1.Quality control of large scale clinical trials
Chinese Journal of Clinical Pharmacology and Therapeutics 2000;0(01):-
In the recent 2 decades,the clinical medical mode has been changed greatly.The experience-based medical mode is gradually replaced by evidence-based mode,ie,evidence-based medicine.Large scale clinical trials provide robust evidence for clinical practice and quality control is critical for the success of one trial.We discuss six facets on this subject,including protocol design,staff training,manual formulating,organization,data management and monitoring.The objective of quality control is to ensure the study conducted according to the protocol,the results are reliable and protect the human rights of participants.
2.Clinical research progresses in umbilical cord blood transplantation in the treatment of hematologic malignancies
China Oncology 2014;(10):732-737
Allogeneic hematopoietic stem cell transplantation is the only treatment method to cure hemato-logic malignancies. However, dififculty in obtaining the human leukocyte antigen (HLA) match donors is a major lim-itation in this therapeutic strategy. Many studies have demonstrated that umbilical cord blood is rich in hematopoietic stem cells and can be used as a source of stem cells of hematopoietic stem cell transplantation. Growing evidence also supports the efifcacy of cord blood transplantation (CBT) to treat patients with haematological malignancies, and the number of CBTs is rapidly increasing. Compared to other sources of stem cells, umbilical cord blood is physical cryo-preserved. Therefore, it is very convenient for transplantation, particular for those who need to receive transplantation sooner. In addition, the incidence and severity of graft versus host disease(GVHD) in CBT are usually relatively lower. Herein, we review considerations regarding status, research progresses and selection of umbilical cord blood in CBT.
3.The relationship between nurse' well-being and personality characteristics from the perspective of positive psychology
Chinese Journal of Practical Nursing 2014;30(34):12-16
Objective To explore the relationship between the subjective well-being and personality characteristics of nurses,and provide the basis for managers to implement humanized management and improve the nurse happiness from the perspective of positive psychology.Methods A total of 190 nurses were selected from a hospital of Zhongshan city by convenience sampling technique.And General Situation Questionnaire,Happiness Scale and the revised Eysenck Personality Questionnaire-Short Form (Chinese version) were used in the investigation.Results The average score of general happiness was (54.91± 9.18) points for male nurses,which was lower than that of the national norm.The sense of happiness between male and female nurses showed statistical difference.The emotional stability of nurses with different marital status showed significant difference.Nurses' subjective well-being and personality characteristics had a significant causal relationship by multiple stepwise regression analysis.Conclusions The general wellbeing about nursing staff is lower than the national norm,male nurses' happiness was lower than that of female and married nurses' emotional instability is higher than unmarried nurses.The nurses' personality is an important factor that affect their happiness.Managers should be under the guidance of the positive psychology,pay attention to the nurse' personality characteristics to improve the nurse' happiness,improve the level of nurse' mental health,to stabilize and optimize the nursing team,and improve the quality of nursing.
4.Initial investigation of serum homocysteine as cancer biomarker
Liyuan WANG ; Ling MA ; Jianrong SU
International Journal of Surgery 2012;39(11):752-755
Objective To study the expression of homocysteine in serum of patients with common malignant tumor,and initially investigate the possibility of serum homocysteine as cancer biomarker.Methods Expression levels of homocysteine and caner biomarkers (CEA,AFP,CA125,CA199) in serum of 180 patients with established malignant tumor and 30 healthy controls (control) were measured,the results of homocysteine were compared with that of the cancer biomarkers based on the cutoff value used in clinic.Results The expression levels of homocysteine was significantly higher in patients with malignant tumor than in controls [(13.89 ± 4.95) μmol/L-(21.40 ± 9.38) μ mol/L vs (11.40 ± 3.13) μmol/L,P < 0.05)].Conclusions The positive predictive rate of homocysteine is higher than the four kind of cancer biomarkers in lung cancer,breast cancer,esophageal cancer.The increase of homocysteine in tumors may be universal,and Homocysteine may be used as cancer biomarker in lung cancer,breast cancer and esophageal cancer.
5.Comparative analysis of clinical characteristics of children and adults with brucellosis osteoarthritis in Yinchuan, Ningxia
Liyuan MA ; Sen SHI ; Linghua DONG ; Jinhai MA
Chinese Journal of Endemiology 2021;40(4):315-320
Objective:To investigate the difference of clinical characteristics of children and adults with brucellosis osteoarthritis in Yinchuan, Ningxia.Methods:The clinical data of patients with brucellosis osteoarthritis who were diagnosed in General Hospital of Ningxia Medical University from January 2009 to September 2019 were collected retrospectively. According to age, the patients were divided into two groups: children (0-14 years old, 50 cases) and adults (≥15 years old, 236 cases). Epidemiological characteristics, clinical manifestations and laboratory examination results of the two groups were compared and analyzed.Results:Among children, 39 were males and 11 were females, school age children (8-14 years old, 25 cases) were more common; among adults, 179 were males and 57 were females, middle-aged and elderly people (46-65 years old, 128 cases) were more common. The peak incidence of both groups was from March to August (39 children and 142 adults). In the two groups, a total of 266 patients (40 children and 226 adults) were recorded with a history of exposure, of which 226 patients (28 children and 198 adults) had contacted with cattle, sheep and other live animals. In clinical manifestations, compared with children, adults had higher incidences of low back pain [38.00% (19/50) vs 63.98% (151/236)], hyperhidrosis [6.00% (3/50) vs 30.08% (71/236)] and fatigue [8.00% (4/50) vs 34.75% (82/236)], and lower incidences of single joint pain [70.00% (35/50) vs 19.49% (46/236)], fever [72.00% (36/50) vs 49.15% (116/236)], and lymph node enlargement [30.00% (15/50) vs 2.54% (6/236)], and the differences were statistically significant ( P < 0.05). Among children, the knee joint involvement (62.00%, 31/50) and hip joint involvement (42.00%, 21/50) were more common, but spinal involvement was not found; while among adults, spinal involvement (55.51%, 131/236) was the most common. The incidences of elevated white blood cell count [18.00% (9/50) vs 6.36% (15/236)], elevated percentage of lymphocytes [82.00% (41/50) vs 27.12% (64/236)], elevated platelet [24.00% (12/50) vs 8.90% (21/236)], elevated aspartate aminotransferase [64.00% (32/50) vs 30.08% (71/236)], elevated alanine aminotransferase [38.00% (19/50) vs 20.76% (49/236)] and anemia [42.00% (21/50) vs 16.53% (39/236)] in children were higher than those in adults; the incidences of elevated percentage of neutrophils [0 (0/50) vs 9.75% (23/236)], hypoalbuminemia [2.00% (1/50) vs 14.41% (34/236)], low sodium [2.00% (1/50) vs 10.17% (24/236)], elevated C-reactive protein [50.00% (25/50) vs 77.12% (182/236)] in children were lower than those in adults, and the differences were statistically significant ( P < 0.05). The positive rate of blood culture in children (65.22%, 30/46) was higher than that in adults (40.54%, 60/148), and the difference was statistically significant ( P < 0.05). Conclusions:There are differences in clinical characteristics between children and adults with brucellosis osteoarthritis in Yinchuan, Ningxia. In particular, there is a significant difference between children and adults in the location of bone and joint involvement.
6.Ability of reproduction and maintaining characteristics of hypertension and stroke in prone-stroke spontaneously hypertensive rats
Wen WANG ; Ruicheng SUN ; Peihe WANG ; Huidong ZHANG ; Liyuan MA
Chinese Journal of Tissue Engineering Research 2005;9(21):231-233
BACKGROUND: Stroke-prone spontaneously hypertensive rat(SHRsp) is an animal model of hypertensive stroke commonly used. The species is hard to be maintained due to hypertension and easily affected by environmental factors, therefore the characteristics of stroke are always aberrated.OBJECTIVE: To observe the abilities of reproduction and maintaining the characteristics of hypertensive stroke in SHPsp.DESIGN: Observational controlled study based on rats.SETTING: Cardiovascular Disease Institute and Fuwai Hospital of Chinese Academy of Medical Sciences.MATERIALS: The experiment was conducted Cardiovascular Disease Institute and Fuwai Hospital of Chinese Academy of Medical Sciences during September 1999 to December 2001. Totally 93 pairs(186) strain SHRsp, 48stroke-prone spontaneously hypertensive rats of 8 weeks age as well as 98pairs(196) rats of normal blood pressure [Wistar Kyoto rat (WKY) ] were selected.METHODS: Brother sister mating method was used. And the conception rate, number of litter size(only calculating the litter size of mother rat not eating neonatal rats), rate of eating neonatal rats by mother rats were recorded and compared with those of WKY. The systolic pressure and heart rate of strain rat were measured when they were 12, 16 and 20 weeks old. In addition, 488-week SHRsp were loaded 10 g/L salty water to accelerate the occurrence of stroke and hypertension and executed when they naturally dead or 12 weeks after salty water load. The brain tissue was processed by H-E staining and observed under microscope to detect the incidence of stroke.MAIN OUTCOME MEASURES: Conception rate of female rats within 2years; litter rate of pregnant rats; eating, rate of eating neonatal rats by mother rats; systolic pressure of strain rat; heart rate; detection rate of stroke.RESULTS: Totally 93 pairs(186) strain rats of SHRsp, 98 pairs(196) WKY and 48 SHRsp of 8 weeks old entered the final analysis. In the first year there were 2 generations delivered, the average conception rate( 100% ) and average litter number (10.3 rats) of SHRsp were higher than those of WKY of the same term(90%, P < 0. 001; 6. 5 rats, P < 0. 001) . In the second year, there were 2 generations of which the conception rate and average litter number(89%, 8.2 rats) of SHRsp were higher than those of WKY(59%, P < 0. 001; 4. 3 rats, P < 0. 001). There were 87 SHRsp female rats and 67normal blood pressure rats pregnant within 2 years, the rate of eating neonatal rats within 4 weeks postnatal was 6% (5/87) which was lower than that of WKY(18%, 12/67), P > 0.05. The systolic pressure of 12weeks old male rats and female rats was 191.6-223.8 mm Hg and 174. 2-196. 3 mm Hg respectively, while that of 16-week old and 20-week male rats were 219.0 -224. 9 mm Hg and 232.0 -242.6 mm Hg respectively. The blood pressure of SHRsp increased with the advancing of age. The heart rate of 12-week old male and female rats was 388-428 times per minute and 373-417times/minute respectively while that of 16-week and 20-week male rats were 392 -410 times per minute and 404-425 times per minute respectively. The pathological detection rate of 48 SHRsp was 81% (39/48).CONCLUSION: The reproduction ability of SHRsp is similar to normal rats. The blood pressure, heart rate and pathological examination of brain tissue of them all maintain the characteristics of hypertension and stroke so that they can be used as qualified experimental model.
7.Effects of Indwelling Time Duration of Femoral Vein Catheter on Bacterial Colonization in Patients with Hemodialysis Treatment
Liang MA ; Qin XU ; Haifeng MAO ; Liyuan ZHANG
Chinese Journal of Nosocomiology 2006;0(12):-
OBJECTIVE To study the effects of indwelling time of femoral vein catheter on bacterium colonization in patients with hemodialysis treatment,then to choose the optimal one from infection prevention viewpoint.METHODS The patients were divided randomly into three groups according to their catheter indwelling time(group A2 weeks)(20 patients in each group).Samples from skin and the tip of the catheter were cultured,and compared the colony number and strain distribution.RESULTS There was bacterium colonization on punctured skin and the tip of the catheter after using it for a long time.The longer it was,the higher the positive rate was.The positive rate of bacterium colonization in groups B,and C was 25% vs 100%(P
8.Synthesis of Boronic Acid-functionalized Soluble Dendrimers and Its Application in Detection of Human Liver Microsomal Glycoprotein Based on Enzyme-linked Immunosorbent Assay
Tiantian LI ; Liyuan ZHANG ; Zhenlong YU ; Xiaochi MA ; Sa DENG
Chinese Journal of Analytical Chemistry 2017;45(9):1259-1263
The glycoproteins in the biological sample are low abundance and are susceptible to be inhibited and interfered by other non-glycoproteins.An enrichment step is usually required before the glycoprotein analysis, but the operation steps of conventional solid-phase-based glycoprotein enrichment methods are difficult to be compatible with the most classical enzyme-linked immune sorbent assay (ELISA) technique.In this study, a novel water-soluble dendrimer based boronic acid capture (DBC) material was developed using PAMAM 4.0 as the carrier and boronic acid as the affinity group.The method was applied to the detection of glycoproteins in human liver microsomes using ELISA.In this study, the DBC enrichment conditions were optimized by model glycoprotein, and then its sensitivity and anti-interference ability were investigated.This method was applied to the enrichment of glycoproteinsin human liver microsomal.The results showed that the enrichment selectivity of DBC for glycoprotein could be up to 100000 folds, and the enrichment signal of glycoprotein could be increased by 100 times.Therefore, the ELISA method using DBC as a novel enrichment material for glycoprotein had high sensitivity and selectivity in detection of biological samples with only one simple incubation step, which was useful for glycoproteins researches.
9.Effects of combination of maternal hydration and hands and knees posture on nursing of breech pregnancy
Lina LI ; Liyuan ZHAO ; Hong XIAO ; Shengnan MA ; Yaqin XIE
Chinese Journal of Practical Nursing 2017;33(20):1554-1558
Objective To compare the effects of combination of maternal hydration and hands and knees posture with simple hands and knees posture on correction of breech pregnancy. Methods One hundred patients who were diagnosed breech pregnancy from November 2015 to November 2016 were assigned to experimental group and control group with 50 cases each according to individual willingness. The patients in experimental group received the combination of maternal hydration and hands and knees posture;while the patients in control group received simple hands and knees posture. Results Amniotic fluid index was (18.94±2.44)cm in experimental group and (15.97±2.33)cm in control group, the difference had statistic significance (t=6.239, P<0.05). The effective transfer rate and successfully used time was 92%(46/50) , (2.10 ± 0.75) weeks in experimental group and 64%(32/50), (4.27 ± 0.98) weeks in control group, the difference had statistic significance (χ2=11.422, P<0.05; t=-12.463, P<0.05). For primipara and multipara, the effective transfer rate was 90.91%(30/33), 16/17 in experimental group, and 68.75%(22/32), 10/18 in control group, the difference had statistic significance (χ2=4.986, 6.806, all P<0.05). The rate of vaginal and cesarean section deliveries was 86%(43/50), 14%(7/50) in experimental group, and 56%(28/50), 44%(22/50) in control group, the difference had statistic significance(χ2=10.928, P=0.001). Patients who had fetal movement or who didn′t have time to do correction or missed was 17.10%(46/269), 1.49%(4/269) in experimental group, and 12.55% (22/255), 7.06% (18/255) in control group. Conclusions @Therapic effects of combination of maternal hydration and hands and knees posture is much better than that of the simple hands and knees posture therapy on correction of breech pregnancy, which is worthy of popularization and application in clinic.
10.Effects ofLiuwei-Dihuang Pills combined with Ginkgo Biloba Leaves Extract Tablets on complications of type 2 diabetes mellitus
Yaping WU ; Liyuan FU ; Lin GUO ; Jiangyi YU ; Jianhua MA
International Journal of Traditional Chinese Medicine 2015;(3):213-216
Objective To investigate the effects ofLiuwei-Dihuang Pills combined with Ginkgo Biloba Leaves Extract Tablets on diabetic complications in patients with type 2 diabetes mellitus (T2DM). Methods Seventy-eight patients with T2DM were randomized into a TCM treatment group and a conventional treatment group by random number table method, 39 in each group. The patients in the conventional treatment group were regularly using antihyperglycemic drugs or insulin. On the basis of conventional treatment group, the patients in the TCM treatment group were additionally treated withLiuwei-Dihuang Pills and Ginkgo Biloba Leaves Extract Tablets. Intima-media thickness (IMT) of internal carotid artery, vibration perception threshold (VPT) and diabetic retinopathy in both groups were detected before the treatment, 12 and 36 months after the treatment.Results The VPT in the left foot 12 months after the treatment in the TCM treatment group were significantly lower than that in the conventional treatment group (13.98 ±4.38 Vvs. 18.70 ±2.43 V;t=2.764, P=0.008). IMT of internal carotid artery (left: 0.81 ± 0.16 mmvs.0.70 ± 0.10 mm,t=3.120,P=0.003; right: 0.81 ± 0.17 mmvs. 0.73 ± 0.12 mm,t=2.286,P=0.026), VPT (left foot: 14.82 ± 6.45 Vvs. 20.63 ± 9.75 V,t=2.714, P=0.009; right foot: 16.73 ± 7.10 Vvs. 20.73 ± 10.35 V,t=2.001,P=0.048) and incidence of diabetic retinopathy (35.9%vs. 53.8%;χ2=5.804,P=0.016) 36 months after the treatment in the TCM treatment group were significantly lower than those in the conventional treatment group.ConclusionsLiuwei-Dihuang Pills combined with Ginkgo Biloba Leaves Extract Tablets can effectively reduce the progression of diabetic complications in patients with T2DM.