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[Medscape健康新闻]:维生素鸡尾酒疗法治疗全身性感染面临更广泛的验证
2018年06月20日 研究点评, 进展交流 暂无评论

Vitamin Cocktail for Sepsis Getting Wider Test

Matt Smith

May 29, 2018

A simple vitamin cocktail to treat sepsis has shaken up the medical world, raising hopes of a more effective treatment for one of history's great killers. But will it stand up to tougher tests?

一种简单的维生素鸡尾酒疗法治疗全身性感染对医学界产生了震动,为治疗这种一个世纪以来危及生命的临床疾病带来了有效治疗的曙光。但是,这种疗法能否经受更加严苛的验证呢?

Researchers at several hospitals around the world are trying to reproduce the success reported by a critical-care doctor in Virginia in beating back sepsis, one of the leading causes of hospital deaths.

全世界多所医院的研究者正在试图重复弗吉尼亚州一名ICU医生治疗全身性感染的成功报告。全身性感染是住院患者死亡的主要原因之一。

Paul Marik, MD, chief of pulomonary and criitical care medicine at Eastern Virginia Medical School, reported in 2017 that he gave a mix of vitamin C, vitamin B1, and a steroid to nearly four dozen patients who had sepsis in his Norfolk intensive care unit. In the 7 months before he started using the treatment, 19 of 47 sepsis patients died. Of the 47 who got the treatment, all but four survived.

2017年,东弗吉尼亚医学院呼吸和重症医学科主任Paul Marik对47名全身性感染的ICU患者同时给予维生素C、维生素B1和皮质激素。在开始上述治疗前的7个月内,47名全身性感染患者中的19名死亡。在接受上述治疗的47名患者中,仅有4名死亡。

The results got a lot of attention. But it was a small study, comparing before-and-after patient outcomes. Now, researchers are gearing up to test the therapy with large-scale trials using patients selected at random, with some given the cocktail and others given a placebo.

这一结果受到了极大关注。但是,这是一项小样本研究,采用前后对照比较患者预后。目前,研究者正在计划随机选择患者接受鸡尾酒疗法或安慰剂,通过大样本试验验证这一治疗的效果。

"Dr. Marik feels very strongly that it's worked in his patients, and he's changed his practice because of his own experience," says Jonathan Sevransky, MD, a critical care doctor at Emory University in Atlanta who is leading one of the studies. "If you think something works, it makes sense for a doctor to try something and to change their own practice. But if you want to change other people's practices, the way to do that is do a randomized, controlled trial -- and ideally, you'd have more than one randomized, controlled trial."

“Marik医生坚信这种治疗对他的患者有效,而且,基于上述经验,他改变了临床治疗。”Jonathan Sevransky如此说到。Jonathan Sevransky是位于亚特兰大的Emory大学的一名ICU医生,他正在领导进行众多验证试验中的一项。“如果你认为某些治疗有效,那么医生当然会进行尝试并改变自己的临床实践。但是,如果你希望改变其他人的行为,你只能依靠随机对照临床试验—理想的情况下,应当有超过一项随机对照试验。”

An Ancient Danger 对于人类健康的古老威胁

Sepsis has been in the medical books since the time of Hippocrates. It happens when the body's immune system responds to an infection with overwhelming force, triggering complications that can cause blood clots, inflammation, and other problems, leading to organ failure and death.

自希波克拉底时代以来,全身性感染就已经出现在医学书籍中。当机体免疫系统对感染产生反应时即可发生全身性感染,从而引发凝血、炎症及其他并发症,最终导致器官功能衰竭甚至死亡。

In the days before sterile instruments and antibiotics, sepsis was a frequent and deadly complication of wounds. It still hits than 1 million people in the United States every year, and between a quarter and half of them die.

在没有无菌设备及抗生素的年代,伤口感染引发的全身性感染是常见且病死率很高的并发症。美国每年仍有超过100万人发病,其中1/4至1/2死亡。

Survival often depends on an immediate dose of antibiotics and intravenous fluids, along with tests to look for signs of an infection or organ failure. Estimates of how much it costs to treat sepsis approach $24 billion a year.

若希望改善全身性感染患者的生存率,应当及时给予抗生素并输注静脉液体,同时寻找感染或器官功能衰竭的表现。估计每年用于治疗全身性感染的费用高达240亿美元。

Jarone Lee, MD, medical director of the intensive care unit at Massachusetts General Hospital, says finding a good treatment for sepsis would solve a lot of health care problems.

麻省总医院ICU主任Jarone Lee医生认为,找到全身性感染的有效治疗措施将解决很多健康问题。

But it's too early to declare victory without better data, says Lee, who is not involved in the ongoing trials.

但是,Lee医生认为,如果没有更好的数据支持,就宣称对全身性感染的治疗取得了胜利,恐怕为时尚早。Lee医生没有参加正在进行的验证研究。

"What I think we're looking for is essentially hard science and great science about how this will work," he says. "It doesn't even have to show the amazing results like Paul did, just that we're moving the needle forward and decreasing mortality or some other process measure that improves outcomes."

“我认为,我们正在寻找的证据关系到上述治疗为何有效。”他谈到。“我们甚至无需证实Paul所观察到的神奇结果,仅仅需要表明我们正在进步,能够在一定程度上降低病死率,或者通过改进其他过程指标从而改善预后。”

Ambitious Studies Planned 雄心勃勃的研究计划

Sevransky's study plans to involve at least 500 and up to 2,000 patients at multiple hospitals for about a year and a half. The plan is to wrap up work in December 2019.

Sevransky的研究计划在一年到一年半期间,在多家医院纳入500-2000名患者。研究计划于2019年12月结束。

The researchers will be looking at what the vitamin mixture does to speed recovery in sepsis patients who need life support, either by mechanical means or through drugs that help keep blood pressure at normal levels. They will also be watching the results for any improvements in death rates and may extend the study if it shows promise, Sevransky says.

对于需要生命支持治疗(通过机械或药物手段维持血压在正常水平)的全身性感染患者,研究者希望验证多种维生素治疗能否加快患者病情恢复。Sevransky说到,他们还将验证病死率是否改善,如果得到阳性结果,将进一步扩大研究。

"The thing that's most likely to change people's care is if the treatment does show a difference in mortality," he says.

他说:“如果研究证明治疗的确改变病死率,则最可能改变患者的医疗。”

A second study, led by Michael Donnino, MD, at Harvard's Beth Israel Deaconess Medical Center, involves about 200 patients and  a wider number of hospitals. It is expected to end in a year, says Ari Moskowitz, MD, a pulmonary care and critical care specialist at Beth Israel Deaconess.

Harvard医学院Beth Israel Deaconess医学中心的Michael Donnino医生主导进行了第二项研究。他计划从更多的医院纳入200名患者。Beth Israel Deaconess医学中心呼吸与重症医学科的Ari Moskowitz医生表示,研究预计在1年内结束。

Moskowitz says they hope the vitamin cocktail will  help limit injury to organs, such as the kidneys or heart. The study will evaluate how well it prevents organ injury along with survival rates. "Saving lives is the ultimate goal of the intervention," he says.

Ari Moskowitz医生谈到,他们希望维生素鸡尾酒疗法有助于限制器官(如肾脏或心脏)损伤。研究将评估治疗对器官损伤及生存率的影响。“”他说到。“挽救患者生命是治疗的最终目的。”

Similar studies are underway in New Jersey, Slovenia, China, Australia, and Qatar.

新泽西、斯洛文尼亚、中国、澳大利亚和卡塔尔正在进行类似的研究。

Limited Risk of Side Effects 副作用有限

Marik says he's pleased with the interest and has spoken with some of the researchers involved in the planned trials, but he's not waiting on the results. He's now treated more than 700 sepsis patients with the vitamin-steroid mixture, which supplements -- but doesn't replace -- other drugs like antibiotics. He says his patients have not had any serious side effects.

Marik谈到,他非常高兴看到大家对此治疗感兴趣,而且与部分研究者进行了交流,但是,他不会等待研究结果。他目前已经采用维生素—激素治疗了超过700名全身性感染患者。这一治疗是对其他药物(如抗生素)的补充而非替代。他说,患者未出现任何严重的副作用。

People who take a lot of vitamin C can be more likely to get kidney stones, Sevransky says. And vitamin C can throw off measurements of blood sugar, which may be a concern for people who are getting extra glucose in the hospital. So people who are being given the therapy should use meters that aren't likely to be thrown off by that effect, he says.

Sevransky谈到,服用大量维生素C的人更容易发生肾结石。维生素C可能影响血糖水平的测定结果,这对于接受额外葡萄糖摄入的住院患者可能造成影响。他认为,接受上述治疗的患者在监测血糖水平时,应采用不受上述治疗影响的方法。

The dose being studied is about 1.5 grams intravenously, every 6 hours for 4 days -- several times higher than people get from ordinary vitamin supplements or eating fruit, but less than some patients get while having chemotherapy, he said.

他谈到,研究中采用的剂量约为1.5 g iv,每6小时一次,疗程4天 — 与日常补充维生素或食用水果的人群相比,剂量增加数倍,但剂量小于接受化疗的部分患者。

Lee says Massachusetts General has used Marik's cocktail sometimes in patients that aren't responding to conventional treatment -- "But it's not routine in any way, and I don't think it should be routine in any way until the data is better."

Lee医生说到,对于传统治疗无效的患者,麻省总医院有时会采用Marik的鸡尾酒疗法 — “但无论如何这并非常规治疗,除非有更好的数据支持,否则我不认为这能够成为常规治疗。”

In a follow-up paper in April, Marik wrote that vitamin C lowers oxidative stress and inflammation, and it helps stop blood vessels from dilating, which helps maintain blood pressure. People who have sepsis often don't have enough vitamins C and B1, and those vitamins appear to combine with the steroid hydrocortisone to boost the effects.

在4月份发表的一项随访研究论文中,Marik写到,维生素C能够减弱氧化应激和炎症,防止血管扩张,从而有助于维持血压。全身性感染患者常常缺乏维生素C和B1,这些维生素联合皮质激素能够增强疗效。

"There is in fact an enormous amount of basic science to support this," he says. An Australian study found that if Marik's mixture works, it could shave more than 40% off the long-term cost of treating the disease.

“事实上,有很多很多基础研究结果支持这种治疗,”他说到。澳大利亚的一项演技发现,如果Marik的鸡尾酒疗法有效,将可以节约超过40%的远期治疗费用。

"The bottom line is it saves billions of dollars and millions of life-years, and at worst, if it doesn't work, all it does is waste a little bit of money and nothing is lost," he says.

“关键点在于这样能够节约大量费用,挽救许多生命,在最差的情况下,即使治疗无效,治疗费用低廉,我们不会有任何损失”,他说到。

Sevransky says previous research has suggested vitamin C can improve blood flow to tissues in the body of a sepsis patient, keeping the cells supplied with nutrients and oxygen and preventing organ failure.

Sevransky提到,既往研究提示维生素C能够改善全身性感染患者的组织血流,维持细胞的营养物质和氧的供应,预防器官功能衰竭。

And an earlier study by Donnino's team at Harvard found that vitamin B1, or thiamine, could help prevent kidney failure in sepsis patients. Thiamine is essential to the mitochondria, your cells' powerhouses, and patients with vitamin B and C deficiencies show some of the same symptoms as people with sepsis -- including low blood pressure and an increase in blood acid levels.

Harvard医学院Donnino医生团队较早的一项研究发现,维生素B1有助于预防全身性感染患者的肾功能衰竭。维生素B1对于线粒体功能非常关键,维生素B1和C缺乏患者的临床表现与全身性感染相似 — 包括低血压及酸中毒。

"When we targeted select populations of critically ill patients, we have found that upwards of 30% may be thiamine deficient," Harvard's Moskowitz says.

“当我们针对性地选择危重病患者时,我们发现,多达30%的患者缺乏维生素B1,”Harvard医学院的Moskowitz医生说到。

But Sevransky says research is full of promising cures that never panned out.

但是,Sevransky也提到,有很多有前景的治疗手段最终被证实无效。

"Even though the theory behind it was solid, the treatment didn't work," he says.

他谈到:“即使理论上站得住脚,但治疗仍可能无效。”

SOURCES:

National Institute of General Medical Sciences: "Sepsis."

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