Last update 01 Nov 2024

Oedema vascular

Last update 01 Nov 2024

Basic Info

Synonyms

Edema vascular, Oedema vascular, edema vascular

+ [2]

Introduction-

Drugs associated with Oedema vascular

Chlorpheniramine Maleate

Target

H1 receptor

Mechanism

H1 receptor antagonists

Active Org.

Fuji Yakuhin Co., Ltd. [+10]

Originator Org.

Schering Plough A/S

Active Indication

Oedema vascular [+10]

Inactive Indication

Cutaneous hypersensitivity [+3]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date13 Jul 1949

Clinical Trials associated with Oedema vascular

CTR20220095 / CompletedNot Applicable

羟苯磺酸钙胶囊在健康受试者中随机、开放、单剂量、两制剂、两序列、两周期交叉空腹/餐后状态下的生物等效性试验

[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of calcium dobesilate capsules in healthy subjects under fasting/fed conditions

主要目的：健康受试者空腹/餐后状态下，口服单剂量羟苯磺酸钙胶囊（受试制剂T，上海海虹实业（集团）巢湖今辰药业有限公司生产，规格：0.5g）与羟苯磺酸钙胶囊（参比制剂R，Ebewe Pharma Ges.m.b.H.Nfg.KG.，商品名：Doxium®，规格：0.5g）后，考察空腹/餐后条件下受试制剂与参比制剂的吸收速度和吸收程度，评价受试制剂与参比制剂是否具有生物等效性。次要目的：观察受试制剂羟苯磺酸钙胶囊和参比制剂羟苯磺酸钙胶囊（Doxium®）在健康受试者中的安全性。

[Translation]

Primary objective: To investigate the absorption rate and extent of calcium dobesilate capsules (test preparation T, produced by Shanghai Haihong Industry (Group) Chaohu Jinchen Pharmaceutical Co., Ltd., specification: 0.5g) and calcium dobesilate capsules (reference preparation R, Ebewe Pharma Ges.m.b.H.Nfg.KG., trade name: Doxium®, specification: 0.5g) in healthy subjects under fasting/postprandial conditions, and to evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary objective: To observe the safety of the test preparation calcium dobesilate capsules and the reference preparation calcium dobesilate capsules (Doxium®) in healthy subjects.

Start Date06 Jan 2022

Sponsor / Collaborator

Shanghai Haihong Industrial Group Chaohu Jinchen Pharmaceutica

CTR20202695 / CompletedNot Applicable

一项单中心、随机、开放、双周期、自身交叉、单剂量给药设计进行空腹及餐后给药评价羟苯磺酸钙胶囊的人体生物等效性试验

[Translation] A single-center, randomized, open-label, two-period, self-crossover, single-dose design to evaluate the bioequivalence of calcium dobesilate capsules in humans with fasting and fed administration

采用单中心、随机、开放、双周期、自身交叉、单剂量给药设计比较空腹和餐后给药条件下，贵州天安药业股份有限公司生产的羟苯磺酸钙胶囊（规格：0.5 g）与持证商为Ebewe Pharma Ges.m.b.H.Nfg.KG的羟苯磺酸钙胶囊（商品名：Doxium®/导升明®，规格：0.5 g）在中国健康人群中吸收程度和吸收速度的差异，并评价贵州天安药业股份有限公司生产的羟苯磺酸钙胶囊的安全性。

[Translation]

A single-center, randomized, open, two-period, self-crossover, single-dose design was used to compare the differences in absorption extent and rate between calcium dobesilate capsules (specification: 0.5 g) produced by Guizhou Tianan Pharmaceutical Co., Ltd. and calcium dobesilate capsules (trade name: Doxium®/Doxium®, specification: 0.5 g) produced by Ebewe Pharma Ges.m.b.H.Nfg.KG in healthy Chinese people under fasting and postprandial administration conditions, and to evaluate the safety of calcium dobesilate capsules produced by Guizhou Tianan Pharmaceutical Co., Ltd.

Start Date04 Jan 2021

Sponsor / Collaborator

Guizhou Tian'an Pharmaceutical Co. Ltd.

CTR20202144 / CompletedNot Applicable

羟苯磺酸钙胶囊随机、开放、两周期、两交叉单次空腹/餐后状态下中国成年健康受试者人体生物等效性试验

[Translation] A randomized, open-label, two-period, two-crossover single-dose bioequivalence study of calcium dobesilate capsules in healthy Chinese adult volunteers under fasting/fed conditions

考察健康受试者空腹/餐后单次口服受试制剂羟苯磺酸钙胶囊（北京京丰制药集团有限公司生产，规格：0.5 g）的人体药代动力学特征，并以已上市的羟苯磺酸钙胶囊（商品名：导升明/Doxium；Ebewe Pharma Ges.m.b.H.Nfg.KG生产，规格：0.5 g）为参比制剂，两周期两交叉设计进行人体生物等效性研究，并观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

The pharmacokinetic characteristics of the test preparation calcium dobesilate capsules (produced by Beijing Jingfeng Pharmaceutical Group Co., Ltd., specification: 0.5 g) were investigated in healthy subjects after a single oral administration on an empty stomach or after meals. The marketed calcium dobesilate capsules (trade name: Doxium; produced by Ebewe Pharma Ges.m.b.H.Nfg.KG, specification: 0.5 g) were used as the reference preparation. A two-period, two-crossover design was used to conduct a human bioequivalence study, and the safety of the test preparation and the reference preparation in healthy subjects was observed.

Start Date01 Nov 2020

Sponsor / Collaborator

Beijing Jingfeng Pharmaceutical Co. Ltd.

100 Clinical Results associated with Oedema vascular

100 Translational Medicine associated with Oedema vascular

0 Patents (Medical) associated with Oedema vascular

Literatures (Medical) associated with Oedema vascular

22 Mar 2024·Medicine

Efficacy and safety of Xiaofeng powder in the treatment of chronic urticaria: A systematic review and meta-analysis

Review

Author: Wei, Fengqin ; Jia, Yuqi ; Bi, Chenhao

Background:Chronic urticaria is a group of skin diseases characterized by pruritus and/or vascular oedema and belongs to the category of “addictive rash” in Traditional Chinese Medicine, and its aetiology is closely related to wind evil. Antihistamines are often used in treatment. Although they have certain effects, they also easily cause disease recurrence. Xiaofeng powder treats this disease has a significant effect in improving the disease state and reducing the recurrence rate. However, there is a lack of evidencebased research. This study to systematically evaluate the clinical efficacy of modified Xiaofeng powder in the treatment of chronic urticaria (CU).Methods:Computer searches of Chinese databases such as China National Knowledge Infrastructure, China Scientific Journal Database, China Biomedical Literature Database, and WanFang Date and foreign databases such as PubMed and the Web of Science were performed. We retrieved published clinical randomized controlled trials of Xiaofeng powder in the treatment of CU from the establishment of the databases to November 2023. The data were extracted from clinical trials that met the inclusion criteria of this study, and the quality was evaluated through the Cochrane Handbook of Systematic Reviews 5.1.0. Finally, a meta-analysis was performed using RevMan 5.3 statistical software.Results:A total of 11 randomized controlled trials involving 1076 patients were included. The cure rate odds ratio (OR) and 95% confidence interval (CI; shown in brackets) were 2.11 [1.45, 3.07]; the total effective rate OR and CI were 2.42 [1.60, 3.68]; the recurrence rate OR and CI were 0.22 [0.15, 0.34]; the adverse reaction rate OR and CI were 0.23 [0.12, 0.45]; and the mean weighted mean difference (MD) and 95% CI (shown in brackets) of itching degree, wind mass size, wind mass number and wind mass duration in symptom and sign integrals were −0.70 [−0.73, 0.67], −0.64 [−0.96, 0.31], , −0.72 [−1.23, 0.22], and −0.68 [−1.13, 0.23], , respectively.Conclusion:The clinical efficacy of modified Xiaofeng powder in the treatment of CU is better than that of antihistamine drugs, with lower adverse reaction and recurrence rates and higher safety. However, the quality of clinical research included is relatively low, and findings need to be confirmed by high-quality research.

01 Jan 2024·Developmental Neuroscience

Quantification of Diffusion Magnetic Resonance Imaging for Prognostic Prediction of Neonatal Hypoxic-Ischemic Encephalopathy

Review

Author: Graham, Ernest M ; Oishi, Kenichi ; Everett, Allen D ; Northington, Frances J ; Chavez-Valdez, Raul ; Onda, Kengo

Neonatal hypoxic-ischemic encephalopathy (HIE) is the leading cause of acquired neonatal brain injury with the risk of developing serious neurological sequelae and death. An accurate and robust prediction of short- and long-term outcomes may provide clinicians and families with fundamental evidence for their decision-making, the design of treatment strategies, and the discussion of developmental intervention plans after discharge. Diffusion tensor imaging (DTI) is one of the most powerful neuroimaging tools with which to predict the prognosis of neonatal HIE by providing microscopic features that cannot be assessed by conventional magnetic resonance imaging (MRI). DTI provides various scalar measures that represent the properties of the tissue, such as fractional anisotropy (FA) and mean diffusivity (MD). Since the characteristics of the diffusion of water molecules represented by these measures are affected by the microscopic cellular and extracellular environment, such as the orientation of structural components and cell density, they are often used to study the normal developmental trajectory of the brain and as indicators of various tissue damage, including HIE-related pathologies, such as cytotoxic edema, vascular edema, inflammation, cell death, and Wallerian degeneration. Previous studies have demonstrated widespread alteration in DTI measurements in severe cases of HIE and more localized changes in neonates with mild-to-moderate HIE. In an attempt to establish cutoff values to predict the occurrence of neurological sequelae, MD and FA measurements in the corpus callosum, thalamus, basal ganglia, corticospinal tract, and frontal white matter have proven to have an excellent ability to predict severe neurological outcomes. In addition, a recent study has suggested that a data-driven, unbiased approach using machine learning techniques on features obtained from whole-brain image quantification may accurately predict the prognosis of HIE, including for mild-to-moderate cases. Further efforts are needed to overcome current challenges, such as MRI infrastructure, diffusion modeling methods, and data harmonization for clinical application. In addition, external validation of predictive models is essential for clinical application of DTI to prognostication.

01 Sep 2023·Intensive care medicine

Clinical targeting of the cerebral oxygen cascade to improve brain oxygenation in patients with hypoxic-ischaemic brain injury after cardiac arrest.

Review

Author: Robba, Chiara ; Sandroni, Claudio ; Citerio, Giuseppe ; Menon, David K ; Hoiland, Ryan L ; Sekhon, Mypinder S

The cerebral oxygen cascade includes three key stages: (a) convective oxygen delivery representing the bulk flow of oxygen to the cerebral vascular bed; (b) diffusion of oxygen from the blood into brain tissue; and (c) cellular utilisation of oxygen for aerobic metabolism. All three stages may become dysfunctional after resuscitation from cardiac arrest and contribute to hypoxic-ischaemic brain injury (HIBI). Improving convective cerebral oxygen delivery by optimising cerebral blood flow has been widely investigated as a strategy to mitigate HIBI. However, clinical trials aimed at optimising convective oxygen delivery have yielded neutral results. Advances in the understanding of HIBI pathophysiology suggest that impairments in the stages of the oxygen cascade pertaining to oxygen diffusion and cellular utilisation of oxygen should also be considered in identifying therapeutic strategies for the clinical management of HIBI patients. Culprit mechanisms for these impairments may include a widening of the diffusion barrier due to peri-vascular oedema and mitochondrial dysfunction. An integrated approach encompassing both intra-parenchymal and non-invasive neuromonitoring techniques may aid in detecting pathophysiologic changes in the oxygen cascade and enable patient-specific management aimed at reducing the severity of HIBI.

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Oedema vascular

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