RU2602223C1 - Method of treating bilateral paralysis of larynx muscles - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to otorhinolaryngology, and can be used for treating bilateral paralysis of larynx muscles. For this purpose preparation is introduced by injection into thickness of larynx muscles, which contains type A botulinum toxin, namely preparation "Kseomin" in total dose of 20-30 UN. Wherein Kseomin is injected in cricothyroid muscles of larynx to depth of 1-2 cm with needle for spinal anaesthesia 24G Quinke type.

EFFECT: method provides improvement of patency of bronchial tree at level of bronchi of all passes, improvement of lung vital capacity (LVC), as well as improvement of breathing in patients with double-sided larynx paralysis due to expansion of vocal fold with maximum reduction of risk of local complications and side effects.

1 cl, 4 dwg, 6 tbl

Description

The invention relates to medicine, namely to otorhinolaryngology, and can be used in the treatment of bilateral paralysis of the muscles of the larynx.

Laryngeal muscle paralysis is a condition that is one of the causes of stenosis of the upper respiratory tract, characterized by a unilateral or bilateral disorder of the motor function of the larynx in the form of a violation or complete absence of voluntary movements of the vocal folds due to a violation of the innervation of the corresponding muscles, ankylosis of the cricoid joints, and the inflammatory process [1].

Bilateral paralysis of the muscles of the larynx (DPG) disrupts one of the vital functions - respiratory, which leads to significant morphological and functional changes in other organs and systems of the body.

Trauma to the recurrent laryngeal nerve is one of the most common pathologies in the field of laryngology [2, 3]. If this nerve is damaged, the innervation of the larynx muscles responsible for opening the glottis (when breathing, coughing) is disturbed, the vocal folds are in the median or paramedian position, and patients, as a rule, have no problems with the voice. The clinical picture depends on the size of the glottis. With stenosis of the larynx and respiratory compensation, there is a shortening of the pause between inhalation and exhalation, lengthening of the inspiration (inspiratory dyspnea), a decrease in the number of respiratory movements by 1 minute and a distortion of the normal ratio of the number of respiratory movements and pulse strokes, when instead of the normal ratio of 1: 4, the ratio 1: 6, 1: 7 and 1: 8. In this case, breathing becomes noisy, there is a change in the frequency, voltage and rhythm of the pulse. Cyanosis of fingers and face, shortness of breath at rest and with little physical exertion, noisy breathing, voiced breath (inspiratory dyspnea), rapid breathing, involvement of auxiliary muscles in breathing, tachycardia, increased blood pressure are noted. Over time, the clinical picture of chronic stenosis can be “blurred” due to the body's adaptation to hypoxia due to compensatory-adaptive reactions.

The development of surgery of the thyroid gland, aorta and carotid artery, and mediastinal organs also led to an increase in the number of patients with paralysis of the muscles of the larynx (4, 5).

For the treatment of patients with DPH, various methods of treatment are used from conservative ones: phonopedic treatment, acupuncture, electrical stimulation of the neuromuscular apparatus of the larynx, stimulating therapy (proserin, galantamine, nimodipine, glucocorticosteroids), to surgical ones: reconstructive operations aimed at removing the vocal fold and increasing the glottis .

The use of surgical methods for the treatment of DPH still causes a lot of controversy, because even gentle surgical methods are very traumatic and often lead to loss of voice, and over time, the breathing problem may return. In addition, the methods of conservative treatment that are currently proposed give a good result in the early stages of the onset of DPH and do not play a significant role in long-term paralysis of the larynx muscles (6, 7, 8).

Closest to the claimed method, the prototype, is a method for treating bilateral paralysis of the larynx muscles by administering the Botox drug in a dose of 2.5 Units (UNITS) in paired thyroid muscles (9). To inject Botox containing type A botulinum toxin, use a 1.0 ml tuberculin syringe with a monopolar needle electrode with a diameter of 27 G. The needle tip is isolated so that the recorded signal is sent only from the tip of the needle connected to the electromyograph via an amplifier. The position of the needle is checked for phonation by the sound “AND”. The correct placement of the monopolar needle electrode is confirmed by an increase in the electric pulse. The sound signal helps the surgeon to be sure that the tip of the needle is correctly oriented in the muscle. The drug "Botox" is injected into the muscle when the sound of the electromyograph reaches a peak. The proposed method allows metered relaxation of the thyroid muscles, which helps to increase the distance between the vocal folds and improve breathing.

However, the proposed method of introducing the drug "Botox" into the thyroid muscle in the control of the sound signal of the electromyograph has a number of significant drawbacks.

Firstly, the introduction of Botox into each thyroid muscle in such a dosage of 2.5 units is not enough.

Secondly, the Botox preparation containing Botulinum toxin type A refers to the first series of preparations containing a complexing protein that stabilizes the pharmacokinetic activity of the drug in tissues that can cause an immune response in the patient’s body, more specifically, allergic or infectious inflammatory processes in injection zones manifested by rash and swelling.

Thirdly, the introduction of a needle under the control of the sound signal of the electromyograph is possible only with sufficient preservation (or restoration) of the function of the muscles of the larynx. With bilateral paralysis of the larynx muscles, such a possibility is limited and erroneous signals from neighboring muscles are possible, which significantly reduces the effectiveness of the Botox drug and can cause unwanted side complications (dysphagia).

The objective of the invention is to increase the effectiveness of treatment and reduce side effects.

EFFECT: improved patency of the bronchial tree at the level of bronchi of all calibers, improved indicators of vital capacity of the lungs (VC), as well as improved breathing in patients with bilateral paralysis of the larynx muscles due to the expansion of the glottis.

The problem is achieved by the proposed method, which consists in the following.

The patient, who is in a semi-vertical position (the head is thrown back), is determined by palpation of the thyroid and cricoid cartilage, the cricothyroid membrane located between the lower edge of the thyroid and the upper edge of the cricoid cartilage of the larynx is visualized and local anesthesia is performed by introducing 1 ml of a solution of 2% membranes into the membrane . Then, with a 24G spinal anesthesia needle, type Quinke, 90 mm long with a diameter of 0.55 mm, the cricothyroid membrane is pierced, using a flexible fiber microscope that is inserted through the patient’s nasal passage, the cricothyroid muscle is located and Xeomin is administered in a dose of 10-15 units to a depth of 1-2 cm, and then determine the location of the paired cricothyroid muscle and inject the drug "Xeomin" in a dose of 10-15 PIECES to a depth of 1-2 cm.

Treatment control is carried out using a spirogram using the following indicators: FVC, FEV1, FEV / FVC, PEF, MEF75, MEF50, MEF25. MMEF, FIV1, as well as the use of a flexible fiberscope from Otopront, with photo and video recording of the distance between the vocal folds before and after the introduction of botulinum toxin type A.

Salient features of the proposed method, compared with the prototype, are:

1. As a preparation containing botulinum toxin type A, a more purified preparation “Xeomin” is used in a total dose of 20-30 units, which allows to increase the effectiveness of treatment by expanding the glottis and to reduce side complications.

2. As an injection needle for the Xeomin preparation, a 24G type Quinke spinal anesthesia needle is used, 90 mm long, 0.55 mm in diameter, which makes it possible to simplify and reduce the cost of treatment, since a 24G Quinke type spinal anesthesia needle costs only 120 rubles, and the needle for the electromyograph is in the range of 1500-2000, while the muscles of the larynx into which the drug is administered are anatomically positioned so that control by the electromyograph is not required.

3. The introduction of the drug "Xeomin" is carried out in paired cricothyroid muscles of the larynx to a depth of 1-2 cm, which allows to minimize the risk of local complications and side effects and increase the effectiveness of treatment.

4. The location of the cricothyroid muscles (zone for drug injection) is determined under the control of a flexible fiber microscope, which is inserted through the patient’s nasal passage to visualize the larynx, which makes it possible to accurately determine the location of the cricoid muscles, increase the effectiveness of the Xeomin preparation and prevent the drug from entering the trachea.

The cricothyroid muscle (m. Cricothyroideus) is attached at one end to the anterior surface of the cricoid cartilage arc to the side of the midline, and the other to the lower edge of the thyroid cartilage. With the contraction of this muscle, the thyroid cartilage leans forward, the vocal folds are stretched, and the glottis narrows. With the introduction of type A botulinum toxin, the opposite effect is obtained: the vocal folds relax, which facilitates the easier passage of air through the glottis.

A positive effect of the proposed method is achieved by creating an artificial controlled paresis of the muscles of the larynx, due to this, the vocal folds relax and the glottis expands, thereby improving breathing.

The mechanism of action of the drug "Xeomin" includes 4 stages:

1) Immediately after injection, botulinum toxin binds to the presynaptic membrane (nerve cell membrane). Then the toxin enters the nerve ending. Botulinum toxin is encapsulated inside a vesicle that migrates into the cytoplasm of a neuron. 2) Botulinum toxin passes through the membrane of the vesicle and exits into the cytoplasm before splitting. 3) Then, inhibition or blocking of the release of acetylcholine into the synaptic cleft occurs. 4) At the final stage - sprouting - new nerve endings begin to develop in the adjacent muscle fibers, due to which muscle activity begins to recover.

The drug begins within four to seven days after the injection. The effect of each procedure lasts, as a rule, three to four months, although it can last significantly longer or less.

The test drug "Xeomin" was performed on two groups of patients. Control group - 7 patients (standard treatment); The experimental group - 11 patients who were injected with the drug "Xeomin" in the muscles of the larynx of the claimed method.

Table 1 presents the spirometry indicators of two groups of patients before the introduction of the drug "Xeomin" (equalization of the initial data between the groups)

Table 2 presents the spirometry indices of two groups of patients 14 days after the administration of the Xeamine preparation.

From table 2 it can be seen that as a result of the introduction of the drug "Xeomin" in the claimed way, there is a significant improvement in patency on the bronchi of small and medium caliber, an increase in the vital capacity of the lungs (VC), an increase in the distance between the vocal folds, as evidenced by an improvement in spirometry indicators: 92% after 99%; FEV1 - up to 55% after 89%; FEV / FVC - up to 60% after 90%, PEF - up to 28% after 45%; MEF75 - up to 28% after 49%; MEF50 - up to 32% after 62%; MEF25 - up to 59% after 77%; MMEF - up to 36% after 68%; FIV1 - up to 80% after 91%. Endoscopic control also clearly indicates positive dynamics, since the distance between the vocal folds increased by 60% to 5 mm (before the introduction of the drug, the distance between the vocal folds was 2 mm).

The invention is illustrated by the following examples of specific performance of the method.

Example 1

Patient P., 29 years old, was admitted with a diagnosis of bilateral laryngeal muscle paralysis. Case history: In 2008, after resection of the thyroid gland, breathing problems appeared, bilateral paralysis of the muscles of the larynx was diagnosed.

On examination:

1. Spirography before administration of Xeamine

2. Endoscopic examination before treatment

The width of the glottis was 2 mm (Fig. 1)

No vocal cord mobility

The patient was introduced the drug "Xeomin" of the claimed method. In the semi-vertical position (the head is thrown back), the thyroid and cricoid cartilages were palpated, local anesthesia was performed by introducing 1 ml of a 2% lidocaine solution into the cricothyroid membrane. Next, a needle for spinal anesthesia of 24G type Quinke 90 mm long with a diameter of 0.55 mm punctured the cricothyroid membrane, under the control of a flexible fiber microscope that was inserted through the nasal passage of the patient, the location of the right cricothyroid muscle was determined and Xeomin was injected in a dose of 10 units to a depth of 1 cm, then the location of the left cricothyroid muscle was determined and an injection of Xeomin at a dose of 10 units was made into the left cricothyroid muscle to a depth of 1 cm.

When examining the patient after 14 days, the following was revealed:

Spirography

Endoscopic control after treatment (Fig. 2)

The glottis increased to 5 mm, breathing improved, the vocal cords due to the fact that they lost tension, became mobile on inhalation and exhalation.

Example 2

Patient P., 42 years old, was admitted with a diagnosis of bilateral laryngeal muscle paralysis. Case history: In 2010, after resection of the thyroid gland, breathing problems appeared, bilateral paralysis of the larynx muscles was diagnosed.

On examination:

1. Spirography

2. Endoscopic examination

The width of the glottis was 1 mm (Fig. 3)

Vocal cord mobility is absent.

The patient was introduced the drug "Xeomin" of the claimed method.

In the semi-vertical position (the head is thrown back), the thyroid and cricoid cartilages were palpated, local anesthesia was performed by introducing 1 ml of a 2% lidocaine solution into the cricothyroid membrane. Next, a 24 mm Quinke type spinal anesthesia needle with a length of 90 mm and a diameter of 0.55 mm punctured the cricothyroid membrane, under the control of a flexible fiber microscope, the location of the right cricothyroid muscle was determined and Xeomin was injected at a dose of 15 units to a depth of 2 cm, then the location was determined the left cricothyroid muscle and the injection of the drug "Xeomin" in a dose of 15 units in the left cricothyroid muscle to a depth of 2 cm.

When examining the patient after 14 days, the following was revealed:

Spirography

Endoscopic control

Glottis increased to 5 mm (Fig. 4).

Breathing improved, vocal cords due to the fact that they lost tension, became mobile on inhalation and exhalation.

As a result of the study, a significant improvement in patency on the bronchi of small and medium caliber, an increase in vital lung capacity (VC), an increase in the distance between the vocal folds, as evidenced by an improvement in spirometry indicators: FVC - up to 92% after 99%; FEV1 - up to 55% after 89%; FEV / FVC - up to 60% after 90%, PEF - up to 28% after 45%; MEF75 - up to 28% after 49%; MEF50 - up to 32% after 62%; MEF25 - up to 59% after 77%; MMEF - up to 36% after 68%; FIV1 - up to 80% after 91%, and endoscopic control of the distance between the vocal folds before and after treatment: clearly indicates an increase in the lumen of the glottis from 1-2 mm to 5 mm, which is 70-60% more than the initial indicators.

Thus, the proposed method allows to improve the patency of the bronchial tree at the level of the bronchi of all calibers, to improve indicators of vital capacity of the lungs (VC), and also to improve breathing in patients with bilateral laryngeal paralysis.

Information sources

1. Palchun V.T. Otorhinolaryngology. National leadership. M., 2008.S. 760-766.

2. Kytta J. Prognosis of idiopathic paralysis of the vocal cord in the light of stroboscopy / J. Kytta // Acta Otolaryngol. Suppl. (Stockh). - 1982. - Vol. 386. - P. 193-195.

3. Yamada M. Recurrent laryngeal nerve paralysis. A 10-year review of 564 patients / M. Yamada, M. Hirano, H. Ohkubo // Auris Nasus Larynx. - 1983. - Vol. 10 (Suppl.). - P. 1-15.

4. Bondarenko B.O., Ermolov A.C., Magomedov RB Prevention of damage to the laryngeal nerve during operations on the thyroid gland // Surgery. - 2001. - No. 1. - S. 63-66.

5. Yumoto E., Mino da R., Hyoda M., Yamaguta T. Causes of recurrent laryngeal nerve paralysis // Auris Nasus Larynx. - 2002. - Vol. 29, N 1. - P. 41-45

6. Vetshev P.S., Karpova O.Yu., Chilingaridi K.E. and other Prevention and treatment of disorders of the mobility of the vocal folds during operations on the thyroid gland // Surgery. - 2005. - No. 10. - S. 28-34.

7. Deryagin N.I., Lepekhina T.V., Kokorina V.E. To the question of treatment tactics for patients with impaired motor innervation of the larynx // Dalnevost. honey. Journal. - 2002. - No. 1. - S. 71-72.

8. Knyazev L.S., Bogomolova E.G. Comprehensive rehabilitation treatment of paresis and laryngeal paralysis after thyroid surgery: materials of the 17th Congress of Otolaryngologists of Russia (N. Novgorod, June 7–9, 2006). - N. Novgorod, 2006 .-- S. 190-191.

9. Kubilay U., Ünver F., Kaytaz A., Berk D., Gözükara F. Botulinum Toxin injections to cricothyroid muscles for relief of bilateral recurrent laryngeal nerve paralysis. Turkish Archives of Otolaryngology. 2003; 41: 82-87.

Claims (2)

1. A method of treating bilateral paralysis of the larynx muscles by injecting a preparation containing botulinum toxin type A into the thickness of the muscles of the larynx, characterized in that as a preparation containing botulinum toxin type A, the drug Xeomin is used in a total dose of 20-30 units, which is administered into the cricothyroid muscles of the larynx to a depth of 1-2 cm using a Quinke type 24G spinal anesthesia needle. 2. The method according to p. 1, characterized in that to determine the location of the cricothyroid muscles, the cricothyroid membrane is punctured using a spinal anesthesia needle, a flexible fibroscope is inserted through the patient’s nasal passage, and the location of the cricoid muscles is visualized.

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