甲状腺片临床应用进展及再评价必要性探讨

Progress in clinical application of thyroid tablets and necessity of re-evaluation

甲状腺片为治疗甲状腺功能减退症的药物,已在临床使用多年。原有药典标准采用化合物碘的含量作为甲状腺片的质控指标,导致甲状腺片批次间生物效价差异大,影响了甲状腺片临床使用的安全性及有效性。新的药典标准对甲状腺片中起效成分左甲状腺素(T_4)和碘塞罗宁(T_3)进行含量控制,并增加了含量均匀度的检查,大大提高了甲状腺片的质量及稳定性。本文总结了甲状腺片在国内外临床上的应用情况,呼吁对标准及质量提高后的甲状腺片进行临床再评价。

Thyroid tablets is the drug for the treatment of hypothyroidism and has been clinically used for many years. Iodine content was used as quality control of thyroid tablets in the original pharmacopoeia, which leads to differences in the bioavailability of thyroid tablets between batches and affects the safety and effectiveness in their clinical use. The contents of levothyroxine （T4） and triiodothyronine （T3） as active ingredients have been used as quality control indicators and the detection of the uniformity of dosage units was added in new version of pharmacopoeia, which can greatly improve their quality and stability. We summarize the clinical application of thyroid tablets in domestic and foreign countries and expect to perform a clinical re- evaluation of the standard-enhanced thyroid tablets.