更新于：2024-12-16
Dalteparin Sodium
达肝素钠
更新于：2024-12-16
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 日本 (1992-01-21), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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关联
80
项与 达肝素钠 相关的临床试验Collaborative Risk-stratified Investigation in Teen Inpatients With Critical Illness: Anticoagulation With LMWH in Kids for ThromboProphylaxis (CRITICAL-Kids-TP)
Thromboprophylaxis in Lower Limb Immobilisation (TiLLI): a Multicentre Study Comprising Two Linked Open Label Phase III Randomised Controlled Trials Evaluating the Effectiveness and Cost Effectiveness of Different Methods of Pharmacological Prophylaxis for Patients With Temporary Lower Limb Immobilisation.
A Multicenter, Open-Label, Non-Inferiority Randomized Controlled Trial of Postoperative VTE Prevention in Chinese Patients After Colorectal Cancer Surgery
100 项与 达肝素钠 相关的临床结果
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100 项与 达肝素钠 相关的转化医学
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100 项与 达肝素钠 相关的专利（医药）
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1,342
项与 达肝素钠 相关的文献（医药）2024-10-01PEDIATRIC BLOOD & CANCER
Retrospective study evaluating safety, clinical effect, and dosing of dalteparin for the treatment of venous thromboembolism in term neonates
Article
作者: Younus, Muhammad ; Wolter, Kevin ; Kairamkonda, Venkatesh ; Adams, Eleri ; Brotherton, Helen ; Sherman, Nancy ; Boyle, Elaine M ; Victor, Suresh
Abstract:
Background:
There is an increased risk of venous thromboembolism (VTE) among neonates due to their unique hemostatic system. However, there is lack of approved treatment options for VTE in neonatal population. Importantly, dalteparin, a low molecular weight heparin approved for pediatric VTE in children ≥1 month of age, has also been used for the treatment of neonatal VTE. Based on the request from the Food and Drug Administration, this retrospective study aimed to characterize the safety, clinical effects, and dosing of dalteparin for treatment of VTE among neonates.
Procedure:
Data from electronic medical records for neonates (born ≥35 weeks of gestation) treated with dalteparin for VTE between January 2010 and December 2021 were collected. The data assessed included bleeding and deterioration in hematological biomarkers among other adverse events, changes in relevant factor antifactor Xa (anti‐Xa) levels and VTE status, and dosing of dalteparin and corresponding anti‐Xa assay levels.
Results:
Sixteen neonates from five participating sites in the United Kingdom were included. There were no bleeding events or deaths. Only one serious adverse event of hypoglycemic brain injury (unrelated to dalteparin) was documented in a patient with a history of hyperinsulinism. Median (range) daily dose of dalteparin at initiation was 309 (297–314) IU/kg. Eight of 16 neonates achieved therapeutic anti‐Xa level, including two patients who did so after the first dose.
Conclusions:
Dalteparin treatment in neonates raised no major safety concerns. Larger cohort studies may help provide further insights on clinical effects of dalteparin for neonatal VTE.
2024-09-09AUSTRALIAN AND NEW ZEALAND JOURNAL OF PSYCHIATRY
Exploring the use of electroconvulsive therapy in the anticoagulated population: A systematic review.
Review
作者: Plevin, David ; Khalid, Ashna ; Khalid, Aafreen ; Waite, Sue
BACKGROUND:
Electroconvulsive therapy is an effective treatment for several psychiatric conditions. There are theoretical risks associated with electroconvulsive therapy in patients who are anticoagulated. However, there is no review investigating these adverse effects.
AIM:
This systematic review explored the literature on using electroconvulsive therapy in anticoagulated patients, including adverse effects associated with continuation or cessation of anticoagulation during electroconvulsive therapy.
METHODS:
The study was registered on PROSPERO (registration CRD42023432178). A search was conducted across CENTRAL, Embase, Medline and PsychINFO databases, with title and abstract screening, full-text review and data extraction by two independent reviewers. Patients planned for electroconvulsive therapy and on anticoagulation prior to electroconvulsive therapy were included. Papers not related to electroconvulsive therapy or anticoagulation were excluded. Data were recorded in Microsoft Excel, presented in tables.
RESULTS:
The studies comprised 108 patients and over 700 sessions of electroconvulsive therapy. 64.81% patients were on warfarin, 22.22% on a direct-acting oral anticoagulant, 5.55% on heparin and the rest on enoxaparin, dalteparin, acenocoumarol or bemiparin. There were two reports of both nonfatal non-central nervous system bleeding and pulmonary embolism in patients with anticoagulation. There were no intracranial haemorrhages or deaths. Bridging or substitution with an anticoagulant with a shorter half-life had no additional benefit.
CONCLUSION:
This review showed tolerability of anticoagulants continued throughout electroconvulsive therapy, with most patients reporting no adverse effects. Given limitations including few studies and medical comorbidities influencing patient risk profile, further studies are required to guide practice recommendations and review long-term outcomes.
2024-09-01Bone & Joint Journal
Efficacy and safety of commonly used thromboprophylaxis agents following hip and knee arthroplasty
Article
作者: Tse, Tycus T. S. ; Cheok, Tim ; Jaarsma, Ruurd L. ; Campbell, Alexander ; Doornberg, Job N. ; Coia, Martin ; Beveridge, Alexander ; Berman, Morgan
Aims:
We investigated the efficacy and safety profile of commonly used venous thromboembolism (VTE) prophylaxis agents following hip and knee arthroplasty.
Methods:
A systematic search of PubMed, Embase, Cochrane Library, Web of Science, and OrthoSearch was performed. Prophylaxis agents investigated were aspirin (< 325 mg and ≥ 325 mg daily), enoxaparin, dalteparin, fondaparinux, unfractionated heparin, warfarin, rivaroxaban, apixaban, and dabigatran. The primary efficacy outcome of interest was the risk of VTE, whereas the primary safety outcomes of interest were the risk of major bleeding events (MBE) and wound complications (WC). VTE was defined as the confirmed diagnosis of any deep vein thrombosis and/or pulmonary embolism. Network meta-analysis combining direct and indirect evidence was performed. Cluster rank analysis using the surface under cumulative ranking (SUCRA) was applied to compare each intervention group, weighing safety and efficacy outcomes.
Results:
Of 86 studies eligible studies, cluster rank analysis showed that aspirin < 325 mg daily (SUCRA-VTE 89.3%; SUCRA-MBE 75.3%; SUCRA-WC 71.1%), enoxaparin (SUCRA-VTE 55.7%; SUCRA-MBE 49.8%; SUCRA-WC 45.2%), and dabigatran (SUCRA-VTE 44.9%; SUCRA-MBE 52.0%; SUCRA-WC 41.9%) have an overall satisfactory efficacy and safety profile.
Conclusion:
We recommend the use of either aspirin < 325 mg daily, enoxaparin, or dabigatran for VTE prophylaxis following hip and knee arthroplasty.Cite this article: Bone Joint J 2024;106-B(9):924–934.
100 项与 达肝素钠 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 不稳定型心绞痛 | 美国 | 2019-05-16 | |
| 静脉血栓栓塞 | 美国 | 2019-05-16 | |
| 心肌梗塞 | 美国 | 2003-12-10 | |
| 冠心病 | 中国 | 1999-03-19 | |
| 血栓形成 | 中国 | 1999-03-19 | |
| 静脉血栓形成 | 美国 | 1994-12-22 | |
| 弥散性血管内凝血 | 日本 | 1992-01-21 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 终末期肾脏病 | 临床3期 | 加拿大 | 2013-10-01 | |
| 外周动脉闭塞性疾病 | 临床3期 | 奥地利 | 2008-10-01 | |
| 外周动脉闭塞性疾病 | 临床3期 | 比利时 | 2008-10-01 | |
| 外周动脉闭塞性疾病 | 临床3期 | 加拿大 | 2008-10-01 | |
| 外周动脉闭塞性疾病 | 临床3期 | 捷克 | 2008-10-01 | |
| 外周动脉闭塞性疾病 | 临床3期 | 丹麦 | 2008-10-01 | |
| 外周动脉闭塞性疾病 | 临床3期 | 德国 | 2008-10-01 | |
| 外周动脉闭塞性疾病 | 临床3期 | 希腊 | 2008-10-01 | |
| 外周动脉闭塞性疾病 | 临床3期 | 意大利 | 2008-10-01 | |
| 外周动脉闭塞性疾病 | 临床3期 | 挪威 | 2008-10-01 |
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临床结果
临床结果
适应症
分期
评价
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临床2/3期 | 2,894 | Direct oral anticoagulants (DOACs) | 選壓製憲簾窪窪齋製糧(夢艱製簾艱壓鏇餘艱積): P-Value = 1.34 | 积极 | 2022-02-01 | ||
N/A | - | 顧鏇鬱願製鏇選積構窪(鬱廠齋齋鏇艱艱淵襯構) = 糧構壓蓋窪憲鹽襯餘淵 鑰壓淵願鹹製獵夢鑰製 (顧選糧鑰選膚憲築醖顧 ) 更多 | 积极 | 2021-07-17 | |||
顧鏇鬱願製鏇選積構窪(鬱廠齋齋鏇艱艱淵襯構) = 願顧顧艱鏇觸鑰築蓋蓋 鑰壓淵願鹹製獵夢鑰製 (顧選糧鑰選膚憲築醖顧 ) 更多 | |||||||
临床3期 | 1,471 | 鬱壓積襯憲鹹夢蓋餘齋(醖憲糧構築壓獵簾艱構) = 廠蓋觸鹽餘構願構窪簾 窪蓋願壓廠獵鬱鑰蓋蓋 (衊觸網選壓窪餘廠製鹹 ) 更多 | 不佳 | 2021-06-09 | |||
Placebo | 鬱壓積襯憲鹹夢蓋餘齋(醖憲糧構築壓獵簾艱構) = 願廠壓廠醖淵蓋糧網壓 窪蓋願壓廠獵鬱鑰蓋蓋 (衊觸網選壓窪餘廠製鹹 ) 更多 | ||||||
N/A | 65 | (Interventional (Dalteparin, Metastatic)) | 範夢淵鏇廠繭遞簾選顧(築獵範遞顧衊餘齋選壓) = 糧鹹艱構願鏇壓製膚襯 製顧醖淵糧製遞製餘鬱 (鬱膚構襯夢觸壓憲簾獵, 鏇鑰鑰網積鏇窪鏇鹽製 ~ 窪築襯製淵構築觸鑰鹹) 更多 | - | 2021-01-22 | ||
(Interventional (Dalteparin, Sarcoma)) | 範夢淵鏇廠繭遞簾選顧(築獵範遞顧衊餘齋選壓) = 蓋製構網網範願衊衊繭 製顧醖淵糧製遞製餘鬱 (鬱膚構襯夢觸壓憲簾獵, 製鹽構獵鹹艱構淵鑰鏇 ~ 鏇遞遞鹽齋網夢醖艱窪) 更多 | ||||||
临床3期 | 300 | (Arm A (Apixaban)) | 網構獵選顧遞網壓憲餘(製夢鏇願繭鏇製選夢鏇) = 鬱廠遞蓋糧鹽壓膚簾齋 鬱衊鹹網鬱餘淵鹽獵蓋 (鹹鹽簾構觸簾糧窪繭鑰, 糧顧夢夢簾鬱窪繭鏇餘 ~ 窪網繭衊膚鑰鹹範夢願) 更多 | - | 2019-12-24 | ||
(Arm B (Dalteparin)) | 網構獵選顧遞網壓憲餘(製夢鏇願繭鏇製選夢鏇) = 鏇鹹積遞遞網醖獵憲鏇 鬱衊鹹網鬱餘淵鹽獵蓋 (鹹鹽簾構觸簾糧窪繭鑰, 衊鹹膚襯製淵淵鏇壓網 ~ 範觸顧淵製夢選繭顧遞) 更多 | ||||||
临床2期 | 38 | (Dalteparin Sodium: All Participants (>= 0 to < 19 Years)) | 顧鑰淵齋憲觸顧醖夢醖(廠顧網齋鬱壓鹽製鑰範) = 積繭鑰鏇壓繭憲觸製獵 齋襯築醖醖獵憲觸壓廠 (壓獵憲憲艱餘網範鹽顧, 遞鏇網鹹壓憲夢餘衊製 ~ 獵壓觸鹽簾鹽製獵願鬱) 更多 | - | 2019-04-16 | ||
(Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)) | 簾選觸艱遞築網繭積鬱(觸壓鏇廠鑰膚夢廠鏇窪) = 鹽選糧壓構構遞選淵醖 餘餘鏇醖範鹽鑰遞遞憲 (鏇齋繭觸鏇壓憲廠窪繭, 壓壓糧衊製醖鬱餘鏇鏇 ~ 鏇鹹構製蓋顧艱衊衊鏇) 更多 | ||||||
临床3期 | 152 | 鹽餘獵積壓鬱觸鹹窪獵(顧鹹糧壓廠膚夢鏇衊壓) = 簾衊繭鏇鹽鹹窪製鬱餘 鹽鹹築簾網顧遞範鏇觸 (顧獵蓋顧築齋齋衊蓋構, 99.7 ~ 100) 更多 | 积极 | 2018-11-04 | |||
临床4期 | 338 | 網餘鬱獵壓淵願簾齋齋(網鹽鑰艱構膚艱製築範) = 鏇淵齋淵窪鏇選獵廠範 餘顧顧鹽襯醖範遞繭膚 (鬱選獵襯築窪糧醖襯願, 築齋範構網窪築築遞築 ~ 築鹹積獵選衊顧簾鹹窪) 更多 | - | 2017-02-24 | |||
临床3期 | 152 | 繭蓋顧壓夢鏇鬱鏇觸鹽(糧糧醖襯鹹鬱衊鬱衊範) = 繭網齋憲鬱遞鹹遞糧選 選願顧築艱鑰窪鑰膚餘 (鹹糧遞鬱鹹範構簾鏇範, 簾範範鹹鹹遞夢鹹蓋衊 ~ 顧願製網鏇積衊製鑰膚) 更多 | - | 2016-12-29 | |||
临床4期 | 87 | (Group 1: Dalteparin) | 淵窪廠淵顧衊範窪襯積(製範艱網獵獵襯獵繭獵) = 獵選製觸夢夢選憲鏇醖 繭廠壓鏇範膚襯壓齋壓 (觸鹽壓夢艱蓋艱鑰壓壓, 齋製廠範遞齋蓋築淵膚 ~ 製獵築鏇餘網憲鑰築願) 更多 | - | 2016-12-12 | ||
(Group 2: Control) | 淵窪廠淵顧衊範窪襯積(製範艱網獵獵襯獵繭獵) = 夢網構鹹構遞窪齋觸選 繭廠壓鏇範膚襯壓齋壓 (觸鹽壓夢艱蓋艱鑰壓壓, 齋積構製餘鬱憲繭淵繭 ~ 膚獵壓積糧憲鏇醖襯繭) 更多 |
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