1.Pathway of vancomycin dosage decision based on therapeutic drug monitoring
The Chinese Journal of Clinical Pharmacology 2017;33(23):2484-2488
Objective To develop the pathway of vancomycin dosage decision based on therapeutic drug monitoring (TDM) in order to improve the clinic operability.Methods To systematically study the TDM target of vancomycin and their variances among populations,infusion approach and decided factors of dosing.Results It was found that area under curve/minimum inhibitory concentration (AUC/MIC) was a more accurate target compared to trough concentration for vancomycin.The trough concentration of 10-15 mg · L-1 may not be enough.The pathway of vancomycin dosage decision had been developed based on patients' characteristics.The simple calculation approach was relative inaccurate but simple and efficiency.The pharmacokinitc/pharmacodynamic (PK/PD) modeling approach was more accurate but relative complex and needing supportive software.The special parameters need to be considered for special populations.Conclusion The pathway of vancemycin dosage decision based on TDM have been developed and it can be used to improve the clinic operability and provide clear decision path for clinics.
2.Design and Application of the Security Mode for the Mobile Business Platform of Hospital
Xiao XU ; qing Ai LI ; lian Min CHEN ; guang Wai HU ; shan Shan HU
Journal of Medical Informatics 2017;38(10):47-50
Taking Children's Hospital in Hunan Province as an example,the paper introduces the design and application of the security mode for the mobile business platform of hospital from the aspects of the overall structure,implementation plans of security access equipment,security authentication modes and strategies,etc.,and provides ideas for safely implementing remote deployment and mobile application.
3.Design and Application of Virtual Isolation Private Cloud Storage in Hospital
Xiao XU ; Ai-Qing LI ; Min-Lian CHEN ; Wai-Guang HU ; Shan-Shan HU
Journal of Medical Informatics 2018;39(1):30-32
In order to improve the access and control of core data in medical information security,the paper builds a virtual isolation private cloud storage architecture in hospital,including virtualized reconstruction,metadata model application based on hierarchical model,access to remote clients design and application based on virtual isolation and so on,providing a reliable method for the isolation and intercommunication between the intranet and extranet.
4.Influence and effect of three significant databases on impact factors of journals in China
The Chinese Journal of Clinical Pharmacology 2015;(8):677-680
This paper introduces the evaluation systems of three domesti-cally significant databases , A Guide to the Core Journals of China, Chinese S&T Journal Citation Reports and Annual Report for Chinese Academic Journal Impact Factors ( Natural Science) , and discusses indi-vidual features as well as indexing requirements for promotion in depart-ments of title appraisal .This paper aims to promote domestic journals to better understand characteristics of big databases , further the integration with high level international journals.Meanwhile, it hopes to provide correct reference of various impact factors for staff in medical management industry in the process of title appraisal .
5.Advanced development of target molecule affinity coupled with mass spectrometry for the screening of bioactive compounds in traditional Chinese medicines
De-Qiang LI ; Yuan-Yuan XIAO ; Rong-Yuan DAI ; Zhi-Qing ZHANG ; Ai-Lian SHAN
The Chinese Journal of Clinical Pharmacology 2015;(21):2164-2169
Rapid screening and characterization of bioactive compounds from traditional Chinese medicines ( TCM) is one of the highlighted re-search challenges in the field of drug development.Target molecule affin-ity coupled with mass spectrometry ( MS) has become a new method for the screening of bioactive compounds from complex mixture, the recent development of which since 2005 will be reviewed.According to the prin-ciple of affinity screening, the methods could be classified into pre -column affinity screening including ultrafiltration -MS, size -exclusion chromatography-MS, turbulent-flow chromatography-MS, restricted-access material-MS and immobilized target-MS and post-column af-finity screening (HPLC-continuous-flow bioassay-MS).Each meth-od with its typical applications would be introduced, providing technique references for the screening of bioactive compounds from complex mixture such as TCM.
6.Simultaneous determination of six coumarins in Radix Glehniae using pressurized liquid extraction and HPLC
De-Qiang LI ; Yuan-Yuan XIAO ; Rong-Yuan DAI ; Ai-Lian SHAN
The Chinese Journal of Clinical Pharmacology 2015;(24):2433-2436
Objective To develop a HPLC method for simultaneous de-termination of six coumarins in Radix Glehniae from different sources. Methods The samples were analyzed by HPLC after pressurized liquid extraction ( PLE ) .The chromatographic conditions were as following:The column was Kinetex core-shell-C18 column (50 mm ×4.6 mm, 2.6 μm) , the mobile phase consisted of acetonitrile-water using gradi-ent elution, the flow rate was 0.4 mL? min-1 and the column tempera-ture was 30℃.The detection wavelength was set at 310 nm and the sam-ple injection volume was 20 μL.The method was validated by investiga-ting its specificity, linearities and limit of detection, precision, extraction recovery, stability and repeatability.Results Six components were de-termined by HPLC, including psoralen, xanthotoxin, bergapten, impera-torin, cnidilin and isoimperatorin. The linearities of them were good ( r≥0.999 2 ) in the concentration ranges of 0.50 -10.00 , 1.00-20.00, 0.32-6.40, 0.25 -5.00, 0.05 -1.00, 0.17 -3.50μg? mL-1 , respectively.The coumarins showed the overall recoveries ranging from 91.7%-107.6%.The contents of six compounds of Radix Glehniae from different areas had an obvious difference.Conclusion Six coumarins in Radix Glehniae were analyzed by PLE and HPLC. The method has good specificity, reproducibility and high sensitivity, which can be applied for the quality control of Radix Glehniae.
7.Interpretation of guidance for clinical investigation of medicinal products in the pediatric population
Chao ZHANG ; Xiao-Ling WANG ; Shuang MU ; Suo-Di ZHAI ; Zai-Ling LI ; Ai-Lian SHAN
The Chinese Journal of Clinical Pharmacology 2015;(24):2496-2498
The pediatric population is different from adults in their physi-ological function and tissues structure, and therefore they should not be assumed simply as the small adults.The drug development for pediatric population is helpful to improve the health of children in the whole coun-try.However, the clinical investigation of medicinal products for adults can not apply for children and there has not available guidance for chil-dren for a while.Accordingly, Chinese Food and Drug Administration ( CFDA) issues the guidance for clinical investigation of medicinal prod-ucts in the pediatric population, which ensure the clinical trials are more scientific and ethic. This paper means to interpret the guidance and therefore to help the development of clinical trials in pediatric population.
8.Interpretation of guidance for clinical investigation of medicinal products in the pediatric population
Chao ZHANG ; Xiao-Ling WANG ; Shuang MU ; Suo-Di ZHAI ; Zai-Ling LI ; Ai-Lian SHAN
The Chinese Journal of Clinical Pharmacology 2015;(24):2499-2501
The pediatric population is different from adults in their dis-ease types and medication use in clinics.The drug clinic trial in pediatric population provides reliable clinic data for new drug development and medication use, and is helpful to promote the health of children.Howev-er, considering the specificity of children, it is changeable to conduct the drug clinic trials, especially for the study protocol design.Accordingly, CFDA issues the guidance for clinical investigation of medicinal products in the pediatric population, which ensure the clinical trials are more sci-entific and ethic.This paper means to interpret the guidance and there-fore to help the development of clinical trials in pediatric population.
9.Similarities and differences of new drug phase Ⅳ clinical trials and post -marketing drug evaluation as well as existing problems
The Chinese Journal of Clinical Pharmacology 2014;(5):387-390,396
With the retrospection of the background information of new drug phase Ⅳ clinical trials and post -marketing drug evaluation , this paper compared their similarities and differences and explored the exist-ing problems.Meanwhile , it illustrated the characteristics of clinically verified trials having inclination to pharmaceutical promotion , anticipating helping clinicians and clinical pharmacists clarify the purpose and range of clinical trials, and providing data for clinical rational drug use by dis-tinguishing among new drug phase IV clinical trial , post-marketing drug evaluation and clinical trials having inclination to pharmaceutical promotion.
10.Situation of standardized training of Chinese clinical research coordinator
Xin WANG ; Fang WANG ; Yan LI ; Ai-Lian SHAN ; Rui WANG
The Chinese Journal of Clinical Pharmacology 2016;32(12):1144-1146
Objective To understand the domestic situation of the clinical research coordinator ( CRC) training, and discuss the standard training of CRCs.Methods Adopt the method of questionnaire , using descriptive statistics and inferential statistics method , analysis and sum-marize the problems existing in the CRC training.Results The trainings in different companies are diverse , and the training content is too simple.Conclusion China ’ s CRC industry need the standard training , we should study the experience of Japan and the United States , and establish China ’ s own CRC training system and evaluation system.