Objective We aimed to develop a self-management assessment scale for children with epilepsy and test its reliability and validity. Methods A research group was established, and the items were revised through literature review, group discussion and pre-investigation, and 280 patients with epilepsy in children were included, and the reliability and validity of the scale were tested. Results 28 items in 4 dimensions were developed to form the scale, namely, knowledge and belief of diseases and medication, compliance of medication and treatment, self-efficacy of medication and obstacles of medication. Confirmatory factor analysis extracted four common factors with characteristic roots greater than 1, and the cumulative variance explanation rate was 65.639%. The factor load of all items is > 0.5. The overall Cronbach’s alpha is 0.880, and the coefficients in seven measurement dimensions are all greater than 0.8. Conclusion The self-management assessment scale for children’s epilepsy drugs has good reliability and validity, and can provide a measuring tool for the drug management of children’s epilepsy diseases.
Objective To compare the 2009 edition national essential medicine list (part of basic medicine and heath institution ) in China and WHO model list of essential medicines for children update in 2010, so as to provide the evidence for model list of essential medicines for children of China. Methods We compared the diference in composition of content, the categories, speciic drugs, formulation, and introduction and sign of list by descriptive analysis. Results (1) WHO model list of essential medicines for children were comprised with core and complimentary lists, which were not in the 2009 edition national essential medicine list of China; (2) The 2009 edition essential medicine lists of China included 20 categories in WHO model list of essential medicines for children ,while lacked of antineoplastic agents, blood products, disinfectants, peritoneal dialysis luid and speciic medicines for neonatal care; (3) he average conincidence rate with WHO model list of essential medicines for children of the same drugs was 52.61%. here were 15 categories in the interval of 20%-80%, which accounted for 75%. he average conincidence rate with 2009 edition national essential medicine list of China was 44.19%. here were 11 categories in the interval of 20%-50%,which accounted for 55%. the same drugs of regulate water, electrolyte and acid-base balance in the two list accounted for more than 80% of WHO model list of essential medicines for children. Drugs of ear, nose and throat were totally diferent. (4) he 2009 edition essential medicine list of China didn’t have speciication and sign of drug for children, age limitation, instruction of list, suitable drug formulations for children such as suspension, syrup, drops, granules, scored tablets, etc. Conclusion 2009 edition national essential medicine list of China can’t meet the demand of children. WHO model list of essential medicines for children which bases on global burden of disease, can not be copied into China. We suggest to reference fromWHO model list of essential medicines for children to carry out selecting essential medicines for children in China, formulating essential medicine list for children in China which bases on burden of children disease and clinical demand in China to improve rationality of drugs in children.
ObjectiveTo learn the development and implementation of orphan drug policies, in order to provide decision-making references for the establishment of orphan drug policy according with China's national conditions. MethodsWe electronically searched databases including CBM, CNKI, VIP, EMbase, PubMed, Web of Knowledge, National Library of Medicine, CRD database, The Campbell Library, The Cochrane Library and the drug administration websites of USA, Canada, UK, Ireland, the Netherlands, Germany, Spain, France, Australia, New Zealand, China, India, South Korea, Japan, and South Africa to collect studies about orphan drug policy. The search date was up to February 2014. Two reviewers independently screened literature, and extracted data. Then, all included orphan drug policies were summarized and a comparative analysis was performed. ResultsA total of 110 studies were included. USA, Singapore, Japan, Australia, European Union, Chinese Taiwan and South Korea had introduced orphan drugs incentive policies. South Africa, India, Canada, New Zealand and Chinese Hongkong were producing orphan drugs policy frameworks. The main items of orphan drug policy included marketing exclusivity, tax incentives, technical assistance, grant funding, expedite approval process and prolong re-evaluated time. ConclusionIn mainland China, there is no orphan disease management policy. China should establish specific organization and working procedures, promote orphan drug policy related legislative work, clarify the definition and prevalence of orphan diseases, provide incentive mechanism to promote the research and development of orphan drugs, provide enterprises to develop compensation mechanism to safeguard the rights and interests of patients, as well as establish patients register network platform to track the processes of the diseases.
ObjectiveTo systematically review the medication adherence in children with tic disorder to assist in the selection of clinical treatment options and enhance the efficacy of medications for tic disorder.MethodsDatabases including Medline (Ovid), EMbase (Ovid), The Cochrane Library, PsycINFO (EBSCOhost), CINAHL Plus (EBSCOhost), CNKI, WanFang Data and VIP were searched from inception to August 2020, and original studies on medication adherence in children with tic disorder were included. Two researchers independently screened literature, extracted data on the definition of compliance, compliance rate, and factors affecting compliance, and evaluated risk bias of included studies. Systematic review was performed to analyze the status of medication adherence in children with tic disorder.ResultsA total of 12 studies were included, involving seven randomized controlled trials, two case series studies, and three cross-sectional studies. Most studies failed to specify the definition of compliance. The results of cross-sectional studies showed that the proportion of children with good medication compliance was 29.3% to 47.1%. The first-line treatment drugs, tiapride, risperidone, aripiprazole, and clonidine, had relatively good adherence. Medication adherence was affected by drug factors, patient and family factors, and environmental factors.ConclusionsThe adherence rate of medications for tic disorder varies between studies. Few studies have analyzed the factors that affect medication adherence for tic disorder, and some influencing factors are controversial. The first-line treatment drugs, tiapride, risperidone, aripiprazole, and clonidine, have high medication adherence and are recommended for clinical use.
Objective To assess the global situation of off-label drug use in outpatient children.Methods A search was conducted in PubMed, EMbase, CBM, CNKI and VIP for collecting studies on off-label drug use in outpatient children aged 0 to 18 years, and the publication language was limited to English and Chinese. The quality assessment was based on Crombie Criteria for cross-sectional studies, and the descriptive analysis was performed to analyze the incidence of off-label drug use at all levels of medical institutes and different age groups, the common types of off-label used drugs, and the constitution ratio of off-label use drugs. Results A total of 20 cross-sectional studies were included, involving 1 933 760 children and 5 262 573 prescriptions. The results of descriptive analysis showed: a) The incidence of off-label drug use in outpatient children in primary care and tertiary care institutes were 19.5% (IQR 13.5%, 24.5%) and 26.0% (IQR 24.0%, 35.0%), respectively; b) The primary studies reported that neonate, infant and adolescent had the highest incidence of off-label drug use, while the other children had the lowest incidence; c) Drugs for respiratory system, anti-infection, sensory organs, and dermatosis were listed as the top 5 frequently used off-label drugs by more than half of the studies; d) The studies with issue of “lack of instruction for children” showed it was exactly the type with highest incidence of off-label use, while other studies without that issue showed the highest incidence was over aged off-label use. Conclusion a) Off-label drug use is common in outpatient children. The incidence of off-label drug use may be higher in tertiary care institutes than primary care institutes, and it is higher in neonate, infant and adolescent rather than other age groups of children; b) Incidence of off-label use may be higher in inpatient children than outpatient ones; c) Drugs for respiratory system, anti-infection, sensory organs, and dermatosis were most common types of off-label use; and d) Off-label use due to both “lack of instruction for children” and “over aged use” is more common. So it suggests that further studies trials should focus on fields in which clinical trials of drugs are totally absent.
ObjectiveTo systematically review the methodological quality of guidelines concerning attention-deficit/hyperactivity disorder (ADHD) in children and adolescents, and to compare differences and similarities of the drugs recommended, in order to provide guidance for clinical practice. MethodsGuidelines concerning ADHD were electronically retrieved in PubMed, EMbase, VIP, WanFang Data, CNKI, NGC (National Guideline Clearinghouse), GIN (Guidelines International Network), NICE (National Institute for Health and Clinical Excellence) from inception to December 2013. The methodological quality of included guidelines were evaluated according to the AGREE Ⅱ instrument, and the differences between recommendations were compared. ResultsA total of 9 guidelines concerning ADHD in children and adolescents were included, with development time ranging from 2004 to 2012. Among 9 guidelines, 4 were made by the USA, 3 in Europe and 2 by UK. The levels of recommendations were Level A for 2 guidelines, and Level B for 7 guidelines. The scores of guidelines according to the domains of AGREE Ⅱ decreased from "clarity of presentations", "scope and purpose", "participants", "applicability", "rigour of development" and "editorial independence". Three evidence-based guidelines scored the top three in the domain of "rigour of development". There were slightly differences in the recommendations of different guidelines. ConclusionThe overall methodological quality of ADHD guidelines is suboptimal in different countries or regions. The 6 domains involving 23 items in AGREE Ⅱ vary with scores, while the scores of evidence-base guidelines are higher than those of non-evidence-based guidelines. The guidelines on ADHD in children and adolescents should be improved in "rigour of development" and "applicability" in future. Conflicts of interest should be addressed. And the guidelines are recommended to be developed on the basis of methods of evidence-based medicine, and best evidence is recommended.
Objective To systematically review the diseases constitution of children in Chinese medical institutions from 2010 to 2016, and to provide evidence for establishing essential medicine list for children (EMLc) of China. Methods We searched PubMed, EMbase, The Cochrane Library, CBM, CNKI, VIP and WanFang Data from January 2010 to February 2016 to collect studies about diseases constitution of Chinese children. Two reviewers independently screened literature, extracted data, and assessed the risk bias of included studies, then data was descriptively analyzed. Results A total of 33 studies of diseases constitution were included, involving 1 797 696 children among 0 to 18 years from 17 provinces of China. Neonatal hyperbilirubinemia, neonatal pneumonia and premature were the main diseases of inpatient newborns. The main diseases of children hospitalized were pneumonia, upper respiratory tract infection and tumor. Upper respiratory tract infection, bronchopneumonia, bronchitis and diarrhea were the main diseases of outpatients. Hyperspasmia, upper respiratory tract infection and pneumonia were the main diseases of emergency patients. Diseases constitution of different medical institution: the main diseases were pathological jaundice, neonatal asphyxia and neonatal pneumonia in both tertiary and secondary medical institution in the newborn group. In the children group, the main diseases were pneumonia, upper respiratory tract infection and bronchitis in both tertiary and secondary medical institution. Besides these diseases, indigestion and fever of unknown origin were also the main diseases of primary medical institution. Disease constitution of different areas: in the newborn group, pathological jaundice, neonatal pneumonia and neonatal hyperbilirubinemia were the main diseases in coastal areas. Neonatal pneumonia, neonatal hyperbilirubinemia and premature were the main diseases in inland areas. Neonatal hyperbilirubinemia, neonatal pneumonia and neonatal hypoxic-ischemic encephalopathy were the main diseases in remote areas. In children group, pneumonia, bronchitis and premature were the main diseases in coastal areas. Pneumonia, bronchitis and hand-foot-and-mouth disease were the main diseases in inland areas. Upper respiratory tract infection, bronchopneumonia and bronchitis were the main diseases in remote areas. Conclusion Diseases constitutions of children vary in different medical institution, and because of extreme lack of date from primary medical institution, we suggest to carry out investigation in primary medical institution to provide evidence for EMLc. Diseases constitutions of children vary in different area, additions should be made according to local conditions when essential drugs of children selected. Newborn, as a special group of children, should be considered separately when EMLc of China established.
Objective To study the medication usage in children with crush syndrome in Wenchuan Earthquake. Methods The information of the medications of 7 children with crush syndrome in West China Second University Hospital, Sichuan University was collected by medical history. The cases and times of medication, the total number of drugs, the drug cost per capita and the drug cost per day were calculated by Excel. Results A total of 113 drugs in 19 categories were appl ied to 7 children with crush syndrome. Most children used Vitamins and antibacterial agents. The cost of gamma globul in injection was the highest. Conclusions The rational ity valuation for children medication lacks international vulgate index and needs more basic research.