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Article ; Online: Special Section on Medical Countermeasures, From Bench to Battlefield: Translating Experimental Therapies for Effective Combat Against Chemical Threats-Editorial.

Reddy, Doodipala Samba

The Journal of pharmacology and experimental therapeutics

2024 Volume 388, Issue 2, Page(s) 257–259

MeSH term(s)	Medical Countermeasures ; Chemical Hazard Release
Language	English
Publishing date	2024-01-17
Publishing country	United States
Document type	Editorial ; Introductory Journal Article
ZDB-ID	3106-9
ISSN	1521-0103 ; 0022-3565
ISSN (online)	1521-0103
ISSN	0022-3565
DOI	10.1124/jpet.123.002025
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Article ; Online: Progress and Challenges in Developing Medical Countermeasures for Chemical, Biological, Radiological, and Nuclear Threat Agents.

Reddy, Doodipala Samba

The Journal of pharmacology and experimental therapeutics

2024 Volume 388, Issue 2, Page(s) 260–267

Abstract: This Commentary delves into the current progress and challenges on ongoing research on medical countermeasures (MCs) for chemical, biologic, radiologic, and nuclear (CBRN) threats. CBRN agents pose a serious risk to human health and safety, with the ... ...

Abstract	This Commentary delves into the current progress and challenges on ongoing research on medical countermeasures (MCs) for chemical, biologic, radiologic, and nuclear (CBRN) threats. CBRN agents pose a serious risk to human health and safety, with the potential for mass casualties in both military and civilian settings. Chemical threats are toxic compounds that could be used in a terrorist attack, an accidental release, or chemical warfare. They include nerve agents, organophosphates, pulmonary agents, metabolic/cellular agents, vesicants, ocular toxicants, and opioid agents. Developing effective MCs is crucial for mitigating the acute and chronic effects of exposure to CBRN agents. The papers in this special issue of JPET highlights the latest advancements in MC research, showcasing insightful outcomes on experimental models, mechanisms, and translational research on MCs for CBRN threats. They portray several notable contributions, including the development of neurosteroid and combination anticonvulsant therapies for nerve agent poisoning, the exploration of chronic impacts and diagnostic tracers for OP neurotoxicity, the establishment of innovative pediatric OP models, the identification of novel molecules for ocular, pulmonary and vesicant injuries, and the repurposing of existing drugs for the treatment of botulism, cyanide, and OP poisoning. These crucial outcomes underscore the breadth of current research covering a variety of chemical threats. Overall, this collection of articles highlights the importance of ongoing research and development in the field of MCs, emphasizing the potential of these countermeasures to effectively treat and mitigate the effects of toxicant exposures and thereby enhance our preparedness for mass casualty incidents. SIGNIFICANCE STATEMENT: CBRN agents pose a significant threat to public health. Effective MCs exist for certain chemical threats, but there is a need for new and improved MCs for many others. The research presented in this special issue of JPET highlights the latest advancements in MCs for CBRN threats. This research has the potential to lead to the development of new and repurposed MCs that are more effective, broad-spectrum, and easier to administer to mitigate acute and long-term consequences of chemical exposures.
MeSH term(s)	Humans ; Child ; Medical Countermeasures ; Terrorism
Language	English
Publishing date	2024-01-17
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	3106-9
ISSN	1521-0103 ; 0022-3565
ISSN (online)	1521-0103
ISSN	0022-3565
DOI	10.1124/jpet.123.002040
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Article ; Online: Neurosteroids as Novel Anticonvulsants for Refractory Status Epilepticus and Medical Countermeasures for Nerve Agents: A 15-Year Journey to Bring Ganaxolone from Bench to Clinic.

Reddy, Doodipala Samba

The Journal of pharmacology and experimental therapeutics

2024 Volume 388, Issue 2, Page(s) 273–300

Abstract: This article describes recent advances in the use of neurosteroids as novel anticonvulsants for refractory status epilepticus (RSE) and as medical countermeasures (MCs) for organophosphates and chemical nerve agents (OPNAs). We highlight a comprehensive ... ...

Abstract	This article describes recent advances in the use of neurosteroids as novel anticonvulsants for refractory status epilepticus (RSE) and as medical countermeasures (MCs) for organophosphates and chemical nerve agents (OPNAs). We highlight a comprehensive 15-year journey to bring the synthetic neurosteroid ganaxolone (GX) from bench to clinic. RSE, including when caused by nerve agents, is associated with devastating morbidity and permanent long-term neurologic dysfunction. Although recent approval of benzodiazepines such as intranasal midazolam and intranasal midazolam offers improved control of acute seizures, novel anticonvulsants are needed to suppress RSE and improve neurologic function outcomes. Currently, few anticonvulsant MCs exist for victims of OPNA exposure and RSE. Standard-of-care MCs for postexposure treatment include benzodiazepines, which do not effectively prevent or mitigate seizures resulting from nerve agent intoxication, leaving an urgent unmet medical need for new anticonvulsants for RSE. Recently, we pioneered neurosteroids as next-generation anticonvulsants that are superior to benzodiazepines for treatment of OPNA intoxication and RSE. Because GX and related neurosteroids that activate extrasynaptic GABA-A receptors rapidly control seizures and offer robust neuroprotection by reducing neuronal damage and neuroinflammation, they effectively improve neurologic outcomes after acute OPNA exposure and RSE. GX has been selected for advanced, Biomedical Advanced Research and Development Authority-supported phase 3 trials of RSE and nerve agent seizures. In addition, in mechanistic studies of neurosteroids at extrasynaptic receptors, we identified novel synthetic analogs with features that are superior to GX for current medical needs. Development of new MCs for RSE is complex, tedious, and uncertain due to scientific and regulatory challenges. Thus, further research will be critical to fill key gaps in evaluating RSE and anticonvulsants in vulnerable (pediatric and geriatric) populations and military persons. SIGNIFICANCE STATEMENT: Following organophosphate and nerve agent intoxication, refractory status epilepticus (RSE) occurs despite benzodiazepine treatment. RSE occurs in 40% of status epilepticus patients, with a 35% mortality rate and significant neurological morbidity in survivors. To treat RSE, neurosteroids are better anticonvulsants than benzodiazepines. Our pioneering use of neurosteroids for RSE and nerve agents led us to develop ganaxolone as a novel anticonvulsant and neuroprotectant with significantly improved neurological outcomes. This article describes the bench-to-bedside journey of bringing neurosteroid therapy to patients, with ganaxolone leading the way.
MeSH term(s)	Humans ; Child ; Aged ; Anticonvulsants/therapeutic use ; Nerve Agents ; Neurosteroids/therapeutic use ; Midazolam ; Medical Countermeasures ; Status Epilepticus/drug therapy ; Seizures/drug therapy ; Benzodiazepines ; Organophosphates ; Pregnanolone/analogs & derivatives
Chemical Substances	Anticonvulsants ; Nerve Agents ; Neurosteroids ; Midazolam (R60L0SM5BC) ; ganaxolone (98WI44OHIQ) ; Benzodiazepines (12794-10-4) ; Organophosphates ; Pregnanolone (BXO86P3XXW)
Language	English
Publishing date	2024-01-17
Publishing country	United States
Document type	Journal Article ; Review ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	3106-9
ISSN	1521-0103 ; 0022-3565
ISSN (online)	1521-0103
ISSN	0022-3565
DOI	10.1124/jpet.123.001816
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Article ; Online: Building evidence on therapeutic efficacy and innovative mechanisms of cannabinoids in neurological disorders.

Reddy, Doodipala Samba

Experimental neurology

2023 Volume 364, Page(s) 114390

MeSH term(s)	Humans ; Cannabinoids/pharmacology ; Cannabinoids/therapeutic use ; Nervous System Diseases/drug therapy
Chemical Substances	Cannabinoids
Language	English
Publishing date	2023-03-28
Publishing country	United States
Document type	Editorial
ZDB-ID	207148-4
ISSN	1090-2430 ; 0014-4886
ISSN (online)	1090-2430
ISSN	0014-4886
DOI	10.1016/j.expneurol.2023.114390
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Article ; Online: Neuroendocrine insights into neurosteroid therapy for postpartum depression.

Reddy, Doodipala Samba

Trends in molecular medicine

2023 Volume 29, Issue 12, Page(s) 979–982

Abstract: Postpartum depression (PPD) is associated with a decline in progesterone-derived anxiolytic-antidepressant neurosteroids after delivery. Neurosteroid replacement therapy (NRT) with GABA-A receptor-modulating allopregnanolone (brexanolone) shows promise ... ...

Abstract	Postpartum depression (PPD) is associated with a decline in progesterone-derived anxiolytic-antidepressant neurosteroids after delivery. Neurosteroid replacement therapy (NRT) with GABA-A receptor-modulating allopregnanolone (brexanolone) shows promise as the first drug treatment for PPD. Here we describe the molecular insights of the neurosteroid approach for rapid relief of PPD symptoms compared with traditional antidepressants.
MeSH term(s)	Female ; Humans ; Neurosteroids/therapeutic use ; Depression, Postpartum/drug therapy ; Antidepressive Agents/pharmacology ; Antidepressive Agents/therapeutic use ; Receptors, GABA-A
Chemical Substances	Neurosteroids ; Antidepressive Agents ; Receptors, GABA-A
Language	English
Publishing date	2023-08-02
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2036490-8
ISSN	1471-499X ; 1471-4914
ISSN (online)	1471-499X
ISSN	1471-4914
DOI	10.1016/j.molmed.2023.07.006
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Article ; Online: Long-Term Neuropsychiatric Developmental Defects after Neonatal Organophosphate Exposure: Mitigation by Synthetic Neurosteroids.

Neff, Michael James / Reddy, Doodipala Samba

The Journal of pharmacology and experimental therapeutics

2024 Volume 388, Issue 2, Page(s) 451–468

Abstract: Children are much more susceptible to the neurotoxic effects of organophosphate (OP) pesticides and nerve agents than adults. OP poisoning in children leads to acute seizures and neuropsychiatric sequela, including the development of long-term ... ...

Abstract	Children are much more susceptible to the neurotoxic effects of organophosphate (OP) pesticides and nerve agents than adults. OP poisoning in children leads to acute seizures and neuropsychiatric sequela, including the development of long-term disabilities and cognitive impairments. Despite these risks, there are few chronic rodent models that use pediatric OP exposure for studying neurodevelopmental consequences and interventions. Here, we investigated the protective effect of the neurosteroid ganaxolone (GX) on the long-term developmental impact of neonatal exposure to the OP compound, diisopropyl-fluorophosphate (DFP). Pediatric postnatal day-28 rats were acutely exposed to DFP, and at 3 and 10 months after exposure, they were evaluated using a series of cognitive and behavioral tests with or without the postexposure treatment of GX. Analysis of the neuropathology was performed after 10 months. DFP-exposed animals displayed significant long-term deficits in mood, anxiety, depression, and aggressive traits. In spatial and nonspatial cognitive tests, they displayed striking impairments in learning and memory. Analysis of brain sections showed significant loss of neuronal nuclei antigen(+) principal neurons, parvalbumin(+) inhibitory interneurons, and neurogenesis, along with increased astrogliosis, microglial neuroinflammation, and mossy fiber sprouting. These detrimental neuropathological changes are consistent with behavioral dysfunctions. In the neurosteroid GX-treated cohort, behavioral and cognitive deficits were significantly reduced and were associated with strong protection against long-term neuroinflammation and neurodegeneration. In conclusion, this pediatric model replicates the salient features of children exposed to OPs, and the protective outcomes from neurosteroid intervention support the viability of developing this strategy for mitigating the long-term effects of acute OP exposure in children. SIGNIFICANCE STATEMENT: An estimated 3 million organophosphate exposures occur annually worldwide, with children comprising over 30% of all victims. Our understanding of the neurodevelopmental consequences in children exposed to organophosphates is limited. Here, we investigated the long-term impact of neonatal exposure to diisopropyl-fluorophosphate in pediatric rats. Neurosteroid treatment protected against major deficits in behavior and memory and was well correlated with neuropathological changes. Overall, this pediatric model is helpful to screen novel therapies to mitigate long-term developmental deficits of organophosphate exposure.
MeSH term(s)	Humans ; Child ; Rats ; Animals ; Organophosphates/pharmacology ; Neurosteroids ; Neuroinflammatory Diseases ; Organophosphorus Compounds/pharmacology ; Brain ; Isoflurophate/toxicity ; Fluorides ; Phosphates
Chemical Substances	Organophosphates ; Neurosteroids ; fluorophosphate (15181-43-8) ; Organophosphorus Compounds ; Isoflurophate (12UHW9R67N) ; Fluorides (Q80VPU408O) ; Phosphates
Language	English
Publishing date	2024-01-17
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	3106-9
ISSN	1521-0103 ; 0022-3565
ISSN (online)	1521-0103
ISSN	0022-3565
DOI	10.1124/jpet.123.001763
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Article ; Online: Therapeutic and clinical foundations of cannabidiol therapy for difficult-to-treat seizures in children and adults with refractory epilepsies.

Reddy, Doodipala Samba

Experimental neurology

2022 Volume 359, Page(s) 114237

Abstract: Novel and effective antiseizure medications are needed to treat refractory and rare forms of epilepsy. Cannabinoids, which are obtained from the cannabis plant, have a long history of medical use, including for neurologic conditions. In 2018, the US Food ...

Abstract	Novel and effective antiseizure medications are needed to treat refractory and rare forms of epilepsy. Cannabinoids, which are obtained from the cannabis plant, have a long history of medical use, including for neurologic conditions. In 2018, the US Food and Drug Administration approved the first phytocannabinoid, cannabidiol (CBD, Epidiolex), which is now indicated for severe seizures associated with three rare forms of developmental and epileptic encephalopathy: Dravet syndrome, Lennox-Gastaut syndrome, and tuberous sclerosis complex. Compelling evidence supports the efficacy of CBD in experimental models and patients with epilepsy. In randomized clinical trials, highly-purified CBD has demonstrated efficacy with an acceptable safety profile in children and adults with difficult-to-treat seizures. Although the underlying antiseizure mechanisms of CBD in humans have not yet been elucidated, the identification of novel antiseizure targets of CBD preclinically indicates multimodal mechanisms that include non-cannabinoid pathways. In addition to antiseizure effects, CBD possesses strong anti-inflammatory and neuroprotective activities, which might contribute to protective effects in epilepsy and other conditions. This article provides a succinct overview of therapeutic approaches and clinical foundations of CBD, emphasizing the clinical utility of CBD for the treatment of seizures associated with refractory and rare epilepsies. CBD has shown to be a safe and effective antiseizure medicine, demonstrating a broad spectrum of efficacy across multiple seizure types, including those associated with severe epilepsies with childhood onset. Despite such promise, there are many perils with CBD that hampers its widespread use, including limited understanding of pharmacodynamics, limited exposure-response relationship, limited information for seizure freedom with continued use, complex pharmacokinetics with drug interactions, risk of adverse effects, and lack of expert therapeutic guidelines. These scientific issues need to be resolved by further investigations, which would decide the unique role of CBD in the management of refractory epilepsy.
MeSH term(s)	Child ; Adult ; Humans ; Cannabidiol/therapeutic use ; Cannabidiol/pharmacology ; Drug Resistant Epilepsy/drug therapy ; Anticonvulsants/therapeutic use ; Anticonvulsants/pharmacology ; Lennox Gastaut Syndrome/drug therapy ; Seizures/drug therapy ; Seizures/chemically induced ; Epilepsies, Myoclonic/drug therapy ; Epilepsy/drug therapy ; Epilepsy/chemically induced ; Cannabinoids/pharmacology
Chemical Substances	Cannabidiol (19GBJ60SN5) ; Anticonvulsants ; Cannabinoids
Language	English
Publishing date	2022-10-04
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	207148-4
ISSN	1090-2430 ; 0014-4886
ISSN (online)	1090-2430
ISSN	0014-4886
DOI	10.1016/j.expneurol.2022.114237
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Zs.A 184: Show issues

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Article ; Online: Neurosteroid replacement therapy for catamenial epilepsy, postpartum depression and neuroendocrine disorders in women.

Reddy, Doodipala Samba

Journal of neuroendocrinology

2021 Volume 34, Issue 2, Page(s) e13028

Abstract: Neurosteroids are involved in the pathophysiology of many neuroendocrine disorders in women. This review describes recent advancements in pharmacology of neurosteroids and emphasizes the benefits of neurosteroid replacement therapy for the management of ... ...

Abstract	Neurosteroids are involved in the pathophysiology of many neuroendocrine disorders in women. This review describes recent advancements in pharmacology of neurosteroids and emphasizes the benefits of neurosteroid replacement therapy for the management of neuroendocrine disorders such as catamenial epilepsy (CE), postpartum depression (PPD) and premenstrual brain conditions. Neurosteroids are endogenous modulators of neuronal excitability. A variety of neurosteroids are present in the brain including allopregnanolone (AP), allotetrahydro-deoxycorticosterone and androstanediol. Neurosteroids interact with synaptic and extrasynaptic GABA
MeSH term(s)	Depression, Postpartum/drug therapy ; Epilepsy, Reflex ; Female ; Humans ; Neurosteroids/therapeutic use ; Neurotransmitter Agents/physiology ; Receptors, GABA-A ; Seizures ; gamma-Aminobutyric Acid
Chemical Substances	Neurosteroids ; Neurotransmitter Agents ; Receptors, GABA-A ; gamma-Aminobutyric Acid (56-12-2)
Language	English
Publishing date	2021-09-10
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	1007517-3
ISSN	1365-2826 ; 0953-8194
ISSN (online)	1365-2826
ISSN	0953-8194
DOI	10.1111/jne.13028
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Zs.A 2634: Show issues

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Article ; Online: Protective Activity of Novel Hydrophilic Synthetic Neurosteroids on Organophosphate Status Epilepticus-induced Chronic Epileptic Seizures, Non-Convulsive Discharges, High-Frequency Oscillations, and Electrographic Ictal Biomarkers.

Ramakrishnan, Sreevidhya / Singh, Tanveer / Reddy, Doodipala Samba

The Journal of pharmacology and experimental therapeutics

2024 Volume 388, Issue 2, Page(s) 386–398

Abstract: Nerve agents and organophosphates (OP) are neurotoxic chemicals that induce acute seizures, status epilepticus (SE), and mortality. Long-term neurologic and neurodegenerative effects manifest months to years after OP exposure. Current benzodiazepine ... ...

Abstract	Nerve agents and organophosphates (OP) are neurotoxic chemicals that induce acute seizures, status epilepticus (SE), and mortality. Long-term neurologic and neurodegenerative effects manifest months to years after OP exposure. Current benzodiazepine anticonvulsants are ineffective in preventing such long-term neurobehavioral and neuropathological changes. New and effective anticonvulsants are needed for OP intoxication, especially for mitigating the long-term sequelae after acute exposure. We developed neurosteroids as novel anticonvulsants and neuroprotectants in OP exposure models. In this study, we evaluated the long-term efficacy of novel synthetic neurosteroids in preventing the development of chronic epilepsy and hyperexcitable ictal events in a rat OP model of SE. Rats were exposed to the OP nerve agent surrogate diisopropylfluorophosphate (DFP), and the experimental groups were treated with the synthetic neurosteroid valaxanolone (VX) or lysaxanolone (LX) 40 minutes post-exposure in conjunction with midazolam. Video-electroencephalography was monitored for two months to assess spontaneous recurrent seizures (SRS), epileptiform discharges, interictal spikes, and high-frequency oscillations (HFOs). Within 60 days of DFP exposure, rats developed chronic epilepsy characterized by frequent SRS, epileptiform discharges, and HFOs. LX treatment was associated with a dose-dependent reduction of epilepsy occurrence and overall seizure burden with a significant decrease in SRS and epileptiform discharges. It also significantly reduced the occurrence of epileptic biomarkers of HFOs and interictal spikes, indicating potential disease-modifying activity. Similarly, the neurosteroid analog VX also significantly attenuated SRS, discharges, HFOs, and ictal events. These results demonstrate the long-term protective effects of synthetic neurosteroids in the OP-exposed post-SE model, indicating their disease-modifying potential to prevent epilepsy and ictal abnormalities. SIGNIFICANCE STATEMENT: The effects of nerve agents and organophosphate (OP) exposure are persistent, and survivors suffer from a number of devastating, chronic neurological dysfunctions. Currently, there is no specific therapy for preventing this disastrous impact of OP exposure. We propose synthetic neurosteroids that activate tonic inhibition provide viable options for preventing the long-term neurological effects of OP intoxication. The results from this study reveal the disease-modifying potential of two novel synthetic neurosteroids in preventing epileptogenesis and chronic epileptic seizures after OP-induced SE.
MeSH term(s)	Rats ; Animals ; Neurosteroids/therapeutic use ; Anticonvulsants/adverse effects ; Organophosphates/adverse effects ; Nerve Agents/adverse effects ; Rats, Sprague-Dawley ; Seizures/chemically induced ; Seizures/drug therapy ; Seizures/prevention & control ; Status Epilepticus/chemically induced ; Status Epilepticus/drug therapy ; Epilepsy/drug therapy ; Organophosphate Poisoning ; Electroencephalography ; Biomarkers ; Organothiophosphorus Compounds
Chemical Substances	VX (9A4381183B) ; Neurosteroids ; Anticonvulsants ; Organophosphates ; Nerve Agents ; Biomarkers ; Organothiophosphorus Compounds
Language	English
Publishing date	2024-01-17
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	3106-9
ISSN	1521-0103 ; 0022-3565
ISSN (online)	1521-0103
ISSN	0022-3565
DOI	10.1124/jpet.123.001817
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Article: Brain structural and neuroendocrine basis of sex differences in epilepsy.

Reddy, Doodipala Samba

Handbook of clinical neurology

2020 Volume 175, Page(s) 223–233

Abstract: This chapter reviews the current information about sex differences in epilepsy and potential mechanisms underlying sex differences in seizure susceptibility and epilepsy. The susceptibility to and occurrence of seizures are generally higher in men than ... ...

Abstract	This chapter reviews the current information about sex differences in epilepsy and potential mechanisms underlying sex differences in seizure susceptibility and epilepsy. The susceptibility to and occurrence of seizures are generally higher in men than women. There is gender-specific epilepsies such as catamenial epilepsy, a neuroendocrine condition in which seizures are most often clustered around the perimenstrual or periovulatory period in adult women. Structural differences in cerebral morphology, the structural and functional circuits may render men and women differentially vulnerable to seizure disorders and epileptogenic processes. Changes in seizure sensitivity are evident at puberty, pregnancy, and menopause, often attributed to circulating steroid hormones and neurosteroids as well as neuroplasticity in receptor systems. An improved understanding of the sexual dimorphism in neural circuits and the neuroendocrine basis of sex differences or resistance to protective drugs is essential to develop sex-specific therapies for seizure conditions.
MeSH term(s)	Anticonvulsants/therapeutic use ; Brain ; Epilepsy/drug therapy ; Epilepsy/epidemiology ; Female ; Humans ; Male ; Neurosecretory Systems ; Seizures/drug therapy ; Sex Characteristics
Chemical Substances	Anticonvulsants
Language	English
Publishing date	2020-06-12
Publishing country	Netherlands
Document type	Journal Article ; Review
ISSN	0072-9752
ISSN	0072-9752
DOI	10.1016/B978-0-444-64123-6.00016-3
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