更新于：2024-11-04

Levothyroxine Sodium

左甲状腺素钠

更新于：2024-11-04

概要

概要

基本信息

简介左旋甲状腺素钠是一种小分子药物，作用于甲状腺激素受体，是甲状腺激素受体的激动剂。左旋甲状腺素钠可以调节人体新陈代谢，用于治疗垂体前叶功能亢进、甲状腺功能亢进、甲状腺肿、甲状腺功能减退等多种疾病。其作用机制是增加甲状腺激素的水平，从而调节人体的新陈代谢、心血管系统、中枢神经系统等方面的功能。左旋甲状腺素钠是由AbbVie公司开发的，并于1964年8月7日首次获得批准。

药物类型

小分子化药

别名

Levothyroxine Sodium Hydrate、LT4、Sustained-release levothyroxine sodium

+ [29]

靶点

THR

作用机制

THR激动剂(甲状腺激素受体激动剂)

治疗领域

肿瘤神经系统疾病遗传病与畸形+ [3]

在研适应症

分化型甲状腺癌粘液性水肿昏迷垂体功能亢进+ [6]

非在研适应症-

原研机构

AbbVie, Inc.

在研机构

Cediprof, Inc.

IBSA Institut Biochimique SAXeris Biopharma Holdings, Inc.

+ [13]

非在研机构

BERLIN-CHEMIE AG

Genus Lifesciences, Inc.

Alvogen, Inc.

最高研发阶段批准上市

首次获批日期

日本 (1964-08-07),

甲状腺功能减退症

最高研发阶段(中国)批准上市

特殊审评-

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结构

分子式C15H13I4NNaO5

InChIKeyVSGRWOHSMUGJIF-LTCKWSDVSA-N

CAS号6106-07-6

关联

275

项与左甲状腺素钠相关的临床试验

NCT06647602 / Not yet recruitingN/A

Comparing Effects of Thyroid Hormone Medication Liothyronine and Levothyroxine in Treatment for Thyroid Cancer

This study will be a multicentre prospective cohort study on TH-substitution with liothyronine (L-T3) and levothyroxine (L-T4) in DTC patients after TH-withdrawal. The first cohort is patients treated in the University Medical Centre Groningen (UMCG) with L-T3 according to standard local protocol. The second cohort is patients treated in the Radboud University Medical Centre (Radboud UMC) with L-T4, also according to standard local protocol. We will compare effects of L-T3 or L-T4 on TSH, Thyroglobulin (Tg), quality of life (QoL), weight and cardiovascular parameters.

开始日期2025-02-01

申办/合作机构

University Medical Center Groningen

[+1]

NCT06652113 / Not yet recruitingN/AIIT

The Efficacy of Hydroxychloroquine Combined With Levothyroxine in Euthyroid Women With Thyroid Antibody Positive and Unexplained Recurrent Pregnancy Loss：A Multicenter, Randomized Controlled Study

The goal of this clinical trial is to learn if combined treatment of levothyroxine and hydroxychloroquine would improve the live birth of euthyroid women with thyroid peroxidase antibodies and unexplained recurrent pregnancy loss.
Researchers will compare combined treatment of levothyroxine and hydroxychloroquine to a treatment of levothyroxine alone to see if combined treatment works to improve live birth of euthyroid participants with thyroid peroxidase antibodies and unexplained recurrent pregnancy loss.
Participants will:
* Receive combined treatment of levothyroxine and hydroxychloroquine or treatment of levothyroxine alone every day at least 8 weeks before pregnancy, and continue their treatment till the end of pregnancy.
* Visit the clinic 4 weeks and 8 weeks after their treatments, and every 12 weeks before they get pregnant for checkups and tests. During their pregnancy, they will visit the clinic before gestation of 12 weeks, and will be followed up with phone call in the second trimester and after parturition.

开始日期2024-12-01

申办/合作机构

Sun Yat-Sen Memorial Hospital

NCT06653907 / Not yet recruiting临床4期IIT

Randomized Control Study of Levothyroxine Intervention in Pregnant Women with Thyroid Stimulating Hormone Between 2.5 MIU/L and Upper Limit of Reference Range and Negative Thyroid Peroxidase Antibody

The goal of this clinical trial is to learn if levothyroxine (L-T4) works to treat pregnant women with TSH 2.5 mIU/L-the upper limit of reference range (ULRR) of pregnancy and TPOAb-negative. It will also learn about the safety of L-T4. The main quesitons the investigator want to answer are:
* Will L-T4 reduce miscarriage rates and have an impact on pregnancy complications in pregnant participants?
* What medical issues do participants have when taking L-T4 during pregnancy? -Investigators will compare L-T4 with placebo (a substance with a similar appearance without medication) to see if L-T4 could reduce miscarriage rates
Participants should:
* Take L-T4 or placebo during the whole pregnancy.
* Visit the hospital once every 6-8 weeks during pregnancy for checkups and tests
* Keep a diary of their pregncny complications and daily record of L-T4 or placebo intake.
* Visit the hospital for examination 42 days postpartum for checkups and follow up by phone at 6 and 12 months postpartum.

开始日期2024-10-25

申办/合作机构

北京大学第一医院

100 项与左甲状腺素钠相关的临床结果

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100 项与左甲状腺素钠相关的转化医学

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100 项与左甲状腺素钠相关的专利（医药）

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20,924

项与左甲状腺素钠相关的文献（医药）

2025-06-01·Neural Regeneration Research

Dip2a regulates stress susceptibility in the basolateral amygdala

Article

作者: Zhu, Xiaojuan ; Yu, Huali ; Li, Jing ; He, Xiaoxiao ; Chai, Weitai ; He, Zixuan ; Tian, Meng

JOURNAL/nrgr/04.03/01300535-202506000-00025/figure1/v/2024-08-08T040853Z/r/image-tiff Dysregulation of neurotransmitter metabolism in the central nervous system contributes to mood disorders such as depression, anxiety, and post–traumatic stress disorder. Monoamines and amino acids are important types of neurotransmitters. Our previous results have shown that disco-interacting protein 2 homolog A (Dip2a) knockout mice exhibit brain development disorders and abnormal amino acid metabolism in serum. This suggests that DIP2A is involved in the metabolism of amino acid–associated neurotransmitters. Therefore, we performed targeted neurotransmitter metabolomics analysis and found that Dip2a deficiency caused abnormal metabolism of tryptophan and thyroxine in the basolateral amygdala and medial prefrontal cortex. In addition, acute restraint stress induced a decrease in 5-hydroxytryptamine in the basolateral amygdala. Additionally, Dip2a was abundantly expressed in excitatory neurons of the basolateral amygdala, and deletion of Dip2a in these neurons resulted in hopelessness-like behavior in the tail suspension test. Altogether, these findings demonstrate that DIP2A in the basolateral amygdala may be involved in the regulation of stress susceptibility. This provides critical evidence implicating a role of DIP2A in affective disorders.

2025-02-01·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Doping of Mn2+ ion into boron quantum dots with enhanced fluorescence properties for sensing of L-thyroxine biomarker and bioimaging applications

Article

作者: Malek, Naved I ; Jha, Sanjay ; Joshi, Dharaben J ; Malek, Naved I. ; Kailasa, Suresh Kumar ; Park, Tae Jung ; Joshi, Dharaben J.

L-thyroxine serves as a primary biomarker for diagnosing hypothyroidism and it is also utilized in hormone replacement therapy. Regular assessment of thyroxine levels is crucial for preventing health issues in hypothyroid patients, suggesting the requirement of a facile analytical tool for the detection of L-thyroxine. In this work, a straightforward and efficient synthetic method is introduced for in-situ preparation of Mn²⁺-doped boron quantum dots (Mn²⁺@B-QDs) derived from boron powder through a solvothermal reaction. The introduction of Mn²⁺ ion into B-QDs not only enhances fluorescence efficiency but also provides favorable sites within the QDs, expanding their potential applications in analytical chemistry. The blue fluorescent Mn²⁺ @B-QDs exhibited excellent performance for the selective recognition of L-thyroxine via a dynamic quenching mechanism. Under ideal conditions, a good linear relation was observed between the fluorescence emission intensity ratio of Mn²⁺@B-QDs and the concentration of L-thyroxine in the range of 0.125-5 μM, with a lower detection limit of 59.86 nM. The Mn²⁺@B-QDs exhibited the negligible cytotoxicity against A549 lung cancer cell lines and demonstrated good biocompatibility toward Saccharomyces cerevisiae cells.

2025-01-01·JOURNAL OF ETHNOPHARMACOLOGY

Haizao–Gancao herb pair ameliorates propylthiouracil-induced goiter by regulating the Beclin1-mediated autophagy

Article

作者: Liao, Wenyong ; Chen, Siyu ; Xiu, Linlin ; Zhong, Gansheng ; Yu, Xue ; Xu, Xiangnan ; Wu, Meijing ; Dong, Xiao ; Cao, Can ; Tian, Yi ; Zhang, Wenkang ; Liu, Xiaoqing

ETHNOPHARMACOLOGICAL RELEVANCE:

Haizao, Sargassum, is widely used to treat goiter. Gancao, Glycyrrhizae radix et rhizome, is renowned for reducing toxicity or increasing effects in traditional Chinese medicine. As a classic herb pair, Haizao-Gancao (HG) is a commonly used and effective combined therapy for goiter. The underlying biological mechanisms of HG on goiter is still unclear.

AIM OF THE STUDY:

To explore the effect of HG on goiter, employing molecular docking combined with experimental validation to elucidate the molecular mechanism.

MATERIALS AND METHODS:

The rat goiter model was created by gavageing propylthiouracil (PTU) intragastrically for a duration of 14 days. The rats had been separated into six groups: control, model, euthyrox, HG high-dose (HG-H), medium-dose (HG-M) and low-dose (HG-L) group. Based on general observations (such as the rats' living status, body weight, and rectal temperature), the relative weight of the thyroid, thyroid function, hematoxylin-eosin (HE) staining, and transmission electron microscopy (TEM) to view the pathological variations of the thyroid glands, the effect of HG was evaluated. Discovered the chemical composition of HG by UPLC-MS/MS and the possible targets were predicted adopting several databases. Next, we explored their pharmacological mechanisms using molecular docking and validated key targets using western blotting (WB) and co-immunoprecipitation (Co-IP).

RESULTS:

HG significantly increased the levels of triiodothyronine(T3), free triiodothyronine (FT3), free thyroxine (FT4), gained body weight and reduced tumescent thyroid glands in PTU-induced rats. The model group pathological changes such as uneven size, irregular shape and disordered arrangement of follicular epithelial cells occurred. However, HG groups thyroid follicles and epithelial cells appeared apparently normal. A variety of characteristic changes of autophagic vesicles appeared in the HG groups as opposed to the model group. In conclusion, the HG-L showed the best therapeutic effect. By UPLC-MS/MS, the major chemical components of HG were identified. The result revealed that HG contained flavonoids, alkaloids, organic acids, phenolic acidsand and terpenoids, etc. The molecular docking results of formononetin and naringenin and Beclin1 protein showed a high interaction of -5.38 kcal/mol and -5.25 kcal/mol. This implies that formononetin and naringenin may have a therapeutic effect in goiter rats by controlling the Beclin1-mediated autophagy. Western Blot (WB) and co-immunoprecipitation (Co-IP) results showed that HG can disrupt Beclin1/class III phosphatidylinositol 3-kinase(PI3KC3) binding and promote Beclin1/B-cell leukemia/lymphoma-2(Bcl-2) complex formation. Taken together, results demonstrate that autophagy inhibition via reducing Beclin1/PI3KC3 formation and increasing Beclin1/Bcl-2 binding activity.

CONCLUSIONS:

HG ameliorates propylthiouracil-induced goiter by regulating the Beclin1-mediated autophagy, thus promoting the autophagy of thyroid cells.

项与左甲状腺素钠相关的新闻（医药）

2024-10-30

·今日头条

【Lancet子刊】复旦大学附属肿瘤医院王宇团队：探索低风险甲状腺癌TSH抑制治疗新视角

【导读】全球每年有超过500,000例新病例被诊断出患有甲状腺癌（PTC），其中绝大多数属于低风险分层。尽管当前指南传统上建议对所有术后PTC进行促甲状腺激素（TSH）抑制，但其在低风险患者中的必要性仍然存在很大争议。由于当前指南中的相关建议仍然是实证性的，团队的目标是提供直接、大规模、真实世界的证据。 2024年10月28日，复旦大学附属肿瘤医院王宇团队在期刊《eClinicalMedicine》上发表了题为“Thyroid-stimulating hormone suppression in low-risk papillary thyroid cancer: a large-scale retrospective analysis of real-world data”的研究论文。研究结果表明，低危PTC患者的术后TSH水平与肿瘤复发无关；对于这些患者，可以免除故意的TSH抑制，以避免潜在的继发性并发症。将TSH水平维持在正常范围内对这些患者可能是安全的，需要进一步的真实世界多中心前瞻性研究。 https://www-thelancet-com.libproxy1.nus.edu.sg/journals/eclinm/article/PIIS2589-5370(24)00491-7/fulltext 关于甲状腺癌 01 甲状腺癌是最常见的内分泌恶性肿瘤，全球发病率增长非常迅速，每年约有600,000例新诊断病例。随着超声检查的广泛使用，绝大多数新诊断的甲状腺癌病例实际上是低风险PTC，尤其是甲状腺微小状癌（PTMC，指直径≤1cm的PTC）。实验和临床数据表明，甲状腺滤泡细胞增殖依赖于促甲状腺激素（TSH，或促甲状腺激素），因此，为PTC管理中抑制TSH，提供了基本原理。众所周知，TSH抑制可能会引起与医源性甲状腺功能亢进症相关的危害，包括心血管疾病、骨质疏松症、焦虑、抑郁，甚至睡眠功能不佳。目前，仍然缺乏直接的大规模研究，来评估TSH抑制对低风险PTC的预后影响。在这项研究中，团队建立了一个大型PTC患者回顾性队列，并在两家中国大型医院进行了高质量的随访。基于这些资源，团队的目标是用10,000多名患者的真实数据，为这一临床争议提供令人信服的证据。 TSH抑制对Tg阳性甲状腺全切除术患者结构复发的预后影响 02 在团队的PSM后队列中，1,417例患者最初接受了全甲状腺切除术治疗，其中1,204例（85.0%）在随访期间血清Tg阳性（>0.04ng/mL）。Kaplan-Meier分析显示，TSH≤2和>2组的生存曲线几乎重叠（TSH≤2和>2组的5年RFS率：98.8%对99.3%；10年RFS率：97.3%对96.8%）。多变量Cox分析还显示，TSH抑制不是结构复发的独立预后因子（TSH≤2组作为参考，HR 0.95，95%CI 0.28-3.30，TSH>2组）。同样，当团队根据NCCN指南的建议，使用0.5mU/L作为临界值时，团队未能在Kaplan-Meier分析中观察到较低TSH水平的预后益处（TSH≤0.5和>0.5组的5年RFS率：97.8%对99.1%；10年RFS率：97.3%对97.1%）。（A）TSH≤2和>2组和（B）TSH≤0.5和>0.5组 PSM后队列，接受全甲状腺切除术治疗的Tg阳性低风险PTC患者中的RFS生存图（n=1204）。总结 03 1. TSH抑制与复发的负相关：本研究提供证据支持术后TSH抑制与结构复发之间的负相关，且较低的TSH水平未能带来更有利的预后，表明过量服用左旋甲状腺素以将TSH抑制到特定值，可能是不必要的。 2. 生化反应的担忧：甲状腺球蛋白（Tg）作为监测疾病复发的血清生物标志物，在单独肺叶切除术或无RAI的肺叶切除术更广泛地用于低风险患者的时代，其预测价值受到争议。 3. 未来研究方向：需要未来的多中心前瞻性分析，来确定低风险PTC患者是否可以免除TSH抑制治疗，以避免继发并发症；而L-T4替代治疗只需要通过将TSH水平维持在正常范围内，来纠正甲状腺功能减退症。参考资料： 1.Sung, H. ∙ Ferlay, J. ∙ Siegel, R.L. ∙ et al. Global cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries CA Cancer J Clin. 2021; 71:209-249 2.Chen, D.W. ∙ Lang, B.H.H. ∙ McLeod, D.S.A. ∙ et al. Thyroid cancer Lancet. 2023; 401:1531-1544 【关于投稿】转化医学网（360zhyx.com）是转化医学核心门户，旨在推动基础研究、临床诊疗和产业的发展，核心内容涵盖组学、检验、免疫、肿瘤、心血管、糖尿病等。如您有最新的研究内容发表，欢迎联系我们进行免费报道（公众号菜单栏-在线客服联系），我们的理念：内容创造价值，转化铸就未来！转化医学网（360zhyx.com）发布的文章旨在介绍前沿医学研究进展，不能作为治疗方案使用；如需获得健康指导，请至正规医院就诊。热门推荐活动点击免费报名 🕓 上海｜11月15日-16日 ▶ 2024第一届中国类器官转化医学大会 🕓 上海｜11月21日-24日 ▶ 第七届上海国际肿瘤内科学论坛 🕓 全国｜2024年12月-2025年03月 ▶ 中国转化医学产业大会 🕓 上海｜2025年02月28日-03月01日 ▶ 第四届长三角单细胞组学技术应用论坛暨空间组学前沿论坛点击对应文字查看详情

临床研究放射疗法

2024-09-16

·PipelineReview

Autobahn Therapeutics Announces Initiation of its AMPLIFY Phase 2 Trial of ABX-002 as an Adjunctive Treatment for Major Depressive Disorder

AMPLIFY 230-patient trial aims to improve on efficacy and safety established with thyroid hormone as an adjunctive treatment for MDD; topline data expected in the second half of 2025 ABX-002 deemed safe and well-tolerated in Phase 1 and showed clinical evidence of enhanced target engagement consistent with brain-activating thyroid hormone biology Company on-track to expand ABX-002 depression program with Phase 2 trial for bipolar disorder depression to begin late 2024 SAN DIEGO, CA, USA I September 16, 2024 I Autobahn Therapeutics, a biotechnology company developing restorative treatments for people affected by neuropsychiatric and neuroimmunologic disorders, today announced initiation of AMPLIFY, a Phase 2 clinical trial evaluating ABX-002 as an adjunctive treatment for adults with major depressive disorder (MDD). ABX-002 is a highly potent, oral, thyroid hormone beta receptor (TRβ) selective agonist designed to enhance the CNS benefits of thyroid hormone biology and drug concentrations directly in the brain, for greater potency, efficacy and safety. In a completed Phase 1 trial of ABX-002 , ABX-002 demonstrated clinical evidence of CNS target engagement consistent with brain-activating thyroid effects and was well-tolerated, with no serious adverse events observed. “Among the millions of people in the U.S. suffering from the debilitating effects of depression, more than half experience an inadequate response to their current antidepressant, underscoring the urgent need for treatment options that provide relief for patients,” said Dan Iosifescu, M.D., Professor of Psychiatry at NYU Grossman School of Medicine. “Synthetic thyroid hormone has long been known to provide benefit as an adjunctive treatment for MDD, and a highly potent and selective TRβ agonist may offer the therapeutic benefits of synthetic thyroid hormone, with a safety profile that enables chronic use for optimal patient management.” AMPLIFY is a placebo-controlled, double-blind Phase 2 trial in 230 adults with moderate-to-severe depression. The trial will evaluate the safety, tolerability, efficacy and pharmacodynamic (PD) effects of ABX-002 as an adjunctive treatment to patients’ current selective serotonin reuptake inhibitor (SSRI) or serotonin-noradrenaline reuptake inhibitor (SNRI). The primary endpoint is the change from baseline on the Hamilton Depression Rating Scale-17 (HAMD–17) after six weeks of treatment. Key secondary endpoints include changes from baseline on the HAMD-29 to assess improvements on atypical depression symptoms, the Montgomery–Åsberg Depression Rating Scale (MADRS), and other measures of clinical improvement. “We are thrilled to initiate this Phase 2 trial of ABX-002, marking a substantially evolved profile for Autobahn as a mid-stage development company progressing multiple clinical development candidates,” said Gudarz Davar, M.D., Executive Vice President, Head of Research and Development for Autobahn. “The clinical data we’ve generated with ABX-002 support its promise as a brain-penetrating, centrally active thyromimetic with favorable safety, and give us greater confidence in its potential as a game-changing treatment for depression, especially for patients who remain underserved by today’s treatment options. Our team is dedicated to advancing innovative therapies that have the potential to transform lives, and this milestone with ABX-002 is a significant step toward achieving our vision.” Autobahn anticipates reporting topline data from the AMPLIFY Phase 2 trial of ABX-002 in patients with MDD in the second half of 2025. In addition, by yearend 2024, Autobahn plans to initiate a second Phase 2 trial with ABX-002 in patients with bipolar disorder depression, a chronic and difficult mental health condition. About Autobahn Therapeutics Autobahn Therapeutics is a biotechnology company developing a portfolio of neuropsychiatric and neuroimmunologic clinical candidates leveraging its brain-targeting chemistry platform. Autobahn aims to unlock new therapeutic opportunities through precision tuning of CNS exposure, pursuing validated clinical and biologic targets, and guiding development with biomarkers. The company’s pipeline is led by ABX-002, a thyroid hormone receptor beta (TRβ) agonist being developed as a potential adjunctive treatment for people with major depressive disorder and bipolar disorder depression. Autobahn Therapeutics is based in San Diego. For more information, visit www.autobahntx.com . About ABX-002 ABX-002 is an orally administered, potent and selective thyroid hormone beta receptor (TRβ) agonist designed to enhance the CNS benefits of thyroid hormone biology while also reducing the peripheral liabilities of synthetic thyroid hormone (e.g., triiodothyronine, T3), a treatment which has shown efficacy in numerous placebo-controlled human studies across MDD and bipolar disorder depression. Thyroid hormone agonism has demonstrated activity on cellular energy metabolism pathways, which play an important role on the regulation of brain bioenergetics and may be uniquely suited to address symptoms of atypical depression, a highly prevalent and underserved sub-population of MDD. In nonclinical and clinical studies, ABX-002 has demonstrated optimized PK properties, target engagement in brain regions associated with depression, and an attractive safety and tolerability profile. SOURCE: Autobahn Therapeutics

临床2期临床1期临床结果

2024-08-25

·行舟Drug

国家集中采购药品与基本药物目录收录药品比较

点击上方的行舟Drug ▲ 添加关注国家集中采购药品与基本药物目录收录药品比较来源《医药导报》 2024年7月第43卷第7期作者邓晓媚，张瑾，张哲弢，李会婷，柳晓，马旖旎，吴文信，史天陆中国科学技术大学附属第一医院（安徽省立医院）药学部；精准药物制剂与临床药学安徽省重点实验室摘要目的：比较第1~8批国家组织集中采购（集采）药品与2018年版国家基本药物（基药）目录的差异，分析药品品种差异的原因，为更新和完善我国基药目录以及国家集采药品政策提供参考。方法：收集并整理集采药品目录与基药目录中药品类别、品种、规格、剂型等信息，通过归类比较找出其中差异，分析原因。结果：39%集采药品为基药；按药理学分类，基药中有40种药品集采药品未涉及；抗凝血药及溶栓药类药品中，同时属于基药和集采的药品品种占比小于品规占比。结论：集采药品与基药目录存在差异，具有一定的合理性，同时也存在待完善的问题。关键词国家药品集中采购；国家基本药物；比较 _ 正文 _ 国家基本药物（简称基药）是适应基本医疗卫生需求，保障供应，公众可公平获得的药品[1]，是临床用药的首选[2]。我国现行的2018年版《国家基本药物目录》优化了药品结构，可满足常见病、慢性病以及负担重、危害大疾病和公共卫生等方面的基本用药需求，并注重儿童等特殊人群用药[3]。为深化医药卫生体制改革，完善药品价格形成机制，减轻患者药费负担，提高群众用药安全，2018—2023年，国家多部委多次通过国家药品集中采购（简称集采）相关方案[4⁃6]，且组织完成了集采工作8批。但与此同时，药品使用、种类范围、落实情况等方面问题依然存在[7]。集采药品目录和基药目录虽然制定背景不同，但都作为临床合理用药的重要参考，同时为医疗机构药品使用考核指标。两者在药品选择范围上的差异，可能导致医生临床决策时产生困惑，从而对医疗服务质量稳定性产生一定影响。因此，本研究通过比较上述两目录药品异同，分析差异原因，以期提高基药目录和集采目录在满足临床需求和不断完善方面的协调配合，同时减少临床医生用药选择困惑，提高药品使用合理性和医疗服务质量。 1 资料与方法第1—8批集采目录参考上海阳光医药采购网[8]，基本药物见2018年版基药目录[3]。剂型或规格不同、主要化学成分或处方组成相同药品的列为同一品种；通用名、规格和剂型均相同的列为同一品规。双人核对药品品种及品规。将集采药品分为2种情况：（1）双属性药品：药品同时被列入集采和基药目录；（2）非双属性药品：①名称不同，如集采目录中为厄贝沙坦片，基药目录中为缬沙坦片；②剂型不同，如集采目录中为甲钴胺片，基药目录中为甲钴胺胶囊；③规格不同，如集采目录中为达比加群酯胶囊75mg，基药目录中为达比加群酯胶囊110mg和150mg。药理学分类参考药品采购使用管理分类代码与标识码（行业标准WS/T778⁃2021）中化学药品药理分类与代码及基本药物药理学分类，将基药目录和集采药品进行药理学分类汇总，描述药品分类并统计差异，统计双属性药品在基药目录中的品种占比和品规占比。具体方法举例：硝基咪唑类，基药品种为甲硝唑、替硝唑，集采品种为甲硝唑、替硝唑和奥硝唑，因此甲硝唑和替硝唑列为双属性药品，双属性药品在基药中的品种占比为100%；基药中甲硝唑品规为片剂0.2g、胶囊剂0.2g、甲硝唑氯化钠注射液100mL: 0.5g，替硝唑品规为片剂0.5g、胶囊剂0.5g。集采药品为甲硝唑片剂0.2g、氯化钠注射液100mL: 0.5g，替硝唑规格为片剂0.5g，奥硝唑规格为片剂0.25g和0.5g、注射液3mL: 0.5g和6mL: 1g。双属性药品品规为甲硝唑片剂0.2g、甲硝唑氯化钠注射液100mL: 0.5g、替硝唑片剂0.5g，双属性药品在基药中的品规占比为60%。文章内容由凡默谷小编查阅文献选取，排版与编辑为原创。如转载，请尊重劳动成果，注明【来源：凡默谷公众号】。 2 结果 2.1 基药目录与集采药品目录基本统计描述对基药目录进行品规拆分，对第1—8批集采目录进行品种合并，基药目录中基本药物化学药品和生物制品部分依据药理学分类，共涉及108个类别，共计417个品种，1126个品规。集采药品目录涉及72个类别，共计279个品种，443个品规，见图1。 2.2 基药与集采药品的药理学分类差异参照基药目录，集采药品覆盖其68个药理学分类，占比63.0%，详见表1。按照药理学分类，集采药品数量排名前10位的药理学类别分别是头孢菌素类，胰岛素及口服降糖药，抗高血压药，解热镇痛、抗炎、抗风湿药，抗精神病药，抗凝血药及溶栓药，抗病毒药，抗抑郁药，抗酸药及抗溃疡病药。大部分集采药品收录药品品种数少于基本药物，见图2。头孢菌素类、其他抗菌药、硝基咪唑类、良性前列腺增生用药、抗肿瘤植物成分药、抗肿瘤激素类药、抗痴呆药和利胆药类，集采药品收录品种数高于或等于基本药物，见图3。 2.3 集采药品双属性药品的占比集采药品目录中有171个（38.6%）为双属性药品；272个（61.4%）为非双属性药品，其中名称不符占64%，剂型不符占25%，规格不符占11%。 2.4 按药理学分类双属性药品占比集采药品中良性前列腺增生用药、硝基咪唑类药物、抗甲状旁腺药物、局部麻醉药、头孢菌素类药物、喹诺酮类药物、利胆药的双属性药品品种占比达100%。抗凝血药及溶栓药，品种占比为29%，品规占比为38%，其他类别双属性药品品种占比均高于品规占比，见图4。 3 讨论由国家卫生健康委员会联合国家中医药管理局发布的《国家基本药物目录》与国家组织药品集中采购和使用试点工作小组制定的药品集中带量采购目录，其目的均为规范医疗行为，促进合理用药。因此，两者纳入的药品存在共性，如集采药品数量排名前3的药理学类别为头孢菌素类、胰岛素及口服降血糖药和抗高血压药，这与基本药物目录高度重合，考虑感染、糖尿病、高血压作为常见病和慢性病的医疗费用较高以及患者疾病负担较重。但两者功能定位方面存在明显差异，基药是保证临床首选，防治必需，而集采政策旨在将基本医保药品目录内用量大、采购金额高的药品纳入采购范围，逐步覆盖国内上市的临床必需、质量可靠的各类药品，做到应采尽采。因此两目录内药品存在差异，并具有一定合理性，同时也存在待完善问题。 3.1 两者差异合理性本研究发现，在同一药理学分类下，两者纳入药品品种存在差异，此种差异由两者的功能定位不同所致。以抗菌药物为例，集采目录纳入了更多的限制使用级及特殊使用级抗菌药物。考虑因基本药物核心理念为保障防治必需用药，结合抗菌药物的分级管理政策，并未过多纳入限制使用级及特殊使用级抗菌药物。集采药品政策要求结合医保药品目录，覆盖使用量大、采购金额高的药品，随着细菌耐药性的攀升和新型抗菌药物的研发，更多的抗菌药物被纳入到集采目录，其中就包括各种限制级和特殊使用级抗菌药物。本研究显示，基本药物目录中尚有40种药理学分类药物未纳入集采，考虑部分药品使用具有局限性，受总体用量及金额所限，尚不适用于现阶段集采机制。如抗血吸虫病药物等抗寄生虫药，其疾病发病率存在地域性，该类药物属于药品实施分类采购的按照国家规定采购方式进行采购（如麻精药品、传染病和寄生虫病免费用药、部分疫苗、计划生育药品和中药饮片），为国家规定采购方式[9]；抗重症肌无力药如新斯的明和溴吡斯地明主要用于罕见病治疗[10]，解毒药所治疗的中毒疾病发生具有不确定性，需求量均较低，生产企业缺乏积极性[11]。 3.2 两者差异待完善性双属性药品同时具备临床必需及价格优势，因此扩大双属性药品的范围有助于减轻群众用药负担，且有助于医疗机构完成基本药物和集采药品政策的双重考核。部分类别药品可以考虑纳入集采范畴，包括：①肠内营养药。营养不良作为全球性问题，各国指南均推荐对于存在营养风险和营养不良的患者进行营养治疗。尤其对于肿瘤患者、克罗恩病患者等炎症性肠病患者，营养支持是一种重要治疗手段[12⁃13]。对于存在或部分存在胃肠道消化吸收功能的患者，应优先考虑使用肠内营养治疗，而肠内营养制剂价格较高，限制了其临床使用，减少了患者获益。目前集采药品已部分覆盖肠外营养药，但未涉及肠内营养药物，该类药品可以考虑纳入集采范畴。②肝病辅助治疗药。感染性疾病、免疫功能异常、肿瘤、血液循环障碍等疾病均可能造成一定程度的肝脏损伤，同时抗肿瘤药、免疫抑制剂、抗结核药、部分中草药等药物也可能对患者的肝功能造成影响[14]。我国肝病辅助用药物处方量呈上升趋势[15]，医疗费用压力较大，该类药品纳入集采，可以发挥政策价格优势同时有助于规范药品合理使用。③甲状腺疾病药物。最新调查结果显示，我国老年人甲状腺疾病总体患病率50.96%[16]，甲状腺疾病的常用药物如左甲状腺素钠片、甲巯咪唑等临床使用量较高，单价适中，但考虑其总体销售金额较高，部分省份已将其纳入区域集采目录，建议纳入国家集采目录。④中成药。作为中华文化文明的瑰宝，中医中药在防治疾病方面发挥了其独特的优势，尤其在治疗新型冠状病毒感染中发挥了重要作用[17]。但中成药尚无一致性评价，需进一步探索符合中成药特点的集采方式。另一方面，抗凝血药达比加群酯，基本药物目录纳入品规为110和150mg2种，集采目录在此基础上增加了75mg品规；临床实际治疗过程中，常用治疗方案为每日2次，每次110或150mg，而非75mg；从药物经济学角度看，中标的达比加群酯胶囊150mg规格单粒最低价格4.58元，75mg规格单粒价格为4.75元，可见，75mg规格并不具有更高的经济学优势，提示国家集采政策应结合药物经济学评价进一步优化准入细则。综上所述，本研究以目录为抓手，分析集采药品与基药目录的异同。两者均重点关注常见病及慢性病等常用药物。集采药品药理学分类覆盖率有待进一步扩大，建议纳入肠内营养药、肝病辅助治疗药及甲状腺疾病药物等，适当提高双属性药品的占比可以更有效地实现合理用药安全性、有效性和经济性。同时集采政策应进一步关注临床用药合理性，建立相应调入和调出机制，并积极探索罕见病药、中成药适宜采购方式。参考文献详见《医药导报》 2024年7月第43卷第7期文章信息源于公众号凡默谷，登载该文章目的为更广泛的传递行业信息，不代表赞同其观点或对其真实性负责。文章版权归原作者及原出处所有，文章内容仅供参考。本网拥有对此声明的最终解释权，若无意侵犯版权，请联系小编删除。学如逆水行舟，不进则退；心似平原走马，易放难收。行舟Drug 每日更新欢迎订阅+ 医药大数据|行业动态|政策解读

带量采购

100 项与左甲状腺素钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01010	左甲状腺素钠	H03AA01	DB00451

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
分化型甲状腺癌	美国	Mylan Pharmaceuticals, Inc.	2022-04-29
粘液性水肿昏迷	美国	Fresenius Kabi USA LLC	2011-06-24
垂体功能亢进	美国	King Pharmaceuticals Research & Development LLC	2001-05-25
甲状腺功能亢进症	中国	深圳市中联股份合作公司	2000-01-01
甲状腺癌	中国	深圳市中联股份合作公司	2000-01-01
甲状腺肿	日本	ASKA Pharmaceutical Co., Ltd.	1998-02-12
粘液水肿	日本	ASKA Pharmaceutical Co., Ltd.	1998-02-12
先天性甲状腺功能减退症	日本	ASKA Pharmaceutical Co., Ltd.	1994-09-07
甲状腺功能减退症	日本	Takeda Pharmaceutical Co., Ltd.	1964-08-07

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04782856 (CTgov)	临床2期	甲状腺功能减退症 \| 甲状腺肿 \| 甲状腺癌	13	Placebo+Levothyroxine (Single Therapy)	襯壓淵獵製遞獵憲淵齋(鑰襯構鹹簾餘積夢齋繭) = 網廠襯範獵襯鑰網積淵淵願積觸糧廠艱鏇願襯 (鑰糧積夢網範鹽願構淵, 觸繭願淵獵簾鹽夢構衊 ~ 糧獵壓繭糧顧選齋憲衊) 更多	-	2024-06-14
				Liothyronine+Levothyroxine (Combination Therapy)	襯壓淵獵製遞獵憲淵齋(鑰襯構鹹簾餘積夢齋繭) = 餘糧衊網憲網範鹽築範淵願積觸糧廠艱鏇願襯 (鑰糧積夢網範鹽願構淵, 壓遞獵繭膚衊製襯糧壓 ~ 網顧願獵壓鏇憲觸鏇範) 更多
NCT05823012 (Biospace) 人工标引	临床2期	甲状腺功能减退症	46	XP-8121	願膚襯鑰鬱範艱鬱齋艱(衊壓鹽鏇鏇繭構膚簾積) = 鹹簾餘壓願襯壓繭鑰積鬱夢遞選製鬱醖淵獵鹽 (淵鏇鏇餘製繭艱襯繭壓 )	积极	2024-05-30
NCT04415658 (CTgov)	临床3期	心脏衰竭 \| 脑死亡	838	Thyroxine (Thyroxine)	鬱構糧糧鑰蓋鹽憲遞願(築鏇鬱構積醖餘鹽鑰膚) = 醖繭夢廠襯鏇鑰鬱淵簾憲鏇鹽繭齋獵選選夢網 (鏇製蓋鹽築網鏇衊觸鹽, 築積膚衊鏇蓋鬱範範齋 ~ 觸艱繭築積獵糧鬱獵襯) 更多	-	2024-01-10
				Saline (Saline Placebo)	鬱構糧糧鑰蓋鹽憲遞願(築鏇鬱構積醖餘鹽鑰膚) = 網鑰獵簾餘艱蓋衊範淵憲鏇鹽繭齋獵選選夢網 (鏇製蓋鹽築網鏇衊觸鹽, 蓋選鹽構壓膚願壓築廠 ~ 醖鏇選膚廠蓋積範選窪) 更多
P-166 (ESMO_GI2023)	N/A	转移性结直肠癌一线 RAS wild type \| RAS mutated \| BRAF mutant	139	Levothyroxine	網顧廠鹽積衊獵膚願鏇(鹽壓製鬱廠鹹鏇構繭顧) = 鬱淵餘選築觸築顧選鹽蓋構鹹願鹽蓋餘艱鏇窪 (艱鹹願艱選壓糧醖淵襯 ) 更多	不佳	2023-07-01
				No Levothyroxine	網顧廠鹽積衊獵膚願鏇(鹽壓製鬱廠鹹鏇構繭顧) = 淵構艱鹽簾遞鏇觸顧構蓋構鹹願鹽蓋餘艱鏇窪 (艱鹹願艱選壓糧醖淵襯 ) 更多
NCT03094416 (CTgov)	临床4期	甲状腺功能减退症	66	Tirosint (Tirosint Capsules)	夢衊鬱鏇構獵廠築鏇遞(顧鏇淵積糧齋繭製淵簾) = 鑰膚顧壓艱製憲廠憲衊夢獵壓積膚醖夢積觸襯 (醖窪艱鑰鹽簾構鹹觸餘, 鏇觸齋鏇製糧廠膚夢醖 ~ 顧鹽餘糧築夢淵獵遞網) 更多	-	2022-04-05
				Tirosint (Treatment Period: Tirosint Capsules)	餘艱鏇淵淵衊糧淵淵網(蓋鹽衊窪襯鏇獵鏇簾網) = 壓構鹽艱顧憲鹹糧積鏇獵蓋窪憲鬱壓廠衊餘衊 (衊遞選鏇構膚衊選鑰製, 夢鑰構壓蓋鏇淵網窪窪 ~ 願蓋鑰範醖鹽繭蓋鑰鹹) 更多
NCT01660126 (TRUST, Pubmed \| Bone)	临床4期	甲状腺功能减退症	98	Levothyroxine therapy	(顧鹹齋選襯選簾廠襯醖): %ΔBMC = 0.3 (95% CI, -0.7 ~ 1.21), P-Value = 0.91	不佳	2022-04-02
				Placebo
NCT01660126 (Pubmed \| J Clin Endocrinol Metab)	临床4期	甲状腺功能减退症	669	Levothyroxine	鹽積餘鬱憲餘衊齋積築(壓網窪遞願顧積選鹹範) = 膚襯鹹築襯簾艱鹹築夢齋衊夢構構繭鬱鑰夢膚 (齋膚艱衊鏇膚蓋鬱鏇鬱, -0.16 ~ 0.11)	-	2022-02-26
Pubmed \| Front Endocrinol (Lausanne)	N/A	低甲状腺素血症	-	L-T4 treatment	鬱窪壓衊選繭選簾選艱(觸築願壓廠蓋選淵鑰醖): adjusted odds ratio = 1.36 (95% CI, 1.01 ~ 1.83), P-Value = 0.04	-	2022-01-01
				No L-T4 treatment