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Objective:This study aims to summarize the achievements of the research wards in a large grade A tertiary hospital in Beijing, discuss the important role of pharmacists, and provide a reference for improving the functions and responsibilities of pharmacists in the research ward construction.Methods:Combining the practice of research ward construction in a grade A tertiary hospital in Beijing, the important role of pharmacists in the construction and operation of research wards were analyzed in system construction, information construction, analysis laboratory construction, and project management.Results:The participation of pharmacists with professional pharmaceutical knowledge and familiarity with the relevant policies and regulations of clinical research can greatly improve the quality and efficiency of research ward construction and operation.Conclusions:Pharmacists' participation in the construction of research wards is beneficial to improving clinical research ability and quality, and is of great significance to the development of China′s pharmaceutical health industry.
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Objective:By strengthening the management of external provision of data generated by clinical trials in medical institutions, to improve the effectiveness of supervision of human genetic resource information, and to promote the legal sharing and effective use of data.Methods:Analyzed problems identified in filing human genetic resource information in clinical trials since July 1, 2019, put forward possible solutions and suggestions.Results:Main problems were identified in external provision of human genetic resource information, including the specification and time limit of external provision of information, the information recipient, the storage location and the final disposal method of information.Conclusions:Hospital and regulatory authority need to carry out more tailored training, optimize management systems and procedures in order to strengthen the management of the external provision of human genetic resources information.
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Objective The funding management of drug clinical trials is one of the most important step in the management of clinical trials.Strengthening the management of clinical trial funds can improve the efficiency of fund utilization and ensure the smooth implementation of clinical trials.Methods This paper summarizes the problems of clinical trial fund management,proposes some main strategies for fund management based on root cause analysis.Results Through the establishment and improvement of the drug clinical trial fund management system in our hospital,the management of funds is strengthened,the trial carry out more smoothly and the result is more accurate.Conclusions Improving the management system of drug clinical trial funds and standardizing the management of clinical trials is of great significance to ensure the quality of clinical trials.Also it will improve the clinical trial management level of our hospital.
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Objective To strengthen human genetic resource management in clinical trials.Methods This article analyzes the common problems in the process of reviewing human genetic resources application by the drug clinical trial institute in our hospital,and proposes solutions for solving the problems.Results Common questions are also the key points for future review of human genetic resources applications,including the collection of sample and consistency with clinical trial plan,ethical review and informed consent,intellectual property rights etc.Conclusions Strictly reviewing applications of human genetic resources,as well as strengthen the management of human genetic resources in clinical trials,are not only make traceability of human genetic resources traceable,but also have important significance for the authenticity and scientific validity of trial results.
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Objective To strengthen the management of clinical trials' contracts and funds and improve the standardization of clinical trials.Methods Based on the analysis of the common problems in the management of clinical trials' contracts and funds,putting forward corresponding countermeasures and suggestions.Results Managing clinical trials' contracts and funds scientifically could protect the rights and interests of subjects and research institutions.Conclusions Strengthening the management of clinical trials' contracts and funds could improve the management of institutions and the quality of clinical trials.
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Objective To discuss our drug clinical trial institution's experience and findings during the process of establishing drug clinical trial central pharmacy.Methods Analyze the previous key issues identified during the drug management under different modes,discuss the necessity and feasibility of establishing drug clinical trial central pharmacy.Meanwhile,discuss the planning and construction of hardware including location site of the central pharmacy,equipment and facilities,staff,as well as software such as electronic management system and standard operation procedures.Results After the adoption of central trial pharmacy,space and energy are saved,manpower and material resources are saved,the quality of clinical trials also improved.Conclusions Standardized and unified management of investigational drugs through establishing drug clinical trial central pharmacy,is the strong guarantee for the drug safety of human subject,as well as the accuracy and scientificity of trial results.
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Objective To detect the changes in the immune function of opioid-dependent subjects during the withdrawal stage through the administration of Jitai tablet.Methods Subjects were treated as Jitai tablet alone,Jitai tablet plus buprenorphine and placebo,in a randomized,double-blind,placebo-controlled trial.Before and after the 14th day of withdrawal,levels of immunoglobulin (IgM,IgA,IgG),T cell subsets (CD3+,CD4+,CD8+,CD4+/CD8+) and cytokines (IL-2,IFN-γ,IL-4,IFN-γ/IL-4) were detected.Results Compared with healthy people,immunity function before withdrawal among the opioid abusers showed higher levels of IgM,IL-2,IFN-γ,IL-4 and lower level of CD3+ T,as (1.67 ± 0.87) g/L,(14.44 ± 13.50)％,(20.23 ± 15.10)％,(1.97 ± 1.59)％,(47.01 ± 13.62)％,respectively,with difference statistically significant (P＜0.05).There was no big difference of other immunity indicators between the two groups (P＞0.05).At the 14th day of withdrawal in placebo group,levels of IL-4 returned to normal while IFN-γ/IL-4 ratio increased by 3.43 times (P＜0.05).Levels of IgA,IgG,CD4+ and CD4+/CD8+ ratio fluctuated within normal range.There were no significant changes in other immunity indicators (P＞0.05).Compared with placebo group,fluctuation of IgG and IgM decreased in Jitai group during withdrawal period,together with a normal level of IgM at the 14th day.Level of IL-4 abnormally rose up by 0.54 times in Jitai tablet plus buprenorphine group,while IFN-γ/IL-4 ratio been switched back at the 14th day of withdrawal.Other immune indicators were not affected by medical interventions.Conclusion We noticed that certain impairment of the immune function might be restored by Jitai tablet during the withdrawal period.
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Objective To detect the changes in the immune function of opioid-dependent subjects during the withdrawal stage through the administration of Jitai tablet.Methods Subjects were treated as Jitai tablet alone,Jitai tablet plus buprenorphine and placebo,in a randomized,double-blind,placebo-controlled trial.Before and after the 14th day of withdrawal,levels of immunoglobulin (IgM,IgA,IgG),T cell subsets (CD3+,CD4+,CD8+,CD4+/CD8+) and cytokines (IL-2,IFN-γ,IL-4,IFN-γ/IL-4) were detected.Results Compared with healthy people,immunity function before withdrawal among the opioid abusers showed higher levels of IgM,IL-2,IFN-γ,IL-4 and lower level of CD3+ T,as (1.67 ± 0.87) g/L,(14.44 ± 13.50)％,(20.23 ± 15.10)％,(1.97 ± 1.59)％,(47.01 ± 13.62)％,respectively,with difference statistically significant (P＜0.05).There was no big difference of other immunity indicators between the two groups (P＞0.05).At the 14th day of withdrawal in placebo group,levels of IL-4 returned to normal while IFN-γ/IL-4 ratio increased by 3.43 times (P＜0.05).Levels of IgA,IgG,CD4+ and CD4+/CD8+ ratio fluctuated within normal range.There were no significant changes in other immunity indicators (P＞0.05).Compared with placebo group,fluctuation of IgG and IgM decreased in Jitai group during withdrawal period,together with a normal level of IgM at the 14th day.Level of IL-4 abnormally rose up by 0.54 times in Jitai tablet plus buprenorphine group,while IFN-γ/IL-4 ratio been switched back at the 14th day of withdrawal.Other immune indicators were not affected by medical interventions.Conclusion We noticed that certain impairment of the immune function might be restored by Jitai tablet during the withdrawal period.
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Objective To improve the quality of medical device clinical trial.Methods To analyze medical device clinical trials conducted in our hospital from 2006 to 2010,and proposed the strategy to strengthen medical device clinical trial management.Results Most of the medical devices clinical trials were class Ⅲ medical devices clinical validation in our hospital,Surgical departments undertook most of the clinical trials.Until July 2013,49 trials were done only 56％ of undertake the project.96％ of completed trials were approved for medical device registration certificate.Conclusions The quality of clinical trials must be improved,andthe quality control process in medical device clinical trial should be reinforced.
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BACKGROUND:The new formulation and preparation technology of new drugs have become a hot spot for improving the utilization of polypeptides. In particular, the development of nanotechnology in recent years has promoted the clinical application of polypeptide drugs. OBJECTIVE:To review the current research of nanoparticles as carriers of polypeptide drugs for oral administration. METHODS:A computer-based search of CNKI database and SCI database was performed for relevant articles published from 1996 to 2014 by using the keywords of“protein, peptide drugs, nanoparticles, oral administration”in Chinese and English, respectively. RESULTS AND CONCLUSION:The encapsulation efficiency, release rate of drug delivery, stability of nanoparticles in the gastrointestinal tract and penetrability of the intestinal mucosa are determined by many factors, such as the kind, size, surface charge and modification of nanoparticles. The nanoparticles can increase the stability of protein drugs and improve the bioavailability of drugs. The targeting property of the nanoparticles can decrease the adverse reactions of some drugs. The release effect of the nanoparticles can decrease the dosage of drugs and increase the drug circulating time. However, there are stil many problems to be solved in nanotechnology:the activities of some protein drugs are lost in the preparation process;theencapsulation efficiency and drug loading need to be improved;protein burst release cannot be solved completely;the mass production of nanoparticles is stil difficult.
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Objective To study alkaloids from the twigs and leaves of Picrasma quassioides. MethodsCompounds were isolated and purified by column chromatography over Sephadex LH-20 and silica gel column. Their chemical structures were elucidated on the basis of physicochemical properties and spectral data. Results Sixteen alkaloids were isolated, purified, and identified as: 5-methoxycanthin-6-one (Ⅰ), 11-hydroxycanthin-6-one (Ⅱ), canthin-6-one (Ⅲ), 4, 5-dimethoxycanthin-6-one (Ⅳ), 4-methoxy-5-hydroxycanthin-6-one (Ⅴ), 3-methylcanthin-2, 6-dione (Ⅵ), 1-formyl-4-methoxy-?-carboline (Ⅶ), 1-methoxy-?-carboline (Ⅷ), 1-ethyl-4, 8-dimethoxy-?-carboline (Ⅸ), 1-methoxycarbonyl-4-hydroxyl-?-carboline (Ⅹ), 1-methyl-4-methoxy-?-carboline (Ⅺ), 1-ethoxycarbonyl-?-carboline (ⅩⅡ), 1-formyl-?-carboline (ⅩⅢ), 1-methoxycarbonyl-?-carboline (ⅩⅣ), 1-ethyl-4-methoxy-?-carboline (ⅩⅤ), and 1, 2, 3, 4-tetrahydro-1, 3, 4-trioxo-?-carboline (ⅩⅥ). Conclusion Compound Ⅺ is separated from the natural plant for the first time and compounds Ⅱ, Ⅷ, and ⅩⅤ are separated from plants of Picrasma Bl. for the first time.