據(jù)報(bào)道，美國食品藥品管理局(FDA)于2012年12月14日宣布批準(zhǔn)注射用瑞希巴庫(raxibacumab)用于吸入性炭疽治療，該藥物同時(shí)還被批準(zhǔn)在沒有或不適合替代藥物治療的情況下作為吸入性炭疽的預(yù)防用藥。瑞希巴庫是一種單克隆抗體，能夠中和炭疽芽胞桿菌產(chǎn)生的毒素，后者可導(dǎo)致廣泛且不可逆性組織損傷和死亡。

　　炭疽是一種潛在的生物恐怖威脅，因?yàn)槠溲挎唠y以殺滅且易于通過空氣傳播。

　　瑞希巴庫是首個(gè)基于FDA動(dòng)物有效性規(guī)則被批準(zhǔn)的單克隆抗體。該規(guī)則是在人體試驗(yàn)不可行或不符合倫理的情況下，只基于來自控制良好的充分動(dòng)物研究的有效性結(jié)果的數(shù)據(jù)支持，F(xiàn)DA可以批準(zhǔn)其用于臨床使用。瑞希巴庫實(shí)驗(yàn)研究證明，在1項(xiàng)猴子和3項(xiàng)家兔實(shí)驗(yàn)中證實(shí)了治療吸入性炭疽的有效性。對(duì)所有實(shí)驗(yàn)動(dòng)物給予炭疽桿菌芽孢氣霧劑，在研究結(jié)束時(shí)通過存活率確定有效性。動(dòng)物接受不同劑量的瑞希巴庫、安慰劑或通常用于炭疽治療的抗生素。

　　與接受安慰劑治療的動(dòng)物相比，接受瑞希巴庫治療動(dòng)物存活比例更高。在猴子研究和1項(xiàng)家兔研究中，暴露于炭疽的動(dòng)物接受40mg/Kg劑量的瑞希巴庫，存活率分別為64%和44%，而安慰劑組無一存活，所有存活動(dòng)物體內(nèi)均產(chǎn)生了中和毒素的抗體。另1項(xiàng)家兔研究顯示，接受抗生素和瑞希巴庫治療的動(dòng)物存活率為82%，而單純接受抗生素治療的動(dòng)物存活率僅為65%。

　　瑞希巴庫的安全性人體試驗(yàn)在326例健康志愿者中得到了評(píng)價(jià)，常見不良反應(yīng)包括皮疹、劇痛、瘙癢和困倦。

　　On December 14, 2012, the US Food and Drug Administration (FDA) announced the approval of injectable raxibacumab for the treatment of inhalational anthrax. The drug is also approved for the prevention of inhalational anthrax when alternative therapies are not available or not appropriate. Raxibacumab is a monoclonal antibody that neutralizes toxins produced by Bacillus anthracis that can cause massive and irreversible tissue injury and death.

　　Anthrax is a potential biological terrorism threat because the spores are resistant to destruction and can be easily spread by release in the air.Raxibacumab is the first monoclonal antibody approved under the FDA's Animal Efficacy Rule, which allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct trials in human beings. Raxibacumab's effectiveness for the treatment of inhalational anthrax was demonstrated in 1 study in monkeys and 3 studies in rabbits. All animals were administered aerosolized B anthracis spores, and efficacy was determined by survival at the end of the studies. Animals received varying doses of raxibacumab, placebo, or antibiotics normally used to treat anthrax.

　　More animals treated with raxibacumab survived compared with animals treated with placebo. Sixty-four percent of animals in the monkey study and 44% of animals in 1 rabbit study that received the 40 mg/Kg dose of raxibacumab survived exposure to anthrax, compared with none in the placebo groups. All surviving animals developed toxin-neutralizing antibodies. Another study in rabbits showed that 82% of animals treated with antibiotics and raxibacumab survived exposure to anthrax compared with 65% of animals receiving antibiotic treatment alone.

　　The safety of raxibacumab was evaluated in 326 healthy human volunteers. Common adverse effects included rash, extremity pain, itching, and drowsiness.