RU2388477C1 - Method for prevention and treatment of cicatrical stenoses of larynx and trachea - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, specifically to otorhinolaryngology and toracal surgery, and can be used for prevention and treatment of chronic cicatrical stenosis of larynx and trachea. To that end, mixture of diprospan (0.5 - 1.0 ml), longidasa (1500-3000 UI), 2% lidocain (0.04 g) and ketorolac (0.03 g) diluted to 5 ml with 10% glucose solution is administered retrosternally, peritracheally. The mixture is administered once a week, a course including 1-3 injections. 3-5 inhalations are performed with compressor nebuliser of longidasa 1500 ME dissolved in 3 ml of broncholytic or mucolytic medicine once a week in intervals between administrations.

EFFECT: increased therapeutic efficiency in stenoses treatment and restenosis process prevention due to improved lymph flow, blood flow, microcirculation, tissues trophism, prolonged anaesthesia and lowering of endotoxemia level leading to quick inflammation relief and prevention of excessive development of cicatrical and granulation tissue in larynx and trachea.

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Description

The invention relates to medicine, specifically to otorhinolaryngology and thoracic surgery, can be used in the treatment of cicatricial stenosis of the larynx and trachea, for the prevention of their restenosis after reconstructive plastic surgery and endoscopic restoration of the lumen of the respiratory tract.

Currently, in most cases, cicatricial stenosis of the trachea develops as a result of resuscitation measures, including tracheostomy and prolonged mechanical ventilation (IVL) through an endotracheal (orotracheal) or tracheostomy tube. The development and use of modern thermoplastic endotracheal and tracheostomy tubes did not solve the problem of prevention of postresuscitative airway stenosis [1-4].

Most often, cicatricial stenosis is based on damage to the normal structures of the tracheal wall by an excessively inflated cuff of the respiratory tube, or directly direct trauma to the tracheal wall during intubation or tracheostomy. The main disease or condition that led to the need for respiratory resuscitation, the immune disorders that inevitably accompany it, a decrease in nonspecific resistance and infection of the tracheal wall with the development of a purulent-inflammatory process contribute to the healing of the damaged area by secondary tension with excessive formation of granulation tissue and subsequent replacement with coarse connective tissue. With cicatricial stenosis of the trachea, inflammatory infiltration always develops in the narrowing and suprastenotic section, as well as in the tracheobronchial tree [2].

A radical treatment for cicatricial stenosis is circular resection of the narrowed segment of the trachea with tracheal anastomosis of the end-to-end type [2, 5, 6]. However, this operation is technically complicated, traumatic, associated with a large operational and anesthetic risk and is available only to highly specialized specialized clinics. In some patients, it is not feasible due to the extent of stenosis and severe concomitant pathology, or is contraindicated in tracheogastric localization of stenosis, bilateral laryngeal paralysis, purulent tracheobronchitis, and the patient has tracheostomy. In addition, there remains a high frequency of such formidable complications as anastomotic suture failure, arrosive bleeding, mediastinitis, pleural empyema, laryngeal paralysis, recurrence of stenosis and postoperative mortality [1, 2].

There are methods for endoscopic treatment of cicatricial stenosis of the trachea, aimed at restoring and maintaining the lumen of the respiratory tract. They are conditionally divided into dilating and excision methods. Dilating methods consist in expanding the site of narrowing by holding a tube of a rigid bronchoscope, a fibrobronchoscope, endotracheal tube, plastic and laminar bougie, Fogarty catheter, etc. Prolonged dilatation of the lumen of the airways on various tubes is rather traumatic, multi-stage and gives only a temporary effect due to the recurrent overgrowth of granulation and fibrous tissue. Excision methods include exposure to an electric knife, electrocautery, biopsy nippers, laser photocoagulation, ultrasound and cryodestruction [2, 3]. Excision of scar tissue in the stenosis zone by high-frequency currents and laser radiation is dangerous due to the high probability of damage to adjacent unchanged sections of the trachea, the subsequent development of an inflammatory process in them and an increase in the length of stenosis [7, 8]. Excision of stenosis with a rigid bronchoscope tube, special circular knives or biopsy forceps is fraught with perforation of the deformed tracheal wall and the development of serious complications (mediastinitis, bleeding and asphyxiation). Ultrasonic exposure to scar tissue is rather delicate, therefore the method is ineffective. The cryosurgical method for the treatment of tracheal stenosis has such advantages as painlessness, good tolerance, the absence of bleeding and severe scarring, but the treatment is long and ineffective [2, 9].

Known methods of combined endoscopic exposure to scar tissue of tracheal stenosis are more effective [2], but do not prevent the recurrence of excessive growth of granulation and fibrous tissue in the damaged area of the trachea.

Known methods for conservative treatment of tracheal stenosis, including the introduction of tracheostomy tubes through an existing tracheostomy or endoscopic endoprosthesis of various configurations that prevent the formation of scars in the lumen of the trachea before epithelialization of the mucous membrane; intravenous, intramuscular or local in the form of applications, the appointment of drugs (antibiotics, steroidal and non-steroidal anti-inflammatory drugs, lidase, zinc sulfate, biostimulants, vitamins); physiotherapy (magnetic laser, microwaves, electrophoresis of calcium ions, lidase, corticosteroids) [2]. However, they have an effect only with limited fresh cicatricial stenosis of the trachea, formed due to immature granulation tissue, while treatment is long and requires long-term preservation of the tracheostomy (cannula carriage), which invalidates the patient, supports inflammation in the airways. The most common complications of endoprosthetics are spontaneous displacement of the stent and its obstruction with bronchial secretions. Prolonged stent placement in the trachea can lead to an increase in the length of stenosis as a result of tracheal wall injury. In most cases, restenosis occurs in the long term after stent removal.

There is a method of conservative treatment of tracheal stenosis, including the introduction of hormonal drugs (triamsinolone acetonide, prednisone methyl acetate) in combination with hyaluronidase through the skin into the area of excess granulation tissue [10]. The disadvantages are the uneven distribution of the drug and its repeated administration due to the short duration of the action, in this regard, there is a low efficiency of the method and the limited therapeutic effect of granulation stenoses. In addition, with the introduction of a hormonal drug directly into the pathological focus, there is a high risk of developing purulent-necrotic complications and long-term non-healing ulcers at injection sites.

The trauma, and in some cases the ineffectiveness of existing surgical and endoscopic interventions for cicatricial stenosis of the larynx and trachea, requires the search for new, more effective methods of conservative therapy in this category of patients. It is shown that the effectiveness of drugs increases with their introduction into the lymphatic system. By acting on the lymphatic system directly or indirectly, stimulating its drainage and detoxification function, it is possible to pathogenetically affect the inflammatory process as a whole. Currently, experience has been gained with the use of lymphotropic therapy in various diseases and conditions [11].

The closest (prototype) to the proposed is a method of treating granulation stenosis of the larynx and trachea by introducing diprospan intramucosally into the area of the pathological focus [12]. The disadvantages of the method are the uneven distribution of the drug in the pathological focus, in connection with which it is difficult to choose the dose of the drug, which is necessary to achieve a certain effect, and the limited therapeutic effect only granulation stenosis. In addition, there is a high risk of development of purulent-necrotic complications with the introduction of a hormonal drug through the infected mucous membrane, slowing down epithelization and the appearance of long-term non-healing ulcers at injection sites.

A new technical task is to increase the efficiency and reduce the duration of treatment of patients with cicatricial stenosis of the larynx and trachea, prevent their restenosis after reconstructive plastic surgery and endoscopic restoration of the airway lumen by improving lymph flow, blood flow, microcirculation, tissue trophism, prolonged analgesia and lowering the level of endotoxemia As a result of which there is a more rapid relief of inflammation and the prevention of excessive development of scar-gran ulative tissue in the larynx and trachea.

To solve the problem in a method for the prevention and treatment of cicatricial stenosis of the larynx and trachea, including the administration of a drug, a drug mixture consisting of diprospan 0.5-1.0 ml, longidase 1500-3000 ME, lidocaine 2% 0.04 is administered retrosternally near tracheal g, ketorolac 0.03 g, diluted to 5 ml with a 10% glucose solution, once a week, with a course of 1-3 injections, and in the intervals between injections and after the end of the injection course, inhalations are carried out through a compressor nebulizer of longidase 1500 ME diluted in 3 ml of bronchodilator or ukoliticheskogo the drug once a week, a total of 3-5 inhalations.

The set of features leading to the solution of the problem is new, unknown from the prior art and does not follow explicitly for a specialist. This method has been clinically tested. Thus, it meets the criteria of the invention: “novelty”, “inventive step”, “industrially applicable”.

The method is as follows. On the eve of bougieurage, dilatation, cryosurgical or any endoscopic method of restoring airway patency with cicatricial stenosis of the larynx or trachea, in the case of stenosis of the laryngotracheal or tracheal anastomosis after reconstructive-plastic interventions due to excessive growth of scar-granulation tissue, a drug mixture is prepared immediately before administration consisting of diprospan 0.5-1.0 ml, longidase 1500-3000 ME, lidocaine 2% 0.04 g, ketorolac 0.03 g, diluted up to 5 ml with a 10% glucose solution, and injected retrosternally into the peritracheal fiber once a week, with a course of 1-3 injections, and in the intervals between administrations and after the end of the injection course, inhalations are carried out through a compressor nebulizer of longidase 1500 ME diluted and 3 ml of bronchodilator or a mucolytic drug, once a week for a total of 3-5 inhalations.

Justification of the regime. Our proposed regimen is selected on the basis of literature data on normal and pathological anatomy and human physiology, pharmacodynamics and pharmacokinetics of drugs. The property of the proposed drug mixture to influence the formation of scar-granulation tissue in the larynx and trachea and the method of its administration were substantiated experimentally and clinically confirmed.

1. The choice of place and route of administration: the lymphotropic administration of the drug mixture retrosternally (through the jugular notch) is almost tracheally justified by the presence of a large representation of lymphatic collectors in the tissue of the anterior mediastinum. The retrosternal perotracheal route of administration contributes to the rapid delivery of the drug to the pathologically altered segment of the larynx and trachea, including located deep, at the level of the bifurcation of the trachea, which is difficult to achieve by traditional methods.

2. The composition of the drug mixture is justified by the fact that the included drugs, having lymphostimulating and lymphomodulating effects, pathogenetically affect inflammation and the formation of scar-granulation tissue in the larynx and trachea. There is an improvement in lymph flow, blood flow, microcirculation, trophism, prolonged analgesia, a decrease in the level of endotoxemia, which manifests itself as a result of tracheobronchitis, and a reduction in the duration of treatment of patients with this pathology.

Diprospan is a glucocorticosteroid with a powerful anti-inflammatory, antitoxic, desensitizing effect. The anti-inflammatory effect is based on reducing the permeability of the capillary wall, maintaining the integrity of the cell and liposomal membranes, which leads to a decrease in tissue edema. At the tissue level, glucocorticosteroids inhibit early and late manifestations of inflammation. Diprospan thanks to two fractions in its composition provides a quick and prolonged effect.

Longidase is a drug with enzymatic activity, prolonged action, immunomodulatory, antioxidant and anti-inflammatory properties. The pharmacological properties of the drug are due to the combination of the enzyme hyaluronidase with polyoxidonium, which has its own pharmacological activity. This combination increases the resistance of the enzyme to inhibitors destroying it and suppresses the allergic properties of the enzyme. Polyoxidonium increases the body's resistance to local and generalized infections, increases the resistance of cell membranes to the cytotoxic effect of drugs, and reduces their toxicity.

The combination of a local anesthetic of lidocaine and the non-steroidal anti-inflammatory drug Ketorolac provides a complete removal of the pain syndrome during and after the procedures of bugging, dilatation of the trachea due to the potentiation and prolongation of the analgesic effect. In addition, lidocaine is a powerful lymph-stimulating agent.

The glucose solution has a strong lymphostimulating effect, thereby, exhibiting a pronounced dehydration effect, increases the permeability of lymphatic capillaries and increases lymph flow.

3. The need for one to three sternal blockade is associated with the fact that there is a gradual saturation (titration) of drugs to obtain a stable clinical effect, the formation of a depot in the regional zone of the pathological focus. The appointment of more than 3 procedures is impractical due to excessive drug load on the patient and a high likelihood of side effects. The introduction of a lymphoactive drug mixture once a week is most optimal due to the cumulative effect of its constituent drugs.

4. The need for inhalation therapy is related to the fact that the pathological process is localized in the airways and the local use of drugs in the form of inhalation seems pathogenetically justified. Inhaled forms of drugs are more preferable, since the clinical effect of their use occurs much faster. A significant advantage of inhaled administration is also a high concentration of the drug in the respiratory tract at a low concentration throughout the body due to dilution after absorption. In addition, during inhalation, lymphostimulation of the lymphatic collectors of the submucosal layer of the respiratory tract occurs, which play an important role in the pathogenesis of the development of cicatricial-granulation stenosis of the larynx and trachea, and potentiation of the drainage and detoxification function of the lymphatic system of the lungs. Inhaled administration of a lymphoactive drug (longidase), diluted on bronchial or mucolytic drugs, enhances the activity of the drug, increases its concentration in the lesion, and generally increases the effectiveness of treatment.

5. Inhalation once a week is most optimal taking into account the duration of the drug (pharmacokinetics). Drug delivery via a nebulizer provides high doses of the drug in the tracheobronchial tree with minimal sedimentation of the drug in the oral cavity, the ability to include oxygen and mechanical ventilation in the inhalation circuit, and the ability to use it even in the most severe conditions, in elderly patients and children, with motor disorders and impaired consciousness.

Clinical examples

Example 1. Patient N., 27 years old, medical history No. 954, was hospitalized on November 8, 2007 at the hospital clinic of the Siberian State Medical University with complaints of shortness of breath with minimal physical exertion. In September 2007, she received a through gunshot thoracoabdominal shot in the left with damage to the diaphragm, left costal arch, left lobe of the liver, spleen, splenic angle of the colon, complicated by left-side hemopneumothorax, contusion of the lower lobe of the left lung, stomach, intraperitoneal bleeding, shock of mixed genesis. She was urgently operated on in the design bureau (Tomsk). A thoracolaparotomy, resection of the anterior segments of 7–9 ribs, aperture repair, splenectomy, suturing of wounds of the liver and colon, drainage of the pleural and abdominal cavities were performed. In the postoperative period, ventilation was performed through the orotracheal and then through the tracheostomy tube for 26 days due to respiratory failure. As a result of intensive complex treatment, the patient's condition improved, and spontaneous breathing was restored. Produced by decanulation. However, 4 weeks later shortness of breath appeared. Diagnosed with cicatricial stenosis of the trachea. The patient was urgently transferred to the clinic of the Siberian State Medical University. Upon receipt, the general condition is severe, stridor during physical exertion. The skin and visible mucous membranes are pale with a cyanotic hue. It was endoscopically established that the lumen of the upper thoracic trachea is circularly narrowed to 6 mm over 2 cm due to cicatricial deformation of the walls and minor granulations. The mucous membrane of the trachea is edematous, hyperemic. A tracheostomy was applied under local infiltration anesthesia, partial excision of the scar-granulation tissues was made, the stenosis zone was enlarged by increasing endotracheal tubes, followed by prolonged dilatation on endotracheal tube No. 9 with an outer diameter of 12 mm. Subsequently, through the tracheostomy, cryodestruction of the stenosis zone was repeatedly performed, and a thermoplastic tracheostomy tube with a fenestrating opening for voice and breathing through the natural airways was installed. At the urgent request, the patient was discharged 07.12.07, with recommendations. On the night of December 13, 2007, complaints of abdominal pain, repeated vomiting, delayed stools and gas discharge, were delivered to the surgical on-duty hospital with a diagnosis of acute adhesive intestinal obstruction. Emergency surgery - laparotomy, dissection of adhesions. Discharged on December 29, 2007, without coordination with us the tracheostomy tube was removed, the healing of the tracheostomy is independent. I did not contact the clinic of the Siberian State Medical University. She reappeared on 10.01.2008 and was hospitalized at the clinic of the Siberian State Medical University with a diagnosis of tracheal restenosis, medical history No. 12, with complaints of shortness of breath, poor sputum cough, choking with minimal physical exertion. Upon receipt, the general condition is severe, stridor with minimal physical exertion. The skin and visible mucous membranes with a cyanotic hue. During fibrobronchoscopy (FBS), it was found that the tracheal lumen was narrowed to 4 mm at the site of previously existing stenosis, it was not possible to go beyond the stenosis site, and the mucous membrane of the trachea was swollen and hyperemic in the examined area. With tracheal tomography - at the level of Th3-Th4, the air column of the trachea is narrowed to 3-4 mm, length up to 2.5 cm. Before tracheostomy and the planned restoration of airway obstruction, a drug mixture consisting of 1 ml diprospan, longidase 3000 was introduced into the peritracheal tissue sternum ME, lidocaine 2% 0.04 g, ketorolac 0.03 g, diluted to 5 ml with 10% glucose solution. Retracheostomy, partial excision of scar-granulation tissues, stenosis of the stenosis area along the increasing endotracheal tubes, followed by prolonged dilatation on a tracheostomy tube with an external diameter of 13.2 mm were performed. Subsequently, stenosis was subjected to cryodestruction through a tracheostomy once a week, and a thermoplastic tracheostomy tube with a fenestrating hole was installed for a sonorous voice and breathing through the natural airways. Before cryodestruction of the tracheal stenosis, a sternum drug mixture was administered. In total, 3 blockades were completed. In the intervals between and after the course of injections, inhalations were performed once a week through a compressor nebulizer of Longidase 1500 ME diluted in 3 ml of lazolvan. A total of 5 inhalations were performed. Discharged 05.02.08 g in satisfactory condition with a tracheostomy. Examined after 6 and 12 months after treatment, clinically and endoscopically there are no signs of recurrence of stenosis, the tracheostomy is functioning. Preparing for the planned closure of the defect in the anterior wall of the trachea (tracheoplasty).

Example 2. Patient V., 60 years old, medical history No. 849, was admitted to the hospital clinic of the Siberian State Medical University with a diagnosis of postresuscitative tracheoesophageal fistula, tracheomalacia of the cervical-upper thoracic trachea, esophagostoma; post-tracheostomy limited cicatricial stenosis of the cervical trachea of the II degree, tracheostomy; severe concomitant pathology: Bronchial asthma of mixed origin, coronary artery disease, hypertension III stage, risk IV, polyvalent allergy, obesity III stage From the anamnesis - from April to September 2008 she was treated at the TB clinic for a postoperative ventral hernia complicated by small intestine infringement, acute intestinal obstruction, hernia repair, dissection of adhesions, and plastic with local tissues were performed. In connection with respiratory failure for 3 weeks, mechanical ventilation was performed through the orotracheal and then through the tracheostomy tube. The postoperative period was complicated by eventration, recurrent bleeding from stressful stomach ulcers, the formation of a tracheoesophageal fistula in combination with tracheomalacia and cicatricial stenosis of the trachea. Concerning the complications, several interventions were performed on the abdominal wall and organs of the abdominal cavity, esophago- and tracheostomy with the installation of a tracheostomy cannula. As a result of intensive complex treatment, the patient's condition stabilized, spontaneous breathing was restored. Transferred to the hospital clinic. A.G. Savinykh for further surgical treatment.

Upon admission, the general condition is severe, functioning esophago- and tracheostomy. Independent breathing through the tracheostomy tube. Endoscopically, it was found that the tracheal-esophageal fistula is 3.5 × 1.5 cm in size, along the upper edge of the tracheostomy opening is cicatricial stenosis of the trachea with a triangular shape. Given the extent of tracheal lesion, the presence of a tracheostomy and severe concomitant pathology, the implementation of a circular resection of the trachea was considered extremely risky. Cervicomediastinotomy, dissection of the tracheoesophageal fistula were performed, and a T-shaped silicone tube was inserted into the lumen of the trachea. Within 4 months formed the lumen of the trachea. The next day after removing the tube, difficulty breathing through the natural airways appeared. In FBS - in place of previously existing stenosis, the lumen of the trachea is again narrowed, single granulation. Cryodestruction of the stenosis zone was performed once with the preliminary injection of the drug mixture consisting of diprospan 0.5 ml, longidase 1500 ME, lidocaine 2% 0.04 g, ketorolac 0.03 g diluted to 5 ml of 10% glucose into the perotracheal fiber. Just completed 2 blockades. In the intervals between and after injections, inhalations were performed once a week through a compressor nebulizer of Longidase 1500 ME diluted in 1 ml of berodual and 2 ml of lazolvan. A total of 5 inhalations were performed. Additionally, to reduce bronchial obstruction, a suspension of 1 mg budesonide was prescribed once a day through a nebulizer for 5 days. After a complex course of treatment, a T-tube was reinstalled in the lumen of the airways. After a month, the T-tube was removed. Examined after 1 and 3 months after treatment, there are no clinical and endoscopic signs of recurrence of stenosis, the tracheostomy closed on its own.

Example 3. Patient M., 19 years old, medical history No. 42, was hospitalized on January 28, 2009 at the hospital clinic of the Siberian State Medical University with complaints of tracheostomy, difficulty in sputum discharge. From the anamnesis - lives in one of the remote areas of the Tomsk region. Delivered on medical examination to the TOKB, where she was treated from 01/11/09 to 01/28/09 with a diagnosis of acute strangulation commissural small bowel obstruction, complicated by gangrene of the small intestine, diffuse peritonitis. An emergency operation was performed - laparotomy, adhesion excision, obstructive resection and intubation of the small intestine, laparostomy. Double programmed sanitation of the abdominal cavity, overlapping entero-enteroanastomosis of the type side to side, drainage of the abdominal cavity, suturing of the laparostomy. An extended mechanical ventilation was carried out through the endotracheal tube for 4 days. As a result of intensive therapy, the patient's condition improved, independent breathing was restored. Shortly after extubation, complaints of shortness of breath. FBS revealed circular stenosis at the c / 3 level of the trachea up to 9 mm in diameter. Cartilaginous half rings in this zone do not differentiate. The condition is regarded as tracheomalacia of the upper thoracic trachea with a length of up to 2.0 cm, a conservative treatment is prescribed, including non-steroidal anti-inflammatory drugs, bronchodilators, oxygen and antibiotic therapy are continued. Further complaints of shortness of breath at rest, clinically increasing respiratory failure. FBS revealed an eccentric narrowing due to granulation growths on the membranous part of c / 3 of the trachea, floating during breathing and almost completely covering the lumen of the trachea.

Tracheotomy, excision of granulations were performed, a tracheostomy tube was installed as an endostent. Transferred to the hospital clinic. A.G. Savinykh for further treatment.

On admission, a general state of moderate severity, a functioning tracheostomy. Independent breathing through the tracheostomy tube. The skin and visible mucous membranes of normal color. After removal of the tracheostomy tube, FBS was performed. It was found endoscopically that starting from the lower edge of the tracheostomy there are scar-granulation growths that eccentrically narrow the tracheal lumen by 1/3 of the diameter of the airway. The mucous membrane of the trachea is edematous, hyperemic. Before cryosurgical restoration of airway patency, a drug mixture consisting of diprospan 0.5 ml, longidase 1500 ME, lidocaine 2% 0.04 g, ketorolac 0.03 g diluted to 5 ml with 10% glucose was injected once retrosternally into the perotracheal fiber. After injection, inhalation was performed once a week through a compressor nebulizer of Longidase 1500 ME diluted in 3 ml of lazolvan. A total of 3 inhalations were performed. After each inhalation, a thermoplastic tracheostomy tube with a fenestrating opening for a sonorous voice and breathing through the natural airways was installed through the tracheostomy. Tracheostomy tube removed. Healing of the tracheostomy is independent. Discharged 02/18/09 in satisfactory condition. The patient was examined after 1 and 2 months after treatment, no clinical and endoscopic signs of recurrence of stenosis were found. Spirography is performed - the function of external respiration is within normal limits.

Thus, the proposed method can improve efficiency, reduce the duration of treatment of patients with cicatricial stenosis of the larynx and trachea, prevent their restenosis after reconstructive plastic surgery and endoscopic restoration of the lumen of the respiratory tract.

Information sources

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Claims (1)

A method for the prevention and treatment of cicatricial stenosis of the larynx and trachea, comprising administering a drug, characterized in that the drug mixture consisting of diprospan 0.5-1.0 ml, longidase 1500-3000 ME, lidocaine 2% 0 is administered retrosternally near tracheal 04 g, ketorolac 0.03 g, diluted to 5 ml with 10% glucose solution, once a week, with a course of 1-3 injections, and in the intervals between and after the injection course, inhalations are carried out through a compressor nebulizer of longidase 1500 ME diluted on 3 ml of bronchodilator or mucolytic drug Once a week, a total of 3-5 inhalations.