I can extract side effects

Chapter 449 The First Clinical Application

After learning the news of artificial blood, Suzhou Blood Center attached great importance to it.

Deputy Director Huang, who is in charge of the blood laboratory, rushed over immediately.

He hurried into Liu Zhengming's office and asked impatiently, "Where are the artificial blood samples?"

Liu Zhengming pointed to the refrigerated transport box on the table and said, "In it, I have done a blood type test, and the A, B, and H antigens are negative, and the Rh antigen is positive. The initial consideration is the Mumbai blood type."

He spread his hands and said, "But you came too fast, and further tests haven't been done yet."

Director Huang stepped forward quickly, opened the box, looked at it, and immediately said happily: "Great, after I take it back, I will do a blood type genetic test directly, and the final result will be confirmed."

After speaking, he turned his head and looked around, and found Jia Qing who was sitting beside him, and immediately extended his hand with a smile.

"You are from Sanqing, right? The artificial blood developed by Sanqing this time has done a great favor to the national blood banks and has positive strategic significance."

Jia Qing said somewhat cautiously: "This is what we should do. I hope this clinical trial can go smoothly."

Director Huang waved his hand and said, "This clinical trial will be carried out by our tripartite cooperation."

"Our blood center will create a corresponding blood type file when a rare blood type is found in daily blood donation. At present, 6 cases of Mumbai blood type have been found in this province, and files have been established for all of them."

"I will notify them one by one when I go back and ask if they are willing to be volunteers. These people with rare blood types are generally very united, friendly and helpful, and I believe they will agree."

"In addition, dozens of volunteers with the four major blood types must be recruited to participate in clinical trials together."

"If the clinical trial is successful, it will greatly solve the problem of blood shortage in my country, make up for the vacancies in blood banks, and reduce the risk of blood transfusion-related infections."

"By the way," he asked suddenly: "How far has the project progressed? Can it only be produced in the laboratory? Or can it be mass-produced?"

Jia Qing shook his head: "We are overcoming the difficulty of mass production. At present, we can only manufacture in the laboratory, and the time required is relatively long. I am afraid that we cannot supply it in large quantities, but if the amount of blood transfusion required by no more than ten people is satisfied, then Not a problem."

Director Huang's eyes brightened immediately: "That's pretty good, at least some rare blood types can be cultivated in the laboratory, which can save lives at critical times."

Speaking of this, he said with great emotion: "You don't know how scarce the rare blood types are in the national blood bank. In order to obtain blood donations in time, we have established files. When needed, we will contact them one by one and recruit blood donors. Temporary blood collection."

"It takes nearly 16 hours for a bag of blood to recruit blood donors, collect blood, prepare and separate blood, test the blood, store it, and infuse it into the patient!"

"16 hours!" Director Huang said sadly, "With such a long waiting time, if there is no supplement outside the body, it will greatly delay the patient's prime time for rescue."

Jia Qing couldn't help asking: "Then why don't you keep some blood in storage?"

Director Huang sighed: "I don't know, even if the donated blood is refrigerated, it has a certain shelf life, and the interval between a person donating blood cannot be less than 6 months, so generally it can only be used when there is an urgent need." Calling for donations."

"However, we also have a small amount of frozen blood in stock, but the thawing time is very long, which cannot meet the emergency needs."

"After the fresh blood is collected, in addition to ensuring the daily supply, the blood bank will add glycerin, and the frozen red blood cells are stored below -65°C, which can generally be stored for 10 years. But when used, the frozen red blood cells need to be washed to remove the glycerol. It takes too long to use, and I really can’t keep up.”

"A few years ago, when mutual aid blood was not canceled, family members could find someone to donate blood, but the biggest disadvantage of this is that it is easy to breed paid blood donation. There was once a blood dealer who raised the price of a bag of rare blood to 70,000 yuan So it was canceled later, and you can only get blood donations from blood banks."

Jia Qing scratched his head in doubt, and said, "But our laboratory produces blood, and the production cycle is relatively long. I'm afraid it can't keep up with the urgent needs of rare blood types."

Director Huang pondered: "First solve the problem of availability, and then solve other problems. Our blood bank may consider keeping some rare blood types on a regular basis."

"But in this way, the cost should be very high. By the way, have you settled on the price of artificial blood?"

Jia Qing shook his head: "It's still too early, not yet."

Director Huang laughed and said, "Indeed, I was too anxious."

He came and went in a hurry, and soon he carried the suitcase and disappeared into the crowd downstairs.

A few days later, Director Huang came again excitedly with a team.

"It is confirmed that the Mumbai blood is correct." He slapped the genetic test report on the table, and said with a happy face: "The blood center has contacted the six registrants based on the files, and all of them are willing to participate in this clinical trial."

"Three of them happened to be near Ning City, so I brought them along, and others will come to report one after another."

Liu Zhengming looked at the three people following Director Huang, nodded and said, "Yes, I also found 50 people with common blood types, and they all agreed to participate in the clinical trial."

Of course, the clinical trials this time are all paid, and only with Sanqing’s money-making ability can we find suitable volunteers so quickly.

After a brief physical examination, the three volunteers who participated in the experiment came to a separate ward.

Under the watchful eyes of a group of people, the nurse used a syringe to draw out 5ml of artificial blood and slowly injected it into the volunteers.

The volunteers sat on the hospital bed with nervous expressions.

Liu Zhengming comforted: "Don't worry, the amount of blood transfused is very small, so the possibility of a transfusion reaction is very small."

"The most common clinical transfusion reaction occurs 15-20 minutes after blood transfusion. As long as you wait for 20 minutes, if there are no side effects, it means that the blood transfusion is successful."

The volunteers licked their lips and nodded subconsciously, feeling a little relieved.

Jia Qing stood aside, holding a notebook, and recorded carefully.

20 minutes passed quickly.

Liu Zhengming conducted a physical examination on each volunteer again to make sure that they did not show any adverse reactions.

The group left the ward.

Since the onset of blood transfusion reactions is sometimes delayed, nurses will pay close attention to these volunteers and give first aid immediately if there is a blood transfusion reaction.

In the next few days, all 56 volunteers, including 6 Mumbai blood workers, received blood transfusions of about 5ml.

None of them showed any adverse reactions, which proved the safety of artificial blood to a certain extent.

This kind of artificial blood produced in the laboratory is indeed a kind of universal blood, which can be delivered to ordinary people regardless of the four major blood types of ABO.

Seeing such a result, all the researchers were refreshed and breathed a sigh of relief.

The follow-up research was relatively simple. Since the amount of blood transfusion was very small, in order to track the operation and changes of artificial blood in volunteers, they used hydrogen isotopes to label artificial blood.

In this way, as long as nuclear detectors are used, the location, quantity, change, and lifespan of artificial blood in the body can be tracked.

The number of protons in the same element is the same, but the number of neutrons is different, so they can be called isotopes.

Tritium is a common hydrogen isotope, which is radioactive and can replace hydrogen atoms in chemical substances, so it is widely used in isotope tracking methods.

The lifespan of blood is mainly determined by red blood cells, which is about 120 days. When the time is up, dead red blood cells can be catabolized by the spleen.

But the volunteers obviously couldn't wait that long, and they left the hospital after a week.

During these four months, they will come to the hospital every two weeks for follow-up examinations.

At the same time, volunteers with ABO blood type have successively participated in clinical trials in other Sanqing cooperative hospitals.

Due to the special nature of artificial blood, whole blood is not strictly considered a drug, and only various blood products are considered drugs.

Moreover, this is a significant innovative breakthrough, so it has been approved by the Food and Drug Administration and can take the fast track to carry out the combined clinical trials of phase I and phase II.

There are more than 500 volunteers in the entire Phase I and Phase II clinical trials.

If no major adverse reactions are reported during the clinical trial and everything goes well, the Phase III clinical trial will begin.

The number of participants in the Phase III trial will be greatly increased to thousands, and the amount of blood transfused will also increase from 5ml to 50ml, and it will be used appropriately in patients with anemia or acute blood loss.

For special products such as blood products that are used in large quantities and on a large scale, pharmaceutical companies must be cautious in carrying out clinical trials and consider all aspects of the situation in order to avoid any medical accidents.

In this way, the overall clinical process will last for more than half a year, and it is expected that it will not be officially launched until next year.

*****

Kunming, First People's Hospital.

Liu Zhengming looked at the clinical trial report in his hand and was overjoyed.

"Very good, the data is very detailed, it seems that my thesis should be fine."

Suddenly, a nurse rushed in from the door and said in a panic.

"Director Liu, it's not good. A patient just had a car accident and suffered massive kidney bleeding. He is in a state of extreme anemia and needs a massive blood transfusion!"

Without raising his head, Liu Zhengming said, "What do you mean by flustered? Is there not enough blood in the blood bank?"

The nurse hurriedly said: "The patient is a volunteer who came to the hospital today to participate in the re-examination of the clinical trial. He has a Mumbai blood type, which is not available in our blood bank."

Liu Zhengming suddenly stood up, stared wide-eyed and said: "What? Reexamination is reexamination. How could there be a car accident?"

The nurse wiped the cold sweat from her forehead and said, "Yeah, it seems that I just drove out of the city and got into a car accident on the highway, and I have been sent to the emergency room. The operation requires a blood transfusion of 800-1200 milliliters."

"The patient has temporarily stopped the bleeding, but if no suitable blood can be found, it is impossible to perform follow-up surgery for the patient."

"We contacted the blood station in the city center, and there is only 200 milliliters of eligible blood in the city."

After hearing this, Liu Zhengming had an unbelievable expression, and couldn't help muttering to himself: "This is too bad luck."

"It's a rare blood type, but it ended up in a car accident and required a massive blood transfusion."

He hurriedly said: "You should quickly contact Director Huang of the Provincial Blood Center to see if he has stock. By the way, you should quickly contact the other 5 Mumbai blood type volunteers to see if they are willing to come back as soon as possible to donate blood to save lives."

The nurse nodded and said, "After the car accident, some media followed to the hospital. After they learned about the situation, they were also very anxious. They are helping us spread the news to the whole platform and find a suitable donor. I hope we can find them as soon as possible."

After speaking, he left in a hurry.

As Liu Zhengming paced back and forth in the office, a thought suddenly popped up in his mind and became clearer and clearer.

Maybe, you can try Sanqing's artificial blood?

After all, this patient had received a small amount of artificial blood transfusion before and did not experience any discomfort.

Thinking of this, he grabbed the clinical experiment report on the table and went straight to the emergency room.

"How is the patient?" He asked the emergency doctor next to him.

The other party looked heavy, shook his head and said: "The patient's condition is not optimistic. After transfusing 200ml of blood and 2000ml of Lactated Ringer's solution in stock, the bleeding has stopped, and the hemoglobin content has recovered to 63g/L, but it is still in the middle. severe anemia and, if the bleeding continues, it can be life-threatening."

"At the same time, the patient still needs surgery, at least 800ml of blood transfusion."

Liu Zhengming asked, "Have you found a blood donation volunteer?"

The emergency doctor smiled wryly and said, "I got in touch with five volunteers who participated in the clinical trial before, but two of them couldn't come because of personal reasons, and three of them agreed to come to the blood bank to donate blood."

"But each of them can only donate 200ml of blood. Three people can donate about 600ml of blood. After the blood is processed, it will take some time to send it to the hospital."

"If follow-up patients still need blood transfusions, more Mumbai blood donors are needed to lend a helping hand."

Liu Zhengming thought about it and asked, "Will the patient's life be in danger if he doesn't get a blood transfusion?"

The emergency doctor nodded: "Very likely."

Liu Zhengming gritted his teeth and said, "Actually, I have a solution. You know about the artificial blood clinical trial in cooperation between the Hematology Department and Sanqing?"

"I heard that this patient seems to be one of the volunteers participating in the trial."

"He has transfused about 5ml of artificial blood without any adverse reactions, so I think if we really can't find enough blood, in order to save the patient's life, maybe we can try Sanqing's artificial blood? Wait for the follow-up The blood buys some time."

The emergency doctor's face became serious: "Tell me about it in detail. I need to know more data from human blood clinical trials before I can make a decision."

"Look at this." Liu Zhengming handed over the report in his hand.

The emergency doctor looked at it carefully, and said with a look of shock: "Is this artificial blood really done?"

Immediately he cheered up and said: "In this way, we can indeed try it. We can transfuse 50ml of blood at a time, then observe for a while, and then continue the blood transfusion. Infuse 200ml of artificial blood into the patient's body several times, which can greatly disperse the risk. If there is Adverse reactions stop immediately."

"If it's 200ml, it shouldn't be a big problem if the amount is not too much, but it can greatly maintain the patient's life."

"In this way, after the blood of the next three blood donors arrives, the operation can be performed immediately."

"But you have to talk to the patient's family and sign a consent form."

"Okay, that's it. You go to the family members, and I'll get the blood."

Liu Zhengming breathed a sigh of relief, and brought a 200ml bag of artificial blood from the blood laboratory.

Since the patient lived in Suzhou City next door, the family members came quickly after hearing the news, and after some explanations, they immediately signed the consent form.

The emergency doctor took the bag of artificial blood, feeling heavy in his hands, just like his mood at the moment.

In fact, he didn't have much confidence in his heart. Although the artificial blood sounds powerful and the data looks reliable, no one can guarantee that there will be no problems if it is not injected into the patient's body.

"Fortunately, the injection of 50ml at a time should not be a big problem, and any adverse reactions can be rescued immediately."

He silently comforted himself in his heart, but without stopping, he injected 50ml of artificial blood into the patient's body.

Liu Zhengming waited quietly aside, and everyone present was very nervous.

Half an hour later, the patient had no adverse reactions.

Liu Zhengming smiled immediately: "It seems that there is something going on."

The emergency doctor nodded, most of the tension in his heart dissipated, and he injected another 50ml of artificial blood.

In this way, until 200ml of artificial blood was transfused into the patient's body, the patient still did not experience any adverse reactions.

"It's done!" Liu Zhengming said excitedly, raising his fist.

Just now, he witnessed the world's first clinical use of artificial blood.

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