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Sudden deafness is a common emergency in otorhinolaryngology. As the etiology and mechanism of sudden deafness remains unknown, there is no specific treatment. Therefore, to explore new treatments for sudden deafness is a urgent and challenging problem. Extracellular vesicles therapy has been proved to be effective for several diseases. From our previous study, extracellular vesicles from mesenchymal stem cell can effectively improve noise-induced sensorineural deafness in mice. While mesenchymal stem cell therapy faces immune rejection in clinical use, the investigators use autologous blood monocyte vesicles to avoid immune rejection and guarantee patients' safety. In this interventional study, the investigators aimed to study the clinical effects and adverse reactions of autologous blood monocyte vesicle therapy in the treatment of sudden deafness. A total of 30 patients with severe or worse sudden deafness will enroll in this study and randomly assigned to 3 group, which are control group (Intratympanic glucocorticoid injection), lower-dose apoVs group (lower dose of Intratympanic monocyte vesicles injection) and higher-dose apoVs group (higher dose of Intratympanic monocyte vesicles injection). This study will further promote new treatment for sudden deafness and improve the quality of life and prognosis of patients with sudden deafness, especially those with severe or extremely severe deafness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Active Comparator | Intratympanic injection of methylprednisolone (methylprednisolone succinic acid for injection) at a dose of 40mg/mL, three times a week. 40mg of methylprednisolone was dissolved in 0.2 ml of lidocaine injection and 0.8 ml of sterilized injection water. |
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| apoVs(lower dose) | Experimental | Intratympanic injection of autologous blood monocyte vesicles, three times a week. Autologous blood monocyte vesicles were extracted from 20 ml peripheral blood from patients and dissolved in 0.2 ml of lidocaine injection and 0.8 ml of sterilized injection water. |
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| apoVs(higher dose) | Experimental | Intratympanic injection of autologous blood monocyte vesicles, three times a week. Autologous blood monocyte vesicles were extracted from 50 ml peripheral blood from patients and dissolved in 0.2 ml of lidocaine injection and 0.8 ml of sterilized injection water. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous blood monocyte vesicles (lower dose) | Biological | 20 ml peripheral venous blood was extracted from each patient, anticoagulated with heparin and diluted with PBS. Peripheral blood mononuclear cells were isolated by Ficoll stratified solution. Extracellular vesicles of mononuclear cells were extracted by gradient centrifugation (800g centrifugation at 4 ℃ for 10 minutes, then 2000g centrifugation at centrifuged at 4 ℃ for 10 minutes and then 16000g centrifugation at 4 ℃ for 30 minutes. The precipitate was taken as monocyte vesicle and stored in refrigerator at 4 ℃. For intratympanic injection, precipitate was dissolved in 0.2 ml of lidocaine and 0.8 ml of sterilized injection water. Intratympanic injection of apoVs was performed three times a week. |
| Measure | Description | Time Frame |
|---|---|---|
| Audiometry | Pure tone audiometry. | 4 weeks after intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Audiometry | Pure tone audiometry | 1 week, 2 weeks after intervention |
| THI scale | THI (tinnitus handicap inventory) is one of the most widely used tinnitus self-rating scales in the world.It consists of three dimensions: functional, emotional and severity and effect of decreased tinnitus on patients' daily life. The THI score is totally 100 points. The more score participants get, the severer tinnitus symtoms they suffer from. According to the total score, paticipants were divided into five grades, Grade I (0-16, light) , Grade II (18-36, mild) , Grade III (38-56, moderate) , grade IV (58-76, severe) , grade V (78-100, catastrophic). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Haidi, Doctor | Contact | 13178821663 | yanghd@mail.sysu.edu.cn | |
| Huang Xiaotong | Contact | huangxt26@mail2.sysu.edu.cn |
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| Methylprednisolone | Drug | 40mg of methylprednisolone was dissolved in 0.2 ml of lidocaine injection and 0.8 ml of sterilized injection water. Intratympanic injection of methylprednisolone was performed three times a week. |
|
| autologous blood monocyte vesicles (higher dose) | Biological | 50 ml peripheral venous blood was extracted from each patient, anticoagulated with heparin and diluted with PBS. Peripheral blood mononuclear cells were isolated by Ficoll stratified solution. Extracellular vesicles of mononuclear cells were extracted by gradient centrifugation (800g centrifugation at 4 ℃ for 10 minutes, then 2000g centrifugation at centrifuged at 4 ℃ for 10 minutes and then 16000g centrifugation at 4 ℃ for 30 minutes. The precipitate was taken as monocyte vesicle and stored in refrigerator at 4 ℃. For intratympanic injection, precipitate was dissolved in 0.2 ml of lidocaine and 0.8 ml of sterilized injection water. Intratympanic injection of apoVs was performed three times a week. |
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| 1 week, 2 weeks, 4 weeks after intervention. |
| Tinnitus VAS | The VAS(visual analogue scale) for subjective severity of tinnitus focuses on the subjective assessment of general sensation. The VAS has a scale score of 0 to 10, with 0 being completely unaffected and 10 being very severely affected. | 1 week, 2 weeks, 4 weeks after intervention. |
| SAS | The SAS(Self-Rating Anxiety Scale) consists of 20 items which reflect the subjective and feeling of Anxiety. The more score paticipants get, the more anxiety they suffer. The SAS score can be divided into 4 levels: normal(less than 50 score), mild anxiety(50-59 score), moderate anxiety(60-69 score) and severe anxiety(more than 69 score). | 1 week, 2 weeks, 4 weeks after intervention. |
| Adverse Events | Local adverse events include hearing loss, otitis media, and unperforation of tympanic membrane. Systemic adverse events include vital signs instability, new-onset anemia, liver and kidney dysfunction and so on. The severity of adverse events was graded according to the Common Adverse Event Evaluation Criteria (CTCAE) 5.0, Grade 1: mild; asymptomatic or mild; clinical or diagnostic only; treatment free. Grade 2: Moderate; requiring small, local, or non-invasive treatment; limited instrumental daily living activities comparable to age. Grade 3: serious or medically significant but not immediately life threatening; hospitalization or prolonged hospitalization; disability; limited activities of daily life. Grade 4: life-threatening; requiring urgent treatment. Grade 5: Death related to AEs. | 1 week, 2 weeks, 4 weeks after intervention. |
| ID | Term |
|---|---|
| D003639 | Hearing Loss, Sudden |
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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