1.Methodological Consideration on Combination Model of TCM Clinical Practice Guidelines and Real-world Study
Guozhen ZHAO ; Huizhen LI ; Ning LIANG ; Haili ZHANG ; Bin LIU ; Qianzi CHE ; Feng ZHOU ; He LI ; Xiaowen CHEN ; Long YE ; Jiahao LIN ; Xingyu ZONG ; Dingyi WANG ; Nannan SHI ; Yanping WANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):87-93
The clinical practice guidelines of traditional Chinese medicine (TCM) have problems such as limited clinical application and unclear implementation effects, which may be related to the lack of clinical practice evidence. To provide reliable and precise evidence for clinical practice, this article proposes a model of combining TCM guidelines with real-world study, which includes 4 steps. Firstly, during the implementation process of the guidelines, a high-quality research database is established. Secondly, the recommendations in the guidelines are evaluated based on the established database in multiple dimensions, including applicability, effectiveness, safety, and cost-effectiveness, and thus their effectiveness in practical applications can be determined. Thirdly, based on the established database, core prescriptions are identified, and the targeted populations and medication plans are determined. That is, the best treatment regimen is established based on the analysis of abundant clinical data regarding the effects of different medication frequencies, dosages, and duration on efficacy. Fourthly, the guidelines are updated according to the real-world evidence. The research based on this model can provide real-world evidence for ancient and empirical prescriptions, improving their application in clinical practice. Moreover, this model can reduce research costs and improve research efficiency. When applying this model, researchers need to pay attention to the quality of real-world evidence, ensuring that it can truly reflect the situation in clinical practice. In addition, importance should be attached to the clinical application of guideline recommendations, ensuring that doctors can conduct standardized diagnosis and treatment according to the guidelines. Finally, full-process participation of multidisciplinary experts is encouraged to ensure the comprehensiveness and scientificity of the study. In conclusion, the application of this model will contribute to the development of TCM guidelines responsive to the needs of clinical practice and achieve the goal of promoting the homogenization of TCM clinical diagnosis and treatment.
2.Methods and Challenges for Identifying and Controlling Confounding Factors in Traditional Chinese Medicine Observational Studies
Guozhen ZHAO ; Ziheng GAO ; Chen ZHAO ; Huizhen LI ; Ning LIANG ; Bin LIU ; Qianzi CHE ; Haili ZHANG ; Yixiang LI ; Feng ZHOU ; He LI ; Bo LI ; Nannan SHI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):120-126
As a supplement to randomized controlled trials, observational studies can provide evidence for the effectiveness of traditional Chinese medicine (TCM) treatment measures. They can also study influencing factors of diseases, etiology, and prognosis. However, there is a confounding effect due to the lack of randomization, which seriously affects the causal inference between the study factors and the outcome, resulting in confounding bias. Therefore, identifying and controlling confounding factors are key issues to be addressed in TCM observational studies. According to the causal network and the characteristics of TCM theory, confounding factors can be categorized into measured and unmeasured confounding factors. In addition, attention must be paid to identifying confounding factors and intermediate variables, as well as the interaction between confounding factors and study factors. For methods of controlling confounding factors, measured confounding factors can be controlled by stratification, multifactor analysis, propensity scores, and disease risk scores. Unmeasured and unknown confounding factors can be corrected using instrumental variable methods, difference-in-difference methods, and correction for underlying event rate ratios. Correcting and controlling confounding factors can ensure a balance between groups, and confounding bias can be reduced. In addition, methods such as sensitivity analysis and determination of interactions make the control of confounding factors more comprehensive. Due to the unique characteristics of TCM, observational studies of TCM face unique challenges in identifying and controlling confounding factors, including the ever-changing TCM treatment measures received by patients, the often-overlooked confounding effects in the four diagnostic information of TCM, and the lack of objective criteria for TCM evidence-based diagnosis. Some scholars have already conducted innovative explorations to address these issues, providing a methodological basis for conducting higher-quality TCM observational studies, so as to obtain more rigorous real-world evidence of TCM and gradually develop quality evaluation criteria for OS that are consistent with the characteristics of TCM.
3.Construction of rehabilitation nursing program for stroke patients based on international classification of functioning, disability and health
Weiwei LI ; Guozhen SUN ; Jianying SHEN ; Qian LU ; Chuan HE ; Meiyan LU
Journal of Clinical Medicine in Practice 2024;28(8):138-141
Objective To construct a rehabilitation nursing program for stroke patients based on the international classification of functioning, disability and health (ICF). Methods The relevant domestic and foreign literatures were systematically searched, and a draft of the rehabilitation nursing program for stroke patients based on the 17 functional items in the four dimensions of ICF functional evaluation was constructed. The Delphi method was used to consult experts to further improve the program. Results A total of 16 experts completed two rounds of expert consultation. The expert authority coefficients of the first and second rounds of consultation were 0.897 and 0.897, respectively, with coefficient of variations ranging from 0.05 to 0.27 and 0.05 to 0.19, respectively. The Kendall's W coefficients were 0.384 and 0.452 (
4.Aristolochic acids exposure was not the main cause of liver tumorigenesis in adulthood.
Shuzhen CHEN ; Yaping DONG ; Xinming QI ; Qiqi CAO ; Tao LUO ; Zhaofang BAI ; Huisi HE ; Zhecai FAN ; Lingyan XU ; Guozhen XING ; Chunyu WANG ; Zhichao JIN ; Zhixuan LI ; Lei CHEN ; Yishan ZHONG ; Jiao WANG ; Jia GE ; Xiaohe XIAO ; Xiuwu BIAN ; Wen WEN ; Jin REN ; Hongyang WANG
Acta Pharmaceutica Sinica B 2022;12(5):2252-2267
Aristolochic acids (AAs) have long been considered as a potent carcinogen due to its nephrotoxicity. Aristolochic acid I (AAI) reacts with DNA to form covalent aristolactam (AL)-DNA adducts, leading to subsequent A to T transversion mutation, commonly referred as AA mutational signature. Previous research inferred that AAs were widely implicated in liver cancer throughout Asia. In this study, we explored whether AAs exposure was the main cause of liver cancer in the context of HBV infection in mainland China. Totally 1256 liver cancer samples were randomly retrieved from 3 medical centers and a refined bioanalytical method was used to detect AAI-DNA adducts. 5.10% of these samples could be identified as AAI positive exposure. Whole genome sequencing suggested 8.41% of 107 liver cancer patients exhibited the dominant AA mutational signature, indicating a relatively low overall AAI exposure rate. In animal models, long-term administration of AAI barely increased liver tumorigenesis in adult mice, opposite from its tumor-inducing role when subjected to infant mice. Furthermore, AAI induced dose-dependent accumulation of AA-DNA adduct in target organs in adult mice, with the most detected in kidney instead of liver. Taken together, our data indicate that AA exposure was not the major threat of liver cancer in adulthood.
5.Current status and influencing factors of radiological protection knowledge, attitude and practice among nurses of Interventional Catheterization Room
Ying HE ; Guozhen SUN ; Zhipeng BAO ; Lihua ZHOU ; Yan ZHOU
Chinese Journal of Modern Nursing 2022;28(2):141-147
Objective:To explore the current status of radiological protection knowledge, attitude and practice of nurses in Interventional Catheterization Room, and analyze their influencing factors so as to provide a basis for formulating intervention strategies.Methods:This study was a cross-sectional study. From April to May 2021, convenience sampling was adopted to select 240 nurses in Interventional Catheterization Room from 32 hospitals of member units of the China Heart Federation as the research subject. The self-designed General Information Questionnaire and the Radiological Protection Knowledge, Attitude and Practice Scale for Interventional Catheterization Room Nurses were used for investigation. Single factor analysis and multiple linear regression analysis were used to explore the influencing factors of radiological protection knowledge, attitude and practice among nurses of Interventional Catheterization Room. A total of 240 questionnaires were issued, and 220 valid questionnaires were returned with the valid response rate of 91.67%.Results:Among 220 nurses in Interventional Catheterization Room, the scores of radiological protection knowledge, attitude and practice dimensions were (5.92±1.83) , (29.15±1.97) , (43.76±5.73) , respectively. Multiple linear regression analysis showed that gender, hospital grade and training frequency were the influencing factors of radiological protection knowledge of nurses in Interventional Catheterization Room, and the differences were statistically significant ( P<0.05) . The training frequency and the type of radiological protective equipment were the influencing factors of the radiation protection attitude of nurses in Interventional Catheterization Room, and the differences were statistically significant ( P<0.05) . Gender, training frequency, regular monitoring of radiation dosimeters, and types of radiation protective equipment were the influencing factors of radiation protective practice of nurses in Interventional Catheterization Room ( P<0.05) . Conclusions:Interventional Catheterization Room nurses have a low level of radiological protection knowledge, and their attitudes towards radiological protection are relatively positive, but their radiological protection practice is not in place. The radiation protection training of nurses in Interventional Catheterization Room should be optimized, and adequate and high-quality protective equipment should be provided, and gender-specific management should be conducted, personal radiation dose monitoring should be standardized, and the radiation guidance role of Class Ⅲ hospitals should be used to ensure the safety and health of medical and nursing staff.
6.Omalizumab for the treatment of chronic spontaneous urticaria
Lin ZHENG ; Zhenrui SHI ; Mintong HE ; Guozhen TAN
Chinese Journal of Dermatology 2019;52(1):60-63
Chronic spontaneous urticaria is defined as recurrent wheals of unknown etiology for more than 6 weeks,with or without angioneurotic edema.The key step in the pathogenesis of chronic spontaneous urticaria is activation and degranulation of mast cells and basophils.Omalizumab,a recombinant humanized IgG monoclonal antibody,can selectively bond the Fc region of free IgE antibodies,and then block IgE-FCeR Ⅰ-mediated activation of mast cells and basophils.Three phase Ⅲ clinical trials have been reported on the efficacy of omalizumab in the treatment of chronic spontaneous urticaria,which confirm the efficacy and safety of omalizumab in the treatment of refractory chronic spontaneous urticaria.
7."A preliminary establishment of the""single-cell-transplant-tumorigenic-test""model for identifying liver cancer stem cells"
Wei JIA ; Yanhui CEN ; Juan BAO ; Rui YANG ; Guozhen HE ; Xiaojun WU ; Yiyi LI
Chinese Journal of Tissue Engineering Research 2017;21(9):1324-1328
BACKGROUND: There is no effective method to identify liver cancer stem cells until now, which has become one of the major challenges in this field. OBJECTIVE: To explore a more effective and suitable way for the identification of liver cancer stem cells in hepatocellular carcinoma cell lines. METHODS: Firstly, the single cell separation technique was used to obtain single cells, which were seeded into 96-wel plates one by one. Secondly, cell sublines derived from single cell colonies (tumorigenic colonies) were selected and obtained. At last, the cells from these clones were transplanted into the forelimb armpits of nude mice to observe the tumorigenic ability. RESULTS AND CONCLUSION: The number of holes of single cells obtained was 371 by the single cell separation technique, and the success rate was 96.4%. According to the growth of cell clone, tumorigenic colonies were selected to be transplanted to the forelimb armpits of nude mice, and the tumor formation rate of the colonies was 100%. The identification model of single-cell-transplant-tumorigenic-test for liver cancer stem cells is confirmed to be preliminarily established, which lays the technology and methodological basis for the follow-up research.
8.Establishment and identification of pancreatic stem cell strain derived from islets of Kunming mice under feeder layer conditions
Yanhui CEN ; Rui YANG ; Wei JIA ; Zhonghua LI ; Zhenguo ZHONG ; Jing ZHONG ; Juan BAO ; Guozhen HE ; Xiaojun WU ; Yiyi LI
Chinese Journal of Tissue Engineering Research 2017;21(13):2087-2093
BACKGROUND:Until now, little has been reported on establishment of pancreatic stem cell strains and lines,and the purification of pancreatic stem cells is difficult since the cell line establish rate is low.OBJECTIVE:To explore a more rational and effective technique of in vitro separation and continuous passage of pancreatic stem cells, with the hope to establish cell strains and even cell lines and to lay the foundation for the follow-up study of pancreatic stem cells in the treatment of diabetes.METHODS:Firstly, Percoll discontinuous density gradient centrifugation method was applied to separate the mouse pancreatic endocrine portion from the exocrine portion, then to obtain cell strains with highly proliferative ability and low differentiation from pancreatic endocrine portion-the islet. We used mouse embryonic fibroblasts treated with mitomycin C as a feeder layer, for in vitro continuous culture of islet-derived pancreatic stem cells under feeder layer conditions until they were transferred to the 30th passage to establish cell lines. Then pancreatic stem cell line derived from pancreatic islet was detected and identified by a series of tests including growth characteristic test, morphological observation, related molecular marker identification and differentiation characteristic identification.RESULTS AND CONCLUSION:In the continuous process of passage, pancreatic stem cells showed active proliferative ability, and maintained the typical morphological characteristics of stem cells and expression of pancreatic stem cell marker-Nestin. After induction, pancreatic stem cells showed insulin gene expression,reflecting their differentiation potential. Therefore, under the condition of feeder layer, the pancreatic stem cell line derived from Kunming mice was successfully established and the related identification was completed,which lays the foundation for the following research.
9.Study of Efficiency of Coupling Peptides with Gold Nanoparticles
Qiang ZHANG ; Ruixue LI ; Xin CHEN ; Xingxing HE ; Ailing HAN ; Guozhen FANG ; Jifeng LIU ; Shuo WANG
Chinese Journal of Analytical Chemistry 2017;45(5):662-667
Fluorescence spectroscopy was used to investigate the efficiency of coupling peptides to gold nanoparticles via 1-(3-dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride-N-hydroxysuccinimide (EDC-NHS).The experiment conditions including buffer solution, pH value and concentrations of buffer solution, concentrations of NHS and EDC, concentration ratios of NHS to EDC, and coupling reaction time on the coupling efficiency were investigated and optimized.The experimental results indicated that the optimized experimental conditions were as follows: 25 mmol/L HEPES buffer solution, pH 7.0;2∶1 of concentration ratio of NHS to EDC, 0.4 mol/L NHS, 0.2 mol/L EDC, and coupling reaction time of 24 h.This study may provide references for the relative research involving coupling peptide or protein with gold nanoparticles
10.A dimer formed by activator protein-1 family proteins c-Jun and Fra1 increases viability of dopaminergic neurons SH-SY5Y
Weiwen HE ; Guozhen HE ; Jianwei WU ; Jianfeng LIANG ; Zhongmin YUAN
Chinese Journal of Neuromedicine 2014;13(12):1218-1222
Objective To investigate the roles ofc-Jun/Fra1 dimer in viability ofdopaminergic neurons.Methods (1) Dopaminergic neuron-like cell line SH-SY5Y was cultured in vitro.Cells were lysed for immunoprecipitation to determine whether c-Jun dimerized with Fra1.(2) Cells received treatments were divided into four groups:Jun N-terminal kinase (JNK) inhibitor SP600125 treatment group,mitogen-activated kinase (MEK) 1/2 inhibitor U0126 treatment group,SP600125+U0126 treatment group and control group (treated with dimethyl sulfoxide [DMSO]).Western blotting was performed to detect the c-Jun and Fral expression levels and MTT assay was used to observe the cell viability.(3) Cells infected with adenovirus (Ad) carrying c-Jun or Fra1 genes were divided into three groups:Ad-c-Jun group,Ad-Fra1 group and Ad-c-Jun+Ad-Fra1 group,and cells transfected with GFP were used as control group; immunofluorescence and MTT assay were performed to determine the infectious rate and the cell viability,respectively.Results (1) Co-immunoprecipitation showed that the c-Jun dimerized with Fral in SH-SY5Y cell line.(2) Western blotting indicated that inhibition of JNK by SP600125 reduced c-Jun expression and MEK1/2 by U0126 inhibited Fra1 expression; MTT assay indicated that there were significant differences in the cellular viability among the four groups (F=16.647,P=0.000),the cellular viability in control group obviously differed from that in SP600125 treatment group,U0126 treatment group or SP600125+U0126 treatment group (P<0.05).(3) Immunofluorescence showed that most of cells infected by adenovirus expressed c-Jun or Fra1.MTT assay indicated that there were significant differences in the cellular viability among the four groups (F=14.543,P=0.000),and there were significant differences in their viabilities between control group and Ad-Fra1 group,and between Ad-Fra1 group and Ad-Fra1+Ad-c-Jun group (P<0.05).Conclusion The c-Jun and Fra1forming a dimer promotes the viability of dopaminergic neuron-like cells.


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