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The withdrawal of drugs from the market due to serious adverse reactions arising from the risk of cardiac arrhythmia has been a major concern for regulatory authorities in recent years. In 2005, the International Council for the Harmonisation of Registration of Medicinal Products for Human Use (ICH) issued preclinical S7B and clinical E14 guidelines for the evaluation of arrhythmia risk. The former includes in vitro hERG experiments and in vivo animal-based QT studies, while the latter is the TQT study (thorough QT study, TQT study). The high cost and conservative results of TQT studies have led to the introduction of new alternative methods, and the E14 guidelines were revised in 2015 and introduced concentration-QT analysis (C-QTc), based on the PK/PD (pharmacokinetics/pharmacodynamics) concept, by making full use of high-quality double-negative data from the non-clinical phase (double-negative, low risk of hERG tests at high clinical exposure, and low risk of QTc prolongation in vivo QTc study) makes it possible to substitute TQT studies based on specific situations. This article reviews the history of the development of E14 and its latest developments, analyses the specific situations in which C-QT can replace TQT studies through case studies, introduces the preclinical-clinical arrhythmia risk stage assessment system and compares the drug assessment process and decision making under different versions of E14 guidelines, with a view to providing a reference for the arrhythmia risk assessment system in China.
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Objective:To explore the influencing factors of massive blood transfusion during liver transplantation and establish a prediction model for massive blood transfusion.Methods:Clinical data were analyzed retrospectively for 103 patients undergoing liver transplantation performed by the same surgical team of our hospital in 2018 from Department of Blood Transfusion Affiliated Drum Tower Hospital Nanjing University Medical School. According to the intraoperative volume of red blood cells, they were divided into two groups of massive transfusion (≥12U, n=40) and non-massive transfusion (<12U, n=63). General patient data and preoperative laboratory parameters were compared between two groups. Logistic regression analysis was utilized for constructing a prediction model for massive transfusion during liver transplantation. Results:No significant inter-group difference existed in gender, age or blood group ( P>0.05) while preoperative diagnosis, hemoglobin (Hb), hematocrit (HCT), platelet count (PLT), international normalized ratio (INR), prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), total bilirubin (TBIL), direct bilirubin (DBIL) and end-stage liver disease (MELD) score were correlated with intraoperative massive blood transfusion ( P<0.05). By Logistic regression analysis, the predictive model of massive blood transfusion in liver transplantation was Y = 3.545-0.112 × HCT-0.009 ×P LT + 0.005×DBIL. The area under ROC curve was 0.813 and the sensitivity and specificity 80.0% and 71.4% respectively. Youden's index of 0.514 indicated that if Y value was greater than or equal to 0.514, massive blood transfusion might occur. Conclusions:Preoperative HCT, PLT and DBIL may be employed as independent predictors of intraoperative massive transfusion during liver transplantation. The prognostic model has demonstrated an excellent sensitivity and specificity.
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Objective:To investigate the correlation between mental health and symptom distress in breast cancer patients.Methods:The clinical data of 110 female breast cancer patients at Shanxi Bethune Hospital from June 2017 to March 2018 were collected. The patients were assessed for symptomatic distress with depression self-rating scale (SDS). Functional assessment of cancer therapy-breast (FACT-B) and the functional assessment of chronic illness therapy-spiritual well-being (FACIT-SP) were used to make the mental assessment. Multiple linear regression analysis was used to analyze the effect of symptom distress on the mental health of the patients.Results:The scores of symptom distress, mental health, FACT-B and FACIT-SP were (19.94±5.78), (50.68±10.64), (16.85±4.75), (33.83±8.33), respectively. Multivariate analysis showed that mental health score of the patients with symptom distress > 18 scores was reduced by 5.15 points ( P=0.01) compared with the patients with symptom distress≤18 scores. Compared with the patients with annual household income < 50 000 yuan, the mental health score of patients with annual household income of 50 000-79 000 yuan was increased by 9.46 points ( P < 0.01), and the mental health score of patients with annual family income ≥ 80 000 yuan was increased by 5.92 points ( P < 0.01); compared with the patients in phase I, the mental health score of the patients in phaseⅡwas decreased by 2.62 points ( P=0.02), and the mental health score of the patients in phase Ⅲ was decreased by 4.98 points ( P < 0.01). Conclusions:Symptom distress is an independent risk factor for affecting mental health of breast cancer patients. Solving symptom distress of patients can improve mental health status of the patients.
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Objective:Differentially expressed circ_Dock6 was screened in vivo by applying circRNA high-throughput sequencing technology in lung tissue of newborn rats suffering from acute respiratory distress syndrome (ARDS). The corresponding target genes of microRNAs were predicted by bioinformatics, and their biological processes and signal pathways were analyzed as well. Methods:Real-time quantitative PCR was utilized to detect the expression of circ_Dock6 in the lung tissue of newborn rats in ARDS group (12 cases) and normal control group (12 cases). TargetScan, RNAhybrid and miRanda databases were adopted to predict the possible recruitment of miRNAs and their corresponding target genes by circ_Dock6.Functional enrichment analysis and signal pathway enrichment analysis were carried out on the target genes of each miRNA.Results:The expression of circ_Dock6 (0.44±0.29) in the lung tissue of ARDS group was significantly down-regulated ( t=2.060, P<0.05) compared with normal control group(1.63±1.33). The target gene intersections of miRNAs (miR-24-3p, miR-667-3p, miR-711, miR-203b-5p, miR-5132-5p, etc.) may be recruited by circ_Dock6 and were obtained from three databases.Its target gene aggregation function was enriched in various biological processes, including protein metabolism, protein amino acid phosphorylation, DNA-dependent transcriptional regulation, biological regulation, tissue and organ development, cell differentiation, signal regulation, gene expression, response to stimuli, almost all cellular components such as intracellular, organelle, cytoplasm, and nucleus, as well as molecular functions such as transferase activity, transcription factor activity, and phosphotransferase activity.The involved signaling pathways, including enrichment in mitogen-activated protein kinase(MAPK) signaling pathway, phosphatidylinositol-3-kinase-protein kinase B(PI3K-Akt)signaling pathway, and mammalian rapamycin target protein(mTOR)signaling pathway, were closely related to ARDS.Circ_Dock6 may play a significant role in the pathogenesis of ARDS. Conclusions:Circ_Dock6 may be closely correlated with the pathogenesis of neonatal ARDS.Through bioinformatics analysis, the prediction of its target genes and related signaling pathways laid the foundation for further explorations of its mechanism of action.
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Objective To study the application effect of systematic emergency nursing process in treatment of neonatal hypoxic ischemic encephalopathy (HIE). Methods One hundred and four neonates with HIE who were treated in the First Hospital of Hebei Medical University from January 2016 to January 2018 were selected as the subjects of this study, and they were divided into a control group and a study group according to different nursing care process, with 52 cases in each group. The infants in the control group were resuscitated according to conventional traditional first aid measures, while the infants in the study group received systematic emergency nursing care process on the basis of routine first aid (including the preparation of early rescue drugs and equipment; warmth kept in the whole course, the room temperature controlled in 30 - 32 ℃; rapid assessment of maternal delivery methods and procedures, delivery of the newborn and assessment of babies general conditions; performance of preliminary resuscitation for neonate, tracheal intubation for mechanical ventilation, and external chest compression if necessary; close monitor of the vital signs of newborn; symptomatic treatment; reassessment of the baby's disease condition). The successful rescue rate, total rescue time, hospitalization time, neonatal Apgar score and quality of nursing care before and after resuscitation were compared between the two groups. Results The successful rescue rate of the study group was higher than that of the control group [96.2% (50/52) vs. 82.7% (43/52), P < 0.05], and the total rescue time (minutes: 8.9±2.1 vs. 12.4±3.2) and hospitalization time (days: 8.1±2.2 vs. 11.4±2.9) in study group were shorter than those in control group, all the differences being statistically significant (all P < 0.05). After resuscitation for 5 minutes, the Apgar scores of the newborns in the two groups were higher than those before the resuscitation (study group: 8.3±1.1 vs. 2.2±0.7, control group: 6.7±2.0 vs. 2.1±0.9), and after resuscitation for 5 minutes, the Apgar score of the study group was higher than that of the control group (8.3±1.1 vs. 6.7±2.0), the difference being statistical significant (P < 0.05). The scores of rescue technique (5.0±2.9 vs. 2.7±0.6), humanistic care (5.6±2.1 vs. 2.8±0.9), rescue efficiency (5.3±1.2 vs. 3.0±0.6), and rescue effect (5.7±1.3 vs. 2.9±0.8) in the study group were all higher than those in the control group (all P < 0.05). Conclusion The systematic emergency nursing care process can effectively elevate the successful rescue rate of neonates with HIE, shorten the total rescue time and hospitalization time, enhance the rescue effect, and improve the quality of nursing care, thus it is worthy to be widely applied clinically.
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Objective To analyze the predictive value of serum interleukin-27 (IL-27) for acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT) from unrelated donors. Methods Serum samples were collected from 72 patients after receiving allo-HSCT from unrelated donors during January to December 2012. Serum samples collected from 70 patients received allo-HSCT in 2013 were used for confirmation. All patients received myeloablative conditioning regimen prior to allo-HSCT. Cyclosporin A (CsA)+mycophenolate mofetil (MMF)+short-term methotrexate (MTX) were used for GVHD prophylaxis. Serum IL-27 levels in patients with aGVHD were measured by ELISA. The pre-dictive value of IL-27 index,defined as the ratio of serum IL-27 level at neutrophil engraftment to that before pre-conditioning regimen, for allogeneic HSCT was retrospectively analyzed. Results Serum IL-27 index was significantly decreased in patients with gradeⅡ-ⅣaGVHD(grade 0-Ⅰ : 1.89±0.68 vs gradeⅡ-Ⅳ :1.26±0.49;P<0.000 1). IL-27 index had good value for grade Ⅱ-Ⅳ aGVHD (AUC=0.782,95% CI:0.675-0.889,P<0.001). Patients with a lower serum IL-27 index (<1.33) were more likely to have a higher cumulative incidence of grade Ⅱ-Ⅳ aGVHD than those with a higher serum IL-27 index (P<0.001). Multivariate analysis confirmed that low IL-27 index was the most significant risk factor for gradeⅡ-Ⅳ aGVHD (HR=4.50,95% CI:2.1-9.8,P<0.01). These findings were consistent with the results found in the serum samples collected in 2013. Conclusion Low IL-27 index could be used to predict the incidence of grade Ⅱ-Ⅳ acute GVHD after allo-HSCT from unrelated donors.
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AIM To observe the anti-inflammatory effects of total flavones from Xueli Formula (Violae Herba,Serissa japonica,Plantaginis Herba and Salvia plebeia,TFXL) on LPS-stimulated RAW264.7 macrophages.METHODS The effects of different concentrations of TFXL on RAW264.7 cell viability were examined by MTT assay.The NO kit assay was adopted to detect the NO release amount of TFXL on LPS-stimulated RAW264.7 cells.The secretions of tumor necrosis factor-α (TNF-α),interleukin-6 (IL-6) and interleukin-10 (IL-10) were tested by enzyme linked immunosorbent assay (ELISA).Reverse transcriptase-polymerase chain reaction (RTPCR) was used to determine the expressions of inducible nitric oxide synthase (iNOS),TNF-α,IL6 and IL10 mRNA.The protein expressions of IκB-α and p65 were tested by Western blot.RESULTS Compared with the LPS model group,TFXL could significantly reduce the secretions of NO,TNF-α and IL-6;increase the secretion of IL-10;inhibit the expressions of iNOS,TNF-α and IL6 mRNA;promote the expression of IL10 mRNA;inhibit the phosphorylations of IκB-α and p65.The TFXL high-dose group could inhibit the degradation of IκB-α.CONCLUSION This study preliminarily proves the protective effects of TFXL on LPS-stimulated RAW264.7 cell inflammation,whose action mechanism may be related to NF-κB signal pathway.
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Objective To analyze the risk factors of Gram‐negative bacterial blood‐stream infection in ICU for conducting the risk evaluation and guiding medication .Methods The inpatients were diagnosed with Gram‐negative bacterial blood‐stream infec‐tion in ICU of the Renmin Hospital of Wuhan University from January 2013 to December 2014 were retrospectively surveyed and analyzed .The risk factors of blood‐stream infection caused by Gram‐negative bacteria were analyzed and screened by the Logistic re‐gression analysis method .Results A total of 172 case‐times of blood‐stream infection occurred in ICU during this period ,including 93 case‐times of Gram‐negative bacterial infection .The Gram‐negative pathogenic bacteria were Acinetobacter baumanii ,Klebsiella pneumoniae ,Acinetobacter calcoaceticus baumanii ,E .coli ,pseudomonas aeruginosa ,etc .Except E .coli was mainly originated from community acquired infection ,other bacteria were mainly originated from nosocomial infection .In order to differing from other pathogenic bacterial blood stream infection ,the Logistic regression analysis results showed that the independent risk factors of G‐negative bacterial blood‐stream infection in ICU had serum PCT levels over 10 .0 ng/mL (OR= 60 .52 ,P= 0 .001) ,receiving the therapy of carbapenem and third generation cephalosporins (OR=16 .09 ,P=0 .03) ,hospitalization duration less than 2 weeks be‐fore suffering from disease (OR=13 .79 ,P=0 .03) and digestive system basic disease(OR=12 .94 ,P=0 .01) .Conclusion Gram‐negative bacterial blood‐stream infection in ICU of the Renmin Hospital of Wuhan University is mainly caused by multi‐drug resist‐ant bacteria .Serum PCT level over 10 .0 ng/mL ,hospitalization duration less than 2 weeks before infection ,receiving the therapy of carbapenem and third generation cephalosporin and basic diseases of digestive system are the independent risk factors influencing the occurrence and diagnosis of blood‐stream infection .
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Objective To evaluate the effect of plan-do-check-act (PDCA)cycle method in improving disinfection efficacy of object surface in intensive care unit (ICU).Methods On the basis of management of healthcare-associat-ed infection (HAI)and prevention of multidrug-resistant organisms,disinfection efficacy of object surface in an ICU was intervened,data about surface object specimens taken before,during,and after intervention,HAI in patients, as well as detection of MDROs were collected.Results The total qualified rate of specimens taken before,during, and after intervention was 58.24%,76.74%,and 88.71 %,respectively,there was an increased tendency,the difference was significant (χ2 =17.41 ,P =0.009);the incidence of HAI was 3.72%,2.42%,and 1 .78%,respec-tively,there was a decreased tendency(χ2 =6.03,P =0.039),case infection rate was 4.36%,2.75%,and 2.37%respectively,there was a decreased tendency (χ2 = 7.24,P = 0.046 );detection rate of MDROs was 34.03%, 27.45%,and 14.05%,respectively,there was a decreased tendency (χ2 =33.84,P =0.007),the percentage of pa-tients who were detected MDROs and HAI caused by MDROs showed a decreased tendency(χ2 =6.14,6.02,both P<0.05).Conclusion The implementation of PDCA cycle can effectively improve disinfectant efficacy of ICU object surface,and reduce the incidence of MDRO HAI.
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Objective To analyze risk factors and antimicrobial use for hospital-acquired pneumonia (HAP)due to multidrug-resistant organisms (MDROs)in an intensive care unit(ICU),so as to perform risk assessment and guide antimicrobial use.Methods From January 2012 to December 2013,HAP patients were conducted retrospective co-hort study,risk factors for MDRO-HAP and rationality of antimicrobial use were analyzed.Results A total of 110 cases of HAP occurred in ICU,63 cases (57.27%)were MDR-HAP.Logistic regression analysis revealed that re-cent hospital stay ≥5 days (OR=19.94),transference from other hospitals (OR =19.33),infection type of late-onset HAP (OR=7.98),and antimicrobial use in recent 90 days (OR =3.42)were independent risk factors for MDR-HAP.Initial empirical anti-infective treatment revealed that there were no significant difference in timing of antimicrobial administration within 24 hours after clinical diagnosis was confirmed,and rationality of antimicrobial selection between MDR-HAP group and non-MDR-HAP group (both P >0.05);The isolation rate of pathogens in MDR-HAP group was lower than non-MDR-HAP group (73.02% vs 91 .49% P 0.05 );the rationality rate of therapy course in MDR-HAP group was higher than no-MDR-HAP group,but rationality rate of combination use of antimicrobial agents was slightly lower than the latter (both P < 0.05 ).Conclusion Patients in ICU should be conducted risk factor assessment,and according prevention and control measures should be formulated,so as to reduce the occurrence of MDR-HAP,health care workers should standardized the initial empirical anti-infective treatment.
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Objective:To investigate the entry point of clinic pharmaceutical care performed by clinical pharmacists in diabetic ne-phropathy patients with chronic renal insufficiency. Methods: Clinical pharmacists played an important role in the service of clinical pharmacy by doing pharmaceutical care in main treatment agents such as hypoglycemic agents, hypotensive drugs and symptomatic treatment agents including diuretics, lipid-lowering drugs and microcirculation improving drugs, and in the healthy diet education for the patients. Results:Clinical pharmacists improved the compliance of the patients and the trust in clinical pharmacists, which en-sured the safety and efficacy of clinical drugs. Conclusion:Clinical pharmacists can guarantee the safety of medication and delay the development of diabetic nephropathy with chronic renal insufficiency.
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Objective: To provide some experience and help for the pharmaceutical care for drug-induced acute kidney injury through analysis and pharmaceutical care performed by clinical pharmacist for two cases of drug-induced acute kidney injury. Meth-ods:Clinical pharmacist analyzed the mechanism of drug-induced acute kidney injury, provided some suggestions for the medication, helped doctors select hormone drugs reasonably and performed medical education in the patients. Results:The kidney function of the two patients was recovered during the hospitalization after the reasonable treatment and care by doctors and pharmacists. Conclusion:The drug-induced acute kidney injury should be paid high attention, and the medical education should be strengthened in the patients.
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To evaluate five methods in the estimation on the rate of case fatality during the epidemics of diseases based on the summarizing data. Case fatality rates,derived from the simulation data,2003 SARS epidemic data in Hong Kong,Singapore Beijing and the 2013 H7N9 epidemic data in mainland China were analyzed,using these 5 methods. Results from the simulation analysis discovered that the relative errors and the standard deviations of the Chen[7,8] (method 3),Chen[9] (method 4) were minor with high accuracy. Data from the analysis on 2003 SARS epidemic was noticed that the estimation from method 3,4 in Hong Kong and Singapore both showing high veracities. Since the case fatality rate reported in Beijing was not a constant value,method 5 showed low accuracy even though it was close to the final case fatality rate. Data from the 2013 H7N9 epidemic showed that the estimations of method 1,2,3,4 were all higher than that in the method 5, suggesting that method 3,4 could be used to estimate the case fatality rates of epidemics more precisely.
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To evaluate five methods in the estimation on the rate of case fatality during the epidemics of diseases based on the summarizing data. Case fatality rates,derived from the simulation data,2003 SARS epidemic data in Hong Kong,Singapore Beijing and the 2013 H7N9 epidemic data in mainland China were analyzed,using these 5 methods. Results from the simulation analysis discovered that the relative errors and the standard deviations of the Chen[7,8] (method 3),Chen[9] (method 4) were minor with high accuracy. Data from the analysis on 2003 SARS epidemic was noticed that the estimation from method 3,4 in Hong Kong and Singapore both showing high veracities. Since the case fatality rate reported in Beijing was not a constant value,method 5 showed low accuracy even though it was close to the final case fatality rate. Data from the 2013 H7N9 epidemic showed that the estimations of method 1,2,3,4 were all higher than that in the method 5, suggesting that method 3,4 could be used to estimate the case fatality rates of epidemics more precisely.
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To evaluate five methods in the estimation on the rate of case fatality during the epidemics of diseases based on the summarizing data. Case fatality rates, derived from the simulation data, 2003 SARS epidemic data in Hong Kong, Singapore Beijing and the 2013 H7N9 epidemic data in mainland China were analyzed, using these 5 methods. Results from the simulation analysis discovered that the relative errors and the standard deviations of the Chen [7, 8] (method 3), Chen [9] (method 4)were minor with high accuracy. Data from the analysis on 2003 SARS epidemic was noticed that the estimation from method 3, 4 in Hong Kong and Singapore both showing high veracities. Since the case fatality rate reported in Beijing was not a constant value, method 5 showed low accuracy even though it was close to the final case fatality rate. Data from the 2013 H7N9 epidemic showed that the estimations of method 1, 2, 3, 4 were all higher than that in the method 5, suggesting that method 3, 4 could be used to estimate the case fatality rates of epidemics more precisely.
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Humans , China , Epidemiology , Hong Kong , Epidemiology , Influenza A Virus, H7N9 Subtype , Influenza, Human , Mortality , Regression Analysis , Severe Acute Respiratory Syndrome , MortalityABSTRACT
Objective To determine the effect of age,body figure and risk framing in making treatment decision for female patients with breast cancer.Methods Two groups of healthy female:one group of 60 female ages 18-24 from undergraduate student and the other group of 60 female ages 35-60 from the university community.Healthy women imagined that they had been diagnosed with breast cancer and received information regarding lumpectomy versus mastectomy and recurrence rates.Participants indicated whether they would choose lumpectomy or mastectomy and reasons.Results The different concern levels of body appearance between younger and older women influences treatment selection of lumpectomy versus mastectomy.Facing the risk information,older women were unlikely to select the breast conserving operation.Conclusions The factors of age and the attention to body figure would effect the choice of breast conserving operation or mastectomy.Risk information on the selection of treatment would not affected directly,but the effects of risk information on younger and older female is different.Nurses should provide the age-appropriate information who recently have been diagnosed with breast cancer regarding treatment alternatives to ensure their active participation in the decision-making process,female who have different levels of investment in body figure also may have different concerns about treatment,and should be alert on empathetic of such concerns.
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Resveratrol is a naturally occurring stilbene, a kind of polyphenolic compounds, found in a limited number of plant species such as grape, peanut, and pine. It has been considered as a phytoalexin in plants, and many studies have also shown its health benefits such as antioxidant activities, cancer prevention, blood thinning, and life span extension. This paper reviews the characteristics of resveratrol in aspects of synthesis, extraction, purification, and determination. In particular, the new outcomes of physiology function and the transgenic approaches have been presented. The challenges and chances for genetic engineering and health-related industries were also discussed.