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FDA approves 1st pill made from human poop
The U.S. Food and Drug Administration (FDA) has approved the first pill manufactured from donated human poop, the agency announced(opens in new tab) Wednesday (April 26). It's the second human poop-derived treatment ever approved; the first was an enema-based treatment(opens in new tab) cleared for use in December 2022.
Previously, such "fecal microbiota transplants" were considered investigational treatments and were therefore harder for patients to access and often not covered by insurance.
Like the approved enema treatment, the newly approved pill, called Vowst, also contains live bacteria and has been approved for use in people ages 18 and older as a preventive treatment for recurrent infections with the bacterium Clostridioides difficile. Called C. diff for short, this infection is often acquired in health care settings after patients have taken antibiotics for a different infection.
Antibiotics can disrupt the balance of bacteria that normally populate the gut, and this gives C. diff the opportunity to proliferate. The rapidly replicating bacteria secrete toxins that can lead to diarrhea, abdominal pain, fever and colitis (inflammation of the colon) and, in some cases, organ failure and death. C. diff infections are associated with about 15,000 to 30,000 deaths a year in the U.S., according to the FDA.
Those who recover from C. diff have a roughly 1 in 6 chance of developing the infection again within two to eight weeks of recovery, according to the Centers for Disease Control and Prevention(opens in new tab). The risk of these recurrent infections increases each time a person gets C. diff, in part because the antibiotics used to treat them further disrupt the gut microbiome, the community of microorganisms in the lower digestive tract.
So-called fecal microbiota products, made from healthy human gut bacteria, offer a new way to prevent recurrent C. diff by essentially replenishing the gut microbiome. And now, with the approval of Vowst, there's a version of the treatment that can be taken orally, rather than being administered as a liquid treatment into a patient's rectum.
"The availability of a fecal microbiota product that can be taken orally is a significant step forward in advancing patient care and accessibility for individuals who have experienced this disease that can be potentially life-threatening," Dr. Peter Marks(opens in new tab), director of the FDA's Center for Biologics Evaluation and Research, said in the agency's statement.
The Vowst treatment regimen involves taking four capsules once a day for three days in a row; patients start taking the drug two to four days after finishing a course of antibiotics for C. diff. The donated feces used to make the pills is carefully screened for transmissible pathogens before being used in manufacturing, but taking Vowst still carries some risk of being exposed to pathogens, as well as to food allergens, the FDA cautioned.
In clinical trials, the most common side effects of Vowst were abdominal bloating, fatigue, constipation, chills and diarrhea; these side effects occurred at a greater frequency in the treated patients than in the placebo recipients.
In a comparison of about 90 people who received the pills and 90 who didn't, those in the treated group had a 12.4% rate of recurrent C.diff infection within eight weeks of recovering from an initial bout of the infection, whereas the untreated group had a 39.8% rate of recurrence.
注释：
enema: n
表示"灌肠"，如：I'm going to give you an enema to help you pass motion. 我要给您灌肠,帮助您排便。
fecal: adj
表示" 排泄物的；"，means "of or relating to feces"，如：A dark green fecal material that accumulates in the fetal intestines and is discharged at or near the time of birth.胎便汇集于腹部小肠中的一种深绿色渣滓物，并在出生时或将近出生之时排出
microbiota: n
表示"微生物丛"，如：Eventually, an individual's gut microbiota becomes as unique as a fingerprint. 最终每个人体内的微生物种类变得像指纹一样独特。
investigational: adj
表示"调查的"，means “ of or relating to an investigation", 如： It is considered an investigational new drug for each of these indications.它被认为调查新药物为每个的这些征兆。
recurrent： adj
表示" 再发生的；周期性的；循环的"，means "recurring again and again"，如：The World Food Program says people are suffering from a combination of factors, including high food prices, the global financial crisis, unemployment and recurrent poor food crops.
世界粮食计划署表示人们正遭受各种因素结合的影响，包括粮食价格过高，全球金融危机，失业以及循环的粮食农作物贫乏。
Clostridioides difficile: n
表示"艰难梭状芽胞杆菌"，如：The germ Clostridium difficile is an intestinal bug that is found in the colon. 艰难梭状芽胞杆菌是在结肠内发现的一种肠内菌。
populate: v
表示"居住于；"，means ""，如：Carcasses populate the brush, their putrid remains swallowed whole by the land.尸体居住于刷子，他们的腐败遗骸由土地吞下了整体。
proliferate: v
表示" 繁殖；增生"，means "increase in mumber rapidly;multiply"，如：Microbes proliferate rapidly. 微生物繁殖迅速。
secrete: v
表示" 分泌"，means "generate and separate from cells or bodily fluids"，如：The kidneys secrete urine. 肾脏是分泌尿液的器官。
toxin: n
表示" 毒素；"，means " a poisonous substance produced during the metabolism and growth of certain microorganisms and some higher plant and animal species"，如：Our toxin will destroy the enemy. 我们的毒素将毁灭敌人。
abdominal: adj
表示"腹部的"，means "of, relating to, or located in the abdomen"，如：Why is sit-ups indelible abdominal adipose? 为什么仰卧起坐不能消除腹部的脂肪呢？
colitis: n
表示" [医]结肠炎"，means "inflammation of the colon"，如：he ate a bland diet because of his colitis. 他因为大肠炎而饮食清淡。
colon: n
表示"结肠；大肠"，means "lower and greater part of the large intestine"，如：The old man died from colon cancer. 这位老人死于结肠癌。
microbiome
表示" 微生物组"，means "A microbial biome, such as the community of microbes within the human gut."，如：What is making the Human Microbiome Project feasible is the recent development of superfast gene sequencing technologies. 近来基因序列技术的超速发展使人类微生物组计划成为可能。
tract： n
表示"[解]道；束"，如：Osteoporosis is a late complication of digestive tract disease. 骨质疏松症是消化道疾病的晚期并发症之一。
replenish: v
表示" 补充"，means "fill something that had previously been emptied"，如：We need to replenish our stocks of coal. 我们需要再次补充煤的储备。
rectum: n
表示"直肠"，如：The patient's temperature should be obtained by rectum. 病人的体温自直肠测得。
pathogen: n
表示" 病原体"，如：The opposite end latches onto the pathogen. 相对的一端锁在病原体上。
allergen: n
表示"变应原"，如：The most common allergen was spring pollen. 而花粉过敏患者对春季花粉过敏者最多。
bloat: v
表示" 使肿胀"，means "make bloated or swollen"，如：The planet's heated gases would have then expanded, causing the world to bloat.这个星球上的热气体会随之扩大，最后导致世界的膨胀。
constipation: n
表示"便秘"，means "irregular and infrequent or difficult evacuation of the bowels;"，如：He was bothered with constipation. 他害便秘。
bout: n
表示"一场"，如：here are three rounds in an amateur boxing bout. 一场业余拳击比赛打三个回合。
中文简要说明：
几个月前，一则假消息在媒体间传播，谣言是「进口螺蛳粉成分中含有中药人中黄（吸取人粪的甘草粉块)），幸好不久后，被证实那是无良网军的变造改图。不过，在现代医学中，人粪还真的是一种重要的药材。美国食品和药物管理局(FDA)批准了由捐赠者的粪便所制成的药丸，以治疗严重的肠躁症。
生活科学(LiveScience)报导，FDA批准第一种由捐赠的人类粪便制成的药丸，这是有史以来「第二种」获得批准的人类粪便衍生疗法；上一种是基于灌肠的治疗，于2022年12月获准使用。
这听起来很不可思议，但是这绝对科学。在学理上，这称为「粪便微生物群移植法」。与去年批准的粪便灌肠疗法一样，新批准的名为 Vowst 的药丸，也含有重要的肠道益生菌，对抗艰难梭菌(Clostridium difficile)造成的反复感染。
艰难梭菌是一种肠道内的厌氧菌，原本与人类无益也无害，但是假如患者因为其他的感染而服用抗生素后，情况可能出现变化。进入肠道的抗生素，会破坏肠道内细菌的平衡，这给艰难梭菌增殖的机会。当艰难梭菌快速增殖时，它就从原本的「无益无害」变成危险，因为它会开始分泌毒素，导致腹泻、腹痛、发烧和结肠炎，在最严重的情况，会导致器官衰竭和死亡。
根据 FDA 的统计，美国每年约有1.5万~3万因艰难梭菌感染而死亡。
艰难梭菌也可以被其他的抗生素杀死，但是由于肠道菌群已经失衡，所以康复后仍然有很大的复发风险，有六分之一的患者在两到八周内出现再次感染，然后再用抗生素治疗，演变成恶性循环。
由于艰难梭菌的初期感染，与肠道菌群失衡有关，因此，直接移植健康人的肠道细菌，到患者的肠道，在理论上就成为根治艰难梭菌复发的新方法。在过去5年，利用灌肠的方式移植健康者的粪便，就成为第一代的治疗方式，也就是去年通过FDA的灌肠治疗。
如今，同样原理制成的Vowst口服药丸也通过FDA，这样就更方便了。
Vowst 的疗程包括连续三天，每天服用4粒含粪胶囊；患者在完成艰难梭菌抗生素疗程后的隔天到第四天开始服药。FDA 警告说，用于制造药丸的捐赠粪便，在用于制造之前会仔细筛选可传播的病原体，但服用 Vowst 仍存在一定的暴露于病原体和食物过敏原的风险。
在临床试验中，Vowst 最常见的副作用是腹胀、疲劳、便秘、发冷和腹泻；这些副作用在接受治疗的患者中，发生的频率高于安慰剂接受者。
不过，Vowst的效力是可观的，90名接受Vowst药物治疗的艰难梭菌感染患者，和90名仅服安慰剂患者的比较中，接受Vowst治疗的人，8星期内的复发率为12.4%，而安慰剂组的复发率为39.8%。
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