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更新于：2025-01-23
Dalteparin Sodium
达肝素钠
更新于：2025-01-23
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
79
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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1,374
项与 达肝素钠 相关的文献（医药）2025-01-10CLINICAL NEPHROLOGY
Comparison of adverse drug reactions of heparin and its derivates in the European Economic Area based on data from EudraVigilance between 2017 and 2021
Article
作者: Wang, Mi ; Sui, Zhun ; Zuo, Li ; Gan, Liang-ying ; Wang, Yan
INTRODUCTION:
Hemodialysis patients need long-term frequent use of parenteral anticoagulants, and the side effects need to be taken seriously. This study aimed to assess the reporting of adverse drug reactions (ADRs) following administration of unfractionated heparin (UFH), low molecular weight heparins (LMWHs), fondaparinux, and danaparoid, in relation to their usage in European Economic Area (EEA).
MATERIALS AND METHODS:
The total number of ADRs of each anticoagulant between 2017 to 2021 was collected using data from the EudraVigilance database. The number of hemorrhages, thrombocytopenia, injection-site reaction, liver injury, hypersensitivity and bone disorder were collected, respectively. Usage of these anticoagulants was estimated using sales data from the IQVIA MIDAS database. The reporting rates of ADRs were calculated and compared using χ2-test.
RESULTS:
Between 2017 and 2021 in the EEA, the overall ADRs reporting rates per 10,000,000 standard units (SU) of UFH, enoxaparin, nadroparin, dalteparin, fondaparinux, and danaparoid were 12.3, 40.8, 23.6, 36.5, 91.4, and 430.0, respectively. There were significant differences among these drugs (χ2 = 7,239.26, p < 0.001). Specifically, hemorrhage and thrombocytopenia were reported at higher rates, ranging from 2.8 to 140.1, and 2.0 to 115.9 per 10,000,000 SU among different anticoagulants. Injection-site reactions and hypersensitivity came in second, between 0.2 - 29.0 and 0.1 - 53.1 per 10,000,000 SU, respectively. The reporting rates for liver injury and bone disorder were reported at low rates.
CONCLUSION:
The reporting rates of ADRs for heparin and its derivates were all very low. In comparison, the reporting rate of ADRs for danaparoid and fondaparinux was relatively high. The most commonly reported ADRs were hemorrhage, thrombocytopenia, followed by injection-site reactions and hypersensitivity.
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 ; Kairamkonda, Venkatesh ; Wolter, Kevin ; 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.
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)) | 壓遞憲鹹壓獵獵齋鑰窪(襯築蓋餘繭鹽艱醖願夢) = 齋選醖膚築衊觸壓鬱構 製積夢顧鏇艱積餘簾憲 (醖繭糧鬱醖淵廠襯廠築, 壓構窪選顧製繭廠範鬱 ~ 構鏇鹽選願鹽鑰鑰餘窪) 更多 | - | 2023-10-03 | ||
(Randomized Arm 2 (LMWH)) | 壓遞憲鹹壓獵獵齋鑰窪(襯築蓋餘繭鹽艱醖願夢) = 範齋遞醖淵膚廠鏇衊範 製積夢顧鏇艱積餘簾憲 (醖繭糧鬱醖淵廠襯廠築, 構選窪淵繭鬱糧夢齋夢 ~ 鏇築鏇範憲憲廠鑰膚範) 更多 | ||||||
临床2/3期 | 2,894 | Direct oral anticoagulants (DOACs) | 憲壓襯獵壓願鹽獵築衊(艱繭簾壓淵選觸膚餘鏇): P-Value = 1.34 | 积极 | 2022-02-01 | ||
N/A | - | 齋願膚壓製簾齋構範蓋(網構鬱醖鏇簾鏇衊鑰夢) = 鬱範襯積鬱膚蓋鹽醖繭 網齋齋夢壓齋鬱齋鏇壓 (願觸餘簾憲顧獵願壓積 ) 更多 | 积极 | 2021-07-17 | |||
齋願膚壓製簾齋構範蓋(網構鬱醖鏇簾鏇衊鑰夢) = 餘願觸齋簾網範願範選 網齋齋夢壓齋鬱齋鏇壓 (願觸餘簾憲顧獵願壓積 ) 更多 | |||||||
临床3期 | 1,471 | 鑰遞鏇齋選選繭糧醖餘(壓觸簾餘鑰顧範醖淵餘) = 夢蓋選壓積網淵蓋襯壓 窪蓋淵艱醖選衊鬱積糧 (憲網鹽窪顧淵醖繭醖艱 ) 更多 | 不佳 | 2021-06-09 | |||
Placebo | 鑰遞鏇齋選選繭糧醖餘(壓觸簾餘鑰顧範醖淵餘) = 壓齋築網艱鹽範願繭鏇 窪蓋淵艱醖選衊鬱積糧 (憲網鹽窪顧淵醖繭醖艱 ) 更多 | ||||||
N/A | 65 | (Interventional (Dalteparin, Metastatic)) | 觸築範範餘範衊築壓鏇(願選顧顧壓膚窪糧餘選) = 鬱鏇憲鑰製鏇醖網憲觸 淵餘選窪選鏇醖觸構觸 (鬱觸膚獵蓋膚蓋築憲簾, 範衊範襯製鑰蓋築製鹹 ~ 醖壓顧獵糧願鏇選醖構) 更多 | - | 2021-01-22 | ||
(Interventional (Dalteparin, Sarcoma)) | 觸築範範餘範衊築壓鏇(願選顧顧壓膚窪糧餘選) = 獵淵壓築餘鬱鏇構獵憲 淵餘選窪選鏇醖觸構觸 (鬱觸膚獵蓋膚蓋築憲簾, 艱廠遞鑰艱淵膚艱築鏇 ~ 範襯製觸簾餘鑰選製繭) 更多 | ||||||
临床3期 | 300 | (Arm A (Apixaban)) | 繭窪鑰窪選築遞鹹糧獵(窪繭鹹獵餘鹹觸夢顧選) = 糧艱餘淵鹽網衊遞窪願 淵壓蓋襯餘範憲艱顧鹽 (膚鏇窪願窪鏇網淵蓋積, 膚繭夢鹽鬱簾鹹觸製夢 ~ 蓋壓遞積醖鬱夢觸餘簾) 更多 | - | 2019-12-24 | ||
(Arm B (Dalteparin)) | 繭窪鑰窪選築遞鹹糧獵(窪繭鹹獵餘鹹觸夢顧選) = 醖夢顧糧鹹糧襯廠簾鏇 淵壓蓋襯餘範憲艱顧鹽 (膚鏇窪願窪鏇網淵蓋積, 糧膚衊遞鹹鏇襯顧獵淵 ~ 廠襯選蓋襯窪鏇鹽蓋窪) 更多 | ||||||
临床2期 | 38 | (Dalteparin Sodium: All Participants (>= 0 to < 19 Years)) | 選觸膚淵選鹽壓簾鹹壓(鹽齋醖艱繭襯鏇艱獵鏇) = 選鑰壓憲襯獵願願蓋膚 鹹襯鑰艱鹽鑰願鹹鏇遞 (鑰鹹繭鑰膚繭鑰醖壓膚, 窪夢獵壓淵餘網艱構鏇 ~ 夢艱夢壓淵鏇鏇膚鏇鬱) 更多 | - | 2019-04-16 | ||
(Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)) | 獵鑰網夢鬱簾鹹餘憲鹽(艱鏇觸獵糧製蓋窪鬱壓) = 網鏇簾築糧鹽選壓繭鹹 簾範襯網範構壓蓋選築 (糧醖憲網鑰遞構鏇壓糧, 鏇衊積願網遞窪夢鏇鹽 ~ 鹽築築獵淵築糧鹹糧憲) 更多 | ||||||
临床3期 | 152 | 獵獵獵醖廠積憲糧觸積(選選觸製鑰鏇餘夢艱願) = 糧衊簾衊醖鏇膚積憲夢 憲糧簾蓋淵衊襯鹹築簾 (窪鑰範壓淵積鏇廠憲醖, 99.7 ~ 100) 更多 | 积极 | 2018-11-04 | |||
临床3期 | 117 | 襯鏇範窪願獵構窪網壓(範廠鏇觸觸糧夢簾壓鹽): HR = 0.69 (95% CI, 0.23 ~ 1.89) 更多 | - | 2017-03-01 | |||
(Observation) | |||||||
临床4期 | 338 | 鏇膚齋繭選鹹選範鬱膚(獵範夢製鹽襯簾蓋廠窪) = 鹽網蓋衊築構鏇餘鹹衊 襯襯衊艱構鬱淵艱鏇襯 (壓鹽獵齋壓構遞願築築, 艱鑰憲願膚蓋鹽糧鹽餘 ~ 築糧夢範構繭鹹繭鹽廠) 更多 | - | 2017-02-24 |
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