• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验

rhPTH(1-84)治疗甲状旁腺功能减退症:疗效和安全性的前瞻性 8 年研究。

Therapy of Hypoparathyroidism With rhPTH(1-84): A Prospective, 8-Year Investigation of Efficacy and Safety.

机构信息

Department of Medicine, Division of Endocrinology, College of Physicians and Surgeons, Columbia University, New York, New York.

Department of Medicine, Sengkang General Hospital, Singapore.

出版信息

J Clin Endocrinol Metab. 2019 Nov 1;104(11):5601-5610. doi: 10.1210/jc.2019-00893.

DOI:10.1210/jc.2019-00893
PMID:31310310
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6977408/
Abstract

CONTEXT

Conventional treatment of hypoparathyroidism is associated with decreased renal function and increased bone mineral density (BMD).

OBJECTIVE

To evaluate the effects of 8 years of recombinant human parathyroid hormone (1-84) [rhPTH(1-84)] therapy on key biochemical and densitometric indices.

DESIGN

Prospective open-label trial.

SETTING

Tertiary medical center.

PARTICIPANTS

Twenty-four subjects with hypoparathyroidism.

INTERVENTION

Treatment with rhPTH(1-84) for 8 years.

MAIN OUTCOME MEASURES

Supplemental calcium and vitamin D requirements, serum calcium and phosphorus levels, calcium-phosphate product, urinary calcium excretion, estimated glomerular filtration rate (eGFR) and BMD.

RESULTS

PTH therapy was associated with progressive reduction in supplemental calcium (57%; P < 0.01) and active vitamin D (76%; P < 0.001) requirements over 8 years. Serum calcium concentration was stable; urinary calcium excretion declined 38% (P < 0.01). eGFR remained stable and was related to baseline eGFR and serum calcium levels. Calcium-phosphate product was below the recommended limit; serum phosphorus remained within normal range. Lumbar spine and total hip BMD increased, peaking at 4 (mean ± SE, 4.6% ± 1.5%; P = 0.01) and 8 years (2.6% ± 1.1%; P = 0.02), whereas femoral neck BMD did not change and one-third radius BMD decreased (mean ± SE, -3.5% ± 1.1%; P = 0.001). BMD at all sites was higher throughout the 8 years than in the age- and sex-matched reference population. Hypercalcemia and hypocalcemia were uncommon.

CONCLUSION

rhPTH(1-84) is a safe and effective treatment for hypoparathyroidism for 8 years. Long-term reductions in supplemental requirements and biochemical improvements with stable renal function are maintained.

摘要

背景

甲状旁腺功能减退症的传统治疗与肾功能下降和骨密度(BMD)增加有关。

目的

评估 8 年重组人甲状旁腺激素(1-84)[rhPTH(1-84)]治疗对关键生化和密度计指标的影响。

设计

前瞻性开放标签试验。

地点

三级医疗中心。

参与者

24 例甲状旁腺功能减退症患者。

干预

rhPTH(1-84)治疗 8 年。

主要观察指标

补充钙和维生素 D 的需求、血清钙和磷水平、钙磷乘积、尿钙排泄、估计肾小球滤过率(eGFR)和 BMD。

结果

甲状旁腺激素治疗与 8 年内补充钙(57%;P < 0.01)和活性维生素 D(76%;P < 0.001)需求的逐渐减少有关。血清钙浓度稳定;尿钙排泄减少 38%(P < 0.01)。eGFR 保持稳定,与基线 eGFR 和血清钙水平相关。钙磷乘积低于推荐范围;血清磷仍在正常范围内。腰椎和全髋 BMD 增加,在第 4 年(平均 ± SE,4.6% ± 1.5%;P = 0.01)和第 8 年(2.6% ± 1.1%;P = 0.02)达到峰值,而股骨颈 BMD 没有变化,三分之一半径 BMD 减少(平均 ± SE,-3.5% ± 1.1%;P = 0.001)。在整个 8 年期间,所有部位的 BMD 均高于年龄和性别匹配的参考人群。高钙血症和低钙血症不常见。

结论

rhPTH(1-84)是甲状旁腺功能减退症 8 年的安全有效治疗方法。补充需求的长期减少和肾功能稳定的生化改善得以维持。

相似文献

1
Therapy of Hypoparathyroidism With rhPTH(1-84): A Prospective, 8-Year Investigation of Efficacy and Safety.rhPTH(1-84)治疗甲状旁腺功能减退症:疗效和安全性的前瞻性 8 年研究。
J Clin Endocrinol Metab. 2019 Nov 1;104(11):5601-5610. doi: 10.1210/jc.2019-00893.
2
Therapy of Hypoparathyroidism With PTH(1-84): A Prospective Six Year Investigation of Efficacy and Safety.甲状旁腺激素(1-84)治疗甲状旁腺功能减退症:一项为期六年的疗效与安全性前瞻性研究。
J Clin Endocrinol Metab. 2016 Jul;101(7):2742-50. doi: 10.1210/jc.2015-4135. Epub 2016 May 4.
3
Safety and Efficacy of 5 Years of Treatment With Recombinant Human Parathyroid Hormone in Adults With Hypoparathyroidism.甲状旁腺功能减退症成人患者接受重组人生长激素治疗 5 年的安全性和疗效。
J Clin Endocrinol Metab. 2019 Nov 1;104(11):5136-5147. doi: 10.1210/jc.2019-01010.
4
Therapy of hypoparathyroidism with PTH(1-84): a prospective four-year investigation of efficacy and safety.甲状旁腺功能减退症的 PTH(1-84)治疗:疗效和安全性的前瞻性四年研究。
J Clin Endocrinol Metab. 2013 Jan;98(1):137-44. doi: 10.1210/jc.2012-2984. Epub 2012 Nov 15.
5
Effects of parathyroid hormone rhPTH(1-84) on phosphate homeostasis and vitamin D metabolism in hypoparathyroidism: REPLACE phase 3 study.重组人甲状旁腺激素rhPTH(1-84)对甲状旁腺功能减退症患者磷稳态及维生素D代谢的影响:REPLACE 3期研究
Endocrine. 2017 Jan;55(1):273-282. doi: 10.1007/s12020-016-1141-0. Epub 2016 Oct 12.
6
Pharmacokinetics and pharmacodynamics of subcutaneous recombinant parathyroid hormone (1-84) in patients with hypoparathyroidism: an open-label, single-dose, phase I study.皮下注射重组甲状旁腺激素(1-84)在甲状旁腺功能减退患者中的药代动力学和药效学:一项开放标签、单剂量、I期研究。
Clin Ther. 2014 May;36(5):722-36. doi: 10.1016/j.clinthera.2014.04.001. Epub 2014 May 5.
7
AN OPEN-LABEL EXTENSION STUDY OF PARATHYROID HORMONE RHPTH(1-84) IN ADULTS WITH HYPOPARATHYROIDISM.一项关于甲状旁腺激素rhPTH(1 - 84)在成人甲状旁腺功能减退症患者中的开放标签扩展研究。
Endocr Pract. 2016 May;22(5):523-32. doi: 10.4158/EP15936.OR. Epub 2015 Dec 18.
8
Therapy of hypoparathyroidism with intact parathyroid hormone.用完整甲状旁腺激素治疗甲状旁腺功能减退症。
Osteoporos Int. 2010 Nov;21(11):1927-34. doi: 10.1007/s00198-009-1149-x. Epub 2010 Jan 22.
9
Drug safety evaluation of parathyroid hormone for hypocalcemia in patients with hypoparathyroidism.甲状旁腺激素用于甲状旁腺功能减退症患者低钙血症的药物安全性评估。
Expert Opin Drug Saf. 2017 May;16(5):617-625. doi: 10.1080/14740338.2017.1311322. Epub 2017 Apr 3.
10
Long-term treatment of 12 children with chronic hypoparathyroidism: a randomized trial comparing synthetic human parathyroid hormone 1-34 versus calcitriol and calcium.12 例慢性甲状旁腺功能减退症患儿的长期治疗:比较合成人甲状旁腺激素 1-34 与骨化三醇和钙的随机试验。
J Clin Endocrinol Metab. 2010 Jun;95(6):2680-8. doi: 10.1210/jc.2009-2464. Epub 2010 Apr 14.

引用本文的文献

1
Switch From rhPTH1-84 to TransCon PTH With Individual Dose Adjustment in Adult Hypoparathyroidism-4-Week Results.成人甲状旁腺功能减退症中从重组人甲状旁腺激素1-84转换为TransCon甲状旁腺激素并进行个体化剂量调整——4周结果
J Endocr Soc. 2025 Jun 30;9(9):bvaf113. doi: 10.1210/jendso/bvaf113. eCollection 2025 Sep.
2
Phase 1 clinical trial of eneboparatide, a novel PTH receptor 1 agonist.新型甲状旁腺激素受体1激动剂依奈博帕肽的1期临床试验。
Endocr Connect. 2025 Jun 19;14(6). doi: 10.1530/EC-24-0464. Print 2025 Jun 1.
3
Impaired renal function in patients with permanent hypoparathyroidism after thyroidectomy: analysis of a nationwide cohort in Spain.甲状腺切除术后永久性甲状旁腺功能减退患者的肾功能损害:西班牙全国队列分析
Endocrine. 2025 Mar 3. doi: 10.1007/s12020-025-04187-x.
4
PTH Substitution Therapy for Chronic Hypoparathyroidism: PTH 1-84 and Palopegteriparatide.慢性甲状旁腺功能减退症的甲状旁腺激素替代疗法:PTH 1-84和帕罗西汀特立帕肽。
Curr Osteoporos Rep. 2025 Feb 22;23(1):12. doi: 10.1007/s11914-025-00905-6.
5
Hypoparathyroidism: diagnosis, management and emerging therapies.甲状旁腺功能减退症:诊断、管理及新出现的治疗方法。
Nat Rev Endocrinol. 2025 Jun;21(6):360-374. doi: 10.1038/s41574-024-01075-8. Epub 2025 Feb 4.
6
Parathyroid allotransplantation for severe post-surgical hypoparathyroidism: a Brazilian experience.严重手术后甲状旁腺功能减退的甲状旁腺同种异体移植:巴西的经验。
3 Biotech. 2024 Dec;14(12):299. doi: 10.1007/s13205-024-04147-8. Epub 2024 Nov 14.
7
Treatment of Hypoparathyroidism by Re-Establishing the Effects of Parathyroid Hormone.甲状旁腺激素作用的重建治疗甲状旁腺功能减退症。
Endocrinol Metab (Seoul). 2024 Apr;39(2):262-266. doi: 10.3803/EnM.2024.1916. Epub 2024 Apr 4.
8
Performance in Behavioral Testing in an Animal Model of Post-Surgical Hypoparathyroidism.术后甲状旁腺功能减退动物模型的行为测试表现
J Pers Med. 2024 Feb 17;14(2):215. doi: 10.3390/jpm14020215.
9
Ultrasound characteristics of normal parathyroid glands and analysis of the factors affecting their display.正常甲状旁腺的超声特征及影响其显示因素的分析。
BMC Med Imaging. 2024 Feb 13;24(1):42. doi: 10.1186/s12880-024-01214-7.
10
A Phase I Randomized Trial of Once-Daily Versus Twice-Daily Recombinant Human Parathyroid Hormone (1-84) for Hypoparathyroidism.一项关于每日一次与每日两次重组人甲状旁腺激素(1-84)治疗甲状旁腺功能减退症的I期随机试验。
JBMR Plus. 2023 May 31;7(7):e10758. doi: 10.1002/jbm4.10758. eCollection 2023 Jul.

本文引用的文献

1
Standards of care for hypoparathyroidism in adults: a Canadian and International Consensus.成人甲状旁腺功能减退症的护理标准:加拿大与国际共识
Eur J Endocrinol. 2019 Mar;180(3):P1-P22. doi: 10.1530/EJE-18-0609.
2
The Effects of Long-term Administration of rhPTH(1-84) in Hypoparathyroidism by Bone Histomorphometry.甲状旁腺功能减退症患者长期给予 rhPTH(1-84)治疗的骨组织形态计量学研究
J Bone Miner Res. 2018 Nov;33(11):1931-1939. doi: 10.1002/jbmr.3543. Epub 2018 Aug 16.
3
Long-Term Complications in Patients With Hypoparathyroidism Evaluated by Biochemical Findings: A Case-Control Study.甲状旁腺功能减退症患者的生化检查评估的长期并发症:病例对照研究。
J Bone Miner Res. 2018 May;33(5):822-831. doi: 10.1002/jbmr.3368. Epub 2018 Feb 14.
4
Therapy of Hypoparathyroidism With PTH(1-84): A Prospective Six Year Investigation of Efficacy and Safety.甲状旁腺激素(1-84)治疗甲状旁腺功能减退症:一项为期六年的疗效与安全性前瞻性研究。
J Clin Endocrinol Metab. 2016 Jul;101(7):2742-50. doi: 10.1210/jc.2015-4135. Epub 2016 May 4.
5
Management of Hypoparathyroidism: Summary Statement and Guidelines.甲状旁腺功能减退症的管理:总结声明和指南。
J Clin Endocrinol Metab. 2016 Jun;101(6):2273-83. doi: 10.1210/jc.2015-3907. Epub 2016 Mar 4.
6
European Society of Endocrinology Clinical Guideline: Treatment of chronic hypoparathyroidism in adults.欧洲内分泌学会临床指南:成人慢性甲状旁腺功能减退症的治疗。
Eur J Endocrinol. 2015 Aug;173(2):G1-20. doi: 10.1530/EJE-15-0628.
7
The Epidemiology of Nonsurgical Hypoparathyroidism in Denmark: A Nationwide Case Finding Study.丹麦非手术性甲状旁腺功能减退症的流行病学:一项全国性病例发现研究。
J Bone Miner Res. 2015 Sep;30(9):1738-44. doi: 10.1002/jbmr.2501. Epub 2015 May 31.
8
Cardiovascular and renal complications to postsurgical hypoparathyroidism: a Danish nationwide controlled historic follow-up study.手术后甲状旁腺功能减退症的心血管和肾脏并发症:一项丹麦全国范围的对照历史随访研究。
J Bone Miner Res. 2013 Nov;28(11):2277-85. doi: 10.1002/jbmr.1979.
9
PTH(1-84) replacement therapy in hypoparathyroidism: a randomized controlled trial on pharmacokinetic and dynamic effects after 6 months of treatment.甲状旁腺激素(1-84)替代治疗在甲状旁腺功能减退症中的应用:一项治疗 6 个月后药代动力学和动态效应的随机对照试验。
J Bone Miner Res. 2013 Oct;28(10):2232-43. doi: 10.1002/jbmr.1964.
10
Therapy of hypoparathyroidism with PTH(1-84): a prospective four-year investigation of efficacy and safety.甲状旁腺功能减退症的 PTH(1-84)治疗:疗效和安全性的前瞻性四年研究。
J Clin Endocrinol Metab. 2013 Jan;98(1):137-44. doi: 10.1210/jc.2012-2984. Epub 2012 Nov 15.