OF THE INVENTION

This method refers to the section of medicine, namely on oncology, and considers the integrated management of patients with superficial bladder cancer and can be used in practice when examining and treating patients suffering from this disease.

Currently, there are many causes that affect the development of bladder cancer. Among the latter, there is a mechanical effect on urothelial bladder (the presence of catheters, stones, foreign bodies, etc.), ionizing effect, and chemical. The role of bacteria and viruses is not fully understood. The most studied is the influence of various chemical compounds that we get with food, drugs, in contact with paints, as well as from the environment.

Irrespective of the nature of the effect, inflammation of the mucosa develops, accompanied by an increase in proliferative activity with an increase in the number of mutations.

He draws attention to the prevalence among men of men over women, as well as the increase in the number of sick men with increasing age. In connection with this, there is a theory about the dangers of urostasis (Matveev BP Bladder cancer / BP Matveev, KM Figurin, OB Karyakin .- M: Verdana, 2001. - 13 pp.). . This theory provides for the presence of an infravesical obstruction, accompanied by a high concentration of urine, as well as the development of a tumor in the neck and the zone of the Lieto triangle, at the site of the greatest contact with urine. Among the chemical compounds are aniline and its derivatives, acrolein, chlorine, which have the most pronounced carcinogenic effect.

In connection with this, we consider chronic urinary retention in patients with bladder cancer as a phenomenon that leads to an increase in the concentration of carcinogens in the urine with an increase in the time spent in the bladder and, as a result, increased contact of urothelial bladder with these substances. The method proposed by us compares favorably with the method proposed in UA UA 51226 A. 15.11.2002 by the fact that in addition to determining the proliferative activity of urothelium for the purpose of predicting attention is paid to the influence of carcinogens on urothelium, and the possibility of assessing the role of urostasis in increasing the concentration of carcinogens in urine A single patient.

In order to determine the concentration of these carcinogens and clarify their role, we propose to take the first morning portion of urine 250 ml in the pre-operative period, by conducting the next sample preparation. The urine sample to be analyzed is placed in a separatory funnel, 30 g of sodium chloride and 10 ml of chloroform are added to 100 ml of urine, the contents of the funnel are vigorously shaken for 15 minutes, after settling, the chloroform extract is poured into a tube and centrifuged for 20 minutes to denature the protein. The resulting centrifuge is evaporated on a rotary evaporator followed by chromatography-mass spectrometric determination of the content of aniline, toluidine, diethylaniline, diphenyl, 1-naphtholamine using the equipment of an analytical American firm Hewllett-Packard using a mass spectrometer-5989 Engine with a mass-selective detector . Software HPG-1034 MS Chem Station (DOS series). The column is quartz, capillary, chromatographic, 30 meters long, 0.25 mm inner diameter, coated with a stationary phase of polymethylsiloxane with 55 phenyl groups (HP-5MS). Conditions for performing the chromatography-mass spectrometric analysis: the evaporation temperature is 250 degrees Celsius, the temperature of the chromatographic column is 60 degrees Celsius for 1 minute. Then heating at a rate of 12 degrees per minute to 260 degrees Celsius. The mass spectra of electron impact of organic compounds are obtained at the energy of the mass spectrum of an individual organic compound (aniline) and ionizing electrons of 70 eV and a temperature of a mass-selective detector of 177 degrees Celsius. The range of mass scanning is 45-350 m / z, the number of scans per second is 1.2. The number of samples is 2, the voltage at the electronic multiplier is 2700 V, and the emission current is 50 μA. The area of ​​the peak of the molecular ion is measured, the aniline area is 93 m \ z, for toluidine 106 m \ z, N, N-diethylaniline 134 m \ z, diphenyl 154 m \ z, 1-naphthylamine 143 m \ z and Calibration characteristic is determined by its mass in the run (ng). Retention time: aniline - 4.22 min, toluidine - 5.37 min, N, N-diethylaniline, diphenyl-8.96 min, 1-naphthylamine - 10.71 min. The procedure is described in: Determination of chemical compounds in biological media. Collection of methodical instructions. - Moscow: Federal Center for State Sanitary and Epidemiological Supervision of the Ministry of Health of Russia, 2000. - 152 p. Ed. Acad. RAEN dms Prof. Zaitseva NV, p. 4 (MUK 4.1.764-99.)

Another aspect of our methodology is forecasting, which in general echoes the application UA ​​51226 A. 15.11.2002.

To date, the search for criteria for predicting bladder cancer continues.

In this connection I propose: the material taken during the multifocal biopsy during transurethral resection of the tumor and correction of the bladder neck, visually unchanged, the bladder mucosa in patients with transitional cell carcinoma of the bladder fixed in formalin solution, to prepare slices with a thickness 4 μm and stained with Ki-67 using the PAP-(peroxidase-antiperoxidase) method, using the Ki-67 Antigen monoclonal antibody from Dakoblon MIB-1 and developing the LSAB2 system from Dako. The staining intensity was assessed by cytophotometry of 50 randomly selected cells of the transitional cell epithelium on the obtained video images of stained micropreparations using a computerized microscopic video system Quantimet 550 IW from Leica, England, for digital analysis of pathomorphological and cytological material and in-depth diagnostics with a high-resolution camera allowing quantitative Analysis of the image by real colors or optical densities with an image format of 6000 by 4000 pixels. The degree of Ki-67 expression is suggested to be evaluated in scores (max-4), given the existence of a direct relationship between the expression of Ki-67 and proliferative activity of the urothelium (Wu T. The role of bcl-2 p-53 and Ki-67 index is predicting tumor recurrence For low superficial transitional cell bladder carcinoma. / T. Wu, JN Chen, Y. Lee // J. Urol .- 2000. - Vol.163 .-- P.758-760.) Ie. One of the tasks for which the proposed method of treatment is directed is to evaluate the proliferative activity of the urothelium with the possibility of predicting the course of bladder cancer. Exclusively in case of detection of carcinogens in sufficiently high concentrations in order to reduce the negative impact of carcinogens on urothelium in patients suffering from superficial bladder cancer in the background of chronic urinary retention due to infravesical obstruction, we suggest, in addition to transurethral resection of the tumor of the bladder and multifocal biopsy of the unmodified bladder mucosa TUR of the prostate or incision for sclerosis of the neck of the bladder. In the postoperative period: an increase in the amount of fluid intake and a decrease in the number of smoked cigarettes, and a decrease in contacts with various chemicals at work and at home, with a control study of the level of carcinogen concentrations in the urine and multifocal biopsy at 3 months according to the above methodology, Volume of residual urine. In the case of changes in urodynamics towards an increase in the volume of residual urine with an increase in the concentration of carcinogens in the postoperative period and a persistent high level of expression of Ki-67 after treatment, I propose to consider it as an unfavorable prognosis with the need for cystectomy. Analogues for the combined determination of the concentration of carcinogens in urine and the proliferative activity of urothelium in order to clarify the prognosis and tactics of patient management in the literature have not been found. The disadvantages include the invasiveness of the method and the high cost of the tests.

Example 1
Patient K., aged 35, No. 2497, entered the MUK KB1 on February 24, 2004 with the diagnosis: Transitional cell carcinoma of the bladder. Hematuria. March 1, 2004. From an anamnesis for 2 years unsuccessfully treats a trichomoniasis prostatitis, smokes. When preparing for surgery, urine is taken - 250 ml in the morning after sleep. A study was performed using the described procedure, aniline was detected in a concentration of 0.0022 mg in a volume of 250 ml of urine. The volume of residual urine was 80 ml.

Operation: TOUR of the bladder. Induction of the prostate. Multifocal biopsy of the bladder. Primary histological conclusion of tumor 6984-87 from 02.03.04. Transitional-cell carcinoma, in a visually unchanged mucosa the picture of lymphocytic infiltration.

The material was prepared and investigated according to the above procedure.

Expression of Ki-67 was 3.67 points.

Later the patient underwent a course of chemotherapy and treatment with immunopreparations.

At a control examination at 3 months (cystoscopy, multifocal biopsy), the volume of residual urine is not determined, the concentration of aniline decreased to 0.00009 mg in 250 ml of urine. The evaluation of the proliferative activity of urothelium according to the proposed procedure was repeated, the degree of expression of Ki-67 decreased to 1.45 points. Clinically, the patient notes improvement in well-being and absence of dysuria, there is no data for relapse of the disease at the time of examination.

Example 2
Patient A., aged 70, No. 13,561, entered the MUZ KB 1 in Irkutsk on November 22, 2003 with the diagnosis: Hematuria of unknown origin. In the anamnesis: the experience of the smoker of 35 years. In the preoperative period, urine was taken 250 ml in the morning after sleep, a study was carried out according to the above procedure and diphenyl 0.009 mg was detected in a volume of 250 ml of urine, other compounds were not detected. In ultrasound, the volume of residual urine was 150 ml. In the further operation: transurethral resection of the bladder, multifocal biopsy, visually unchanged, bladder mucosa, and transurethral resection of the prostate gland, anti-inflammatory therapy is prescribed. PGZ 35703-709 dated December 2 Highly differentiated transitional cell carcinoma of the bladder, in a visually unchanged mucous pattern of inflammation. Ki-67 was 3.2 points.

For three months the patient received adjuvant chemotherapy, at our insistence reduced the number of cigarettes consumed from 45 to 10 pcs. A day, and increased the amount of fluid used. In the control urine examination, this method showed a decrease in the concentration of biphenyl to 0.00013 mg in a volume of 250 ml of urine. The volume of residual urine was 20 ml. Cystoscopy and multifocal biopsy were performed. Expression of Ki-67 was 2 points. At the same time, during the control examination there was no relapse, the patient noted improvement in well-being and a decrease in dysuria.

CLAIM

The method of diagnosis and treatment of patients with superficial bladder cancer, characterized by the concentration of the following carcinogens - aniline, toluene, diethylaniline, diphenyl, 1-naphtholamine in the urine and a violation of urodynamics, a and evaluate the proliferative activity of urothelium by the degree of expression of Ki-67 And in case of high carcinogen concentrations and urodynamic disturbances, in addition to tumor removal and biopsy of unchanged mucosa, transurethral resection of the prostate or resection of the bladder neck is performed, after which it is recommended to increase the consumed liquid in the postoperative period, reduce contact with carcinogens, and after three months carry out a control study And with the continued high level of carcinogens and the absence of a decrease in the proliferative activity of urothelium, against the background of urodynamic disturbances, a second operation is performed-cystectomy.

print version
Date of publication 06.01.2007gg

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