Chapter 97 Clinical Trials
At this time, whether it is China, the United States, or the European Union, the research on the pathogen of the epidemic has come to a standstill, and in the face of the unknown virus, infectious disease and pathology experts have suffered a huge setback, and have entered a confused and clueless situation. Pen & Fun & Pavilion www.biquge.info
It's very sad that a group of experts can't do anything about a small virus!
It wasn't until the Office of the Golden Autumn Garden, the White House Office, and the European Commission's Dedicated Commissioner for Health and Food conveyed the technical documents provided by Stellar Life Medical, that these confused experts and institutions finally cleared the fog and saw a ray of light.
The causative agent of the epidemic is actually prions!
After seeing the conclusions in the document, everyone was shocked.
Although the team of experts at the University of Washington School of Medicine showed such expressions, when the pathogen was indeed confirmed to be a prion, they did not have a little sense of relief or accomplishment in their hearts, but were filled with a suffocating heaviness.
Prions are universally recognized as pathogens that are not easy to kill, they are too advanced with existing medical methods, and the treatment of prions in the current research in the field of biological medicine is completely an insurmountable ditch!
Because it is a mutation of a normal protein in an animal, it is impossible to treat prions as well as other viruses and bacteria, and if it is confirmed that the pathogen of the epidemic is a prion, it will be the most difficult problem they face. Because this is tantamount to a death sentence for the patient! Thinking of the strong contagiousness of the epidemic that is getting worse and worse now, it can be regarded as a disaster for the entire human race!
Fortunately, the cause of PRP-C brain tissue virus and its spatial structure diagram are elaborated in the technical documents, and there is also a comprehensive explanation of the detection methods and treatment methods.
This made everyone breathe a sigh of relief, and for a while, the little-known company "Stellar Life Medical" took advantage of this epidemic to enter the eyes of global infectious disease and pathology experts, who contacted it one after another, and obtained simple diagnostic test strips and treatment reagent samples from Stellar Life Medical.
Like a bunch of straw that suddenly floats over as a drowning person is dying, major institutions have seized on this straw and launched non-stop exploratory experiments according to the description of the technical documents.
Stellar Life Medical's simple diagnostic test strip is a color-sensitive test strip that requires only the patient's saliva to quickly confirm whether the patient is infected with the PRP-C brain tissue virus. The treatment reagent is divided into two types: bottle A is a 1ml brown vial, which contains a strictly confidential prion lethal ingredient; Bottle B is a large medical saline bottle containing the main components of the isozyme of the PRP protein and all other proteins in the protein synthesis profile associated with the PRP protein.
The use of the treatment agent is very simple, the A bottle is directly dissolved with normal saline, injected into the B bottle, and then slowly injected into the patient's body by intravenous injection. The instructions for use indicate that a group of bottles A and B are the daily dosage of the standard treatment ratio, and for patients with severe conditions, two groups can be entered at the same time.
After the treatment reagent enters the patient's body, it can kill the PRP-C brain tissue virus very quickly, but the brain tissue and central nervous system damage caused by the PRP-C brain tissue virus can only be slowly repaired by the patient himself.
It's not perfect, but it's undoubtedly the best treatment at the moment.
As soon as the test drug was obtained, major medical institutions around the world organized exploratory clinical trials.
After learning that a new drug had the potential to cure them, many of the patients' families signed the informed consent form for the clinical trial without objection and waited with mixed feelings.
Zhang Laohan is an old man over seventy years old, named Zhang Xianxian, in the spread of the epidemic, his wife, two daughters, and two sons-in-law were unfortunately infected with the virus, and Zhang Laohan himself was also required to isolate at home, and the original reunion day suddenly became life and death.
This morning, the hospital informed him by phone that his wife had unfortunately passed away at six o'clock this morning, and his two daughters and son-in-law were also in critical condition.
At eight o'clock, the hospital called again, his little daughter was critically ill, and at this time, Zhang Laohan had come to the isolation area of the hospital without listening to the advice.
When he came to the quarantine area, he found that the heavily armed doctor at the window was arguing with several patients' family members, and he couldn't hear the content of the quarrel clearly, as if they wanted to sign some kind of clinical trial informed consent form, and some family members did not agree to sign it, but asked the hospital to use drugs for their family members.
The direction of the quarrel is the entrance of the quarantine area, Zhang Laohan walked over with a heartfelt heart, and then he also heard the reason for the matter, it turned out that there was a company that developed a drug to deal with the condition, but due to the urgency of the situation, the new drug has not been certified by the national authority, and there may be some unknown risks, and this drug trial is directly organized by the state, for patients who are interested in trying new drugs.
Originally, there was legal compensation for the failure of clinical trials of some drugs, but due to the extremely high intensity of the epidemic this time, according to the terms of "compensation according to the degree of damage and relevant national laws and regulations" in the general clinical trial informed consent form, it is impossible to determine whether the death of the patient caused by the side effects of the drug or the death of the epidemic caused by the failure of treatment.
In other words, after signing the informed consent form for clinical trials, it is possible to do a drug test, but in the end, it is still determined according to the death of the epidemic, which is nothing more than that the condolence money may be more, but where can it be more?
This makes some family members unable to agree, they feel that the new drug is extremely unreliable, and their own family members have taken the risk of testing the new drug as guinea pigs, how can they treat it normally? After all, this new drug, who knows if it is poisonous! If you try it, you might get in with half a life.
Zhang Laohan walked over, stopped, he thought of his daughter and son-in-law who were critically ill, and carried the party membership card in his pocket, he came to the hospital this time, he had already risked being infected by the virus, an old man like him, still attaches great importance to the identity of party members, going out to run errands or going to government departments to talk about things, reflecting the situation, there will always be a certificate of his identity in his pocket - party membership card, it seems that this small certificate gave him strong courage to support.
"Comrade, they don't sign this clinical trial informed consent form, I'll sign it, I'm a party member, my daughter and son-in-law are critically ill, I can sign it!"
Zhang Laohan came to the doctor who maintained order, with a hint of determination on his old face. He believes that the state, since the country puts the new drug in the hospital for testing, must have some kind of certainty, and even if it is not sure, can it bring worse results? Someone has to step up for a new drug trial.
He looked at the families of the patients who were crying sadly, but who were unwilling to sign the consent form on the issue of treatment, and seemed to see some kind of ugly appearance.
The scene became a little strange because of Zhang Laohan's interruption, the doctor looked at him, then at the red book he took out of his pocket, communicated with the medical staff next to him, and nodded in agreement.
This time, Peking University People's Hospital, as the key hospital of the first batch of trials, got a total of 25 trial patients, and the communication of the first 20 places was very smooth, and the patient's family members seemed to accept the reality and signed the consent with the attitude of being a dead horse and a live horse doctor, but in the last few places, there was a situation where the patient's family members refused to sign the informed consent form in series.
Who is this new drug clinical trial quota for?
Soon, Zhang Laohan saw his daughter and son-in-law, at this time they had fallen into a severe coma, their lives were in danger, Zhang Laohan saw through the thick isolation glass that the doctor took out a packaging box, and then used a syringe to absorb normal saline to dissolve the A bottle powder into the B bottle, and then slowly flowed into the blood vessels of his daughter and son-in-law through intravenous injection.
The ward was very calm, and the testing equipment was definitely not enough at this time, but in order to accurately observe the reaction after using the new drug, the hospital still mobilized a full set of equipment.
The ECG showed normal, and the heartbeat gradually decreased from 120 beats per minute to 80 beats per minute, and gradually returned to normal levels. The blood pressure monitor shows that the blood pressure is stabilizing, but the effect is not too obvious.
The rest of the indicators are also at a critical level.
Zhang Laohan stayed outside the ward for more than four hours, and he did not hear the news of his daughter and son-in-law's critical illness, which made his rickety body slowly harden.
At four o'clock in the afternoon, six hours after the new drug was used, the doctor came to Zhang Laohan.
"Good news, your daughter and son-in-law are out of danger of life, and after dipstick testing, the content of PRP-C brain tissue virus has been reduced from the original severe danger to a low-to-moderate mild index, and she only needs to stay in the hospital for observation and treatment for a few days before she can recover and be discharged."
"Are they out of danger?" Zhang Laohan's voice trembled a little.
Seeing that the doctor nodded affirmatively, at this moment, Zhang Laohan couldn't help but cover his old face and cry with joy, hugged with some other family members of patients who participated in the clinical trial, and then took the doctor's hand and said thank you.
At this moment, there was a heart-wrenching cry in the distance, and when I turned my head, I saw that the family members of the patients who were unwilling to sign the consent form in the morning were crying bitterly after receiving the news of the death of their relatives and friends.