I can extract side effects

Since the main purpose of the first phase of clinical trials is to detect the toxic and side effects of drugs, a small number of healthy subjects are selected.

These people are carefully selected to ensure that they do not have any diseases or take other medicines.

The insulin molecules used are also third-generation insulin analogs that have passed the patent protection period, namely insulin aspart and insulin glargine.

The former is an ultra-short-acting insulin used during meals, while the latter is a long-acting insulin. The combination of the two has been tested by patients for a long time. It is not only safe, but also has the best effect. It can jointly control basal blood sugar and postprandial blood sugar. .

The ingredients of nanoparticles and absorption enhancers are also safe and harmless, so it passed the phase I clinical trial in just one month.

Wei Kang was very satisfied when he got the first-phase clinical trial report.

Although there are only more than 20 cases, it is enough to prove the initial success of oral insulin.

"Yes, oral insulin does not have any toxic side effects in healthy people."

"Trialists took it before meals, and the spike in blood sugar was effectively controlled, and remained stable within 24 hours, and there was no hypoglycemia at night."

"With the most important safety data obtained, we can expand the number of people to carry out the second phase trial."

"The next step is to recruit patients and conduct randomized double-blind controlled trials."

Phase II clinical trials are mainly to verify the therapeutic effect and safety of drugs.

First of all, it is necessary to determine the effectiveness of the drug, compare it with a placebo, evaluate the patient's tolerance, and determine the minimum dosage.

After the efficacy of oral insulin has been verified in hundreds of patients and it is confirmed that there are no serious adverse reactions, large-scale phase III clinical trials can be carried out in multiple hospitals.

At that time, it will be compared with similar drugs already on the market, and it is necessary to prove that the efficacy of oral insulin is not worse than that of injected insulin before applying for a new drug marketing authorization.

Of course, with the breakthrough oral drug delivery method, as long as the average level of treatment data can be obtained, even if the effect is worse than that of insulin injection, there is no doubt that it will be approved for marketing.

The usual process is like this, but in order to obtain the most eye-catching data and pass the review as soon as possible, pharmaceutical companies will always carefully select patients for drug trials to achieve the greatest therapeutic effect.

Sanqing is no exception.

To highlight the huge gap between oral and injectable administration, highlight the biggest advantage of oral insulin.

Wei Kang set his sights on the group of diabetic patients who had the worst compliance and benefited the most.

*****

Kunming, First People's Hospital.

Cao Fang hurried to the outpatient hall with her daughter in her arms, only to see that there were several long queues at the triage desk for registration, and she was extremely anxious.

She looked at the daughter in her arms. She was only one year old, with a thin face and a pointed face. She was struggling to open her eyes, showing an innocent and lovely smile.

Cao Fang was heartbroken and blamed herself deeply, wishing to slap herself several times to bear the crime for her daughter.

My daughter has just turned one year old. A few days ago, she experienced polydipsia and polyuria. The amount of water she drank was three times that of usual, and the frequency of urination also increased significantly.

It lasted for several days, but she didn't pay attention to it. Later, she lost weight day by day. She thought it was because the diet was not in place, so she searched for formulas on the Internet to strengthen her daughter's nutrition, but there was no improvement.

Until yesterday, my daughter stopped breastfeeding, and frequently vomited, and her mental state became very poor. She fell asleep at every turn and could not wake up.

She was frightened immediately, and hurriedly took her daughter to the pediatrics department of a nearby hospital for treatment.

Unexpectedly, when I checked my blood sugar, it was as high as 32.5, which was 5 times higher than the normal range.

The doctor was shocked when they saw it, and immediately sent them to the First People's Hospital for hospitalization, otherwise the children would fall into a coma at any time and their lives would be in danger.

Cao Fang and his wife panicked for a moment and rushed to the hospital immediately.

But looking at the long queue, her eagerness made her unable to wait any longer.

She held her daughter in one hand and the test sheet in the other, begging one by one: "Hello, my child is about to faint, can I register first?"

People near the window may have seen her holding the child, and they felt compassionate and agreed to let her jump in line.

She explained the situation to the registered staff, and then got the emergency number of the emergency department.

At this time, the daughter's complexion became even worse.

After waiting for another minute, the child finally lay on the bed in the emergency room.

When the doctor saw the test report, he was surprised: "Why is the blood sugar so high, I need to draw blood for re-examination."

As he spoke, he began to infuse the child with normal saline, and observed the blood pressure and heartbeat.

At this time, the child's face was pale, and he was lying quietly, breathing clearly.

Cao Fang looked at the beating numbers on the instrument and knew clearly that her daughter was still alive, and her hanging heart was finally relieved.

Half an hour later, the doctor saw the results of the re-examination, and frowned: "The blood sugar is too high, the child should be ketoacidosis, and need to be hospitalized immediately."

"The initial judgment is type I diabetes. You should be mentally prepared. This disease is mainly caused by the destruction of pancreatic beta cells, which leads to the absolute lack of insulin. The child will need insulin injections for life in the future, and he cannot recover."

"Now we can only use insulin to lower the blood sugar. We need to keep giving injections to maintain the delivery of insulin, and we need to add normal saline. We can't give the child anything to eat until the blood sugar drops."

"Tonight is especially critical. Pay attention to observe the child's blood pressure, heartbeat and other conditions. If there is any discomfort, rescue must be carried out."

When Cao Fang heard the word "diabetes", her mind was buzzing. She couldn't understand what the doctor said later, and only grasped a few key words.

"Lifetime", "injection", "irrecoverable".

Listening and listening, her tears kept streaming down, approaching the verge of collapse.

She could never imagine why her daughter got diabetes when she was only one year old.

Isn't diabetes exclusive to middle-aged and elderly people?

Why would such a young child get sick?

Is it genetic? But no one in my family has ever had diabetes.

She followed the nurse to transfer the child to the ward in a daze, and couldn't figure it out.

Looking at the sleeping face of the child, she took out her mobile phone with trembling hands and began to search for relevant knowledge.

Three excesses and one deficiency symptoms, ketoacidemia, type 1 diabetes, onset, causes, initial manifestations, complications, treatment methods, etc., massive information floods in instantly.

The more Cao Fang watched, the more chilled she became, but she kept searching for information. At this moment, she was like a drowning person, waving her hands frantically, trying to find the life-saving straw.

"Yes, there will definitely be miracles. We have been kind all our lives, we have never done anything bad, and we have never hurt anyone. It is impossible for this kind of thing to happen to us. There must be miracles!"

"The doctor said that there is only a 90% probability of type I, and there is still 10% hope. Maybe we are that 10%."

"Maybe after the injection, the blood sugar level will drop, and I will be able to leave the hospital happily with my daughter, and I will never use this place again."

"Everything is still variable, don't worry, calm down first."

She kept comforting herself, and after a while the tears seemed to flow from her eyes, only her heart was bleeding.

During the long night, the nurses have been working shifts. Every hour, they will come to prick their fingers with needles and measure their blood sugar. After one night, the child's hands can already see small holes, and there are still blood stains on them.

The needle stuck in the child's body, but it hurt Cao Fang's heart.

Her heart was sore and she suffered so much that she didn't close her eyes all night.

It wasn't until the sky was getting brighter that I began to rejoice that nothing scary happened, and the child's blood sugar also slowly dropped.

During the rounds in the morning, I saw the attending doctor.

"I'm still correcting the ketosis. Now the blood sugar has dropped. I can feed the child something to eat, but all the food has to be weighed and calculated."

The doctor in charge said kindly: "Now you parents should start learning about diabetes, know how to test blood sugar, food calculation methods, injection methods, insulin matching, how to deal with high blood sugar, hypoglycemia manifestations and emergency treatment methods etc."

"During the hospitalization, parents must learn the relevant knowledge well and know how to use it before they can be discharged from the hospital."

"In the next few days, I have to look at the situation of ketosis again. I need to monitor the blood sugar at 8 points every day, and the blood ketones at 3 points before meals."

From this moment on, Cao Fang began to officially enter the state of study and preparation. All the situations were obediently recorded in a notebook, and summed up and corrected every day.

She seems to have returned to her student days, and she has only one thought in her mind, she must let her daughter survive and be her strongest backing, even if she is sad, she must secretly clean up her emotions.

The most difficult night is over, as long as you live well, you will have unlimited opportunities and possibilities.

When her daughter woke up, she had wiped away her tears, put away her anxiety, and became that smiling sunny mother again.

Therefore, getting up on time, eating regularly and quantitatively, getting injections, and measuring blood sugar have become essential things for her every day.

In the evening, summarize the details of the day, count the specific amount of breakfast, lunch, and dinner, convert the carbohydrates of the food, record the order of meals, and the situation of sugar rise for reference the next day.

4 injections are given every day, and blood sugar is measured 4 times. After a few days, the child's fingers are pricked into a hornet's nest.

Moreover, when she tried to give her daughter an injection, she was often frightened, and sometimes she would get capillary bleeding accidentally, and it was difficult for beginners to find the rules of adjustment to control blood sugar perfectly.

If you take less shots, your blood sugar will not be well controlled, and if you take more shots, you will suffer from hypoglycemia.

This made her very anxious, constantly blaming herself, and even doubting herself why she couldn't choose a better place to play, why she was so stupid, couldn't do better and learn faster.

Fortunately, she also met other family members in the hospital. Everyone encouraged each other and learned how to control blood sugar better.

Slowly, I also gained some self-confidence, and I was no longer as scared as I was at the beginning.

A week passed quickly, and the attending doctor looked at the child's bruised fingers after finishing the rounds, and couldn't help sighing.

He didn't leave as usual, but hesitated to speak, hesitating for a while before uttering a word.

"Cao Fang, your child's condition may require insulin treatment for the rest of his life."

"Type I diabetes is very troublesome. There is no good treatment at present. The only way to control blood sugar at a relatively stable level is through insulin injections. This process requires great patience and tenacity. Long-term subcutaneous injections may cause local lumps or lumps in the skin. shrink."

"She is too young, and her skin and blood vessels are very fragile. If she keeps injecting like this, it will be a huge burden on the child."

"That's right. Sanqing has a clinical trial of oral insulin. Are you interested in participating in the trial? Maybe it will improve the situation."

Cao Fang raised her head abruptly, and a light flashed in her eyes: "Insulin taken orally? You mean to take insulin like a pill? No more injections?"

The attending doctor nodded: "That's right, it's like taking cold medicine, but you still need to control your diet and measure your blood sugar."

Cao Fang was ecstatic and said: "That's great, I'll sign up for my child. You see, my child has needle holes all over his body. After his stomach is pierced, his arms are pierced, and his buttocks are pierced after his arms are pierced. It's too painful. If he can use oral medicine instead, I really can't ask for more."

The doctor kindly reminded: "This drug has just come out and is undergoing phase II clinical trials. It has not yet undergone large-scale clinical safety verification, and it is likely to have some adverse reactions."

Cao Fang didn't care and said: "You have said that it is the medicine of Sanqing Group. Their medicine is famous for its safety. I am very relieved. Besides, if there is any adverse reaction, it is not too late to stop and continue the insulin injection."

"Okay, then you sign the agreement."

After signing, the doctor quickly brought over a plastic cup with a quarter of the pill in it.

"The medicine is here. Considering that the patient is only 1 year old, it is too young, and the minimum dose is prescribed for her."

"I'll ask the nurse to bring it over on time, and you can just take it as usual."

Cao Fang carefully brought it to her daughter's mouth, and passed it down with warm water, the tension in her heart dissipated a bit.

"It should work." She secretly encouraged herself.

On the following day, she paid more attention to her daughter's state than usual, for fear that she would experience any coma or vomiting.

Fortunately, after taking insulin orally, my daughter did not have any abnormal reactions, and she was still the same as before.

After a few days, just like injecting insulin, the blood sugar and blood pressure are all very stable and there is no abnormality at all.

This made her amazed, and at the same time moved to tears.

Finally, I don't need to prick my daughter's body with needles every day. A one-year-old child is already small, and the places where he can get injections are limited.

The daughter's stomach, buttocks, and small arms and legs are being devastated every day.

And the child was fine when he was young, parents can force the child to get an injection, and when he is a little older, he will start to resist.

Some children even have a rebellious psychology and are unwilling to take insulin.

Parents can't keep an eye on it every day. Over time, it's easy for accidents to happen again.

If oral insulin can be used instead of injections, the child will certainly not be so resistant, and can better control blood sugar and avoid health problems.

She has even thought about buying a painless blood sugar tester when oral insulin is on the market in the future.

The daughter can completely get rid of the days of getting needles every day and return to a normal life.