Iopath "Shenyao" Atto Internet Discontinvous: A Battle of Visual Defense

After the child Xuanxuan was checked in myopia in the first grade of elementary school, Zhang Lin, who was nearly forty years old, mastered various ophthalmology knowledge. She counts the method of preventing myopia: to ensure at least two hours of outdoor activity time every day; for twenty minutes at a close distance, it is necessary to see a long time; ; Compared with white light, warm light can protect vision.

However, Zhang Lin often regrets: these ophthalmology knowledge learned late, and she failed to prevent and control in time before her son Xuanxuan myopia.

In March of this year, at the advice of the doctor, Zhang Lin bought three boxes of low -concentration Atto eye drops online at the applet of Shenyang Xingqi Ophthalmology Hospital, hoping to control Xuanxuan's myopia. The colorless Atto eye drops were installed in a single transparent plastic tube. At first, Xuan Xuan said that there was a slight dazzling feeling, but after a long time, the dazzling feeling gradually disappeared. Three months later, Zhang Lin was pleased to find that Xuan Xuan's myopia and the length of the eye axis have almost no increase.

However, on the evening of July 21, Xingqi Eye Medicine suddenly announced that it closed the Internet sales channel for low -concentration Atto eye drops. Many companies such as He's Ophthalmology and Opangshi have also announced that they have suspended the sales of low -concentration Atropine eye drops at Internet hospitals. Patients need to buy them at the hospital when they go to the hospital.

The suspension of the Internet originated from May 9 this year. The State Drug Administration publicly solicited the "Regulations on the Implementation of the Pharmaceutical Management Law of the People's Republic of China (revised draft solicitation draft)", and for the first time to formulate regulations on the management of drug network sales. Among them, Article 82 pointed out that the sales of drugs should be a variety held by a drug listing license holder or a variety of drug management enterprises.

As a preparation in the hospital, Atropine has not yet been officially launched, and it will no longer be sold through the network channels.

Atropine's eye drops were once known as the "magic medicine" of myopia. Suddenly stopped selling, so that parents were at a loss for a while. Some people grabbed a sufficient amount of Atto, while some people were anxiously seeking medicine, and the purchasing agents of Atto began to be active in various platforms. Behind the medicine, a war -defense battle with myopia is aging, and it is quietly carried out in the parent group.

Seek medicine

The news of online stop selling came suddenly.

On the evening of July 20, Zhang Lin learned from his colleagues that the low -concentration Atropine eye drops will suspend the Internet for sale. Waking up early the next morning, she ordered the applet of Xingqi Eye Hospital to try to buy it, but the doctor was not yet online, and Zhang Lin could not buy it.

At five or six in the evening of the day, Zhang Lin opened the applet again. The homepage had a discontinued announcement of low -concentration Atropine eye drops.

Originally, Zhang Lin had two ways to buy low -concentration Atto eye drops. The first is to go to a hospital with an in -hospital preparation. Doctors will be purchased by the doctor, but only a few hospitals such as Shandong Ophthalm Hospital, Shanghai Children's Hospital, and Fudan University Affiliated Earlier Ear and Earlier Hospital can open in -hospital preparations.

The other is the way through the Internet hospital: after she took her child to the ophthalmology clinic at Beijing Tongren Hospital, the doctor would write a prescription of low -concentration Atropine eye drops on the medical records. Zhang Lin took the medical record in Xingqi Eye Department in Shenyang Xingqi Ophthalmology Department After consulting on the hospital applet, the child can be purchased by providing the child's eye examination report within three months.

Like Zhang Lin, Gao Rui, who lives in Beijing, did not have time to stock up Atto. Seeing the only ten of Atto in the family, Gao Rui searched the information about Atropine on the major platforms. By "medicine" on the social platform, "three boxes of uniform boxes" from other parents.

At the doctor's advice, Gao Rui split another Atto into two days for two days -Adoupin eye drops did not add preservatives, only 24 hours a shelf life. Now it can only be divided into two times: Put it in the refrigerator with a sealing bag, and rush to the child to get the child before 24 hours.

With the disconnected supply, more and more medicines for social platforms have emerged, and many Adoppin eye drops have also appeared.

Some purchasing agents will increase the price of 298 yuan a box, which will increase by 40 yuan. Another 8 yuan registration fee and 10 yuan courier fee will be added. She claims that customers only need to provide names and calls, no prescriptions for hospitals. But she couldn't inform the specific purchase channels, but only said, "It's all genuine, rest assured."

Another purchasing said that he was ordered from the person in charge of the hospital. Because of the recent number of parents and tight supply, only three boxes could be opened at a time, and each box needs to be added 20 yuan.

Parents are rushing to Atto. Wang Lei felt that she had to be lucky: she successfully grabbed ten boxes of Atto before the Atto Internet officially stopped sale.

Wang Lei thinks that compared with other prevention and control methods, it is much more convenient to use Atropine eye drops for his son: Gently twist the cover of the plastic tube, drip the eye drop into the eyes, and then discard the single -family packaging.

Wang Lei calculated that the cost of Atropine's eye drops was around 3600 yuan a year. But compared to the price, Wang Lei felt that he valued more: the increase in the axis and myopia degree after three months of using Atropine.

Is it "myopia magic medicine" or one of the prevention and control methods?

When Xuanxuan was 7 years old, after the routine medical examination of the school, the teacher suddenly found Zhang Lin and said that Xuanxuan was a little myopia. Zhang Lin took Xuanxuan to the hospital to check, and found that he had myopia from his eyes.

Although Zhang Lin was ready for my son's myopia: the husband's eyes were nine hundred -Baidu myopia, and she also had four hundred -time myopia. But she still couldn't believe it: Xuan Xuan was only in the first grade, which was five or six years earlier than her expected myopia.

At first, Zhang Lin spent more than 4,000 to match Xuanxuan a boring mirror. But after half a year, her eyes were 50 degrees deep, and she had to spend more than 3,000 more new ones. Earlier this year, seeing Xuan Xuan's myopia is getting deeper, the doctor suggested that Zhang Lin tried Xuanxuan's attempt to concentrate 0.01%of the sulfate octoprotic eye drops. This is the first time Zhang Lin heard that some medicines can be used for myopia prevention and control. When she was young, there were not many people around her. There was no other prevention and control measures except wearing glasses. After entering high school, myopia has gradually increased.

Myopia has become a "epidemic" in China. According to the results of the "China Eye Health White Paper" issued by the National Health and Health Commission, the overall myopia rate of children and adolescents nationwide in 2018 was 53.6%. Among them, 6 -year -old children are 14.5%, elementary students are 36.0%, junior high school students are 71.6%, and high school students are 81.0%. "53.6%" — This means that one of the two children have myopia.

On August 30, 2018, the "Implementation Plan for Comprehensive Prevention and Control of Children and Adolescent I amopathic" jointly issued by the eight departments such as the Ministry of Education pointed out that in recent years, the myopia rate of children and adolescents in my country has remained high and rising. It has become a major issue that is related to the future of the country and nation.

The plan proposes the goal of the implementation of my country's prevention and control myopia: By 2030, the new myopia rate of children and adolescents across the country has declined significantly. The 6 -year -old children's myopia rate is controlled at about 3%, the myopia rate of primary school students will drop below 38%, junior high school student myopia rate rate rate Fall to less than 60%, high school students 'myopia rates drop below 70%, and national students' physical health standards have reached more than 25%.

In this context, in October 2019, the National Health and Health Commission launched the document of the "Advanced Magnote Prevention and Control of Children and Adolescents", which first mentioned the use of "low concentration Atto" in adolescent myopia prevention and control. The guide pointed out that when Iopathy children and adolescents use low concentrations of Atto or wearing corneal shaping mirrors to slow down myopia, they need to go to regular medical institutions to conduct in accordance with the guidance of a doctor.

Qu Jia, director of the National Center for Clinical Medicine of Eye Curbal and Earlophane Diseases, said that under the current reality of preventing and controlling less myopia, low -concentration Atropine's intra -hospital preparations have become one of the main means to delay myopia. The other two methods are daily outdoor outdoor outdoor outdoor Two hours of activity, wearing a cornea shaping mirror (OK mirror) or a separate mirror.

"Outdoor activities are the best means to prevent and control myopia." Qu Jia said that many schools do not allow students to go out of the classroom because of safety considerations. In the case of reality when outdoor activities cannot be guaranteed, many parents have to ask for medical treatment Measures to prevent myopia.

Atto was originally a medicine that was used to relieve the visceral colic, and has been used for eye -catching optometry for many years. The article "Applied Expert Consensus (2022)", "Low -concentration Attoppin Drops in Children and Adolescents (2022), which was involved in the opinions of 86 ophthalmologists across the country. Reports applied in myopia prevention and control.

In 2005, the Singapore National Ophthalmology Research Center released the results of the clinical research of Atropine's eye drops. The study lasted two years. For the first time, the application of Atto eye drops on myopia was promoted to the clinical trial stage. Research the use of high concentration (1%) Atto eye drops for 400 children 6 to 12 years old. The results of two years of clinical data show that 1%of Atropine's eye drops can delay 77%of myopia progress and confirm that it has confirmed it. The effective role in delaying myopia in Asian children.

However, due to a series of adverse reactions such as the decline in the vision of the user's severe light and the decline in eye regulation, the high -concentration Atto has not been extensive worldwide due to the high -concentration of adversity of the user's severe light and decline in the eyes. Apply to adolescent myopia prevention and control.

The transition occurred in 2016. The National Ophthalmology Research Center of Singapore released a five -year clinical trial report of Atto eye drops. The center carried out clinical trials of Atto eye drops of different concentrations on 400 children. The results showed that the use of 0.01%concentration Atto eye drops can slow down the development speed of myopia by 50%, and the rebound response after stopping the drug is lighter, and there are fewer visually side effects. However, the test report also pointed out that in the first two years of the 0.01%group test, 9.3%of children's myopia increased by 150 degrees, proving that some children had a poor response to Atto.

The completion of this clinical trial has made the 0.01%concentration of Adin's eye drops the mainstream choice of myopia prevention and control, including Singapore, Japan and Malaysia and other countries to start using 0.01%concentration of Adopta eye drops in hospitals and ophthalmology clinics.

The difficulty of being listed by Atropine

Although Attoppin's prevention and control effect on myopia is recognized, the road to the listing of Atropine's eye drops seems a bit long.

Public information shows that in China, from 2005 to 2018, many companies have successively approved the clinical study of Atropine's eye drops. None of the clinical trials of the third phase of the third phase of the clinical trials were not completed due to unknown reasons.

Internationally, even the Singapore National Ophthalmology Research Center, which has made major breakthroughs in the clinical trials of low -concentration Adoppin eye drops, has not yet been officially launched. The latest progress is that the low -concentration Atropine preparation "Myopine" developed by the center was approved by the Singapore Health Science Bureau for the first time on October 30, 2018. Clinical use in various hospitals in Singapore and near -vision clinics. Clinical trial stage. It was not until September 2021 that the world's first low -concentration Atto eye drops that were clearly used to alleviate the development of children's myopia were approved in Australia. The low -concentration Atto eye drops developed by countries such as the United States are still in the third phase of the clinical trial stage.

It was Shenyang Xingqi Eye Medicine. In January 2019, Shenyang Xingqi Ophthalmology Hospital, a subsidiary of Xingqi Eye Medicine, received the "Registration and Approval of Preparations for Medical Institutions", which was allowed to configure the Atto eye drops with a concentration of 0.01%in the form of a preparation concentration in the hospital.

The intra -hospital preparation refers to a fixed prescription preparation prepared and used by medical institutions according to the clinical needs of the unit. At present, there are more than ten hospitals in China that configure low -concentration Atto eye drops in the form of preparations in the hospital.

Chu Renyuan, a professor of ophthalmology at the Ophthalmology Hospital affiliated to Fudan University, introduced that the internal preparations are configured by the pharmacy department of various hospitals, which are mainly used for clinical trials of hospitals. Unlike the listing medicines, the internal preparations need to be approved by the State or Provincial Drug Administration, and can only be configured by the consent of the ethics committee of the medical institution. It can only be used for the hospital's clinical trials and cannot be sold in the market. "After the internal preparation in the hospital, the hospital must also contact the patient regularly and whether there is any side effects to form a clinical research report."

While using the in -hospital preparations for clinical trials, the State Drug Administration also agreed to Xingqi Eye Medicine's clinical trials that delay the progress of children's myopia. National drug clinical trial registration and information publicity platform shows that as of now, there are nine indications with myopia related Attoppin eye drop clinical trials. Enterprises such as Ruizi Medicine Subsidies have been in the third phase of the clinical stage.

The application process of an innovative medicine needs to complete the related research work such as pharmacy, pharmacology and drugs, and pharmaceutical first, second, and third phases in order to apply for listing. The third phase of the clinical trial is the actual stage of the drug treatment effect, and it is a key stage for providing a basis for the application for the approval of drug registration.

Dr. Liu Liekui, president and chief scientific officer of Zhaofe Ophthalmology, said that the main difficulty of the launch of low -concentration Atto eye drops is its instability, and drugs are short. Liu Liekui said that due to commercial considerations, the shelf life of a drug is too short (such as less than 6 months), which is difficult to meet the purchase requirements of general pharmacies. "The pharmacy itself is under pressure, so everyone will not sell a short shelf life."

Liu Liekui said that many domestic and foreign companies are still in the third phase of the clinical trial stage. Even pharmaceutical companies that start abroad have officially launched tests in 2017. The two three -phase clinical trials of Zhaoko Ophthalmology have been undergoing the group, and the subject has been completed, and it is expected to become one of the first drugs in China to delay the deepening of children and adolescent myopia.

On August 23, Gu Hong, the person in charge of the clinical trial of Shenyang Xingqi Eye Pharmaceutical Company, said that the third phase of clinical trials of Xingqi Atto's eye drops are underway, and the specific progress is not convenient to disclose.

Professor Yang Xiao, a professor at Sun Yat -sen University of Ophthalmology, participated in several domestic pharmaceutical companies in the third phase of clinical trials of low -concentration Atropine eye drops. She pointed out that in accordance with the "Principles of the Technical Guidance of Pharmaceutical Research Research on myopia progress" released by the National Drug Administration in December 2020, a drug that controls myopia progress in the third phase of clinical trials requires at least two years of effectiveness in the third phase of clinical trials. Sexual inspection and one -year drug suspension observation period, coupled with the clinical trials of the first and second phases, the time for children's admission group, and the time of drug approval, "We count it, it takes seven or eight years to complete the registration of such drugs."

Dispute "Internal Preparation+Internet Hospital"

In Wang Lei's view, although Atropine's eye drops have not yet been officially launched, the son's myopia "can't afford". She said that her son was only ten years old this year, and the number of myopia had reached more than 100 degrees. After wearing an OK mirror for a year, the degree was still growing. After three months of using Atto, the growth of vision and axis was controlled. Therefore, she intends to drop her son for a long time.

"Maybe we can wait, but the child's eyes can't wait." Wang Lei said.

In December 2019, Shenyang Xingqi Eye Medicine issued an announcement that Shenyang Xingqi Ophthalmology Hospital received the "Medical Institutional Practice License" issued by the Shenyang City Health Committee, which has the ability and conditions to carry out Internet diagnosis and treatment. After that, Xingqi Eye medicine launched the "intra -hospital preparation+Internet hospital" model, which opened the internal preparation in the form of Internet diagnosis and treatment.

In addition to Xingqi Eye Pills, El Ophthalmology, He's Ophthalmology, Opangshi and other companies have adopted this model to sell the internal preparations of Atto eye drops in the Internet hospital.

This model also allows whether the sales method of low -concentration Adopay eye drops in the courtyard in the courtyard meets the regulations into continuous controversy.

The State Council's Legal Office of the State Council on January 26, 2015 "Measures for the Registration Administration of Medical Institutions (Draft for Soliciting Opinions)" pointed out that the preparation of medical institutions can only be used by the prescription of a practicing physician or a practicing assistant physician in this medical institution. Medical preparations are sold in the market or in disguise. The "Administrative Measures for Internet Hospital (Trial)" issued by the National Health and Health Commission only provides for the prescription regulations of special management drugs such as anesthesia drugs and psychotropic drugs for Internet diagnosis and treatment. There are no specific regulations. There was a voice on the Internet: if you can sell the in -hospital preparations across the country through an Internet hospital, why should you work hard to register for drugs?

In Chu Renyuan's view, the pharmaceutical regulatory department needs to be approved to be listed on a drug, which requires strict basis. Only when a medicine is officially approved as a product, can it be sold on the Internet. The form of sales of Internet hospitals can easily cause drug abuse. "At present, the production of various hospitals is only provided for clinical research and use."

Qu Jia believes that the sales model of "intra -hospital preparations+Internet hospitals" does not have violations. He believes that the in -hospital preparation Atto in various hospitals is currently produced and produced under the strict review of the provincial drug regulatory authorities, and the drug sales process of Internet hospitals also strictly stipulates. After opening the Atto eye drops, the clinical research of the hospital will also closely track the use of the testor. "Especially during the epidemic, Internet hospitals play a great role."

The reasons behind the suspension of the Gato of the Internet hospital were the rectification of the Internet hospital. On May 9 this year, the State Drug Administration publicly solicited the "Regulations on the Implementation of the Pharmaceutical Management Law of the People's Republic of China (the draft draft for the draft)". It is a variety held by the holder of the drug listing or the license to operate by the pharmaceutical business enterprise. According to the regulations, the low -concentration Atto eye drops that have not been listed can no longer be sold on Internet hospitals.

In response to the suspension of the Internet, on August 4, Xingqi Eye Medicine responded on its investor interactive platform that "At present, the company's main business is operating healthy. Regarding the medical institution preparation, patients can reach Xingqi Ophthalm hospital line if need Next to the physical hospital prescription. "

Qu Jia believes that the sudden stop selling on Internet hospitals has made it a bit overwhelmed by doctors and parents who originally opened and used Ada in accordance with the specifications. In his opinion, because the low concentration of Atropine is aimed at the youth group, and the use time is long, it is usually continuously used until the age of 16. "It is right to adopt a cautious attitude at the national level." But he was not worried: formal channels suspended sales, and irregular channels could not help but flood. "We all saw illegally selling at high prices online, and even the name was changed to 'Ando". "

Qu Jia said that due to different reasons, some children have no obvious response to the use of Atropine's eye drops. "But for doctors and parents, there must always be several methods to choose from."

"At present, the review of Internet hospitals is in place. Before prescribing the medicine, a doctor will be evaluated to determine whether the child’s age and situation are suitable for the use of Atto." Yang Xiao believes that the regular Internet hospitals should be made and the irregular Internet hospitals should be. Online sales are separated. "Some irregular Internet Haitao does not require prescriptions and doctors to evaluate. These are the standardized purchase channels."

According to Yang Xiao, in the use of non -registered drugs such as low -concentration Atropine such as Singapore, the United States and other countries, the risk of medication is borne by doctors who prescribe drugs. For some drugs that are urgent but not listed, this method is relatively relative flexible. In China, the risk of drug use is mainly borne by the Pharmaceutical Supervision Bureau. It is more cautious in approval, but it is also prone to "one -size -fits -all" situation.

After the Internet hospital was discontinued by Atropine, Yang Xiao's hospital did not produce internal preparations. Yang Xiao could only use other ways to prevent and control myopia. "The effect is not as good as the joint use of Atropine. The time of myopia prevention and control is the years when children's growth. I hope that there can be compliant ways to allow clinicians to use it reasonably as soon as possible," Yang Xiao said.

Wang Kai, chief physician of the E -Optimum Center of the People's Hospital of Peking University, also said that Atropine can control myopia with clear evidence -based medical evidence, "and the level of evidence is very high." At the moment when myopia is getting older One of the main means for nationwide ophthalmologists to prevent myopia.

He also believes that myopia prevention and control is a comprehensive issue, and we must not rely on a single means such as Atto. "Including eye habits, sitting positions, distance of eyes, the brightness of indoor light, time of outdoor activities, Atto products, etc., need comprehensive means to control. Shortsighted."

After the channels of the Internet hospital were shut down, Zhang Lin counted a few boxes of low -concentration Atropine's eye drops, "I can persist for more than a month." She considered it, or I would like to go to Xingqi, Shenyang Xingqi from Beijing. Go to buy an ophthalmology hospital? But I also feel that the time and money cost of this method are too high, "the cost is too high." Even if there is a certain risk of purchasing, Zhang Lin still inquires, hoping to find a relatively reliable purchasing agent. Speaking of longer plans, Zhang Lin expects that low -concentration Atto eye drops can be listed as soon as possible, and he can buy Adop eye drops in a compliant way. Since her daughter checked myopia, Gao Rui told friends who had children one by one: if you did not check his eyes after birth, he must take them to check immediately. After that, Gao Rui kept tracking the progress of the inspection of friends. She regards this as a kind of compensation that she does not pay attention to children's eye health earlier. "If someone told me when the child was three or four years old, she should pay special attention to her eye health, set up archives for her, and keep tracking. Maybe I will pay more attention. Maybe she will not be at 8 years old. Such a young age is close to my eyes. "

After her daughter's myopia, Gao Rui felt that she had done everything: she first replaced the lights at home with eye protection lights, and changed the tables used by the family to read the book. As soon as you look up, you can see the trees outside.

After that, she stopped all the extra -curricular tuition again, went to the outdoor and ride on Saturdays and Sundays, and took the whole winter and summer vacation to ski outdoors or play tennis. Even at noon in school, Gao Rui asked Qi to go home for dinner. With a few minutes walking on the way home, he could look at the outdoor relaxation.

At each review, Gao Rui himself sorted out the length, refractiveness, eye pressure, and naked eye vision of the eye axis in the hospital's optometry data, and put the data into the mobile phone. She plans that if Atropine's eye drops are effective for her daughter for a long time, she intends to let her use it until adulthood.

Even so, Gao Rui knew that once he was relaxed, the degree of his eyes could not be reversed. She was ready for this: a long -lasting battle with myopia.

- END -