1.Bionic design,preparation and clinical translation of oral hard tissue restorative materials
Han ZHAO ; Yan WEI ; Xuehui ZHANG ; Xiaoping YANG ; Qing CAI ; Chengyun NING ; Mingming XU ; Wenwen LIU ; Ying HUANG ; Ying HE ; Yaru GUO ; Shengjie JIANG ; Yunyang BAI ; Yujia WU ; Yusi GUO ; Xiaona ZHENG ; Wenjing LI ; Xuliang DENG
Journal of Peking University(Health Sciences) 2024;56(1):4-8
Oral diseases concern almost every individual and are a serious health risk to the popula-tion.The restorative treatment of tooth and jaw defects is an important means to achieve oral function and support the appearance of the contour.Based on the principle of"learning from the nature",Deng Xu-liang's group of Peking University School and Hospital of Stomatology has proposed a new concept of"microstructural biomimetic design and tissue adaptation of tooth/jaw materials"to address the worldwide problems of difficulty in treating dentine hypersensitivity,poor prognosis of restoration of tooth defects,and vertical bone augmentation of alveolar bone after tooth loss.The group has broken through the bottle-neck of multi-stage biomimetic technology from the design of microscopic features to the enhancement of macroscopic effects,and invented key technologies such as crystalline/amorphous multi-level assembly,ion-transportation blocking,and multi-physical properties of the micro-environment reconstruction,etc.The group also pioneered the cationic-hydrogel desensitizer,digital stump and core integrated restora-tions,and developed new crown and bridge restorative materials,gradient functionalisation guided tissue regeneration membrane,and electrically responsive alveolar bone augmentation restorative membranes,etc.These products have established new clinical strategies for tooth/jaw defect repair and achieved inno-vative results.In conclusion,the research results of our group have strongly supported the theoretical im-provement of stomatology,developed the technical system of oral hard tissue restoration,innovated the clinical treatment strategy,and led the progress of the stomatology industry.
2.Expert consensus on the workflow of digital aesthetic design in prosthodontics
Zhonghao LIU ; Feng LIU ; Jiang CHEN ; Cui HUANG ; Xianglong HAN ; Wenjie HU ; Chun XU ; Weicai LIU ; Lina NIU ; Chufan MA ; Yijiao ZHAO ; Ke ZHAO ; Ming ZHENG ; Yaming CHEN ; Qingfeng HUANG ; Yi MAN ; Mingming XU ; Xuliang DENG ; Ti ZHOU ; Xiaorui SHI
Journal of Practical Stomatology 2024;40(2):156-163
In the field of dental aesthetics,digital aesthetic design plays a crucial role in helping dentists to predict treatment outcomes vis-ually,as well as in enhancing the consistency of knowledge and understanding of aesthetic goals between dentists and patients.It serves as the foundation for achieving ideal aesthetic effects.However,there is no clear standard for this digital process currently in China and abroad.Many dentists lack of systematic understanding of how to carry out digital aesthetic design for treatment.To establish standardized processes for dental aesthetic design and to improve the homogeneity of treatment outcomes,Chinese Society of Digital Dental Industry(CSD-DI)convened domestic experts in related field to compile this consensus.This article elaborates on the key aspects of digital aesthetic data collection,integration steps,and the digital aesthetic design process.It also formulates a decision tree for dental aesthetics at macro level and outlines corresponding workflows for various clinical scenarios,serving as a reference for clinicians.
3.The approaches and implications of emergency drug authorization by the U.S. FDA
Dan HAN ; Wen GAO ; Lunuan WANG ; Rui SUN ; Mingming GUO ; Lixin SHU
Journal of Pharmaceutical Practice and Service 2024;42(12):533-536
Objective To provide valuable insights for improving China’s special drug approval system by conducting an in-depth analysis of the practices of the U.S. Food and Drug Administration (FDA) in granting Emergency Use Authorizations (EUAs) for drugs. Methods A retrospective analysis was conducted on the FDA’s EUA decision-making process for COVID-19 therapeutics between January 2020 and June 2023. Results During the COVID-19 pandemic, the FDA adopted a series of regulatory science approaches to facilitate rapid approval of COVID-19 therapeutic drugs. The FDA granted EUA for a total of 15 COVID-19 therapeutic drugs and 4 COVID-19 vaccines, including expanded indications for marketed drugs, EUA for investigational drugs, revocation of EUA, and marketing after EUA. The main mechods for the rapid approval of EUA drugs by the FDA included the use of existing clinical trial data, omission of animal efficacy testing, merging of phase 1 and phase 2 clinical trials, and the use of clinical outcomes as surrogate endpoints, among other regulatory science methods. Conclusion The practices of the FDA in Emergency Use Authorization (EUA) of drugs, particularly its incorporation of regulatory scientific methods into the EUA process and the establishment of proactive monitoring mechanisms for drugs granted EUA, are worthy of emulation by China. It is suggested that China consider the experience of the FDA in the EUA system for drugs to further optimize and improve its special approval system for drugs.
4.Factors affecting dyslipidemia among residents in Chengdu City
YU Zhimiao ; HAN Mingming ; QIAN Wen ; WEI Yonglan ; WANG Liang
Journal of Preventive Medicine 2024;36(7):598-602
Objective:
To investigate the prevalence and influencing factors of dyslipidemia among residents in Chengdu City, so as to provide insights into improving the prevention and control of dyslipidemia.
Methods:
Based on the baseline survey of the Natural Population Cohort Study in Southwest China, residents aged 30 to 79 years was selected from 34 towns (communities) in 5 counties (districts) of Chengdu City using the multi-stage stratified cluster random sampling method in 2018. Demographic information and lifestyle behaviors were collected through questionnaires. Blood pressure, fasting blood glucose, serum uric acid, total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) were collected through physical examination and laboratory tests. A multivariable logistic regression model was used to identify the factors affecting dyslipidamia.
Results:
A total of 21 113 participants were surveyed, including 9 331 males (44.20%) and 11 782 females (55.80%), and had a mean age of (50.80±12.32) years. The prevalence rate of dyslipidemia was 35.64%, and the prevalence rates of high TG, low-HDL-C, high TC and high LDL-C were 17.25%, 11.88%, 10.11% and 7.35%, respectively. Multivariable logistic regression analysis identified gender (male, OR=1.584, 95%CI: 1.463-1.716), age (50 to 79 years old, OR:1.221-1.444, 95%CI: 1.079-1.632), residence (urban, OR=1.123, 95%CI: 1.052-1.198), marital status (not married, OR=1.246, 95%CI: 1.128-1.376), educational level (high school and above, OR=0.914, 95%CI: 0.849-0.983), current smoking (OR=1.220, 95%CI: 1.121-1.327), drinking (1 to 2 d/week, OR=1.525, 95%CI: 1.368-1.700; 3 to 5 d/week, OR=1.857, 95%CI: 1.575-2.191; almost every day, OR=1.512, 95%CI: 1.269-1.801), sedentary time in leisure time (>2 h/d, OR=1.123, 95%CI: 1.046-1.206), central obesity (OR=2.212, 95%CI: 1.986-2.265), hypertension (OR=1.489, 95%CI: 1.388-1.598), diabetes (OR=1.998, 95%CI: 1.833-2.157) and hyperuricemia (OR=2.012, 95%CI: 1.848-2.192) as factors affecting dyslipidemia.
Conclusion
The prevalence of dyslipidemia among residents in Chengdu City was mainly associated with smoking, drinking, sedentary time, central obesity, hypertension, diabetes and hyperuricemia.
5.Construction of blood quality monitoring indicator system in blood banks of Shandong
Qun LIU ; Xuemei LI ; Yuqing WU ; Zhiquan RONG ; Zhongsi YANG ; Zhe SONG ; Shuhong ZHAO ; Lin ZHU ; Shuli SUN ; Wei ZHANG ; Jinyu HAN ; Xiaojuan FAN ; Hui YE ; Mingming QIAO ; Hua SHEN ; Dunzhu GONGJUE ; Yunlong ZHUANG
Chinese Journal of Blood Transfusion 2024;37(3):249-257
【Objective】 To establish a blood quality monitoring indicator system, in order to continuously improve blood quality and standardized management. 【Methods】 Based on the research of literature and standards, and guided by the key control points of blood collection and supply process, the blood quality monitoring indicator system was developed. Through two rounds of Delphi expert consultation, the indicator content was further revised and improved according to expert opinions after six months of trial implementation. The indicator weight was calculated by questionnaire and analytic hierarchy process. 【Results】 A blood quality monitoring indicator system covering the whole process of blood collection and supply was constructed, including five primary indicators, namely blood donation service, blood component preparation, blood testing, blood supply and quality control, as well as 72 secondary indicators, including definitions, calculation formulas, etc. Two rounds of expert consultation and two rounds of feasibility study meeting were held to revise 17 items and the weight of each indicator was obtained through the analytic hierarchy process. After partial adjustments, a blood quality monitoring indicator system was formed. 【Conclusion】 A blood quality monitoring indicator system covering the whole process of blood collection and supply has been established for the first time, which can effectively evaluate the quality management level of blood banks and coordinate blood quality control activities of blood banks in Shandong like pieces in a chess game, thus improving the standardized management level
6.Application of quality monitoring indicators of blood testing in blood banks of Shandong province
Xuemei LI ; Weiwei ZHAI ; Zhongsi YANG ; Shuhong ZHAO ; Yuqing WU ; Qun LIU ; Zhe SONG ; Zhiquan RONG ; Shuli SUN ; Xiaojuan FAN ; Wei ZHANG ; Jinyu HAN ; Lin ZHU ; Xianwu AN ; Hui ZHANG ; Junxia REN ; Xuejing LI ; Chenxi YANG ; Bo ZHOU ; Haiyan HUANG ; Guangcai LIU ; Ping CHEN ; Hui YE ; Mingming QIAO ; Hua SHEN ; Dunzhu GONGJUE ; Yunlong ZHUANG
Chinese Journal of Blood Transfusion 2024;37(3):258-266
【Objective】 To objectively evaluate the quality control level of blood testing process in blood banks through quantitative monitoring and trend analysis, and to promote the homogenization level and standardized management of blood testing laboratories in blood banks. 【Methods】 A quality monitoring indicator system covering the whole process of blood collection and supply, including blood donation service, blood component preparation, blood testing, blood supply and quality control was established. The questionnaire Quality Monitoring Indicators for Blood Collection and Supply Process with clear definition of indicators and calculation formulas was distributed to 17 blood banks in Shandong province. Quality monitoring indicators of each blood bank from January to December 2022 were collected, and 31 indicators in terms of blood testing were analyzed using SPSS25.0 software. 【Results】 The proportion of unqualified serological tests in 17 blood bank laboratories was 55.84% for ALT, 13.63% for HBsAg, 5.08% for anti HCV, 5.62% for anti HIV, 18.18% for anti TP, and 1.65% for other factors (mainly sample quality). The detection unqualified rate and median were (1.23±0.57)% and 1.11%, respectively. The ALT unqualified rate and median were (0.74±0.53)% and 0.60%, respectively. The detection unqualified rate was positively correlated with ALT unqualified rate (r=0.974, P<0.05). The unqualified rate of HBsAg, anti HCV, anti HIV and anti TP was (0.15±0.09)%, (0.05±0.04)%, (0.06±0.03)% and (0.20±0.05)% respectively. The average unqualified rate, average hemolysis rate, average insufficient volume rate and the abnormal hematocrit rate of samples in 17 blood bank laboratories was 0.21‰, 0.08‰, 0.01‰ and 0.02‰ respectively. There were differences in the retest concordance rates of four HBsAg, anti HCV and anti HIV reagents, and three anti TP reagents among 17 blood bank laboratories (P<0.05). The usage rate of ELISA reagents was (114.56±3.30)%, the outage rate of ELISA was (10.23±7.05) ‰, and the out of range rate of ELISA was (0.90±1.17) ‰. There was no correlation between the out of range rate, outrage rate and usage rate (all P>0.05), while the outrage rate was positively correlated with the usage rate (r=0.592, P<0.05). A total of 443 HBV DNA positive samples were detected in all blood banks, with an unqualified rate of 3.78/10 000; 15 HCV RNA positive samples were detected, with an unqualified rate of 0.13/10 000; 5 HIV RNA positive samples were detected, with an unqualified rate of 0.04/10 000. The unqualified rate of NAT was (0.72±0.04)‰, the single NAT reaction rate [(0.39±0.02)‰] was positively correlated with the single HBV DNA reaction rate [ (0.36±0.02) ‰] (r=0.886, P<0.05). There was a difference in the discriminated reactive rate by individual NAT among three blood bank laboratories (C, F, H) (P<0.05). The median resolution rate of 17 blood station laboratories by minipool test was 36.36%, the median rate of invalid batch of NAT was 0.67%, and the median rate of invalid result of NAT was 0.07‰. The consistency rate of ELISA dual reagent detection results was (99.63±0.24)%, and the median length of equipment failure was 14 days. The error rate of blood type testing in blood collection department was 0.14‰. 【Conclusion】 The quality monitoring indicator system for blood testing process in Shandong can monitor potential risks before, during and after the experiment, and has good applicability, feasibility, and effectiveness, and can facilitate the continuous improvement of laboratory quality control level. The application of blood testing quality monitoring indicators will promote the homogenization and standardization of blood quality management in Shandong, and lay the foundation for future comprehensive evaluations of blood banks.
7.Application of quality control indicator system in blood banks of Shandong
Qun LIU ; Yuqing WU ; Xuemei LI ; Zhongsi YANG ; Zhe SONG ; Zhiquan RONG ; Shuhong ZHAO ; Lin ZHU ; Xiaojuan FAN ; Shuli SUN ; Wei ZHANG ; Jinyu HAN ; Xuejing LI ; Bo ZHOU ; Chenxi YANG ; Haiyan HUANG ; Guangcai LIU ; Kai CHEN ; Xianwu AN ; Hui ZHANG ; Junxia REN ; Hui YE ; Mingming QIAO ; Hua SHEN ; Dunzhu GONGJUE ; Yunlong ZHUANG
Chinese Journal of Blood Transfusion 2024;37(3):267-274
【Objective】 To establish an effective quality monitoring indicator system for blood quality control in blood banks, in order to analyze the quality control indicators for blood collection and supply, and evaluate blood quality control process, thus promoting continuous improvement and standardizing management of blood quality control in blood banks. 【Methods】 A quality monitoring indicator system covering the whole process of blood collection and supply, including blood donation services, component preparation, blood testing, blood supply and quality control was established. The Questionnaire of Quality Monitoring Indicators for Blood Collection and Supply Process was distributed to 17 blood banks in Shandong, which clarified the definition and calculation formula of indicators. The quality monitoring indicator data from January to December 2022 in each blood bank were collected, and 20 quality control indicators data were analyzed by SPSS25.0 software. 【Results】 The average pass rate of key equipment monitoring, environment monitoring, key material monitoring, and blood testing item monitoring of 17 blood banks were 99.47%, 99.51%, 99.95% and 98.99%, respectively. Significant difference was noticed in the pass rate of environment monitoring among blood banks of varied scales(P<0.05), and the Pearson correlation coefficient (r) between the total number of blood quality testing items and the total amount of blood component preparation was 0.645 (P<0.05). The average discarding rates of blood testing or non-blood testing were 1.14% and 3.36% respectively, showing significant difference among blood banks of varied scales (P<0.05). The average discarding rate of lipemic blood was 3.07%, which had a positive correlation with the discarding rate of non testing (r=0.981 3, P<0.05). There was a statistically significant difference in the discarding rate of lipemic blood between blood banks with lipemic blood control measures and those without (P<0.05). The average discarding rate of abnormal color, non-standard volume, blood bag damage, hemolysis, blood protein precipitation and blood clotting were 0.20%, 0.14%, 0.06%, 0.06%, 0.02% and 0.02% respectively, showing statistically significant differences among large, medium and small blood banks(P<0.05).The average discarding rates of expired blood, other factors, confidential unit exclusion and unqualified samples were 0.02%, 0.05%, 0.003% and 0.004%, respectively. The discarding rate of blood with air bubbles was 0.015%, while that of blood with foreign body and unqualified label were 0. 【Conclusion】 The quality control indicator system of blood banks in Shandong can monitor weak points in process management, with good applicability, feasibility, and effectiveness. It is conducive to evaluate different blood banks, continuously improve the quality control level of blood collection and supply, promote the homogenization and standardization of blood quality management, and lay the foundation for comprehensive evaluation of blood banks in Shandong.
8.Quality monitoring indicator system in blood banks of Shandong: applied in blood donation services, component preparation and blood supply process
Yuqing WU ; Hong ZHOU ; Zhijie ZHANG ; Zhiquan RONG ; Xuemei LI ; Zhe SONG ; Shuhong ZHAO ; Zhongsi YANG ; Qun LIU ; Lin ZHU ; Xiaojuan FAN ; Shuli SUN ; Wei ZHANG ; Jinyu HAN ; Haiyan HUANG ; Guangcai LIU ; Ping CHEN ; Xianwu AN ; Hui ZHANG ; Junxia REN ; Xuejing LI ; Chenxi YANG ; Bo ZHOU ; Hui YE ; Mingming QIAO ; Hua SHEN ; Dunzhu GONGJUE ; Yunlong ZHUANG
Chinese Journal of Blood Transfusion 2024;37(3):275-282
【Objective】 To establish an effective quality indicator monitoring system, scientifically and objectively evaluate the quality management level of blood banks, and achieve continuous improvement of quality management in blood bank. 【Methods】 A quality monitoring indicator system that covers the whole process of blood collection and supply was established, the questionnaire of Quality Monitoring Indicators for Blood Collection and Supply Process with clear definition of indicators and calculation formulas was distributed to 17 blood banks in Shandong. Statistical analysis of 21 quality monitoring indicators in terms of blood donation service (10 indicators), blood component preparation (7 indicators ), and blood supply (4 indicators) from each blood bank from January to December 2022 were conducted using SPSS25.0 software The differences in quality monitoring indicators of blood banks of different scales were analyzed. 【Results】 The average values of quality monitoring indicators for blood donation service process of 17 blood banks were as follows: 44.66% (2 233/5 000) of regular donors proportion, 0.22% (11/50) of adverse reactions incidence, 0.46% (23/5 000) of non-standard whole blood collection rate, 0.052% (13/25 000) of missed HBsAg screening rate, 99.42% (4 971/5 000) of first, puncture successful rate, 86.49% (173/200) of double platelet collection rate, 66.50% (133/200) of 400 mL whole blood collection rate, 99.25% (397/400) of donor satisfaction rate, 82.68% (2 067/2 500) of use rate of whole blood collection bags with bypass system with sample tube, and 1 case of occupational exposure in blood collection.There was a strong positive correlation between the proportion of regular blood donors and the collection rate of 400 mL whole blood (P<0.05). The platelet collection rate, incidence of adverse reactions to blood donation, and non-standard whole blood collection rate in large blood banks were significantly lower than those in medium and small blood banks (P<0.05). The average quality monitoring indicators for blood component preparation process of 17 blood banks were as follows: the leakage rate of blood component preparation bags was 0.03% (3/10 000), the discarding rate of lipemic blood was 3.05% (61/2 000), the discarding rate of hemolysis blood was 0.13%(13/10 000). 0.06 case had labeling errors, 8 bags had blood catheter leaks, 2.76 bags had blood puncture/connection leaks, and 0.59 cases had non-conforming consumables. The discarding rate of hemolysis blood of large blood banks was significantly lower than that of medium and small blood banks (P<0.05), and the discarding rate of lipemic blood of large and medium blood banks was significantly lower than that of small blood banks (P<0.05). The average values of quality monitoring indicators for blood supply process of 17 blood banks were as follows: the discarding rate of expired blood was 0.023% (23/100 000), the leakage rate during storage and distribution was of 0.009%(9/100 000), the discarding rate of returned blood was 0.106% (53/50 000), the service satisfaction of hospitals was 99.16% (2 479/2 500). The leakage rate of blood components during storage and distribution was statistically different with that of blood component preparation bags between different blood banks (P<0.05). There were statistically significant differences in the proportion of regular blood donors, incidence of adverse reactions, non-standard whole blood collection rate, 400 mL whole blood collection rate, double platelet collection rate, the blood bag leakage rate during preparation process, the blood components leakage rate during storage and distribution as well as the discarding rate of lipemic blood, hemolysis blood, expired blood and returned blood among large, medium and small blood banks (all P<0.05). 【Conclusion】 The establishment of a quality monitoring indicator system for blood donation services, blood component preparation and blood supply processes in Shandong has good applicability, feasibility and effectiveness. It can objectively evaluate the quality management level, facilitate the continuous improvement of the quality management system, promote the homogenization of blood management in the province and lay the foundation for future comprehensive evaluation of blood banks.
9.Mass spectrometry analysis of intact protein N-glycosylation signatures of cells and sera in pancreatic adenocarcinomas
XU MINGMING ; LIU ZHAOLIANG ; HU WENHUA ; HAN YING ; WU ZHEN ; CHEN SUFENG ; XIA PENG ; DU JING ; ZHANG XUMIN ; HAO PILIANG ; XIA JUN ; YANG SHUANG
Journal of Zhejiang University. Science. B 2024;25(1):51-64,中插9-中插28
Pancreatic cancer is among the most malignant cancers,and thus early intervention is the key to better survival outcomes.However,no methods have been derived that can reliably identify early precursors of development into malignancy.Therefore,it is urgent to discover early molecular changes during pancreatic tumorigenesis.As aberrant glycosylation is closely associated with cancer progression,numerous efforts have been made to mine glycosylation changes as biomarkers for diagnosis;however,detailed glycoproteomic information,especially site-specific N-glycosylation changes in pancreatic cancer with and without drug treatment,needs to be further explored.Herein,we used comprehensive solid-phase chemoenzymatic glycoproteomics to analyze glycans,glycosites,and intact glycopeptides in pancreatic cancer cells and patient sera.The profiling of N-glycans in cancer cells revealed an increase in the secreted glycoproteins from the primary tumor of MIA PaCa-2 cells,whereas human sera,which contain many secreted glycoproteins,had significant changes of glycans at their specific glycosites.These results indicated the potential role for tumor-specific glycosylation as disease biomarkers.We also found that AMG-510,a small molecule inhibitor against Kirsten rat sarcoma viral oncogene homolog(KRAS)G12C mutation,profoundly reduced the glycosylation level in MIA PaCa-2 cells,suggesting that KRAS plays a role in the cellular glycosylation process,and thus glycosylation inhibition contributes to the anti-tumor effect of AMG-510.
10.Application of V-Y advancement flap with facial artery perforator for the repair of midface skin defects
Xinjiang XU ; Mingming TANG ; Qingwen CHEN ; Jingtian SHI ; Liang HAN ; Bin JIANG
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2024;59(3):238-242
Objective:To investigate the efficacy of V-Y advancement flap with facial artery perforator for the repair of midface skin defects.Methods:A retrospective analysis was performed on 18 patients with facial skin cancer, including 11 males and 7 females, aged 65-83 years, who underwent the repair of midface skin defects using V-Y advancement flap with facial artery perforator in the Department of Head and Neck Surgery, Affiliated Cancer Hospital of Nantong University from January 2020 to April 2023. Medium, large or complex midface skin defects developed after surgical resections of the primary lesions. According to the defect site, size, location information of facial vessels, a V-Y advancement flap with appropriate shape was designed for each case. During the operation, the facial vessels and their perforators were retained in the pedicle of the flap, the facial nerve branches were dissected and protected, and the further denuded pedicle was determined according to actual amount of advancement. After the flap was advanced, the facial defect area was repaired without tension, and the anatomical positions and functions of the eyes, nose and mouth were restored as far as possible. Postoperative follow-ups were conducted to observe the survival rate of the flaps, postoperative complications, recurrences and metastases of tumors.Results:Midface defects of 3.0 cm×3.5 cm-6.5 cm×7.5 cm were observed after tumor resections, which involved one or more subregions. The sizes of the flaps were 3.5 cm×9.0 cm-7.0 cm×18.0 cm. All flaps were completely alive except for one with temporary local bruising. With following-up of 4-40 months, 5 of the 12 patients with lower eyelid and inner canthus invasions had lower eyelid ectropion, but no exposed keratitis was found; one case with poorly differentiated squamous cell carcinoma had lymph node metastasis in the submandibular region and underwent neck dissection again; no recurrence or metastasis occurred in the remaining cases.Conclusion:The V-Y advancement flap with facial artery perforator can be used to repair medium, large or complex midface skin defects, with a high survival rate, and the operation method is safe and reliable.


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