目的： "The superoxygenated blood helps reduce capillary swelling to restore blood flow to surrounding tissue and decrease infarct size"
AMIHOT 2で、MACE増加傾向あり
承認後退したように見えたが、IC-HOT研究で、安全性データ、プライマリエンドポイントリスク増加なしで承認へ
http://www.therox.com/wp-content/uploads/2019/04/TherOx-FDA-Approval-Release-04-02-2019-FINAL.pdf
FDA承認
https://www.medscape.com/viewarticle/911365
During SSO2 therapy developed by the Irvine, Calif., biotechnology company TherOx Inc., saline is drawn into a chamber in a disposable cartridge inserted into the treatment system. Supersaturated oxygen is sprayed into a second chamber and mixed with the saline.
The patient's blood is circulated through a third chamber where it mixes with the SSO2 saline. The blood-oxygen-saline solution is then directed by catheter into the patient's coronary artery where it infuses the capillary bed and surrounding heart tissue. The procedure takes about one hour.
https://www.medgadget.com/2013/10/super-saturated-ozygen-therapy-to-treat-heart-attack-patients-interview.html
適応症例： anterior STEMI and proximal or mid‐LAD occlusion presenting within 6 hours of symptom onset
Evaluation of intracoronary hyperoxemic oxygen therapy in acute anterior myocardial infarction: The IC‐HOT study
Shukri W. David, et al.
First published: 28 September 2018
https://doi.org/10.1002/ccd.27905
https://onlinelibrary.wiley.com/doi/abs/10.1002/ccd.27905
Median [interquartile range] infarct size was 24.1% [14.4%, 31.6%] at 4 days and 19.4% [8.8%, 28.9%] at 30 days.
re-perfusion injury (damage)が思い浮かぶのだが・・・
0 件のコメント:
コメントを投稿