プラセボ対照無作為化試験による亜鉛欠乏性または特発性味覚障害219例に対するポラプレジンク投与の臨床的検討

  • 池田 稔
    日本大学医学部耳鼻咽喉・頭頸部外科学分野
  • 黒野 祐一
    鹿児島大学大学院医歯学総合研究科耳鼻咽喉科・頭頸部外科学教室
  • 井之口 昭
    佐賀大学医学部耳鼻咽喉科学教室
  • 武田 憲昭
    徳島大学大学院医科学教育部・医学研究科耳鼻咽喉科学分野
  • 愛場 庸雅
    大阪市立総合医療センター耳鼻咽喉科・小児耳鼻咽喉科・小児言語科
  • 野村 泰之
    日本大学医学部耳鼻咽喉・頭頸部外科学分野
  • 阪上 雅史
    兵庫医科大学耳鼻咽喉科学講座

書誌事項

タイトル別名
  • The Effect of Zinc Agent in 219 Patients with Zinc Deficiency-inductive/Idiopathic Taste Disorder: A Placebo Controlled Randomized Study
  • プラセボ タイショウ ムサクイカ シケン ニ ヨル アエン ケツボウセイ マタハ トクハツセイ ミカク ショウガイ 219レイ ニ タイスル ポラプレジンク トウヨ ノ リンショウテキ ケントウ

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抄録

Diagnosis and treatment of taste disorders are challenging because the disorder can only be determined by the awareness of the patient. Hence, these disorders still require comprehensive evidence. We conducted a randomized, placebo-controlled double-blind study to investigate the effect of polaprezinc, a zinc-containing agent, in 219 patients with either zinc deficiency-inductive or an idiopathic taste disorder. As a result, the zinc-treated arm experienced a statistically significant improvement against the placebo-treated arm in the perceptible threshold scores of the filter-paper disk method 8 weeks after the administration of the investigational drug. Moreover, the effect lasted for 4 weeks after discontinuation of the drug. However, the effective ratios based on the initial criteria were 55.6% in the treatment group and 43.2% in the placebo, where no statistical significance was recorded. Sex and degree of depression could be two of the potential factors to explain this discrepancy. Furthermore, the effect was not significant among male patients and patients with a high depression score based on the Self-rating Depression Scale (SDS) test. These results indicate that determining the symptom among such patients remains undisclosed. Whereas, in approximately 77%, or 168 patients with “normal” SDS scores and with completely impaired taste qualities, the ratio of effective cases reached 60.9% in the zinc-treated group, the ratio of the placebo-treated group reached 39.5%, resulting in a statistical significance. This may be partly because of a problem in the adaption of male subjects to the gustatory analyses, especially to the identification of saltiness and sourness. Care must also be taken regarding the depressive state of patients when diagnosing and treating taste disorders. Taste disorders caused by depression may not be cured by zinc supplementation due in part to the fact that the symptom is based on a mental issue, and due in part to the conservative responding bias generated by the depression itself, which may inhibit accurate and precise diagnosis of the disorder. In conclusion, administration of a zinc agent is effective for patients with taste disorders, provided selection of appropriate patients is performed, and that proper examination and evaluation are conducted. The present study also indicated that examining depressiveness based on the SDS scores and investigating disturbance of each taste quality using the filter-paper disk method are recommended for the diagnosis and determination of the treatment effect of a taste disorder.

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