What is the difference between Korean type plasma therapeutic and American type?

 

 

The cumulative number of corona 19 infected people in Korea has exceeded 20,000, but the infection is unlikely to break. Mutations such as the GH virus, which is up to 9.3 times more infectious than the beginning of this year, have already been confirmed among over 1,000 infected people from the First Church of Ai. In addition to this, amid growing anxiety such as re-infection cases appearing one after another in the world, worldwide attention is focused on the development of a therapeutic plasma therapy for the completely cured patient, which is known to be the most reliable treatment method. I am. 

In Korea, last April, a team of professor Choi Joon-young from Severance Hospital revealed that there was a clear therapeutic effect as a result of plasma treatment of two patients with severe corona 19 in parallel with complete cure. I gathered.

Plasma means a liquid component that excludes red blood cells, white blood cells, and platelets from blood. The reason why attention is paid to plasma in the convalescent stage of a fully cured person is that the hypothesis that there is a "neutralizing antibody" that suppresses the growth of the virus in plasma has been accepted. In addition, if a large amount of immunoglobulin can be extracted from the plasma of a completely cured person, the development of a therapeutic agent is possible.

Recently, a plasma therapeutic agent approved by the US FDA has been released, but it has a completely different character from the plasma therapeutic agent currently being developed in Korea. The FDA-approved plasma therapeutic agent is a principle that neutralizes the virus that causes infections by immune antibodies in the blood of convalescent patients. Administer to Some argue that there is insufficient scientific evidence regarding plasma therapy, as some have not been reported.

On the other hand, the plasma therapeutic agent currently under development at GC Green Cross is a drug made with a “high immunoglobulin” preparation in which immune proteins such as antibodies are extracted and fractionated and concentrated from plasma in the blood of a completely healed person. It's a real cure. The most important thing in the realization of such plasma treatment is "donation of plasma for a large number of healers". This is because meaningful antibodies can be obtained in research and treatment only by providing antibodies through a large number of blood donations.

Fortunately, the development of therapeutic agents will soon be realized by the active donation of plasma by the Shintenchi believers who suffered from Corona 19. Following July, an additional group plasma donation of 1100 completely cured patients from Shintenchi was carried out from August 27, resulting in a total of more than 1700 plasma donations from Shintenchi alone. Against this, the Central Epidemic Countermeasures Headquarters once again expressed appreciation for the donation of group plasma by the Shintenchi people.

The plasma therapeutic agent being developed by the Green Cross has already been approved by the Food and Drug Safety Administration for a clinical two-bed study with the help of the previous Shincheonji primary plasma donors and general plasma donors. From September, the corresponding therapeutic agent will undergo a two-bed clinical trial in 19 corona patients at 6 hospitals such as Samsung Seoul Hospital.

In general, new drugs such as vaccines are used in a single-bed clinical trial in a small number of healthy subjects, in two beds to investigate the therapeutic effect by administering to target patients, and whether a large number of vaccinated persons will be harmed. Registration and approval will occur after the final three-bed clinical trial to be validated.

 

 

韓国型血漿治療剤、米国型との違いは？

 

[天地日報=パク・ソナ記者] 韓国国内のコロナ19の累積感染者が2万名を突破しましたが、感染推移は折れそうにありません。既に1千名を超えた愛の第一教会発の感染者などからは今年の初めより最大9.3倍感染力が高いGH型ウィルスが確認されるなどの変異が続いています。これに加えて、世界的に再感染事例が続々と現れるなど、不安感が高まる中で、最も確実な治療法と知られている完治者の血漿治療剤の開発に全世界の関心が集中しています。 

 

韓国国内では、去る4月、セブランス病院のチェ・ジュンヨン教授のチームがコロナ19の重症患者2名に完治者の血漿治療を並行した結果、明らかな治療効果が出たと明かした事で、関心が集りました。

 

血漿は血液の中から赤血球と白血球、血小板などを除外した液体成分を意味します。完治者の回復期の血漿が注目されている理由は、血漿内にウィルスの増殖を抑制する「中和抗体」が存在するという仮説が認められているからです。また、完治者の血漿から免疫グロブリンを多量抽出できれば、治療剤の開発も可能です。

 

最近、アメリカのFDAの承認を受けた血漿治療剤が出たものの、これは、現在韓国国内で開発中の血漿治療剤とは性格が全く違います。FDAが承認した血漿治療剤は回復期の患者の血液の中の免疫抗体によって、感染症の原因のウィルスを無力化する原理で、このために、完治者の血漿を重症患者に直接、受血するように投与します。血漿治療に関して、一部では明らかな効果が報告されていないため、科学的な根拠が足りないという主張もあります。

 

一方、現在GC緑十字で開発中の血漿治療剤は完治者の血液の中の血漿から抗体などの免疫タンパク質を抽出・分画して濃縮させた「高免疫グロブリン」製剤で作った医薬品です。実質的な治療薬であるというわけです。このような血漿治療の現実化で最も重要な事は「多数の完治者の血漿供与」です。多数の献血を通して、抗体を提供されてこそ、研究と治療で有意味な結果を導き出す事ができるからです。

 

幸い、治療剤の開発はコロナ19で苦しんだ新天地信徒らの積極的な血漿供与によって、まもなく現実化される見通しです。7月に続いて、新天地の完治者1100名の団体血漿供与が8月27日から追加で行われることによって、新天地だけでも総1700名余りが血漿供与に出たわけです。これに対しては中央防疫対策本部も二度に渡って、新天地信徒の団体血漿供与に感謝の気持ちを現しました。

 

緑十字が開発中の血漿治療剤は前回の新天地1次血漿供与者らと一般の血漿供与者らの参加に力を得て、既に食品医薬品安全処から臨床2床試験を承認されました。該当治療剤は9月からサムソンソウル病院などの6カ所の病院で、コロナ19患者を対象に2床臨床試験を行います。

 

一般的に、ワクチンなどの新薬は少数の健康な被験者を対象にした1床臨床試験、対象の患者らに投与して治療効果を探索する2床、多数の接種者に害を加えないかを検証する最後の3床臨床試験を経た後に、登録と承認が行われます。

 

出所 : 天地日報(http://www.newscj.com)

http://www.newscj.com/news/articleView.html?idxno=775479