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.
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.
ObjectiveThis study aims to compare different references for the fetal risk of drugs used in pregnancy to provide evidence for the safety of drug use in pregnancy.MethodsFour drug databases, including Lexicomp, Micromedex, TERIS, and Reprotox, as well as two books of drugs in pregnancy edited by Briggs and Schaefer, were searched. Descriptive analysis was performed regarding the definition of pregnancy recommendations and the specific content of medication.ResultsThe six references employed slightly different approaches to drugs in pregnancy, however, all of them included summaries of the risk in pregnancy, data of crossing the placenta, and human and animal data. The databases of Micromedex, TERIS, and a book edited by Briggs had their risk classification systems for drug use during pregnancy. For specific drugs, the summary of different information in pregnancy was different, the amount and content of listed evidence varied, and there was no evaluation of the quality and relevance of evidence among the references.ConclusionsThere is no consensus on the risk assessment of drugs in pregnancy. Risk classification systems for drugs in pregnancy are still an important method for determining the fetal risk of drugs. The existing references merely list studies of drugs in pregnancy, without comprehensive quality assessment. A methodological study of assessment of the risk of drugs in pregnancy is required.
ObjectivesTo evaluate the level and variation of Chinese scholars' scientific research capability in the world by analysing the status of literature published on top-five global biomedicine journals by Chinese scholars in the past 10 years.MethodsLiterature published on NEJM, JAMA, BMJ, Lancet and PLoS Medicine from 2007 to 2016 were searched in PubMed database. Types of diseases were classified by using International Classification of Diseases (version 10) (ICD-10). Quantitatively analysis were used to classify the different authors, institutes, studies designs, quality of publication and variation.ResultsLiterature (56.4%) published on Lancet had the largest quantity among the top-five journals. Infectious and parasitic diseases, circulation system diseases, cancers, endocrine, nutrition and metabolic diseases and neuropsychiatric diseases were the top-five in disease categories list, accounting for 38.4%. In different study design, reviews (non-experimental research) and randomized controlled trials were the first and the second study types, separately.ConclusionsFor productivity of Chinese scholars’ diseases publications on top-five medical journals, the top-five specific diseases are from the top-five disease categories-infectious and parasitic diseases, circulation system diseases, cancer, endocrine, nutrition and metabolic diseases and neuropsychiatric diseases. The main study types are reviews, randomized controlled trials and cross-sectional studies.
ObjectiveTo systematically review the efficacy and safety of deproteinized calf blood extractives (DCBE) for diabetic complications. MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data, CBM and VIP databases were electronically searched to collect studies on the efficacy and safety of DCBE for diabetic complications from inception to July 8th, 2020. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies; then, meta-analysis was performed using RevMan 5.3 software. ResultsA total of 69 studies were included. The results of meta-analysis showed that for diabetic neuropathy, the effect rate of DCBE was superior to control, mecobalamin, vitamin B12, vitamin B1+vitamin B12, and vitamin B2, etc. For diabetic foot, the effect rate of DCBE was superior to control, sensitive antibiotic and compound salvia-miltiorrhiza injection. For diabetic retinopathy, the effect rate of DCBE was superior to control. The incidence of adverse events associated with DCBE was 4.59%. However, there was no significant difference with the control group. ConclusionCurrent evidence shows that DCBE has good efficacy and safety in diabetic neuropathy, diabetic foot, diabetic dry eye, diabetic retinopathy, and other diseases. Due to limited quality and quantity of the included studies, more high quality studies are required to verify the above conclusion.