借鉴系统可靠性工程理论,利用GO-FLOW法(关键流程的安全评价法)对冷藏加工食品的冷链物流系统进行安全性分析和风险评价,以某乳品企业的物流系统为例,针对其物流过程,建立乳制品物流系统的GO-FLOW图,并分析其信号流、操作符和运算规则,...借鉴系统可靠性工程理论,利用GO-FLOW法(关键流程的安全评价法)对冷藏加工食品的冷链物流系统进行安全性分析和风险评价,以某乳品企业的物流系统为例,针对其物流过程,建立乳制品物流系统的GO-FLOW图,并分析其信号流、操作符和运算规则,通过GO运算求出各信号流的可靠性,找出影响物流安全的关键环节,然后用故障树分析法(Fault Tree Analysis,即FTA法)对物流关键环节进行定性分析,并针对该环节提出解决方法,最后指出GO-FLOW与FTA相结合的方法是可用来评价物流安全性的有效方法。展开更多
目前普通系统评价/Meta分析都被要求遵循PRISMA(Preferred Reporting Items for Systematic Reviews and Meta-Analyses)进行规范报告。PRISMA harms清单是PRISMA报告规范的衍生版,其主要针对安全性系统评价如何进行报告提出条件要求。P...目前普通系统评价/Meta分析都被要求遵循PRISMA(Preferred Reporting Items for Systematic Reviews and Meta-Analyses)进行规范报告。PRISMA harms清单是PRISMA报告规范的衍生版,其主要针对安全性系统评价如何进行报告提出条件要求。PRISMA harms清单包括标题、摘要、前言、方法、结果、讨论和资助等需要报告的27个条目内容。该规范包括了清单、详尽的解释性文本以方便使用。通过应用PRISMA harms清单,作者、期刊编辑和同行评议者可促进安全性系统评价报告的质量。展开更多
Based on the basic content of advanced technology,safety and reliability, and economic reasonability and the definition of mine ventilation system, 16 assessment indexes of ventilation system are put forward from the ...Based on the basic content of advanced technology,safety and reliability, and economic reasonability and the definition of mine ventilation system, 16 assessment indexes of ventilation system are put forward from the point of 8 aspects such as mine ventilation power, ventilation network, ventilation equipments, ventilation quality, ventilation monitoring, capacity of preventing and fighting disaster, ventilation consumption of power, and the capacity of ventila- tion system. A new assessment index system is put forward and has a good effect after being applied in coal mines.展开更多
A mine ventilation system has a deterministic function for the safety of coal production and for the control of mine accidents. So, it has an important meaning to evaluate the security of a mine ventilation system. Th...A mine ventilation system has a deterministic function for the safety of coal production and for the control of mine accidents. So, it has an important meaning to evaluate the security of a mine ventilation system. This paper studied the evaluation index system of the security of a mine ventilation system, and the security of a mine ventilation system was described quantitatively in the safety degree. Finally, an example of the security evaluation was given.展开更多
As a novel heart rate lowing agent, ivabradine can reduce the heart rate by inhibiting the If (pacemaker) current in the sinoatrial node without affecting blood pressure or left ventricular systolic function. Howeve...As a novel heart rate lowing agent, ivabradine can reduce the heart rate by inhibiting the If (pacemaker) current in the sinoatrial node without affecting blood pressure or left ventricular systolic function. However, the safety of ivabradine remains controversial. In the present work, we aimed to assess any risk of cardiovascular mortality, bradycardia, phosphenes and atrial fibrillation associated with the ivabradine administration by recta-analysis. Studies were retrieved from PubMed, EMBASE, MEDLINE, Web of Science, Cochrane, www.clinicaltrials.gov web site and related conferences. Randomized controlled trials comparing ivabradine with comparators were identified and analyzed. Two reviewers independently extracted relevant information from the eligible trials and processed the data. This recta-analysis was performed by using Review Manager (5.3) and Stata (14.1) software. Moreover, sensitivity analysis and publication bias of the included studies were evaluated. A total of 12 randomized controlled trials meeting the inclusion criteria were included. Results of the meta-analysis revealed that there was no significant difference between ivabradine group and control groups in cardiovascular mortality (RR = 0.97, 95% CI: 0.89-1.06, P = 0.49). While the administration of ivabradine was associated with a significant increase in the incidence of bradycardia (RR = 3.90, 95% CI: 2.47-6.17, P〈0.00001) and phosphenes (RR = 4.95, 95% CI: 3.24-7.55, P〈0.00001) as well as atrial fibrillation (RR = 1.24, 95% CI: 1.07-1.43, P = 0.003). High quality of the included studies was confirmed by quality assessment. No publication bias was observed, and sensitivity analysis confirmed that the obtained results were stable. In conclusion, the meta-analysis proved that the use of ivabradine was associated with a significant increase in the risk of bradycardia, phosphenes and atrial fibrillation. Therefore, clinicians need to take these risks into account when using ivabradine in treatment.展开更多
OBJECTIVE: To systematically research the postmarketing safety of Dengfeng shenmai injection, identify potential risk factors, and ensure its clinical safety. METHODS: We investigated a comprehensive series of studies...OBJECTIVE: To systematically research the postmarketing safety of Dengfeng shenmai injection, identify potential risk factors, and ensure its clinical safety. METHODS: We investigated a comprehensive series of studies on the production process, quality standards, pharmacology, postmarketing clinical studies, and safety evaluation of Shenmai injection, including literature analysis of adverse drug reaction(ADR) case analysis and systematic review. Data from the hospital information system(HIS) and spontaneous reporting system(SRS) were also analyzed. RESULTS: The approximate dosage leading to death in dogs is 45.0-67.5 g raw drug/kg and the toxic reactions are restlessness, skin irritation, salivation, and vomiting. The results of chronic toxicity tests in mice and dogs, and the other tests such as 6-month toxicity, drug safety, genetic toxicity, and reproductive toxicity of rats and dogs, were positive or qualified. Patient ADR history and ADR family history were closely associated with itching based on the data analysis from SRS. There was no damage to renal function from Shenmai injection use at a dosage and a treatment course outside the recommended dosage and treatment course as specified based on data analysis from HIS. The most common ADR from Shenmai injection are difficulty breathing, facial flushing, nausea, vomiting, chest tightness, skin itching, rash, and back pain. CONCLUSION: This study includes complete information on Shenmai injection ADR incidence rate. We found that Shenmai injection is safe and this study can provide clinical, research, and production institutions with an objective, reliable, and scientific basis for use of Shenmai injection.展开更多
OBJECTIVE:To systematically review the efficacy and safety ofTraditional Chinese Medicine(TCM)interventions,compared with control interventions(placebo or conventional Western medical therapy),in the treatment of acqu...OBJECTIVE:To systematically review the efficacy and safety ofTraditional Chinese Medicine(TCM)interventions,compared with control interventions(placebo or conventional Western medical therapy),in the treatment of acquired immunodeficiency syndrome(AIDS).METHODS:Electronic databases including PubMed,the Cochrane Library,China National Knowledge Infrastructure(CNKI),and Wanfang Data were searched to identify relevant randomized controlled trials(RCTs)published as of May 2012.Studies were selected according to the specified inclusion and exclusion criteria and then subjected to methodological quality assessment,data extraction,and meta-analysis according to the Cochrane Handbook for Systematic Reviews of Interventions.RESULTS:Twelve RCTs involving 881 patients with AIDS were included.Methodological quality assessment showed that two were high-quality,two were moderate-quality,and eight were low-quality.Meta-analysis showed that TCM interventions were associated with significantly reduced plasma viral load compared with placebo[odds ratio OR=2.46,95%confidence interval CI(1.02,5.94);P=0.04].However,the reductions in plasma viral load significantly favored conventional Western medical therapy alone over integrated traditional Chinese and Western medical therapy[OR=0.16,95%CI(0.05,0.55);P=0.004].Patients receiving TCM interventions had significantly higher CD4+T lymphocyte counts compared with those on placebo[OR=2.54,95%CI(1.40,4.60);P=0.002].In addition,TCM interventions were significantly more likely to have improved clinical symptoms[OR=2.82,95%CI(1.85,4.31);P<0.00001].TCM interventions conferred a similar risk of adverse events(AEs)compared with control interventions[OR=1.87,95%CI(0.58,6.01);P=0.29].CONCLUSION:Current evidence suggests that TCM interventions are significantly more effective than placebo in reducing plasma viral load and increasing CD4+T lymphocyte count in patients with AIDS.When compared with conventional Western medical therapy,TCM interventions were significantly less effective in reducing plasma viral load,although they were associated with a higher percentage of patients with improved symptoms.Patients receiving TCM interventions did not seem to be at an increased risk of AEs.展开更多
文摘借鉴系统可靠性工程理论,利用GO-FLOW法(关键流程的安全评价法)对冷藏加工食品的冷链物流系统进行安全性分析和风险评价,以某乳品企业的物流系统为例,针对其物流过程,建立乳制品物流系统的GO-FLOW图,并分析其信号流、操作符和运算规则,通过GO运算求出各信号流的可靠性,找出影响物流安全的关键环节,然后用故障树分析法(Fault Tree Analysis,即FTA法)对物流关键环节进行定性分析,并针对该环节提出解决方法,最后指出GO-FLOW与FTA相结合的方法是可用来评价物流安全性的有效方法。
基金Project 0424220161 supported by Science and Technology Foundation of Education Bureau of Henan Province
文摘Based on the basic content of advanced technology,safety and reliability, and economic reasonability and the definition of mine ventilation system, 16 assessment indexes of ventilation system are put forward from the point of 8 aspects such as mine ventilation power, ventilation network, ventilation equipments, ventilation quality, ventilation monitoring, capacity of preventing and fighting disaster, ventilation consumption of power, and the capacity of ventila- tion system. A new assessment index system is put forward and has a good effect after being applied in coal mines.
文摘A mine ventilation system has a deterministic function for the safety of coal production and for the control of mine accidents. So, it has an important meaning to evaluate the security of a mine ventilation system. This paper studied the evaluation index system of the security of a mine ventilation system, and the security of a mine ventilation system was described quantitatively in the safety degree. Finally, an example of the security evaluation was given.
文摘As a novel heart rate lowing agent, ivabradine can reduce the heart rate by inhibiting the If (pacemaker) current in the sinoatrial node without affecting blood pressure or left ventricular systolic function. However, the safety of ivabradine remains controversial. In the present work, we aimed to assess any risk of cardiovascular mortality, bradycardia, phosphenes and atrial fibrillation associated with the ivabradine administration by recta-analysis. Studies were retrieved from PubMed, EMBASE, MEDLINE, Web of Science, Cochrane, www.clinicaltrials.gov web site and related conferences. Randomized controlled trials comparing ivabradine with comparators were identified and analyzed. Two reviewers independently extracted relevant information from the eligible trials and processed the data. This recta-analysis was performed by using Review Manager (5.3) and Stata (14.1) software. Moreover, sensitivity analysis and publication bias of the included studies were evaluated. A total of 12 randomized controlled trials meeting the inclusion criteria were included. Results of the meta-analysis revealed that there was no significant difference between ivabradine group and control groups in cardiovascular mortality (RR = 0.97, 95% CI: 0.89-1.06, P = 0.49). While the administration of ivabradine was associated with a significant increase in the incidence of bradycardia (RR = 3.90, 95% CI: 2.47-6.17, P〈0.00001) and phosphenes (RR = 4.95, 95% CI: 3.24-7.55, P〈0.00001) as well as atrial fibrillation (RR = 1.24, 95% CI: 1.07-1.43, P = 0.003). High quality of the included studies was confirmed by quality assessment. No publication bias was observed, and sensitivity analysis confirmed that the obtained results were stable. In conclusion, the meta-analysis proved that the use of ivabradine was associated with a significant increase in the risk of bradycardia, phosphenes and atrial fibrillation. Therefore, clinicians need to take these risks into account when using ivabradine in treatment.
基金Supported by National Science and Technology Major Projects for "Major New Drugs Innovation and Development":Study on Key Technologies of Postmarketing Evaluation for Chinese Medicine(No.2009ZX09502-030)
文摘OBJECTIVE: To systematically research the postmarketing safety of Dengfeng shenmai injection, identify potential risk factors, and ensure its clinical safety. METHODS: We investigated a comprehensive series of studies on the production process, quality standards, pharmacology, postmarketing clinical studies, and safety evaluation of Shenmai injection, including literature analysis of adverse drug reaction(ADR) case analysis and systematic review. Data from the hospital information system(HIS) and spontaneous reporting system(SRS) were also analyzed. RESULTS: The approximate dosage leading to death in dogs is 45.0-67.5 g raw drug/kg and the toxic reactions are restlessness, skin irritation, salivation, and vomiting. The results of chronic toxicity tests in mice and dogs, and the other tests such as 6-month toxicity, drug safety, genetic toxicity, and reproductive toxicity of rats and dogs, were positive or qualified. Patient ADR history and ADR family history were closely associated with itching based on the data analysis from SRS. There was no damage to renal function from Shenmai injection use at a dosage and a treatment course outside the recommended dosage and treatment course as specified based on data analysis from HIS. The most common ADR from Shenmai injection are difficulty breathing, facial flushing, nausea, vomiting, chest tightness, skin itching, rash, and back pain. CONCLUSION: This study includes complete information on Shenmai injection ADR incidence rate. We found that Shenmai injection is safe and this study can provide clinical, research, and production institutions with an objective, reliable, and scientific basis for use of Shenmai injection.
基金Supported by International Cooperation Project,the Ministry of Science and Technology of the People's Republic of China(S2013ZR0063)Guangxi Key Technologies R&D Program(No.1298003-1-1,11107009-1-3)+2 种基金Guangxi Natural Science Foundation(No.0832016Z)China Postdoctoral Science Foundation(Post Doctor of China Central South Uni-versity 2013M531816)Guangxi Administration of Traditional Chinese Medicine(GZKZ-G1105,GZKZ10-054,2012032)
文摘OBJECTIVE:To systematically review the efficacy and safety ofTraditional Chinese Medicine(TCM)interventions,compared with control interventions(placebo or conventional Western medical therapy),in the treatment of acquired immunodeficiency syndrome(AIDS).METHODS:Electronic databases including PubMed,the Cochrane Library,China National Knowledge Infrastructure(CNKI),and Wanfang Data were searched to identify relevant randomized controlled trials(RCTs)published as of May 2012.Studies were selected according to the specified inclusion and exclusion criteria and then subjected to methodological quality assessment,data extraction,and meta-analysis according to the Cochrane Handbook for Systematic Reviews of Interventions.RESULTS:Twelve RCTs involving 881 patients with AIDS were included.Methodological quality assessment showed that two were high-quality,two were moderate-quality,and eight were low-quality.Meta-analysis showed that TCM interventions were associated with significantly reduced plasma viral load compared with placebo[odds ratio OR=2.46,95%confidence interval CI(1.02,5.94);P=0.04].However,the reductions in plasma viral load significantly favored conventional Western medical therapy alone over integrated traditional Chinese and Western medical therapy[OR=0.16,95%CI(0.05,0.55);P=0.004].Patients receiving TCM interventions had significantly higher CD4+T lymphocyte counts compared with those on placebo[OR=2.54,95%CI(1.40,4.60);P=0.002].In addition,TCM interventions were significantly more likely to have improved clinical symptoms[OR=2.82,95%CI(1.85,4.31);P<0.00001].TCM interventions conferred a similar risk of adverse events(AEs)compared with control interventions[OR=1.87,95%CI(0.58,6.01);P=0.29].CONCLUSION:Current evidence suggests that TCM interventions are significantly more effective than placebo in reducing plasma viral load and increasing CD4+T lymphocyte count in patients with AIDS.When compared with conventional Western medical therapy,TCM interventions were significantly less effective in reducing plasma viral load,although they were associated with a higher percentage of patients with improved symptoms.Patients receiving TCM interventions did not seem to be at an increased risk of AEs.