1.MedDRA and its applications in statistical analysis of adverse events.
Acta Pharmaceutica Sinica 2015;50(11):1396-401
Safety assessment in clinical trials is dependent on an in-depth analysis of the adverse events to a great extent. However, there are difficulties in summary classification, data management and statistical analysis of the adverse events because of the different expressions on the same adverse events caused by regional, linguistic, ethnic, cultural and other differences. In order to ensure the normative expressions, it's necessary to standardize the terms in recording the adverse events. MedDRA (medical dictionary for regulatory activities) has been widely recommended and applied in the world as a powerful support for the adverse events reporting in clinical trials. In this paper, the development history, applicable scope, hierarchy structure, encoding term selection and standardized query strategies of the MedDRA is introduced. Furthermore, the practical process of adverse events encoding with MedDRA is proposed. Finally, the framework of statistical analysis about adverse events is discussed.
2.Effects of semirecumbent positions of different degrees on mechanical ventilation and prevention of compli-cations for ventilated patients
Qixia JIANG ; Juan LIU ; Yuxiu LIU
Journal of Medical Postgraduates 2016;29(10):1083-1088
Objective Mechanical ventilation is an important life support treatment in ICU, however, patients are at high risk for ventilator?associated pneumonia(VAP) and other complications which can increase the risk of death. In the article, comparative investigation was made on ventilation effects of different degrees of semirecumbent positions and preventive effects of VAP and pressure ulcers in order to provide evidence for preferred position. Methods 46 patients were divided into 30° group and 45° group in halves according to the angle of semirecumbent position. Patient position changes were performed among semirecumbent, right and left laterally inclined positions every two hours in both groups for consecutive 7 days. The peak airway pressure (PAP) and minute ventilation (MV) changes were measured every half an hour in two hours after semire?cumbent positioning every day during ventilation. The pressure of arte?rial oxygen(PaO2), pressure of arterial carbenoxide (PaCO2) and PaO2/FiO2(fraction of inspired oxygen,FiO2) were tested every day during intervention, along with the observation on the incidence of VAP and pressure ulcers. Results MV at each time point was normal in two hours after semirecumbent positioning in both groups with no changes to prolonged time ( P<0.05) . PAP increased with the prolonged time at each time point, which was higher in 45° group compared with 30°group(P<0.05). No significant difference was found in the incidence of VAP and pressure ulcers between two groups (P>0.05). Conclusion Both 45° and 30°semirecumbent po?sitions can be applied in ventilated patients and the patient′s medical condition and tolerance are the keys when choosing preferred posi?tion and duration.
3.Incidences of malnutrition and abdominal obesity in elderly type 2 diabetes
Kang YU ; Yuxiu LI ; Qiuying LIU
Chinese Journal of Clinical Nutrition 2009;17(1):13-16
Objective To investigate the incidences of malnutrition (including undernutrition, overweight, and obesity) and abdominal obesity in elderly type 2 diabetes. Methods Totally, 133 elderly type 2 diabetes patients [study group, aged (66.9 5±.4) years] and 133 age-matched healthy subjects [control group, aged (66. 3 ±5.8) years] who met entry criteria and obtained informed consent were randomly enrolled into this study. Body weight, total body fat (TBF), abdominal fat, visceral fat, visceral fat area, and waist-to-hip ratio (WHR) were measured by multi-frequency bioelectric impedance analysis. The incidences of undernutrition, overweight, obesity, and abdominal obesity judged by BMI and WHR respectively were compared between the two groups. Results Com- pared to control group, BMI [(25.7 3.8) vs. (24.2 2.2) kg/m2, P = 0.001 ], TBF [ (20.1±6.9) vs. (17.4 5.0) kg, P = 0.001], WHR (0. 92±0.10 vs. 0.87±0.06, P =0.001), abdominal fat [(10.2 3.4) vs. (8.6 2.5)kg, P= 0.001], visceral fat [(2.7±0.9) w. (2.3 0.7)kg, P =0.001 ], and visceral fat area [ (89.1±28. 8) vs. (75. 7±21. 6) cm2, P =0.001 ] significantly increased in study group. The incidences of undernutrition (BMI<18.5, 3.8% vs. 0, P=0.024) and obesity (BMI^28.0, 26.3% vs. 6.0%, P = 0.001) judged by BMI Chinese standard in study group were significantly higher than those in control group. The incidences of "over-TBF" (52. 1% vs. 34. 1% , P =0.023) and abdominal obesity in males of study group (83.6% vs. 67.1% , P =0. 017) were significantly higher than those in control group. Conclusion Measurement and control of TBF, waist circumference, and abdominal and visceral fats should be emphasized in elderly patients with type 2 diabetes.
4.Significance of thyroid function screening in high-risk pregnant women with gestational diabetes in early pregnancy
Yingying MU ; Yuxiu LIU ; Xia XIU
Clinical Medicine of China 2015;31(5):461-463
Objective To investigate the significance of thyroid function screening in high-risk pregnant women with gestational diabetes (GDM) in early pregnancy.Methods A total of 194 cases with GDM were selected as our subjects.The patients were divided into group A(three normal items,a total of 109 cases),group B (one abnormal item,a total of 57 cases) and group C (two abnormal items,a total of 28 cases).The levels of serum anti-thyroglobulin antibody (TGAb),anti-thyroid peroxidase antibody (TPOAb),serum three triiodothyronine(TT3),thyroxine (TT4),free three triiodothyronine (FT3),free thyroxine (FT4) and thyroidstimulating hormone (TSH) were screened.Results TSH levels in group A was (1.45 ± 0.43) mU/L,significantly lower than in group B and group C((1.77±0.53),(1.89±0.74) mU/L).FT4 levels in group A was (11.62±0.98) nmol/L,significantly higher in group B and group C((10.23±0.75),(9.87±0.88) nmol/L)).Proportion of TPOAb,TGAb positive in group A were 9.17%(10/109) and 21.05%(12/57),significantly lower than that of group B and group C((28.57%(8/28) and 3.67%(4/109),7.02%(5/57) and 17.86%(5/28)).And the differences were significant (P< 0.05).And TPOAb + TGAb in group A was 0.92%(1/109),significantly lower than that of group B and group C(7.02% (4/57),17.86% (5/28);P <0.05).Conclusion The importance of screening thyroid function in early pregnancy in women at high risk for gestational diabetes is worthy of clinical promotion.
5.Uniform requirements for reporting Meta-analysis of randomized controlled trials: the QUOROM statement
Yuxiu LIU ; Dan ZHANG ; Mei SHENG ;
Chinese Journal of Clinical Pharmacology and Therapeutics 2002;0(05):-
The QUOROM statement means a set of quality standards of Meta analysis report. It comprises a checklist and a flowchart for reporting a Meta analysis. They are primarily used in writing, reviewing or evaluating reports of Meta analysis for simple two group, parallel RCTs. The statement is a continually evolving document. A few international medical journals have endorsed the QUOROM statement and require authors submitting manuscripts for publication to include all the information on the checklist and flowchart of QUOROM statement. Based on introducing the background, processes of forming QUOROM statement and reviewing the contents and requirements of QUOROM, we prepare this paper, hoping to improve the quality of Meta analysis report for randomized controlled clinical trials in our country. Some comments and suggestions are given at the same time.
6.All-round administrating scientific research grants to ensure their quality
Shuguang ZHANG ; Yuxiu LIU ; Jun ZHENG
Journal of Medical Postgraduates 2003;0(03):-
Grant administration in hospitals is one of the important tasks for administrators of scientific research, and all leaders should also pay enough attention to it and regard it as a strategic assignment of hospital development. In this paper, we found out the key points in different phases of scientific researches through quality analysis of grants and the whole procedure of research, and put forward the keystone administration. We also discussed a new model of subject construction, thesis and achievements administration leaded by grant administration, which should basically and greatly raise the level of scientific research in the hospital.
7.Variation of hospitalization expenses with different accounting quotas
Lin CHEN ; Yuxiu LIU ; Shouyi YU
Journal of Medical Postgraduates 2003;0(05):-
Hospitalization expenses constitute the main part of the compensation of medical insurance.The aim of this paper is to analyze the variation of medical expenses of hospitalized patients with medical insurance in different modes of accounting,find the influencing factors in accounting quotas on hospitalization expenses,and set up a scientific and reasonable mode of accounting with a full consideration of the huge demands of medical resources.
8.MAOA gene polymorphism and aggression: A review
Shaojiang LIU ; Yuxiu SHI ; Fang HAN
Chinese Mental Health Journal 2017;31(7):580-584
Monoamine oxidase A (MAOA) can catalyze the degradation of a variety of amine neurotransmitter,including serotonin.The abnormalities of these neurotransmitter are closely associated with many psychiatric disorders.Studies have found that MAOA is polymorphic,with a low activity variant (MAOA-L),and a high activity variant (MAOA-H).In this review,through the studies of early stress on human and animal models,the effects of early stress and MAOA polymorphism on the behavior and emotional loop of individuals are analyzed.Analysis shows that,MAOA-L,versus MAOA-H,is more plastic.In early adverse environment,MAOA-L will increase the risk of adult violence,and in the early of energetically favorable environment will reduce the incidence of violence.Abnormality is more likely to occur in the emotional processing and cognitive function in the neural affective loop of individuals with MAOA-L,which makes them more environmentally susceptible than those with MAOA-H.
9.Expression of Caspase-12 in cellular apoptosis of hippocampus in the rat model of posttraumatic stress disorder
Hong LIU ; Fang HAN ; Yuxiu SHI
Acta Anatomica Sinica 2014;(4):452-456
Objective To observe changes of apoptosis and Caspase-12 expression in hippocampus of the rat model of posttraumatic stress disorder ( PTSD ) .Methods Single prolonged stress ( SPS ) was used to duplicate a rat model of PTSD.Male Wistar rats were randomly divided into 1, 4, 7 days groups after exposure to SPS and a normal control group.Transmission electron microscopy was used to observe morphologic changes of the hippocampus neurons .The expression of Caspase-12 was detected by immunohistochemistry , Western blotting and RT-PCR.Results After SPS, the hippocampus neurons had characteristic morphologic changes of apoptosis , and the expression of Caspase-12 reached the peak at SPS 4d.Conclusion PTSD activates the ERS-mediated apoptosis in hippocampus via Caspase-12, which may be a pathophysiology base of the atrophy of the hippocampus in PTSD .
10.The clinical laboratory characteristic of Candida albicans caused antibiotic-associated diarrhea
Qianya ZOU ; Guozhong LIU ; Yuxiu ZHOU
International Journal of Laboratory Medicine 2014;(19):2586-2588
Objective To analyze the clinical laboratory characteristic of Candida albicans caused antibiotic-associated diarrhea (AAD) .Methods 100 cases of AAD were selected .Based on the results ,they were divided into Candida albicans group and non-Candida albicans group .The levels of sodium ,potassium ,fasting blood-glucose and albumin ,investigation of antimicrobial usage were compared in two groups .Results Candida albicans were detected in 42 cases .The levels of sodium ,potassium and fasting blood-glucose in the Candida albicans group were significantly higher than those in non-Candida albicans group(P<0 .01) ,and al-bumin were significantly lower than that in non-Candida albicans group(P< 0 .01) .The rate of two or more antibiotic usage in Candida albicans group was significantly higher than that in non-Candida albicans group(P<0 .05) .The drug resistance rates of fluconazole ,itraconazole ,voriconazole ,amphotericin B and flucytosine in Candida albicans group were significantly lower than those in non-Candida albicans group(P<0 .05) ,and the antibiotic sensitive rates of fluconazole ,itraconazole ,voriconazole ,amphotericin B and flucytosine in Candida albicans group were significantly higher than those in non-Candida albicans group(P<0 .05) .The drug resistance rates of vancomycin and macrodantin in Candida albicans group were significantly higher than those in non-Candida al-bicans group(P<0 .01) ,and the antibiotic sensitive rates of vancomycin and macrodantin in Candida albicans group were signifi-cantly lower than those in non-Candida albicans group(P<0 .01) .Conclusion For AAD cases ,the fecal culture can provide exper-imental basis for clinical treatment and avoid the abuse of antibiotics .