Topics: Clinical trial, Ebola, Immune system Pages: 5 (1863 words) Published: September 30, 2014
-에볼라 바이러스 취사율
Ebola virus is one of the four ebolaviruses known to cause disease in humans. It has the highest case-fatality rate of these ebolaviruses, averaging 83% since first described in 1976, although fatality rates up to 90% have been recorded in one epidemic (2002–03). There have also been more outbreaks of ebola virus than of any other ebolavirus.

- 사망자
26 September 2014 – The United Nations World Health Organization (WHO) today said it is intensifying its cooperation with a wide range of partners trying to accelerate work on experimental therapies and vaccines as it announced that Ebola has now sickened more than 6,500 and killed more than 3,000.

-신약 ZMapp
ZMapp is an experimental biopharmaceutical drug comprising three humanized monoclonal antibodies under development as a treatment for Ebola virus disease. The drug was first tested in humans during the 2014 West Africa Ebola virus outbreak and was credited as helping save lives, but it has not been subjected to a randomized clinical trial to prove its safety or its efficacy.

-임상실험을 거치지않은 ZMapp 을 허용한 WHO
ZMapp has not yet been tested in a clinical trial to support widespread usage in humans.[33] In light of the 2014 Ebola outbreak, an expert panel from the World Health Organization (WHO) announced on August 12, 2014, "In the particular circumstances of this outbreak, and provided certain conditions are met, the panel reached consensus that it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention."

-임상실험 과정
Phase I: Usually designed to evaluate safety, determine a safe dosage range, and identify side effects on a small group of patients. Phase II: If Phase I is successful, the trial is then repeated with a larger group to further evaluate its effect and safety. Phase III: Trials are conducted on an ever larger group and are compared with the best current treatment while gathering more information on effect and safety. Phase IV: These studies monitor long-term side effects after the treatment has been marketed.

-BSL_4연구기관이 필요하다
Ebola viruses are World Health Organization Risk Group 4 pathogens, requiring biosafety level 4-equivalent containment. Laboratory researchers must be properly trained in BSL-4 practices and wear proper personal protective equipment.

What is ZMapp?
ZMapp, being developed by Mapp Biopharmaceutical Inc., is an experimental treatment, for use with individuals infected with Ebola virus. It has not yet been tested in humans for safety or effectiveness. The product is a combination of three different monoclonal antibodies that bind to the protein of the Ebola virus. How effective is the experimental treatment?

It is too early to know whether ZMapp is effective, since it is still in an experimental stage and has not yet been tested in humans for safety or effectiveness. Some patients infected with Ebola virus do get better spontaneously or with supportive care. However, the best way to know if treatment with the product is efficacious is to conduct a randomized controlled clinical trial in people to compare outcomes of patients who receive the treatment to untreated patients. No such studies have been conducted. It's important to note that the standard treatment for Ebola remains supportive therapy. This includes the following measures:

balancing the patients' fluids and electrolytes;
maintaining their oxygen status and blood pressure; and
treating them for any complicating infections.
In addition, the most effective way to stop the current Ebola outbreak in West Africa is meticulous work in finding Ebola cases, isolating and caring for those patients, and tracing contacts to stop the chains of transmission. It means educating people about safe burial practices and having health care workers strictly follow infection control in hospitals. This is how all previous Ebola outbreaks have been stopped. Why aren't more people getting ZMapp?...
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