Method for applying prolonged pharmacotherapy

FIELD: medicine.

SUBSTANCE: method involves incubating antibiotics and/or chemopreparations in therapeutic doses with autoplasma 30 min at 37°C and introducing the preparations into paravaginal cellular tissue to patients suffering from genitalia diseases and into paravesical cellular tissue to patients suffering from urinary bladder diseases and into pararectal cellular tissue to patients suffering from rectum diseases. Tumor proliferation into neighboring small pelvis organs (into paravaginal and/or pararectal and/or paravesical cellular tissue) taking place, the treatment is applied twice a week.

EFFECT: increased pathological focus regression percent; reduced manifestations of drug therapy complications.

 

The invention relates to medicine, namely to methods of administration of drugs, and can be used to treat diseases of different nosology.

When choosing a method of drug therapy of various diseases of the greatest importance localization and extent of the process, as well as aspects of applied pharmacokinetics of drugs, including determining the speed and completeness of absorption of drugs in oral application, binding to plasma proteins (in all ways), time to reach the maximum concentration in blood plasma half-life, the time of complete removal. The definition of these parameters and their comparison with the dynamics of therapeutic effect allow you to set the optimal doses and modes (frequency and duration) of the drug, to assess the advantages of different ways of its introduction (Mashkovsky PPM Medicines: 2 T. T.1. - 14th ed., Rev., Corr. and extra - M.: OOO "publishing house New Wave" Publisher Sbelow, 2002, - 540 S.).

To select the optimal dosage form also requires knowledge of its pharmacological characteristics. In recent preference for prolonged dosage forms. The prolongation of the action is achieved by the inclusion of increased doses of the substance in the polymer wear and, the microencapsulation and other technological techniques. The effect is achieved due to the slow release of the active substance. In some cases the use of these dosage forms allows not only to reduce the number of doses of the drug (usually up to 1 times per day), but also to improve the tolerability and efficacy. In some cases, the rollover effect is achieved due to the specific chemical structure of the compounds.

However, for a prolonged forms are used, typically, polymeric dyes, the release of which medicinal substances depends on the activity of some enzyme systems of the body sick, condition of the gastrointestinal tract, the level of acidity of gastric juice, the condition of the liver parenchyma. For the adequate release of the drug from the carrier of these parametry should be close to physiological norm, which is practically impossible in patients with serious inflammatory or neoplastic diseases. The second thing that you must note is the introduction of a medicinal product, even in its extended form, in the General bloodstream. Getting into the blood, the medicine is not only in the lesion, but also spreads throughout the body by binding part with healthy tissues.

One way fiziologicheskogo the deposition of drugs in the body of patients is the method of endolymphatic introduction. To date, the indications for endolymphatic therapy identified in many diseases. Endolymphatic administration of drugs allows you to more actively influence of pathogenic factors, localized in the lymphatic system (microorganisms, toxic metabolites, migratory tumor cells and others), to accelerate the activation of the immune system in the presence of a tumor, to introduce into the body a large single doses of toxic drugs without apparent toxic effect appearing when other routes of administration, to reduce the number of medical complications. Pay attention to the facts about high positive effect of endolymphatic therapy for cancer, septic and other pathological processes, localized outside of the lymphatic system (Levin, Y.M. basis of the medical lymphology. - M.: Medicine, 1986).

However, the view that with the introduction of the lymphatic system drugs weakens their General toxic effect, can create a false impression of harmlessness endolymphatic infusion of high doses of toxic drugs. Infusion of lymph vessel maximum single dose, for example gentamicin, creates in regional and some other nodes in the concentration above therapeutic approximately 25 times. Naturally, this leads to a pronounced m the local toxic effect suppresses not only pathogenic start, but the protective functions of the lymphatic system. Characteristically, and thus remain lymph nodes even on the paths of motion of the antibiotic through the lymphatic system, in which the accumulation of the drug may be missing. In other nodes, in which he acts, its toxic effect is compounded by the extremely slow nature of the lymph flow compared to the flow that determines the prolonged contact of the drug with the surrounding tissue. Therefore, the use of the lymphatic system as a gate for high doses toksicheskikh drugs in order to achieve organismic effect can only be justified in special cases, for example in the treatment of cancer patients with the tablets that cause in other ways their introduction severe adverse reactions. However, the procedure itself endolymphatic injection involves the stage of "minor" surgery, consisting in the detection and exposure of the lymph vessel of the foot. However, varicose blood vessels of the lower extremities, which often occurs in older women, this procedure becomes impossible. Contraindicated endolymphatic administration of drugs and in violation of the blood coagulation system. Frequent complication remain lymphangitis.

The purpose of this image is to be placed is to improve the results of treatment of cancer and inflammatory diseases of the pelvic organs.

This goal is achieved by the fact that different drugs in therapeutic doses, incubated for 30 minutes at 37°With autoplasma, injected patients inflammatory or cancer of the genitals in paravaginal fiber, with the defeat of the bladder in perivesical tissue, diseases of the rectum in adrectal fiber, and when the spread of the tumor to the adjacent pelvic organs in paravaginal, and/or parasitically, and/or adrectal fiber 2 times a week, repeating manipulation 4 times in the course of treatment.

Analysis of the known methods of drug therapy and claimed can be concluded that the developed method has novelty. The novelty of the method lies in the possibility of infiltration of the tissues surrounding the lesion largest number of medicinal substances, bypassing the blood and lymphatic vessels. This allows you to have the greatest effects of medicinal substances on tumor cells and pathogenic flora.

In the available sources of information Russia, CIS and abroad instructions on this method depositing prolonged treatment of patients with diseases of the pelvic organs of various origins was not found.

The invention is industrially applicable, as may the be repeatedly reproduced and used in health care, in hospitals and specialized therapeutic profile.

The method is as follows.

From the peripheral (second) of Vienna patient taking 150 ml of blood in a standard sterile vial logician, which is centrifuged for 15 minutes at 1500 rpm the blood Plasma are selected, the cell suspension is re-infused intravenously, drip. In the blood plasma of add medicines needed depending on disease and clinical situation and incubated at 37°C for 30 minutes. Then autoplaza drug drug is administered to patients

1) gynecological diseases after appropriate treatment of external genital organs and the introduction of a spoonlike mirrors vaginal mucosa was treated with a solution of furacin 1:5000 or other traditional antiseptic. The wall of the vagina was functionals on the middle line on the border of the lower and middle thirds. The needle is introduced perpendicular to the wall of the vagina to a depth of 1 cm, and then in a direction parallel to the wall of the vagina, was conducted to a depth of 7-8 cm In the process of moving the needle was injected drug. After manipulation of the needle is removed, the puncture site was treated with alcohol. Similarly, an injection drug preparatov the opposite wall of the vagina. The amount of fluid 20-40 cm3in each of the sides of;

2) in diseases of the bladder for deposition of drugs in Priestley tissue introduction of medicinal substances was performed after appropriate processing of the external genitalia and vagina along the borders of the front wall and the side (right and left) wall of the vagina. The manipulation was performed after complete emptying of the bladder. By way of introduction, directly reached 0.5 cm left and right of the external opening of the urethra in parallel with the catheter inserted in the urethra. In this embodiment, the puncturing amount of fluid should not exceed 10 cm3;

3) For deposition of drugs in the field of rectovaginal tissue injection drug agents were carried out on the borders of the bottom wall and the side (right and left) wall of the vagina. Control of correctness of advancement of the needle in the tissue served as the finger introduced into the rectum. The amount of fluid 20-40 cm3in each of the sides of introduction.

The rhythm of the administration of medicinal agents - 2 times a week. To achieve clinical effect, as a rule, had enough of holding 4 manipulations.

To prove the result in the statement of case histories, confirming the clinical effect of the treatment approach.

Examples of the clinical note is in

1. Patient A. 41 (East. bol. No. 16112/o), was 13.11.01 under the supervision RNAI diagnosed with cervical cancer T4NxMo, mixed growth form, vaginally-parametric option. Histological analysis No. 24889 - moderately differentiated squamous cell carcinoma.

Complaints upon receipt of lower abdominal pain and lumbar region, bloody discharge from the genital tract with a sharp odor, constipation, sharp pain when urinating, mucus in the stool, weakness.

Local status at admission: the cervix is affected mixed tumor growth. Hypertrophic front lip 3,5×5 cm with a shiny whitish color of the mucous. Rear lip cervical smears presents exophytic tumor with crater, destroying tissue. The transition process on the rear arch and the back wall of the vagina with cartilage density infiltration her to the lower third. In the rear of the arch is determined by deep ulceration with dense edges, sizes up to 1 cm, filled with necrotic masses. The uterus is normal size, heavy, limited in mobility. The degree of mobility of the pelvic floor - 0.9 cm, the appendages are not defined. In parametric infiltration of fiber left massive, reaching the walls of the pelvis, the right - moderate infiltration, not reaching the bony structures of the pelvis. The rectum is narrowed, the front wall direct Kish and dense, smoothed.

Colonoscopy 14.11.01 - at a distance of 9.5 cm from the anal mucosa of the rectum hyperemic, infiltrated, dense. Folding is missing on the area up to 5 cm In the center section seal pupkoobraznym indrawing mucous diameter up to 0.8 cm, with uneven scalloped edges of the roller. Conclusion: given the underlying disease, we cannot exclude the germination of the rectum to the submucosal layer.

Cytological analysis (smear with ulceration of the anterior wall of the rectum) No. 33990 - blood cells of chronic inflammation. Found a single atypical cells with dyskaryosis likely squamous cell cancer.

General analysis of blood from 13.11.01. HB 98 g/L. er - 3,9×1012/l CPU 0,9; lake. to 8.0×109/l as. - 2%. fell. - 9%, segm. - 58%. limp - 26%, mon 5%, ESR 54 mm/h.

Given the proliferation of cervical cancer in the rectum, radiation and surgical treatment of the patient is not subject. With this problem 16.11.01 on the borders of the right and left side wall with the rear wall of the vagina is entered 20 mg thio-Tepa, 15 mg of methotrexate and 0.8 g of gentamicin, preincubating with 40 ml of autoplasma at a temperature of 37°C for 30 minutes.

After 2 days the patient's condition has improved: faded pain when urinating and lower abdomen, significantly decreased the volume and character of vaginal discharge (disappeared fetid smell).

Given the subjective effect, injection, similar in composition and dose, is a mixture of medicinal agents implemented 19.11.01 again.

When viewed 22.11.01 (after 2 injections of drugs on autoplasma) the observed decrease in the infiltration of the posterior wall of the vagina, pitting in the rear arch was reduced in size, fully cleansed from necrotic masses are much softer than the surrounding tissue. The mucosa of the anterior wall of the rectum is less invasive and less dense.

22.11.01 and 26.11.01 On the lower border of the right and left lateral walls of the vagina from the back of his wall put on 800 mg of cyclophosphamide, 15 mg cisplatin, pre-incubated with 40 ml of autoplasma at a temperature of 37°C for 30 minutes.

30.11.01 Complaints only serous vaginal discharge and lower abdominal pain at night. Stopped the pain in the lumbar region, pain when urinating and abnormal excretion with the feces.

Local status: tumor of the cervix decreased in size: endophytic component on the front lip of 1.5×3 cm exophytic growths on the back wall of the vagina and the code disappeared. The formation of the rear lip is defined by marked limitation from the surrounding tissue and release the back arch. Disappeared infiltration rectovaginal tissue. Pitting in the rear arch is not palpated and Lodge it presents as a slightly inverted hyperemic area of mucous membrane. The uterus is normal size. The degree of mobility of the pelvic floor 1,3 see Left infiltration of the parametrium testovaty consistency reaches the walls of the pelvis, right - scar tictacti.

Colonoscopy 03.12.01 - the rectum is free. The front wall of the smoothed, hyperemic. At 9 cm from the anal verge atrophic area, injected vessels.

Cytology (PAP smear with the anterior wall of the rectum) No. 47001 - blood cells inflammation. Atypical cells were not found.

The total dose of drug agents, preincubating with autoplasma and used to treat the patient in this case: 80 mg thio-Tepa, 60 mg of methotrexate, 1600 mg cyclophosphate, 30 mg cisplatin, 3.2 g of gentamicin.

General analysis of blood from 30.11.01: HB 96 g/l, er - 4,0×1012/l CPU 0,82; lake. - 4,4×109/l as. - 1%, fell to 7%, segm. - 58%, limp - 29%, mon 5%, ESR - 24 mm/hour.

Started 03.12.01 and conducted in full combined radiation treatment in the conventional fractionation with alternating components of external and intracavitary irradiation. The treatment was without the effects of radiation reactions and complications. The patient was discharged 29.01.02 after treatment with clinical recovery. Observed in the course of a year with no signs of recurrence and metastasis.

2. Patient F., 37 (East. bol. No. 14330/o), received 15.09.01 with open admission in RNAI with complaints is mi on intense abdominal pain with irradiation to the rectum, blood discharge from the genital tract, chills, body temperature of 37.8°With frequent urination.

Considers herself a patient in the course of 2 months, when after medical abortion appeared and intensified these complaints, in spite of the place of residence conservative detoxification and antibiotic therapy.

At admission the patient's condition moderate, pale skin. The vesicular breathing, tachycardia - the heart rate of 110 beats per 1 minute, rhythmic, BP 100/60 mm Hg Tongue moist, coated with white bloom. The stomach is involved in the act of breathing, soft. Palpation tenderness and small muscles of the anterior abdominal wall into the ileum departments, defined as weakly positive symptom Shchetkina-Blomberg.

Genital status: cervix formed, without tumors of the cervical canal serous, sero-purulent discharge. Is determined by the tension of the arches. The uterus is a bit more than normal, its contours are not clearly defined. Pain during examination and traction for the cervix. Appendages strokes increased on both sides, bumpy, painful when researching more on the right.

15.09.01 HB 124 g/L. er - 3,8×1012/l CPU 1,0; lake. - 9,4×109/l as. - 1%, Miele. - 2; PAL. - 21%, segm - 55%, limp - 16%, mon 5%, ESR 24 mm/hour.

Ultrasound of the pelvic organs from 15.09.01 - uterine size 9,× 6,3×4,4 see Cavity swabs expanded liquid content. In the zone of the median M-echo defined Hyper and hypoechoic areas of various sizes and shapes. In the basal layer of the endometrium from 0.1-0.2 cm hyperechoic areas of fibrosis and calcification. Appendages increased right 8,1×6,4×5.1 cm to the left of 6.7×5,4×5,3 see

Diagnosis: bilateral salpingo-oophoritis, metroendometrit.

16.09.01 the midline, right and left lateral walls of the vagina paravaginal introduced in 10 ml of 0.5% solution of novocaine, 25 mg of hydrocortisone, 1.0 ml of 1% Dimedrol and 10 ml europlasma, preincubating for 30 minutes at a temperature of 37°With 4 g of claforan.

The next day, the body temperature returned to normal, significantly decreased pain in the lower abdomen.

20.09.01 similar doses of drugs introduced paravaginal again.

To 24.09.01 disappeared all clinical symptomatology. Complaints the patient does not show.

Genital status: cervix formed, mouth closed. The vaults and walls of the vagina soft. The uterus is normal size, mobility is restricted. Appendages thickened on both sides, painless on palpation, is fixed.

Ultrasound from 25.09.01, uterine size 6,7×5,1×3.6 cm, the median M-the echo is visualized as a thin hyperechoic strips. Appendages to the right of 4.5×3,2×2.1 cm, left - 2,9×3,1× 2.3 cm, the average degree of the echo density, without pathological architectonics and angiokeratoma. The follicles at the periphery to 9 mm

The clinical recovery of the patient. Exacerbation of chronic inflammatory process is not marked for 1.5 years.

The proposed method was carried out treatment of 22 patients with locally advanced cervical cancer. 34 patients with purulent-inflammatory diseases of genitals, 14 patients with cystitis various etiologies, 6 patients with invasive bladder cancer, 8 patients with rectal cancer, 13 patients paraproctitis. Before treatment and after its completion, all patients were examined in the mirrors, rectovaginal examination, General and biochemical blood tests, radiography of the chest, excretory urography and radioisotope tests of kidney function, ultrasound of the pelvic organs, the condition of the lymphatic system, pelvis and paraaortal departments, biopsy with the morphological study.

The effectiveness of the proposed method of treatment was: purulent-inflammatory diseases (in General) was 89.2%for cancer of 85.2%, of which 70% occasion was a complete regression and 30% partial regression of the tumor. The stabilization process is registered in 14.8%. The progression of the process is not detected in any case.

Improve their results is to increase the local concentration of drugs or antibiotics, on the background objectively reduced overall toxicity of their actions, as well as prolongation of finding drugs in the body of patients, specifically in the area of the pathological process that allows you to enter the drugs less frequently than in the systemic use.

Technical and economic efficiency "How prolonged drug therapy" is that

- patients tolerate the procedure without complications,

- decrease the toxic side effects of drug therapy;

- achieved a higher percentage of regression of the pathological lesion and in a shorter time.

The way prolonged drug therapy of inflammatory or neoplastic diseases of the pelvic organs, including the incubation of antibiotics and/or drugs in therapeutic doses autoplasma for 30 min at 37°and With the introduction of these drugs in paravaginal tissue of patients with diseases of the genitals in perivesical tissue - diseases of the bladder, in adrectal tissue - diseases of the rectum, and in the spread of the tumor to the adjacent pelvic organs in paravaginal, and/or adrectal, and/or perivesical tissue; introducing carried out 2 times a week.



 

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3 cl, 8 tbl, 5 ex

FIELD: medicine, oncology, pharmacy.

SUBSTANCE: after proving the pleural fluid sterility method involves its exfusion from pleural cavity and administration of antitumor chemopreparations. Firstly, 20 mg of bleomycetin is incubated with 20 ml of autopleural fluid, pleural fluid remained after exfusion is placed into packages "Gemakon" and centrifuged at 2000 rev/min for 60 min and liquid part is frozen. Pleural fluid is removed again as its accumulation and administration of incubated mixture of pleural fluid with bleomycetin is repeated also wherein the bleomycetin dose is increased up to 25 mg. In 2-3 days after removal of pleural liquid chemopreparations incubated with preliminary defrosted liquid part of pleural fluid are administrated each 5-7 days in the following sequence and doses: the first administration - 100 mg of cisplatin; the second administration - 100 mg of cisplatin; third, fourth and fifth administrations - 30 mg of doxorubicin and 1000 mg of cyclophosphan up to the total amount - cisplatin, 200 mg; doxorubicin, 90 mg, and cyclophosphan, 3000 mg. Method provides elimination of pleural fluid in full volume, to compensate loss of liquid, protein and trace elements, to reduce tumor size and to avoid toxic symptoms of chemotherapy. Invention can be used in the presence of exudative pleuritis in patients with lung cancer who can't to be subjected for operative and radiation treatment.

EFFECT: improved treatment method.

2 ex

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