RU2769669C1 - Medicinal dressing of herbal extracts for local prevention and treatment of 0 and 1 stages of bisphosphonate necrosis of jaw - Google Patents

Abstract

FIELD: medicine; pharmaceutics.

SUBSTANCE: invention refers to pharmaceutical industry, namely to a therapeutic dressing for preventing and treating bisphosphonate osteonecrosis of jaw of 0 and 1 stages. Therapeutic dressing for the prevention and treatment of bisphosphonate osteonecrosis of jaw of 0 and 1 stages, which is made in the form of a collagen sponge impregnated with an infusion of an herbal tea obtained from garden sage leaves, calendula flowers, plantain leaves, rhizomes and roots of great burnet, leaves of stinging nettle and purified water at the following ratio of components, wt. %:

Garden sage leaves 2.0 Calendula flowers 2.0 Common plantain leaves 2.0 Rhizomes and roots of great burnet 2.0 Stinging nettle leaves 2.0 Purified water up to 100.0

See table.

EFFECT: disclosed dressing has pronounced anti-inflammatory, regenerating, antiseptic and haemostatic properties, reduces the healing time of the hole due to improved regeneration and microcirculation in the area of the operative wound, reduces injuries due to reduced number of dressings.

1 cl, 3 ex

Description

The invention relates to medicine, namely pharmacy, as well as surgical dentistry, and can be used for prevention in patients taking bisphosphonates, in persons with risk factors for the disease, as well as for the treatment of stages 0 and 1 of bisphosphonate osteonecrosis of the jaws according to the proposed classification American Association of Oral and Maxillofacial Surgeons in 2014.

The development of methods for the prevention and treatment of bisphosphonate osteonecrosis of the jaws (BONJ) is being actively pursued by domestic and foreign doctors.

Currently, many methods are used to prevent the development of ONJ: treatment of sockets of extracted teeth with an erbium laser in a scanning mode with a defocused beam (300–320 mJ, 10 Hz, vsp pulses) [1. Zaslavskaya N.A., Drobyshev A.Yu., Lezhnev D.A., Volkov A.G. Tarasenko S.V. Experience in the treatment of a patient with bisphosphonate osteonecrosis of the jaw against the background of chronic periodontitis of the teeth of the lower jaw (clinical observation) // Endodontics Today. 2014. No. 2. pp. 56-60. 2. Tarasenko S.V., Drobyshev A.Yu., Shipkova T.P., Zhukova N.A., Tarasenko I.V. Tactics of treatment of patients with bisphosphonate osteonecrosis of the jaws // Russian Dentistry. 2012. V. 5. No. 2. pp. 3-13.]; the use of sulodexide [Petrosyan A.L., Kutukova S.I., Chefu S.G. Sulodexide as a choice for the prevention of bisphosphonate osteonecrosis. Smolensk honey. almanac. 2018; (4): 118-120.], the use of pentoxifylline and tocopherol [Owosho A.A., Estilo C.L., Huryn J.M. et al. Pentoxifylline and tocopherol in the management of cancer patients with medication-related osteonecrosis of the jaw: an observational retrospective study of initial case series. Oral Surg. Oral Med. Oral Pathol. Oral Radiol. 2016; 122(4): 455-459. DOI: 10.1016/j.oooo.2016.06.019], teriparatide [Kakehashi H., Ando T., Minamizato T. et al. Administration of teriparatide improves the symptoms of advanced bisphosphonate-related osteonecrosis of the jaw: preliminary findings. Int. J. Oral Maxillofac. Surg. 2015.44(12): 1558-1564. DOI: 10.1016/j.ijom.2015.07.018.], vitamin D [Bedogni A., Bettini G., Bedogni G. et al. Is vitamin D deficiency a risk factor for osteonecrosis of the jaw in patients with cancer? A matched case-control study. J. Craniomaxillofac. Surg. 2019; 47(8): 1203-1208. DOI: 10.1016/j.jcms.2019.03.007]; nitric monoxide therapy [Christoforando D.Yu., Pechenkin E.V., Spevak E.M., Ebzeev A.K. The effectiveness of the use of exogenous nitric oxide in the preoperative period in patients with bisphosphonate osteonecrosis of the jaws // Modern problems of science and education. 2019. №2. S. 145]; the use of platelet-rich fibrin [Andreev A.A., Stepanov I.V., Khryachkov V.I., Podoprigora A.V., Khodorkovsky M.M., Gulyaev O.A. The use of platelet-enriched fibrin in the treatment of osteonecrosis of the lower jaw // Smolensk Medical Almanac. 2020. №3. S. 20-23.].

Known biosorption wound dressing from a sorbent obtained from cotton powder cellulose with a fiber length of at least 10 μm, which is poured into a purulent wound, completely covering it, for the treatment of a complicated course of biophosphonate osteomyelitis of the jaw bones. Dressing is carried out by adding powder every 12 hours until the wound is completely cleansed [patent RU 2700497, 2019].

In the available scientific, medical and patent literature, information about the popularity of medicinal herbal dressings for the treatment of osteonecrosis of the jaw has not been found. The closest analogue of the invention is a therapeutic bandage with a hydrophilic-based ointment levomekol, which is used in the complex treatment of BONC, which also includes antiseptic treatment of osteonecrosis zones with antiseptic solutions and restorative treatment. The average treatment time is 15-20 days. When inflammation appeared, antibacterial and anti-inflammatory therapy was prescribed for up to 10 days (in most cases, patients were prescribed Amoxiclav 625 mg, 1 t 3 times a day [Zaslavskaya N.A. Optimization of the prevention and treatment of bisphosphonate osteonecrosis of the jaws in patients with malignant neoplasms // Abstract for the degree of Candidate of Medical Sciences Moscow, 2014].

The objective of the invention is to develop a therapeutic and prophylactic bandage that promotes primary epithelialization of the socket at stages 0 and 1 of bisphosphonate osteonecrosis of the jaws, as well as the prevention of its development after surgical intervention in the oral cavity.

The technical result when using the invention is to expand the therapeutic effect of the dressing by obtaining an agent with pronounced anti-inflammatory, regenerating, antiseptic and hemostatic properties, to reduce the healing period of the hole by improving regeneration and microcirculation in the area of the surgical wound, to reduce trauma by reducing the number of dressings. The proposed therapeutic bandage for the prevention and treatment of bisphosphonate osteonecrosis of the jaw of stages 0 and 1 is a collagen sponge, which is impregnated with an infusion of a herbal preparation containing leaves of sage officinalis, flowers of calendula officinalis, leaves of plantain large, rhizomes and roots of burnet officinalis, leaves of nettle at the following ratio components, wt. %:

The method for obtaining a medical dressing includes the preparation of an infusion according to the State Pharmacopoeia of the XIV edition: each type of medicinal plant material is crushed separately to a particle size of not more than 5-7 mm. Then the plant material is weighed and thoroughly mixed in equal proportions to a uniform mixture, the dust is sieved through a sieve with a hole diameter of 0.18 mm. To obtain an infusion, 100.0 g of the collection is poured into 1 liter of water. In a boiling water bath, stand for 15 minutes and then insist at room temperature for 45 minutes, then filter. After that, the hemostatic sponge is impregnated with infusion. After surgical manipulation, the tooth socket is filled with a hygroscopic material, a hemostatic sponge soaked in an infusion from a collection of medicinal plants containing leaves of sage officinalis, flowers of calendula officinalis, leaves of plantain large, rhizomes and roots of burnet officinalis, leaves of nettle.

Collagen sponge undergoes biodegradation within 3-6 weeks. Collagen biodegradation (lysis) products stimulate wound repair processes, accelerating wound healing.

All components included in the dressing are approved for medical use.

Salvia officinalis leaves - contain essential oils, flavonoids, tannins, which thicken epithelial tissues, reduce the permeability of cell membranes, strengthen the walls of damaged blood vessels. They have an astringent, anti-inflammatory, antiseptic and hemostatic effect.

Calendula officinalis flowers - contain carotenoids (carotene, lycopene, violaxanthin, citraksanthin, rubixanthin, flavochrome), flavonoids (narcisin, rhamnetin, isorhamnetin-3-triglucoside, isoquercitrin), essential oil, saponins, bitter substance calendene, resinous and tannic substances, mucus , inulin, organic acids (malic, salicylic, pentadecyl), phytosterol, enzymes, vitamin C, alkaloids. This complex of biologically active substances has an anti-inflammatory, wound healing, bactericidal effect, accelerates the processes of tissue regeneration.

Large plantain leaves - contain mucus, bitter and tannins, carotene, vitamin C, vitamin K, resins, proteins, oleic and citric acids, saponins, sterols, aucubin glycoside, invertin enzymes and emulsions, alkaloids, essential oil, chlorophyll, phytoncides, flavonoids, mannitol, sorbitol, macro- and microelements and other biologically active substances. They have anti-inflammatory, antimicrobial bacteriostatic (against staphylococci, Pseudomonas aeruginosa, hemolytic streptococcus), antiviral, hemostatic, antiallergic, analgesic action.

Rhizomes and roots of burnet officinalis - contain tannins, saponins, flavonoids. It has astringent, hemostatic, antiseptic and anti-inflammatory effect.

Nettle leaves - contain vitamin K, ascorbic acid, carotenoids, chlorophyll, tannins, pantothenic acid, flavonoids, organic acids, macro- and microelements, and other biologically active substances and have a hemostatic effect.

The invention is illustrated by the following examples of the use of the proposed dressing.

Example #1. Patient N., 81 years old, complained of constant throbbing pain in the area of the sockets of previously extracted teeth in the lower jaw on the right.

Concomitant diseases: Prostate cancer stage 4 group 4. T3NxM1 MTS in the bone. Over the past 5 years, injections of Zoledronic acid 4 mg No. 1 intravenously have been carried out once a month. Hypertension, kidney disease, chronic cerebral ischemia,

Anamnesis: According to the patient, the teeth were removed 5 days ago in a private dental clinic.

On objective examination: the general condition is satisfactory, the face is symmetrical, the skin is of physiological color, the submandibular lymph nodes on the right are enlarged, painful on palpation, not soldered to the skin, mouth opening is within the physiological norm, painless, COR in the area of the holes of 43.44 teeth is hyperemic , edematous, painful, there are no blood clots in the holes, exposure of the area of necrotic bone in the area of \u200b\u200bthe holes of 43.44 teeth.

Based on complaints, objective data, anamnesis, the diagnosis was made: Bisphosphonate osteonecrosis of the jaw, stage 1.

Under infiltration anesthesia Sol. Ultracaini D-S Forte 4% - 1.7 ml, the well was drug-treated with 1:5000 solution of furacillin, a medicinal herbal bandage was placed in the well from a hemostatic sponge soaked in an infusion from the collection of medicinal plants containing leaves of sage officinalis, flowers of calendula officinalis, large plantain leaves , rhizomes and roots of burnet officinalis, nettle leaves, then sutured. The patient is scheduled for a follow-up examination every other day. Reducing pain in intensity, the sutures are not consistent, the well was washed again with 1:5000 solution of furacillin, a medicinal herbal dressing was placed in the well. When examining the patient on the 7th day, there is a beginning of the formation of granulation tissue on 1/3 of the hole. When examining the patient on the 14th day, he does not complain, the hole heals by secondary intention by 2/3. The prognosis is favorable. The patient did not seek further help.

Example #2. Patient V., 69 years old, complained of aching pain in the tooth on the lower jaw on the left.

Concomitant diseases: Breast cancer, stage IV. T1N1M1, MTS in the lymph nodes of the neck on the right, bones, lungs. The patient underwent 5 courses of treatment with zoledronic acid. Hypertension, ischemic heart disease, angina pectoris, rheumatism.

An atraumatic extraction of tooth 36 was performed, without curettage of the hole, medical treatment 1: 5000 solution of furacillin, a phytobandage from a hemostatic sponge soaked in an infusion from a collection of medicinal plants containing leaves of sage officinalis, flowers of calendula officinalis, leaves of plantain large, rhizomes and the roots of the burnet officinalis, the leaves of the nettle, sutured. Medical treatment was prescribed.

On the second day after the removal of the complaint of moderate pain in the area of the socket of the extracted tooth, the COP in the area of the socket is hyperemic, edematous, painful. The seams are not consistent, the area of exposed bone tissue in the area of the socket of the extracted tooth.

Based on complaints, objective data, anamnesis, the diagnosis was made: Bisphosphonate osteonecrosis of the jaw, stage 0.

Under infiltration anesthesia Sol. Ultracaini D-S Forte 4% - 1.7 ml, the well was drug-treated with 1:5000 solution of furacillin, the medicinal herbal dressing was re-placed in the well. The patient was scheduled for a follow-up examination in 5 days. Pain reduction in intensity, the well was washed again with 1:5000 solution of furacillin, a medicinal herbal dressing was added to the well. When examining the patient on the 7th day, there is a beginning of the formation of granulation tissue on 1/3 of the hole. When examining the patient on the 10th day, she has no complaints, the hole heals by secondary intention by 2/3. The prognosis is favorable. The patient did not seek further help.

Example #3.

Patient S., 54 years old, complained of a decayed tooth in the upper jaw on the left.

Concomitant diseases: Postmenopausal osteoporosis, once a year injections of Zoledronic acid 5 mg No. 1 are carried out intravenously. Hypertension, type 2 diabetes mellitus, ischemic heart disease, angina pectoris.

An atraumatic extraction of tooth 26 was performed, without curettage of the hole, medical treatment 1: 5000 solution of furacillin, a phytobandage was placed in the hole from a hemostatic sponge soaked in an infusion from a collection of medicinal plants containing leaves of sage officinalis, flowers of calendula officinalis, leaves of plantain large, rhizomes and the roots of the burnet officinalis, the leaves of the nettle, sutured. Medical treatment was prescribed. On the second day after the removal of the complaint about minor pain in the area of the socket of the extracted tooth, the COP in the area of the socket is moderately hyperemic, the socket heals by primary intention. On the 7th day the patient does not complain, the wound heals without complications. The patient did not seek further help.

Thus, the proposed drug dressing from plant extracts can reduce the healing time of the hole, provides anti-inflammatory properties, improved regeneration and microcirculation in the area of the surgical wound.

Claims (2)

Therapeutic dressing for the prevention and treatment of bisphosphonate osteonecrosis of the jaw of stages 0 and 1, characterized in that it is made in the form of a collagen sponge, which is impregnated with an infusion of a herbal preparation obtained from the leaves of sage officinalis, flowers of calendula officinalis, leaves of plantain large, rhizomes and roots of burnet officinalis, nettle leaves and purified water in the following ratio of components, wt.%: