1.Comparison of system architecture between Chinese,United States,European and Japanese pharmacopoeias
Xinyi XU ; Zhen LIU ; Leran TAO ; Haoyun SONG ; Dan LI ; Wenli YU ; Guannan WANG ; Hao LI ; Zhaopeng YANG
Drug Standards of China 2024;25(3):209-219
The standard system refers to the scientific organic whole formed by the internal connections of stand-ards within a certain range.The completeness of the drug standard system plays a crucial role in ensuring drug safety.Pharmacopoeia is the core of the drug standard system.This article compared the architecture of the Chi-nese Pharmacopoeia,the United States Pharmacopoeia,the European Pharmacopoeia,and the Japanese Pharma-copoeia on the aspects of overall architecture,monographs architecture,general notice architecture,general tech-nical requirements architecture,and other standard architecture,as well as the implementation of various types of standards,aiming to provide reference for the optimization and improvement of the standard system of the Chinese Pharmacopoeia.
2.Long-term efficacy of oblique lateral interbody fusion combined with vertebral screw fixation for the treatment of lumbar specific infection
Wen-Hui ZHANG ; Yang-Yang DOU ; Feng-Guang YANG ; Zong-Ru HE ; Yu-Ping YANG ; Li-Zhen FAN ; Qing-Hao CHENG ; Jie LIU ; Hui-Ping TAI
China Journal of Orthopaedics and Traumatology 2024;37(9):893-898
Objective To explore medium and long term efficacy of oblique lateral interbody fusion(OLIF)in treating lumbar specific infection.Methods From October 2017 to January 2021,24 patients with lumbar specific infection were treated by OLIF combined with vertebral screw internal fixation,including 15 males and 9 females,aged from 27 to 61 years old with an average of(43.0±15.0)years old;the courses of disease ranged from 6 to 24 months with an average of(14.0±7.0)months;7 patients with L2-L3,12 patients with L3-L4 and 5 patients with L4-L5;19 patients with tuberculosis infection and 5 patients with brucella infection.The amount of intraoperative blood loss,operative time and complications were recorded,and erythro-cyte sedimentation rate(ESR),C-reactive protein(CRP),visual analogue scale(VAS),Japanese Orthopaedic Association(JOA)score and American Spinal Injury Association(ASIA)rating were compared before and one month after opertaion.Re-sults All patients were followed up from 9 to 24 months with an average of(13.0±6.0)months.Operative time was(132.5±21.4)min,and intraoperative blood loss was(227.3±43.1)ml.ESR and CRP were decreased from(82.34±18.62)mmol·h-1 and(53.08±21.84)mg·L-1 before operation to(33.52±17.31)mmol·h-1 and(15.48±8.36)mg·L-1 at one month after opera-tion,respectively(P<0.05).VAS was decreased from(7.52±1.36)before opertaion to(1.74±0.87)at one month after opera-tion(P<0.05).JOA was increased from(17.86±3.95)before operation to(24.72±3.19)at one month after operation(P<0.05).Four patients had neurological symptoms before operation,and were classified to grade D according to ASIA classifica-tion,who were recovered to grade E at 1 month after operation.One patient was suffered from psoas major muscle injury after operation,and returned to normal at 3 weeks.One patient was suffered from abdominal distension and difficulty in defecation,and relieved after gastrointestinal decompression and enema.No complications such as abdominal organ injury and poor wound healing occurred in all patients.Conclusion OLIF combined with vertebral screw internal fixation is a new minimally invasive surgical method for the treatment of lumbar specific infection,especially the lesion located on the middle lumbar vertebra.It has advantages of less trauma,short operation time,less blood loss,convenient operation,complete removal of the lesion,safety and effectiveness,and has good medium-and long-term efficacy for lumbar specific infection.
3.Accessibility assessment of medical services in suburban plains and mountainous villages of Beijing:An investigation-based 2SFCA study
Hao-Peng LIU ; Cheng-Yu MA ; Yan-Bin YANG ; Wei-Zhen LIAO ; Si-Yu LYU
Chinese Journal of Health Policy 2024;17(7):65-74
Objective:This study evaluates the accessibility and equity of healthcare resources in deep mountain,shallow mountain,and plain suburban areas,taking Huairou,Mentougou,and Tongzhou districts of Beijing as examples,to identify factors contributing to the imbalance in resource allocation.Methods:Accessibility of healthcare services in the sample areas was measured using village-level health survey data and the Two-Step Floating Catchment Area(2SFCA)method.Equity of resource allocation was assessed using the Gini coefficient among other methods.Factors influencing imbalance were identified using the Geodetector and Spatial Lag Model.Results:The average accessibility scores for Huairou,Mentougou,and Tongzhou were 202.06,179.68,and 187.02,respectively.The Gini coefficients were 0.48,0.37,and 0.24,respectively.GDP,population density,and altitude were significant factors affecting accessibility.Conclusions and Suggestions:In Beijing,both plain and mountainous rural areas exhibited a spatial clustering of healthcare accessibility,higher near the city and lower in the suburbs,with plains performing better than mountains.Healthcare equity was ranked as plains>shallow mountains>deep mountains.Policies covering full healthcare services improved equity.It is recommended to strengthen the construction of village healthcare facilities and medical teams,improve the linkage of medical services at all rural levels,and enhance the willingness of villagers to seek primary care.Furthermore,gradual improvement of transportation and internet infrastructure is suggested to enhance the accessibility of online and offline medical services for villagers.
4.Application of China-made Toumai? Robot in laparoscopic radical prostatectomy
Zhi-Feng WEI ; Yu-Hao CHEN ; Ze-Peng ZHU ; Qi JIANG ; Yu XIONG ; Feng-Feng LU ; Zhen-Qian SONG ; Bin JIANG ; Xiao-Feng ZHU ; Tian-Hao FENG ; Xiao-Feng XU ; Gang YANG ; Wu WEI ; Ai-Bing YAO ; Jing-Ping GE
National Journal of Andrology 2024;30(8):696-700
Objective:To evaluate the safety and efficiency of China-made Toumai Robot-assisted laparoscopic radical prosta-tectomy(LRP).Methods:This study included 40 cases of PCa treated from January 2023 to May 2023 by robot-assisted LRP with preservation of the bladder neck and maximal functional urethral length,15 cases with the assistance of Toumai Robot(the TMR group)and the other 25 with the assistance of da Vinci Robot as controls(the DVR group).We recorded the docking time,laparo-scopic surgery time,vesico-urethral anastomosis time,intraoperative blood loss and postoperative urinary continence,and compared them between the two groups.Results:Operations were successfully completed in all the cases.No statistically significant differ-ences were observed between the TMR and DVR groups in the docking time(6 min vs 5 min,P>0.05)or intraoperative blood loss(200 ml vs 150 ml,P>0.05).The TMR group,compared with the DVR group,showed a significantly longer median laparoscopic surgery time(146 min vs 130 min,P<0.05)and median vesico-urethral anastomosis time(19 min vs 16 min,P<0.05).There were no statistically significant differences between the TMR and DVR groups in the rates of urinary continence recovery immediately af-ter surgery(60.0%[9/15]vs 64.0%[16/25],P>0.05)or at 1 month(80.0%[12/15])vs(76.0%[19/25],P>0.05),3 months(93.3%[14/15])vs(92.0%[23/25],P>0.05)and 6 months postoperatively(100%[15/15])vs(96%[24/25],P>0.05).Conclusion:China-made Toumai? Robot surgical system is safe and reliable for laparoscopic radical prosta-tectomy,with satisfactory postoperative recovery of urinary continence.
5.Longitudinal analysis of the effects of golf training on the three-dimensional structure of children's spine using grating-based stereoscopic imaging
Hao PENG ; Yanping SONG ; Na YAO ; Zhen SHEN ; Yang JIANG ; Yueyu SONG ; Qigang CHEN
Chinese Journal of Medical Physics 2024;41(8):1041-1045
Objective To conduct a systematic study on the potential impact of long-term specialized golf training on the three-dimensional structure of the spine in adolescent children,and to reveal the biomechanical adaptation mechanism of children's spine,providing a theoretical basis for preventing potential sports injuries caused by golf training.Methods A longitudinal observational design was adopted,with 15 male adolescent children from a golf training center selected as research subjects.Three-dimensional spinal image data were collected using digital radiography at baseline,3 months and 6 months,and dynamic monitoring and analysis were performed.Results Golf training led to a series of adaptive changes in the three-dimensional structure of children's spine,mainly reflected in significant changes in pelvic tilt distance,vertebral body offset,vertebral rotation angle,pelvic rotation angle,and pelvic torsion angle.These changes exhibited a time-effect characteristic,indicating the strong adaptability of biomechanical system of children's spine.Conclusion Golf training can cause adaptive changes in the three-dimensional structure of children's spine,highlighting the need to maintain biomechanical balances of the spine and pelvis,and to take intervention measures such as symmetrical training to prevent sports injuries,improve training quality,and prolong athletic careers.
6.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.
7.Rupture-A symbolic timing point of the natural abdominal rupture during cadaver decay
Xingchun ZHAO ; Fan YANG ; Sheng HU ; Hao NIE ; Jiajia FAN ; Zhen PENG ; Gengqian ZHANG ; Peng GUI ; Zengtao ZHONG
Chinese Journal of Forensic Medicine 2024;39(1):68-74
Objective Corruption is the most common cadaver phenomenon in forensic practice and an important basis for inferring time of death(PMI),but the definition of corruption degree and the construction of model inference models have always been difficult in the practice of forensic science.Methods In this study,the late postmortem phenomena were observed.Meanwhile,the microbial flora structure of gut and gravesoil and the nature of gravesoil were detected,for analyzing the changes before and after the key moment of abdominal rupture which naturally happened during the cadaver decay.Results The results found that from the macroscopic and microscopic levels,there were significant differences in cadaver decay,including microbial flora structure and gravesoil properties before and after the key moment of the natural abdominal rupture during cadaver decay.The phenomena are highly observable and can be accurately judged by forensic examinations,as well as related means in the field of biology and physiochemistry.In this study,this critical event was called Rupture Point.Conclusion The Rupture Point can be used as an important node for the assessment of cadaver decay degree in the practice of forensic medicine.It can be utilized for a cut-off point as well when constructing PMI inference models based on microbial flora structure changes.The accuracy of PMI inference models can be improved when the models were constructed in segments.
8.Expert consensus on the diagnosis and treatment of osteoporotic proximal humeral fracture with integrated traditional Chinese and Western medicine (version 2024)
Xiao CHEN ; Hao ZHANG ; Man WANG ; Guangchao WANG ; Jin CUI ; Wencai ZHANG ; Fengjin ZHOU ; Qiang YANG ; Guohui LIU ; Zhongmin SHI ; Lili YANG ; Zhiwei WANG ; Guixin SUN ; Biao CHENG ; Ming CAI ; Haodong LIN ; Hongxing SHEN ; Hao SHEN ; Yunfei ZHANG ; Fuxin WEI ; Feng NIU ; Chao FANG ; Huiwen CHEN ; Shaojun SONG ; Yong WANG ; Jun LIN ; Yuhai MA ; Wei CHEN ; Nan CHEN ; Zhiyong HOU ; Xin WANG ; Aiyuan WANG ; Zhen GENG ; Kainan LI ; Dongliang WANG ; Fanfu FANG ; Jiacan SU
Chinese Journal of Trauma 2024;40(3):193-205
Osteoporotic proximal humeral fracture (OPHF) is one of the common osteoporotic fractures in the aged, with an incidence only lower than vertebral compression fracture, hip fracture, and distal radius fracture. OPHF, secondary to osteoporosis and characterized by poor bone quality, comminuted fracture pattern, slow healing, and severely impaired shoulder joint function, poses a big challenge to the current clinical diagnosis and treatment. In the field of diagnosis, treatment, and rehabilitation of OPHF, traditional Chinese and Western medicine have accumulated rich experience and evidence from evidence-based medicine and achieved favorable outcomes. However, there is still a lack of guidance from a relevant consensus as to how to integrate the advantages of the two medical systems and achieve the integrated diagnosis and treatment. To promote the diagnosis and treatment of OPHF with integrated traditional Chinese and Western medicine, relevant experts from Orthopedic Expert Committee of Geriatric Branch of Chinese Association of Gerontology and Geriatrics, Youth Osteoporosis Group of Orthopedic Branch of Chinese Medical Association, Osteoporosis Group of Orthopedic Surgeon Branch of Chinese Medical Doctor Association, and Osteoporosis Committee of Shanghai Association of Integrated Traditional Chinese and Western Medicine have been organized to formulate Expert consensus on the diagnosis and treatment of osteoporotic proximal humeral fracture with integrated traditional Chinese and Western medicine ( version 2024) by searching related literatures and based on the evidences from evidence-based medicine. This consensus consists of 13 recommendations about the diagnosis, treatment and rehabilitation of OPHF with integrated traditional Chinese medicine and Western medicine, aimed at standardizing, systematizing, and personalizing the diagnosis and treatment of OPHF with integrated traditional Chinse and Western medicine to improve the patients ′ function.
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.Bioequivalence study of olmesartan medoxomil tablet in Chinese healthy subjects
Na SHAN ; Da-Hai JIANG ; Lin-Lin MIAO ; Zhen-Li REN ; Peng-Bo JIN ; Pei-Qi HAO ; Li AN ; Hong ZHU ; Yong XIN ; Guang-De YANG ; Feng LIU
The Chinese Journal of Clinical Pharmacology 2024;40(20):3033-3037
Objective To study the bioequivalence of test and reference olmesartan tablet in Chinese healthy subjects after single dose under fasting and fed conditions.Methods A single-center,random,open,single-dose,two-preparations,double-period,crossover study was adopted.A total of 48 healthy adult male and female subjects(24 cases of fasting test and 24 cases of fed test)were included in the random crossover administration.Single oral dose 20 mg of test and reference were taken under fasting and postprandial conditions,respectively.Plasma concentration of olmesartan in plasma were determined by liquid chromatography tandem mass spectrometry.The main pharmacokinetic parameters were calculated by Phoenix WinNonlin 8.0 software.Results The main pharmacokinetic parameters of the test and reference preparations of olmesartan tablets in the fasting group were as follows:Cmax were(653.06±133.53)and(617.37±151.16)ng·mL-1,AUC0-t were(4 201.18±1 035.21)and(4 087.38±889.99)ng·mL-1·h,AUC0-∞ were(4 254.30±1 058.90)and(4 135.69±905.29)ng·mL-1·h.The main pharmacokinetic parameters of the test and reference preparations of olmesartan tablets in the postprandial group were as follows:Cmax were(574.78±177.05)and(579.98±107.74)ng·mL-1,AUC0-t were(3 288.37±866.06)and(3 181.51±801.06)ng·mL-1·h,AUC0-∞ were(3 326.11±874.26)and(3 242.01±823.09)ng·mL-1·h.Under fasting and postprandial conditions,the 90%confidence intervals of the main pharmacokinetic parameters of the test and reference preparations are both 80.00%-125.00%.Conclusion Under fasting and postprandial conditions,a single oral dose of test and reference preparations olmesartan tablets in Chinese healthy adult volunteers showed bioequivalence.

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