Objective To make an individualized administration scheme via evidence-based medicine methods, namely adding heparin into the total nutrient admixture (TNA) solution, so as to help a neonate to prevent the occlusion of peripherally inserted central catheter (PICC). Methods After carefully assessing the condition of neonate, this clinical issue was put forward in accordance with the PICO principles. Randomized controlled trials (RCTs) and systematic reviews on neonates’ PICC occlusion were collected from The Cochrane Library, CCTR, DARE, NGC, MEDLINE (Ovid) and CBM from inception to 2011. The clinical intervention scheme was finally made after the assessment of the retrieved evidence and neonate’s physiological condition. Results A total of 4 RCTs and 1 systematic review related to the issues were identified. The following scheme was finally made for the neonate through the assessment of the retrieved evidence and combination of intentions of the patient’s family members: heparin (0.5 U/mL) was added into TNA to prevent PICC occlusion. During the application, blood routine test and blood coagulation were monitored, and the catheter opening time and extubation reason were recorded. Through the above treatment, the neonate successfully completed the treatment before extubation. The time of both PICC detaining and opening was 20 days in total, and there were no PICC occlusion, no catheter thrombosis, and no catheter related bloodstream infection. Moreover, no observation showed thrombopenia and aggravated coagulation disorders resulted from heparin. Conclusion The evidence-based medicine method is an effective way to make reasonable heparin scheme for neonate, so as to prevent PICC occlusion, reduce catheter thrombosis, decrease risks of catheter related blood circulation infection, assure successful completion of treatment, and guarantee the safety of patients.
Objective Inappropriate drug dosage is a serious problem in pediatrics, mainly due to the lack of clinical evidence in children, suitable preparation formulation, and standardized methods for dose adjustment. A method for evaluating and monitoring appropriate dosage in pediatrics is urgently needed. The drug utilization index (DUI) based on the Anatomical Therapeutic Chemical/Defined Daily Dose (ATC/DDD) has been widely used in the assessment of appropriate dosage in adults. We explored possible methods for assessing appropriate dosage in children. Methods Based on our previous studies, we discuss cDUI in the assessment of appropriate dosage in children as follows: the meaning of cDDD, the establishment of a standardized system, and the classified evaluation of dosage in pediatrics. Results Although the definition of cDDD draws on the concept of defined daily dose (DDD), the meaning of cDDD is different from that of the latter. Specifically, the purpose of cDDD is to evaluate appropriate pediatric dose, while DDD is a unit of measurement. cDDD could be used to assess dose rationality for common and serious pediatric diseases, and would be refined over time. A single cDDD should be assigned per drug and indication and given per drug and route of administration. The influence of age, weight, diagnosis, and administration route on the dosage should be considered. Classified evaluation should be used and weight should be given to the above mentioned factors in order to evaluate the appropriate dose objectively and comprehensively. Conclusion Dosage regulation in pediatrics has an important role in improving medical quality and protecting the safety, effectiveness, and economy of medical therapy in children. The establishment of a cDUI system is a good try in pediatric dosage evaluation. Although there are still defects within this proposed system and methodology, the principle seems feasible.
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 systematically evaluate the structure, publication type and contents of current guidelines for guideline development, so as to provide methodology references for guideline development in China. MethodsSix biomedical research literature databases, six guideline databases and 18 websites of academic institutions and health administrative departments were searched to locate guidelines for guideline development. We included the latest versions of guidelines from guideline development departments or academic institutions. We extracted information consisting of general guideline information, structure, principles, methods and procedure of guideline development. A descriptive analysis was conducted to analyze the general information, structure, principles, methods and procedure of guidelines among different guidelines for guideline development. ResultsAmong all the included 25 guidelines for guideline development published from 1998 to 2014, 50% of them were from North America. Structure of these guidelines were similar while detail levels of recommended guideline development methods and procedures were slightly different. The guideline development groups, systematic literature search, evidence assessment and recommendation formulation were vital part of guideline development. The ineffective promotion and implementation of guidelines for guideline development were common problems of current guidelines. ConclusionsProcedures recommended by current guidelines for guideline development are almost the same, but the methods and statements are different. We could develop our own guideline for guideline development based on the current relative high-quality guideline in order to provide guidance to the clinical guideline development in China.
Objective To provide evidence for the definition, current development and prospect of Evidence-based pharmacy through systematically assessing the extant literatures. Methods We searched CBM, VIP, CNKI, PubMed, EMbase, and Google for supplement. We extracted definitions of evidence-based pharmacy, types of studies, published year, topics of studies, and the author information from the included studies. We compared the definitions on different domains, and assessed the current development of evidence-based pharmacy literature. Results a) The definition of evidence-based pharmacy: We found 4 definitions, and there were great differences among them on the people who practiced evidence-based pharmacy as well as the methods and areas of the practice. b) The evidence-based pharmacy literature: 12 English and 202 Chinese articles were included in the review. The number of Chinese evidence-based pharmacy articles was increasing annually, especially in recent 3 years; Most of their authors were from hospitals, especially from pharmacy department; Their study orientations mostly involved clinical pharmacy and hospital pharmacy; The topics mainly refered to the practice and development of clinical pharmacy, rational drug use, and development of hospital pharmacy. Conclusion a) There is yet no consensus on the definition of evidence-based pharmacy. b) Few researchers worldwide know or show interest in evidence-based pharmacy, while, so far, more and more researchers are getting to know evidence-based pharmacy in China. c) Further efforts should be made to develop the theoretical system of evidence-based pharmacy and the pattern of its practice.
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 safety of low molecular weight heparin (LMWH) in pregnancy. MethodsPubMed, EMbase, The Cochrane Library, WanFang Data, VIP, and CNKI databases were electronically searched to collect randomized controlled trials (RCTs) and cohort studies on the safety of LMWH in pregnancy from inception to March 30th, 2020. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Meta-analysis was then performed using RevMan 5.3 software. ResultsA total of 77 RCTs and 13 cohort studies were included. The results of meta-analysis showed that LMWH increased the incidence of postpartum hemorrhage (RR=1.50, 95%CI 1.00 to 2.25, P=0.05). However, there was no significant difference. The incidence of hematological adverse events was different from the results of RCTs and cohort studies. The results of RCT subgroup analysis showed that LMWH increased ecchymosis at the injection site (RR=1.60, 95%CI 1.24 to 2.08, P=0.000 4). However, the incidence of overall skin system adverse events did not increase significantly. LMWH reduced the incidence of cardiovascular adverse events (RR=0.18, 95%CI 0.07 to 0.46, P=0.000 3). LMWH failed to increase the occurrence of fetal congenital malformations, digestive system, central nervous system, skeletal system, and systemic adverse events. ConclusionsCurrent evidence suggests that LMWH is relatively safe to use during pregnancy. However, whether it increases postpartum hemorrhage and hematological adverse events is unclear. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify the above conclusions.
ObjectiveTo evaluate the developing methodologies of Essential Medicines Lists for Children (EMLcs) in global, in order to provide reference in developing EMLc of China. MethodsWe searched ProQuest, ScienceDirect, SpringerLink and MEDLINE databases, World Health Organization (WHO) official website, and 67 websites of National Ministry of Health and Drug Administration Section, to collect literature about selection methodology of children and/or adult essential medicines list (EML). A descriptive analysis was conducted. ResultsA total of fourteen literatures were included. Of which, 6 were about the essential medicines selection methodology in children, and the other 8 were about the essential medicines selection methodology in adult. The WHO had established independent EMLc selection committee. Paediatricians were involved in the selection of EMLc in the WHO and India. There was no selection criteria and process for EMLc globally. The WHO, India, and South Africa selected their EMLcs referring to the WHO EML selection criteria. The WHO and South Africa had their own updating time, period and process for EMLc. The WHO EMLc was updated per 2 years, which in high frequency and conducts in rigorous process. However, the EMLc of India had not been updated yet. ConclusionIt is suggested that China could build a national EMLc selection committee involving paediatricians and evidence-based medicine experts etc. in referring to the framework of the WHO Child Health Working Group. The EMLc selection criteria and process of China could be established referring to the one of the WHO, based on the disease burden, drug accessibility and medical insurance of children of China. The EMLc of China should be simultaneously updated with the adult EML of China.
ObjectiveComparing the worldwide Essential Medicines Lists for Children (EMLcs) and National Essential Medicine List (NEML) of China (2012 edition), to provide evidence for establishing EMLc of China. MethodWe searched the official websites of WHO and Ministry of Health of some countries to identify published EMLcs. We compared the situation of updating, the number and classification of medicines, and the dosage forms between these EMLcs and NEML of China (2012). ResultBy August 2013, the WHO, India and South Africa had established EMLc. The number of medicines of NEML of China (2012) ranked first in the four lists. The WHO, India and China classified the medicines by pharmacologic action, while South Africa classified it by anatomical therapeutic chemical (ATC) classification. Except the WHO, India, South Africa and China did not have specific medicines for neonatal care or medicines for diseases of joints. The main administration routes in these four lists were oral administration, injection, and topical application. There were medicine restrictions in EMLcs of WHO and India, while no medicine restrictions in lists of South Africa and China. ConclusionMedicines listed in NEML of China (2012) do not match children's disease burden of China. The applicable dosage forms for children are few and the medicine restrictions are absent for the list. So this list is not suitable for Children.