帕洛培格特立帕肽：用于治疗成人慢性甲状旁腺功能减退症的甲状旁腺激素类似物。
完整摘要 · 中文译文
目的：评价帕洛培格替帕拉肽（palopegteriparatide）用于治疗成人慢性甲状旁腺功能减退症的药理学、疗效和安全性。 数据来源：在PubMed中进行文献检索，时间范围为2015年9月至2026年8月。审查了所有与帕洛培格替帕拉肽相关的已发表文献、药品说明书和临床试验。使用的关键词包括：palopegteriparatide、hypoparathyroidism、parathyroid hormone (PTH)、TransCon PTH、hypocalcemia、PTH(1-34)、临床试验和生活质量。 数据提取：审查了所有涉及帕洛培格替帕拉肽的已发表文献、摘要、药品说明书和临床试验。 数据综合：帕洛培格替帕拉肽是一种每日一次皮下注射的药物，利用TransCon技术治疗成人慢性甲状旁腺功能减退症。在3期试验中，帕洛培格替帕拉肽使93%的参与者实现完全脱离常规治疗（钙剂和活性维生素D）。药片负担从基线的6.7片降至第52周的0.26片，参与者的健康相关生活质量显著提高。帕洛培格替帕拉肽的轻度至中度不良事件支持其总体良好的耐受性。与现有药物的相关性及临床实践比较：帕洛培格替帕拉肽是一种新型PTH类似物，模拟生理性PTH暴露，从而获得更稳定的血清钙水平并改善肾脏对钙和磷酸盐的处理。 结论：帕洛培格替帕拉肽是唯一获得美国食品药品监督管理局批准的、针对慢性甲状旁腺功能减退症中PTH缺乏的药物。 尼克氏甲状旁腺功能减退症。该药物可实现24小时持续释放PTH，从而有效管理PTH不足。
完整摘要 · 英文原文
OBJECTIVE: To review the pharmacology, efficacy, and safety of palopegteriparatide for the treatment of chronic hypoparathyroidism in adults. DATA SOURCES: A literature search was conducted in PubMed from September 2015 to August 2026. All relevant publications, package inserts, and clinical trials with palopegteriparatide were reviewed. Keywords used were: palopegteriparatide, hypoparathyroidism, parathyroid hormone (PTH), TransCon PTH, hypocalcemia, PTH(1-34), clinical trials and quality of life. DATA EXTRACTION: All relevant publications, abstracts, package inserts, and clinical trials involving palopegteriparatide were reviewed. DATA SYNTHESIS: Palopegteriparatide is a once-daily subcutaneous injection that uses TransCon technology to treat chronic hypoparathyroidism in adults. Palopegteriparatide led to 93% of participants achieving complete independence from conventional therapy (calcium and active vitamin D) in phase 3 trials. Pill burden decreased from 6.7 at baseline to 0.26 at week 52, and the health-related quality of life of participants significantly increased. The mild-to-moderate adverse effects of palopegteriparatide support its overall favorable tolerability profile.Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:Palopegteriparatide is a new PTH analog that mimics physiologic PTH exposure, resulting in more stable serum calcium levels and improved renal handling of calcium and phosphate. CONCLUSION: Palopegteriparatide is the only Food and Drug Administration-approved medication available that addresses PTH deficiency in chronic hypoparathyroidism. It provides a 24-hour continuous release of PTH enabling effective management of PTH insufficiency.