英国伦敦北部哈罗医院日前证实,14日夜,6名身体健康的志愿者在接受该院一项药物试验3小时后,相继出现不良药物反应。现在,这6人已被转入院内重症看护病房接受紧急治疗。其中一人服药后呼吸非常困难,他的家人被告知此人双腿发紫。试验中服用没有疗效的"安慰剂"的两名志愿者,未出现任何不良药物反应。
据英国《卫报》3月15日报道,事故发生后,英国药品及卫生保健产品管理机构立刻终止了这项药物试验。据透露,这项药物试验所用药品为治疗诸如风湿性关节炎和白血病等疾病的药物,为一家德国药品公司提供。这些药品在进行上述人体临床试验之前均已在动物身上进行了试验,并取得了英国有关当局进行人体临床试验的许可。
这项试验旨在检验该新药在健康人群身上有无副作用或其他不适反应。对于试验中出现的志愿者身体严重不适,英国药品及卫生保健产品管理机构发言人表示"十分关心",但同时表示"闻所未闻"。目前,相关部门已经同警方组成联合调查组,对此次事故进行调查。现在,还不清楚此次事故是人为所致,还是药品本身受到污染或在储存当中发生了药理改变所致。
(国际在线独家资讯 张海山)
Six men were in intensive care in a north London hospital last night after a pharmaceutical company's trial went wrong. Regulatory authorities have suspended the drug trial and are investigating in collaboration with the police.
The six were healthy volunteers, paid to take part in the earliest stage of human testing of a potential new medicine for inflammatory diseases such as rheumatoid arthritis and leukaemia. The volunteers were needed to establish whether there were any side effects or obvious problems with the drug before it was tested on people who have the conditions.
But on Monday, the first day of the trial, the Medicines and Healthcare Products Regulatory Authority (MHRA) said yesterday all six men became ill at the commercially run clinical trials unit at Northwick Park hospital, Harrow. One of the men reportedly had extreme breathing difficulties within three hours of taking the drug and his family was told his legs had turned purple, according to the Sun newspaper.
Two other men at the unit were enrolled in the trial but had been given a placebo and are unaffected.
Because the unit was in the hospital building, the sick men were rapidly given medical help and transferred to intensive care that evening. A spokeswoman for the MHRA said it was "very concerning" but "almost unheard of". The drug company, the German firm Te Genero, had submitted the results from animal safety tests, as it must do under the regulations, to get permission to run a trial on human beings. There had been no irregularities in the animal tests, the MHRA said. Investigators at the site will be looking at whether human error played a part in the incident, whether the product was contaminated or something went wrong with its storage.