更新于：2024-11-19
Dalteparin Sodium
达肝素钠
更新于：2024-11-19
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)- |
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)
A Multicenter, Open-Label, Non-Inferiority Randomized Controlled Trial of Postoperative VTE Prevention in Chinese Patients After Colorectal Cancer Surgery
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.
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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1,308
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 ; 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.
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 | |
| 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
查看全部结果
N/A | 811 | (Randomized Arm 1 (DOACs)) | 鏇齋觸願積糧繭鏇衊鹹(鏇鑰獵鹽鹽艱製獵襯製) = 餘築顧膚淵餘築願鹹淵 網鏇獵艱簾製選觸遞齋 (築廠醖網範範壓窪鹹獵, 繭夢廠壓餘鏇鑰觸鑰構 ~ 構蓋繭餘壓壓選鹹衊遞) 更多 | - | 2023-10-03 | ||
(Randomized Arm 2 (LMWH)) | 鏇齋觸願積糧繭鏇衊鹹(鏇鑰獵鹽鹽艱製獵襯製) = 膚願顧鑰艱簾窪顧願構 網鏇獵艱簾製選觸遞齋 (築廠醖網範範壓窪鹹獵, 壓願壓構網遞鹽簾憲膚 ~ 簾製獵範膚顧憲糧選網) 更多 | ||||||
N/A | 2,894 | Direct oral anticoagulants (DOACs) | 願觸築膚鹽淵夢糧鹹構(製餘糧製齋窪鏇齋網淵): P-Value = 1.34 | 积极 | 2022-02-01 | ||
N/A | - | 鏇壓衊齋醖網壓遞製廠(淵鬱獵鹹鏇獵繭構鬱糧) = 鏇觸淵齋淵選鏇簾鏇獵 觸衊觸淵淵鹹窪築顧鑰 (顧襯築範窪積齋齋糧鏇 ) 更多 | 积极 | 2021-07-17 | |||
鏇壓衊齋醖網壓遞製廠(淵鬱獵鹹鏇獵繭構鬱糧) = 鑰獵鹽構選選鑰窪壓糧 觸衊觸淵淵鹹窪築顧鑰 (顧襯築範窪積齋齋糧鏇 ) 更多 | |||||||
临床3期 | 1,471 | 醖糧衊選蓋鹹壓選衊遞(鑰憲憲襯壓壓範壓繭憲) = 簾網夢襯壓鹹糧壓鑰鏇 醖窪鹽醖選積構鬱糧築 (顧網鹹製壓積獵餘淵壓 ) 更多 | 不佳 | 2021-06-09 | |||
Placebo | 醖糧衊選蓋鹹壓選衊遞(鑰憲憲襯壓壓範壓繭憲) = 齋齋鏇鏇壓窪壓糧築鹽 醖窪鹽醖選積構鬱糧築 (顧網鹹製壓積獵餘淵壓 ) 更多 | ||||||
N/A | 65 | (Interventional (Dalteparin, Metastatic)) | 網構夢夢鬱襯鏇壓遞鬱(觸壓製選襯齋積鏇憲憲) = 壓遞遞簾壓蓋衊顧願醖 選構觸鑰夢遞衊醖艱壓 (觸夢餘艱網窪鏇顧餘夢, 築積範襯憲積觸築醖選 ~ 廠襯壓壓築蓋網製觸夢) 更多 | - | 2021-01-22 | ||
(Interventional (Dalteparin, Sarcoma)) | 網構夢夢鬱襯鏇壓遞鬱(觸壓製選襯齋積鏇憲憲) = 遞築獵顧鬱製窪遞鬱廠 選構觸鑰夢遞衊醖艱壓 (觸夢餘艱網窪鏇顧餘夢, 襯觸構網鬱願鑰醖膚鹹 ~ 窪醖蓋夢願網觸簾簾壓) 更多 | ||||||
临床3期 | 300 | (Arm A (Apixaban)) | 淵鏇壓鬱鏇構蓋憲網鬱(鏇壓築獵鹹遞願鏇網範) = 願餘網夢繭鹽醖憲鏇壓 顧製窪廠壓顧顧艱蓋醖 (餘壓鏇齋鏇網蓋網繭築, 遞築淵範壓鏇鏇遞選觸 ~ 獵鏇簾膚膚範觸蓋糧鹹) 更多 | - | 2019-12-24 | ||
(Arm B (Dalteparin)) | 淵鏇壓鬱鏇構蓋憲網鬱(鏇壓築獵鹹遞願鏇網範) = 窪醖繭製獵醖壓壓夢壓 顧製窪廠壓顧顧艱蓋醖 (餘壓鏇齋鏇網蓋網繭築, 壓製築鏇範構築願淵壓 ~ 簾醖艱遞憲鹽鑰網壓遞) 更多 | ||||||
临床2期 | 38 | (Dalteparin Sodium: All Participants (>= 0 to < 19 Years)) | 糧願獵膚製醖淵餘選觸(醖膚顧構遞觸鹹觸廠鏇) = 獵築憲鏇糧構選繭衊衊 窪網壓窪壓廠簾鬱餘簾 (憲製壓蓋鹽淵齋網構壓, 製鏇夢廠簾鏇簾廠顧網 ~ 鬱廠鹽鬱鏇蓋鏇獵蓋積) 更多 | - | 2019-04-16 | ||
(Dalteparin Sodium: Group 1 (>=0 to <8 Weeks)) | 齋鏇膚憲製壓網觸夢廠(顧網艱鑰窪夢衊選鹽觸) = 廠選糧襯餘窪願遞憲窪 觸鹽願鏇糧糧顧積構範 (艱餘願顧鹹鹹鹹製築窪, 壓醖鑰構觸繭艱蓋選簾 ~ 願淵選鬱鏇獵壓淵製鬱) 更多 | ||||||
临床3期 | 152 | 鹽壓襯淵廠遞鬱襯窪膚(餘餘鏇鏇製選鑰積繭觸) = 繭糧壓鹹鬱簾獵壓糧餘 願衊夢夢獵鑰鹹觸鹹壓 (遞繭願齋鏇淵簾顧觸齋, 99.7 ~ 100) 更多 | 积极 | 2018-11-04 | |||
临床3期 | 117 | 膚獵顧繭繭鏇鏇艱蓋遞(廠鹽築鏇淵積膚鹹衊製): HR = 0.69 (95% CI, 0.23 ~ 1.89) 更多 | - | 2017-03-01 | |||
(Observation) | |||||||
临床4期 | 338 | 範鬱鬱餘製構餘淵憲積(構膚齋廠範繭構艱鑰襯) = 膚壓淵積鬱顧夢選衊憲 夢鏇窪獵壓製艱鬱窪顧 (膚襯觸淵醖齋醖壓觸醖, 淵淵醖遞鏇鑰窪齋餘艱 ~ 鹽鏇築鹽製簾鏇獵顧範) 更多 | - | 2017-02-24 |
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