1.Enzyme-directed Immobilization Strategies for Biosensor Applications
Xing-Bao WANG ; Yao-Hong MA ; Yun-Long XUE ; Xiao-Zhen HUANG ; Yue SHAO ; Yi YU ; Bing-Lian WANG ; Qing-Ai LIU ; Li-He ZHANG ; Wei-Li GONG
Progress in Biochemistry and Biophysics 2025;52(2):374-394
Immobilized enzyme-based enzyme electrode biosensors, characterized by high sensitivity and efficiency, strong specificity, and compact size, demonstrate broad application prospects in life science research, disease diagnosis and monitoring, etc. Immobilization of enzyme is a critical step in determining the performance (stability, sensitivity, and reproducibility) of the biosensors. Random immobilization (physical adsorption, covalent cross-linking, etc.) can easily bring about problems, such as decreased enzyme activity and relatively unstable immobilization. Whereas, directional immobilization utilizing amino acid residue mutation, affinity peptide fusion, or nucleotide-specific binding to restrict the orientation of the enzymes provides new possibilities to solve the problems caused by random immobilization. In this paper, the principles, advantages and disadvantages and the application progress of enzyme electrode biosensors of different directional immobilization strategies for enzyme molecular sensing elements by specific amino acids (lysine, histidine, cysteine, unnatural amino acid) with functional groups introduced based on site-specific mutation, affinity peptides (gold binding peptides, carbon binding peptides, carbohydrate binding domains) fused through genetic engineering, and specific binding between nucleotides and target enzymes (proteins) were reviewed, and the application fields, advantages and limitations of various immobilized enzyme interface characterization techniques were discussed, hoping to provide theoretical and technical guidance for the creation of high-performance enzyme sensing elements and the manufacture of enzyme electrode sensors.
2.Polycystin-2 Ion Channel Function and Pathogenesis in Autosomal Dominant Polycystic Kidney
Kai WANG ; Yuan HUANG ; Ce-Fan ZHOU ; Jing-Feng TANG ; Xing-Zhen CHEN
Progress in Biochemistry and Biophysics 2024;51(1):47-58
Polycystin-2 (also known as PC2, TRPP2, PKD2) is a major contributor to the underlying etiology of autosomal dominant polycystic kidney disease (ADPKD), which is the most prevalent monogenic kidney disease in the world. As a transient receptor potential (TRP) channel protein, PC2 exhibits cation-permeable, Ca2+-dependent channel properties, and plays a crucial role in maintaining normal Ca2+ signaling in systemic physiology, particularly in ADPKD chronic kidney disease. Structurally, PC2 protein consists of six transmembrane structural domains (S1-S6), a polycystin-specific “tetragonal opening for polycystins” (TOP) domain located between the S1 and S2 transmembrane structures, and cytoplasmic N- and C-termini. Although the cytoplasmic N-terminus and C-terminus of PC2 may not be significant in the gating of PC2 channels, there is still much protein structural information that needs to be thoroughly investigated, including the regulation of channel function and the assembly of homotetrameric ion channels. This is further supported by the presence of human disease-associated mutation sites on the PC2 structure. Moreover, PC2 synthesized in the endoplasmic reticulum is enriched in specific subcellular localization via membrane transport and can assemble itself into homotetrameric ion channels, as well as form heterotrimeric receptor-ion channel complexes with other proteins. These complexes are involved in a wide range of physiological functions, including the regulation of mechanosensation, cell polarity, cell proliferation, and apoptosis. In particular, PC2 assembles with chaperone proteins to form polycystic protein complexes that affect Ca2+ transport in cell membranes, cilia, endoplasmic reticulum, and mitochondria, and are involved in activating cell fate-related signaling pathways, particularly cell differentiation, proliferation, survival, and apoptosis, and more recently, autophagy. This leads to a shift of cystic cells from a normal uptake, quiescent state to a pathologically secreted, proliferative state. In conclusion, the complex structural and functional roles of PC2 highlight its critical importance in the pathogenesis of ADPKD, making it a promising target for therapeutic intervention.
3.A multicenter prospective study on early identification of refractory Mycoplasma pneumoniae pneumonia in children
Dan XU ; Ailian ZHANG ; Jishan ZHENG ; Mingwei YE ; Fan LI ; Gencai QIAN ; Hongbo SHI ; Xiaohong JIN ; Lieping HUANG ; Jiangang MEI ; Guohua MEI ; Zhen XU ; Hong FU ; Jianjun LIN ; Hongzhou YE ; Yan ZHENG ; Lingling HUA ; Min YANG ; Jiangmin TONG ; Lingling CHEN ; Yuanyuan ZHANG ; Dehua YANG ; Yunlian ZHOU ; Huiwen LI ; Yinle LAN ; Yulan XU ; Jinyan FENG ; Xing CHEN ; Min GONG ; Zhimin CHEN ; Yingshuo WANG
Chinese Journal of Pediatrics 2024;62(4):317-322
Objective:To explore potential predictors of refractory Mycoplasma pneumoniae pneumonia (RMPP) in early stage. Methods:The prospective multicenter study was conducted in Zhejiang, China from May 1 st, 2019 to January 31 st, 2020. A total of 1 428 patients with fever >48 hours to <120 hours were studied. Their clinical data and oral pharyngeal swab samples were collected; Mycoplasma pneumoniae DNA in pharyngeal swab specimens was detected. Patients with positive Mycoplasma pneumoniae DNA results underwent a series of tests, including chest X-ray, complete blood count, C-reactive protein, lactate dehydrogenase (LDH), and procalcitonin. According to the occurrence of RMPP, the patients were divided into two groups, RMPP group and general Mycoplasma pneumoniae pneumonia (GMPP) group. Measurement data between the 2 groups were compared using Mann-Whitney U test. Logistic regression analyses were used to examine the associations between clinical data and RMPP. Receiver operating characteristic (ROC) curves were used to analyse the power of the markers for predicting RMPP. Results:A total of 1 428 patients finished the study, with 801 boys and 627 girls, aged 4.3 (2.7, 6.3) years. Mycoplasma pneumoniae DNA was positive in 534 cases (37.4%), of whom 446 cases (83.5%) were diagnosed with Mycoplasma pneumoniae pneumonia, including 251 boys and 195 girls, aged 5.2 (3.3, 6.9) years. Macrolides-resistant variation was positive in 410 cases (91.9%). Fifty-five cases were with RMPP, 391 cases with GMPP. The peak body temperature before the first visit and LDH levels in RMPP patients were higher than that in GMPP patients (39.6 (39.1, 40.0) vs. 39.2 (38.9, 39.7) ℃, 333 (279, 392) vs. 311 (259, 359) U/L, both P<0.05). Logistic regression showed the prediction probability π=exp (-29.7+0.667×Peak body temperature (℃)+0.004×LDH (U/L))/(1+exp (-29.7+0.667×Peak body temperature (℃)+0.004 × LDH (U/L))), the cut-off value to predict RMPP was 0.12, with a consensus of probability forecast of 0.89, sensitivity of 0.89, and specificity of 0.67; and the area under ROC curve was 0.682 (95% CI 0.593-0.771, P<0.01). Conclusion:In MPP patients with fever over 48 to <120 hours, a prediction probability π of RMPP can be calculated based on the peak body temperature and LDH level before the first visit, which can facilitate early identification of RMPP.
4.Clinical characteristics of patients with MitraClip operation and predictors for the occurrence of afterload mismatch
Xiao-Dong ZHUANG ; Han WEN ; Ri-Hua HUANG ; Xing-Hao XU ; Shao-Zhao ZHANG ; Zhen-Yu XIONG ; Xin-Xue LIAO
Chinese Journal of Interventional Cardiology 2024;32(10):562-568
Objective To explore the risk factors related to afterload mismatch(AM)after transcatheter mitral valve repair(MitraClip).Methods This was a retrospective cohort study.48 patients hospitalized in the Department of Cardiovascular Medicine,the First Affiliated Hospital of Sun Yat-sen University from December 2021 to December 2023,who underwent MitraClip due to severe mitral regurgitation(MR)were included.Preoperative clinical data,laboratory tests,and preoperative and postoperative color Doppler echocardiographic examination results of surgical patients were collected.AM was defined as the left ventricular ejection fraction(LVEF)decreased by 15%or more after surgery compared with the one before(dLVEF≤-15%).Patients were divided into AM group and non-AM group according to whether afterload mismatch occurred.Univariate and multivariate logistic regression were used to analyze the risk factors of postoperative AM.Results Among 48 patients who underwent MitraClip,14 of them(29.2%)developed afterload-mismatched.For those without AM,their overall LVEF was improved after the operation;for patients in both AM group and non-AM group,their overall left ventricular end-diastolic diameter(LVEDd),left ventricular end-diastolic diameter volume index(LVEDVi)was reduced compared with the preoperative ones.Univariate regression analysis showed that C-reactive protein levels(OR 1.98,95%CI 1.02-3.83),platelets(OR 2.22,95%CI 1.08-4.53),systemic immune inflammation index(OR 1.96,95%CI 1.03-3.71)were associated with an increased risk of AM in patients undergoing MitraClip(all P<0.05),while those with larger right atrial diameter(OR 0.35,95%CI 0.13-0.93)or moderate to severe tricuspid regurgitation(OR 0.19,95%CI 0.05-0.81)were less likely to develop into AM(both P<0.05),which is still satisfied after adjustment.Conclusions For patients who underwent MitraClip,C-reactive protein levels,platelets and systemic immune inflammation index(SII)are associated with an increased risk of afterload mismatched,while those with larger right atrial diameter or moderate to severe tricuspid regurgitation were less likely to develop into AM.
5.Cases Analysis of Hemoglobin H Disease Caused by HBA2:c.2T>C and HBA2:c.2delT Mutations
Qiu-Hua WANG ; Xing-Yuan CHEN ; Ning TANG ; Ti-Zhen YAN ; Jun HUANG ; Qing-Yan ZHONG ; Shi-Qiang LUO
Journal of Experimental Hematology 2024;32(2):520-524
Objective:To investigate two cases of rare pathogenic genes,initiation codon mutations in HBA2 gene,combined with Southeast Asian deletion and their family members to understand the relationship of HBA2:c.2T>C and HBA2:c.2delT mutations with clinical phenotype.Methods:The peripheral blood of family members was obtained for blood cell analysis and capillary electrophoresis hemoglobin analysis.Gap-PCR and reverse dot blotting(RDB)were used to detect common types of mutations in α-thalassaemia gene.Sanger sequencing was used to analyze HBA1 and HBA2 gene sequence.Results:Two proband genotypes were identified as--SEA/αα with HBA2:c.2T>C and--SEA/αα with HBA2:c.2delT.HBA2:c.2T>C/WT and HBA2:c.2delT/WT was detected in family members.They all presented with microcytic hypochromic anemia.Conclusion:When HBA2:c.2T>C and HBA2:c.2delT are heterozygous that can lead to static α-thalassemia phenotype,and when combined with mild α-thalassemia,they can lead to the clinical manifestations of hemoglobin H disease.This study provides a basis for genetic counseling.
6.Development of A Model to Predict Mixed Cerebral Palsy in Infants with Periventricular White Matter Injury
Tingting HUANG ; Lan ZHANG ; Wei XING ; Zhen LI ; Fei WANG ; Gang ZHANG
Chinese Journal of Medical Imaging 2024;32(7):659-666
Purpose To development a model to predict mixed cerebral palsy(CP)in infants with periventricular white matter injury(PWMI).Materials and Methods This study retrospectively included infants with PWMI on MRI aged 6 to 24 months and were diagnosed as CP after age of 2 years in the First Affiliated Hospital of Henan University of Chinese Medicine,from September 2015 to October 2022.The eligible infants were divided into mixed group and spastic CP group.Multivariable Logistic regression model was used to select the MRI features associated with PWMI and mixed CP,and was internal validated by using the five-fold cross and repeated cross validation.Model performance was evaluated by the discrimination,calibration and decision curve.The correlation between independent MRI features and the gross motor function classification system levels was evaluated.Results A total of 135 infants with PWMI and CP were included in this study,100 with spastic CP,and 35 with mixed CP.Multivariable Logistic regression analysis found that the involvement of ventralateral of thalamus(OR=27.500,95%CI 8.293-90.942),posterior putamen(OR=13.700,95%CI 4.489-41.549),hippocampus(OR=7.200,95%CI 1.702-30.813)and caudate nucleus(OR 5.800,95%CI 1.973-16.950)were associated with PWMI and mixed CP.A prediction model was constructed using the above four MRI features.The model yielded an area under the receiver operating characteristic curve of 0.960(95%CI 0.934-0.988)and 0.95,0.96 in the five-fold cross and repeated cross validation,respectively.The model had good calibration(χ2=3.712,P=0.529)and clinical application.Furthermore,the four MRI variables were associated with gross motor function classification system levels(r=0.559,0.581,0.171,0.409,all P<0.05).Conclusion The model can early and accurately predict infants with PWMI at high risk of mixed CP.
7.Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients (version 2024)
Yao LU ; Yang LI ; Leiying ZHANG ; Hao TANG ; Huidan JING ; Yaoli WANG ; Xiangzhi JIA ; Li BA ; Maohong BIAN ; Dan CAI ; Hui CAI ; Xiaohong CAI ; Zhanshan ZHA ; Bingyu CHEN ; Daqing CHEN ; Feng CHEN ; Guoan CHEN ; Haiming CHEN ; Jing CHEN ; Min CHEN ; Qing CHEN ; Shu CHEN ; Xi CHEN ; Jinfeng CHENG ; Xiaoling CHU ; Hongwang CUI ; Xin CUI ; Zhen DA ; Ying DAI ; Surong DENG ; Weiqun DONG ; Weimin FAN ; Ke FENG ; Danhui FU ; Yongshui FU ; Qi FU ; Xuemei FU ; Jia GAN ; Xinyu GAN ; Wei GAO ; Huaizheng GONG ; Rong GUI ; Geng GUO ; Ning HAN ; Yiwen HAO ; Wubing HE ; Qiang HONG ; Ruiqin HOU ; Wei HOU ; Jie HU ; Peiyang HU ; Xi HU ; Xiaoyu HU ; Guangbin HUANG ; Jie HUANG ; Xiangyan HUANG ; Yuanshuai HUANG ; Shouyong HUN ; Xuebing JIANG ; Ping JIN ; Dong LAI ; Aiping LE ; Hongmei LI ; Bijuan LI ; Cuiying LI ; Daihong LI ; Haihong LI ; He LI ; Hui LI ; Jianping LI ; Ning LI ; Xiying LI ; Xiangmin LI ; Xiaofei LI ; Xiaojuan LI ; Zhiqiang LI ; Zhongjun LI ; Zunyan LI ; Huaqin LIANG ; Xiaohua LIANG ; Dongfa LIAO ; Qun LIAO ; Yan LIAO ; Jiajin LIN ; Chunxia LIU ; Fenghua LIU ; Peixian LIU ; Tiemei LIU ; Xiaoxin LIU ; Zhiwei LIU ; Zhongdi LIU ; Hua LU ; Jianfeng LUAN ; Jianjun LUO ; Qun LUO ; Dingfeng LYU ; Qi LYU ; Xianping LYU ; Aijun MA ; Liqiang MA ; Shuxuan MA ; Xainjun MA ; Xiaogang MA ; Xiaoli MA ; Guoqing MAO ; Shijie MU ; Shaolin NIE ; Shujuan OUYANG ; Xilin OUYANG ; Chunqiu PAN ; Jian PAN ; Xiaohua PAN ; Lei PENG ; Tao PENG ; Baohua QIAN ; Shu QIAO ; Li QIN ; Ying REN ; Zhaoqi REN ; Ruiming RONG ; Changshan SU ; Mingwei SUN ; Wenwu SUN ; Zhenwei SUN ; Haiping TANG ; Xiaofeng TANG ; Changjiu TANG ; Cuihua TAO ; Zhibin TIAN ; Juan WANG ; Baoyan WANG ; Chunyan WANG ; Gefei WANG ; Haiyan WANG ; Hongjie WANG ; Peng WANG ; Pengli WANG ; Qiushi WANG ; Xiaoning WANG ; Xinhua WANG ; Xuefeng WANG ; Yong WANG ; Yongjun WANG ; Yuanjie WANG ; Zhihua WANG ; Shaojun WEI ; Yaming WEI ; Jianbo WEN ; Jun WEN ; Jiang WU ; Jufeng WU ; Aijun XIA ; Fei XIA ; Rong XIA ; Jue XIE ; Yanchao XING ; Yan XIONG ; Feng XU ; Yongzhu XU ; Yongan XU ; Yonghe YAN ; Beizhan YAN ; Jiang YANG ; Jiangcun YANG ; Jun YANG ; Xinwen YANG ; Yongyi YANG ; Chunyan YAO ; Mingliang YE ; Changlin YIN ; Ming YIN ; Wen YIN ; Lianling YU ; Shuhong YU ; Zebo YU ; Yigang YU ; Anyong YU ; Hong YUAN ; Yi YUAN ; Chan ZHANG ; Jinjun ZHANG ; Jun ZHANG ; Kai ZHANG ; Leibing ZHANG ; Quan ZHANG ; Rongjiang ZHANG ; Sanming ZHANG ; Shengji ZHANG ; Shuo ZHANG ; Wei ZHANG ; Weidong ZHANG ; Xi ZHANG ; Xingwen ZHANG ; Guixi ZHANG ; Xiaojun ZHANG ; Guoqing ZHAO ; Jianpeng ZHAO ; Shuming ZHAO ; Beibei ZHENG ; Shangen ZHENG ; Huayou ZHOU ; Jicheng ZHOU ; Lihong ZHOU ; Mou ZHOU ; Xiaoyu ZHOU ; Xuelian ZHOU ; Yuan ZHOU ; Zheng ZHOU ; Zuhuang ZHOU ; Haiyan ZHU ; Peiyuan ZHU ; Changju ZHU ; Lili ZHU ; Zhengguo WANG ; Jianxin JIANG ; Deqing WANG ; Jiongcai LAN ; Quanli WANG ; Yang YU ; Lianyang ZHANG ; Aiqing WEN
Chinese Journal of Trauma 2024;40(10):865-881
Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.
8.Correlation analysis of robotic autonomous vertebral puncture pressure and path accuracy based on animal specimens
Tong XING ; Junsheng HUANG ; Ming LI ; Yuxi LI ; Yuwei LIANG ; Zhen CHE ; Enming CHEN ; Lin HUANG
Chinese Journal of Orthopaedics 2024;44(15):1018-1024
Objective:To investigate the impact of peak pressure upon different bone densities during autonomous puncture by orthopedic robot on puncture path deviation and bone cement leakage.Methods:A spinal surgery robot system was designed for autonomous vertebral puncture and bone cement injection, and six porcine spine specimens were used for single-segment or double-segment simulated percutaneous vertebral augmentation surgery. The accuracy of puncture path (Gertzbein-Robbins grading), bone cement leakage classification, and peak bone drill pressure were measured to assess the accuracy of autonomous vertebral puncture and bone cement leakage in vertebral cortical and cancellous bone of different densities.Results:A total of 64 porcine vertebrae were simulated for puncture, among which 53 vertebrae were classified as Grade A, 8 as Grade B, and 3 as Grade C according to the Gertzbein-Robbins grading. The cortical bone pressure of Grade A vertebrae was 6.663±0.319 N which was lower than that of Grade B (8.348±0.418 N) and Grade C (11.500±0.600 N), with significant differences ( F=341.000, P<0.001). The cancellous bone pressure of Grade A, B, and C vertebrae were 3.660±0.317, 3.594±0.608, and 4.117±0.257 N, respectively, with no significant difference ( F=2.496, P=0.091). There were 40 cases of no leakage, 20 cases of Type I leakage (leakage into the surrounding vertebrae), and 3 cases of Type II leakage (leakage into the vertebral canal), with an overall leakage rate of 36% (23/64). The peak cortical bone pressure for no leakage, Type I, and Type II leakage was 6.638±0.301, 6.792±0.404, and 6.753±0.473 N, respectively, and the peak cancellous bone pressure was 3.634±0.279, 3.783±0.423, and 3.920±0.255 N, respectively, with no significant difference ( F=1.521, P=0.227; F=2.106, P=0.131). Conclusion:During the autonomous puncture process of the novel orthopedic robot, the accuracy of autonomous puncture path decreased when the puncture pressure through the cortical bone was high, and the probability of invading the pedicle increased. The puncture pressure of cortical and cancellous bone had no significant effect on the occurrence rate of bone cement leakage.
9.Cardiovascular health status of Chinese adults based on "Life's Essential 8" score.
Tao Tao XUE ; Li Min WANG ; Zhen Ping ZHAO ; Xiao ZHANG ; Chun LI ; Zheng Jing HUANG ; Xing Xing GAO ; Chen Yi LIU ; Ning YU ; Yu Shu ZHANG ; Xiao Qing DENG ; Lan WANG ; Mei ZHANG
Chinese Journal of Epidemiology 2023;44(7):1054-1062
Objective: To assess the cardiovascular health status of adults in China by using the "Life's Essential 8" score, and provide reference for the development and improvement of cardiovascular disease prevention and control policies and measures. Methods: Chronic Disease and Nutrition Surveillance was conducted in 298 counties/districts in 2015 in 31 provinces (autonomous regions, municipalities) across China, multi-stage stratified cluster random sampling was used to select 45 households in each village or neighborhood, and 20 households were further selected to conduct dietary surveys. In this study, a total of 70 093 adults aged ≥20 years who completed the dietary survey and had complete information were included, their cardiovascular health status were assessed by using the "Life's Essential 8" score, a cardiovascular health scoring standard released by the American Heart Association in 2022. All results were adjusted using complex design-based sampling weights to achieve a better estimate of the population. Results: In 2015, the overall cardiovascular health score of Chinese adults aged ≥20 years was 73.3±12.6, the score was significantly higher in women (77.9±11.6) than in men (68.7±11.8), and higher in urban area (74.5±12.8) than in rural area (71.9±12.2), the differences were significant (P<0.001). It was estimated that about 0.25% (95%CI: 0.16%-0.33%) of adults in China had cardiovascular health score of 100, and 33.0% (95%CI: 31.6%-34.3%), 63.2% (95%CI: 62.1%-64.3%), and 3.9% (95%CI: 3.5%-4.2%) of adults had high, moderate and low cardiovascular health scores, respectively. The proportion of those with high cardiovascular health scores was relatively low in men, those with low education level, those with low income, those living in rural areas, and those living in southwest China (P<0.001). Of the eight factors, diet had the lowest mean score (46.0, 95%CI: 44.7-47.3), followed by blood pressure (59.4, 95%CI: 58.2-60.6) and tobacco exposure (61.4, 95%CI: 60.6-62.2). Conclusions: The cardiovascular health status of two-thirds of adult population in China needs to be improved. Diet, tobacco exposure, and blood pressure are the factors affecting the cardiovascular health of Chinese population, to which close attention needs to be paid, and men, rural residents, and those with lower socioeconomic status are key groups in cardiovascular health promotion.
Adult
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Female
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Humans
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Male
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Asian People
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Cardiovascular Diseases/prevention & control*
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China/epidemiology*
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Diet
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East Asian People
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Health Status
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Risk Factors
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United States
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Young Adult
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Health Status Indicators
10.Guideline for clinical comprehensive evaluation of Chinese patent medicine (2022 version).
Wei-An YUAN ; Jun-Hua ZHANG ; Jian-Ping LIU ; Zhong-Qi YANG ; Jun-Ling CAO ; Xing LIAO ; Xiao-Yu XI ; Mei HAN ; Wen-Yuan LI ; Zhen-Wen QIU ; Shi-Yin FENG ; Yuan-Yuan GUO ; Lu-Jia CAO ; Xiao-Hong LIAO ; Yan-Ling AI ; Ju HUANG ; Lu-Lu JIA ; Xiang-Fei SU ; Xue WU ; Ze-Qi DAI ; Ji-Hua GUO ; Bing-Qing LU ; Xiao-Xiao ZHANG ; Jian-Yuan TANG
China Journal of Chinese Materia Medica 2023;48(1):256-264
Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.
Medicine, Chinese Traditional
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Nonprescription Drugs
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Consensus
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China
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Reference Standards
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Drugs, Chinese Herbal

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