Intratimpanijski kortikosteroidi za iznenadni senzorneuralni gubitak sluha.
The Cochrane database of systematic reviews
Sažetak istraživanja
Pozadina Idiopatski iznenadni senzorineuralni gubitak sluha (ISSNHL) je čest i definiran je kao naglo smanjenje senzorineuralne osjetljivosti sluha nepoznate etiologije. Sistemski kortikosteroidi se široko koriste, ali njihova vrijednost ostaje nejasna. Intratimpanijske injekcije kortikosteroida postale su sve češće u liječenju ISSNHL-a.
Ciljevi Procijeniti efekte intratimpanijskih kortikosteroida kod osoba sa ISSNHL.
Metode pretraživanja Cochrane ENT specijalista za informacije je pretražio Cochrane ORL registar ispitivanja; CENTRALNA (2021, broj 9); PubMed; Ovid Embase; CINAHL; Web of Science; ClinicalTrials. gov; ICTRP i dodatni izvori za objavljena i neobjavljena ispitivanja (datum pretrage 23. septembar 2021.). Kriterijumi odabira Uključili smo randomizirana kontrolirana ispitivanja (RCT) koja su uključivala osobe s ISSNHL-om i praćenje od više od tjedan dana. Intratimpanijski kortikosteroidi davani su kao primarni ili sekundarni tretman (nakon neuspjeha sistemske terapije). Prikupljanje i analiza podataka Koristili smo standardne Cochrane metode, uključujući GRADE za procjenu sigurnosti dokaza. Naš primarni ishod bila je promjena praga sluha uz audiometriju čistog tona. Sekundarni ishodi uključivali su udio ljudi čiji se sluh poboljšao, konačni prag čujnosti, audiometriju govora, promjene sluha specifične za frekvenciju i štetne efekte. Glavni rezultati Uključili smo 30 studija koje su obuhvatile 2133 analizirana učesnika. Neke studije su imale više od dva kraka liječenja i stoga su bile relevantne za nekoliko poređenja. Studije su ispitivale intratimpanijske kortikosteroide kao primarnu (početnu) terapiju ili sekundarnu (spasilačku) terapiju nakon neuspjeha početnog liječenja. 1. Intratimpanijski kortikosteroidi u odnosu na sistemske kortikosteroide kao primarna terapija Identificirali smo 16 studija (1108 učesnika). Intratimpanijska terapija može dovesti do malog ili nikakvog poboljšanja u promjeni praga sluha (srednja razlika (MD) -5,93 dB bolje, 95% interval pouzdanosti (CI) -7,61 do -4,26; 10 studija; 701 učesnik; niska sigurnost). Pronašli smo malu ili nikakvu razliku u udjelu učesnika čiji je sluh poboljšan (omjer rizika (RR) 1,04, 95% CI 0,97 do 1,12; 14 studija; 972 učesnika; umjerena sigurnost). Intratimpanijska terapija može dovesti do male ili nikakve razlike u konačnom pragu sluha (MD -3,31 dB, 95% CI -6,16 do -0,47; 7 studija; 516 učesnika; niska sigurnost). Intratimpanijska terapija može povećati broj ljudi koji imaju vrtoglavicu ili vrtoglavicu (RR 2.53, 95% CI 1.41 do 4.54; 1 studija; 250 učesnika; niska izvjesnost) i vjerovatno povećava broj ljudi s bolom u ušima (RR 15.68, 6.2% CI; 6.2% CI; 9.2% CI; 289 učesnika; To je također rezultiralo upornom perforacijom bubnjića (raspon od 0% do 3,9%; 3 studije; 359 učesnika; vrlo niska izvjesnost), vrtoglavica/vrtoglavica u vrijeme injekcije (1% do 21%, 3 studije; 197 učesnika; vrlo niska sigurnost) i bol u uhu do 10% do 10% vremena. 2 studije; 289 učesnika; 2. Intratimpanijski plus sistemski kortikosteroidi (kombinovana terapija) naspram samo sistemskih kortikosteroida kao primarne terapije Identifikovali smo 10 studija (788 učesnika). Kombinovana terapija može imati mali efekat na promenu praga sluha (MD -8,55 dB bolji, 95% CI -12,48 do -4. 61; 6 studija; 435 učesnika; niske sigurnosti). Dokazi su veoma nesigurni da li kombinovana terapija menja proporciju učesnika čiji je sluh poboljšan (RR 1.27, 95% CI 1.15 do 1.41; 10 studija; 788 učesnika; veoma niska izvesnost). Kombinovana terapija može rezultirati nešto nižim (povoljnijim) konačnim pragom sluha, ali dokazi su vrlo nesigurni i nije jasno da li bi promjena bila važna za pacijente (MD -9,11 dB, 95% CI -16,56 do -1,67; 3 studije; 194 učesnika; vrlo niska sigurnost). Neki neželjeni efekti su se javili samo kod onih koji su primali kombinovanu terapiju. One su uključivale upornu perforaciju bubne opne (raspon od 0% do 5,5%; 5 studija; 474 učesnika; vrlo niska sigurnost), vrtoglavicu ili vrtoglavicu u trenutku injekcije (raspon od 0% do 8,1%; 4 studije; 341 učesnik; vrlo niska sigurnost) i studija bola u uhu 1,5%; 73 učesnika sa vrlo malom sigurnošću); 3. Intratimpanijski kortikosteroidi naspram bez tretmana ili placeba kao sekundarne terapije. Identifikovali smo sedam studija (279 učesnika). Intratimpanijska terapija može imati mali efekat na promenu praga sluha (MD -9,07 dB bolji, 95% CI -11,47 do -6,66; 7 studija; 280 učesnika; niska sigurnost). Intratimpanijska terapija može dovesti do mnogo većeg udjela učesnika čiji je sluh poboljšan (RR 5,55, 95% CI 2,89 do 10,68; 6 studija; 232 učesnika; niska sigurnost). Intratimpanijska terapija može rezultirati nižim (povoljnijim) konačnim pragom sluha (MD -11,09 dB, 95% CI -17,46 do -4,72; 5 studija; 203 učesnika; niska sigurnost). Neki neželjeni efekti su se javili samo kod onih koji su primili intratimpansku injekciju. To uključuje upornu perforaciju bubnjića (raspon od 0% do 4,2%; 5 studija; 185 učesnika; vrlo niska izvjesnost), vrtoglavicu ili vrtoglavicu u vrijeme injekcije (raspon od 6,7% do 33%; 3 studije; 128 učesnika; vrlo niska izvjesnost; 0% ispitanika; bol u uhu; 4% ispitanika; bol u uhu; 4 ispitanika; vrlo niska sigurnost). 4. Intratimpanijski plus sistemski kortikosteroidi (kombinovana terapija) u odnosu na samo sistemske kortikosteroide kao sekundarnu terapiju Identifikovali smo jednu studiju sa 76 učesnika. Promjena praga sluha nije prijavljena. Kombinovana terapija može rezultirati većom proporcijom poboljšanja sluha, ali dokazi su vrlo nesigurni (RR 2.24, 95% CI 1.10 do 4.55; vrlo niska sigurnost). Neželjeni efekti su slabo prijavljeni samo sa podacima za upornu perforaciju bubne membrane (stopa 8,1%, vrlo niska sigurnost).
Zaključci autora Većina dokaza u ovom pregledu je niske ili vrlo niske izvjesnosti, stoga je vjerovatno da bi daljnje studije mogle promijeniti naše zaključke. Za primarnu terapiju, intratimpanijski kortikosteroidi mogu imati mali ili nikakav učinak u poređenju sa sistemskim kortikosteroidima. Možda postoji mala korist od kombinovanog liječenja u poređenju sa samim sistemskim liječenjem, ali dokazi su nesigurni. Za sekundarnu terapiju, postoje dokazi niske sigurnosti da intratimpanijski kortikosteroidi, u poređenju sa bez liječenja ili placebom, mogu dovesti do mnogo većeg udjela sudionika čiji je sluh poboljšan, ali mogu imati samo mali učinak na promjenu praga sluha. Vrlo je neizvjesno da li postoji dodatna korist od kombiniranog liječenja u odnosu na sam sistemski steroid. Iako su nuspojave slabo prijavljene, pri odabiru odgovarajućeg liječenja treba uzeti u obzir različite profile rizika intratimpanijskog liječenja (uključujući perforaciju bubne opne, bol i vrtoglavicu/vertigo) i sistemskog liječenja (na primjer, problemi s glukozom u krvi).
Prikaži originalni naslov i sažetak na engleskom
Intratympanic corticosteroids for sudden sensorineural hearing loss.
Background Idiopathic sudden sensorineural hearing loss (ISSNHL) is common, and defined as a sudden decrease in sensorineural hearing sensitivity of unknown aetiology. Systemic corticosteroids are widely used, however their value remains unclear. Intratympanic injections of corticosteroids have become increasingly common in the treatment of ISSNHL.
Objectives To assess the effects of intratympanic corticosteroids in people with ISSNHL. Search methods The Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; CENTRAL (2021, Issue 9); PubMed; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials (search date 23 September 2021). Selection criteria We included randomised controlled trials (RCTs) involving people with ISSNHL and follow-up of over a week. Intratympanic corticosteroids were given as primary or secondary treatment (after failure of systemic therapy). Data collection and analysis We used standard Cochrane methods, including GRADE to assess the certainty of the evidence. Our primary outcome was change in hearing threshold with pure tone audiometry. Secondary outcomes included the proportion of people whose hearing improved, final hearing threshold, speech audiometry, frequency-specific hearing changes and adverse effects. Main results We included 30 studies, comprising 2133 analysed participants. Some studies had more than two treatment arms and were therefore relevant to several comparisons. Studies investigated intratympanic corticosteroids as either primary (initial) therapy or secondary (rescue) therapy after failure of initial treatment. 1. Intratympanic corticosteroids versus systemic corticosteroids as primary therapy We identified 16 studies (1108 participants). Intratympanic therapy may result in little to no improvement in the change in hearing threshold (mean difference (MD) -5.93 dB better, 95% confidence interval (CI) -7.61 to -4.26; 10 studies; 701 participants; low-certainty). We found little to no difference in the proportion of participants whose hearing was improved (risk ratio (RR) 1.04, 95% CI 0.97 to 1.12; 14 studies; 972 participants; moderate-certainty). Intratympanic therapy may result in little to no difference in the final hearing threshold (MD -3.31 dB, 95% CI -6.16 to -0.47; 7 studies; 516 participants; low-certainty). Intratympanic therapy may increase the number of people who experience vertigo or dizziness (RR 2.53, 95% CI 1.41 to 4.54; 1 study; 250 participants; low-certainty) and probably increases the number of people with ear pain (RR 15.68, 95% CI 6.22 to 39.49; 2 studies; 289 participants; moderate-certainty). It also resulted in persistent tympanic membrane perforation (range 0% to 3.9%; 3 studies; 359 participants; very low-certainty), vertigo/dizziness at the time of injection (1% to 21%, 3 studies; 197 participants; very low-certainty) and ear pain at the time of injection (10.5% to 27.1%; 2 studies; 289 participants; low-certainty). 2. Intratympanic plus systemic corticosteroids (combined therapy) versus systemic corticosteroids alone as primary therapy We identified 10 studies (788 participants). Combined therapy may have a small effect on the change in hearing threshold (MD -8.55 dB better, 95% CI -12.48 to -4.61; 6 studies; 435 participants; low-certainty). The evidence is very uncertain as to whether combined therapy changes the proportion of participants whose hearing is improved (RR 1.27, 95% CI 1.15 to 1.41; 10 studies; 788 participants; very low-certainty). Combined therapy may result in slightly lower (more favourable) final hearing thresholds but the evidence is very uncertain, and it is not clear whether the change would be important to patients (MD -9.11 dB, 95% CI -16.56 to -1.67; 3 studies; 194 participants; very low-certainty). Some adverse effects only occurred in those who received combined therapy. These included persistent tympanic membrane perforation (range 0% to 5.5%; 5 studies; 474 participants; very low-certainty), vertigo or dizziness at the time of injection (range 0% to 8.1%; 4 studies; 341 participants; very low-certainty) and ear pain at the time of injection (13.5%; 1 study; 73 participants; very low-certainty). 3. Intratympanic corticosteroids versus no treatment or placebo as secondary therapy We identified seven studies (279 participants). Intratympanic therapy may have a small effect on the change in hearing threshold (MD -9.07 dB better, 95% CI -11.47 to -6.66; 7 studies; 280 participants; low-certainty). Intratympanic therapy may result in a much higher proportion of participants whose hearing is improved (RR 5.55, 95% CI 2.89 to 10.68; 6 studies; 232 participants; low-certainty). Intratympanic therapy may result in lower (more favourable) final hearing thresholds (MD -11.09 dB, 95% CI -17.46 to -4.72; 5 studies; 203 participants; low-certainty). Some adverse effects only occurred in those who received intratympanic injection. These included persistent tympanic membrane perforation (range 0% to 4.2%; 5 studies; 185 participants; very low-certainty), vertigo or dizziness at the time of injection (range 6.7% to 33%; 3 studies; 128 participants; very low-certainty) and ear pain at the time of injection (0%; 1 study; 44 participants; very low-certainty). 4. Intratympanic plus systemic corticosteroids (combined therapy) versus systemic corticosteroids alone as secondary therapy We identified one study with 76 participants. Change in hearing threshold was not reported. Combined therapy may result in a higher proportion with hearing improvement, but the evidence is very uncertain (RR 2.24, 95% CI 1.10 to 4.55; very low-certainty). Adverse effects were poorly reported with only data for persistent tympanic membrane perforation (rate 8.1%, very low-certainty). Authors' conclusions Most of the evidence in this review is low- or very low-certainty, therefore it is likely that further studies may change our conclusions. For primary therapy, intratympanic corticosteroids may have little or no effect compared with systemic corticosteroids. There may be a slight benefit from combined treatment when compared with systemic treatment alone, but the evidence is uncertain. For secondary therapy, there is low-certainty evidence that intratympanic corticosteroids, when compared to no treatment or placebo, may result in a much higher proportion of participants whose hearing is improved, but may only have a small effect on the change in hearing threshold. It is very uncertain whether there is additional benefit from combined treatment over systemic steroids alone. Although adverse effects were poorly reported, the different risk profiles of intratympanic treatment (including tympanic membrane perforation, pain and dizziness/vertigo) and systemic treatment (for example, blood glucose problems) should be considered when selecting appropriate treatment.
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- DOI
- 10.1002/14651858.cd008080.pub2
- PMID
- 35867413
- PMCID
- PMC9307133
- Provjereno
- 2026-07-26
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