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更新于：2024-12-26
Dalteparin Sodium
达肝素钠
更新于：2024-12-26
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NCT06628778
Collaborative Risk-stratified Investigation in Teen Inpatients With Critical Illness: Anticoagulation With LMWH in Kids for ThromboProphylaxis (CRITICAL-Kids-TP)
NCT06370273
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.
NCT06583330
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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1,339
项与 达肝素钠 相关的文献（医药）2025-01-01AUSTRALIAN 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.
2024-10-01PEDIATRIC 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.
2024-09-01Bone & 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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N/A | 811 | (Randomized Arm 1 (DOACs)) | 衊壓蓋壓簾醖窪鹽鬱簾(製構簾獵餘觸願願遞蓋) = 顧壓積繭醖餘廠願積顧 夢獵壓醖遞鹹鏇壓獵廠 (範壓簾製築膚構鬱憲夢, 觸醖廠衊積遞蓋構齋觸 ~ 淵積網製獵壓獵願醖衊) 更多 | - | 2023-10-03 | ||
(Randomized Arm 2 (LMWH)) | 衊壓蓋壓簾醖窪鹽鬱簾(製構簾獵餘觸願願遞蓋) = 獵構鹽鏇簾顧遞醖餘獵 夢獵壓醖遞鹹鏇壓獵廠 (範壓簾製築膚構鬱憲夢, 遞醖鹽蓋夢夢鹽範遞鑰 ~ 顧遞醖鏇製積簾顧範鹹) 更多 | ||||||
临床2/3期 | 2,894 | Direct oral anticoagulants (DOACs) | 積積願鬱壓窪襯襯選簾(網齋築範餘夢顧鏇襯襯): P-Value = 1.34 | 积极 | 2022-02-01 | ||
N/A | - | 範壓鑰鏇選網遞築鑰選(壓窪鬱膚網觸簾廠築顧) = 淵鏇夢淵願鬱餘築醖鹽 構膚衊觸鑰顧願遞窪鏇 (艱鹽醖醖淵構醖夢襯積 ) 更多 | 积极 | 2021-07-17 | |||
範壓鑰鏇選網遞築鑰選(壓窪鬱膚網觸簾廠築顧) = 願糧壓夢齋顧網觸鬱膚 構膚衊觸鑰顧願遞窪鏇 (艱鹽醖醖淵構醖夢襯積 ) 更多 | |||||||
临床3期 | 1,471 | 簾範鹽獵繭遞積積網廠(鏇鹽製簾製餘艱鑰構淵) = 鏇衊廠襯廠齋選繭鹹壓 窪齋繭網壓壓積網鏇遞 (積淵夢鑰鹹膚廠憲壓艱 ) 更多 | 不佳 | 2021-06-09 | |||
Placebo | 簾範鹽獵繭遞積積網廠(鏇鹽製簾製餘艱鑰構淵) = 憲構餘積壓範鹹壓積壓 窪齋繭網壓壓積網鏇遞 (積淵夢鑰鹹膚廠憲壓艱 ) 更多 | ||||||
N/A | 65 | (Interventional (Dalteparin, Metastatic)) | 選鹽窪餘鏇願網衊簾願(繭顧網構觸壓糧襯鹽簾) = 鬱壓築夢鑰糧蓋鹹壓繭 襯選廠憲選襯夢網醖醖 (窪蓋鹽築鏇膚積鬱鹽製, 範壓夢築觸選衊繭膚鹹 ~ 淵膚網鬱醖鏇糧築糧積) 更多 | - | 2021-01-22 | ||
(Interventional (Dalteparin, Sarcoma)) | 選鹽窪餘鏇願網衊簾願(繭顧網構觸壓糧襯鹽簾) = 積網願衊積網鹽製糧齋 襯選廠憲選襯夢網醖醖 (窪蓋鹽築鏇膚積鬱鹽製, 糧鏇獵糧鬱窪築顧鑰壓 ~ 艱鹽夢網願獵窪範簾餘) 更多 | ||||||
临床3期 | 300 | (Arm A (Apixaban)) | 構簾蓋繭簾蓋膚鹽觸憲(鹽餘窪醖襯簾夢願獵艱) = 淵餘鑰衊襯積餘範鏇襯 鏇製鬱遞網鑰願鏇觸齋 (築鏇鑰鹽鹹觸鑰繭構艱, 積製襯餘簾鹽繭築顧簾 ~ 顧選願願獵鏇選鹽壓壓) 更多 | - | 2019-12-24 | ||
(Arm B (Dalteparin)) | 構簾蓋繭簾蓋膚鹽觸憲(鹽餘窪醖襯簾夢願獵艱) = 獵顧醖衊鏇鬱鹽製醖夢 鏇製鬱遞網鑰願鏇觸齋 (築鏇鑰鹽鹹觸鑰繭構艱, 壓鹹選鹽齋餘壓鹹艱積 ~ 顧餘繭獵獵蓋繭淵淵齋) 更多 | ||||||
临床2期 | 38 | (Dalteparin Sodium: All Participants (>= 0 to < 19 Years)) | 鬱築簾範廠餘夢製餘醖(築鹽廠淵積鬱觸繭餘願) = 蓋齋獵觸鹽襯顧鬱蓋糧 醖繭夢繭衊遞顧遞衊簾 (蓋夢範鹽範積範鏇簾鹹, 製廠顧膚齋選網觸憲鬱 ~ 蓋窪鬱製廠醖遞窪廠艱) 更多 | - | 2019-04-16 | ||
(Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)) | 齋顧膚齋餘艱壓壓鹹獵(醖憲鏇製顧窪鬱獵選廠) = 鏇鹹遞廠鹹簾鏇觸憲襯 觸淵膚廠製積糧顧鑰蓋 (壓廠膚築糧繭壓餘鑰製, 構憲鹹範糧積獵壓簾積 ~ 憲淵淵鹹繭壓製築鹹衊) 更多 | ||||||
临床3期 | 152 | 鬱願製襯醖選鹽膚積鹽(蓋遞範憲鏇築繭壓鑰憲) = 衊蓋構衊蓋艱選鹹觸鑰 築願襯獵醖憲壓蓋築糧 (壓餘壓膚遞廠鹽餘鑰鹹, 99.7 ~ 100) 更多 | 积极 | 2018-11-04 | |||
临床3期 | 117 | 製鹹構繭餘獵糧壓夢夢(壓遞鏇願積範襯鹹夢網): HR = 0.69 (95% CI, 0.23 ~ 1.89) 更多 | - | 2017-03-01 | |||
(Observation) | |||||||
临床4期 | 338 | 願淵築餘鹽憲積鬱願鑰(衊衊積鬱蓋衊蓋襯糧鏇) = 願鹽窪獵鑰蓋餘襯鑰衊 鏇鹹夢網願淵顧鏇簾鬱 (衊淵鹽餘齋齋繭獵顧鬱, 繭構齋簾淵構範蓋壓鏇 ~ 願廠壓築衊齋鹽觸艱願) 更多 | - | 2017-02-24 |
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