Investigation and analysis of Chinese public 's cognition for clinical research / 中南大学学报(医学版)

OBJECTIVES@#Clinical research plays a vital role in disease research and population health. The public is the main source of clinical research volunteers. Understanding the public's cognition of clinical research plays a decisive role in the development of clinical research. This study aims to understand the Chinese public's cognition for clinical research and the influencing factors.@*METHODS@#The questionnaire based on Chinese-translated Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment (PARTAKE) was used to investigate the public's cognition for clinical research.@*RESULTS@#Of the 2 513 valid respondents, 91.84% had heard of "clinical research", 91.76% of the respondents believed that clinical research was beneficial to society, 65.90% were willing to participate in clinical research, 87.50% believed that confidentiality was a very important thing, 73.70% believed that their personal information had been protected when participating in clinical research, and, 46.40% did not know whether volunteers participating in clinical research could receive adequate compensation. Educational levels, employment status, and annual income impacted in public perceptions of willingness to participate in clinical research, especially in privacy protection, informed consent, whether clinical research is intended for society, compensation for clinical research, and safety of clinical research (all P<0.01).@*CONCLUSIONS@#The Chinese public's cognition level for clinical research is acceptable, but there is still a lot of room for improvement in privacy protection, informed consent, and compensation. By designing a reasonable knowledge training program for clinical research and using the multimedia, improving access to the relevant knowledge, more public will know about clinical research recruitment information, which is of great significance for the development of clinical research in China.

Feasibility analysis based on BI evaluation index of SCI journals :Taking the Third Xiangya Hospital as an example / 中华医学科研管理杂志

Objective This paper selects indicators,such as SCI journal publication fee,impact factors,annual Web of Science Documents,volume of publications in China,articles cited and so on,to conduct the feasibility analysis of using publication fee /impact factor (BI) as evaluation index of SCI journals.Methods Information from Web of Science,InCites,Journal Citation Reports database and the real-time data of 2013-2017 years SCI publication fees in Central South University,the third Xiangya Hospital were collected,SPSS and EXCEL was used to conduct Correlation and Basic analysis.Results In 2013-2017,a total number of 31 kinds of SCI journals were included in sample size,the SCI journal impact factor was positively correlated with the publication fee.BI was negative correlated with IF,The publication fee was not related to annual Web of Science Documents,volume of publications in Mainland China and Cites/Paper.Conclusions The SCI journal publication fee/impact factor (BI) can be used as a macro evaluation index for SCI journals.The BI values also can provide reference and reference of decision support and journal selection for scientific research personnel and scientific research administrators.

Reliability and validity of the Chinese version on Alcohol Use Disorders Identification Test / 中华流行病学杂志

Objective To assess the reliability and validity of the Chinese version on Alcohol Use Disorders Identification Test (AUDIT) among medical students in China and to provide correct way of application on the recommended scales.Methods An E-questionnaire was developed and sent to medical students in five different colleges.Students were all active volunteers to accept the testings.Cronbach's α and split-half reliability were calculated to evaluate the reliability of AUDIT while content,contract,discriminant and convergent validity were performed to measure the validity of the scales.Results The overall Cronbach's α of AUDIT was 0.782 and the split-half reliability was 0.711.Data showed that the domain Cronbach's α and split-half reliability were 0.796 and 0.794 for hazardous alcohol use,0.561 and 0.623 for dependence symptoms,and 0.647 and 0.640 for harmful alcohol use.Results also showed that the content validity index on the levels of items I-CVI)were from 0.83 to 1.00,the content validity index of scale level (S-CVI/UA) was 0.90,content validity index of average scale level (S-CVI/Ave) was 0.99 and the content validity ratios (CVR) were from 0.80 to 1.00.The simplified version of AUDIT supported a presupposed three-factor structure which could explain 61.175％ of the total variance revealed through exploratory factor analysis.AUDIT semed to have good convergent and discriminant validity,with the success rate of calibration experiment as 100％.Conclusion AUDIT showed good reliability and validity among medical students in China thus worth for promotion on its use.

Value of γ-interferon release test in the diagnosis of entry-exit people with tuberculosis / 国际检验医学杂志

Objective To investigate the clinical significance of γ-interferon release test (IGRA) in the diagnosis of entry-exit people with tuberculosis.Methods A total of 64 patients with tuberculosis and 46 healthy people were detected by IGRA,tuberculin skin test (TST),LAM,38× 103 and 16 × 103.The results of different methods were compared and analyzed.Results The sensitivity of IGRA detection method (88.9 ％) and specificity (95.8 ％) were both higher,while the sensitivity (92.7 ％) of the TST method was higher and the specificity (76.7 ％) was lower.Conclusion The sensitivity and specificity of IGRA in the detection of tuberculosis are higher,and it has important clinical application value.

Reliability and validity of the Chinese version on Alcohol Use Disorders Identification Test / 中华流行病学杂志

Objective To assess the reliability and validity of the Chinese version on Alcohol Use Disorders Identification Test (AUDIT) among medical students in China and to provide correct way of application on the recommended scales.Methods An E-questionnaire was developed and sent to medical students in five different colleges.Students were all active volunteers to accept the testings.Cronbach's α and split-half reliability were calculated to evaluate the reliability of AUDIT while content,contract,discriminant and convergent validity were performed to measure the validity of the scales.Results The overall Cronbach's α of AUDIT was 0.782 and the split-half reliability was 0.711.Data showed that the domain Cronbach's α and split-half reliability were 0.796 and 0.794 for hazardous alcohol use,0.561 and 0.623 for dependence symptoms,and 0.647 and 0.640 for harmful alcohol use.Results also showed that the content validity index on the levels of items I-CVI)were from 0.83 to 1.00,the content validity index of scale level (S-CVI/UA) was 0.90,content validity index of average scale level (S-CVI/Ave) was 0.99 and the content validity ratios (CVR) were from 0.80 to 1.00.The simplified version of AUDIT supported a presupposed three-factor structure which could explain 61.175％ of the total variance revealed through exploratory factor analysis.AUDIT semed to have good convergent and discriminant validity,with the success rate of calibration experiment as 100％.Conclusion AUDIT showed good reliability and validity among medical students in China thus worth for promotion on its use.

Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products of agomelatine in Chinese subjects

The aim of this study was to apply the reference-scaled average bioequivalence (RSABE) approach to evaluate the bioequivalence of 2 formulations of agomelatine, and to investigate the pharmacokinetic properties of agomelatine in Chinese healthy male subjects. This was performed in a single-dose, randomized-sequence, open-label, four-way crossover study with a one-day washout period between doses. Healthy Chinese males were randomly assigned to receive 25 mg of either the test or reference formulation. The formulations were considered bioequivalent if 90% confidence intervals (CIs) for the log-transformed ratios and ratio of geometric means (GMR) of AUC and C max of agomelatine were within the predetermined bioequivalence range based on RSABE method. Results showed that both of the 90% CIs for the log-transformed ratios of AUC and C max of 7-desmethyl-agomelatine and 3-hydroxy-agomelatine were within the predetermined bioequivalence range. The 90% CIs for natural log-transformed ratios of C max, AUC0-t and AUC0-∞ of agomelatine (104.42-139.86, 101.33-123.83 and 97.90-117.94) were within the RSABE acceptance limits, and 3-hydroxy-agomelatine (105.55-123.03, 101.95-109.10 and 101.72-108.70) and 7-desmethyl-agomelatine (104.50-125.23, 102.36-111.50 and 101.62-110.64) were within the FDA bioequivalence definition intervals (0.80-1.25 for AUC and 0.75-1.33 for C max). The RSABE approach was successful in evaluating the bioequivalence of these two formulations.

Study on the Differences of Pregnancy Informs between Chinese and Foreign Informed Consent Form in Drug Clinical Trial / 中国医学伦理学

Objective:To explore and discuss the differences of pregnancy contents and inform formats in in-formed consent form ( ICF) for the drug clinical trial between China and foreign countries. Methods:We collected Chinese and foreign ICFs for drug clinical trial that had been audited by the Ethics Committee of the third Xiangya Hospital for the past five years. Based on the relevant domestic and foreign law, we concluded the element stand-ards and inform formats about pregnancy inform. By analyzing the integrity of the whole elements, the inform rate of every element and the using rate of every inform format, we compared the differences of pregnancy contents and in-form formats between Chinese ICFs and foreign ICFs. Results:The total number of ICFs was 177 in this study, in-cluding 107 Chinese ICFs and 70 foreign ICFs. The integrity rate of pregnancy in Chinese ICFs was statistically lower than them in foreign ICFs (19% vs. 56%, P=0. 000). Compared with foreign ICFs, the low informed ele-ments were the study of the pregnancy risk (32% vs. 73%, P=0. 000), the pregnancy test during the following-up period (33% vs. 56%, P=0. 002) and the measurements for contraception (22% vs. 53%, P=0. 000). Conclusion:The integrity level of pregnancy content in Chinese ICFs was lower than that of the foreign ICFs. And the three elements including pregnancy risk study, pregnancy test during the following-up period and measure-ments for contraception was obviously defected. Pregnancy informing forms of informed consent in China was inferi-or to abroad.

Multi-slice CT Enterography with Double-iflling Method in Diagnosis of Inlfammatory Bowel Diseases / 中国医学影像学杂志

Purpose To summarize the imaging features of inflammatory bowel diseases (IBD) with double-filling method using multi-slice CT enterography (MSCTE), and to evaluate the clinical significance of MSCTE in diagnosis of IBD. Materials and Methods MSCTE data with double-filling method of 52 patients with IBD were retrospectively analyzed. 52 IBD patients included 42 cases of Crohn's disease (CD) and 10 cases of ulcerative colitis (UC). Bowel dilatation and lesions display were evaluated. Results Among 52 patients, ileum dilated optimal in 10 cases (19.23%) and good in 42 cases (80.77%); jejunum dilated good in 21 cases (40.38%) and poor in 31cases (59.62%). Exhaustive evaluation for large bowel diseases were good in 50 cases (96.15%). The ileocecal junction displayed well in 52 cases (100.00%). Among the 42 cases of CD, 20 cases (47.62%) had lesions limited in the small intestine, 22 cases (52.38%) had lesions involved both small intestine and colon. Among 10 cases of UC, 9 cases had lesions limited in the colon, and 1 case with the terminal ileum and the colon involved simultaneously. The MSCTE findings of 52 patients included bowel wall thickening and abnormal enhancement in 52 cases, stenosis in 28 cases, increased mesenteric vascularity in 46 cases, enlarged mesenteric lymph nodes in 27 cases, phlegmon in 10 cases, incomplete intestinal obstruction in 4 cases, abscess or inflammatory masses in 7 cases, fistulas in 3 cases, perianal lesion in 12 cases, serous cavity effusion in 15 cases, sacroiliitis in 13 cases, the urinary and biliary stones in 18 cases, and hepatosplenomegaly in 9 cases. Conclusion MSCTE with double-filling method can delineate the wall lesions of small bowels and colons very well, and can also display extraintestinal lesions and complications. It obviously improves the accuracy of localization and qualitative diagnosis on IBD.

Study on Content Determination of Chlorphenamine Maleate Tablets and Injections / 中国药师

Objective:To unify the content determination method for chlorphenamine maleate tablets and injections. Methods:An Inertsil C8(150 mm × 4. 6 mm,5 μm)column was used,the mobile phase was phosphate buffer( ammonium phosphate monobasic 11. 5g was dissolved in water,1 ml phosphoric acid was added and diluted to 1 000 ml by water)-acetonitrile(70:30),the flow rate was 1. 0 ml·min-1 ,the column temperature was room temperature,the sample volume was 10 μl and the detection wavelength was 262 nm. Results:The linear range of chlorpheniramine was 0. 017 8-0. 445 0 mg·ml-1(r=0. 999 9);the average recovery of the tablets and injections was 100. 2%(RSD=0. 4%,n=9)and 100. 3%(RSD=0. 9%,n=9),respectively. Conclusion:The method is simple,reproducible and accurate,and can provide reliable basis for the standards of chlorpheniramine maleate tablets,injections and dropping pills.

Observation of clinical effect of budesonide combined with ambroxol hydrochloride on the treatment of infant bronchopneu-monia through oxygen atomizing inhalation / 中国医师杂志

Objective To observe the clinical effect of budesonide combined with ambroxol hydrochloride on the treatment of infant bronchopneumonia through oxygen atomizing inhalation .Methods One hundred and twenty -two cases of infant patients suf-fered with bronchopneumonia were randomly divided into two groups , control group (60 cases), the patients accept conventional treat-ment such as antibiotics, oxygen inhalation and anti-cough;treatment group (62 cases), patients were given budesonide combined with ambroxol hydrochloride through oxygen atomizing inhalation , beside conventional treatment .Main clinical signs and pulmonary symp-toms disappear time and treatment efficacy in two groups were observed and analyzed .Results The total effectiveness was obviously higher in treatment group(91.9%) than that of control group(81.7%) ( P <0.01).Wheezing disappearance time, wheezing sounds disappear time , crackles disappear time and cough disappear time in treatment group were significantly shorter than that in the control group ( P <0.01 ) .There were no adverse reactions on infant patients in both groups .Conclusions The effect of budesonide com-bined with ambroxol hydrochloride on the treatment of infant bronchopneumonia through oxygen atomizing inhalation was significant , and it is worthy of promotion in the clinic .

Improvement of Mobile Phase in Determination Method for Penicillin V Potassium Tablets in Chinese Phar-macopoeia / 中国药师

Objective:To improve the determination method for penicillin V potassium tablets. Methods:An Inertis ODS-SP C18 column (150 mm × 4. 6 mm, 5 μm) was used. The mobile phase consisted of A and B(60∶40) [ A: pH 3. 5 phosphate buffer(0. 5 mol·L-1 potassium dihydrogen phosphate solution, adjusting pH to 3. 5 with phosphoric acid)-acetonitrile-water (10∶30∶60);B:pH 3. 5 phosphate buffer-acetonitrile-water (10∶55∶35)]. The flow rate was 1. 0 ml·min-1, the detection wavelength was 268nm, the column temperature was room temperature and the injection volume was 10 μl. Results:The linear range of penicillin V potassium was 0. 032 9-0. 821 6 mg·ml-1(r=0. 999 9, and the average recovery was 99. 9%( RSD=0. 6%, n=9). Conclusion:The method is reproducible and accurate, and can be used in the content determination of penicillin V potassium tablets and capsules.

Senescent endothelial dysfunctions were mediated by S1P2 receptor in cultured human umbilical vein endothelial cells / 中南大学学报(医学版)

OBJECTIVE@#To investigate the variation of senescent endothelial function by regulating the sphingosine-1-phosphate receptor type 2 (S1P2) expression in cultured human umbilical vein endothelial cells (HUVECs).@*METHODS@#The S1P2 receptor expression was regulated by transfecting the cDNA or shRNA of S1P2 in cultured HUVECs. The expression levels of S1P2 receptor in HUVECs were detected by RT-PCR and Western blot. EC chemotaxis was measured by the transwell migration assay. The wound healing assay was performed by a scratch wound model on EC monolayer. Matrigel morphogenesis assay was employed to assess the in vitro angiogenic responses.@*RESULTS@#After up-regulating the S1P2 expression in young ECs, the S1P-stimulated formation of a tubular-like network in Matrigel was dramatically diminished in transfected ECs (P<0.05). Quantification of the wound healing assay showed that transfected ECs grew much slower than young ECs (P<0.05). The chemotactic capability was significantly decreased in transfected ECs (P<0.05). Furthermore, the senescent-associated impairments were revoked by the downregulation of S1P2 receptor in senescent HUVECs.@*CONCLUSION@#The impaired functions (chemotactic, wound-healing and morphogenetic responses) in senescent HUVECs in vitro are mediated by S1P2 receptor.

A multi-center, randomized, controlled, double blind and double dummy clinical trial of antofloxacin hydrochloride tablet versus levofloxacin tablet for the treatment of acute bacterial infections / 中华内科杂志

Objective To evaluate the clinical efficacy and safety of antofloxacin hydrochloride tablet for the treatment of acute bacterial infections. Methods A multi-center randomized control, double blind and double dummy clinical trial was conducted; levofloxacin tablet was chosed as controlled drug. The duration of treatment was 7-14 days in both groups. Results A total of 719 patients were enrolled in the study, in which 359 patients treated with antofloxacin and 360 patients treated with levofloxacin were included. Three hundred and thirty and 337 patients completed the study and met with all the criteria for perprotocol analysis, respectively. By the end of chemotherapy, the cured rates in per protocol set (PPS)population were 79.7% and 77.4%, the effective rates were 95.2% and 96. 7%, and the bacterial clearance were 96. 7% and 97. 5% for the treating and control group, respectively. The clinical and bacterial efficacy of antofloxacin and levofloxacin was comparable by the analysis of infectious sites. Three hundred and fifty-seven and 356 patients in antofloxacin and levofloxacin groups were evaluated the safety.The drug adverse events occurred both in 10. 1%, and drug adverse reactions accurred in 7. 8% and 7.9%patients in the two groups. The most common drug adverse reactions were mild gastroenteric symptoms. No QTc prologation was detected in all the patients. One patient in each group had mild blood glucose increase at the end of therapy, but the glucose returned to normal level without any intervention. No statistic significant difference between the two groups in clinical efficacy and safety was detected (P＞0.05).Conclusions Antofloxacin hydrochloride tablet was effective and safe for the treatment of acute bacterial infections.

Expression and significance of matrix metalloproteinase-2 and basic fibroblast growth factor in human glioma / 中国医师进修杂志

Objective To explore the expression and significance of matrix metalloproteinase-2 (MMP-2) and basic fibroblast growth factor (bFGF) in human glioma.Methods The expression levels of bFGF and MMP-2 in 56 cases of human glioma and 9 cases of normal brain tissue specimen were detected by immunohistochemistry technique.Furthermore,the correlation between the expression of the bFGF and MMP-2 was compared.Results In normal brain tissue,grade Ⅰ,Ⅱ and grade Ⅲ,Ⅳ,the positive expression of bFGF were (9.51 + 2.69)％,(24.78 ±- 7.57 )％,(41.23 ± 12.35 )％,respectively,and MMP-2were (7.18 ± 2.12)％,(21.56 ± 3.85 )％,(54.32 + 7.32)％,respectively.The differences were significant among them (P ＜0.05).bFGF and MMP-2 were positive correlated (r ＝0.71,P ＜0.01).Conclusions There is an intrinsic correlation between the expression of the bFGF and MMP-2 and histological grade of human gliomas.These findings suggest that the synergistic interaction of bFGF and MMP-2 play an important role during the tumor invasion.

Distribution Characteristics and Drug Resistance Analysis of Pathogens from 2005 to 2007 / 中华医院感染学杂志

OBJECTIVE To investigate the uses of antibacterials,the characteristics of bacterial distribution and the drug resistance and provide a foundation for reasonable application of antibacterials.METHODS Germs isolation and cultivation were carried out according to National Clinical Testing Operation Procedures(2nd edition).Germs definition and resistance test were carried out by using VITEK 2 Compact microbiological assay system.Statistical analysis was processed by using WHONET 5.4.RESULTS Totally 7815 strains of bacteria were isolated from clinical samples,most of which were Gram-negatives(G-)(58.0%,56.3% and 59.5%,respectively in the 3 years).The tendency of Gram-positives(G+) didnot charee obviously(about 20%).Theresistance were increasing.The resistance rate of Staphylococcus aureus was more than 70.0 % to the most antibacterials.Up to now,there was no vancomycin-resistant isolate.CONCLUSIONS We should use antibacterials reasonably and efficiently to delay and control drug resistance,according to the susceptibility test.

The effects of insulin-like growth factor-II on the proliferation of osteoblast-like cells in vitro / 中华口腔医学杂志

<p><b>OBJECTIVE</b>To seek for the appropriate concentration, at which IGF-II can exerts its strong effects on postirradiation proliferation, physiological function and differentiation of the rat's osteoblast-like cells (ROB).</p><p><b>METHODS</b>The osteoblast-like cells used were isolated from the calvariae of neonatal (one-day-old) SD rats by sequential enzymatic digestion. The third passages of the cells were irradiated with gamma-ray from a (60)Co source at the doses of 100, 400, 600, and 900 cGy. The medium was changed immediately after irradiation and 5 concentrations of IGF-II, i.e., 0, 0.1, 1.0, 10.0, and 100.0 microgram/L were added. 6 days after radiation (9 days in culture), the examination, or the measurement of relative cell number, was carried out.</p><p><b>RESULTS</b>Radiation inhibited the ROB, even lethally. IGF-II completely counteracted the inhibitory effects when the cells were exposed to the radiation at lower dose (100 cGy), and partially when at higher dose (400 cGy). But after the radiation at much higher dose as 900 cGy, the damages were irreversible, even with the existence of this growth factor.</p><p><b>CONCLUSIONS</b>At least a portion of effective recovery of postirradiation damages may be due to IGF-II-induced radioresistance. Incubation with IGF-II can increase radioresistance or repair of radiation-induced cells damages. However, this effect depends on the dose of radiation.</p>

Effect of herbal tongxinluo on thrombus formation and neointimal hyperplasia of the balloon injured rabbit peripheral arteries / 中国临床药理学与治疗学

AimThe effect of herbal tongxinluo on the thrombus formation and neointimal hyperplasia of the balloon injured rabbit abdominal aorta and iliac artery was observed. Methods36 New zealand rabbits were divided randomly into 3 groups: tongxinluo group(16 rabbits); aspirin group(11 rabbits) and control group(9 rabbits). The rabbits were treated with herb tongxinluo 0.38g·kg-1 · d-1, aspirin 50mg·kg-1 · d -1 and 0.09% natrium chloride 10 ml · d-1 alternatively. The arterial injury model was made 1 week after taking the medicine and the injured segments were taken at 24 hours,1 week or 1 month after the procedure, then the samples were stained by hematoxylin and eosin. The thrombus formation and the neointimal hyperplasia of the injured arteries were observed under microscope. Results The arterial neointimal hyperplasia was seen in both abdominal aorta and iliac artery 24 hours and 7 days after the balloon injury in each group,which led to stenosis in 5%～40% of the arterial lumen, the neointimal hyperplasia was much more significant in 2 rabbits 1 month after the balloon injury. The ratio of the arteries with thrombosis in aspirin group was less than that in the other 2 groups, but the difference was not significant. The ratio of neointimal hyperplasia in tongxinluo group was significantly less than that in aspirin and control groups. Conclusion The balloon injured rabbit abdominal aorta and iliac artery appeare to be an ideal model in researching restenosis after percutaneous transluminar coronary angioplasty(PTCA) . Herbal Tongxinluo significantly inhibit the neointimal hyperplasia of the balloon injured rabbit peripheral arteries, which indicate that herbal Tongxinluo might be a promising medicine in preventing restenosis.

Automatic Control of Air Quality in BSL-3 Laboratory / 环境与健康杂志

Objective To keep the homeostasis of pressure grad, temperature and humidity among every area, and to ensure the protective effect of engineering barrier in biology safety. Methods DDC was used in the control system based on the transducer and special data collection equipment, and the figure monitoring system was established. The computer was used to save and process the data of real time and then the related output devices were regulated according to the situation. The alarm will be sounded if any data is out of the limit. Results The system could collect real-time simulation quantity signal of pressure, temperature, humidity, resistance, device work condition and so on in every area in laboratory, such as air-condition, air filter, fan and electric-performer's start-stop(operate) state. The alarm information was showed by CRT coloured dynamic emulational figure. Monitoring center could rework the local control parameters through the DDC controller, the system could adjust the device output automatically. Monitoring center could make alert automatically and the tache and causation were displayed then the operator could deal with the alert message according to the user grade. Conclusion The automatic control system introduced in this article can observe the indoor environment state and control the running parameters of the device availably and immediately. It can meet the requirement of laboratory biological safety.

Study of the Preparation Technique and Stability of Ketorolac Tromethamine Eye Drops / 中国药房

OBJECTIVE:To establish a reasonable formulation and preparation technique of Ketorolac Tromethamine eye drops and to study the stability.METHODS:The content,related substances and pH value were taken as the observing pa?rameters to design the formulation and preparation technic.The stability of3batches of sample was tested.RESULTS&CONCLUSION:The eye drops was rational in formulation and feasible in preparation technic.The preparation in commercial packing was stable after6-month acceleration test and9-month storage at room temperature.