Regarding "antibody cocktail therapy" that can be used for mildly ill patients with the new coronavirus, the Ministry of Health, Labor and Welfare has begun to consider whether to allow it to be used in home visits under the direction of Prime Minister Kan.
On the other hand, since serious symptoms with suspected side effects have been reported in rare cases, the Ministry of Health, Labor and Welfare has a policy of carefully assessing whether safety can be ensured.
"Antibody cocktail therapy," in which two drugs made of antibodies are administered by intravenous drip at the same time, was approved in July as the first therapeutic drug that can be used even in mildly ill patients.
Initially, it was intended only for inpatients, but since last month, it has been conditionally approved for outpatient use in addition to accommodation facilities.
Prime Minister Suga instructed the Minister of Health, Labor and Welfare Tamura to consider using it for home visits, and the Ministry of Health, Labor and Welfare has begun a concrete study, but the issue is ensuring safety.
According to the Ministry of Health, Labor and Welfare, an estimated 5,800 people received the drug by the 21st of last month, and 27 people, or 0.46%, reported serious symptoms with suspected side effects such as fever, decreased oxygen saturation, and angina. I am.
Currently, the Ministry of Health, Labor and Welfare has set the condition of use that it can be grasped even if the patient's condition deteriorates for 24 hours after administration, but when used in home visits from medical personnel, especially for patients living alone. It has been pointed out that it may not be possible to grasp.
According to the Ministry of Health, Labor and Welfare, "Clinical data are limited and the possibility of new symptoms being reported cannot be denied. I want to. "
1.35% of patients who received the drug ・ Symptoms of suspected side effects in 79 patients
According to the Ministry of Health, Labor and Welfare and Chugai Pharmaceutical, which has license agreements with related companies, 1.35% of the 5871 people who received the drug during the one-month period from July 22 to 21 last month. Symptoms with suspected side effects were reported in 79 people.
Of these, 27 were serious, with fever in 5, oxygen saturation in 4, chills in 2, angina, vomiting, and blood pressure decrease or increase in 1 each. increase.
Since the causal relationship between the administration and administration of any of these symptoms is unknown, the Ministry of Health, Labor and Welfare and others are continuing to collect information.
Multiple issues
Hiroaki Iwama, director of "Shinetsu Clinic" in Shinagawa-ku, Tokyo, who is visiting people who are infected with the new coronavirus and undergoing medical treatment at home, said that "antibody cocktail therapy" should be used in home visits as well. It is desirable to have more means to prevent aggravation, "he said, adding that there are multiple challenges.
There may be concerns that the family will immediately notice if the patient develops an allergy, or there may be cases where there is no one to watch over by living alone. It needs to be built, but it won't be easy to achieve. "
He added, "The medicines used for antibody cocktail therapy are mainly distributed for two people in one bottle and must be used up within 48 hours after opening. The medicines are expensive, so do not discard them. We also need a system to coordinate patients among doctors so that they can be used without any problems. "
"Take a positive view and welcome"
Kazuma Tashiro, director of Hinata Zaitaku Clinic Sanno, who has visited home recuperators in Ota Ward, Tokyo, said, "Since the treatments that can be done at home were limited, we are positive in the sense that effective options will be added. We are welcoming you. "
On top of that, "The number of patients that can be treated per day is limited, considering that it takes time to prepare before administration such as mixing two antibodies and it is necessary to follow up for side effects after administration. I think that it will be possible to reduce the number of people who become seriously ill by enhancing the system to smoothly perform antibody cocktail therapy to multiple patients by utilizing vacant beds in hospitals, and depending on the situation, if some of them are handled at home. From now on, all institutions need to work together to prepare for the "6th wave" and take drastic measures. "
"It is also necessary to create rules for proper use"
Dr. Ryo Kikuchi, the representative of the group of doctors "Fast Doctor" who visits home-care patients, said, "It is premised that the drug is administered in a place with a sufficient system such as a hospital or accommodation facility. However, it takes time to adjust hospitalization. In some cases, it may not be possible to administer the drug at the appropriate time, so I think it is necessary to create a system that can handle it even at home. "
Dr. Kikuchi said that even if there was a patient who thought that antibody cocktail therapy was necessary at the time of the home visit, he could not propose it to the patient as a treatment option when the bed was too tight to be hospitalized. I felt that it was not good for some patients to be unable to receive treatment due to the limited choices. "
On top of that, "It is highly effective to prevent aggravation of high-risk patients, but since it is an inexperienced drug, it should be used appropriately, such as how to take measures against side effects when using it at home visits. It is also necessary to create rules for. "