數(shù)百名患有抑郁癥的歐洲人將很快有機(jī)會利用迷幻物質(zhì)來擺脫現(xiàn)有的藥物療法,這將是有史以來為評估一種精神活性物質(zhì)的藥效而開展的規(guī)模最大的一次臨床試驗。
A British start-up is preparing a groundbreaking experiment to start early next year in eight European countries for 400 patients with treatment-resistant depression. The aim is to test whether psilocybin, the active ingredient in magic mushrooms, can help improve their condition over three months.
一家英國初創(chuàng)公司正在為一項突破性的試驗做準(zhǔn)備,試驗將從明年初開始,對8個歐洲國家的400名難治性抑郁癥患者展開。試驗?zāi)康氖菧y試“神奇蘑菇”中的活性成分裸蓋菇素(psilocybin)是否能在3個月的時間里改善這些患者的病情。
The trial — still subject to final approval from regulators — marks the boldest attempt yet to relaunch scientific study of the psychedelic substance in more than half a century. There was a clampdown on psychoactive drugs from the 1960s after they were popularised for recreational use by counter-cultural figures such as Alexander Shulgin and Timothy Leary, the psychologist who called for people to “turn on, tune in, drop out”.
這項尚需得到監(jiān)管機(jī)構(gòu)最終批準(zhǔn)的試驗,是半個世紀(jì)以來重啟迷幻物質(zhì)科學(xué)研究的最大膽的一次嘗試。自上世紀(jì)60年代以來,在精神藥物被亞歷山大•舒爾金(Alexander Shulgin)和蒂莫西•利里(Timothy Leary)等反文化人物宣揚用于消遣后,這類藥物受到了打壓。利里是一名心理學(xué)家,他曾呼吁人們利用這種藥物的幫助達(dá)到“激發(fā)、同調(diào)和脫離”的狀態(tài)。
There has been recent renewed interest by academic groups and companies into psychedelics including MDMA, LSD, ketamine and psilocybin for conditions including depression, post-traumatic stress disorder, obsessive compulsive disorder, severe headaches and alcohol dependency for which existing therapies are often ineffective.
近來,學(xué)術(shù)機(jī)構(gòu)和企業(yè)對將迷幻物質(zhì)應(yīng)用于一些現(xiàn)有療法常不奏效的病癥重燃興趣。這些迷幻物質(zhì)包括MDMA、LSD、氯胺酮(譯注:俗稱K粉)和裸蓋菇素等,對應(yīng)的病癥則包括抑郁癥、創(chuàng)傷后應(yīng)激障礙(PTSD)、強(qiáng)迫癥、嚴(yán)重頭痛和酒精依賴等。
Compass Pathways, a UK company created by a group of health specialists, has been in discussions with the European Medicines Agency and other regulators to prepare a trial that would administer psilocybin and use digital technology to monitor participants’ reactions.
由一批健康專家創(chuàng)立的英國公司Compass Pathways正與歐洲藥品管理局(European Medicines Agency)和其他監(jiān)管機(jī)構(gòu)討論,為一次對參與者施用裸蓋菇素并利用數(shù)字技術(shù)監(jiān)測參與者反應(yīng)的試驗做準(zhǔn)備。
George Goldsmith, one of the founders with a relative who had serious depression, said: “This is not about going back to the 1960s, but about taking forward 21st century science with digital innovation and medicines now that we understand how they work.”
創(chuàng)始人之一喬治•戈德史密斯(George Goldsmith)有一名親屬罹患嚴(yán)重的抑郁癥,他表示:“這不是要回到上世紀(jì)60年代,而是利用數(shù)字創(chuàng)新和我們現(xiàn)在已經(jīng)理解藥理的藥物來推進(jìn)21世紀(jì)的科學(xué)。”
A positive result in the trial could trigger regulatory approval and challenge both psychotherapy and the use of anti-depressants produced by the drugs industry. An estimated one-third of people with diagnosed depression do not respond well to current treatments.
如果試驗取得積極結(jié)果,不僅可能獲得監(jiān)管部門的批準(zhǔn),還會對心理治療和制藥業(yè)生產(chǎn)的抗抑郁藥的使用提出挑戰(zhàn)。據(jù)估計,現(xiàn)有療法對三分之一被診斷為抑郁癥的患者效果不佳。
The widespread recreational use of magic mushrooms has given regulators reassurance that psilocybin is safe, while studies including a small one last year by London academics showed significant benefit in patients with depression.
“神奇蘑菇”被廣泛用于消遣娛樂,這讓監(jiān)管部門認(rèn)為,裸蓋菇素是安全的,而包括去年倫敦學(xué)者們做的一項小型研究在內(nèi)的科研成果顯示,裸蓋菇素對抑郁癥患者大有裨益。
Compass has already received £4m in seed funding from its founders and external backers including Christian Angermayer, and is in discussions with private equity funds, venture capital and strategic investors to raise £15m for the European trial.
Compass已經(jīng)獲得了400萬英鎊的初期融資,出資人包括其創(chuàng)始人和克里斯蒂安•安格梅爾(Christian Angermayer)等外部支持者,該公司也在與一些私募股權(quán)基金、風(fēng)險資本和戰(zhàn)略投資者磋商,爭取為歐洲的試驗?zāi)技?500萬英鎊資金。
Mike Novogratz, the US investor and former principal at Fortress who is providing £1m, said: “My sense is I’m betting on the right horse at the right moment. If it works, this will push society forward, and I’ll get a good return.”
美國投資者、峰堡(Fortress)前高管邁克•諾沃格拉茨(Mike Novogratz)將出資100萬英鎊,諾沃格拉茨說:“我感覺自己正在一個準(zhǔn)確的時機(jī)下注一匹正確的賽馬。如果能成功,這將推動社會的進(jìn)步,我也將得到很好的回報。”
Alfred Hofmann, the Swiss scientist who first synthesised LSD in 1938, produced psilocybin for Sandoz, now part of Novartis, from the late 1950s until the mid-1960s, when governments began to make psychedelic substances illegal.
瑞士科學(xué)家艾伯特•霍夫曼(Albert Hofmann)在1938年首次合成了LSD,上世紀(jì)50年代末到60年代中期,霍夫曼為現(xiàn)為諾華集團(tuán)(Novartis)成員的山德士(Sandoz)制藥公司研制出裸蓋菇素,而這段時間政府開始將迷幻物質(zhì)列為非法。
Compass has overseen production of the first significant quantity of psilocybin made to regulatory standards since that time. It is also using digital technologies to monitor patients for any signs of relapse during their participation in the trials, such as indicators that they are becoming inactive and isolated.
Compass實現(xiàn)了自那時以來符合監(jiān)管標(biāo)準(zhǔn)的裸蓋菇素的首次大批量生產(chǎn)。該公司還將利用數(shù)字技術(shù)監(jiān)測在試驗期間病人的任何復(fù)發(fā)跡象,例如顯示他們正變得消極和孤獨的指標(biāo)。
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