Clinical Research Of Comprehensive Hyperbaric Oxygen Therapy In Refractory Idiopathic Sudden Hearing Loss

BackgroundAlso named sudden hearing loss (SHL) in domestic country and just as the same as idiopathic sudden sensorineural hearing loss (ISSNHL) in America, the incidence rate of idiopathic sudden hearing loss (ISHL) is rising year by year and the average ages of the patients are more and more young. With moderate to severe, long duration, Poor effect and Limited treatments in special disease, refractory ISHL is the ISSHL after failure of the initial treatment in patients.The diagnosis and treatment of ISHL is controversial on its unclearly pathogenesis, different aim emphasis in treatment options, diversity views between Chinese and American Guideline and urgent improved hyperbaric oxygen(HBO) therapy programme.As a special type of ISHL, lacking scientific and systematical definition and the epidemiological characteristics changed, refractory ISHL becomes a systemic disease which shows a main symptom on ear and affects the life quality severely.An ever increasing number of ISHL patients saw a doctor in PLA hyperbaric oxygen therapy center in Navy general hospital for the past few years. Just as Pioor effect, missing the best treatment time-window, moderate to severe hearing loss, even combined with special disease, they were mostly refractory ISHL. It observed that there were obviously psychological problems and badly surroundings, diversity treatments resulting in diffenent curative effects for the refractory ISHL patients. So the research was designed.ObjectiveRandomized partly doubled-blind controlled clinical trials were designed to explore:(1) new clinical characteristics of refractory ISHL;(2) the correlation between stress disorder and refractory ISHL, one-way pathogenesis hypothesis and quantifiable evaluation index;(3) the therapeutic effect of HBO therapy combined with glucocorticoid to refractory ISHL;(4) the clinical efficiency of different oxygen way with Drugs in treating refractory ISHL;(5) individualized treatment options to refractory ISHL combined with special diseases for providing some advices.Subjects and Methods1. Subjects53Cases refractory ISHL inpatients from2012.02～2013.12,67Cases refractory ISHL inpatients from2012.01～2014.02,79Cases refractory ISHL outpatients and inpatients from2012.01～2014.02,101Cases refractory ISHL outpatients and inpatients from2011.02～2014.01,6cases refractory ISHL combined with special diseases and1children refractory ISHL from2012.02～2014.01were selected in PLA hyperbaric oxygen therapy center in Navy general hospital.2. Admission Criterias:①Compliance with SHL diagnostic criteria developed by Chinese Medical Association of Otolaryngology Head and Neck Surgery Branch;②Hearing loss only for one ear, treatment options exclude intravenous corticosteroid and just for a short time;③Compliance with refractory ISHL criteria and the duration more than14d;④Skull or temporal bone (internal auditory canal) imaging showed no abnormalities;⑤ excluding absolute contraindications of Systemic glucocorticoid therapy, hyperbaric and hypobaric oxygen therapy;⑥excluding the patients combined with arrhythmia, hyperthyroidism or hypothyroidism, type2diabetes and anemia.3. Methods3.1Related Clinic Factors Analysis of Refractory ISHL in53Cases.The self-Scale, Pittsburgh sleep quality index (PSQI) and Symptom Checklist90(SCL-90) were performanced in48hours after admission. The scores of SCL-90were Comparative analysised with the results of China Normal norm (N=1388). Pure tone audiometry and tympanic acoustic impedance were carried out in Navy General Hospital ENT noise shielded room before treatment starting. Related datas were collected for epidemiological Analysis.3.2Explore the pathogenesis of Refractory ISHL.Stress (pressure) response questionnaire (SRQ), PTA, heart rate variability (HRV) and thyroid function (T3, T4, TSH) were performanced before treatment starting. PTA was reviewed at the14th day after treatment carried out."Invalid group"and "effective group" were divided out following the efficacy after treatment for14days. A retrospective analysis of examination and laboratory indicators datas at the point of admission were performanced in two groups.3.3Clinic research of hyperbaric oxygen (HBO) combined with glucocorticoid (GC) to Refractory ISHL.Combined with the preferences of patients and the principle of random trials, all Refractory ISHL patients in PLA hyperbaric oxygen therapy center were divided into single-HBO group (35cases) and HBO-GC group (44cases). Similar patients treated with GC were collected from the otorhinolary department as the GC group (32cases).Pure tone audiometry was carried out before and after treatment. Hearing improvement rate=(pre-treatment hearing-hearing after treatment)/(pre-treatment of hearing-hearing on the unaffected ear) x100%. The treatment effects were comparaed.3.4Different Oxygen Way with Drugs for Treatment of Refractory ISHL.101patients were randomly allocated to group A (37cases), B (37cases) and C (27cases). All the three groups were received dexamethasone sodium phosphate, extract of ginkgo biloba leaves injection and pure oxygen inhalation for14days. The atmosphere absolute of pure oxygen inhalation were0.20MPa,0.16MPa and0.1OMPa. In group A, B and C. During the treatment,9casas from group A and B had a more ear stuffiness and "C curve" in aural acoustic impedance were changed to receive the hypobaric oxygen at0.07MPa, allocated as group D. The rest patients in group A and B were allocated as group Al (34cases) and group B1(31cases). Pure tone audiometry and aural acoustic impedance were performed in all groups pre and post14days treatment. The treatment effects were comparaed.3.5Clinical Research of comprehensive Hyperbaric Oxygen Therapy in Refractory ISHL combined special diseases.Clinical datas as well as nursing experience of7cases (4cases combined with chronic renal failure,2cases with leukemia and1child) were assembled and related literatures were reviewed.4. Therapy MethodsAll patients were given dexamethasone sodium phosphate injection (10mg, feed into Murphy’s tube,1/d, continuous5-7d;5mg, feed into Murphy’s tube,1/d, continuous5-7d); ginkgo biloba extract injection (20ml, iv,1/d, continuous10-14d), Tianma injection (0.6g, iv,1/d, continuous10-14d), mecobalamin oral tablets (500ug, po,3/day), intravenous infusion simultaneously HBO therapy (1/d, a total of10-20times) or atmospheric oxygen therapy. According to the condition, sleeping pills, anti-anxiety drugs, anti-depression drugs and psychotherapy were provided. 5. Statistical analysis.SPSS13.0software was used for statistical processing, and accumulating data is defined as average value plus or minus standard deviation (x±s). T-tests were used for the comparison among groups, chi-square test for the cure rate and efficiency in all three kinds of therapy, Rank sum test for comparison of efficiency, analysis of variance for comparison of PTA value, taking P<0.05as a significant difference.Results1. Related factors Analysis of Refractory ISHL in53Cases.Refractory ISHL is inclined to occur in summer. All of the refractory ISHL inpatients,64.2%were female, as well as84.9%With a degree of bachelor, junior college and master,75.5%white collars,47.2%with blood type A,30.2%with blood type O, and35.8%were recurrent sudden hearing loss. Its Common predisposing factors were ahypnosis, tired, losing one’s temper, staying up late, drinking and noising. Hyperlipemia with41.5%was the greatest proportion in all complicating basic diseases. The incidence of ahypnosis was60.4%and the total score was8.5±2.6points in PSQI. Compared with the national norm, refractory ISHL inpatients got increased scores in factors of somatization, compulsion, depression, anxiety, hostility, horror and psychosis, and the differences was significant (P<0.05).2. Explore the pathogenesis of Refractory ISHL.The total efficiency was79.1%. SRQ scores between the two groups were significantly different in statistics (P<0.05), and both of two group scores were higher than the norm group. The values of HF, LF, and LF/HF in valid group were higher than that in invalid group; the differences were statistically significants (P<0.05). The values of LF, LF/HF in invalid group were below the normal range, while tht average of LF value in effective group were significantly higher than the upper limit of the normal range. The concentrations of T3, TSH in two groups both had significant difference (P<0.05). T3concentrations in effective group was higher than that in ineffective group, however for TSH, it was lower in effective group.3. Clinic research of HBO combined with glucocorticoid (GC) to Refractory ISHL.During the treatment duration,1case was unable to tolerate glucocorticoid therapy because of blood pressure and glucose concentration worsens, as well as4cases was HBO therapy for their middle ear disorders.17cases (16%) were cured and44cases (41.5%) were effective.Compared with simple HBO and simple GC group, the effective rate (59.52%) and hearing improvement rate (61.3±4.7%) in HBO combined with GC group were significantly higher (P<0.05). There were no diffenences during three groups (P>0.05).4. Different Oxygen Way with Drugs for Treatment of Refractory ISHL.In group A1, B1, C and D, the total efficiency were82.4%,83.9%,59.3%and77.8%and the increasing pure tone average (PTA) were increased by (43.7±17.4) dB,(46.3±21.2)dB,(28.1±12.3)dB and (41.9±19.8)dB. For the total effective rates, there was a significant difference (X2=6.218, P<0.05) during the group A1, B1and C and no significant difference (X2=0.876, P>0.05) during the group A1, B1and D. Compared with the PTA in group C, it was improved greatly in group Al and B1, while the ear stuffiness relieved more obviously in group D.5. Clinical Research of comprehensive Hyperbaric Oxygen Therapy in Refractory ISHL combined special diseases.They are mostly the whole frequency sensorineural hearing loss in patients of refractory ISHL combined with chronic renal failure. One of the main treatment options was glucocorticoid, especially the intratympanic approach. Chinese medicine, vitamin, HBO therapy are also important. A great emotion and sleep is the key of relieving stress, improving effect and accepting therapy. Although hemodialysis has not been proved effective, it can ensure the safety and tolerance to renal function during drug therapy. They are may play a role in promoting the recovery of hearing loss as for anemia on erythropoietin, folic acid and iron.It has a poor effect on Refractory ISHL with leukemia. Not enough treatment duration and no effective antiviral therapy are perhaps partly of the reasons for poor response. It is easily to cause the glucocorticoid receptor affinity or glucocorticoid resistance and reduce the anti-inflammatory potency for patients combined with leukemia when long-term using of immunosuppressants or glucocorticoids. Therefore, the conventional dose and duration of corticosteroids may be poor effect in anti-inflammatory therapy. Repeated changes of anemia and hypoxia, granulocyte or coagulation function can often cause internal ear stress stimulation, which leaded ear cells persistent edema and inflammatory damage. Limited by the effect of granulocyte level, severe anemia, the infectious fever and so on, HBO therapy is difficult for full duration. With plenty of drugs, a great many of complications and easily anxiety, it is a difficult treatment and poor compliance for the patients of refractory ISHL combined wit leukemia.Refractory ISHL in Children are almostly found late with seriously hearing impairment. Virus infection may be the main cause, while a Multi-frequency stead-state response (MFSSR) is one of the important audiological examinations.Short-acting glucocorticoids can be used as an option with a more long-term teatment even if the duration more than2months. Low pressure HBO therapy can discontinuous carry out for10～20times. Before using a high-power acousticon or surgical intervention, any internal medicine treatments for hearing recovery should be applied to improve or restore hearing function in refractory ISHL children, especially glucocorticoids and HBO therapy. During the nursing process, health education should be strengthed according to the characteristics of children refractory ISHL and psychological nursing may focus on between children and parents. Irritation and noise stimuli should be avoided during treatment. Based on positive Guide and material incentives, parents should communicate with children more.Conclusion1. Refractory ISHL commonly occurs in summer, menopause females, higher education groups, white collars, people with blood type A and O and recurrent sudden hearing loss patients. Stress disorder may be one of the pathogenesis. Prevention should be paid great attention to avoid ahypnosis and psychological state suffering from a vicious circle.2. Stress disorder may be predisposing factors of refractory ISHL, which even lead to a secondary injury as another aggravating factor. HRV results can be used as one of sensitivity and predictive indicators for glucocorticoid therapy efficacy in refractory ISHL. T3and TSH concentration changes may be related to the degree of stress in refractory ISHL.3. The therapeutic effect of hyperbaric oxygen combined with glucocorticoid for sudden deafness stubborn effect is better than no-combination therapy. The adverse reaction of hormone should be monitored in the process of combined treatment.4. It is proved that hyperbaric oxygen combined with dexamethasone sodium phosphate and extract of ginkgo biloba leaves injection is a efficacy protocol for SHL. HBO at0.16MPa atmosphere absolute is not only efficent but also economical. Pure oxygen inhalation under0.07MPa atmosphere absolute is suitable for the patients with ear stuffiness.5. As combined with diffenent diseases, individualized treatment options should be obey to avoid aggravating the underlying disease and reduce complications in refractory ISHL patients, as well as in the pursuit of maximum effect.