1.Exploration of basket trial design with Bayesian method and its application value in traditional Chinese medicine.
Si-Cun WANG ; Mu-Zhi LI ; Hai-Xia DANG ; Hao GU ; Jun LIU ; Zhong WANG ; Ya-Nan YU
China Journal of Chinese Materia Medica 2025;50(3):846-852
Basket trial, as an innovative clinical trial design concept, marks the transformation of medical research from the traditional large-scale and single-disease treatment to the precise and individualized treatment. By gradually incorporating the Bayesian method during development, the trial design becomes more scientific and reasonable and increases its efficiency. The fundamental principle of the Bayesian method is the utilization of prior knowledge in conjunction with new observational data to dynamically update the posterior probability. This flexibility enhances the basket trial's capacity to effectively adapt to variations during the research process. Consequently, it enables researchers to dynamically adjust research strategies based on accumulated data and improve the predictive accuracy regarding treatment responses. In addition, the design concept of the basket trial aligns with the traditional Chinese medicine(TCM) principle of "homotherapy for heteropathy". The principle of "homotherapy for heteropathy" emphasizes that under certain conditions, different diseases may have the same treatment. Similarly, basket trials allow using a uniform trial design across multiple diseases, offering enhanced operational and significant practical value in the realm of TCM, particularly within the context of syndrome-based disease research. By introducing basket trials, the design of TCM clinical studies will be more scientific and yield higher-quality evidence. This study systematically categorized various Bayesian methods and models utilized in basket trials, evaluated their strengths and weaknesses, and identified their appropriate application contexts, so as to offer a practical guide for designing basket trials in the realm of TCM.
Bayes Theorem
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Humans
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Medicine, Chinese Traditional/methods*
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Research Design
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Clinical Trials as Topic/methods*
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Drugs, Chinese Herbal/therapeutic use*
2.Investigation and disposal of a cluster of suspected neonatal bloodstream infection with carbapenem-resistant Klebsiella pneumoniae
Yu-Lin LI ; Wen-Ting CHEN ; Xue-Yun LI ; Chan NIE ; Song-Tao HAN ; Li-Yuan CHEN ; Lan TANG ; Zhen-Yu WANG ; Ya-Hui LI ; Yan XU ; Xia MU
Chinese Journal of Infection Control 2024;23(8):1031-1036
Objective To investigate the causes of a cluster of suspected neonatal carbapenem-resistant Klebsiella pneumoniae(CRKP)bloodstream infection(BSI)in the neonatal department of a hospital,and provide references for the effective control of the occurrence of healthcare-associated infection(HAI).Methods Epidemiological in-vestigation on 3 neonates with CRKP BSI in the neonatal department from January 31 to February 6,2023 was per-formed.Specimens from environmental object surfaces were taken for environmental hygiene monitoring,and effec-tive control measures were taken according to the risk factors.Results From January 31 to February 6,2023,a to-tal of 60 neonates were admitted in the neonatal department,including 16 with peripherally inserted central venous catheter(PICC).Three neonates had CRKP BSI,with a incidence of 5.00%.There were 33 hospitalized neonates on the day(February 7)when the cluster of HAI was reported,with a prevalence rate of 9.09%(3/33).CRKP BSI rate in the neonatal department of this hospital from January 31 to February 6,2023 was higher than that in 2022(P<0.001).The incubators of the 3 neonates with CRKP BSI were in the same ward and adjacent to each other.The first neonate with CRKP BSI(who developed BSI on January 31)underwent PICC maintenance on Feb-ruary 4,and the other 2 neonates with PICC maintenance immediately following the first one also developed CRKP BSI.CRKP were isolated from blood culture of all 3 neonates,and antimicrobial susceptibility testing results were consistent.Conclusion The occurrence of the cluster event of neonatal CRKP BSI may be related to the failure of strict implementation of aseptic procedures during PICC maintenance and cross contamination among items.
3.Inverted U-Shaped Associations between Glycemic Indices and Serum Uric Acid Levels in the General Chinese Population: Findings from the China Cardiometabolic Disease and Cancer Cohort (4C) Study.
Yuan Yue ZHU ; Rui Zhi ZHENG ; Gui Xia WANG ; Li CHEN ; Li Xin SHI ; Qing SU ; Min XU ; Yu XU ; Yu Hong CHEN ; Xue Feng YU ; Li YAN ; Tian Ge WANG ; Zhi Yun ZHAO ; Gui Jun QIN ; Qin WAN ; Gang CHEN ; Zheng Nan GAO ; Fei Xia SHEN ; Zuo Jie LUO ; Ying Fen QIN ; Ya Nan HUO ; Qiang LI ; Zhen YE ; Yin Fei ZHANG ; Chao LIU ; You Min WANG ; Sheng Li WU ; Tao YANG ; Hua Cong DENG ; Jia Jun ZHAO ; Lu Lu CHEN ; Yi Ming MU ; Xu Lei TANG ; Ru Ying HU ; Wei Qing WANG ; Guang NING ; Mian LI ; Jie Li LU ; Yu Fang BI
Biomedical and Environmental Sciences 2021;34(1):9-18
Objective:
The relationship between serum uric acid (SUA) levels and glycemic indices, including plasma glucose (FPG), 2-hour postload glucose (2h-PG), and glycated hemoglobin (HbA1c), remains inconclusive. We aimed to explore the associations between glycemic indices and SUA levels in the general Chinese population.
Methods:
The current study was a cross-sectional analysis using the first follow-up survey data from The China Cardiometabolic Disease and Cancer Cohort Study. A total of 105,922 community-dwelling adults aged ≥ 40 years underwent the oral glucose tolerance test and uric acid assessment. The nonlinear relationships between glycemic indices and SUA levels were explored using generalized additive models.
Results:
A total of 30,941 men and 62,361 women were eligible for the current analysis. Generalized additive models verified the inverted U-shaped association between glycemic indices and SUA levels, but with different inflection points in men and women. The thresholds for FPG, 2h-PG, and HbA1c for men and women were 6.5/8.0 mmol/L, 11.0/14.0 mmol/L, and 6.1/6.5, respectively (SUA levels increased with increasing glycemic indices before the inflection points and then eventually decreased with further increases in the glycemic indices).
Conclusion
An inverted U-shaped association was observed between major glycemic indices and uric acid levels in both sexes, while the inflection points were reached earlier in men than in women.
Aged
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Asian Continental Ancestry Group
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Blood Glucose/analysis*
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China/epidemiology*
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Cohort Studies
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Diabetes Mellitus/blood*
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Female
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Glucose Tolerance Test
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Glycated Hemoglobin A/analysis*
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Glycemic Index
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Humans
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Male
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Middle Aged
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Uric Acid/blood*
4.Anti-tumor Effect and Mechanisms of Calycosin: A Review
Xue-zhen WANG ; Xiao-yu ZHANG ; Yue MU ; Lei XIA ; Ya-nan ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2021;27(23):210-217
Calycosin (CA), a functional phytoestrogenic isoflavone extracted from Chinese herb Astragali Radix, is characterized by high efficiency, low toxicity, and multiple targets and has multiple pharmacological activities such as anti-oxidation, anti-radiation, anti-bacteria, cardio-cerebrovascular protection, and immunity enhancement. A number of studies have proved its significant anti-tumor effect, making it expected to become a potential component for the treatment of malignant tumors. Research shows that CA exerts the anti-tumor effect via multiple mechanisms like inducing tumor cell apoptosis and inhibiting tumor cell proliferation, migration, and invasion. It has been proved to be effective in suppressing breast cancer, colorectal cancer, lung cancer, cervical cancer, ovarian cancer, nasopharyngeal cancer, and other common malignant tumors. Its anti-tumor activity is mainly related to the regulation of B-cell lymphoma-2 (Bcl-2) family genes, microRNA (miRNA), and estrogen receptor
5.Anti-tumor Effect and Mechanism of Betulinic Acid: A Review
Xue-zhen WANG ; Yue MU ; Qian HAO ; Ya-nan ZHANG ; Lei XIA
Chinese Journal of Experimental Traditional Medical Formulae 2021;27(21):223-231
Betulinic acid (BA) is a lupane pentacyclic triterpene extracted from a variety of Chinese herbs such as Betulae Platyphyllae Cortex, Astragali Radix, Paeoniae Radix Alba, Jujubae Fructus, Sanguisorbae Radix, Eucommiae Cortex, Glycrrhizae Radix et Rhizoma, Aucklandiae Radix, and Ziziphi Spinosae Semen. It has attracted wide attention from doctors because of its low toxicity, high efficacy, and multiple functions. BA has been found to possess a significant anti-tumor biological activity, and it is expected to become a potential drug for the treatment of malignant tumors. So far, a number of studies have shown that BA is able to promote apoptosis, inhibit proliferation, metastasis and invasion, and induce cell cycle arrest via multiple mechanisms, thus resisting various malignant tumors such as ovarian cancer, breast cancer, gastric cancer, lung cancer, colorectal cancer, and prostate cancer. It exerts the anti-tomor effect by regulating the expression of cancer suppressor genes p53 and p21, triggering the generatoipn of reactive oxygen species (ROS), down-regulating the expression of nuclear transcription factor-
6.Protective effect of astrocyte exosomes on hypoxic-ischemic neurons.
Jing-Lan HUANG ; Yi QU ; Jun TANG ; Rong ZOU ; Shi-Ping LI ; Ya-Fei LI ; Li ZHANG ; Bin XIA ; De-Zhi MU
Chinese Journal of Contemporary Pediatrics 2018;20(5):397-402
OBJECTIVETo study the effect of astrocyte exosomes on hypoxic-ischemic neurons.
METHODSRat astrocytes were cultured in vitro, and differential centrifugation was used to obtain the exosomes from the cell supernatant. Transmission electron microscopy, Nanosight, and Western blot were used for the identification of exosomes. BCA method was used to measure the concentration of exosomes. Rat neurons were cultured in vitro and then divided into control group, exosome group, oxygen glucose deprivation (OGD) group, and OGD+exosome group (n=3 each). The OGD and OGD+exosome groups were cultured in glucose-free medium under the hypoxic condition. The exosome and OGD+exosome groups were treated with exosomes at a final concentration of 22 μg/mL. The control and OGD groups were given an equal volume of phosphate-buffered saline. ELISA was used to measure the level of lactate dehydrogenase (LDH) in neurons. The terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling was used to measure the apoptotic index of neurons.
RESULTSThe identification of exosomes showed that the exosomes extracted by differential centrifugation had the features of exosomes. Compared with the control and exosome groups, the OGD group had significant increases in LDH level and apoptotic index (P<0.05). Compared with the OGD group, the OGD+exosome group had significant reductions in LDH level and apoptotic index (P<0.05).
CONCLUSIONSThe exosomes from astrocytes have a protective effect on neurons with hypoxic-ischemic injury.
Animals ; Apoptosis ; Astrocytes ; physiology ; Cell Hypoxia ; Cells, Cultured ; Exosomes ; physiology ; Glucose ; deficiency ; Hydro-Lyases ; analysis ; Neuroprotection ; Rats ; Rats, Sprague-Dawley
7.Increased pretreatment levels of serum LDH and ALP as poor prognostic factors for nasopharyngeal carcinoma.
Guo LI ; Jin GAO ; Ya-Lan TAO ; Bing-Qing XU ; Zi-Wei TU ; Zhi-Gang LIU ; Mu-Sheng ZENG ; Yun-Fei XIA
Chinese Journal of Cancer 2012;31(4):197-206
Serum enzymes that play potential roles in tumor growth have recently been reported to have prognostic relevance in a diverse array of tumors. However, prognosis-related serum enzymes are rarely reported for nasopharyngeal carcinoma(NPC). To clarify whether the level of serum enzymes is linked to the prognosis of NPC, we reviewed the pretreatment data of lactate dehydrogenase(LDH), alkaline phosphatase (ALP), and glutamyl transferase (GGT) in 533 newly diagnosed NPC patients who underwent radical radiotherapy between May 2002 and October 2003 at Sun Yat-sen University Cancer Center. Patients were grouped according to the upper limit of normal values of LDH, ALP, and GGT. The Kaplan-Meier method and log-rank test were used for selecting prognostic factors from clinical characteristics and serum enzymes, and the chi-square test was applied to analyze the relationships of clinical characteristics and serum enzymes. Finally, a Cox proportional hazards model was used to identify the independent prognostic factors. We found that increased levels of LDH had poor effects on both overall survival and distant metastasis-free survival (P = 0.009 and 0.035, respectively), and increased pretreatment level of serum ALP had poor effects on both overall survival and local recurrence-free survival (P = 0.037 and 0.039, respectively). In multivariate analysis, increased LDH level was identified as an independent prognostic factor for overall survival. Therefore, we conclude that increased pretreatment serum LDH and ALP levels are poor prognostic factors for NPC.
Adolescent
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Adult
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Aged
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Alkaline Phosphatase
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blood
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Antineoplastic Combined Chemotherapy Protocols
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therapeutic use
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Child
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Cisplatin
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administration & dosage
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Female
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Fluorouracil
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administration & dosage
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Humans
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Kaplan-Meier Estimate
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L-Lactate Dehydrogenase
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blood
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Male
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Middle Aged
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Nasopharyngeal Neoplasms
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blood
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drug therapy
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pathology
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radiotherapy
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Neoplasm Metastasis
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Neoplasm Recurrence, Local
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Prognosis
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Proportional Hazards Models
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Radiotherapy, Computer-Assisted
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Radiotherapy, Conformal
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Radiotherapy, Intensity-Modulated
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Survival Rate
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Young Adult
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gamma-Glutamyltransferase
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blood
8.Evaluation of the effect of up-converting phosphor technology in detection of plague antigen-antibody by receiver operating characteristic curve method
Jin-xiao, XI ; Hong, ZHANG ; Peng-fei, GE ; Li-min, GUO ; Wen-ping, DA ; Bin, WU ; Da-qin, XU ; Shi-ming, WANG ; Wei-min, PAN ; Ke-jun, MIAO ; Ya-jun, GE ; Tao-xia, MU ; Guo-juan, CHEN
Chinese Journal of Endemiology 2012;31(6):640-642
Objective To evaluate the effect of up-converting phosphor technology(UPT) in detection of plague antigen-antibody by receiver operating characteristic curve (ROC) method,and to provide a scientific basis for field application of UPT rapid detection technology in plague prevention and control.Methods Two hundred and twenty four serum samples were collected from Marmots and ground squirrels in the plague foci,Yersinia pestis antibody was detected by UPT,ELISA,Colloidal-gold Strips and IHA,respectively; 108 organs and bone marrow samples were collected,and Yersinia pestis antigens were detected by UPT,ELISA,PCR and RIHA,respectively.IHA was used as the gold standard for antibody test results,RIHA,PCR + Colloidal-gold Strips,PCR + ELISA were used as the gold standard for antigen test results.The results were evaluated using ROC method.Results Antibodies detection:the AUCs of UPT,ELISA and Colloidal-gold Strips were greater than 0.5.The difference between UPT and other methods was not statistically significant (z =1.204,P > 0.05).Antigen detection:the AUCs of UPT,ELISA,Colloidal-gold Strips and PCR were greater than 0.5.There was no statistical difference between UPT and other methods(z =0.866,P > 0.05).Conclusions UPT as a new technology works well in the detection of plague antigen-antibody.The technology is simple,fast,accurate,and suitable for on-site monitoring of plague,emergency treatment of sudden plague,and suitable for promotion.
9.Mortality trend on chronic obstructive pulmonary disease in Liaoning province, 1984-2010
Lian-Zheng YU ; Yi-Ping FENG ; Hui-Juan MU ; Li LIU ; Li-Ya YU ; Yan-Xia LI ; Shu-Juan ZHANG ; Guo-Wei PAN
Chinese Journal of Epidemiology 2012;33(4):399-403
Objective To evaluate the mortality trend or chromc obstructive pulmonary disease (COPD) among residents in Liaoning province during the period of 1984-2010.Methods The cut-points were ascertained by Monte Carlo Permutation test in COPD mortality trend lines of Poisson regression with Joinpoint Regression Program.The annual percent changes (APC) before and after the cut-points and the average annual percent change(AAPC) of COPD mortality were examined during the period.Results Significant declining trends on COPD mortality among the urban population during 1984-2010 and that of rural population during 1999-2009 were found.The standardized urban COPD mortality rate by Chinese population declined from 243.93 per 100thousand in 1984 to 33.13 per 100 thousand in 2010.The urban 26 years AAPC was -5.8%.While the mortality in the rural population decreased from 251.33 per 100 thousand in 1999 to 102.25 per 100 thousand in 2009 in the same population.The rural 10 years' AAPC was-6.8%.The total trend of COPD mortality reduction was mainly resulted from the fast decline of bronchitis mortality.The AAPC of COPD mortality of the urban population was-9.0% and greater than that of the rural population (-6.8%) from 1999 to 2009.The urban population had a lower COPD mortality than that of the rural population.In urban area,males had a higher COPD mortality than females,however,in the rural area,males had a lower COPD mortality than the females.Conclusion The COPD mortality among the residents of Liaoning province declined significantly from 1984 to 2010.Further studies are needed to confirm the viewpoint of WHO that the prevalence of COPD would have a continuous increasing trend in China.
10.Decomposition of life expectancy at birth by age and causes of death among residents of Liaoning province,1975-2005
Yi-Ping FENG ; Hui-Juan MU ; Li LIU ; Li-Ya YU ; Yan-Xia LI ; Shu-Juan ZHANG ; Lian-Zheng YU ; Guo-Wei PAN
Chinese Journal of Epidemiology 2011;32(3):264-267
Objective To analyze the impact of mortality by age and causes of death on life expectancy at birth among residents of Liaoning province.Methods The study included mortality data of urban and rural residents in two periods (1973-1975 and 2004-2005).Both Abridged Life Table and Arriaga method were used to calculate and to decompose life expectancy changes by age and causes of death.Results From 1975-2005,the life expectancy increased by 4.68 years in urban residents and 4.91 for rural residents with a higher increment among females than males.Most part of the increase (76.27% and 82.81% for urban and rural male,58.76% and 62.13% for urban and rural female) in life expectancy within the last 30 years could be explained by the decrease of mortality in the populations at age 0-4 and 55-74.Diseases related to respiratory system and infectious disease were contributing the most to the gap in life expectancy between the two periods.Mortality of heart disease was a negative contributor to the changes in life expectancy among both rural and urban residents while the mortalities of cerebro-vascular diseases and malignant tumors were the negative contributors for rural residents.Conclusion The increase of life expectancy in the last 30 years was mainly resulted from the decrease of mortality on both respiratory and infectious diseases.Control of chronic diseases is the key point to increase the life expectancy among the residents of Liaoning province.

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