Assessing the auditory effects of oral chelation therapy drug Deferasirox in individuals with β‐thalassemia major

B. S. Tiwana, Ankita Aggarwal, Sanjeev Bhagat, Harjinder Singh, D. Sahni, Vishav Yadav
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Abstract

Our study aimed to investigate the ototoxicity associated with the iron chelator deferasirox in patients with β‐thalassemia major, who were receiving regular transfusion therapy, along with evaluating the data on audiological tests using appropriate statistical tests.A cross‐sectional observational study was conducted on 100 transfusion‐dependent β‐thalassemia major patients on oral iron chelating agent‐deferasirox. Pure tone audiometry (PTA) and distortion product otoacoustic emissions (DPOAE) was carried out in all patients to assess the auditory side effects of the drug. Data was collected, compiled, and analyzed statistically using appropriate statistical tests. The relationship between ototoxicity and various demographic parameters such as age, sex, hemoglobin (Hb) level, S. ferritin, duration, and dose of chelation therapy was also assessed.Sixteen patients had abnormal DPOAE and the number of patients with pure tone average above 25 dB HL which was taken as hearing deficit on PTA was 13. No statistically significant relationship between hearing loss and age, gender, S. ferritin, duration of therapy, cumulative dose, Hb levels were found.Despite being a lifesaving drug, the advantages of chelating agent‐Deferasirox must be weighed against its probable ototoxic effects. We could not find a relationship of ototoxicity with variable parameters (age, gender, Hb level, Ferritin level, duration, and cumulative dose of drug), thus future research is encouraged to form a definitive basis.
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评估口服螯合疗法药物地拉羅司对β重型地中海贫血患者的听觉影响
我们的研究旨在调查定期接受输血治疗的重型β地中海贫血患者服用铁螯合剂地拉羅司后产生的耳毒性,同时使用适当的统计测试评估听力测试数据。对所有患者进行了纯音测听(PTA)和失真产物耳声发射(DPOAE),以评估药物的听觉副作用。收集、整理数据,并使用适当的统计检验进行统计分析。此外,还评估了耳毒性与各种人口统计学参数(如年龄、性别、血红蛋白(Hb)水平、铁蛋白、螯合疗法的持续时间和剂量)之间的关系。16 名患者的 DPOAE 异常,纯音平均值超过 25 dB HL 的患者人数为 13 人,PTA 将此作为听力损失。听力损失与年龄、性别、铁蛋白、治疗时间、累积剂量、血红蛋白水平之间没有统计学意义上的关系。尽管地拉羅司是一种救命药,但必须权衡其优势和可能的耳毒性作用。我们没有发现耳毒性与可变参数(年龄、性别、血红蛋白水平、铁蛋白水平、疗程和累积用药剂量)之间的关系,因此鼓励今后开展研究,以形成明确的依据。
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