Chinese patent medicine for children: many toxic drugs have unknown adverse reactions

"In the near future, children's traditional Chinese medicine will be an indispensable main force in the traditional Chinese medicine industry More than 500 million strategic products will be produced " This is the consensus reached by experts of traditional Chinese medicine at the first Qihuang Forum recently However, due to the obstacles of many factors, the drug use of Chinese patent medicines in children is currently in confusion Experts believe that it is urgent to start the re research on the drug use of Chinese patent medicines in children Three major factors hinder the development of children's traditional Chinese medicine It is reported that there are 374 varieties of children, children, children and other words in the main items of national drug standards (hereinafter referred to as "involved children Chinese patent medicine") This means that children can use or use special drugs for children, accounting for about 5% of the total number of Chinese patent medicines Among them, 186 varieties (hereinafter referred to as pediatric Chinese patent medicines) with the words of children, children, infants, infants, etc as the names of drugs mean that some varieties are pediatric special drugs, accounting for about 50% of Chinese patent medicines for children "Children ≠ small adults, children ≠ reduction of adult drugs." Li Lianda, academician of the Chinese Academy of engineering, pointed out that at present many people have equated the painting According to him, children's growth and development, function is not perfect, children's drug body process is different, absorption, utilization, decomposition, metabolism, excretion, pharmacokinetics and so on are different from adults The side effects and side effects of children's drugs are not the same as those of adults, but the effects of deafness (dumb due to deafness), hematopoiesis, liver and kidney function are more than that of adults Therefore, the dosage form and specification of children's medication need special consideration Zhang Shichen, vice president of China Association of traditional Chinese medicine, told reporters that at present, three major factors hinder the development of children's traditional Chinese medicine First, the clinical application function and indications of most pediatric traditional Chinese medicine product manuals are unclear; second, the adult to pediatric products lack the specific usage and dosage of children and the warning of adverse reactions; third, most product manuals are still in the stage of "adverse reactions, use taboos and other unclear" Children drug users should be careful to use toxic traditional Chinese medicine expert song Minxian's introduction, pediatric Chinese patent medicine pills 82, powder 72, granules 61, tablets 41, oral liquid (mixture) 35, diabetes 34, capsule 18, oral paste 7, injection 6 There are 130 Chinese patent medicines that can contain toxic herbs, accounting for 34.75% of the total varieties; there are 59 Chinese patent medicines that contain two or more toxic herbs, accounting for 15.77% In the drug standard, there are 117 varieties of Chinese patent medicines for children, accounting for 31% of the total, which have not published prescription drugs and doses, or can not calculate the doses of each preparation unit (such as each tablet, gram, etc.) according to the drug standard There are 116 varieties without age dosage, accounting for 31% of the total number of Chinese patent medicines involved in infants, and there are no rules for those with age "The most important thing is that many Chinese patent medicines for children contain toxic herbs, and the adverse reactions of these ingredients are still unclear." Ma Rong, Dean of the First Affiliated Hospital of Tianjin University of traditional Chinese medicine, told reporters that there are 44 varieties of pediatric Chinese patent medicine in the Pharmacopoeia, including cinnabar price, realgar price, Polygonum multiflorum price and betel nut price Cinnabar price is the most frequently used Most of them focus on the aspects of calming, calming, eliminating accumulation and tonifying, such as the treatment of infantile convulsion, epilepsy, accumulation stagnation, enuresis, cerebral palsy, etc According to the consumption statistics of the First Affiliated Hospital of Tianjin University of traditional Chinese medicine, in 2012, 383.5kg was used for raw Polygonum multiflorum, 428.6kg for areca and 6.18kg for cinnabar However, in 2013, due to the media's attention to the toxic components of traditional Chinese medicine, doctors paid great attention to the adverse reactions In the first five months of the hospital, the consumption of cinnabar decreased the most, only 0.9kg "We should optimize the prescription of old drugs and remove the drugs with high price and content of cinnabar For example, Wang's baochisan and qizhenwan in Tongrentang " He believes that due to the unclear research on the adverse reactions of toxic drugs, careful use of toxic drugs should attract the attention of children drug users On the other hand, the research of Chinese patent medicines containing toxic Chinese herbal medicines for children has become urgent The future research and development focus includes toxic and side effects Wang Junhong, director of Pediatrics, Dongzhimen Hospital, Beijing University of traditional Chinese medicine, has broken the current situation of children's medication Only 16.6% of the drugs for children aged 0-14, less than 2% of the 3500 kinds of drugs for children, 90% of the drugs without children's clothing, 102 kinds of Chinese patent medicines only have one special variety for children, only more than 10 of the 6000 pharmaceutical factories specialize in children's drugs, and only 30 enterprises cover children's drugs "And doctors are on the verge of illegal practice - 50% of children are over prescribed." He said the reasons for these conditions are that pharmaceutical companies do not pay attention to the research and development of children's drugs The market demand for children's medicine is about 50 billion yuan, but the market is not stable and manufacturers are not willing to invest in it For ethical reasons, it is very difficult to recruit clinical trial staff for children Children are lack of experience in drug testing, and the incidence of adverse drug reactions is high In China, the incidence of adverse drug reactions in children was 12.9%, including 24.4% in newborns and 6.9% in adults In addition, R & D costs have risen sharply, which may lack policy support However, many experts said that children's drug use also has development opportunities, and the State Food and Drug Administration began to support the development of children's generic drugs Pharmaceutical enterprises can make contributions in four aspects: first, to develop dosage forms and specifications suitable for children of different ages; second, to declare the dosage forms and specifications of children together with the declaration of innovative drugs; third, to develop innovative drugs for the research of children's special diseases and rare diseases; fourth, to apply for the specifications and dosage forms of generic drugs for children According to Li Lianda, toxicity and side effects will be the focus of research and development of pediatric Chinese patent medicine in the future In addition, it can also include the research and development of children's specific diseases and special drugs, the research and development of children's common diseases and frequently occurring diseases, the selection of new drugs with children's characteristics and the secondary research of old drugs, the research of dosage, times and treatment courses of children's drugs, the safety research of children's drugs, the common side effects, and the prevention and sequelae of side effects and sequelae that have an important impact on growth and development and long-term prognosis Study of treatment