Should traditional Chinese medicine injection be abolished?

15 traditional Chinese medicine injections, including Reduning, Chuankezhi, Shenfu injection and Xiyanping, have been successfully selected in the catalogue of basic drug supplement varieties of Guangdong Province (2013 Edition), which once again pushed the traditional Chinese medicine injections to the forefront of public opinion Traditional Chinese medicine injection is regarded as an extension of the modernization of traditional Chinese medicine, but its safety has been questioned In recent years, the frequent adverse reactions of traditional Chinese medicine injections have caused a great stir in the society, at the same time, they have been labeled as "dangerous" What is the problem of traditional Chinese medicine injection? Event: the list of selected essential drugs was questioned a day ago, the Department of health of Guangdong Province issued the catalogue of essential drugs supplement varieties of Guangdong Province (2013 Edition), expanding the capacity of 278 varieties, 147 varieties of chemical and biological products, and 131 kinds of Chinese patent drugs For the practice of absorbing a large number of traditional Chinese medicine in the supplementary catalogue, some people in the industry think that "it does not meet the requirements of safety, effectiveness and low price of essential drugs" The selection of 15 traditional Chinese medicine injections has become the target of public criticism "In the past few years, there have been frequent accidents of traditional Chinese medicine injections, and a series of events have even triggered a great discussion on the retention and abolition of traditional Chinese medicine injections in the industry." Some pharmaceutical companies suspected that the safety of traditional Chinese medicine injection has been criticized for the unknown allergens and effective ingredients Although the safety re evaluation of traditional Chinese medicine injection led by the State Food and drug administration has been carried out for nearly three years, the current progress has not solved the root problem of traditional Chinese medicine injection The so-called traditional Chinese medicine injection, according to the definition of Chinese Pharmacopoeia, refers to "the sterile preparation of the solution, emulsion, powder or concentrated solution prepared for injection into the body after the extraction and purification of the traditional Chinese medicine and the preparation of the solution before the temporary use." Although the history of traditional Chinese medicine injection is only 70 years and the use history is less than 40 years, the development speed is amazing As of 2009, there are 156 TCM injection varieties and 2043 approvals in China Among them, 61 are single herbs, 16 are two herbs and 79 are more than two herbs In fact, this is not the first time that traditional Chinese medicine injections have been controversial due to their inclusion in the base drug list Before that, every time the national essential drug catalog was adjusted, the debate on whether the traditional Chinese medicine injection would enter the new version of the catalog was "vigorous" It is understood that some people once advocated the total prohibition of traditional Chinese medicine injections In the national basic drug catalog, no more traditional Chinese medicine injections will be included, making it "annihilated" However, in the selection of national essential drugs catalogue, the basic attitude of experts on how to grasp the principle of the selection of traditional Chinese medicine injections is: "we should treat traditional Chinese medicine injections dialectically instead of one size fits all Traditional Chinese medicine injection is a major breakthrough in the treatment of emergency in traditional Chinese medicine It has irreplaceable effects on chronic diseases, elderly diseases, cardiovascular and cerebrovascular diseases, etc basic drugs cannot exclude traditional Chinese medicine injection " Behind: in recent years, the frequent occurrence of adverse events of traditional Chinese medicine injection has caused such a great controversy because of its frequent occurrence of adverse events In the 2012 annual report of ADR monitoring reported by the State Food and drug administration, traditional Chinese medicine injection has become a "serious disaster area" for serious adverse reactions In 2012, the national ADR monitoring network received 103 thousand reports of 14 major traditional Chinese medicine injections, including more than 5500 serious reports, accounting for 5.3% In all the serious adverse reaction reports received by the monitoring network, the top 20 Chinese patent medicines are all traditional Chinese medicine injections, and the top 5 varieties are Qingkailing injection, Shenmai injection, Shuanghuanglian price injection, Xuesaitong injection and Danshen price injection In addition, the State Food and Drug Administration issued a total of 10 information circulars in 2012, of which 5 adverse reactions information circulars can see the figure of traditional Chinese medicine injection, they are Shengmai injection, Xiangdan injection, Xiyanping injection, Mailuoning injection, honghuaji injection According to the reporter, the concern about the adverse reactions of traditional Chinese medicine injection began in the Houttuynia price injection incident in 2006, when it killed six people in Beijing and Wuhan Since then, the problem of traditional Chinese medicine injection has been exposed: from the price of Ciwujia, Yinzhihuang, Qingkailing, Shuanghuanglian, to the recent Xiyanping, Mailuoning traditional Chinese medicine injection, the safety of traditional Chinese medicine injection challenges the public's nerves again and again In recent years, "Houttuynia price" injection, compound "Dandelion price" injection, "Yujin" injection, yanduqing "injection and other traditional Chinese medicine injection have been stopped by the State Food and drug administration due to serious adverse reactions in clinical application In 2009, the State Food and Drug Administration launched the national special action for safety re evaluation of traditional Chinese medicine injections The first batch of re evaluated traditional Chinese medicine injections including Shuanghuanglian price injection and Shenmai injection were determined The drug standards of two varieties of ginsenoside injection and yanduqing injection were cancelled, and the first step of elimination of traditional Chinese medicine injections was taken According to the public data, as of 2012, more than 30 varieties involving nearly 100 traditional Chinese medicine injection enterprises have withdrawn from the market, 16 large varieties with relatively concentrated production, and 13 new traditional Chinese medicine injection standards have been issued Why does traditional Chinese medicine injection cause trouble? In response, Luo Jiabo, director of the new medicine laboratory of traditional Chinese medicine, Department of traditional Chinese medicine, Southern Medical University, said, "ancient Chinese medicine was used according to individual syndrome differentiation, and each person could use a certain amount, but in many cases, it became the patient's own medicine after becoming a Chinese patent medicine Once the dosage form changed from oral to intravenous, the risk increased accordingly Therefore, we do not advocate clinical abuse of injection, unless it is critical Disease, otherwise can take orally don't inject According to sun Rong, a researcher of traditional Chinese medicine pharmacology in Shandong Academy of traditional Chinese medicine, the extraction and preparation technology of traditional Chinese medicine injection is relatively simple, and the manufacturing technology of manufacturers is uneven, but the composition of traditional Chinese medicine is complex, the effective ingredients are unknown, and there are many impurities Most of the raw materials contained in traditional Chinese medicine injection usually have 3-7 kinds, the higher even up to 12 kinds Quality control is very difficult, which makes it easy to not happen Good response Dispute: is traditional Chinese medicine injection safe? Compared with the alarming reports of adverse reactions of traditional Chinese medicine injection, the industry of traditional Chinese medicine injection has been developing rapidly in recent years Under the background of chemicals falling into price competition and the overall growth of pharmaceutical industry slowing down, traditional Chinese medicine injection is a unique branch However, the frequent occurrence of adverse events is still a shadow of traditional Chinese medicine injection As a product of the combination of traditional Chinese medicine theory and modern pharmaceutical technology, after the adverse reactions of Houttuynia cordata price, acanthopanax senticosus price, Yinzhihuang price, Shuanghuanglian price and other traditional Chinese medicine injections were exposed, traditional Chinese medicine injections encountered a "trust crisis": four voices of abolition "The problem of traditional Chinese medicine injection has been exposed and investigated, but no one has clarified the results comprehensively, which makes people have great distrust of traditional Chinese medicine injection, and the whole industry is also affected." Fang Shuting, President of the China Association of traditional Chinese medicine, said that the investigation results of the authoritative departments confirmed that most of the batches of products are based on the reasons such as the solvent aid in the production process, improper transportation and storage, and improper use, rather than the toxicity problems of the traditional Chinese Medicine injection itself The price event of Shuanghuanglian is caused by the combination of illegal and taboo Western medicines (several kinds) that the hospital failed to comply with the requirements of Shuanghuanglian price injection instructions Fang Shuting pointed out that the attitude towards traditional Chinese medicine injection should not go to two extremes It can't be killed with one stick because of some problems, but it can't protect the essence of traditional Chinese medicine blindly We should face up to the problems, find out the causes of the problems, find out the targeted measures, and improve the safety of traditional Chinese medicine injection "The application history of traditional Chinese medicine injection is relatively short Some drugs that should not be developed, produced, sold or entered have been approved for production after public relations treatment." Zhou Chaofan, executive member of the editorial board of the Chinese Pharmacopoeia, said that the high rate of return on the development, production and sales of traditional Chinese medicine injections has prompted pharmaceutical companies to compete for the production line of traditional Chinese medicine injections Taking the daily dosage of inpatients as an example, the price of traditional Chinese medicine injection is 2-3 times higher than that of other conventional dosage forms Pharmaceutical companies, doctors and hospitals can benefit from it, which has opened a green light for the promotion and use of traditional Chinese medicine injection Guo Fanli, a researcher in the pharmaceutical industry of CIC consulting, suggested that to solve the existing problems in the pharmaceutical market, internal and external repairs are needed - internal upgrading of the entire industry is needed, and external environment needs more legislation, such as serious adverse reactions, recall, and severe punishment measures In addition, clinical test standards should be set up for Chinese herbal medicine itself "At present, the state's attitude towards traditional Chinese medicine injections is to support and strictly control them at the same time Some traditional Chinese medicine injections have been selected into the National 863 program, but their safety problems have also attracted the attention of relevant departments." Professor Zhang Shijun, Department of traditional Chinese medicine, the First Affiliated Hospital of Sun Yat sen University, said that a series of adverse reactions before were still warning enterprises to strictly control product quality and doctors should use it reasonably "Traditional Chinese medicine injection belongs to high-risk varieties, so it is imperative to improve the quality standard." Experts believe that the government should strengthen the supervision of them First, strengthen the supervision of clinical drug use, strictly follow the indications and contraindications, try to avoid mixing with other drugs, and avoid rapid infusion; second, supplement the systematic re evaluation of clinical safety, identify the varieties with poor safety and alternative treatment methods, and at the same time, require the hospital to use Chinese medicine injection carefully Intravenous drip.