Original title: let children first stay away from traditional Chinese medicine injections, this Chinese original "magic medicine" will usher in strong supervision.
In the standard of drug quality control, the requirement of injection is most strict, its composition must be clear, the purity of the medicine is high, the curative effect has sufficient evidence, and the toxic side effect is clear, these Chinese medicines are not available. But hundreds of millions of yuan of traditional Chinese medicine injections market, mixed with pharmaceutical companies, employment, department interests and many other entanglements, so that the regulatory authorities are hard to lay down their hands.
He Tao, a journalist of Finance and Economics
"Who is the next?" This question has recently been suspended in the mind of the people in the medical circle.
Since the beginning of May 29, 2018, the State pharmacy administration bureau has issued four announcements in a short period of half a month. It has requested a large variety of Chinese herbal injections, such as Bupleurum injection, Shuanghuanglian injection, Salvia miltiorrhiza injection, and gastrodin injections, and the requirements for forbidden or prudent use for children, newborns and infants.
"It may be difficult for laymen to understand the weight of this announcement." Li Lin, deputy director of the Chinese Medicine Association's protection and innovation of Chinese medicine, told the finance and economics reporter, Li Lin. Bupleurum injection is the "originator" of traditional Chinese medicine injections. It was born in eight crude drug factories in the 1939. This announcement relates to 77 Bupleurum injection approval documents belonging to 73 enterprises.
On the evening of July 3rd, the State Administration of pharmacy and pharmacy again hammered twice, calling for Qingkailing injection and injection of Yiqi compound pulse (freeze-drying) to revise the instructions.
Intensive recruitment reveals that the traditional Chinese medicine injections will usher in a stricter regulation.
In addition to the revision of the instructions, the study on the reevaluation of Chinese medicine injection and the guiding principles of reevaluation are also the key work arrangements of the State Administration of drug administration in 2018.
In fact, in the information bulletin on adverse drug reactions (ADR), which was first released in November 2001 by the national drug adverse drug reaction monitoring center, there were double Huanglian injection and Qingkailing injection, which resulted in 51 cases of anaphylactic shock, of which 3 were dead.
Over the next 17 years, Chinese medicine injections have been repeatedly posted on this bulletin to alert safety risks. The drug regulatory authorities have also made several points of governance, trying to solve the safety problems of traditional Chinese medicine injections.
However, the current supervision method can not thoroughly wash out the congenital defects of traditional Chinese medicine injection. In this already hundreds of billions of yuan market, the survival of pharmaceutical enterprises, social employment, the interests of the Department and many other problems, leading to the supervision department is difficult to lay heavy hands on. Under such circumstances, it is appropriate for all children to stay away from traditional Chinese medicine injections as soon as possible.
At the beginning of the launch of the new State Administration of drug administration, the first Domino card, bupleurum injection, was pushed down. When he learned that the State Food and Drug Administration requested the revision of the instructions of the bupleurum injection, Li Lin applauded it.
The main contents of the revised requirements are: warning the adverse reactions of the drug, including anaphylactic shock, should be used in medical institutions with emergency conditions.
The traditional Chinese medicine injection, which combined the traditional Chinese medicine and the injection method "innovating", originated from the age of lack of medicine and medicine. In the mass movement of Chinese herbal medicine launched in 1965, the development of "great leap forward" was realized, and more than 1400 kinds of traditional Chinese medicine injections had been made in 1980s. After the spectacle.
In the eyes of Fang Fang, a popular science writer and doctor of biology, "traditional Chinese medicine injection is a weird thing." It is derived from traditional Chinese medicine, but it is not eating, but injection, the way is traditional Chinese medicine, it is not in the traditional Chinese medicine, so it is not medium; intravenous injection is the way of modern medicine, because it is to direct injection of blood, so the quality of injection is very high, must be highly purified, and traditional Chinese medicine injections are It contains a lot of impurities, so it is not ocean.
The problem of birth is not important. Safety, effectiveness and quality control are the basic principles of international medicine. But using this principle to contrast, it will be found that traditional Chinese medicine injections have irreparable congenital defects.
As an injection, it will bypass human intestinal barrier with barrier and excretion of harmful substances, and directly hit the drug into the blood, which has a high risk. It can be administered orally without injection, and it can be injected without intramuscular injection. This is the internationally accepted principle of medication.
In the standard of drug quality control, the requirement of injection is most strict, its composition must be clear, the purity of the medicine is high, the curative effect has sufficient evidence, and the toxic side effect is clear, these Chinese medicines are not available.
It is necessary to know that the chemical composition of the compound Chinese medicine injection is more complex, and the chemical composition of the compound Chinese medicine injection is more complicated, and the medicinal herbs used by some Chinese medicine injections are toxic, such as the Aconitum and Aconitum needed in Shenfu injection.
Inject complex mixtures of unknown components into the blood, "subverting" the basic principles of modern medicine, bringing considerable risk of drug use.
The first problem is the allergen. Fang Zhou Zi analysis, a large number of impurities in Chinese medicine injection can inevitably have allergens, allergen, such as entering the blood can cause allergic reactions, so Chinese medicine injection is easy to cause allergies, serious allergies will lead to shock, death.
Data from the National Center for adverse drug reaction monitoring showed that most of the patients who were killed by traditional Chinese medicine injection died from severe anaphylaxis. In the revision of the instructions for multiple Chinese medicine injections, the adverse reactions, including anaphylactic shock, should be warned, which should be used in medical institutions with a rescue condition.
Zhu Wentao, a professor at Beijing University of Chinese Medicine, believes that the adverse reactions of traditional Chinese medicine injections are unpredictable because of the complex composition of the traditional Chinese medicine injection, the uncertainty of the anaphylaxis and the variety of anaphylaxis.
The congenital defects of traditional Chinese medicine injections are also easily contaminated by pyrogen. Pyrogen is a bacterial endotoxin that stimulates the body's fever and is named after it. Fang Zhou Zi said that the injection in production and storage should be paid special attention to not being contaminated by bacteria. Otherwise, after the injection of the pyrogen to the blood, the patient will have a high fever and even death. The growth and storage environment of Chinese medicinal materials will inevitably be contaminated by bacteria. The production process of many Chinese medicine injections has no perfect purification process, and the pyrogen in the medicinal materials will enter the traditional Chinese medicine injection.
Quality control in production is also difficult. Fu Dexing, the chief pharmacist of the pharmacy of Beijing Hospital, said in an interview with the "capital medicine" that the injection of traditional Chinese medicine started from the production link, and there was a lot of uncertainty, which affected the qualified rate of the finished product.
From 1995 to 2000, Beijing inspected 250 batches of traditional Chinese medicine injections, of which nearly 1/6 were not qualified.
However, the use of drugs needs to weigh the pros and cons. Although there is a greater risk of adverse reactions, it does not mean that Chinese medicine injections can not be used, but depends on whether it is necessary to use them.
The curative effect of traditional Chinese medicine injection is often questioned because of its lack of solid clinical data support. The former director of the State Administration of food and drug administration, Bi Jingquan, Tan Chen, early approved the listed injection with Chinese medicine as raw material, and the basic research on safety and effectiveness is weak. Some production enterprises are cutting off the material, using fake raw materials and changing the production process without authorization, which seriously affects the safety and effectiveness of the drugs.
In Fang Zhou Zi, it is not found that any kind of disease can only be treated with traditional Chinese medicine injection, but it is not necessary to use it, but it may take the risk of serious adverse reaction.
Original industry in China
A senior personage of the local drug supervision system revealed that the wanton abuse of intravenous infusion in our country over the past 20 years has caused the small probability to be infinitely magnified until shocking. The Chinese medicine injection, which has a huge sales volume and known as "Chinese god medicine", is the first to bear the brunt and become the focus. For this reason, many manufacturers have configured the "fire rescue team" and mastered a certain amount of funds. Once a serious adverse reaction and even fatal cases occur, it is the first time to arrive at the accident hospital. The final aim of appease and discuss compensation is to control the situation, not to be exposed, and not to affect sales performance. So there are few cases of public exposure.
Behind all the efforts of pharmaceutical companies is a 100 billion yuan market. Although it is difficult to use modern medical principles to weigh it, it is difficult to call it as a drug, but in China, it has achieved a pillar of the pharmaceutical industry, and even some of the listed companies.
In 2016, China's public medical institutions sold more than 104 billion 800 million yuan in the total scale of Chinese medicine injections, including more than 80% of the market share in public hospitals and public hospitals at the county level in China.
Around the injection of traditional Chinese medicine, it has formed a huge industrial chain. From the collection of medicinal herbs, pharmaceutical production enterprises, distributors, hospitals, pharmacies, etc., are divided into different links of the chain to make a living.
There are about 130 Chinese traditional Chinese medicine injections and more than 210 manufacturing enterprises in China. About 80% of the varieties of traditional Chinese medicine injection were approved by 1985, and the clinical effectiveness data and safety data were seriously inadequate according to the more relaxed local standards.
In December 1, 2001, when the newly revised Drug Administration Law came into effect, the local drug standards were abolished and the national standards were unified. But many local standards for traditional Chinese medicine injections, which have fallen behind for many years, are almost unmoved to national standards, Fu Dexing recalls, "this is very puzzling." Some traditional Chinese medicine injections are slightly better, increasing the standard of content determination, but there are still significant deficiencies in safety inspection.
The Chinese medicine industry experts told the "finance and economics" reporter that at that time the Chinese medicine industry experts also strongly opposed the rise of traditional Chinese medicine injection as the national standard, the reason is that traditional Chinese medicine is oral or external use, never intravenous drip. Previously, local standards were applied in a small range. Once they rose to the national level, they would be widely used, which would not have a good effect on traditional Chinese medicine.
At that time, domestic chemical drugs developed rapidly, and many Chinese medicine enterprises were dying. There is an urgent need to find new growth points. Seeing such a life-saving straw, Chinese medicine enterprises did a lot of "work", and finally, they were released by relevant leaders and Chinese medicine injections. Once the "Pandora's box" was opened, it could not be controlled. A large number of varieties were listed until 2008. The National Drug Review Center (CDE) realized the severity of the problem and rarely approved such injections. But this also led to the approved varieties often become exclusive, due to the monopoly of the market, the annual sales can easily reach an astonishing 1 billion -30 billion, of which the degree of profit is more difficult to express, the company is like a listing.
Zhou Chaofan, a researcher at the Institute of basic theory of the Chinese Academy of Chinese medicine, also pointed out that the use of traditional Chinese medicine injection has a short history, and some drugs that should not be developed, should not be produced, should not be sold and should not be entered, have been approved and produced after the public relations treatment.
Compared with conventional dosage forms, the price of Chinese medicine injections is 2 times to 3 times higher than that of conventional dosage forms.
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