Department of Audiology, London Health Sciences Centre, London, Ontario, Canada.
Laryngoscope. 2014 Mar;124(3):E87-94. doi: 10.1002/lary.24360. Epub 2013 Oct 1.
OBJECTIVES/HYPOTHESIS: To evaluate the feasibility and efficacy of transtympanic L-N-Acetylcysteine (L-NAC) administration in patients receiving cisplatin chemotherapy for head and neck cancer.
Prospective randomized nonblinded open-label clinical trial.
Transtympanic 2% L-NAC was administered to one randomly selected ear with the other ear as control in each patient. Primary outcome parameter was the difference in the loss of pure tone averages (PTA) at 2, 4, and 8 kHz between the L-NAC and control ear at 1 to 2 months following chemotherapy.
Eleven patients completed the study, with two patients demonstrating significantly better hearing in the L-NAC treated ear (18.2%). However, for the overall group, the difference in hearing preservation did not reach significance. Two percent L-NAC administration was well tolerated in this patient population. There were no adverse effects associated with L-NAC.
Although the study did not demonstrate a significant benefit overall, transtympanic L-NAC was associated with significantly better hearing in two patients. Better delivery methods may improve the efficacy of this treatment. L-NAC remains a promising drug in preventing cisplatin-induced ototoxicity.
目的/假设：评估顺铂化疗治疗头颈部癌症患者鼓室内给予 L-乙酰半胱氨酸（L-NAC）的可行性和疗效。
前瞻性随机非盲开放性临床试验。
在每位患者中，一侧耳朵随机接受鼓室内 2% L-NAC 治疗，另一侧耳朵作为对照。主要结局参数是化疗后 1 至 2 个月时 L-NAC 耳与对照耳在 2、4 和 8 kHz 纯音平均损失（PTA）的差异。
11 例患者完成了研究，2 例患者在 L-NAC 治疗耳的听力明显改善（18.2%）。然而，对于整个组，听力保护的差异没有达到显著性。该患者人群中，2% L-NAC 给药耐受性良好。没有与 L-NAC 相关的不良反应。
尽管该研究总体上未显示出显著益处，但鼓室内 L-NAC 与两名患者的听力明显改善相关。更好的给药方法可能会提高这种治疗的效果。L-NAC 仍然是预防顺铂诱导的耳毒性的一种有前途的药物。
