List of Abbreviations
NOS - not otherwise specified
HIV – human immunodeficiency virus
OM – otomycosis
УДД – levels of evidence certainty
УУР – levels of recommendation consensus
Terms and Definitions
Otomycosis (OM) – a fungal disease caused by the development of various types of mold and yeast-like fungi on the skin of the auricle, the walls of the external auditory canal, the tympanic membrane, in the tympanic cavity, and the postoperative cavity of the middle ear [6, 18].
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
Fungal external otitis – a fungal disease caused by the development of mold or yeast-like fungi on the skin of the auricle, the walls of the external auditory canal, and the tympanic membrane.
Fungal myringitis – the development of mold fungi on the tympanic membrane.
Fungal middle ear otitis – a fungal disease caused by the development of various types of mold and yeast-like fungi in the tympanic cavity.
Mycosis of the postoperative cavity – a fungal disease caused by the development of various types of mold and yeast-like fungi in the postoperative cavity of the middle ear.
Synonyms – otomycosis.
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
According to data from numerous studies in our climatic zone, the main causative agents of otomycosis are mold fungi of the genus Aspergillus and yeast-like fungi of the genus Candida. Aspergillosis is diagnosed in 65% of cases, and candidiasis in 30%. In some cases, fungal ear infections are caused by fungi of the genera Penicillium, Mucor, Alternaria, Geotrichum, Cladosporium and others, accounting for up to 5% respectively. In 15% of cases, there is a combined infection caused by fungi of the genera Aspergillus and Candida [1, 2, 5, 11, 12, 34, 35].
Species identification reveals the following fungi: genus Aspergillus – A. niger, A. fumigatus, A. oryzae, A. flavus, A. ochraceus, A. versicolor, A. clavatus, A. glaucus, A. nidulans, A. terreus; genus Candida – C. albicans, C. tropicalis, C. pseudotropicalis, C. krusei, C. glabrata, C. parapsilosis, C. stellatoidea, C. intermedia, C. brumptii; genus Penicillium – P. notatum, P. puberulum, P. tardum, P. nidulans, P. chermesinum, P. glaucus, P. chrysogenum, P. citrinum and others [2, 3, 4, 5].
Basically, all species of fungi causing otomycosis belong to opportunistic pathogens and cause disease only under certain factors predisposing to the development and multiplication of fungi, ensuring their transition from saprophytism to pathogenicity. In this regard, it is important to know the predisposing conditions leading to the manifestation of the pathogenic properties of fungi. The main pathogenetic mechanisms of mycosis development are adhesion (attachment of the fungus to the wound surface, skin, etc.), fungal colonization, and invasive growth.
Various endogenous and exogenous factors play a role in the pathogenesis of otomycosis. The main exogenous factor in fungal otitis externa is skin trauma resulting from excessive hygiene of the external auditory canal. During manipulations in the external auditory canal performed by the patient independently, not only is the skin of the external auditory canal damaged, but earwax—its primary protective factor—is also removed [6].
The cause of adhesion and colonization may be an elevated glucose level in patients with diabetes mellitus, since in the early stages of this disease, the glucose level in earwax increases, which promotes fungal growth. Endogenous factors predisposing to otomycosis are somatic diseases. Their associated general weakening of the body, metabolic disorders, and hypovitaminosis can play a significant role in the onset of otomycosis. Another important pathogenetic factor in the development of otomycosis is the patient's prolonged course of systemic and topical antibiotic therapy and the use of corticosteroids. By suppressing the growth of pathogenic and normal bacterial flora, antibiotics ( J01 Antibacterials for systemic use ) thereby contribute to the development of dysbiosis and the activation of fungi. The use of systemic corticosteroids in high doses leads to a decrease in non-specific and specific immunity. In addition, treatment with immunosuppressants and radiation therapy can lead to fungal complications [7].
In the pathogenesis of mycosis of a postoperative ear cavity, the primary causative factor is a prolonged inflammatory process in the postoperative cavity accompanied by epithelial damage. At the same time, inflammatory exudate containing carbohydrates, proteins, peptones, mineral salts, and other substances serves as a good nutrient medium, while the constant temperature, humidity, and free access of air to the postoperative middle ear cavity provide optimal conditions for the activation and development of fungi. The triggering mechanism for the mycosis of the postoperative middle ear cavity can be ear trauma, including surgical trauma, as well as the ingress of non-sterile water. Unfavorable environmental conditions also play a certain role here: humidity, dustiness, and occupational exposure to antibiotics [8, 3, 9].
Fungal otitis is characterized by a recurrent course.
1.3 Epidemiology of the Disease or Condition
The proportion of otomycosis among chronic otitis of other etiologies is up to 18.6% in adults and up to 26.3% in children. They are divided into external fungal otitis (62%), fungal myringitis (1%), fungal otitis media (20%), and postoperative fungal otitis media (17%) [1, 9, 10, 11, 12].
1.4 Features of Coding the Disease or Condition
H60.8 – Other chronic infectious otitis externa;
H66.3 – Other chronic suppurative otitis media;
B37.8 – Candidiasis of other sites;
B44.8 – Other forms of aspergillosis;
H62.2* – Otitis externa in mycoses NOS;
(Otitis externa in:
- aspergillosis (B44.8†);
- candidiasis (B37.2†);
Otomycosis NOS (B36.9†));
B49 – Unspecified mycosis
1.5 Classification of the disease or condition
By localization – external fungal otitis, fungal myringitis, fungal otitis media, and postoperative fungal otitis media.
By causative agent – mold, yeast-like, mixed.
By clinical course – chronic. [13]
1.6 Clinical presentation of the disease or condition
The diversity of species composition of fungi causing inflammation of the external auditory canal, middle ear, and postoperative middle ear cavity is the main reason for the variability of complaints and clinical manifestations in mycotic inflammation. Clinical manifestations largely depend on the genus and species of the causative fungus.
In mycosis caused by yeast-like fungi, the inflammatory process can involve the skin of the auricle and the parotid region. Candidal involvement of the external ear is characterized by: hyperemia, infiltration, and maceration of the skin of the external auditory canal, hyperemia of the tympanic membrane in otitis externa, thickening of the mucous membrane, and the presence of thick turbid discharge in the lumen of the tympanic cavity. Impaired epithelization of the postoperative cavity. The discharge on the walls of the auditory canal is less thick, unlike inflammation caused by mold fungi. The color of the discharge has a whitish tint. When the inflammation spreads to the auricle, skin hyperemia with erosions is observed, granulation and scaling are possible, and the deposits on the skin of the auricle are whitish and easily removable. Involvement of the auricle in the inflammatory process can cause chondroperichondritis with subsequent deformity of the auricle [20, 21].
In otitis caused by mold fungi of the genus Aspergillus, the clinical picture has a specific character. Caseous-necrotic masses are determined in the lumen of the external auditory canal, infiltration of the skin of the external auditory canal is more pronounced in the bony part, and phenomena of myringitis are possible. Deposits on the walls of the external auditory canal are whitish-gray with black inclusions resembling "ground pepper" or "wet newspaper". When the external auditory canal is affected by Aspergillus glaucus, the pathological discharge has a specific greenish tint.
When the external ear is affected by mold fungi of the genus Penicillium, the clinical manifestations are also specific. The color of the discharge has a yellowish tint, in some cases resembling earwax. The skin of the external auditory canal is infiltrated, and pathological discharge is detected throughout the entire external auditory canal. Additional elements on the skin of the external auditory canal may include dry crusts and films [3, 5, 8, 20, 21].
For geotrichosis inflammation of the external auditory canal caused by the strain (Geotrichum capitatum), the characteristic clinical manifestations are: marked infiltration of the skin of the external auditory canal, and phenomena of myringitis. Dense "putty-like" grayish-yellow fungal masses are determined in the lumen of the external auditory canal. Pathological discharge is detected throughout the entire external auditory canal.
2. Diagnostics, medical indications and contraindications for diagnostic methods
Diagnostic criteria are based on the analysis of the results of a comprehensive patient examination:
complaints;
medical history data;
physical examination;
laboratory tests;
instrumental examination.
Comments: diagnosis of fungal infection is based on the analysis of the results of a comprehensive patient examination to establish an accurate diagnosis and choose treatment tactics [1-6].
2.1 Complaints and Anamnesis
Complaints and clinical manifestations of otomycosis are the result of the vegetation of certain fungi in the ear and are largely determined by the localization of the process.
During the interview, it is necessary to clarify the onset time of the disease and the features of its course. It should be found out whether there was a previous otitis or mycosis of another location, what the periodicity, duration, and character of exacerbations are. Previously administered treatment (local or systemic) and its efficacy are taken into account: whether there was deterioration or relapses. It is imperative to find out whether patients were previously treated with antibiotics, corticosteroids, or immunosuppressants (duration and intensity of treatment), as well as occupational and domestic conditions, past illnesses, and allergic history. Patients with otomycosis exhibit an increased frequency of exacerbations and no or negligible effect from standard treatment methods.
The main symptoms of fungal external otitis (otomycosis) include liquid discharge (in candidiasis), crust formation, and debris plugs in the external auditory canal (in aspergillosis), as well as itching, pain, and aural fullness. In the acute stage, some patients may present with headache, fever, and hypersensitivity of the auricle, retroauricular region, and external auditory canal. In all forms of fungal external otitis, hearing impairment is either absent or mild, presenting as a conductive hearing loss.
Clinical manifestations of fungal middle ear otitis and mycosis of the postoperative middle ear cavity are characterized by symptoms of both an inflammatory purulent middle ear process and the mycosis itself.
The main complaints of patients with fungal middle ear otitis are hearing loss, ear discharge, periodic ear itching, and dizziness may occur [13, 14].
The course of otomycosis is prolonged with periodic exacerbations. Exacerbations are characterized by pronounced ear pain, itching, aural fullness, ear discharge, headache, and dizziness [13, 15].
2.2 Physical Examination
Examination of the auditory organ (otoscopy) is recommended using magnifying optical equipment (otoscope, microscope, rigid endoscope) [5, 11, 12, 13, 14, 15,].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
Comments: In candidal infection of the external auditory canal, there is a moderate narrowing of the external auditory canal lumen, more pronounced in the cartilaginous part; the tympanic membrane is hyperemic. The pathological discharge has a more fluid consistency than in mold mycosis, is usually whitish and cheesy in appearance. The process frequently spreads to the skin of the auricle [5, 11, 12].
In aspergillosis infection, the external auditory canal may also be narrowed due to wall infiltration; however, unlike penicilliosis, skin infiltration is more pronounced in the bony part. In almost all cases, the tympanic membrane is involved, showing infiltration, thickening, and the disappearance of landmarks. Granulations are observed in some cases. Pathological discharge in aspergillosis is more abundant than in penicilliosis and differs in color. In most cases, it has various shades of gray, sometimes with black dots, and can be cholesteatoma-like or serous, resembling wet newspaper.
In penicilliosis, the process is localized in the cartilaginous part of the external auditory canal. There is moderate infiltration of the skin of the external auditory canal, which does not lead to complete occlusion of the auditory canal. The tympanic membrane is hyperemic in most cases, sometimes its surface is eroded, and protrusion may occur, creating a false impression of perforation.
A characteristic and specific feature of penicilliosis of the external ear is the appearance of the pathological discharge, which has various shades of yellow and in some cases resembles earwax. The pathological discharge is located throughout the entire length of the external auditory canal and may be combined with dry crusts and films.
An objective sign of fungal middle ear infection is the presence of specific discharge, the color and consistency of which depend on the species of the causative fungus. Signs of external otitis frequently accompany this. The tympanic membrane is hyperemic, infiltrated, with perforations of various sizes. In all cases, the visible mucous membrane of the tympanic cavity is hyperemic, infiltrated, and granulations sometimes form [13, 14].
In mycosis of the postoperative middle ear cavity, epithelialization of the cavity is absent or markedly slowed, the walls of the external auditory canal are hyperemic and unevenly infiltrated, the neotympanic cavity is filled with pathological discharge similar in appearance to that seen in otomycosis of other localizations, and small bleeding granulations are encountered [13, 15].
2.3 Laboratory Diagnostics
In patients with protracted and recurrent courses of otomycosis, general clinical tests are recommended to identify concomitant pathology [3, 6, 13]:
Complete blood count (CBC);
General biochemical blood test: assessment of blood glucose level, total blood protein level, blood aspartate aminotransferase (AST) activity, blood alanine aminotransferase (ALT) activity, and blood creatinine level;
Determination of antibodies of classes M and G (IgM, IgG) to human immunodeficiency virus HIV-1 in blood;
Determination of antibodies of classes M and G (IgM, IgG) to human immunodeficiency virus HIV-2 in blood;
Determination of antibodies to Treponema pallidum in blood;
Determination of hepatitis B virus surface antigen (HBsAg) in blood;
Determination of hepatitis C virus antigen in blood.
GCR BLoE 3Level of Evidence B (Level of Confidence of Evidence – 3)
Comments: general clinical tests are performed to rule out concomitant pathology and identify underlying conditions.
All patients are recommended to undergo mycological examination:
Microscopic examination of ear discharge for fungi (yeast and mold).
Microbiological (culture) examination of ear discharge for yeast fungi.
Microbiological (culture) examination of ear discharge for mold fungi [2, 3, 4, 5, 6, 11, 13, 23, 34].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
Comments: perform the above mycological examinations in patients with chronic otitis in the following cases:
in patients with frequent exacerbations (once every 2 months);
in case of ineffectiveness of anti-inflammatory antibacterial therapy for chronic otitis;
when a characteristic otoscopic picture of mycosis is detected.
After establishing the diagnosis of "otomycosis" and administering appropriate therapy, repeated follow-up mycological examinations are indicated.
To collect biological material samples for mycological examination, an attic probe or Volkmann spoon is used. Pathological discharge should preferably be collected from the deep parts of the external auditory canal under the control of a microscope, otoscope, or rigid endoscope. The pathological material is placed between two degreased sterile glass slides and examined microscopically at x100, x200, and x400 magnification [2, 3, 4, 5, 7, 16, 23, 35].
LeRR CLoE 4Level of recommendation confidence C (level of evidence – 4)
Comments: Microscopic examination (A26.01.015 Microscopic examination of skin scraping for fungi (yeast, mold, dermatophytes)) is the most informative method that reliably identifies the causative agent of the disease [2, 3, 23, 24].
The main criterion for diagnosing mycosis when culturing pathological discharge on nutrient media is a titer of detected fungi of at least 104 CFU/ml.
It is recommended to repeat the examination of the pathological discharge [2, 6, 7, 13, 23].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
Comments: Fungal ear infection can be suspected based on the data of auditory organ examination (otoscopy), but mycological laboratory research methods are of decisive importance. At the same time, a single negative result does not indicate the absence of a fungal disease. In this situation, it is recommended to repeat the examination of the pathological discharge. Conversely, isolated fungal growth in a culture does not always indicate a fungal pathological process.
2.4 Instrumental Diagnostics
All patients are recommended to undergo an examination of the external auditory canal, tympanic membrane, tympanic cavity, and postoperative middle ear cavity using a microscope or otoscope [3, 13, 21].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
Comments: Examination of the auditory organ can be performed using microscopes and binocular loupes, rigid endoscopes (otoscopes) [3, 6, 21]. In all forms of otomycosis, a common micro-otoscopic sign is noted: the presence of colored discharge in the lumen of the external auditory canal and/or middle ear in all patients. The diagnosis of "otomycosis," however, can only be made after verification of the pathogen [7, 8].
2.5 Other Procedures
It is recommended that in cases of ear damage occurring against the background of systemic diseases, including infectious diseases, a consultation with an appropriate medical specialist and additional examination be performed [4, 13].
GoR CLoE 5Grade of Recommendation C (Level of Evidence – 5)
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
Indications for hospitalization include complicated forms of fungal middle ear otitis, labyrinthitis, as well as the inability to ensure daily adequate toilet of the external auditory canal and/or ineffectiveness of adequate outpatient therapy for external fungal otitis within 5–7 days.
3.1 Conservative Treatment
All patients are recommended to start treatment with the elimination of the pathogen. In addition to antimycotic therapy, it is necessary to perform a thorough toilet of the external auditory canal (tympanic cavity, postoperative cavity). [1, 5, 6, 8, 11, 12]
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: When carrying out treatment, it is necessary to take into account previous episodes of fungal infection and treatment with topical antifungal drugs (D01A).
All patients are recommended to start otitis therapy before obtaining the results by prescribing different groups of topical drugs. [1, 5, 6, 8, 11, 12, 25, 27, 30, 31]
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: In case of candidal external otitis, a combination of a 1% #clotrimazole solution and a 1% #naftifine solution is indicated in the form of applications lasting 5–10 min each, 2 times a day for 14 days, with continuation of therapy for 14 days after the subsidence of clinical signs and/or until obtaining a 3-fold negative laboratory test (Table 1). In candidomycosis, the use of miconazole, natamycin**, or #econazole is also possible [13, 21, 25, 26, 27, 30, 31]..
In otitis externa caused by mold fungi, the drugs of choice for topical treatment are #chlornitrophenol and 1% #naftifine solution, also used as applications to the skin of the external auditory canal 2 times a day for 5-10 min each over 10-14 days. Treatment should also be continued for 14 days after resolution of clinical signs and/or until obtaining 3 consecutive negative laboratory tests [7, 4].
For otitis caused by a fungal-bacterial association, the drug of choice is a combination drug – S02C Corticosteroids in combination with anti-infectives #(chloramphenicol+beclometasone+clotrimazole+lidocaine) in the form of instillation into the external auditory canal, 4–5 drops 3–4 times a day for 10 days (for children aged 6 years and older). [36]
In the treatment of fungal otitis media and mycosis of the postoperative cavity of the middle ear caused by fungi of the genus Candida, it is recommended not only local therapy, but also systemic antifungal therapy with – #fluconazole** in an age-appropriate dosage [13, 21, 25, 26, 27, 30, 31].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
In the treatment of fungal otitis media and mycosis of the postoperative cavity of the middle ear caused by molds, it is recommended to prescribe systemic antifungal drugs – itraconazole or terbinafine [17].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
Comments: Topical therapy is similar to that in the treatment of external fungal otitis [7, 18, 19].
The criterion for treatment efficacy in all patients is recommended to be complete clinical cure within a month, confirmed by both the clinical picture and negative results of mycological examination [13, 20, 21, 30].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
Drug #naftifine (ATC: D01AE22) Other topical antifungal drugs. The drug's action is based on the inhibition of squalene epoxidase activity, an enzyme responsible for one of the stages of ergosterol biosynthesis. Due to the lack of ergosterol, the formation of the fungal cell membrane is disrupted, which manifests as a fungistatic effect of the drug. This drug is active against yeast-like fungi of the genus Candida. In addition, this drug has a fungicidal effect against mold fungi. The advantages of the drug include an anti-inflammatory effect and long-lasting effective concentrations on the skin [4, 27, 29, 31].
Drug #Chlornitrophenol – (ATC: D.01.A.E) Other topical antifungal drugs: exerts antifungal and antibacterial action. Inhibits the growth of Microsporum canis, Trichophyton gypseum (at a concentration of 0.0001%), Candida albicans (at a concentration of 0.0007%). A 0.003% solution exerts a fungicidal action. In high concentrations, it exhibits activity against gram-positive and gram-negative bacteria (including Proteus vulgaris and Pseudomonas aeruginosa). Use of the substance #Chlornitrophenol – fungal skin diseases, including epidermophytosis, trichophytosis, candidiasis, fungal eczema; mycosis of the external auditory canal [32].
Drug #clotrimazole – an antifungal drug, an imidazole and triazole derivative.. #Clotrimazole is a highly specific drug against a wide range of yeast-like pathogens of the genus Candida. This drug prevents ergosterol synthesis by acting on the enzyme lanosterol 14α-demethylase, causing fungal cell lysis. The effect of the drug is predominantly fungistatic [4, 7, 34].
Combination ear drops Candibiotic with INN Beclometasone+Clotrimazole+Lidocaine+Chloramphenicol [36]
Treatment regimens for otomycosis are presented in Tables 1 and 2.
Table 1 – Regimen for the treatment of otomycosis with topical antifungal drugs in the form of applications and systemic antifungal drugs [13, 21, 25, 26, 27, 30, 31].
Localization of the lesion | Route of administration | Types of fungi | |
|---|---|---|---|
Yeast-like | Molds | ||
External ear | Topical | Naftifine 1% solution + clotrimazole 1% solution | Naftifine 1% solution + chlornitrophenol 1% solution |
Middle ear | Topical | Naftifine 1% solution + clotrimazole 1% solution | Naftifine 1% solution + chlornitrophenol 1% solution |
Oral | #Fluconazole**, capsules | #Itraconazole, capsules | |
Postoperative cavity | Topical | Naftifine 1% solution + clotrimazole 1% solution | Naftifine 1% solution + chlornitrophenol 1% solution |
Oral | Fluconazole**, capsules | Itraconazole, capsules or #terbinafine, tablets (from 3 years of age) | |
Table 2 – Doses and regimens of systemic antifungals for otomycosis [13, 21, 25, 26, 27, 30, 31].
Drugs | Doses and administration regimens |
|---|---|
#Fluconazole** | Oral, 50–100 mg once daily for 14 days |
#Itraconazole | Oral, 200 mg once daily for 10–14 days |
#Terbinafine | Oral, 250 mg daily for 16 days |
3.2 Surgical Treatment
It is recommended prior to drug therapy, in the presence of polyps or granulations, to perform their removal or cauterization with a 10% silver nitrate solution (ATX Code D08AL01 Silver nitrate AgNO3) [3, 6, 9, 33].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: After cauterization, treatment with topical antifungals, such as naftifine or chlornitrophenol, is mandatory.
3.3 Other Treatment
In addition to local therapy, it is recommended for all patients to perform a thorough preliminary cleaning of the ear from pathological discharge [3, 6, 8, 9, 13, 25, 29, 30].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
Comments: Ear toilet is performed exclusively by a physician using an attic probe and/or a cotton-tipped ear probe moistened with topical antifungal agents, or a vacuum extractor. Thorough ear toilet is of particular importance, as even a minor amount of mycotic masses significantly prolongs treatment duration and, accordingly, delays recovery.
In otitis externa fungosa, great importance is attached to cleaning the anteroinferior part of the external auditory canal. In otitis media fungosa, mycotic masses are completely removed from the area of tympanic membrane perforations. In cases of large perforations, to remove mycotic masses, the tympanic cavity is rinsed with antiseptics and disinfectants, specifically a 0.01% solution of benzyldimethyl[3-(myristoylamino)propyl]ammonium chloride monohydrate. The same approach is used in the treatment of mycosis of the middle ear postoperative cavity. Before starting treatment, in the presence of polyps or granulations, their removal or cauterization with a 10% silver nitrate solution is performed. In postoperative mycosis, the entire neotympanic cavity is thoroughly cleaned, especially in the posterior section, behind the spur.
Physiotherapeutic procedures are not recommended for all patients [3].
GRC CLeE 5Grade of Recommendation C (Level of Evidence – 5)
Comments: It is necessary to limit exposure to harmful environmental factors: contact with dust, gases, and staying in rooms with high humidity. Preventing water from entering the ear is of decisive importance.
4. Medical Rehabilitation and Sanatorium-Resort Treatment
Not performed.
5. Prevention and Dispensary Observation
It is recommended that all patients with fungal otitis undergo follow-up examinations by an otorhinolaryngologist once every 3 months, and in case of a favorable course, once every six months for 2 years [3].
GRC CLeE 5Grade of Recommendation C (Level of Evidence – 5)
Comments: The main measures for the prevention of OM should aim to eliminate factors significant in the pathogenesis of the fungal disease: proper toilet of the external auditory canal and auricle; glycemic profile correction; general strengthening therapy.
Prevention of OM recurrence:
dynamic monitoring of the patient for 6 months;
administration of a prophylactic treatment course;
application of naftifine or chlornitrophenol to the skin of the external auditory canal once a week (for 4–6 weeks).
6. Organization of Medical Care
Primary health care for patients in need of treatment, rehabilitation, and health-improvement measures is provided by general practitioners (family physicians) and primary care otorhinolaryngologists.
Additional types and volumes of medical care for patients are organized and provided by medical institutions of the first and third levels in compliance with the requirements of the legislation of the Russian Federation in the field of health protection.
7. Additional Information
It is recommended to perform repeat ear swabs until microbiological confirmation of pathogen eradication is obtained. [2, 3, 4, 6].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
All patients are recommended to have the medication administered into the ear on a wick.
Comments: Instillation of an alcohol-containing medicinal product into the external auditory canal may lead to a longer retention of the medicinal product in the external auditory canal and cause its irritation. If it enters the mucous membrane of the tympanic cavity in otitis media, it can cause sharp pain, increased mucosal edema, aggravation of mucositis, and the appearance of granulations. The expert panel recommends inserting a wick soaked in a solution of the medicinal product into the external auditory canal, which increases the duration of the drug's therapeutic effect [3, 13, 21, 25, 26, 27, 30, 31].
Criteria for Evaluating the Quality of Medical Care
№ | Criterion | Performance evaluation |
|---|---|---|
1. | Mycological examination of ear discharge was performed | Yes/no |
2. | Therapy with local and/or systemic antifungal drugs was performed for 28 days or more (depending on medical indications and in the absence of medical contraindications) | Yes/no |
3. | Eradication of the mycosis pathogen was achieved | Yes/no |
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Appendix A1. Working Group Composition
Kunelskaya Vera Yakovlevna, Doctor of Medical Sciences
Yunusus Adnan Sultanovich, Doctor of Medical Sciences, member of a professional association;
Shadrin Georgy Borisovich, Candidate of Medical Sciences, member of a professional association;
Artyushkin Sergey Anatolyevich, Doctor of Medical Sciences, member of a professional association;
Ivoylov Alexey Yuryevich, Doctor of Medical Sciences, member of a professional association;
Karneeva Olga Vitalievna, Doctor of Medical Sciences, member of a professional association;
Shakhov Andrey Vladimirovich, Doctor of Medical Sciences, member of a professional association;
Kiselev Alexey Borisovich, Doctor of Medical Sciences, member of a professional association.
No conflict of interest
Appendix A2. Methodology for Developing Clinical Guidelines
Target audience for these clinical guidelines:
Otorhinolaryngologist;
Otologist/Otorhinolaryngologist.
Table P1. Levels of Evidence (LoE) grading scale for diagnostic methods (diagnostic interventions)
LoE | Definition |
|---|---|
1. | Systematic reviews of studies with reference method controls or systematic reviews of randomized clinical trials using meta-analysis |
2. | Individual studies with reference standard control or individual randomized controlled trials and systematic reviews of studies of any design, except randomized controlled trials, with meta-analysis |
3. | Studies without consecutive reference standard control or studies with a reference standard not independent of the test method, or non-randomized comparative studies, including cohort studies |
4. | Non-comparative studies, case report |
5. | Only justification of mechanism of action or expert opinion is available |
Table P2. Levels of Evidence (LoE) grading scale for prevention, treatment, and rehabilitation methods (preventive, therapeutic, and rehabilitative interventions)
LoE | Definition |
|---|---|
1. | Systematic review of randomized controlled trials with meta-analysis |
2. | Individual randomized controlled trials and systematic reviews of studies of any design, except randomized controlled trials, with meta-analysis |
3. | Non-randomized comparative studies, including cohort studies |
4. | Non-comparative studies, case report or case series, case-control study |
5. | Only justification of the mechanism of action of the intervention (preclinical studies) or expert opinion is available |
Table P3. Scale for assessing levels of recommendation certainty (LRC) for prevention, diagnosis, treatment, and rehabilitation methods (preventive, diagnostic, therapeutic, and rehabilitation interventions)
GoR | Definition |
|---|---|
A | Strong recommendation (all considered efficacy criteria (outcomes) are important, all studies are of high or acceptable methodological quality, and their conclusions on the outcomes of interest are consistent) |
C | Conditional recommendation (not all considered efficacy criteria (outcomes) are important, not all studies are of high or acceptable methodological quality, and/or their conclusions on the outcomes of interest are inconsistent) |
C | Weak recommendation (lack of adequate quality evidence (all considered efficacy criteria (outcomes) are unimportant, all studies are of low methodological quality, and their conclusions on the outcomes of interest are inconsistent) |
Procedure for updating clinical guidelines
Clinical guidelines will be updated every 3 years
Appendix A3. Reference Materials
These clinical guidelines have been developed taking into account the following regulatory and legal documents:
Procedure for the provision of medical care in the profile «otorhinolaryngology»: Order of the Ministry of Health of the Russian Federation No. 905n dated November 12, 2012, «On approval of the Procedure for the provision of medical care to the population in the profile „otorhinolaryngology“».
Appendix B. Physician Action Algorithms
Fungal otitis externa
Appendix C. Patient Information
Avoid self-cleaning of the external auditory canal. It is necessary to strictly follow the doctor's prescriptions to prevent chronization of the inflammatory process.
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
No.