10.3969/j.issn.1000-8179.2013.12.003

It is imperative to apply information technology in the area of management of clinical research so as to ensure the quality of clinical trials and to improve management efficiency.In this study,the based analysis method was the quality function deployment (QFD).This methodology is used to analysis the clinical trials management information system on a hospital directly under the Ministry of Health.It ensured user participation,lay a solid foundation for software engineers on system design.

Objective:To analyze the influential factors of medical staff's cognition on medical ethics review in Wuhan municipal medical institutions,and thus to provide suggestions for strengthening the ethical construction.Methods:Aquestionnaire survey was conducted among medical staff.Chi-square test and Logistic regression method were performed to analyze the influential factors of medical staff's cognition on medical ethics review.Results:The results showed that medical staff's cognition on medical ethics review was affected by the technical tide,education background,whether had received ethical education,the cognition on ethics committees and whether the medical institution had established ethics committee.With higher technical titles,they thought more necessity to establish ethics committees and conduct ethical review of the clinical applications of new technology and new business.Those with higher technical titles and had read the ethical propaganda materials thought it more necessary to conduct ethical review of the clinical application of new technology and new business and the ethical review of biomedical research involved human beings.Conclusions:The medical institution should embody the establishment and standardization of ethical committees into the hospital assessment management system,as a necessary condition for the application of research projects and achievement awards.Also,it should conduct medical ethics training for all medical staff.Only those passed the examination can enter into the research and clinical operation with certificates,which can protect the medical ethics education into practice.It should strengthen the medical staff's cognition on ethical review,constantly innovate the operation rules and management system based on following the basic ethical review principles,and constantly improve the medical ethical review mechanism.

Objective:To investigate the correlation between hyperreflective dots (HRD) and lipid levels and systemic inflammatory factors in patients with branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).Methods:A cross-sectional clinical study. From December 2016 to June 2020, 118 eyes of 118 patients with retinal vein occlusion diagnosed in the Department of Ophthalmology, Central Theater Command Hospital of People's Liberation Army were included in the study. Among them, 67 cases of BRVO and 51 cases of CRVO were divided into CRVO group and BRVO group accordingly. Peripheral venous blood was drawn from the patients within 3 days after the eye examination to detect the percentage of neutrophils, monocytes, hypersensitive C-reactive protein (CRP), total cholesterol, triglyceride, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and lipoprotein(a). The ratio of monocytes to high-density lipoprotein (MHR) was also calculated. The 3D OCT-2000 instrument from Topcon (Japan) was used to measure the central retinal thickness (CRT) and the numbers of HRD. According to the different distribution position, HRD is divided into inner retina HRD, outer retina HRD, and total retina HRD.The independent sample t test was used to compare the continuous variables of the two groups, and the χ2 test was used to compare the rates. The correlation between HRD counts and blood lipid levels and peripheral blood inflammation indicators in patients with different types of RVO was analyzed by Spearman correlation analysis. Results:The average age of patients in the BRVO group and CRVO group were 60.1±9.5 and 53.6±15.7 years, respectively; the prevalence of hypertension was 53.7% (36/67) and 24.5% (12/51), respectively. Comparison of age ( t=2.634) and prevalence of hypertension ( χ2=11.298) between the two groups showed statistically significant differences ( P<0.05). Gender ( χ2=2.000), course of disease ( t=-1.101), prevalence of diabetes ( χ2=1.315), eye category ( χ2=1.742), baseline visual acuity ( t=1.792), intraocular pressure ( t=0.708), CRT ( t=1.318), and peripheral blood include the percentage of neutrophils, the absolute number of monocytes, CRP, total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, lipoprotein(a), MHR ( t=-0.559, 1.126, 0.579, 1.299, -0.134, 0.556, 1.230, -0.267, 0.483), the difference was not statistically significant. Correlation analysis showed that the HRD counts in the outer retina of BRVO patients were positively correlated with total cholesterol ( r=0.289, P=0.036); the HRD in the inner retina and total HRD counts of CRVO patients were positively correlated with CRP ( r=0.406, 0.343; P=0.004, 0.014). There was no correlation between HRD counts and percentage of neutrophils, absolute number of monocytes, triglycerides, high-density lipoprotein, low-density lipoprotein, lipoprotein(a), and MHR ( P>0.05). Conclusion:The number of HRD is related to the blood lipid level in BRVO patients and CRP (an inflammatory index) in CRVO patients.

Objective To establish a less-damage method for tracheal intubation so as to improve the quality of post-cardiac arrest syndrome.Methods Thirty rabbits wvere divided into 3 groups of 10 rabbits each according to the random number table:group A receiving direct endotracheal intubation after anesthesia,Group B separation of cervical tissue and retrograde tracheal intubation after anesthesia and Group C percutaneous retrograde tracheal intubation after anesthesia.After the intravenous injection of forskolin,cardiac arrest was induced by endotracheal tube clamping.After 5 minutes of untreated arrest,conventional cardiopulmonary resuscitation was initiated.Changes in arterial pressure,occurrence of post-resuscition syndrome and survival time were examined in all groups.Results Groups A,B and C showed 40％,60％ and 80％ success rate in cardiopulmonary resuscitation (P ＜ 0.01) and animal survival time of 23.4 hours (11.6-35.8 hours),62.7 hours (29.4-88.6 hours) and 79.5 hours (40.9-118.2 hours) (P ＜ 0.01).Conclusions Percutaneous retrograde tracheal intubation is suitable to increase cardiopulmonary resuscitation rate and survival rate in rabbits with post-cardiac arrest.The model has good stability and repeatability and can be used for study of post-cardiac arrest syndrome.

Objective To explore the application of projection pursuit model in anti-assessment on peer reviewer of scientific research project,discussing the rational of this application.Methods Establishing the projection pursuit model of anti-assessment on peer reviewer,with the best projection direction as a weight,making an evaluation on the peer reviewer,and sequencing experts by projection value.Results The projection pursuit model is stable and scientific,the importance of index ranking as correlation coefficient＞ dispersion＞ hit rate＞ synthetic dispersion＞ self dispersion ratio.Conclusions The application of projection pursuit model in anti-assessment on peer reviewer of scientific research project,is reasonable and practicable.

OBJECTIVE:To prepare nifedipine (NF) hollow controlled-release microspheres and evaluate the quality. METH-ODS:Solvent diffusion volatilization method was used to prepare microspheres,using comprehensive scores of cumulative release in 2,12,24 h(Q2 h,Q12 h,Q24 h)as indexes,orthogonal test was designed to screen the carrier material ethyl cellulose(EC),poly-vinyl pyrrolidone(PVP)and main drug NF amounts;appearance,particle size distribution,drug loading,floating and cumulative release of the microspheres prepared by optimal formulation were evaluated and compared of in vitro release behavior with imported preparation of Nifedipine controlled-release tablets (Adalat?). RESULTS:The optimal formulation was as follow as NF 3.00 g, PVP 1.60 g,EC 15.65 g. Prepared NF hollow controlled-release microspheres were spherical in shape with particle size distribution of 24-40 mesh and drug loading of 8.66%;24 h floating rate in release medium was 97.93%,Q2 h,Q12 h,Q24 h were 20.49%, 52.90%,91.00%(RSD<10%,n=3). Compared with the imported preparation,similarity factor f2 values of cumulative release were higher than 50,showing in vitro drug-release was consistent with the zero-order kinetic equation (r=0.9993);n of Rit-ger-Peppas equation (r=0.9807) was 0.478. CONCLUSIONS:Prepare NF hollow controlled-release microspheres show similar drug-release behavior with the imported preparation,the drug is released by the combination of diffusion and erosion.

Peer review anti assessment includes the evaluation of expert and index system in two parts.The current status of anti-assessment study mainly focused on expert,much of the index system anti-assessment study reports.As can be seen from the status,the anti-assessment system not yet formed and the application is rare.In urgent need of further research to improve our peer-reviewed scientific research.

Objective To compare the diagnostic value of shear wave elastography (SWE) and acoustic radiation force impulse imaging (ARFI) in benign and malignant thyroid nodules (TNs).Methods A total of 43 patients with 51 thyroid nodules were included.According to the diameter,all nodules were divided into small nodules (diameter ≤1 cm) and large nodules (1 cm＜diameter≤3 cm).All patients underwent both SWE and ARFI examinations at the same time.SWE (Emax,Emean,Emin),virtual touch tissue quantification (VTQ) and virtual touch tissue imaging (VTI) area ratio were obtained.The optimal cut-off values of SWE,VTQ,VTI area ratio were calculated with ROC curve to identify malignant thyroid nodules from benign ones,and the sensitivity,specificity,accuracy of Emax,VTQ and VTI area ratio were calculated respectively.Results The cut-off value of Emax,VTQ,VTI area ratio in differential diagnosis of benign and malignant TNs was 37.74 kPa,2.19 m/s and 1.24,respectively.The sensitivity was 85.30％ (29/34),76.50％ (26/ 34),64.71％ (22/34),the specificity was 100％ (17/17),94.10％ (16/17),88.20％ (15/17),the accuracy was 90.20％ (46/51),90.20％ (46/51),72.55％ (37/51) of E VTQ and VTI area ratio in diagnosis of malignant thyroid nodules,respectively.The sensitivity of Emax and VTQ in the diagnosis of malignant large NTs was 92.31％ (12/13) and 100％ (13/13),respectively,while the sensitivity of VTI area ratio and Emax in the diagnosis of malignant small NTs were both 80.95％ (17/21).Conclusion Either SWE or ARFI has good diagnostic performance in distinguishing malignant thyroid nodules from benign ones.Emax is of equal value in diagnosing thyroid benign and malignant nodules.VTQ has advantage for diagnosing large NTs,while VTI area ratio shows better diagnostic performance for small NTs.

Monogenic diabetes is a special type of diabetes caused by a single gene mutation, and it is commonly misdiagnosed in clinical practice. The two major forms of monogenic diabetes are neonatal diabetes(NDM) and maturity onset diabetes of the young(MODY). The most common mutations in 6 genes, induding HNF1α, GCK, HNF4α, KCNJ11, ABCC8, and INS, account for more than 90% of all monogenic diabetic cases. This article is to review recent advances in clinical features, and precision medicine of monogenic diabetes, and to discuss the significance of insights gained from monogenic diabetes in better understanding the pathogenesis of type 1 and type 2 diabetes. The current models for screening of monogenic diabetes were also discussed.