I can extract side effects

Weikang has never been so embarrassed by any drug.

"The results of the first and second clinical trials are perfect. After taking the drug, the levels of antioxidant enzymes in the human body are greatly increased."

"However, the research and development of new drugs must have an adaptive disease, in order to prescribe the right medicine, obtain useful data, and pass the review and launch the market."

"The low content of antioxidant enzymes in the human body just makes people prone to illness, but it is not a definite disease in itself. I have to choose an indication to continue the follow-up clinical trials."

"Otherwise, we can only lower the dose and make it into a health product."

After much deliberation, Wei Kang was still a little hesitant, not knowing which disease to choose to design a phase III clinical trial protocol in order to achieve clinical success.

Because from previous cases, it is often difficult to obtain results with statistical differences in clinical trials of antioxidants.

Although some antioxidants have achieved good results in public health and disease prevention, they are rarely used as therapeutic drugs in clinic.

If an antioxidant wants to be used clinically, it should meet the following requirements:

First, the drug needs to be delivered to a designated area of ​​the body.

Secondly, it is necessary to set reasonable evaluation indicators in clinical trials in order to carry out statistical comparisons.

Finally, new methods must be established to elucidate the mechanisms of action of antioxidants.

Drug delivery and evaluation indicators are not difficult problems, but it is difficult to clarify the therapeutic mechanism of antioxidant effects on a certain disease and prove it with clinical data.

Therefore, he must think carefully, carefully select the appropriate disease, and design the clinical trial plan.

In a sense, this new drug is an endogenous antioxidant.

According to animal experiments, after injection, the content of antioxidant enzymes in mice and pigs increased greatly in a short period of time, and it has a good therapeutic effect on some peroxidative damage.

In one of the animal models, the researchers even used X-rays to cause radiation damage to the animals in the experimental group. Due to the ionizing radiation, a large amount of free radical damage was generated in the animals, causing persistent pathological changes.

This is because free radicals have unpaired electrons, which will rob healthy cells of electrons.

After losing electrons, the chemical bonds of protein molecules in healthy cells are broken, which easily promotes a series of distortions and forms a vicious circle, causing continuous damage to cells.

However, after the injection of antioxidant enzyme-promoting drugs, antioxidant enzymes were rapidly synthesized in the body, and the peroxidative damage caused by these radiations was well restored, in sharp contrast to the control group who did not take any drugs.

Not only did the animal experiments have remarkable effects, but in the first and second clinical trials, healthy people not only did not detect any side effects after taking a certain dose, but also detected a significant increase in the SOD content in the body.

Even some patients with low SOD levels in the body, after taking new drugs for treatment, SOD levels returned to normal.

Such experimental data are sufficient to confirm the safety and effectiveness of the drug.

The full name of SOD is superoxide dismutase, which is widely present in the human body and can scavenge superoxide anion free radicals and inhibit the oxidation of free radicals.

Since the biological half-life of free radicals is very short, very unstable, difficult to directly measure, and the formation is very common, and the human body itself has a strong antioxidant capacity, so SOD detection is the most effective means to reflect the level of free radicals.

Clinically, it is one of the important indicators to reflect the metabolic state of free radicals in the human body. Therefore, observing the level of SOD can indirectly reflect the ability of the body to scavenge free radicals and the health status of the human body.

The normal human serum SOD reference range is around 110-215u/mL.

If the content is significantly reduced, it means that free radicals are beginning to endanger human health. In severe cases, it will cause a series of brain and heart diseases, and timely measures need to be taken.

If it is higher than the normal range, it also means that there is an acute disease, which leads to immune stress and inflammatory response in the human body.

In a healthy human body, the formation and removal of free radicals are in a dynamic balance, whether it is too high or too low, it is not good.

At present, people are very interested in the clinical application of antioxidant enzymes (SOD). Recombinant Cu-SOD, Zn-SOD and Mn-SOD have been synthesized, but the plasma half-life is very short.

To improve this defect, scientists have designed a large number of structurally modified SOD, such as pegylated SOD, polysucrose-ylated SOD, hyaluronic acid-ylated SOD, and albumin-ylated SOD, to prolong the plasma half-life of SOD.

They have been used to treat ischemia-reperfusion injury or inflammatory response, but these drugs did not show significant differences in in vivo tests, and there are no human double-blind clinical trials on the effectiveness of SOD on chronic inflammation or autoimmune diseases. According to literature reports, only recombinant Cu-SOD and Zn-SOD injections are effective for premature infants.

It can be seen that it is really difficult to find a disease that is directly related to antioxidants and can be cured by medicine.

Everyone knows that free radicals can cause many diseases, what cancer, aging, heart disease, diabetes, and so on.

Various studies also have sufficient data to prove this conclusion.

But after taking the medicine, increasing the level of SOD and removing excess free radicals in the body, can these diseases be cured immediately?

No one has conclusive clinical evidence.

It is far from enough to prove that it is effective in the laboratory. Large-scale clinical trials must also be conducted to obtain a statistically significant difference before it can be marketed as a successful drug.

Therefore, Weikang must choose the experimental target carefully. Although chronic diseases such as diabetes, coronary heart disease, and hypertension are good diseases, the etiology is complicated, there are too many interfering factors, and the clinical cycle is too long. Years of follow-up time is not the best choice.

The ideal solution is to choose a disease with obvious drug effect and quick results as the experimental target to obtain the most important evaluation index.

Wait until it is on the market, and then treat other adaptive diseases with the support of doctors.

This is to buy a short-distance ticket first, then get on the bus, and then make up a long-distance ticket.

It can be regarded as a public means of pharmaceutical companies within the rules. It is very compliant, and no one can find fault with it.

After all, there are many such examples in the history of drug discovery.

For example, at the beginning of the last century, scientists were studying anti-malarial drugs, but found that a certain drug had an unexpected calming effect, and then gave it to patients directly. They were pleasantly surprised to find that the effect was surprisingly good, and the patient did not cry after taking it. There is trouble.

Next, the psychiatric "penicillin" of promethazine was born, saving countless mentally ill patients from the tragic fate of prefrontal lobotomy.

According to Weikang's thinking, if you directly choose the most difficult solution, such as the treatment of coronary heart disease, it will take three to five years to obtain enough clinical data to go on the market.

Then compared with other lipid-lowering drugs with immediate effect, the effect is very slow, the treatment time is very long, and it is not competitive at all.

There is such a tragic case in history.

In the 1970s, Probucol was listed as the only FDA-approved antioxidant drug, mainly used to treat coronary heart disease caused by atherosclerosis, and it is an antioxidant and lipid-lowering drug.

However, due to the rise of statin drugs at the same time, the mechanism of blood lipid lowering is clearer, the drug effect is more clear, and the treatment effect is better.

The focus of the medical community on the treatment of arteriosclerosis turned to this type of drug, and Probucol quickly lost momentum, and its sales dropped sharply. After the patent expired, the profit was too low, so Probucol was voluntarily withdrawn from the market.

This is the tragedy of a drug that did not find its proper positioning and explored its own advantages. As an antioxidant drug, it chose to treat coronary heart disease. In the competition with lipid-lowering drugs, it was defeated and ended up being withdrawn from the market.

Wei Kang didn't want such a tragedy to happen to his medicine.

Even the most powerful oxidant that claims to be clinically applicable has already encountered Waterloo in the treatment of heart disease. Naturally, he will not be overwhelmed and choose the toughest chronic diseases.

He decided to take a slanted approach, starting from the simplest, and going public first.

In order to achieve this result, the ideal experimental goal should have the most important indicators-mortality and specific disease incidence.

That is to say, if no medication is used, the mortality rate is relatively high.

However, the use of drugs can greatly reduce the mortality rate.

In such a comparison, not to mention people from the Food and Drug Administration, even passers-by know which medicine is better.

As for the incidence of specific diseases, it is better understood.

It mainly refers to the probability of occurrence of a specific disease under different conditions of free radical levels in the body.

Only when these two indicators are met can the test data be evaluated and convincing data obtained.

"It's decided, just choose this disease."

Wei Kang finally made up his mind and made a choice.

"Acute radiation sickness, there is no very symptomatic drug for this disease, and the mortality rate of patients is very high."

"The cause of this disease is very clear. The human body is exposed to a large amount of radiation exposure in a short period of time, and the main mechanism of radiation damage is free radical damage. As long as this problem is solved, the patient will naturally recover."

"Various studies have shown that the radiolysis of molecules is the main cause of free radicals, which not only play an important role in the injury process of acute radiation sickness, but also continue to cause tissue damage during the radiation sickness period after recovery."

"The chain reaction of reactive oxygen species can lead to oxidative damage to biomolecules, triggering early radiation effects and post-radiation effects such as fibrosis."

"Therefore, blocking the production of active oxygen and removing the produced active oxygen is an effective strategy to prevent radiation damage."

"SOD with oxygen as a substrate is an important enzyme for organisms to defend against oxidative damage, and it is also an ideal protective agent for radiation damage."

"After SOD was discovered in the 1970s, it was discovered that it can protect biochemical systems from superoxide anion radical poisoning and reduce radiation damage in a wide range of biochemical systems."

"My new drug can enhance the SOD (antioxidant enzyme) in the human body in a short period of time, and can protect human tissues from radiation damage. It can be said to be very symptomatic."

"It's just that there are not many people suffering from this disease. It is not easy to get enough people to participate in the third phase of clinical trials. We have to find another candidate disease."

Wei Kang's eyes moved slowly on the screen, making choices: "I don't have many choices left for me."

"That's it, ischemia-reperfusion injury."

"There are three main types of diseases. The blood supply is restored after systemic circulatory disturbance, the blood flow is restored after a tissue organ ischemia, or reperfusion injury is caused after a certain blood vessel is recanalized. No matter what the situation is, it will lead to excessive tissue oxidative damage."

"For example, cardiocerebral pulmonary resuscitation after cardiac arrest can cause myocardial ischemia-reperfusion injury, as well as arterial bypass surgery, organ transplantation, replantation of severed limbs, etc., all of which can cause tissue damage and lead to fatal diseases."

"In fact, the main factor causing tissue damage is not ischemia itself, but after the blood supply is restored, excessive free radicals attack the tissue cells that have regained blood supply, resulting in damage."

"The main reason is that in the ischemic tissue, the free radical scavenging antioxidant enzyme SOD synthesis ability is hindered. As long as the synthesis of SOD can be enhanced, it will have a protective effect on such damage."

"This is also a very symptomatic disease, which is very suitable for the clinical application of this drug."

Wei Kang's thinking continued to diverge. There are many diseases caused by free radicals. It can be said that there are all kinds of diseases.

Although not many met the requirements, it was still an eye-opener for him.

"In addition to these two diseases, antioxidant enzymes are also important in the body's detoxification process."

"Not only radiation can produce free radicals, many chemicals such as antibiotics, insecticides, anesthetics, aromatic hydrocarbons, etc. can induce free radicals, and antioxidant enzymes decompose these toxins in the liver and kidneys of the human body."

"Maybe this new drug has the potential to be an antidote, which can treat the poison caused by some chemical substances to the human body."

"In short, the potential of this new drug is endless, and there are still many areas waiting for me to explore."

After solving the problem of clinical protocol design, Wei Kang immediately felt better.

Orders will be issued soon, and the clinical phase III trial of antioxidant enzyme promoters will be officially promoted.

At the same time, the excellent effect of this drug also gave him a new idea.

That is, after the new drug is officially launched, the number of people taking the drug will increase, and its safety and effectiveness will be proved on a larger population sample.

He will improve the drug, reduce the efficacy and dosage, greatly improve the safety, and make it a long-term preventive anti-aging drug.

As a youth version, further basic clinical research will be carried out.

At that time, instead of allowing patients to participate in the clinic, a large number of middle-aged and elderly people will be recruited, and the verified indications will also become anti-aging.

Ordinary people are over 30 years old, and the pace of aging cannot be stopped.

As we get older, the synthesis of antioxidant enzymes in the body will gradually decrease, and the content of free radicals will increase day by day. However, the effect of exogenous SOD-rich foods is really limited, and we cannot replenish production capacity by ourselves.

And there is such a preventive anti-aging drug, which can promote the synthesis of SOD, improve the ability to scavenge free radicals, keep the human body at a healthy level, and naturally delay the aging of the body.

The reason why clinical research in this area is not being done now is that this preventive clinical trial is a type of basic research.

It often takes 5-10 years to draw a definite conclusion, and this is not necessarily a positive result. It may take 5 years to draw a negative conclusion.

During this period, the researchers have to follow up the volunteers for a long time, and the number of participants is as high as tens of thousands.

It is not impossible for Sanqing to do this kind of time-consuming and costly anti-aging basic clinical research, but it should only be done after the drug has proved its effectiveness and is officially on the market, otherwise it will be nothing.

Thinking of this, Wei Kang couldn't help but clenched his fists, and a surge of pride spontaneously filled his heart.

"Basic clinical research on anti-aging drugs, here I come."

"Human health, leave it to Sanqing."