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OBJECTIVE：To reevaluate the guidelines/cons ensus，systematic review/Meta-analysis of proton pump inhibitors （PPIs）in the prevention of drug-induced gastrointestinal injury ，and to provide evidence-based reference for its clinical use. METHODS： The relevant guidelines/consensus and systematic review/Meta-analysis literatures at home and abroad were systematically reviewed ，and the re evaluation was carried out from the effectiveness ，safety and economy dimensions to analyze the current situation of clinical use of PPIs in the prevention of drug-induced gastrointestinal injury in adults and children. RESULTS ： A total of 14 clinical guidelines/consensus and 10 systematic review/Meta-analysis literatures of PPIs for the prevention of drug-related gastrointestinal injury at home and abroad were sorted out and included. In terms of effectiveness ，PPIs could prevent various drug-related gastric mucosal damage ，gastrointestinal bleeding and other damage to the digestive tract ，but PPIs had not yet obtained the indication for children in China ；PPIs were widely used in the treatment of children ’s digestive tract diseases ，which belonged to off-label medication. In terms of safety ，the common adverse reactions of PPIs included headache ，gastrointestinal symptoms，etc. There may be risks of kidney disease and fracture during long-term application. In terms of economy ，for some patients with digestive tract and cardiovascular disease risk ，the economic benefit of NSAIDs combined with PPIs were higher ； esomeprazole 20 mg and 40 mg daily were equally effective in preventing ulcer recurrence caused by NSAIDs ，but increasing the dose could not improve the preventive effect. CONCLUSIONS ：The preventive effect of PPIs on drug-induced gastrointestinal injury is supported by evidence-based evidence. It has good safety in adults and has certain economic benefits ；but it belongs to off-label drug use in children in China ，and the safety and economy still need to refer to the results of adult studies. In the future ，a number of multicenter prospective clinical studies based on Chinese pediatric population are still needed to provide more support for the prevention and treatment of drug-induced gastrointestinal injury by PPIs in children.
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OBJECTIVE： To provide suggestions for improving pediatric medication information in drug instructions of microecological preparations in China. METHODS： Using text analysis method， the pediatric medication information in the instructions of 36 approval number of microecological （29 varieties from 23 enterprises） is statistically analyzed. RESULTS： Among the 36 microecological preparations， there were 2 medicines for children （5.56％）. There were 2 granules （5.56％）， 9 dispersants （25.00％）， 9 tablets （25.00％） and 16 capsules （44.44％）； there were 6 national essential medicines （16.67％）； there were 13 products in the list of national essential medical insurance （36.11％）； there were 22 OTC products （61.11％）. The proportion of children’s indications， children’s usage and dosage， child-related adverse reactions， taboos and matters needing attention in the drug instructions for children were 19.44％， 55.56％， 2.77％， 5.56％ and 8.33％， respectively. The proportion of specific information about children’s drug use marked in the item of “children’s drug use” was 25.00％. CONCLUSIONS： There is a lack of information on pediatric medication in the instructions of microecologial preparations in China， and there are some problems such as unclear wording， scattered labeling position of the medication information for children， and the content is not practical. It is recommended that medical institutions should strengthen the rational use of medical guidance for medical personnel， implement the scientific management process of over-instruction medications； the relevant departments should introduce more incentive policies， encourage enterprises to improve the basis of children’s medications， and make standardized labeling of children’s medication information in drug specifications. In addition， a database of information on children’s medications can be established to provide a reference for rational use of pediatric drugs.
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OBJECTIVE： To provide reference for the selection of inhaled corticosteroids （ICS） in clinic. METHODS： A questionnaire survey was conducted among pediatricians from medical institutions of 11 provinces （districts， cities） to analyze the drug selection and reasons， dosage form selection [by comprehensive score （CS）] of 3 kinds of ICS as budesonide （BUD）， beclomethasone （BDP） and fluticasone （FP）， medication compliance and influential factors （by CS）. RESULTS： A total of 200 questionnaires were sent out， and 196 valid questionnaires were collected with effective rate of 98.00％. Pediatric clinicians preferred BUD as a control drug for asthma in children （158 cases， 80.61％）， followed by FP （22 cases， 11.22％） and BDP （2 cases， 1.02％） and the rest had no tendency （14 cases， 7.14％）. Clinicians who chose BUD mainly believed that the drug had better clinical efficacy， and was more recommended by guidelines and experts， more recognized by patients and so on. In addition， of all inhalation equipment for children asthma， pediatric clinicians believed that parents or children were more easier to master atomizer （CS： 4.04）， followed by pressurized metered dose inhalers （pMDI） （with spacer） （CS： 2.75）， pMDI （without spacer） （CS： 1.71）， dry powder inhalers （DPI） （turbuhaler） （CS： 1.46） and DPI （accuhaler） （CS： 1.08）. For the evaluation of patients’ medication compliance， 48 （24.49％）， 88 （44.90％）， 58 （29.59％） pediatricians thought that the actual administration accounted for ＜50％， 50％-74％， 75％-99％ of the medical order dosages， respectively. Only 2 （1.02％） subjects thought that the patients would fully obey. The main factors affecting children’s medication compliance were worrying about side effects of long-term medication （CS： 9.19）， drug withdrawal after improvement （CS： 8.16）， and children’s treatment incompatibility （CS： 7.82）. CONCLUSIONS： Pediatricians tend to choose BUD as drug for asthma control， and atomizer is treated as the easiest inhalation equipment for children. At the same time， pediatricians have low evaluation on the medication compliance of parents and children.
RESUMO
Due to the weak foundation of clinical trials,the pre-market data of pediatric medicine is insufficient. Therefore,a comprehensive evaluation system of pediatric clinical medicine is urgently needed to safeguard the children′s medication safety. This article provides the method and builds path to establish the comprehensive evaluation system from the aspects of biulding organization?al structure,operational process and evaluation methodology,respectively. Further,based on the concept ofEvidence-based or other?wise evidence-created,and following the example of“Mini-Sentinel”of the United States,the big data in medicine can be used to overcome the“Evidence-created”difficulty in the evaluation of pediatric medication. Thus more extensive comprehensive evaluation can be made through collecting the clinical data generated from the real world for the pediatric medication. In the future ,the compre?hensive evaluation system of pediatric clinical medicine established on the basis of big data can be linked to thePrecision MedicineProject in our country,the evaluation bases can be the Mini-Sentinel to collect big medical data and biological samples,thus to bring a steady flow of power for promoting the pediatric medicine active surveillance and pediatric precision medicine ,and finally to safeguard the children′s health in our country.