RU2647423C2 - Method for treatment of pelvic organs radiation damage - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: for the treatment of radiation damage to the pelvic organs, the drug is systemically and locally applied to the area of the pathological focus, an ultrasound transducer with an adapter is introduced transvaginal or transrectally, then an injection needle is injected through the adapter channel into the area of the pathological process and a uniform liquid mixture of rexode is administered in a dosage of 6.4 million units to 12.8 million units in combination with dexamethasone in a dosage of 6.0 mg to 10.0 mg. The course of treatment is 5 injections every other day, followed by an assessment of its effectiveness.

EFFECT: method allows prevention and treatment of deep radiation injuries of the pelvic organs with exception of severe reconstructive operations.

2 cl, 11 dwg, 4 tbl, 4 ex

Description

The invention relates to medicine, in particular to oncology, and can be used to treat radiation damage to the pelvic organs

Similar Known Solutions

Radiation therapy is the leading treatment for various malignant tumors of the small pelvis. Unfortunately, some patients experience radiation complications of varying severity. The most common are post-radiation cystitis, rectitis, intralase radiation fibrosis. Such injuries bring physical and mental suffering to patients, cause disability, and lead to a loss of social activity. Therefore, a favorable outcome of the underlying disease does not mean complete recovery (Therapeutic Radiology. A Guide for Doctors / Edited by AF Tsyb, Yu.S. Mardynsky. - M.: MK MK, 2010. - 552 p.).

Known "Wound healing agent", patent RU 2259816 from 09/10/2005. The invention relates to medicine, oncology, cosmetology, can be used to treat superficial radiation injuries. The essence of this invention is that the wound healing agent includes a gelling agent, an active substance and distilled (deionized) water. Mexidol (2-ethyl 6-methyl 3-hydroxypyridine succinate) is added as the active substance in the ratio of components, wt. %: gelling agent 0.5-5.0, stabilizer 0.01-0.8, preservative 0.01-1.0, mexidol 0.01-10.0, the rest is distilled (deionized) water.

The disadvantage of the presented invention lies in the impossibility of using this tool in the presence of post-radiation changes in internal organs and tissues. This technique allows you to treat radiation damage to the skin, but cannot be used to treat deep radiation damage to the pelvic organs.

The well-known "Method for the treatment of acute radiation reactions in patients with cancer of the larynx", patent RU 2354423 from 05.10.2009. The invention relates to medicine, oncology, surgery, radiology, physiotherapy and can be used to treat patients with laryngeal cancer. From the first day after the diagnosis of a radiation reaction, they are exposed daily to infrared laser radiation in combination with a constant magnetic field. The intensity of magnetic induction is within 20 mT, the repetition rate of pulsed laser radiation of the infrared spectrum is within 80 Hz, its power is 0.5-1.0 W over the entire irradiation zone with a defocused beam for 30-120 seconds. The course includes 3-8 procedures followed by applications on the irradiation zones and ingestion of pine nut oil per teaspoon and at night daily throughout the entire course of radiation therapy. This technique allows you to treat radiation damage to the skin, but cannot be used to treat deep radiation damage to the pelvic organs.

The disadvantage of this method is the impact only on superficially located structures and tissues.

The well-known "Method for the prevention of radiation injuries of the tear ducts", patent RU 2445941 from 03/27/2012. The invention relates to medicine, namely to oncology, and can be used during radiation therapy of patients with malignant neoplasms of the eyelids in order to prevent obliteration of the lacrimal ducts. According to the method under consideration, twice a day before each radiation therapy session and 10-12 hours after the session, the lacrimal and nasal canal is washed. A solution containing not less than 2.0 ml of 0.1% dexamethasone and 5 mg of methotrexate is injected into the lower nasal point through a blunt-pointed cannula mounted on a syringe under pressure. The method provides the prevention of the symptom of constant lacrimation, as well as the preservation of the light-refracting, protective function of the lacrimal organs, and ultimately the preservation of visual function.

The disadvantage of this method is the inability to improve trophism of the surrounding soft tissues.

The prototype of the proposed technical solution is the "Method for the treatment and prevention of radiation injuries of the lower colon" according to patent RU 2242988. The method consists in systemic and local effects on the patient's body. Moreover, during the entire period of radiation therapy, the drug "Modifilan" is used in the form of a gel-like substance. The drug is injected with microclysters into the rectum after emptying it 30-60 minutes before the radiation therapy session. After the next act of defecation, the drug is again injected into the intestine in a volume of 50-100 ml. Microclysters should be combined with oral administration of 1-2 tablets or the gel-like substance "Modifilan" 3-5 times a day. The presented treatment technique is used throughout radiation therapy and can be extended during the acute period of radiation reactions.

The disadvantages of the method are the limited effect of the drug only on the area of the rectal mucosa. However, other organs and deeper tissues remain intact.

The technical result of the invention is aimed at eliminating the noted drawbacks and is to increase the local effect in the treatment of radiation injuries of the pelvic organs.

This result can be obtained through the use of a minimally invasive method of administering the anti-inflammatory drugs Dexomethasone and Rexod.

Dexometasone is a hormonal drug with pronounced anti-inflammatory activity.

The main mechanisms of action of Dexometasone:

1. Inhibits the release of inflammatory mediators.

2. Reduces capillary permeability.

3. Inhibits prostaglandin synthesis.

4. Reduces the synthesis and secretion of allergy mediators.

The use of Rexod® promotes regression of radiation-induced fibrosis.

The main mechanisms of action of Rexoda:

1. Direct inactivation of free radicals;

2. Blocking their interaction with arachidonic acid;

3. Inhibition of chemotaxis of leukocytes;

4. Induction of reversibility of fibroblasts.

The drugs have a different mechanism, but the action is the same in direction, in fact, they are synergists, which leads to an increase in the impact on the pathological zone.

The dosage of drugs depends on the severity of radiation damage and the depth of the location of the affected tissue.

The essence of the invention includes systemic and local effects of the drug on the affected area. The medicine in the proposed technical solution is a homogeneous liquid mixture of Dexomethasone and Rexoda, administered by transperineal or transvaginal access using an ultrasonic transducer with an adapter. At the same time, an injection needle is passed through the adapter’s injection channel and a solution containing rexod in a dose of 6.2 to 12.8 million units and dexomethasone from 6 to 10 mg is injected.

The course of treatment is 5 injections every other day. After treatment, treatment results are evaluated based on the received instrumental beam data. According to the ultrasound examination, the volume, structure of the affected organ and the nature of the surrounding tissues are evaluated. According to cystoscopy, the severity of hyperemia and edema, as well as a change in a bladder wall ulcer, are assessed. The results of x-ray contrast data assess the degree of restoration of urodynamics and the nature of the passage of feces.

Enumeration of figures.

FIG. 1. Transrectal sensor with an adapter for transperineal access: 1 - sensor, 2 - adapter, 3 - adapter channel, 4 - needle.

FIG. 2. A sensor with an adapter for transvaginal access: 1 - sensor, 2 - adapter, 3 - adapter channel, 4 - needle.

FIG. 3. Patient A. Bladder - before treatment: 5 - the wall of the bladder, 6 - ulcerative defect of the wall of the bladder, 7 - the cavity of the bladder.

FIG. 4. Patient A. During treatment: 4 - needle, 8 - tracer marks.

FIG. 5. Patient A. After treatment.

FIG. 6. Patient B. The rectum before treatment: 9 - the wall of the rectum, 10 - ulcerative defect of the wall of the rectum.

FIG. 7. Patient B. After treatment: 9 - rectal wall, 10 - rectal wall ulcer.

FIG. 8. Patient T. Ureters of the kidney before treatment: 11 - kidney, 12 - expanded pyelocaliceal system, 13 - proximal end of the ureter stent.

FIG. 9. Patient T. Before treatment: 14 — the cavity of the bladder, 15 — the juxtavesical ureter, 16 — the lower third of the ureter, 17 — the distal end of the ureter stent.

FIG. 10. Patient T. After treatment: 11 - kidney, 12 - pyelocaliceal system is not expanded.

FIG. 11. Patient B. In the course of treatment: 4 - a needle, 8 - tracing marks, 9 - a wall of a rectum.

The method is implemented as follows.

Post-radiation injuries of the pelvic organs, such as cystitis, rectitis, intrathoracic radiation fibrosis, bring physical and mental suffering to patients. Each of them requires its own specific treatment and appropriate tools. In FIG. Figure 1 shows a transrectal ultrasound transducer with an adapter and a needle for injecting drugs into the affected area with transperineal access (Positions 1, 2, 3, 4). In FIG. Figure 2 shows a transvaginal ultrasound probe with an adapter and a needle for introducing drugs into the lesion area with transvaginal access (Positions 1, 2, 3, 4).

With each treatment procedure, first, the corresponding ultrasound transducer-1 with adapter-2 is transrectally or transvaginally injected, then an injection needle-4 is injected through the channel of adapter-3 into the zone of greatest interest (pararectal tissue, neck, bladder walls, ureteral orifice) and injected treatment mixture with a course of 5 injections every other day with a subsequent assessment of the result. At the same time, as a therapeutic agent, a solution is prepared containing rexod in a dose of 6.2 to 12.8 million units and dexomethasone from 6 to 10 mg. The resulting solution is introduced into the zone of interest through the injection channel of the adapter using an injection needle.

After treatment, an assessment of the result is carried out in comparison with the initial state. A criterion for achieving a positive result is a reduction in size or a complete regression of the pathological process, as well as stabilization of improving the patient's quality of life.

Method implementation examples

Example 1. Patient A., born in 1943 Received April 18, 2013. Diagnosis: Cervical cancer T1N0M0. Condition after combined radiation therapy is late radiation ulcerative necrotic cystitis. The procedures for the administration of rexod and dexometasone were carried out: 04/19/13, 04/22/13, 04/24/13, 04/26/13 and 04/29/13

Survey

Ultrasound examination (04/19/13): the bladder is sufficiently full, the lumen is free. On the right-rear wall there is a local defect with fixed fibrin deposits with a length of 10 mm. The mucosa of the posterior wall is thickened to 3 mm. Conclusion: ultrasonic signs of post-radiation ulcerative cystitis (Fig. 3. Positions 5, 6, 7).

Cystoscopy: signs of chronic radiation cystitis, a large ulcer along the right-rear wall of the bladder, covered with fibrin. There are no visible elements of the tumor.

The treatment was carried out: anti-inflammatory, symptomatic, antibacterial. Bladder installations with dimexide and conditioned medium. 5 injections were conducted at a dosage of rexod 6.4 million units and dexomethasone 6.0 mg (Fig. 4. Positions 4, 5, 7, 8). Results of treatment: after a course of minimally invasive administration, the ulcer along the right-rear wall of the bladder decreased in size by more than three times. The patient was discharged 04/26/13, in satisfactory condition, no complaints.

Ultrasound examination (08/20/13): the bladder is sufficiently full, the lumen is free. A local defect of the right-back wall was reduced in size to 4 mm, with the presence of fixed salt deposits (Fig. 5. Positions No. 5, 6, 7).

Cystoscopy: a small ulcer along the back wall of the bladder with fixed stones. The stones are removed.

The implementation of a method for the treatment of radiation damage to the bladder. Ultrasound imaging of the bladder is performed by transvaginal - in women or transrectal - in men. The condition of its walls and surrounding tissues is assessed.

After the localization of the zone of interest (the area of the pathological process) is determined, diagnostic and diagnostic manipulation is performed. For precision, precise administration of the drug to the affected area, adapters of various configurations are used, which are fixed on an ultrasonic sensor. The adapter contains channels through which the needle is drawn. Each channel has a corresponding path on the monitor of the ultrasound scanner. The choice of channel depends on the anatomical localization of the zone of interest.

The movement of the needle is visually monitored in real time. At the time of achieving the goal, a pharmaceutical product is fed through the needle, which is concentrated as much as possible in the area of the pathological process (the bottom of the bladder wall ulcer, areas of greatest fibrosis, areas of mucosal edema).

Example 2. Patient V.V. 1935 Received August 2, 2013. Diagnosis: Cervical cancer T2N0M0. The condition after combined radiation therapy is late radiation hemorrhagic rectitis. The procedures were carried out: 08/02/13, 08/05/13, 08/08/13, 08/09/13 and 08/12/13

Ultrasound examination (02.08.13): Data for local recurrence and MTS were not received. On the mucous membrane of the anterior wall of the rectum, a defect of 7 mm length is visualized, covered with fibrin deposits. The intestinal wall is swollen, thickened to 7 mm (Fig. 6. Positions 9, 10).

Rectoscopy: A rectoscope tube was inserted to a depth of 8 cm from the anal edge, an ulcer defect covered with fibrin is noted along the anterior semicircle.

The treatment was carried out: anti-inflammatory, symptomatic, 5 injections of a mixture of rexods in a dosage of 9.6 million units and dexomethasone 8.0 mg.

Results of treatment: after treatment, bleeding from the rectum decreased significantly. A peptic ulcer of the rectal wall was reduced in size.

Stabilization of prolonged remission. The patient was discharged on 13.08.13, in satisfactory condition, no complaints.

Ultrasound examination (12.19.13): the previously determined defect of the anterior rectal wall decreased in size to 3 mm (Fig. 7. Positions 9, 10).

Rectoscopy: ulcerative defect of the anterior semicircle of the rectal wall is markedly reduced in size.

Example 3. Patient V., was admitted to the hospital on 10/14/2012. Diagnosis: Prostate cancer T2aN0M0. The condition after combined radiation therapy is late radiation hemorrhagic rectitis. The procedures were carried out: 10/15/12, 10/17/12, 10/19/12, 10/22/12 and 10/24/12

Ultrasound examination (10.15.12): the volume of the prostate gland is 23 cm ³ , the contours are clear, there are no signs of local cancer growth. The front wall of the rectum without pronounced changes, the surrounding pararectal tissue is moderately compacted due to fibrotic changes, vascularization is weak.

Rectoscopy: the rectal mucosa is edematous, hyperemic, and bleeds contact.

The treatment was carried out: anti-inflammatory, symptomatic, 5 injections of the mixture at a dosage of rexod 9.6 million units and dexomethasone 8.0 mg (Fig. 11. Positions 4, 8, 9). Results of treatment: after the treatment, pain in the rectum was markedly reduced, there was no admixture of blood in the feces. Stabilization of prolonged remission. The patient was discharged 10/26/12, in satisfactory condition, no complaints.

Ultrasound examination: The wall of the rectum is not changed. An increase in the severity of blood supply in the surrounding pararectal tissue is noted.

Rectoscopy: swelling of the intestinal mucosa is less pronounced, there is no bleeding.

The implementation of the method of treatment of radiation injuries of the rectum

Ultrasound imaging of the rectum is performed by transvaginal - in women or transrectal - in men access. The condition of its walls and surrounding tissues is assessed.

After the localization of the zone of interest (the area of the pathological process) is determined, diagnostic and diagnostic manipulation is performed. For the precise and precise administration of the drug to the affected area, adapters of various configurations are used, which are fixed on an ultrasonic sensor. The adapter contains channels through which the needle is drawn. Each channel has a corresponding path on the monitor of the ultrasound scanner. The choice of channel depends on the anatomical localization of the zone of interest.

The movement of the needle is visually monitored in real time. At the time of achieving the goal, a pharmaceutical product is fed through the needle, which is concentrated as much as possible in the area of the pathological process (the bottom of the rectal wall ulcer, the sites of greatest fibrosis of the surrounding tissues, the sections of the intestinal wall edema).

Example 4. Patient T. E. b. 1946 Received February 12, 2014. Cancer of the uterine body T2N0M0. The condition after combined treatment is intra-pelvic radiation fibrosis (WTF), post-radiation cystitis. The procedures were carried out: 02.14.14, 02.17.14, 02.19.14, 02.21.14 and 02.24.14

Ultrasound examination (02.14.14): the pyelocaliceal system (CLS) of the right kidney is expanded: the pelvis is 23 mm, the calyx is 9-10 mm. The cortical layer is saved. The bladder is well filled, the lumen is free, the area of the mouth of the right ureter is swollen, the surrounding soft tissues are densified (Fig. 8, 9. Positions 11-17).

The treatment was carried out: in order to compensate for the enlargement of the HF, a stent was installed in the right ureter, an anti-inflammatory, symptomatic, five injections of 5 injections of the mixture at a dosage of 12.8 million units of Rexod and 10.0 mg of dexomethasone were also performed.

Results of treatment: after the treatment, the ureter stent was removed. According to the results of ultrasound examination and intravenous urography, the kidney transplanter is not expanded, the contrast medium accumulates and is excreted by the kidneys. The patient was discharged 02.24.14, in satisfactory condition, no complaints.

Ultrasound examination (07/23/14): the CLS of the right kidney is not expanded, urine discharge from the right mouth of the ureter is determined (Fig. 10 Positions 11, 12).

The implementation of a method for the treatment of radiation injuries of the juxtasical ureter (the method is used only in women).

Ultrasound imaging of the mouths of the ureters, their lower third by transvaginal access is performed. The condition of surrounding tissues is assessed.

After the localization of the zone of interest (the area of the pathological process) is determined, diagnostic and diagnostic manipulation is performed. For precision, precise administration of the drug to the affected area, an adapter is used that is mounted on an ultrasound transducer. The adapter has a channel through which the needle is drawn. The channel has a corresponding path on the monitor of the ultrasound scanner.

The movement of the needle is visually monitored in real time. At the time of achieving the goal, a pharmaceutical product is fed through the needle, which is concentrated as much as possible in the area of the pathological process (the bottom of the rectal wall ulcer, the sites of greatest fibrosis of the surrounding tissues, the sections of the intestinal wall edema).

Confirmation of the achievement of the technical result

The proposed method allows the prevention and treatment of deep radiation injuries of the bladder and rectum, as well as to exclude severe reconstructive surgery on the pelvic organs.

The results obtained, given in the examples, indicate that the minimally invasive method of administering a mixture of Rexod and Dexomethasone preparations under ultrasound control allows:

- significantly increase the effectiveness of treatment of patients with late radiation injuries of the pelvic organs;

- improve the quality of life of patients of this profile;

- reduce the patient’s hospital stay, as well as increase the time of remission of the postradiation process.

The proposed method is used in the treatment of 60 patients with late radiation injuries of the pelvic organs.

The table shows that in our observations, the bulk of patients regularly received non-narcotic analgesics. As a result of the treatment, most of them (95%) noted a positive effect, manifested in a reduction in the ulcer in the bladder, a decrease in the severity of fibrosis in the surrounding tissues, and increased blood flow, which was confirmed by cystoscopy and ultrasound. Moreover, the vast majority of patients (94.8%) refused to take analgesics. No patients needed narcotic drugs.

From the data given in the table it can be seen that wall thickness normalized in 50% of patients, normal bladder volume was restored in 87%, suspension and other pathological impurities remained in 37.5% of patients.

From the data given in the table it can be seen that the wall thickness returned to normal in 58% of patients, the ulcer defect of the intestinal wall was eliminated in all patients, and vascularization of surrounding tissues improved in 26%.

Rectoscopy data showed that in all patients hyperemia and edema of the rectal mucosa, as well as the complete absence of a ulcerative wall defect, decreased (control after 4 courses of therapy).

From the data given in the table, it is clear that only 58% of patients retain hydronephrosis, however, its severity decreased significantly. In the remaining patients (42%), the expansion of the heart rate completely disappeared. Ureter enlargement was present in 75% of patients with HLF. As a result of the treatment, expansion in the upper third of the ureters was preserved in 44%, and expansion was not determined in 56%.

The regimen and technology of the above measures are fully consistent for female and male patients, with the exception of the introduction of the drug mixture into the juxtavesical ureters of men, due to the anatomy and design of the rectal sensor adapter.

Claims (2)

1. A method of treating radiation injuries of the pelvic organs, including systemic and local effects of the drug into the area of the pathological focus, characterized in that first, an ultrasound transducer with an adapter is introduced transvaginally or transrectally, then an injection needle is passed through the adapter channel into the area of the pathological process and a uniform a liquid mixture of rexod in a dosage of 6.4 million units to 12.8 million units in conjunction with dexamethasone in a dosage of 6.0 mg to 10.0 mg, while the course of treatment is 5 injections after d Hb, followed by evaluation of treatment effectiveness. 2. The method according to p. 1, characterized in that the degree of restoration of urodynamics and the nature of the passage of feces is assessed according to the results of ultrasound and x-ray contrast studies.

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