The aim of the present work was to show the sustainability of fibrin sealant in releasing dexamethasone and adjust the protocol for clinical application of the novel method in the treatment of Meniere’s disease (MD) ...The aim of the present work was to show the sustainability of fibrin sealant in releasing dexamethasone and adjust the protocol for clinical application of the novel method in the treatment of Meniere’s disease (MD) and sudden sensorineural hearing loss (SSHL).Gelation occurred shortly after mixing dexamethasone-containing fibrinogen with thrombin.Dexamethasone was constantly released for at least 16 d at a stable level after 7d in protocol 1 (low-dose),while it was robustly released within 4 d and slowed afterward until 10 d in protocol 2(high-dose).There were significant differences among the time points in Protocol 2 (p<0.01,ANOVA),and the exponential model with the formula y=15.299*e~(-0.483*t) fits the association.The estimated concentration of dexamethasone released on 7 d in protocol 2 was slightly lower than that observed in protocol 1.The fibrin sealant is capable of constantly releasing dexamethasone with adjustable dynamics.Targeted and minimally invasive administration of the material can be achieved in the clinic by sequential injections of the fluids using a soft-tipped catheter.展开更多
Background: Sudden sensorineural hearing loss(SSNHL) is a prevalent emergency in ear, nose, and throat practice. Previous studies have demonstrated that intratympanic steroid therapy(IST) can serve as a salvage treatm...Background: Sudden sensorineural hearing loss(SSNHL) is a prevalent emergency in ear, nose, and throat practice. Previous studies have demonstrated that intratympanic steroid therapy(IST) can serve as a salvage treatment for SSNHL after the failure of systemic steroid therapy(SST).Objective: This study aimed to analyze the efficacy of modified IST involving the insertion of a tympanic tube and gelfoam as a salvage treatment for patients with SSNHL, and to explore its associated factors.Methods: Totally, 74 patients who were aged 22–81 years with SSNHL were enrolled and allocated to either the control group(n = 25) or the treatment group(n = 49) based on their treatment modalities. All patients received SST lasting for at least 7 days. Subsequently, patients in the treatment group, after SST failure, underwent IST twice a week for 2–6 weeks, while the control group did not. Efficacy was assessed by the improvement in pure tone average at the affected frequency at the beginning and end of IST.Results: Hearing improvement in all patients after IST in the treatment group was 9.71 ± 14.84 dB, with significant improvement at affected frequencies(250-8000 Hz) compared with the control group(P < 0.05). The findings indicated the duration from the onset of SSNHL to the beginning of IST as an independent factor for pure tone average improvement after treatment(P = 0.002), whereas age, duration of SST, and time of IST were not(P > 0.05).Conclusion: The modified IST was demonstrated to be a safe and effective method as a salvage treatment for SSNHL. This study explored the efficacy of a modified IST approach, incorporating the utilization of tympanic tubes and gelfoam as key components. The findings underscore the advantages of gelfoam as a strategic drug carrier placed in the round window niche. By minimizing drug loss, extending action time, and increasing perilymph concentration, gelfoam enhances the therapeutic impact of IST, contributing to improved hearing outcomes in patients with SSNHL.展开更多
Safe and efficient drug delivery to the inner ear has always been the focus of prevention and treatment of sensorineural deafness.The rapid development of nanodrug delivery systems based on hydrogel has provided a new...Safe and efficient drug delivery to the inner ear has always been the focus of prevention and treatment of sensorineural deafness.The rapid development of nanodrug delivery systems based on hydrogel has provided a new opportunity.Among them,thermo-sensitive hydrogels promote the development of new dosage form for intratympanic injection.This smart biomaterial could transform to semisolid phase when the temperature increased.Thermo-sensitive hydrogel nanodrug delivery system is expected to achieve safe,efficient,and sustained inner ear drug administration.This article introduces the key techniques and the latest progress in this field.展开更多
Objectives:To evaluate hearing outcome of salvage treatment with intratympanic steroids(ITS)in idiopathic sudden sensorineural hearing loss(ISSNHL)refractory to initial systemic steroid(SS)therapy.Material and methods...Objectives:To evaluate hearing outcome of salvage treatment with intratympanic steroids(ITS)in idiopathic sudden sensorineural hearing loss(ISSNHL)refractory to initial systemic steroid(SS)therapy.Material and methods:A retrospective medical chart review was conducted on 54 consecutive patients with ISSNHL refractory to SS.Salvage treatment with a low dose intratympanic dexamethasone(4 mg/ml)was offered after one week of primary treatment.Patients were divided into two groups:25 patients accepted ITS(treatment group)and 29 patients did not undergo additional treatment(control group).A pure tone average(PTA)gain of at least 10 dB was considered hearing improvement.Results:Hearing improvement rate was higher in ITS group compared to control group(40%vs.13.8%,p=0.035).A mean PTA improvement of 8.6±9.8 dB was observed in the ITS group and,whereas the control group had an average hearing gain of 0.7±2 dB(p<0.001).Audiometric analysis revealed a significant hearing gain in ITS group at all tested frequencies compared to control group(p<0.05).Analysis of the selected variables,identified intratympanic steroid treatment as the only independent prognostic factor for hearing improvement(OR=4.2,95%CI:1.1e15.7;p=0.04).Conclusion:Intratympanic low dose dexamethasone is effective in patients with incomplete hearing recovery after primary systemic steroid treatment.展开更多
BACKGROUND As sudden sensorineural hearing loss(SSNHL)rarely occurs in pregnant women,there is a lack of knowledge and relevant research on its management.AIM To investigate the effect of intratympanic dexamethasone i...BACKGROUND As sudden sensorineural hearing loss(SSNHL)rarely occurs in pregnant women,there is a lack of knowledge and relevant research on its management.AIM To investigate the effect of intratympanic dexamethasone injection in the treatment of pregnant patients with SSNHL.METHODS A retrospective chart review was made for the period between June 2017 and August 2019 at our Department of Otorhinolaryngology-Head and Neck Surgery.Pregnant women who met the criteria for SSNHL were included and grouped based on the therapeutic modalities.The treatment group received intratympanic dexamethasone(2.5 mg)q.o.d.for a total of four times,while the control group received no medication other than bed rest and medical observations.All the patients were under close care of obstetricians.Pure-tone audiograms were performed before and after treatment.RESULTS Eleven patients who met the inclusion criteria were assigned to the treatment group(n=7)and the control group(n=4).The mean age of patients was 31.2±3.8 years;the right ear was affected in seven(63.64%)cases.Two patients(18.2%)suffered from vertigo,10(90.9%)suffered from tinnitus and 6(54.5%)suffered from aural fullness.The time from onset to clinic visit was relatively short,with a mean time of 1.3±0.9 d.All the women were within the second or third trimester;the average gestation period was 26.0±6.2 wk.The pure-tone averages at onset between the two groups were similar.After one wk of therapy,the treatment group had a curative rate of 57.1%and a significantly better hearing threshold and greater improvement compared to the control group(all P<0.05).Some patients experienced transient discomfort from intratympanic injections that disappeared after getting rest,while none had permanent complications.All patients delivered healthy full-term neonates with an average Apgar score of 9.7±0.5.CONCLUSION Intratympanic dexamethasone injections can be used as a first-line therapy in pregnant women with SSNHL.展开更多
This article reviews the effectiveness of intratympanic corticosteroids for vertigo control in Meniere's disease at 2-years follow-up according to the guidelines expressed by the American Academy of Otolaryngology...This article reviews the effectiveness of intratympanic corticosteroids for vertigo control in Meniere's disease at 2-years follow-up according to the guidelines expressed by the American Academy of Otolaryngology-Head & Neck Surgery. Despite the increased use of intratympanic corticosteroids for vertigo control in Meniere's disease there is debate as to their effectiveness, particularly compared to gentamicin. Even so,after just a single course of injections, corticosteroids can reliably provide complete vertigo control(Class A) at 2-years in about 50% of cases as indicated in a recent double-blind randomized controlled clinical trial(Patel et al., 2016). But the effectiveness of intratympanic corticosteroids truly increases when treatment is provided 'as-needed', whereby complete vertigo control is established in up to 91% of cases. On the basis of available literature, there is good evidence to recommend the use of intratympanic steroid treatment for vertigo control in Meniere's disease, but patients must be monitored for non-response. The rationale for treating patients as-needed and the possible reasons for corticosteroid nonresponse are discussed.展开更多
Background Sudden sensorineural hearing loss(SSNHL)is a common disease in otology,and steroids play an important role in its treatment.Steroids can be administered systemically or locally,and the efficacies of differe...Background Sudden sensorineural hearing loss(SSNHL)is a common disease in otology,and steroids play an important role in its treatment.Steroids can be administered systemically or locally,and the efficacies of different administration routes remain controversial.Methods We searched the Cochrane,EMBASE,PubMed,Web of Science,CNKI,Wanfang and Weipu databases for randomized controlled trials(RCTs)on glucocorticoid treatments for SSNHL to compare the efficacy of topical and systemic steroid administration.The Review Manager 5.4 software was used for synthesis of data:the rate of reported hearing improvement and change in pure-tone audiometry(PTA).Results In all the included studies,when intratympanic administration was compared to systemic therapies,the risk difference(RD)using reported hearing improvement as an outcome measure was 0.08(95%CI:0.01–0.14,I2=45%).Using PTA changes as an outcome measure in 4 studies,the mean difference(MD)was 10.43 dB(95%CI:3.68–17.18,I2=81%).Hearing improvement RD was also compared among different types of steroid,recovery criteria,follow-up times and diagnostic criteria,and showed no significant differences exception for recovery criteria(>10 dB)(RD-0.06,95%CI:0.14-0.2,I2=0%).Conclusion As the initial treatment for SSNHL,topical steroids seem to be superior to systemic steroid administration,especially in patients with contraindications to systemic steroids usage.However,further verification based on high-quality research is needed.展开更多
Objective:To evaluate the efficacy and safety of intratympanic and systemic steroid therapies in the initial treatment of Sudden Sensorineural Hearing Loss (SSNHL) patients. Methods:A comprehensive search of PubMed, ...Objective:To evaluate the efficacy and safety of intratympanic and systemic steroid therapies in the initial treatment of Sudden Sensorineural Hearing Loss (SSNHL) patients. Methods:A comprehensive search of PubMed, Wanfang database and CNKI (China National Knowledge Infrastructure) was performed covering the period from January 1990 to July 2014. A meta-analysis was conducted after filtering by the criteria of Cochrane Collaboration. Three hundred fifty six subjects in nine studies allocated to the group of intratympanic steroid therapies and 343 controls receiving systemic steroid therapies met the criteria for meta-analysis. The data were extracted and analyzed using the RevMan 5.3 meta-analysis software. Results: The total effectiveness rate in SSNHL patients receiving intratympanic steroid therapies did not differ statistically from patients receiving systemic therapies (RR ? 1.08, 95%CI ? 0.99e1.99, P ? 0.10), although the rate of full hearing recovery in this group differed significantly from patients receiving systemic therapies (RR ? 1.29, 95%CI ? 1.00e1.66, P ? 0.05). Conclusion: Local steroid therapy appears to generate higher rate of complete hearing recovery than systemic steroid treatment as an initial treatment for SSNHL, which may be especially useful for patients in whom systemic steroids are contraindicated.展开更多
Objective: To assess the outcomes of intratympanic steroids in the management of idiopathic sudden sensorineural hearing loss. Study Design: Retrospective study. Setting: Academic tertiary care medical centre. Materia...Objective: To assess the outcomes of intratympanic steroids in the management of idiopathic sudden sensorineural hearing loss. Study Design: Retrospective study. Setting: Academic tertiary care medical centre. Materials and Methods: A total of 67 patients with idiopathic sudden sensorineural hearing loss were included in our study. Pre- and post-injection audiograms were taken to assess the outcomes in improvement in hearing. Hearing outcomes were assessed with respect to duration of onset of treatment and age of the patient. Improvement in the speech discrimination score was also assessed. Results: A total of 67 patients were included in our study of which unilateral cases were 59 and bilateral cases were 8. Subjectively 35 patients reported improvement in hearing after the therapy while objectively we found 44 ears [41 patients] had improvement. The mean PTA pre ITS was 62.7 and after ITS it was 56.3. Maximum improvement was noted at 2000 Hz and 1000 Hz. Conclusion: Intratympanic steroids can be offered as a first line therapy for idiopathic sudden sensorineural hearing loss as it is minimally invasive, and can be performed as an office based procedure with no systemic side effects. No major complications have been reported in our study and results have been satisfactory.展开更多
Objective: To assess the outcomes of hearing and vertigo in patients with Meniere’s disease who were treated with intratympanic methylprednisolone. Study Design: Retrospective study. Setting: Tertiary referral hospit...Objective: To assess the outcomes of hearing and vertigo in patients with Meniere’s disease who were treated with intratympanic methylprednisolone. Study Design: Retrospective study. Setting: Tertiary referral hospital. Methods: In our study with 151 patients [191 ears] were diagnosed as Menieres as per 1995 AAO-HNS guidelines. As an office based procedure these patients were treated with intratympanic methyl prednisolone. Results: There was a 98.6% improvement in the vertigo control rate, a 73.82% improvement in hearing and 29.31% had a definitive improvement in tinnitus. Conclusion: We conclude from our study that intratympanic steroid injection significantly controls vertigo, tinnitus and improves hearing in Meniere’s disease with minimal complications. Hence, it can be tried as a first line treatment for patients with Meniere’s disease.展开更多
Objective To evaluate the effect of different protocols of intratympanic dexamethasone injection in patients with unilateral sudden sensorineural hearing loss (SSNHL) who have failed to respond to typical medical trea...Objective To evaluate the effect of different protocols of intratympanic dexamethasone injection in patients with unilateral sudden sensorineural hearing loss (SSNHL) who have failed to respond to typical medical treatment (including systemic steroid treatment). Methods From January 2005 to January 2008, 71 patients who were diagnosed with unilateral SSNHL and failed typical medical treatment received intratympanic dexamethasone injection. Four injection protocols were employed: injection of 0.3 ml dexamethasone(5 mg / ml) three times a week for 3 weeks for a total dose of 13.5 mg (Group I, n=16); injection of 0.6 ml (5 mg / ml) dexamethasone three times a week for 3 weeks for a total dose of 27 mg (Group II, n=18); injection at 0.3 ml(5 mg/ml) week for 6 weeks for a total dose of 9 mg (Group III, n=18); injection at 0.3 ml (5 mg / ml) / 2 days for a total dose of 4.5 mg (Group IV n=19). Hearing recovery was assessed by pure tone audiogram. Results The total effective rate was 37.5%, 38.89%, 33.33% and 36.84% for each treatment protocol, respectively, with no statistical difference between them (P > 0.05). The results suggest that a total dose of 4.5 mg (injected once a week for 3 weeks) is the most adequate protocol, and increasing dose or injection frequency yields no additional benefits. Conclusion Intratympanic dexamethasone significantly improves the prognosis of SSNHL. Small dose at low injection frequency is sufficient. Further multicenter studies are needed to determine the standard treatment protocol.展开更多
Aims: The aim of this study was to test the effectiveness of intratympanic dexamethasone injections as a treatment for severe disabling tinnitus and also observe its effect on hearing loss if any. Materials and Method...Aims: The aim of this study was to test the effectiveness of intratympanic dexamethasone injections as a treatment for severe disabling tinnitus and also observe its effect on hearing loss if any. Materials and Methods: Thirty patients with severe disabling tinnitus in the age group 20 to 60 years were selected and randomly assigned to receive intratympanic injections of a dexamethasone solution 4 mg/ml (0.5 ml) or isotonic saline (0.5 ml) solution under topical anaesthesia, once per week for 4 weeks using a zero degree endoscope. Improvement in tinnitus was assessed using a visual analog scale, considering 2-point improvement as significant and alteration in hearing if any was noted by pure tone audiometery before and after the therapy. Results: The improvement in tinnitus was not significant, with no alteration in audiometery reports. Conclusions: Intratympanic therapy is an attractive mode of treatment because of its highly targeted delivery, low concentration of the drugs required and a very good patient tolerance. Although there has been no breakthrough in intratympanic therapy for tinnitus or other otological conditions, accessibility to the inner ear through the semipermeable round window membrane holds many promises in the near future.展开更多
BACKGROUND Sudden sensorineural hearing loss(SSNHL),characterized by a rapid and unexplained loss of hearing,particularly at moderate to high frequencies,presents a significant clinical challenge.The therapeutic use o...BACKGROUND Sudden sensorineural hearing loss(SSNHL),characterized by a rapid and unexplained loss of hearing,particularly at moderate to high frequencies,presents a significant clinical challenge.The therapeutic use of methylprednisolone sodium succinate(MPSS)via different administration routes,in combination with conventional medications,remains a topic of interest.AIM To compare the therapeutic efficacy of MPSS administered via different routes in combination with conventional drugs for the treatment of mid-to high-frequency SSNHL.METHODS The medical records of 109 patients with mid-to high-frequency SSNHL were analyzed.The patients were divided into three groups based on the route of administration:Group A[intratympanic(IT)injection of MPSS combined with mecobalamin and Ginkgo biloba leaf extract injection],Group B(intravenous injection of MPSS combined with mecobalamin and Ginkgo biloba leaf extract injection),and Group C(single IT injection of MPSS).The intervention effects were compared and analyzed.RESULTS The posttreatment auditory thresholds in Group A(21.23±3.34)were significantly lower than those in Groups B(28.52±3.36)and C(30.23±4.21;P<0.05).Group A also exhibited a significantly greater speech recognition rate(92.23±5.34)than Groups B and C.The disappearance time of tinnitus,time to hearing recovery,and disappearance time of vertigo in Group A were significantly shorter than those in Groups B and C(P<0.05).The total effective rate in Group A(97.56%)was significantly greater than that in Groups B and C(77.14%and 78.79%,χ^(2)=7.898,P=0.019).Moreover,the incidence of adverse reactions in Groups A and C was significantly lower than that in Group B(4.88%,3.03%vs 2.57%,χ^(2)=11.443,P=0.003),and the recurrence rate in Group A was significantly lower than that in Groups B and C(2.44%vs 20.00%vs 21.21%,χ^(2)=7.120,P=0.028).CONCLUSION IT injection of MPSS combined with conventional treatment demonstrates superior efficacy and safety compared to systemic administration via intravenous infusion and a single IT injection of MPSS.This approach effectively improves patients'hearing and reduces the risk of disease recurrence.展开更多
Objective: To observe and compare the efficacy of intratympanic application of dexamethasone (DXM) for the treatment of refractory sudden sensorineural hearing loss (SSNHL), the DXM was given in three different ways: ...Objective: To observe and compare the efficacy of intratympanic application of dexamethasone (DXM) for the treatment of refractory sudden sensorineural hearing loss (SSNHL), the DXM was given in three different ways: by tympanic membrane injection, by drip through a ventilation tube, and by perfusion through a round window catheter. Methods: We conducted a nonrandomized retrospective clinical trial involving 55 patients with refractory SSNHL. For 21 patients (the perfusion group), DXM (2.5 mg/0.5 ml) was perfused transtympanically through a round window catheter using an infusion pump for 1 h twice a day for 7 d giving a total amount of 35.0 mg. For 23 patients (the injection group), DXM (2.5 mg/time) was injected by tympanic membrane puncture at intervals of 2 d on a total of four occasions giving a total amount of 10.0 mg. For 11 patients (the drip group), DXM (2.5 mg/0.5 ml) was dripped via a ventilation tube placed by myringotomy, once on the first day and twice a day for the remaining 6 d giving a total amount of 32.5 mg. Thirty-two patients with refractory SSNHL who refused to undertake further treatments were defined as the control group. Hearing recovery and complications were compared among the groups. Hearing results were evaluated based on a four-frequency (0.5, 1.0, 2.0, 4.0 kHz) pure tone average (PTA). Results: Post-treatment audiograms were obtained one month after treatments were completed. The improvements in average PTA for the perfusion, injection, and drip groups were 9.0, 8.6, and 1.7 dB, respectively. Hearing improvement was significantly greater in the perfusion and injection groups than in the control group (1.4 dB) (P<0.05). In the perfusion group, 8 out of 21 patients (38.1%) had a PTA improvement of 15?56 dB (mean 29.8 dB); in the injection group, 8 out of 23 patients (34.8%) had a PTA improvement of 16?54 dB (mean 24.9 dB); in the drip group, 1 of 11 patients (9.1%) had a PTA improvement of 26.0 dB; in the control group, 3 out of 32 patients (9.4%) had a PTA improvement of 15?36 dB (mean 14.9 dB). Conclusions: Topical intratympanic application of DXM is a safe and effective method for the treatment of SSNHL cases that are refractory to conventional therapies.展开更多
Objective: The purpose of the study is to report and to analyze the complications following intratympanic injections (ITI) of steroids. The occurrence rate of complications at different ITI sites, four quadrants of ea...Objective: The purpose of the study is to report and to analyze the complications following intratympanic injections (ITI) of steroids. The occurrence rate of complications at different ITI sites, four quadrants of eardrum, was also compared. Methods: A retrospective clinical review in a medical center. Each patient received ITI twice in a week for 2e3 consecutive weeks as a salvage therapy for sudden sensorineural hearing loss. Post-injection complications, especially transient dizziness and vertigo, were recorded. Patients with acute or chronic vertigo episodes in 1 month were excluded. Results: A total of 59 patients with sudden sensorineural hearing loss and a total of 278 times of ITI were performed in 1 year. The post-injection complications included pain, tongue numbness, transient dizziness, vertigo, tinnitus, and a small persistent perforation. There was no significant difference in the occurrence of these complications between the injections sites on the 4 quadrants of the tympanic membrane. However, there was statistical significance in the post-injection vertiginous episode after IT injections to posterior-inferior quadrant (Q3) and posterior-superior quadrant (Q4) compared to anterior-superior quadrant (Q1) and anterior-inferior quadrant (Q2) (P Z 0.0113).展开更多
基金supported by the National Natural Science Foundation of China(81771006)。
文摘The aim of the present work was to show the sustainability of fibrin sealant in releasing dexamethasone and adjust the protocol for clinical application of the novel method in the treatment of Meniere’s disease (MD) and sudden sensorineural hearing loss (SSHL).Gelation occurred shortly after mixing dexamethasone-containing fibrinogen with thrombin.Dexamethasone was constantly released for at least 16 d at a stable level after 7d in protocol 1 (low-dose),while it was robustly released within 4 d and slowed afterward until 10 d in protocol 2(high-dose).There were significant differences among the time points in Protocol 2 (p<0.01,ANOVA),and the exponential model with the formula y=15.299*e~(-0.483*t) fits the association.The estimated concentration of dexamethasone released on 7 d in protocol 2 was slightly lower than that observed in protocol 1.The fibrin sealant is capable of constantly releasing dexamethasone with adjustable dynamics.Targeted and minimally invasive administration of the material can be achieved in the clinic by sequential injections of the fluids using a soft-tipped catheter.
文摘Background: Sudden sensorineural hearing loss(SSNHL) is a prevalent emergency in ear, nose, and throat practice. Previous studies have demonstrated that intratympanic steroid therapy(IST) can serve as a salvage treatment for SSNHL after the failure of systemic steroid therapy(SST).Objective: This study aimed to analyze the efficacy of modified IST involving the insertion of a tympanic tube and gelfoam as a salvage treatment for patients with SSNHL, and to explore its associated factors.Methods: Totally, 74 patients who were aged 22–81 years with SSNHL were enrolled and allocated to either the control group(n = 25) or the treatment group(n = 49) based on their treatment modalities. All patients received SST lasting for at least 7 days. Subsequently, patients in the treatment group, after SST failure, underwent IST twice a week for 2–6 weeks, while the control group did not. Efficacy was assessed by the improvement in pure tone average at the affected frequency at the beginning and end of IST.Results: Hearing improvement in all patients after IST in the treatment group was 9.71 ± 14.84 dB, with significant improvement at affected frequencies(250-8000 Hz) compared with the control group(P < 0.05). The findings indicated the duration from the onset of SSNHL to the beginning of IST as an independent factor for pure tone average improvement after treatment(P = 0.002), whereas age, duration of SST, and time of IST were not(P > 0.05).Conclusion: The modified IST was demonstrated to be a safe and effective method as a salvage treatment for SSNHL. This study explored the efficacy of a modified IST approach, incorporating the utilization of tympanic tubes and gelfoam as key components. The findings underscore the advantages of gelfoam as a strategic drug carrier placed in the round window niche. By minimizing drug loss, extending action time, and increasing perilymph concentration, gelfoam enhances the therapeutic impact of IST, contributing to improved hearing outcomes in patients with SSNHL.
基金supported by the national key R&D program(2022YFC2402703).
文摘Safe and efficient drug delivery to the inner ear has always been the focus of prevention and treatment of sensorineural deafness.The rapid development of nanodrug delivery systems based on hydrogel has provided a new opportunity.Among them,thermo-sensitive hydrogels promote the development of new dosage form for intratympanic injection.This smart biomaterial could transform to semisolid phase when the temperature increased.Thermo-sensitive hydrogel nanodrug delivery system is expected to achieve safe,efficient,and sustained inner ear drug administration.This article introduces the key techniques and the latest progress in this field.
文摘Objectives:To evaluate hearing outcome of salvage treatment with intratympanic steroids(ITS)in idiopathic sudden sensorineural hearing loss(ISSNHL)refractory to initial systemic steroid(SS)therapy.Material and methods:A retrospective medical chart review was conducted on 54 consecutive patients with ISSNHL refractory to SS.Salvage treatment with a low dose intratympanic dexamethasone(4 mg/ml)was offered after one week of primary treatment.Patients were divided into two groups:25 patients accepted ITS(treatment group)and 29 patients did not undergo additional treatment(control group).A pure tone average(PTA)gain of at least 10 dB was considered hearing improvement.Results:Hearing improvement rate was higher in ITS group compared to control group(40%vs.13.8%,p=0.035).A mean PTA improvement of 8.6±9.8 dB was observed in the ITS group and,whereas the control group had an average hearing gain of 0.7±2 dB(p<0.001).Audiometric analysis revealed a significant hearing gain in ITS group at all tested frequencies compared to control group(p<0.05).Analysis of the selected variables,identified intratympanic steroid treatment as the only independent prognostic factor for hearing improvement(OR=4.2,95%CI:1.1e15.7;p=0.04).Conclusion:Intratympanic low dose dexamethasone is effective in patients with incomplete hearing recovery after primary systemic steroid treatment.
基金Supported by the Health and Family Planning Commission of Shenzhen Municipality,No.SZXJ2017065.
文摘BACKGROUND As sudden sensorineural hearing loss(SSNHL)rarely occurs in pregnant women,there is a lack of knowledge and relevant research on its management.AIM To investigate the effect of intratympanic dexamethasone injection in the treatment of pregnant patients with SSNHL.METHODS A retrospective chart review was made for the period between June 2017 and August 2019 at our Department of Otorhinolaryngology-Head and Neck Surgery.Pregnant women who met the criteria for SSNHL were included and grouped based on the therapeutic modalities.The treatment group received intratympanic dexamethasone(2.5 mg)q.o.d.for a total of four times,while the control group received no medication other than bed rest and medical observations.All the patients were under close care of obstetricians.Pure-tone audiograms were performed before and after treatment.RESULTS Eleven patients who met the inclusion criteria were assigned to the treatment group(n=7)and the control group(n=4).The mean age of patients was 31.2±3.8 years;the right ear was affected in seven(63.64%)cases.Two patients(18.2%)suffered from vertigo,10(90.9%)suffered from tinnitus and 6(54.5%)suffered from aural fullness.The time from onset to clinic visit was relatively short,with a mean time of 1.3±0.9 d.All the women were within the second or third trimester;the average gestation period was 26.0±6.2 wk.The pure-tone averages at onset between the two groups were similar.After one wk of therapy,the treatment group had a curative rate of 57.1%and a significantly better hearing threshold and greater improvement compared to the control group(all P<0.05).Some patients experienced transient discomfort from intratympanic injections that disappeared after getting rest,while none had permanent complications.All patients delivered healthy full-term neonates with an average Apgar score of 9.7±0.5.CONCLUSION Intratympanic dexamethasone injections can be used as a first-line therapy in pregnant women with SSNHL.
基金supported by the National Institute for Health Research(NIHR)Imperial Biomedical Research Centre
文摘This article reviews the effectiveness of intratympanic corticosteroids for vertigo control in Meniere's disease at 2-years follow-up according to the guidelines expressed by the American Academy of Otolaryngology-Head & Neck Surgery. Despite the increased use of intratympanic corticosteroids for vertigo control in Meniere's disease there is debate as to their effectiveness, particularly compared to gentamicin. Even so,after just a single course of injections, corticosteroids can reliably provide complete vertigo control(Class A) at 2-years in about 50% of cases as indicated in a recent double-blind randomized controlled clinical trial(Patel et al., 2016). But the effectiveness of intratympanic corticosteroids truly increases when treatment is provided 'as-needed', whereby complete vertigo control is established in up to 91% of cases. On the basis of available literature, there is good evidence to recommend the use of intratympanic steroid treatment for vertigo control in Meniere's disease, but patients must be monitored for non-response. The rationale for treating patients as-needed and the possible reasons for corticosteroid nonresponse are discussed.
文摘Background Sudden sensorineural hearing loss(SSNHL)is a common disease in otology,and steroids play an important role in its treatment.Steroids can be administered systemically or locally,and the efficacies of different administration routes remain controversial.Methods We searched the Cochrane,EMBASE,PubMed,Web of Science,CNKI,Wanfang and Weipu databases for randomized controlled trials(RCTs)on glucocorticoid treatments for SSNHL to compare the efficacy of topical and systemic steroid administration.The Review Manager 5.4 software was used for synthesis of data:the rate of reported hearing improvement and change in pure-tone audiometry(PTA).Results In all the included studies,when intratympanic administration was compared to systemic therapies,the risk difference(RD)using reported hearing improvement as an outcome measure was 0.08(95%CI:0.01–0.14,I2=45%).Using PTA changes as an outcome measure in 4 studies,the mean difference(MD)was 10.43 dB(95%CI:3.68–17.18,I2=81%).Hearing improvement RD was also compared among different types of steroid,recovery criteria,follow-up times and diagnostic criteria,and showed no significant differences exception for recovery criteria(>10 dB)(RD-0.06,95%CI:0.14-0.2,I2=0%).Conclusion As the initial treatment for SSNHL,topical steroids seem to be superior to systemic steroid administration,especially in patients with contraindications to systemic steroids usage.However,further verification based on high-quality research is needed.
文摘Objective:To evaluate the efficacy and safety of intratympanic and systemic steroid therapies in the initial treatment of Sudden Sensorineural Hearing Loss (SSNHL) patients. Methods:A comprehensive search of PubMed, Wanfang database and CNKI (China National Knowledge Infrastructure) was performed covering the period from January 1990 to July 2014. A meta-analysis was conducted after filtering by the criteria of Cochrane Collaboration. Three hundred fifty six subjects in nine studies allocated to the group of intratympanic steroid therapies and 343 controls receiving systemic steroid therapies met the criteria for meta-analysis. The data were extracted and analyzed using the RevMan 5.3 meta-analysis software. Results: The total effectiveness rate in SSNHL patients receiving intratympanic steroid therapies did not differ statistically from patients receiving systemic therapies (RR ? 1.08, 95%CI ? 0.99e1.99, P ? 0.10), although the rate of full hearing recovery in this group differed significantly from patients receiving systemic therapies (RR ? 1.29, 95%CI ? 1.00e1.66, P ? 0.05). Conclusion: Local steroid therapy appears to generate higher rate of complete hearing recovery than systemic steroid treatment as an initial treatment for SSNHL, which may be especially useful for patients in whom systemic steroids are contraindicated.
文摘Objective: To assess the outcomes of intratympanic steroids in the management of idiopathic sudden sensorineural hearing loss. Study Design: Retrospective study. Setting: Academic tertiary care medical centre. Materials and Methods: A total of 67 patients with idiopathic sudden sensorineural hearing loss were included in our study. Pre- and post-injection audiograms were taken to assess the outcomes in improvement in hearing. Hearing outcomes were assessed with respect to duration of onset of treatment and age of the patient. Improvement in the speech discrimination score was also assessed. Results: A total of 67 patients were included in our study of which unilateral cases were 59 and bilateral cases were 8. Subjectively 35 patients reported improvement in hearing after the therapy while objectively we found 44 ears [41 patients] had improvement. The mean PTA pre ITS was 62.7 and after ITS it was 56.3. Maximum improvement was noted at 2000 Hz and 1000 Hz. Conclusion: Intratympanic steroids can be offered as a first line therapy for idiopathic sudden sensorineural hearing loss as it is minimally invasive, and can be performed as an office based procedure with no systemic side effects. No major complications have been reported in our study and results have been satisfactory.
文摘Objective: To assess the outcomes of hearing and vertigo in patients with Meniere’s disease who were treated with intratympanic methylprednisolone. Study Design: Retrospective study. Setting: Tertiary referral hospital. Methods: In our study with 151 patients [191 ears] were diagnosed as Menieres as per 1995 AAO-HNS guidelines. As an office based procedure these patients were treated with intratympanic methyl prednisolone. Results: There was a 98.6% improvement in the vertigo control rate, a 73.82% improvement in hearing and 29.31% had a definitive improvement in tinnitus. Conclusion: We conclude from our study that intratympanic steroid injection significantly controls vertigo, tinnitus and improves hearing in Meniere’s disease with minimal complications. Hence, it can be tried as a first line treatment for patients with Meniere’s disease.
文摘Objective To evaluate the effect of different protocols of intratympanic dexamethasone injection in patients with unilateral sudden sensorineural hearing loss (SSNHL) who have failed to respond to typical medical treatment (including systemic steroid treatment). Methods From January 2005 to January 2008, 71 patients who were diagnosed with unilateral SSNHL and failed typical medical treatment received intratympanic dexamethasone injection. Four injection protocols were employed: injection of 0.3 ml dexamethasone(5 mg / ml) three times a week for 3 weeks for a total dose of 13.5 mg (Group I, n=16); injection of 0.6 ml (5 mg / ml) dexamethasone three times a week for 3 weeks for a total dose of 27 mg (Group II, n=18); injection at 0.3 ml(5 mg/ml) week for 6 weeks for a total dose of 9 mg (Group III, n=18); injection at 0.3 ml (5 mg / ml) / 2 days for a total dose of 4.5 mg (Group IV n=19). Hearing recovery was assessed by pure tone audiogram. Results The total effective rate was 37.5%, 38.89%, 33.33% and 36.84% for each treatment protocol, respectively, with no statistical difference between them (P > 0.05). The results suggest that a total dose of 4.5 mg (injected once a week for 3 weeks) is the most adequate protocol, and increasing dose or injection frequency yields no additional benefits. Conclusion Intratympanic dexamethasone significantly improves the prognosis of SSNHL. Small dose at low injection frequency is sufficient. Further multicenter studies are needed to determine the standard treatment protocol.
文摘Aims: The aim of this study was to test the effectiveness of intratympanic dexamethasone injections as a treatment for severe disabling tinnitus and also observe its effect on hearing loss if any. Materials and Methods: Thirty patients with severe disabling tinnitus in the age group 20 to 60 years were selected and randomly assigned to receive intratympanic injections of a dexamethasone solution 4 mg/ml (0.5 ml) or isotonic saline (0.5 ml) solution under topical anaesthesia, once per week for 4 weeks using a zero degree endoscope. Improvement in tinnitus was assessed using a visual analog scale, considering 2-point improvement as significant and alteration in hearing if any was noted by pure tone audiometery before and after the therapy. Results: The improvement in tinnitus was not significant, with no alteration in audiometery reports. Conclusions: Intratympanic therapy is an attractive mode of treatment because of its highly targeted delivery, low concentration of the drugs required and a very good patient tolerance. Although there has been no breakthrough in intratympanic therapy for tinnitus or other otological conditions, accessibility to the inner ear through the semipermeable round window membrane holds many promises in the near future.
文摘BACKGROUND Sudden sensorineural hearing loss(SSNHL),characterized by a rapid and unexplained loss of hearing,particularly at moderate to high frequencies,presents a significant clinical challenge.The therapeutic use of methylprednisolone sodium succinate(MPSS)via different administration routes,in combination with conventional medications,remains a topic of interest.AIM To compare the therapeutic efficacy of MPSS administered via different routes in combination with conventional drugs for the treatment of mid-to high-frequency SSNHL.METHODS The medical records of 109 patients with mid-to high-frequency SSNHL were analyzed.The patients were divided into three groups based on the route of administration:Group A[intratympanic(IT)injection of MPSS combined with mecobalamin and Ginkgo biloba leaf extract injection],Group B(intravenous injection of MPSS combined with mecobalamin and Ginkgo biloba leaf extract injection),and Group C(single IT injection of MPSS).The intervention effects were compared and analyzed.RESULTS The posttreatment auditory thresholds in Group A(21.23±3.34)were significantly lower than those in Groups B(28.52±3.36)and C(30.23±4.21;P<0.05).Group A also exhibited a significantly greater speech recognition rate(92.23±5.34)than Groups B and C.The disappearance time of tinnitus,time to hearing recovery,and disappearance time of vertigo in Group A were significantly shorter than those in Groups B and C(P<0.05).The total effective rate in Group A(97.56%)was significantly greater than that in Groups B and C(77.14%and 78.79%,χ^(2)=7.898,P=0.019).Moreover,the incidence of adverse reactions in Groups A and C was significantly lower than that in Group B(4.88%,3.03%vs 2.57%,χ^(2)=11.443,P=0.003),and the recurrence rate in Group A was significantly lower than that in Groups B and C(2.44%vs 20.00%vs 21.21%,χ^(2)=7.120,P=0.028).CONCLUSION IT injection of MPSS combined with conventional treatment demonstrates superior efficacy and safety compared to systemic administration via intravenous infusion and a single IT injection of MPSS.This approach effectively improves patients'hearing and reduces the risk of disease recurrence.
文摘Objective: To observe and compare the efficacy of intratympanic application of dexamethasone (DXM) for the treatment of refractory sudden sensorineural hearing loss (SSNHL), the DXM was given in three different ways: by tympanic membrane injection, by drip through a ventilation tube, and by perfusion through a round window catheter. Methods: We conducted a nonrandomized retrospective clinical trial involving 55 patients with refractory SSNHL. For 21 patients (the perfusion group), DXM (2.5 mg/0.5 ml) was perfused transtympanically through a round window catheter using an infusion pump for 1 h twice a day for 7 d giving a total amount of 35.0 mg. For 23 patients (the injection group), DXM (2.5 mg/time) was injected by tympanic membrane puncture at intervals of 2 d on a total of four occasions giving a total amount of 10.0 mg. For 11 patients (the drip group), DXM (2.5 mg/0.5 ml) was dripped via a ventilation tube placed by myringotomy, once on the first day and twice a day for the remaining 6 d giving a total amount of 32.5 mg. Thirty-two patients with refractory SSNHL who refused to undertake further treatments were defined as the control group. Hearing recovery and complications were compared among the groups. Hearing results were evaluated based on a four-frequency (0.5, 1.0, 2.0, 4.0 kHz) pure tone average (PTA). Results: Post-treatment audiograms were obtained one month after treatments were completed. The improvements in average PTA for the perfusion, injection, and drip groups were 9.0, 8.6, and 1.7 dB, respectively. Hearing improvement was significantly greater in the perfusion and injection groups than in the control group (1.4 dB) (P<0.05). In the perfusion group, 8 out of 21 patients (38.1%) had a PTA improvement of 15?56 dB (mean 29.8 dB); in the injection group, 8 out of 23 patients (34.8%) had a PTA improvement of 16?54 dB (mean 24.9 dB); in the drip group, 1 of 11 patients (9.1%) had a PTA improvement of 26.0 dB; in the control group, 3 out of 32 patients (9.4%) had a PTA improvement of 15?36 dB (mean 14.9 dB). Conclusions: Topical intratympanic application of DXM is a safe and effective method for the treatment of SSNHL cases that are refractory to conventional therapies.
文摘Objective: The purpose of the study is to report and to analyze the complications following intratympanic injections (ITI) of steroids. The occurrence rate of complications at different ITI sites, four quadrants of eardrum, was also compared. Methods: A retrospective clinical review in a medical center. Each patient received ITI twice in a week for 2e3 consecutive weeks as a salvage therapy for sudden sensorineural hearing loss. Post-injection complications, especially transient dizziness and vertigo, were recorded. Patients with acute or chronic vertigo episodes in 1 month were excluded. Results: A total of 59 patients with sudden sensorineural hearing loss and a total of 278 times of ITI were performed in 1 year. The post-injection complications included pain, tongue numbness, transient dizziness, vertigo, tinnitus, and a small persistent perforation. There was no significant difference in the occurrence of these complications between the injections sites on the 4 quadrants of the tympanic membrane. However, there was statistical significance in the post-injection vertiginous episode after IT injections to posterior-inferior quadrant (Q3) and posterior-superior quadrant (Q4) compared to anterior-superior quadrant (Q1) and anterior-inferior quadrant (Q2) (P Z 0.0113).
