1.Using random allocation book for random allocation concealment in a clinical trial
Weihua ZHONG ; Mengjie LU ; Yuxiu LIU ; Tiantian LIU ; Minlin ZHOU
Journal of Medical Postgraduates 2017;30(1):91-94
Objective Random allocation concealment is important in ensuring high-guality randomized controlled clinical trial.In this paper , we aimed to design a more convenient and effective two couplet random allocation method through improving the random allocation concealment technology which uses the envelope method . Methods According to the randomized sequence , a two-couplet random allocation should be prepared for every subject and bound into a book in order , which named random assignment book with cover and instructions .The first couplet is to collect the enroll information and the second couplet is to show the allocation informa -tion.The serial numbers of the two couplets which around sealant are the same , and leave blank at the same areas of the two couplets for signing the enter information .The content of the first couplet can be completely copied to the second couplet .In order to avoid expo-sing the allocation information in advance , the back of the second couplet should be black-printed. When the subjects are sure qualified, the researchers selected the corresponding two couplet in a sequential order .Exposing the allocation infromation in the second couplet, and the subjects will be allocated to the group designated on the second couplet .This random allocation book should be entrusted to professional printing mechanism ,printing according to the random assignment sequence table and in the strict quality control .For the multicenter clinical trials , it can be printed in parts . Results The method has been implemented in nearly ten randomized controlled trials and obtained the consistent high praise . Conclusion The random allocation book method is easy to produce , simple operation and convenient in monitoring , which can effectively achieve the random allocation concealment in a clinical trial as well as having a sig -nificantly practical value in ensuring the quality of randomization .
2.Effects of alexithymia on disability acceptance among uremia patients
Yingxiao WANG ; Fang LIU ; Ling ZHU ; Fang WANG ; Minlin ZHOU ; Guilan Lü
Chinese Journal of Nursing 2017;52(3):346-350
Objective To investigate the current situation of disability acceptance and alexithymia among uremia patients,and to explore the effects of alexithymia on disability acceptance.Methods Totally 342 uremia patients were recruited by convenience sampling method.Patients were investigated with general information questionnaire,Acceptance of Disability Scale (ADS) and the Toronto Alexithymia Scale (TAS-20).Results The mean scores of disability acceptance and alexithymia were 180.45±26.93 and 52.35±8.24,respectively.The affective disorder of recognition,affective disorder of description and extroverted thinking were significantly negatively correlated with each dimension of disability acceptance(P<0.05).Multiple linear regression analysis showed that alexithymia,gender and course of disease were influencing factors of disability acceptance for uremia patients(P<0.05).Conclusion The level of disability acceptance was in the medium level among uremia patients,and alexithymia,gender and course of disease were its influencing factors.Nursing staff could take effective measures to ameliorate alexithymia and to improve the level of disability acceptance for uremia patients.
3.Whole-body MRI for detecting osseous metastases:comparison with bone scintigraphy
Shanshan LU ; Dehang WANG ; Yongjun LI ; Yang FENG ; Minlin ZHOU ; Xuhui LIU
Chinese Journal of Radiology 2011;45(5):459-462
Objective The aim of the study was to evaluate the reliability of whole-body MRI(WBMRI)in detecting osseous metastases.Methods Thirty patients verified with malignant tumor by histology were enrolled.All the patients underwent WB-MRI and bone scintigraphy(BS)with a two week interval.Clinical information,conventional MRI and CT images,and follow-up data were collected as gold standard for the diagnosis of bone metastases.The data of 30 patients and 270 segments as study unit respectively were analyzed.The sensitivity and specificity between WB-MRI and BS were compared with McNemar test.Resuits Bone metastases were confirmed in 27 of 30 patients by gold standard.Twenty-five patients with bone metastases were detected by WB-MRI and no false-positive cases.Twenty-seven patients with bone metastases were Nund by BS but having two false-positive oases.With patients as study unit,the diagnostic sensitivity of WB-MRI and BS were both 92.6%(25/27)and the specificity were 100%(3/3)and 33.3%(1/3),respectively.The area under ROC curve of WB-MRI and BS were 0.9630 and 0.6296,respectively(P>0.05).With segments as study unit,119 bone metastases segments were confirmed.The diagnostic sensitivity of WB-MRI and BS were 90.8%(108/119)and 70.6%(84/119)(P<0.01),while the specificity were 98.0%(148/151)and 90.7%(137/151),respectively(P<0.01).The area under ROC curve of WB-MRI and BS were 0.9438 and 0.8066.The former was obviously higher than the latter(P<0.01).Meauwhile.by WB-MRI,3 cases coexisting with brain metastases,4 cases with lung metastases,and 4 cases with hepatic metastases were found.Conclusion WB-MRI was a good tool for screening osseous metastases.
4.Analysis of clinical characteristics and prognostic factors in 40 cases of acute glyphosate poisoning
Jianrui DOU ; Xin ZHOU ; Runfeng MIAO ; Yan YANG ; Xin LIU ; Feng ZHANG ; Yi ZHAO ; Minlin ZHOU
Chinese Journal of Industrial Hygiene and Occupational Diseases 2021;39(9):676-681
Objective:To explore the clinical characteristics and prognostic factors of patients with acute glyphosate poisoning, and to provide reference for the comprehensive treatment and prognosis judgment of acute glyphosate poisoning.Methods:The complete hospitalized medical records data of 40 patients with acute glyphosate poisoning who were treated in the emergency department of Affiliated Hospital of Yangzhou University from 2014 to 2019 were collected in August 2020. According to the outcome during the follow-up period of 90 d after discharge from hospital, patients were divided into survival group ( n=33) and treatment failure group ( n=7) . The clinical characteristics of the two groups were analyzed. The influencing factors of prognosis were analyzed by binary logistic regression, and the receiver operating characteristic (ROC) curve was used to evaluate the value of white blood cell count level at admission to the prognosis of patients with acute glyphosate poisoning. Results:The average age of the 40 glyphosate poisoning patients was (57.70±19.72) years old, the oral dose was 100 (50, 200) ml, the hospital stay was 4.0 (1.0, 5.0) d, and the fatality rate was 17.5% (7/40) . The main clinical manifestations were the symptoms of the digestive tract, respiratory tract, cardiovascular system and nervous system. Logistic regression showed that white blood cell level at admission was an influencing factor for the prognosis of patients with acute glyphosate poisoning ( OR=1.148, 95% CI: 1.124-1.791, P=0.003) . The ROC curve showed that the best diagnostic cut-off value of white blood cell level at admission to the prognosis of acute glyphosate poisoning was 14.65×10 9/L, the area under the curve (AUC) was 0.9351. The sensitivity was 100.00%, and the specificity was 84.85%. Conclusion:High level of white blood cell at admission is a risk factor for the prognosis of acute glyphosate poisoning, and white blood cell level at admission has a certain predictive value for the prognosis of acute glyphosate poisoning.
5.Analysis of clinical characteristics and prognostic factors in 40 cases of acute glyphosate poisoning
Jianrui DOU ; Xin ZHOU ; Runfeng MIAO ; Yan YANG ; Xin LIU ; Feng ZHANG ; Yi ZHAO ; Minlin ZHOU
Chinese Journal of Industrial Hygiene and Occupational Diseases 2021;39(9):676-681
Objective:To explore the clinical characteristics and prognostic factors of patients with acute glyphosate poisoning, and to provide reference for the comprehensive treatment and prognosis judgment of acute glyphosate poisoning.Methods:The complete hospitalized medical records data of 40 patients with acute glyphosate poisoning who were treated in the emergency department of Affiliated Hospital of Yangzhou University from 2014 to 2019 were collected in August 2020. According to the outcome during the follow-up period of 90 d after discharge from hospital, patients were divided into survival group ( n=33) and treatment failure group ( n=7) . The clinical characteristics of the two groups were analyzed. The influencing factors of prognosis were analyzed by binary logistic regression, and the receiver operating characteristic (ROC) curve was used to evaluate the value of white blood cell count level at admission to the prognosis of patients with acute glyphosate poisoning. Results:The average age of the 40 glyphosate poisoning patients was (57.70±19.72) years old, the oral dose was 100 (50, 200) ml, the hospital stay was 4.0 (1.0, 5.0) d, and the fatality rate was 17.5% (7/40) . The main clinical manifestations were the symptoms of the digestive tract, respiratory tract, cardiovascular system and nervous system. Logistic regression showed that white blood cell level at admission was an influencing factor for the prognosis of patients with acute glyphosate poisoning ( OR=1.148, 95% CI: 1.124-1.791, P=0.003) . The ROC curve showed that the best diagnostic cut-off value of white blood cell level at admission to the prognosis of acute glyphosate poisoning was 14.65×10 9/L, the area under the curve (AUC) was 0.9351. The sensitivity was 100.00%, and the specificity was 84.85%. Conclusion:High level of white blood cell at admission is a risk factor for the prognosis of acute glyphosate poisoning, and white blood cell level at admission has a certain predictive value for the prognosis of acute glyphosate poisoning.
6.Effect of pentraxin-3 on memory improvement and Aβ expression in 5×FAD mice
Qi ZHOU ; Zheng XIE ; Minlin LAI ; Pengpeng XING ; Zhao WANG ; Yaoyuan DONG ; Changlin LIAN ; Boyang LIU ; Hongbo GUO
Chinese Journal of Neuromedicine 2024;23(4):325-332
Objective:To explore the effect of pentraxin 3 (PTX3) on memory improvement and Aβ expression in Alzheimer's disease (AD) model mice.Methods:(1) Ten 5-month-old 5×FAD mice were randomly divided into PTX3 group and model group ( n=5); 5 C57BL/6 wild-type mice at the same age were selected as control group; mice in the PTX3 group and control group were stereotactically injected 4 μL 0.5 g/L PTX3 or same dose of phosphate buffered saline (PBS); Morris water maze test was used to detect the learning and memory abilities, Y maze test was used to detect the short-term memory, and ELISA was used to obsevre the contents of Aβ 40 and Aβ 42 in the brain hemisphere. (2) Twenty-five 3-month-old 5×FAD mice were randomly divided into model group, 2 μg/kg PTX3 group, 4 μg/kg PTX3 group, 8 μg/kg PTX3 group, and 16 μg/kg PTX3 group ( n=5); 5 C57BL/6 wild-type mice at the same age were selected as control group; mice in the PTX3 groups were intranasally injected 2, 4, 8, and 16 μg/kg PTX3, respectively; those in the model group and control group were intranasally injected same dose of PBS; injection was given once every 96 h for a total of 7 times. Morris water maze test was used to detect the learning and memory abilities, Y maze test was used to detect the short-term memory, and ELISA was used to obsevre the contents of Aβ 40 and Aβ 42 in the hippocampus. Results:(1) Compared with the model group, the PTX3 group had significantly shorter platform latency, higher percentage of exploration time and higher percentage of spontaneous alternations ( P<0.05). Compared with those in model group ([63.38±21.42] pg/mL, [29.77±6.11] pg/mL), the concentrations of Aβ 40 and Aβ 42 in the brain tissues of PTX3 group ([15.87±2.11] pg/mL, [16.55±1.95] pg/mL) were statistically lower ( P<0.05). (2) Compared with the model group, the 16 μg/kg PTX3 group had significantly shorter escape latency and higher percentage of exploration time ( P<0.05); compared with the model group, the 2 μg/kg PTX3 group and 16 μg/kg PTX3 group had significantly higher percentage of spontaneous alternations ( P<0.05). The contents of Aβ 40 and Aβ 42 in the hippocampus of 8 μg/kg PTX3 group and 16 μg/kg PTX3 group were statistically lower compared with those in the model group ( P<0.05). Conclusion:PTX3 may attenuate cognitive deficits and decrease Aβ expression in the brain or hippocampus tissues of 5×FAD mice with AD.
7.Alterations of DNA damage response pathway: Biomarker and therapeutic strategy for cancer immunotherapy.
Minlin JIANG ; Keyi JIA ; Lei WANG ; Wei LI ; Bin CHEN ; Yu LIU ; Hao WANG ; Sha ZHAO ; Yayi HE ; Caicun ZHOU
Acta Pharmaceutica Sinica B 2021;11(10):2983-2994
Genomic instability remains an enabling feature of cancer and promotes malignant transformation. Alterations of DNA damage response (DDR) pathways allow genomic instability, generate neoantigens, upregulate the expression of programmed death ligand 1 (PD-L1) and interact with signaling such as cyclic GMP-AMP synthase-stimulator of interferon genes (cGAS-STING) signaling. Here, we review the basic knowledge of DDR pathways, mechanisms of genomic instability induced by DDR alterations, impacts of DDR alterations on immune system, and the potential applications of DDR alterations as biomarkers and therapeutic targets in cancer immunotherapy.