Life science and medical research involving human beings cannot be separated from the support of research participants.The safety,health,and rights and interests of research participants are the primary considerations in clinical research,and their rights and interests include the right of compensation,privacy protection,health and so on.Protecting the compensation rights of research participants is a necessary responsibility of the research-related departments and personnel.Based on laws and regulations and literature review,and combined with practical experience,this paper made an in-depth discussion on compensation rights.It puts forward the types of compensation(conventional compensation,research-related damage compensation),compensation principles(necessity,timeliness,appropriateness,fairness),compensation elements(method,amount,plan,consent,notification,and reference of compensation),compensation under special circumstances(compensation for participants without or with limited informed consent ability and withdraw from the study midway),protection measures of compensation right(sponsor/contract research organizations,research institutions,research management departments,(main)researchers and research teams,ethics(review)committee).The compensation rights should be implemented to protect research participants.

The passing of ethical review is a necessary conditions and prerequisite for the development of life science and medical research involving humans. At present, some medical and health institutions have no or insufficient ethical review capabilities. The lack of ethical review ability has become a bottleneck restricting the development of life science and medical research involving humans. According to documents such as Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices, Opinions on Strengthening the Ethical Governance of Science and Technology, institutions can entrust competent institutional ethics review committees or regional ethics review committees in writing to conduct ethical review. Entrustment ethical review provides a viable solution for institutions that need to carry out life science and medical research involving humans but do not have an ethics (review) committee or the ethics (review) committee is not competent to review. To conduct the entrustment ethical review, the entrustment between the principal and the trustee is required. According to The Measures for Ethical Review of Life Sciences and Medical Research Involving Humans, if medical and health institutions and their ethical review committees do not accept the formal entrustment to provide the ethical review opinions for other institutions, the local health authorities at or above the county level will impose administrative penalties and sanctions on the relevant institutions and personnel in accordance with the law. Signing the entrustment ethical review contract, implementing legal compliance entrusted ethical review to protect the rights and interests of the trustee and the principal, and protect the research participants.

AIM To explore the effects of glycyrrhetinic acid on the gastric ulcer rats infected by Helicobacter pylori (Hp) and its action mechanism.METHODS Gastric ulcer rat models were induced by acetic acid stress and then followed by Hp infection.After treatment with low and high doses of glycyrrhetinic acid,the ulcer index,gastric acid and proteinase activities in gastric ulcer rats were analyzed.The effects of glycyrrhetinic acid on the expressions of BCL2 and Caspase-3,the GSK3β activity in gastric mucosa and gastric epithelial cells,and the cell apoptosis level were then detected.RESULTS Glycyrrhetinic acid reduced the ulcer index,gastric acid and proteinase activities in rats.Besides,the expression of BCL2 was significantly up-regulated by glycyrrhetinic acid in gastric mucosa and gastric epithelial cells,whereas the expression of Caspase-3,level of cell apoptosis,and GSK3β activity were significantly reduced.After the treatment with GSK3 β activator LY294002,the level of BCL2 was down-regulated,Caspase-3 expression was increased,and the level of cell apoptosis was enhanced.CONCLUSION Glycyrrhetinic acid promotes the healing of gastric ulcer infected by Hp via regulating GSK3β activity and inhibiting apoptosis of gastric epithelial cells.

To evaluate the prognostic value of glycated haemoglobin (HbA1c) in patients with acute myocardial infarction (AMI). Methods: A total of 1952 AMI patients were retrospectively studied. Based on medical history and HbA1c level, the patients were divided into 4 groups: Diabetes mellitus (DM) group, the patients with known DM or taking hypoglycemic drugs, n=492, Newly diagnosed DM group, MD was diagnosed during hospital stay and HbA1c≥6.5%, n=128, Pre-DM group, HbA1c 5.7%-6.4%, n=783 and Non-DM group, HbA1c<5.7%, n=549. The patients were followed-up for 25.6 months, prognostic differences during hospital stay and follow-up period were assessed by single- and multi-factor analysis. Results: The in-hospital mortality in DM group, Newly diagnosed DM group, Pre-DM group and Non-DM group were 4.88%, 3.91%, 3.96% and 2.91% respectively, P=0.435. As HbA1c level increasing, the incidences of all-cause mortality, non-fatal MI and re-hospitalization were elevating, while the differences among groups were similar. The incidences of major adverse cardiovascular events (MACE) in above 4 groups were 39.84%, 35.94%, 33.97% and 27.87% respectively, P=0.001. Compared with Non-DM group, MACE incidences in the other 3 groups were as OR=1.33, 95% CI 1.05-1.69, OR=1.45, 95% CI 0.97-2.18 and OR=1.71, 95% CI 1.32-2.22 respectively, Ptrend<0.001; with adjusted baseline parameters, Ptrend=0.008. Conclusion: In our research, MACE incidence was increasing upon HbA1c level elevating in AMI patients and it was not related to in-hospital death. HbA1c level should be screened in AMI patients, lifestyle and drug intervention could be used as necessity.

Objective To evaluate the clinical application of enteral nutrition by nasojejunal tube insertion and by percutaneous endoscopic gastrostomy (PEG) in elderly patients.Methods A total of 65 elderly patients with dysphagia recruited at our department from January 2010 to November 2014 were divided into the nasojejunal tube feeding group (35 cases) and the PEG feeding group (30 cases).Differences between these two groups in nutritional indexes,immunological indexes,complications and mortality were analyzed retrospectively.Results Serum total protein,albumin and prealbumin and upper arm circumferences all increased after treatment with nasojejunal tube feeding or percutaneous endoscopic gastrostomy (P＞0.05).There was overall improvement in nutritional status,as assessed by Nutritional Risk Screening 2002 (NRS2002).Specifically,the before/one month-after-treatment ratio of scores was 3.72±0.91/1.90±0.61 (t=7.24,P＜0.01) for the nasojejunal tube feeding group and 3.52±1.23/2.02±0.53 (t=4.17,P＜0.01) for the PEG feeding group.Compared with NRS2002 scores at one month post-operation,further improvement was achieved at 3 months postoperation both for the nasojejunal tube feeding group (1.89±0.65,t=5.21,P＜0.01) and for the PEG feeding group (1.91±0.62,t=4.40,P＜0.01).There was no difference in the indexes of nutrition,immune status or mortality between the two groups (P＞0.05).Although improvement in CD3+,CD4+,CD8+,CD4+/CD8+,IgA,IgG,and IgM was seen in both groups after operation,the differences did not reach statistical significance (P＞0.05).The incidence of aspiration pneumonia was notably lower (P＜0.05) while the incidence of diarrhea was much higher (P＜0.05) in the nasojejunal tube feeding group than in the PEG feeding group at one month and three months.The two groups had similar causes of death and mortality rates.Conclusion Both nasojejunal tube and PEG feeding can improve the nutritional status of elderly patients with dysphagia.However,the choice for the route of nutrition should be individualized.

[ ABSTRACT] AIM:To investigate the effect of artemisinin on lipopolysaccharide ( LPS)-induced intestinal epi-thelial barrier damage in IEC-6 cells and its molecular mechanism.METHODS:Cultured IEC-6 cells were divided to 5 groups:control group, LPS (100 mg/L) group and LPS +Artemisinin (30, 50 and 100μmol/L) groups.The cytotoxici-ty was detected by MTT assay.The releases of TNF-α, IL-1βand IL-6 in the IEC-6 cells were measured by ELISA.The transepithelial electrical resistance ( TER) was detected by electrical resistance tester, and the horseradish peroxidase (HRP) flux permeability were analyzed by a microplate reader.The expression of tight junction proteins, ZO-1, claudin-1 and occludin, and the expression of TLR4/MyD88/NF-κB at mRNA and protein levels were determined by RT-qPCR and Western blot.RESULTS:Artemisinin alone (up to 100 μmol/L) or in combination with LPS (100 mg/L) was not toxic to IEC-6 cells.Compared with control group, the releases of TNF-α, IL-1βand IL-6 in the culture supernatant of IEC-6 cells significantly increased after treatment with LPS.The expression of TLR4/MyD88/NF-κB was activated by LPS.LPS down-regulated the protein expression of ZO-1, claudin-1 and occludin.However, artemisinin treatment decreased the re-leases of TNF-α, IL-1βand IL-6 in the culture supernatant of IEC-6 cells.The expression of TLR4/MyD88/NF-κB at mR-NA and protein levels was gradually reduced after treatment with artemisinin.In addition, artemisinin upregulated the pro-tein expression of ZO-1, claudin-1 and occludin significantly (P<0.01) in a dose-dependent manner.CONCLUSION:Artemisinin attenuates LPS-induced intestinal epithelial barrier damage by inhibiting TLR4/MyD88/NF-κB activation in the IEC-6 cells.

Objective To investigate the effects of perioperative high loading dose of Atorvastatin treatment on lipoprotein associated phospholipase A2 (Lp-PLA2) and heart function in patients with acute ST-segment elevation myocardial infarction and type 2 diabetes who underwent emergency percutaneous coronary intervention (PCI).Methods Totally 83 cases with acute ST segment elevation myocardial infarction and type 2 diabetes who underwent emergency PCI from September 2012 and August 2014 were randomly divided into two groups.In control group (n=42)patients took Atorvastatin 20 mg daily before and after emergency PCI,and in intensive group (n=41) patients took atorvastatin 40 mg daily before and after emergency PCI.Each group was given the same basic treatment according to the guideline.Blood samples were obtained from all the patients before PCI and at 3,7 days after PCI,and levels of Lp-PLA2 and brain natriuretic peptide (BNP)were detected.And the left ventricular end diastolic diameter (LVEDD) and left ventricular ejection fraction (LVEF) were measured at 1 day and 1 month after PCI.Results The levels of Lp-PLA2 and BNP at 3 days after PCI were obviously increased in the two groups versus baseline [(297.8± 53.4) mg/L vs.(194.7±39.1) mg/L,(270.3±47.0) mag/L vs.(205.6±27.5) mg/L,both P＜0.05],and decreased in intensive versus control group [(270.3±47.0) mg/L vs.(297.8±53.4)mg/L and (353.8±76.3) mg/L vs.(375.4±57.0) mg/L,P＜0.05].And levels of Lp-PLA2 and BNP at 7 days after PCI were improved more in intensive than in control group [(227.2±33.3)mg/L vs.(249.3±42.3) mg/L,(206.0±48.2)mg/L vs.(267.6±50.8) mg/L,P＜0.05].There were no significant differences in LVEDD and LVEF between the two groups 1 day after PCI.Meanwhile,the LVEDD was decreased and the LVEF was increased in the two groups 1 month after PCI as compared with 1 day after PCI (both P＜0.05).Conclusions Perioperative high loading dose of Atorvastatin treatment may stabilize the plaques and improve heart function in acute stage in patients with acute ST-segment elevated myocardial infarction and type 2 diabetes after emergency PCI.

Objective:To explore diagnostic value of nocturnal ST-T changes in 24h dynamic electrocardiogram (DCG)for coronary heart disease (CHD)and its clinical significance.Methods:A total of 103 cases,who showed ST-T changes in 24h DCG,received selective coronary angiography (CAG).Among them,the 56 patients with in-termittent nighttime significant ST-T changes were regarded as research group,while the other 47 patients with per-sistent ST-T changes were treated as control group.CAG results were compared and analyzed between two groups. Results:Compared with control group,there were significant rise in CAG positive rate (31.9% vs.67.9%),inci-dence rates of dyspnea and chest pain (27.7% vs.66.1%),hypertension (48.9% vs.71.4%),hyperlipidemia (31.9% vs.42.9%)and diabetes mellitus (17.0% vs.46.4%),percentages of lesions in left anterior descending artery (LAD,21.3% vs.57.1%),left circumflex coronary artery (LCX,14.8% vs.37.5%)and right coronary artery (RCA,12.8% vs.35.7%)in research group,P <0.05 or <0.01. Conclusion:Nocturnal ST-T signifieantly changes in 24h DCG,it possesses more diagnostic value for CHD,which can be regarded as a more sensitive index diagnosing myocardial ischemia.

Objective To explore the application and clinical values of issue tracking nursing on patients with metabolic syndrome ( MS) . Methods A total of 200 MS patients, who hospitalized from October 2010 to October 2013, were selected and averagely and randomly divided into experimental group and control group by envelop method. The patients of experimental group were given the issue tracking method, while the conventional nursing method was used in the control group. The comparison had been carried out between patients of two groups in disease awareness, patients′ satisfaction for nursing work and biochemical indicator. Results The pass percent of MS disease knowledge awareness reached 95. 0% in the experimental group while it was 77. 0% in the control group (χ2 =13. 46,P<0. 01); the patients′ satisfaction towards nursing work in the experimental group was higher than that of the control group (χ2 =4. 03,P<0. 05);after interventions, the fasting blood glucose, TG, TC, LDL in the experimental group, all of them were lower than those of the control group (t=2. 35,2. 67,2. 64,2. 86;P <0. 05). Conclusions The MS patients are utilized issue tracking nursing intervention, which can enhance patients′ mastery of disease knowledge, satisfaction towards nursing work, so as to promote disease treatment well. The issue tracking nursing has a excellent clinical value.

Objective To investigate the effects of ibutilide and amiodarone on the ventricular transmural heteroge-neity of repolarization and ventricular arrhythmia for the treatment of atrial fibrillation. Methods Eighty-seven patients with paroxymal atrial fibrillation at 48 h~7 d were enrolled and randomized to two groups, ibutilide and amiodarone treat-ment groups. The successful rate of cardioversion to sinus rhythm was compared between two groups. The electrocardiograph-ic QT interval and Tpeak-end/QT ratio were also analyzed before and after treatment in two groups. Results The successful rate of cardioversion was significantly higher in ibutilide group than that of amiodarone group (61.7%vs 40.7%, P＜0.05). The QT intervals and Tpeak-end/QT ratio were both significantly increased in ibutilide group (P＜0.05), which were re-turned to the levels before treatment in 2 hours and 1 hour, respectively (P＜0.05). The QT intervals were significantly in-creased in the amiodarone group (P＜0.01), which were continued until 4 h after treatment. There were no significant differ-ences in the Tpeak-end/QT ratios before and after treatment (P>0.05). Conclusion The successful rate of cardioversion to sinus rhythm for atrial fibrillation by ibutilide was significantly higher compared with that of amiodarone. Ibutilide slightly in-creased the transmural heterogeneity of repolarization within the first hour, which may increase the risk of ventricular arrhyth-mia.