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This paper analyzed the non-registered clinical research program of ethical review in a third-class hospital from 2008 to 2017, and found that the common problems of the program mainly focused on the imprecise standards of inclusion and exclusion, the lack of basis for determining sample size, the unreasonable setting of observation indicators, the insufficient research background, the lack of necessary basis for topic setting, and the lack of privacy and confidentiality provisions. The reasons were as follows: the lack of ethical awareness of researchers, inadequate ability to design clinical research programs, and insufficient attention to program formulation. It is suggested that clinical researchers should pay more attention to the formulation of the program, and properly handle the relationship between scientific research and ethics while consolidating the foundation of scientific research.
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OBJECTIVE:To evaluate the global existed diarrhea guidelines of children,and provide evidence and methodology reference for clinical practice and the formulation of diarrhea evidence-based guideline of children in China. METHODS:Retrieved from PubMed,Embase,CBM,CNKI,VIP,Wanfang databases and related websites,references included in studies were retrieved additionally from database building to Dec. 2017. The methodological quality of the guideline was evaluated by 2 researchers independently with guideline evaluation toolⅡ(AGREEⅡ). ICC analysis was used to calculate the differences between the evaluation results of 2 researchers and analyze the difference of the guidelines. RESULTS:A total of 1 168 literatures were collected primarily, and 15 guidelines were involved finally,among which 3 guidelines were from USA,2 from British,2 from WHO,each one from Italy,Europe,India,Australia,Malaysia,New South Wales,South Africa and China,respectively. Of 15 guidelines,there were 10 evidence-based guidelines and 5 non-evidence-based guidelines;evidence levels of guidelines and the method of recommendation intensity were different. ICC of 2 researchers were higher than 0.75(P<0.05),indicating good homogeneity among them. The quality of 15 guidelines were not high enough,and the scores of included guidelines in the field of AGREEⅡin descending order were as follows:scope and purpose(84.44%),clarity of presentation(79.82%),stakeholder involvement(45.74%), rigor of development(41.18%), editorial independence (36.39%)and applicability(33.89%). Main prevention and treatment method recommended by guideline included that(1) prevention and treatment of dehydration was the key link in the treatment of children's diarrhea;(2)guidelines generally believed continuous breastfeeding during rehydration could reduce the risk of dehydration in children;(3)zinc preparation was recommended to shorten the course of diarrhea;(4)antibiotics were used rationally, etc. CONCLUSIONS:The quality of global existed diarrhea guidelines of children should be improved. There is no comprehensive diarrhea evidence- based guideline of children in China,and there is a large discrepancy between the situation of pediatric diarrhea therapy in China and WHO standard;it is urgent to establish a standard treatment. It is suggested to formulate high quality pediatric diarrhea guideline in accordance with the national conditions of China,based on standards for international guideline report, comprehensively considering disease burden and characteristics of pediatric diarrhea in China.
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OBJECTIVE: To evaluate evidence-based guidelines of current global pediatric idiopathic thrombocytopenic purpura (ITP) drug therapy, and to provide evidence-based reference for pediatric ITP diagnosis and treatment, the formulation of guideline in China. METHODS: Retrieved from PubMed, Embase, National Guideline Clearinghouse, Guidelines International Network, TRIP medical database, CBM, CJFD, VIP and WANFANG DATA, etc., the evidence-based treatment guideline involving pediatric ITP were included, and methodological quality of the guideline was evaluated by using AGREE Ⅱ tool. The similarities and differences of the guidelines were analyzed and compared. RESULTS: A total of 7 pediatric ITP evidence-based guidelines were included, among which 2 came from US, 2 came from Italy, 2 came from British and another one came from Malaysia. The quality of 7 guidelines were not good, among which 6 guidelines were recommended as grade B and 1 guideline was recommended as grade C; only one GRADE evidence-based guideline was found. The score of included guideline in the field of AGREE Ⅱ was in descending order as scope and purpose, clarity, rigor of development, stakeholder involvement, applicability, editorial independence. The main recommended drugs of these guidelines were: glucocorticoids, intravenous immunoglobulin, anti-D-immunoglobulin, while some guidelines recommend platelet, rituximab and combined medication. CONCLUSIONS: The quality of evidence-based guidelines of ITP for children is in low level and should be improved. There is no evidence-based guideline of ITP for children in China. It is suggested to develop high quality evidence-based guideline for ITP children in China based on AGREE Ⅱ items.
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OBJECTIVE:To provide reference for the proper understanding of the content of"Access to Essential Medicine"resolution proposed by China at the 67th World Health Assembly(WHA),policy making and implication of the resolution in Chi-na. METHODS:Through descriptive analysis,the proposal background,approving process and resolution content of the"Access to Essential Medicines"resolution were introduced;the potential impact and effect of the resolution were analyzed. RESULTS:"Ac-cess to Essential Medicine"included"urging member states"and"requesting director-general",20 items."Urging member states"covered 11 items,including national medicine policy,essential medicine selection,medicine related health systems research,inter-national exchanges and cooperation,children's essential medicine accessibility,essential medicine related education,training and public recognition,obstacle recognition and strategy development,essential medicine management system and monitoring mecha-nism,flexible use of the existing policy."Requesting director-general"covered 9 items and put forward the support WHO needed to realize"urging member states"and effect evaluation after the resolution. CONCLUSIONS:"Access to Essential Medicine"is great significance to maintain human health,especially people's health in developing countries,safeguard the rights and interests of peo-ple's basic drug use and promote rational drug use. The approval of"Access to Essential Medicine"at WHA represents China's in-ternational discourse right on improving the basic medical service among basic population,and highlights China's magnitude of a great nation.
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OBJECTIVE:To review therapeutic efficacy of N-acetylcysteine (NAC) for idiopathic pulmonary fibrosis (IPF),and to provide evidence-based reference.METHODS:Retrieved from Central database,PubMed,EMBase,CBM,CJFD,Wanfang database and VIP,randomized controlled trials or semi-randomized controlled trials about NAC (unlimited single drug or combination) vs.placebo/blank control in the treatment of IPF were collected.Meta-analysis was performed by using Rev Man 5.3 statistical software after data extraction and quality evaluation with Cochrane collaboration's bias risk assessment tool(2014 edition).RESULTS:A total of 10 studies were included(2 RCT,8 qRCT),involving 742 patients.Results of Meta-analysis showed that compared to placebo/blank control,NAC couldn't reduce the mortality of IPF patients [OR=1.14,95％ CI(0.50,2.62),P=0.76],but could significantly improve subjective symptom remission rate[OR=3.17,95％ CI (1.98,5.07),P＜0.001] and dyspnea score [SMD =-2.54,95 ％ CI (-5.02,-0.06),P=0.04].CONCLUSIONS:For IPF,NAC can't decrease the mortality of patients,but can relieve main symptoms and dyspnea.
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OBJECTIVE:To review therapeutic efficacy of N-acetylcysteine (NAC) for idiopathic pulmonary fibrosis (IPF),and to provide evidence-based reference.METHODS:Retrieved from Central database,PubMed,EMBase,CBM,CJFD,Wanfang database and VIP,randomized controlled trials or semi-randomized controlled trials about NAC (unlimited single drug or combination) vs.placebo/blank control in the treatment of IPF were collected.Meta-analysis was performed by using Rev Man 5.3 statistical software after data extraction and quality evaluation with Cochrane collaboration's bias risk assessment tool(2014 edition).RESULTS:A total of 10 studies were included(2 RCT,8 qRCT),involving 742 patients.Results of Meta-analysis showed that compared to placebo/blank control,NAC couldn't reduce the mortality of IPF patients [OR=1.14,95％ CI(0.50,2.62),P=0.76],but could significantly improve subjective symptom remission rate[OR=3.17,95％ CI (1.98,5.07),P＜0.001] and dyspnea score [SMD =-2.54,95 ％ CI (-5.02,-0.06),P=0.04].CONCLUSIONS:For IPF,NAC can't decrease the mortality of patients,but can relieve main symptoms and dyspnea.