1.Guideline for the workflow of clinical comprehensive evaluation of drugs
Zhengxiang LI ; Rong DUAN ; Luwen SHI ; Jinhui TIAN ; Xiaocong ZUO ; Yu ZHANG ; Lingli ZHANG ; Junhua ZHANG ; Hualin ZHENG ; Rongsheng ZHAO ; Wudong GUO ; Liyan MIAO ; Suodi ZHAI
China Pharmacy 2025;36(19):2353-2365
OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs, and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization (WHO), strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States, and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions; research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center, and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions, including topic selection, evaluation implementation, evidence evaluation, and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs, which can effectively guide the high-quality and high-efficient development of this work, enhance the standardized output and transformation application value of evaluation evidence, and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.
2.Licorice-saponin A3 is a broad-spectrum inhibitor for COVID-19 by targeting viral spike and anti-inflammation
Yang YI ; Wenzhe LI ; Kefang LIU ; Heng XUE ; Rong YU ; Meng ZHANG ; Yang-Oujie BAO ; Xinyuan LAI ; Jingjing FAN ; Yuxi HUANG ; Jing WANG ; Xiaomeng SHI ; Junhua LI ; Hongping WEI ; Kuanhui XIANG ; Linjie LI ; Rong ZHANG ; Xin ZHAO ; Xue QIAO ; Hang YANG ; Min YE
Journal of Pharmaceutical Analysis 2024;14(1):115-127
Currently,human health due to corona virus disease 2019(COVID-19)pandemic has been seriously threatened.The coronavirus severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)spike(S)protein plays a crucial role in virus transmission and several S-based therapeutic approaches have been approved for the treatment of COVID-19.However,the efficacy is compromised by the SARS-CoV-2 evolvement and mutation.Here we report the SARS-CoV-2 S protein receptor-binding domain(RBD)inhibitor licorice-saponin A3(A3)could widely inhibit RBD of SARS-CoV-2 variants,including Beta,Delta,and Omicron BA.1,XBB and BQ1.1.Furthermore,A3 could potently inhibit SARS-CoV-2 Omicron virus in Vero E6 cells,with EC50 of 1.016 pM.The mechanism was related to binding with Y453 of RBD deter-mined by hydrogen-deuterium exchange mass spectrometry(HDX-MS)analysis combined with quan-tum mechanics/molecular mechanics(QM/MM)simulations.Interestingly,phosphoproteomics analysis and multi fluorescent immunohistochemistry(mIHC)respectively indicated that A3 also inhibits host inflammation by directly modulating the JNK and p38 mitogen-activated protein kinase(MAPK)path-ways and rebalancing the corresponding immune dysregulation.This work supports A3 as a promising broad-spectrum small molecule drug candidate for COVID-19.
3.Establishment and application of measurement range of main blood quality indicators in provincial blood stations
Zixuan ZHANG ; Ying CHANG ; Xiaotong ZHANG ; Qingming WANG ; Yuan ZHANG ; Yue LIU ; Qinghua TIAN ; Ka LI ; Guorong LI ; Lixia CHEN ; Junhua SUN ; Yu KANG ; Pingchen HAN ; Xinyu ZHAO ; Song LI
Chinese Journal of Blood Transfusion 2024;37(8):918-926
Objective To obtain the monitoring measurement range of quality indicators of red blood cells,plasma and derivatives and leukocyte-reduced apheresis platelets provided by blood stations in Hebei province,explore the distribution of monitoring values and the change of monitoring level,so as to further strengthen the homogenization construction of quality control laboratories in blood stations in Hebei.Methods In 2023,the sampling data of 12 blood stations in Hebei from 2015 to 2022 were collected,scatter plots were made and the range markers were set,and the"mean±SD"line was taken as the upper limit and lower limit of the measurement range.In 2024,the monitoring values in 2023 were added,and the changes of two measurement ranges were compared to analyze the stability and overall level.Results Comparison of the measurement range from 2015 to 2022 and the measurement range from 2015 to 2023 showed that the standard deviation of the content of deleukocyte suspension of red blood cells-hemoglobin,washed erythrocyte-hemoglobin,washed erythrocyte-su-pernatant protein,cryoprecipitate coagulation factor-FⅧ,fresh frozen plasma-FⅧ,leukocyte-reduced apheresis platelets-leukocyte residue and leukocyte-reduced apheresis platelet-red blood cell concentration decreased from 8.132 to 7.993,6.252 to 6.104,0.273 to 0.267,57.506 to 56.276,0.920 to 0.892,0.653 to 0.644 and 2.653 to 2.603,respectively.The narrowing of the standard deviation range of the above items led to more concentrated monitoring values and reduced disper-sion.Comparison of the measurement range from 2015 to 2022 and the measurement range from 2015 to 2023 showed that the mean value of leukocyte residue of the deleukocyte suspension of red blood cells,hemoglobin content of the wash eryth-rocyte,protein content of supernatant of the wash erythrocyte,hemolysis rate of the wash erythrocyte,FⅧ content of the cryoprecipitate coagulation factor,plasma protein content of the fresh frozen plasma,FⅧ content of the fresh frozen plasma,platelet content of the leukocyte-reduced apheresis platelets changed from 0.362 to 0.476,44.915 to 44.861,0.280 to 0.283,0.137 to 0.142,133.989 to 133.271,60.262 to 60.208,1.301 to 1.277 and 3.036 to 3.033,respectively,and was closer to the national standard line,which reflects an increase in the number of unqualified monitoring values or values close to the national standard line in 2023.The long-term qualified rate of coagulation items was low,and no improvement has been ob-served.The stability of biochemical items has been enhanced but overall deviation has occurred,with the average value close to the national standard line.The possibility of subsequent testing failure has increased.The counting items showed no obvi-ous common characteristics.Conclusion The use of"mean±SD"in the analysis can visually display the distribution of mo-nitoring values of different items in Hebei,forming an indicator measurement range covering the past nine years.It shows the characteristics of each item,and provides reference for subsequent quality control laboratory data analysis of each blood sta-tions to takes active measures to improve the monitoring level.
4.Research progress on digital dental models and the independent development of digital dental-cranio-cervi-cal model
Jinghui HUANG ; Junhua ZHANG ; Lei LU ; Shibin YU
Journal of Practical Stomatology 2024;40(5):732-736
The application of digital technology in teaching and clinical practice has been hindered by the lack of integrity,consis-tency and accuracy in current digital models.Despite the efforts of domestic and international scholars,the localization,refining and standardization of model data for digital dental models remain inadequate,which limits the promotion and application of digital dental models.A preliminergly produced precise,standardized and multi-form applicable 3D dental-cranio-cervical digital model based on Chinese anatomical data is reported in this paper.The further improvement,application and promotion of this model are expected to contribute to the improvement of the quality of dental education and clinical efficiency.
5.Retrospective study on authorized aeromedical identification of overage military flying personnel
Nan SU ; Di ZHU ; Linsong QI ; Jiakang ZHANG ; Dongrui YU ; Jun WANG ; Junhua XING ; Hongyang JI ; Xianrong XU
Space Medicine & Medical Engineering 2024;35(2):112-115
Objective To retrospectively investigate and analyze the specially permitted aeromedical evaluation results of overage military flying personnel,in order to provide references for health management and related evaluation methods improvement.Methods The clinical data and evaluation results of overage flying personnel were collected from 2012 to 2023.Disease spectrum was analyzed,and qualified rates among different airplane types and aviation duties were compared.Results 79.57%of the 509 flying personnel were detected with diseases,and the top ten were hyperlipidemia,fatty liver,thyroid nodule,renal cyst,hepatic cyst,gallbladder polyps,hyperuricemia,carotid artery arteriosclerosis,hypertension and hepatic hemangioma.96.08%of the personnel were qualified to continue flying,1.96%were disqualified and 1.96%were temporarily disqualified.The qualified rates among different airplane types and aviation duties were not significantly different(P?>?0.05).Conclusion Overage military flying personnel could apply for specially permitted aeromedical evaluation to extend their flying lifespan.Attention should be paid to metabolic and cardiovascular diseases in aeromedical support and evaluation for these experienced flying personnel.
6.External quality assessment of laboratories in blood stations of Hebei Province in 2022: a retrospective analysis of HeBEQA project
Ying CHANG ; Xiaotong ZHANG ; Zixuan ZHANG ; Qinghua TIAN ; Song LI ; Shaoling YANG ; Yu KANG ; Lixia CHEN ; Yuan ZHANG ; Xuanhe ZHAO ; Lina FENG ; Junhua SUN ; Yue LIU ; Yinhai TANG
Chinese Journal of Blood Transfusion 2023;36(10):920-923
【Objective】 To conduct the laboratory quality assessment between 12 blood stations in Hebei province, analyze the results and explore the accuracy and comparability of testing, so as to improve the level of testing ability and quality management. 【Methods】 With reference to the external quality assessment rules of National Center for Clinical Laboratories and combined with the instructions of quality assessment samples, daily testing process of the laboratories were assessed. The quality indicators include blood cell count (WBC, RBC, Hb, HCT, MCV, MCH, MCHC and PLT), biochemical items (TP) and coagulation parameters (FIB and FⅧ). 【Results】 There are still problems in laboratories in terms of personnel operation, instrument maintenance and the impact of different reagent batches, especially in biochemical items and coagulation parameters. The pass rate of biochemical items was the lowest, only 72.75%, and that of blood cell count was the highest, reaching 98.75%. 【Conclusion】 With the progress of the project, the quality monitoring level of daily blood sampling tests in the quality control laboratory of each blood station has been improved. However, it is still necessary for each laboratory to improve the testing ability and quality management to a higher level in Hebei.
7.Clinical characteristics of in-hospital cardiac arrest in emergency patients in Kashgar area and analysis of influencing factors on success rate of cardiopulmonary resuscitation.
Yi LONG ; Xiaojiang LI ; Yu LIANG ; Tuerxun MAIMAITIAILI ; Aili MAIHEMUTI ; Min DENG ; Xingzhou WU ; Guixiang LIU ; Youwu QUAN ; Jinhong YANG ; Junhua HAN ; Tulafu REYIHANGULI ; Chunfu ZHANG
Chinese Critical Care Medicine 2023;35(7):719-723
OBJECTIVE:
To analyze the clinical characteristics of patients with emergency in-hospital cardiac arrest (IHCA) in Kashgar, Xinjiang Uygur Autonomous Region and the factors affecting the success rate of cardiopulmonary resuscitation.
METHODS:
Retrospectively selected patients who had cardiac arrest and cardiopulmonary resuscitation in the emergency department of the People's Hospital of 6 counties and cities in Kashgar area from January 2019 to January 2022. The clinical data of all patients were collected, including gender, age, major underlying diseases, the beginning and duration of resuscitation, the number of electric defibrillation acute physiology and chronic health evaluation II (APACHE II). According to whether the resuscitation was successful, all patients were divided into successful resuscitation group and failed resuscitation group. The clinical characteristics of the two groups were compared. Then, the influencing factors of the success rate of cardiopulmonary resuscitation in IHCA patients were analyzed by binary Logistic regression.
RESULTS:
A total of 1 376 patients were enrolled, including 1 117 cases of failed resuscitation and 259 cases of successful resuscitation. The success rate of resuscitation was 18.82%. Compared with the resuscitation failure group, the patients in the successful resuscitation group were younger (age: 49.10±20.99 vs. 58.44±18.32), the resuscitation start time was earlier [resuscitation start time ≤ 5 minutes: 76.45% (198/259) vs. 66.61% (744/1 117)], the proportion of cardiovascular and cerebrovascular diseases was lower [cardiovascular disease: 49.42% (128/259) vs. 58.19% (650/1 117), cerebrovascular disease: 17.37% (45/259) vs. 21.58% (241/1 117)], the number of electric defibrillation was lower [times: 0 (0, 2) vs. 1 (0, 1)], the proportion of endotracheal intubation was more [80.31% (208/259) vs. 55.60% (621/1 117)], APACHE II score was lower (13.75±8.03 vs. 17.90±4.63), and the difference was statistically significant (all P < 0.01). Binary Logistic regression analysis showed that age, start time of resuscitation, ventilation mode and APACHE II score were protective factors affecting the success rate of cardiopulmonary resuscitation in patients with emergency IHCA [age: odds ratio (OR) = 0.982, 95% confidence interval (95%CI) was 0.973-0.991, P < 0.001; resuscitation start time ≤ 5 minutes: OR = 0.629, 95%CI was 0.409-0.966, P = 0.034; tracheal intubation assisted ventilation: OR = 0.243, 95%CI was 0.149-0.397, P < 0.001; low APACHE II score: OR = 0.871, 95%CI was 0.836-0.907, P < 0.001], while underlying diseases (cardiovascular diseases) are a risk factor affecting the success rate of cardiopulmonary resuscitation (OR = 1.190, 95%CI was 1.015-1.395, P = 0.036).
CONCLUSIONS
Age, resuscitation start time, ventilation mode, APACHE II score and major underlying diseases (cardiovascular diseases) have a greater impact on the success rate of resuscitation in IHCA patients. The above factors are conducive to improving or formulating more effective rescue strategies for IHCA patients, so as to achieve the purpose of improving the success rate of clinical treatment.
Humans
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Adult
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Middle Aged
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Aged
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Retrospective Studies
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Cardiopulmonary Resuscitation
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Heart Arrest/therapy*
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Electric Countershock
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Hospitals
8.Management and operation of extra-large Fangcang hospitals: experience and lessons from containing the highly contagious SARS-CoV-2 Omicron in Shanghai, China.
Yun XIAN ; Chenhao YU ; Minjie CHEN ; Lin ZHANG ; Xinyi ZHENG ; Shijian LI ; Erzhen CHEN ; Zhongwan CHEN ; Weihua CHEN ; Chaoying WANG ; Qingrong XU ; Tao HAN ; Weidong YE ; Wenyi XU ; Xu ZHUANG ; Yu ZHENG ; Min CHEN ; Jun QIN ; Yu FENG ; Shun WEI ; Yiling FAN ; Zhiruo ZHANG ; Junhua ZHENG
Frontiers of Medicine 2023;17(1):165-171
9.A study on using comprehensive geriatric assessment to improve the teaching level of doctor-patient communication from the perspective of Johari Window
Ling DING ; Junhua LI ; Zhen YU ; Jian JIA ; Shuyu LIU ; Xilan YANG
Chinese Journal of Medical Education Research 2023;22(4):564-567
Based on the theory of "Johari Window", this study introduced how to stimulate information content obtained in doctor-patient communication and how to apply the comprehensive geriatric assessment creatively from the four modules of open area, blind area, hidden area and unknown area in the model. It helped students to gain the trust and cooperation of patients, rapidly narrow down the blind area, hidden area and unknown area, guide patients to actively extend the open area, improve the teaching quality of doctor-patient communication in a scientific way.
10.Clinical treatment guideline for pulmonary blast injury (version 2023)
Zhiming SONG ; Junhua GUO ; Jianming CHEN ; Jing ZHONG ; Yan DOU ; Jiarong MENG ; Guomin ZHANG ; Guodong LIU ; Huaping LIANG ; Hezhong CHEN ; Shuogui XU ; Yufeng ZHANG ; Zhinong WANG ; Daixing ZHONG ; Tao JIANG ; Zhiqiang XUE ; Feihu ZHOU ; Zhixin LIANG ; Yang LIU ; Xu WU ; Kaican CAI ; Yi SHEN ; Yong SONG ; Xiaoli YUAN ; Enwu XU ; Yifeng ZHENG ; Shumin WANG ; Erping XI ; Shengsheng YANG ; Wenke CAI ; Yu CHEN ; Qingxin LI ; Zhiqiang ZOU ; Chang SU ; Hongwei SHANG ; Jiangxing XU ; Yongjing LIU ; Qianjin WANG ; Xiaodong WEI ; Guoan XU ; Gaofeng LIU ; Junhui LUO ; Qinghua LI ; Bin SONG ; Ming GUO ; Chen HUANG ; Xunyu XU ; Yuanrong TU ; Liling ZHENG ; Mingke DUAN ; Renping WAN ; Tengbo YU ; Hai YU ; Yanmei ZHAO ; Yuping WEI ; Jin ZHANG ; Hua GUO ; Jianxin JIANG ; Lianyang ZHANG ; Yunfeng YI
Chinese Journal of Trauma 2023;39(12):1057-1069
Pulmonary blast injury has become the main type of trauma in modern warfare, characterized by externally mild injuries but internally severe injuries, rapid disease progression, and a high rate of early death. The injury is complicated in clinical practice, often with multiple and compound injuries. Currently, there is a lack of effective protective materials, accurate injury detection instrument and portable monitoring and transportation equipment, standardized clinical treatment guidelines in various medical centers, and evidence-based guidelines at home and abroad, resulting in a high mortality in clinlcal practice. Therefore, the Trauma Branch of Chinese Medical Association and the Editorial Committee of Chinese Journal of Trauma organized military and civilian experts in related fields such as thoracic surgery and traumatic surgery to jointly develop the Clinical treatment guideline for pulmonary blast injury ( version 2023) by combining evidence for effectiveness and clinical first-line treatment experience. This guideline provided 16 recommended opinions surrounding definition, characteristics, pre-hospital diagnosis and treatment, and in-hospital treatment of pulmonary blast injury, hoping to provide a basis for the clinical treatment in hospitals at different levels.

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