User talk:Jwzib

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Despite the enormity of the problem, scientists have yet to identify an effective drug treatment for TBI. Progesterone is a 21-carbon steroid hormone that is being evaluated as a neuroprotective therapeutic agent for the treatment of TBI. Progesterone is a potent neurosteroid, and progesterone receptors are abundant and widely distributed in the central nervous system. Progesterone is not only synthesized in the gonads and adrenal glands, but also produced by glial cells in the brain and by Schwann cells in the peripheral nervous system. In addition, allopregnanolone, a metabolite of progesterone preferentially produced in the central nervous system, has been shown to be an active neuroprotectant molecule. Previous clinical trials, conducted in the U.S. and China, suggest that progesterone can improve outcomes for TBI victims. Both studies showed about a 50 percent lower mortality in the progesterone-treated group as compared to placebo. The Chinese study also showed a statistically significant functional improvement and the U.S. study showed a similar trend. Building on these promising results, in 2010 BHR Pharma, LLC initiated SyNAPSe® (Study of the Neuroprotective Activity of Progesterone in Severe Traumatic Brain Injuries), a global Phase 3, multi-center clinical trial. SyNAPSe® is designed to evaluate the effectiveness of BHR’s proprietary BHR-100 intravenous progesterone infusion product as a neuroprotective agent for treating severe TBI patients. The U.S. Food and Drug Administration has granted orphan drug status to BHR-100 and has placed the drug on a Fast Track Development Program designed to accelerate its potential approval. (http://www.synapse-trial.com/)

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References:

Alderson P, Roberts I, et al. Corticosteroids for acute traumatic brain injury. Cochrane Database Syst Rev. 2005:CD000196.[PubMed], http://www.ncbi.nlm.nih.gov/pubmed/15674869

Fan L, Young PR, Barone FC, Feuerstein GZ, Smith DH. Mcintosh TK, et al. Experimental Brain injury induces different expression of tumor necrosis factor-alpha mRNA in the CNS. Brain Res Mol Brain Res. 1996;36:2:287-91. [PubMed], http://www.ncbi.nlm.nih.gov/pubmed/8965649, PMID: 8965649

Roberts I, Schierhout G, Alderson P, et al. Absesnce of evidence for the effectiveness of five interventions routinely used in the intensive care management of severe head injury: a systematic reviews, J Neurol Neurosurg Psychiatry. 1998;729-33. [PMC free articles] [PubMed], http://www.ncbi.nlm.nih.gov/pubmed/9810947

Gerhart J. Progesterone Synthesized by Schwann Cells during Myelin Formation Regulates Neuronal Gene Expression, Mol. Biol. Cell July 1, 2000 vol. 11 no. 7 2283-2295. http://www.molbiolcell.org/content/11/7/2283.full#aff-1, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC14919, PMID: 10888668

Stein, D.G. (2008). Progesterone exerts neuroprotective effects after brain injury Brain Res. Rev., 57, issue 2, 386-397.PMID: 17826842

Wright, D.W., Kellermann, A.L., Hertzberg, V.S., Clark, P.L., Frankel, M., Goldstein, F.C., et al. (2007). ProTECT: A Randomized Clinical Trial of Progesterone for Acute Traumatic Brain Injury Ann Emerg Med., 49,391-402. PMID: 17011666

Xiao, G. et.al. (2008). Improved outcomes from the administration of progesterone for patients with acute severe traumatic brain injury: a randomized controlled trial Critical Care, 12, 2, R61. PMID: 18447940


 * Also we need review articles per WP:MEDRS. Doc James (talk · contribs · email) 13:20, 4 March 2012 (UTC)