Wednesday, June 3, 2015

被霸凌 有藥可治??!

台灣/研究社會挫敗 學者讓鼠被霸凌2015-06-02 14:09:26中央研究院今天舉辦2015年輕學者研究著作獎頒獎典禮,其中一位得主研究社會挫敗,發現青春期被霸凌的小鼠,神經和內分泌都會受到影響。台灣大學心理系副教授賴文崧以基因轉殖小鼠為模式,檢驗特定致病假說。其中一項實驗,他發現先天的基因缺損(Akt1)與後天的甲基安非他命藥物濫用,都會造成思覺失調症相關的神經病理與行為功能缺損。中央社台北2日電,賴文崧也以台灣人常見的思覺失調症候選基因「Neuregulin 1」為標的,透過小鼠實驗,發現一種特殊的抗癲癇藥物可能有用。另外,對於近年來熱門的「霸凌」議題,賴文崧也運用小鼠研究,他讓青春期的小鼠互相霸凌,發現弱小的一方,神經和內分泌都會有改變。賴文崧希望找到關鍵藥物,改善被霸凌者的心理狀況,目前他已建立一個測試平台,逐步嘗試各種藥物,希望能找出可行的治療方案。今年中研院年輕學者研究著作獎共有121人提出申請,最後選出16人得獎。中研院長翁啟惠表示,年輕學者對帶動研究風氣,有相當高的影響力,國內獎勵年輕學者的獎項不多,希望這個獎項能為學界帶來正面影響。(李漢揚編)【中央網路報】

 

Tuesday, June 2, 2015

太景PI-initiated trial (德國德勒斯登大學醫院/Cellex & 北醫): 布利沙福(Burixafor)

【鉅亨網記者張旭宏 台北】 新藥廠F*太景(4157-TW)(1)日宣布,與台北醫學大學簽訂合作備忘錄,雙方協議將在美國FDA臨床二期階段的小分子新藥幹細胞驅動劑布利沙福(Burixafor)進行產學合作。F*太景指出,布利沙福為太景自主研發之幹細胞驅動劑。成人幹細胞表面的受體CXCR4與骨髓骨基質的SDF1配體分子結合,大量儲存於骨髓中。只要注射一針布利沙福,就可以打斷CXCR4SDF1的結合,讓大量成人幹細胞脫離骨髓,進入周邊血液循環系,採集後即可進行自體或異體幹細胞移植。此外,醫學研究顯示,CXCR4SDF1的結合與白血病復發關係密切。因此布利沙福也具有應用於化療增敏的治療潛力。F*太景表示,太景正在美國進行布利沙福在FDA IND下的自體幹細胞移植二期臨床試驗,先前曾分別於2009年與2013年,在美國血液醫學年會(ASH)分別發表Phase I針對健康受試者與Phase IIa針對多發性骨髓瘤、霍奇金病及非霍奇金淋巴瘤病人的病患的臨床數據結果。F*太景進一步表示,布利沙福的臨床試驗結果備受國際注意,德國德勒斯登大學附屬醫院即以Cellex公司名義,在今(2015)317日與太景簽署「研究者發起之臨床試驗」(investigator-initiated trial,簡稱IIT)之合作協議,以德方出資並負責法規註冊,太景提供藥物的方式,針對以C-GSF無法動員出足夠數量的造血幹細胞進行移植的志願捐贈者進行臨床試驗,若效果良好,將有機會申請孤兒藥NDAF*太景指出,台北醫學大學是太景在台灣第一家簽署合作協議的醫學大學,也是繼德勒斯登大學附屬醫院之後,第二家與太景簽署合作協議的醫學教學機構,其中閻雲校長更是世界知名的血液腫瘤醫學專家,曾任職美國血液醫學重鎮希望城醫學中心腫瘤治療研究部門。相信結合台北醫學大學的研究能量與醫學資源,將使布利沙福適應症的臨床研究更向前推動一大步。

Flibanserin (Sprout Pharmaceuticals)女性性功能障礙治療藥 第三次FDA送件闖關 !!!

'Women's Viagra' to Seek FDA Approval, AgainAn FDA advisory committee is meeting on Thursday to discuss whether flibanserin — a drug sometimes nicknamed 'women's viagra' — should be approved to treat low libido in women. If approved, the drug would be marketed as treatment for hypoactive sexual desire disorder, which is said to cause a low sex drive in women. Some supporters argue the drug has a role in gender equality and that women do not have the same resources as men to deal with various degrees of sexual dysfunction. The drug, owned by Sprout Pharmaceuticals, has been rejected by the agency two times already. The argument being that its benefit is not notable enough to outweigh its side effects which can include dizziness and nausea. Other pharmaceutical companies including Pfizer and Procter & Gamble have made attempts at drugs to treat lack of libido among women. So far they have not been successful. The FDA's Thursday meeting on flibanserin is open to the public.

力比多(libido)即性力。这里的性不是指生殖意义上的性,它被称为:"力比多"(libido),泛指一切身体器官的快感,包括性倒错者和儿童的性生活。精神分析学认为,力比多是一种本能,是一种力量,是人的心理现象发生的驱动力。

有时,性渴望会被损害或者减少,同样可能表现出无力甚至完全不表现,诸如无性所发生的那样。影响力比多的因素可以是心理的,也可以是生理的。力比多的缺失与不育症以及阳痿的联系也并非绝对。

心理因素 力比多的降低可以发生于心理的原因,比如说隐私以及/或者亲昵的缺失,压力,精神涣散或是抑郁。又或者是来源于环境刺激,比如说长期暴露在高强度的噪音或是强烈的光线当中。其他原因还包括:Depression 抑郁stress or fatigue 压力或疲乏 childhood sexual abuse, assault, trauma, or neglect 儿童性虐待强奸精神创伤或忽视body image issues 身体形象问题 sexual performance anxiety 性焦虑

生理因素  影响力比多的生理因素包括:内分泌问题比如甲状腺功能减退;人体血液当中可利用睾丸素水平;某些药物的影响(比如波斯卡(又名非纳斯特胺)以及米诺地尔),不同生活方式的影响以及,根据研究显示,自己伴侣的吸引程度和健康程度。遗传性性欲的缺乏,就如在无性人群中所经常看到的那样,也可以被认为是由生理因素造成的。生活方式: 体重过轻,过度肥胖或者是营养不良,由于正常荷尔蒙水平的失调,也会导致力比多低下药物:力比多的降低也经常是医原性的,可能由多种药物引起,比如荷尔蒙避孕法,选择性5-羟色胺再摄取抑制剂以及其他抗抑郁药,阿片样物质和β受体阻滞药(治高血压和心脏病的药物)在某些病例中,如PSSDPost-SSRI sexual dysfunction),医原性阳痿或是其他性功能障碍可能是永久性的睾丸素是人体中控制力比多的一种荷尔蒙。最新的研究显示,荷尔蒙避孕法如避孕丸(依靠雌激素和孕酮的共同作用),通过提高性激素结合球蛋白水平,引起女性力比多的降低。性激素,包括睾丸素,与球蛋白的结合后,便不可利用了。研究显示,即使停止荷尔蒙避孕法,SHBG水平仍居高不下,并且当下没有可靠的数据能够预测这种上升现象何时会下降。有人怀疑是否避孕丸以及其他荷尔蒙避孕法(甲羟孕酮避孕针,诺普兰植入等)通过后生性机制已经永久地改变了基因表达。如果不加处理,睾丸素水平低下的妇女将体验到力比多的丧失,而这反过来将会引起其一生人际关系的紧张,以及骨骼和肌肉质量的丧失。(低睾丸素可能也是某些抑郁症和精力衰弱的原因)。相反,雄激素(如睾丸素)在两性中普遍都与力比多有确定的关联。月经周期:女性力比多与她们的月经周期也有关联。许多女性在排卵前的几天里能够体验到高涨的性欲。

Mechanism: The proposed mechanism of action refers to the Kinsey dual control model. Several sex steroids, neurotransmitters, and hormones have important excitatory or inhibitory effects on the sexual response. Among the neurotransmitters, the excitatory activity is driven by dopamine and norepinephrine, while the inhibitory activity is driven by serotonin. The balance between these systems is relevant for a healthy sexual response. By modulating these neurotransmitters in selective brain areas, flibanserin, a 5-HT1A receptor agonist and 5-HT2A receptor antagonist, is likely to restore the balance between these neurotransmitter systems. 5-HT1A receptor activation likely plays a significant role in the empathogenic effects of serotonin releasing agents (SRAs) like MDMA ("Ecstasy") as well.



惹熊惹虎惹醫界VS醫糾法 !!!

醫改法案為何總是出不了國會大門? 2015/05/28 10:56:00 文/陶曉嫚(新新聞) 台灣醫師從政為數不少,照理說,應該可以成為醫療改革、醫護勞動權保障法案的大力推手;但多年以來,醫療法案的國會折衝經常陷入僵局。儘管醫界政商勢力龐大,但內部意見分歧,民代、立委都怕站錯邊,也讓醫療改革法案一直卡關國會。死胎案扯上《醫療糾紛法》,挑起醫界的敏感神經。台北榮總婦產科醫師陳志堯辭職,主因是死胎案?還是早就另有生涯計畫?各方說法讓外界霧裡看花,而台北市議員謝維洲、立委姚文智為黃婦開記者會,原本做選民服務也「沒想太多」,不料被醫界、網友K得滿頭包,唯有再開記者會道歉。市議員助理透露,得知子弟兵捅出大簍子,行政院前院長謝長廷震怒,將謝系的台北市議員統統叫去「震撼教育」。

醫界影響力立委也難招架 《醫糾法》原本是兩大黨都想拚選前通過的「有感法案」,衛福部主張醫界要負擔較高比例的醫糾基金,讓醫界大表不滿,及時賠償機制也引起第一線處理醫糾的醫護人員恐慌,深怕變成有心人拚命找碴的誘因。嗅到風向不對,國民黨大黨鞭賴士葆、立委蔡正元立刻表態,要求「不能讓仇醫法案過關」,搏得醫護界好評。另一方面,衛福部大小官員前去拜會民進黨立法院黨團總召集人柯建銘,希望老柯「想想辦法」;基層醫師則動員萬人網路連署,要求民進黨中常會處理《醫糾法》問題;醫勞盟理事、心臟外科醫師李紹榕也率代表找老柯。再加上姚、謝記者會風波,在二?一六大選前為民進黨投下震撼彈;這也讓各界充分見識到醫界的聲量及動員實力,不容小覷。「惹熊惹虎,少惹醫界」一直是立委之間的潛規則,醫界號稱有十大家族縱橫政商、涵蓋藍綠,很難說一位醫師的背後,會有怎樣驚人的背景。例如國民黨前主席吳伯雄,父親是開業醫師、桃園縣前縣長吳鴻麟,家族中名醫輩出;台大醫院前院長高天成的姻親,則是民進黨大老、總統府前資政彭明敏……,醫界與政商名流開枝散葉,醫師從學生時代起,學長學弟、師徒制形成緊密體系,加上這些年醫師處境愈趨血汗,動員能力自然不在話下。白袍的形象具有社會公信力,「醫而優則仕」的案例也不少。除了以政治素人之姿拿下台北市長寶座的柯文哲,曾任立委的台南市長賴清德、嘉義市長涂醒哲都是醫師;醫師公會全國聯合會理事長、國民黨不分區立委蘇清泉是心臟外科權威;民進黨「永遠的總召」柯建銘是牙醫出身;衛福部前部長邱文達則是神經外科大國手

Novartis 發表於ASCO 2015及時亮點速報 !!

Novartis to highlight strength of its expanded oncology portfolio at ASCO 2015 Published on June 1, 2015 at 3:35 AM · No Comments Novartis will highlight the strength of its expanded oncology portfolio in 21 medicines and 11 investigational compounds across more than 185 data presentations at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, May 29-June 2, and the Congress of the European Hematology Association (EHA), June 11-14. Data will demonstrate advances in research in a variety of cancer types, including melanoma, lung, breast, kidney and blood cancers, underscoring Novartis' leadership in developing treatments with the potential to improve and possibly extend the lives of people with solid and hematologic tumors."Novartis is proud to showcase our portfolio of medicines, enhanced by the acquisition of oncology products and related assets from GSK," said Bruno Strigini, President of Novartis Oncology. "In addition to new data across many disease areas, we look forward to presenting the overall survival data for the combination regimen of two of the assets we acquired – Tafinlar and Mekinist – as these targeted therapies play a critical role for certain patients fighting metastatic melanoma. These medicines – plus the many others highlighted at ASCO and EHA – exemplify our mission to transform cancer care."

Key data presentations show potential benefit of identifying tumor-specific biomarkers and combination treatment strategies:

TafinlarR (dabrafenib) and MekinistR (trametinib): Full COMBI-d overall survival data in metastatic BRAF V600E/K mutation-positive cutaneous melanoma (ASCO Abstract

102; May 31, 9:45 AM CDT), and interim results of a Phase II study of the BRAF inhibitor dabrafenib in combination with the MEK inhibitor trametinib in patients with BRAF V600E mutated metastatic non-small cell lung cancer (ASCO Abstract

8006; May 31, 10:00 AM CDT)

Zykadia (ceritinib): First presentation of data from Phase II ASCEND-2 and ASCEND-3 efficacy and safety studies in ALK+ non-small cell lung cancer (NSCLC) (ASCO Abstract

8059; June 1, 8:00 AM CDT); (ASCO Abstract

8060; June 1, 8:00 AM CDT)

AfinitorR (everolimus): Identification of efficacy biomarkers in a large metastatic renal cell carcinoma cohort through next-generation sequencing; results from RECORD 3 (ASCO Abstract

4509; June 2, 9:45 AM CDT); biomarker analysis of BOLERO-1 and BOLERO-3 in HER2+ breast cancer (ASCO Abstract

512; May 31, 12:18 PM CDT)

"Our significant presence at ASCO demonstrates that Novartis is at the forefront of transforming how cancer is managed and treated, with a commitment to genomic medicine, innovative combinations, as well as the pursuit of scientific partnerships to further advance drug discovery and development," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "Our broad portfolio illustrates how we use scientific insights to 'starve or destroy' cancer cells implicated in a wide range of tumor types."Additional data being presented at ASCO and EHA evaluate efficacy and safety of targeting multiple cancer pathways in a variety of solid tumors and blood cancers:

Phase I study of dabrafenib in pediatric patients (pts) with relapsed or refractory BRAF V600E high- and low-grade gliomas (HGG, LGG), Langerhans cell histiocytosis (LCH), and other solid tumors (OST) (ASCO Abstract

10004; May 30, 4:12 PM CDT) A Phase I/II study of the combination of panobinostat (PAN) and carfilzomib (CFZ) in patients (pts) with relapsed or relapsed/refractory multiple myeloma (MM) (ASCO Abstract

8513; June 2, 11:33 AM CDT)

Panobinostat plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma who received prior bortezomib and IMiDs: A predefined subgroup analysis of PANORAMA 1 (ASCO Abstract

8526; May 31, 8:00 AM CDT) (EHA Abstract

S102; June 12, 11:45 CEST)

Phase I study of ceritinib in pediatric patients (Pts) with malignancies harboring a genetic alteration in ALK (ALK+); Safety, pharmacokinetic (PK), and efficacy results (ASCO Abstract

10005; May 30, 4:24 PM CDT)

First-in-human Phase I study of EGF816, a third generation mutant-selective EGFR tyrosine kinase inhibitor, in advanced non-small cell lung cancer (NSCLC) harboring T790M (ASCO Abstract

8013; June 1, 8:00 AM CDT)

Effect of mutations in distinct components of the PI3K/AKT/mTOR pathway on sensitivity to endocrine therapy in estrogen receptor (ER)-positive breast cancer (ASCO Abstract

532; May 30, 8:00 AM CDT)

Evaluation of possible linkage between everolimus benefit in estrogen receptor (ER)-positive breast cancer and genomic alterations of the PI3K/AKT/mTOR pathway (ASCO Abstract

530; May 30, 8:00 AM CDT)

Phase IIa trial of chimeric antigen receptor modified T cells directed against CD19 (CTL019) in patients with relapsed or refractory CD19+ lymphomas (ASCO Abstract

8516; June 1, 3:24 PM CDT)

Safety and efficacy of anti-CD19 chimeric antigen receptor (CAR)-modified autologous T cells (CTL019) in advanced multiple myeloma (ASCO Abstract

8517; June 1, 3:36 PM CDT)

Safety and antitumor activity of chimeric antigen receptor modified T cells in patients with chemotherapy refractory metastatic pancreatic cancer (ASCO Abstract

3007; June 1, 3:27 PM CDT) Other noteworthy data to be presented at ASCO and EHA:

Final overall survival analysis for the RECORD-3 study of first-line everolimus followed by sunitinib versus first-line sunitinib followed by everolimus in metastatic RCC (mRCC) (ASCO Abstract

4554; June 1, 1:15 PM CDT)

RECORD-4: A multicenter Phase II trial of second-line everolimus (EVE) in patients (pts) with metastatic renal cell carcinoma (mRCC) (ASCO Abstract

4518; June 1, 1:15 PM CDT)

Efficacy and safety of frontline nilotinib in 1089 European patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP): ENEST1st final analysis (EHA Abstract

S486, June 13, 3:45 PM CEST)

Efficacy and safety of nilotinib vs. imatinib in newly diagnosed chronic myeloid leukemia in chronic phase: 6-year follow-up of ENESTnd (EHA Abstract

P228, June 12, 5:15 PM CEST)

ENESTcmr 4-Y results: Patients (pts) with CML in chronic phase (CML-CP) and residual disease more likely to achieve deep molecular response following switch to nilotinib (NIL) (EHA Abstract

P229, June 12, 5:15 PM CEST)

Ofatumumab (O) in combination with fludarabine (F) and cyclophosphamide (C) (OFC) vs. FC in patients with relapsed chronic lymphocytic leukaemia (CLL): Results of the Phase III study COMPLEMENT 2 (EHA Late-Breaker Abstract

LB219, June 12, 5:15 PM CEST)

Ruxolitinib in polycythemia vera: Follow-up from the RESPONSE trial (ASCO Abstract

7087; May 31, 8:00 AM CDT); (EHA Abstract

S447; June 13, 11:45 AM CEST) Throughout ASCO and EHA, Novartis Oncology will host a dedicated webpage that will provide unique insights and perspectives into emerging areas of cancer care and research.

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