"Ivermectin" is a silver bullet for infectious diseases caused by parasites such as blindness.

Information that it may be effective for patients with the new coronavirus has been issued by the chairman of the Tokyo Metropolitan Medical Association and some doctors.


However, national health authorities, the WHO (World Health Organization, manufacturers, etc.) have so far stated that clinical trials have not clearly shown efficacy.

We have compiled the latest information on "ivermectin".

What is ivermectin?

Ivermectin is a drench developed based on the research of Professor Satoshi Omura of Kitasato University, who won the Nobel Prize in Physiology or Medicine. It is used all over the world, mainly in other countries.



In Japan, it has been approved as a remedy for scabies, which causes severe itching of the skin, and in an experiment using cells, it was shown last year that it has the effect of suppressing the growth of the new coronavirus. Therefore, research is being conducted in each country on its efficacy and safety for patients.

Not approved as a Japanese corona drug and investigated for efficacy in clinical trials

Ivermectin is approved as a therapeutic drug for the new corona in some countries in South America, but it is not approved as a therapeutic drug for the new corona in Japan, and Kitasato University's school corporation "Kitasato Institute" Since September last year, doctor-led clinical trials have been conducted at Kitasato University Hospital, etc., targeting some patients with mild to moderate blood oxygen levels of 95% or more to investigate their efficacy and safety. I am.



The original plan was to complete clinical trials for 240 people by the end of March, but according to the Kitasato Institute, each hospital has no choice but to prioritize the treatment of patients with severe symptoms due to the spread of infection. As of June, only about half of the patients participated in the situation.

Overseas effectiveness has not been sufficiently proven and research continues

In addition, various research results have been reported overseas, but their effectiveness has not been sufficiently proven, and research is continuing.

US / NIH “I can't conclude if it is effective for corona”

In February, the US NIH National Institute of Public Health did not approve Ibermectin for the treatment of viral infections, and most of the studies reported on the treatment of the new corona have a large number of patients. The information is incomplete, such as the number is low and the severity of the patient is not clear, and it is not possible to conclude whether it is effective for the new corona.

Merck, a major US and pharmaceutical company, "Therapeutic effect is not sufficiently scientifically grounded."

In February, Merck, an American pharmaceutical giant that manufactures ivermectin, issued a statement saying that "there is no sufficient scientific basis for the therapeutic effect on the new coronavirus."

WHO Scientifically grounded or "extremely uncertain"

In addition, WHO analyzed the results of 16 clinical trials involving a total of 2,407 people in March, and found that it was "extremely uncertain" whether there was any scientific evidence to reduce mortality or accelerate recovery in new corona patients. It is recommended that ivermectin should be administered only in clinical trials.

Ministry of Health, Labor and Welfare "Note that effectiveness and safety have not been established"

In Japan, the Ministry of Health, Labor and Welfare revised the "Clinical Guide" for medical institutions at the end of July, stating that "it was reported that it did not improve all deaths, hospital stays, and virus disappearance time in mildly ill patients." It is positioned as one of the drugs that "keep in mind that the efficacy and safety have not been established" as a treatment for corona.



On the other hand, according to a document attached by a pharmaceutical company about ivermectin, liver dysfunction has been reported as a side effect, and the safety of administration to elderly people and pregnant women has not been established.

Taking ivermectin with a large dose of US / FDA "Stop seriously"

In March, the U.S. FDA = Food and Drug Administration said on its website that "some patients were hospitalized after taking ivermectin for large doses at their own discretion" and "heard that it is okay to take a large amount." It may be a mistake, but it's very dangerous. Not only can it cause serious damage such as nausea, diarrhea, and cramps, but it can also be fatal. " You're not a horse, you're not a cow, please stop taking it seriously. "

Corona remedy 4 approved in Japan

To date, four drugs have been approved for the treatment of the new corona in Japan.

1. Remdesivir

Of these, the antiviral drug "remdesivir" was the earliest to be approved as a treatment for the new coronavirus in May last year.

Originally developed as a treatment for Ebola hemorrhagic fever, it is administered by intravenous drip.



Initially, the target patients were

limited to ▽


ventilators and


▽ critically ill patients with heart-lung machine = ECMO, but


from January, it will be administered to moderately ill patients with pneumonia. It is accepted.

2. Dexamethasone

Next, in July last year, the Ministry of Health, Labor and Welfare recommended dexamethasone, a steroid that suppresses inflammation and allergies, which was originally used to treat severe pneumonia and rheumatism.



The drug has been shown to reduce mortality in critically ill patients in clinical trials conducted in the United Kingdom.



In Japan, treatment with the antiviral drug remdesivir and dexamethasone is widely used, and it is thought that this was one of the factors that caused the case fatality rate to drop significantly due to the subsequent spread of infection compared to the first wave of infection last spring. Has been done.

3. Baricitinib

In April, baricitinib, a drug that suppresses inflammation with drugs such as rheumatoid arthritis, was approved as a therapeutic drug.



This drug is a tablet and is required to be taken in combination with remdesivir for moderately ill or higher inpatients who require oxygen administration.



In international clinical trials, the combination of "baricitinib" and "remdesivir" resulted in an average of one day faster recovery in patients than when "remdesivir" was given alone.

4. Antibody cocktail therapy

And this July, "antibody cocktail therapy" was approved.



By mixing two types of antibodies, "casilibimab" and "imdevimab", and administering them by intravenous drip, it has the effect of suppressing the action of the new coronavirus, and was approved as a therapeutic drug that can be used for the first time in mildly ill patients.



Although it should be administered early after onset, clinical trials conducted overseas have confirmed that it is effective in reducing the risk of hospitalization and death by approximately 70%.

The US FDA (Food and Drug Administration) issued an urgent license in November last year for patients at high risk of worsening symptoms, saying that it would have a certain effect, and in October last year, former President Trump of the United States issued a new corona. It was also used when infected with a virus and hospitalized.



Initially, the Ministry of Health, Labor and Welfare approved the use only for inpatients because it needed to be observed by a doctor, but as the number of patients who could not be hospitalized due to the rapid spread of infection increased, a system for sufficient observation was established on the 13th of this month. On condition that the

patient is

present, it is permitted to administer the drug

at


▽ accommodation medical facilities or


▽ "hospitalization waiting station" set up as a temporary medical facility


.



Regarding this drug, Tsuneo Morishima, a visiting professor at Aichi Medical University, who is familiar with the treatment of the new coronavirus, said, "It is difficult to administer this drug to patients undergoing home care because it requires observation by a doctor after administration. It is necessary to survive this emergency by utilizing facilities such as libraries and gymnasiums that are dormant. "

Drugs in clinical trials and studies

In addition, in Japan


▽ rheumatoid arthritis medicine "Actemra" or


▽ new influenza of the therapeutic agent "Abigan"


▽ suppress the symptoms of asthma, "Orubesuko"


▽ treatment of disease that can be acute pancreatitis and thrombosis "non-attendance"


And


▽ parasitic


Clinical trials and studies are being conducted to confirm the effects of new corona with drugs used to treat other diseases

such as "Ibermectin", a drug for infectious diseases caused by insects

.

Expert Ivermectin "Avoid being used in dark clouds"

Visiting Professor Morishima said, "Ivermectin is one of the promising therapeutic agents, but in order to be widely used, it has been scientifically demonstrated to be as effective as other approved therapeutic agents, and the results are the main convincing ones. It is necessary to publish it in a medical journal. Some of the papers on ivermectin have been tampered with, but few papers mention whether it works for highly infectious delta strains, so it is not clear. In a crisis of the medical system, both medical practitioners and patients understand the desire for medicine, but there is no guarantee as to who will take responsibility in the event of side effects and how to protect the patient. It is a problem to be used and should be avoided in the dark clouds. "

Ivermectin should be stopped at your own discretion

"Ivermectin" is sold on mail-order sites as "expected to have a therapeutic effect on the new coronavirus", and some people buy it personally, but experts who are familiar with clinical trials are currently At the stage, the scientific basis for efficacy is not sufficient, and it should be stopped at the discretion of the individual.

International website "Scientific basis not found at this time"

At the end of last month, the international website Cochrane, where experts from various countries examine the treatises to see if they have a scientific basis, examined the treatises published by each country on the effectiveness of ivermectin for the new corona. He said, "We have not found any scientific basis to support its use for treatment or prevention at this time."

Expert “No high-level evidence of therapeutic effect”

Professor Noriyuki Katsumata of Nippon Medical School Musashi Kosugi Hospital, who is familiar with clinical trials of drugs and treatment methods, said that the scientific basis for effective treatment methods = "evidence" ranges from high to low reliability and is currently available. However, he points out that there is no high level of evidence for the therapeutic effect of ivermectin on the new corona.



The highest level of evidence in the world is a clinical trial called a "randomized controlled trial," which divides the drug into those who administer the drug and those who administer a placebo, and to whom the drug is administered. This is the result of an objective comparison without the patient or doctor knowing.



According to Professor Katsumata, the level of evidence is mainly divided into five levels.


▽ Especially high level "Level 1" is "therapeutic method proved by randomized controlled trials with many patients participating in clinical trials".


Next,


▽ "Level 2" is said to be "a treatment method proved in a randomized controlled trial with a small number of patients".



And


▽ "Level 3" is "Results of clinical trials without comparative control"


▽ "Level 4" is "Report of two or more observational studies and cases"


▽ "Patient's experience and doctor's treatment experience" , Basic research such as animal experiments "is positioned at the lowest" level 5 ".



Professor Katsumata says that there are many cases in which clinical trials do not prove effective even if doctors feel that drugs and treatments are effective when administered to patients.

"Effectiveness has not been clearly shown at this stage."

On that basis, regarding the efficacy of ivermectin for the new corona, "Although some data have been verified in randomized controlled trials, many of them have a small number of patients, and the efficacy has not been clearly shown at this stage. In some cases, the doctor in question mentions the effectiveness from experience, but he is only watching the patient's progress that "the symptoms improved after administration". Many mildly ill patients recover spontaneously, so the drug It is not possible to confirm in the clinic whether or not it was effective. The story based on the individual experience of the doctor is the least reliable "level 5" in the scientific basis, regardless of the doctor or the authoritative doctor. It is considered information. "



"It may be shown to be effective in the future, but it has not been shown at this stage and it is better to stop taking it at your own discretion. Not limited to corona, false information when you become anxious. It is easy to be confused by uncertain information. It is necessary to carefully check whether it is backed by a high level of grounds based on information provided by public institutions. "