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.
Objective To systematically review the association between -589C/T polymorphism in IL-4 gene and the risk of chronic obstructive pulmonary disease (COPD). Method PubMed, EMbase, CNKI and WanFang Data databases were electronically searched to identify case-control studies which investigated the association between IL-4 -589C/T polymorphism and the risk of COPD. The search date was up to February 23th, 2016. Two reviewers independently screened the studies, extracted data and assessed the risk of bias of included studies, and then meta-analysis was performed by using RevMan 5.3 software. Results A total of 8 case-control studies involving 1 400 COPD cases and 1 073 controls were included in meta-analysis. The results showed that: the -589C/T polymorphism in IL-4 gene was not associated with the risk of COPD (TT+TC vs. CC: OR=0.84, 95%CI 0.61 to 1.15, P=0.27; TT vs. CC+TC: OR=0.95, 95%CI 0.72 to 1.25, P=0.69; TT vs. CC: OR=1.14, 95%CI 0.74 to 1.76, P=0.55; TC vs. CC: OR=0.83, 95%CI 0.66 to 1.05, P=0.12; T vs. C: OR=0.91, 95%CI 0.72 to 1.14, P=0.40). Conclusion The IL-4 -589C/T polymorphism is not associated with the risk of COPD.
ObjectiveTo systematically review the association of interleukin-33 (IL-33) expression and coronary heart disease (CHD). MethodsWe searched The Cochrane Library, PubMed, EMbase, CBM, VIP, CNKI and WanFang Data up to June 30th, 2014, to collect case-control studies concerning the association of IL-33 expression with CHD. Two reviewers independently screened literature according the inclusion and exclusion criteria, extracted data and assessed the methodological quality of included studies; and then, meta-analysis was performed using the RevMan 5.2 software. ResultsSix case-control studies were included. The results of meta-analysis showed that:there were no significant differences in the levels of IL-33 between stable angina pectoris or ST-elevation myocardial infarction patients and healthy population (MD=-25.15, 95%CI -51.08 to 0.77, P=0.06; MD=-28.97, 95%CI -62.89 to 4.95, P=0.09). However, there were significant differences in the levels of IL-33 between unstable angina pectoris or non-ST-elevation myocardial infarction patients and healthy population (MD=-24.79, 95%CI -50.00 to 0.42, P=0.05; MD=-14.60, 95%CI -20.09 to -9.12, P<0.000 01). ConclusionIL-33 expression may be associated with unstable angina pectoris and non-ST-elevation myocardial infarction patients.
ObjectiveTo investigate the type, development time, regional distribution, development methods, structure and contents of therapeutic drug monitoring (TDM) guidelines, so as to provide references for the development of TDM guidelines in China. MethodsGuidelines concerning TDM were electronically retrieved in PubMed, Ovid-EMbase, CNKI, VIP, CBM, WanFang Data, NGC (National Guideline Clearinghouse ), GIN (Guidelines International Network), World Health Organization (WHO) guideline database, official websites of governments and societies associated with TDM from inception to October 2015. Two reviewers independently screened literature, extracted data including basic characteristics, formulation methods and text structure, etc.. Then a descriptive analysis was conducted. ResultsA total of 37 guidelines concerning TDM were included, which involved 4 guidelines for management of TDM, 32 for technical practice and 1 for both of them. The results of analysis showed that: for the integrity of reporting items of guidelines, three (75%) management guidelines ranked grade A, but only 1 (3.13%) technical guidelines ranked grade A. The management specifications of TDM included four aspects as follows: standard terminology, the process specification, quality control and personnel qualification. The recommendations to TDM technology of specific drugs included evidence of TDM, standards and procedures, and personnel qualification. ConclusionThere is a rapid but unbalanced development for abroad TDM guidelines. Most of them are TDM technical guidelines. Evidence-based methods are suggested to be used to develop local TDM guidelines, especially for commonly used medicines and technologies without supporting of existed guidelines.
ObjectiveTo investigate the effects of medical simulation (MST) combined with case-based learning (CBL) in training of trainee doctors in emergency department. MethodA total of 120 trainee doctors practicing in the emergency department between March 2008 and December 2014 were randomly divided into two groups:MST combined with CBL group and CBL group, who accepted MST combined with CBL training and merely CBL training, respectively. The training effects were evaluated in terms of theoretical knowledge, practical operation, comprehensive abilities of case analysis and questionnaire survey. The results were compared and analyzed with the t test. The P value less than 0.05 was a significant difference. ResultsTrainee doctors in MST combined with CBL group acquired higher scores in all of the indicators (P<0.05). ConclusionsMST combined with CBL is a feasible method and has a better effect in training of trainee doctors in Emergency Department.
ObjectiveTo systematically review the quality of evidence-based guidelines (EBGs) on medication therapy for neonatal bacterial meningitis, and compare differences and similarities of the drugs recommended, in order to provide references for clinical application. MethodsDatabases such as the TRIP, PubMed, CNKI, VIP, WanFang, CBM, National Guideline Clearinghouse and Guidelines International Network were searched to collect evidence-based guidelines on medication therapy for neonatal bacterial meningitis. Methodological quality of included studies was assessed according to the AGREE Ⅱ instrument, and the differences and similarities among recommendations were compared. ResultsA total of 4 EBGs were included. Among them, one guideline was developed by the America and three guidelines were by the UK. Only one guideline was developed specially for neonates, while the rest were for neonates and children of different ages. According to the AGREE Ⅱ instrument, "scope and purpose", "stakeholder involvement", "rigor of development", "clarity and presentation", "applicability" and "editorial independence" were scored more than 60%. The recommendations of different guidelines were basically the same, only with conflicts in some areas. ConclusionAlthough most guidelines concerning neonatal bacterial meningitis are of high quality, grading levels of evidence and strength of recommendation should be unified.