Rare tumors: a blue ocean of investigation / 医学前沿

Advances in novel drugs, therapies, and genetic techniques have revolutionized the diagnosis and treatment of cancers, substantially improving cancer patients' prognosis. Although rare tumors account for a non-negligible number, the practice of precision medicine and development of novel therapies are largely hampered by many obstacles. Their low incidence and drastic regional disparities result in the difficulty of informative evidence-based diagnosis and subtyping. Sample exhaustion due to difficulty in diagnosis also leads to a lack of recommended therapeutic strategies in clinical guidelines, insufficient biomarkers for prognosis/efficacy, and inability to identify potential novel therapies in clinical trials. Herein, by reviewing the epidemiological data of Chinese solid tumors and publications defining rare tumors in other areas, we proposed a definition of rare tumor in China, including 515 tumor types with incidences of less than 2.5/100 000 per year. We also summarized the current diagnosis process, treatment recommendations, and global developmental progress of targeted drugs and immunotherapy agents on the status quo. Lastly, we pinpointed the current recommendation chance for patients with rare tumors to be involved in a clinical trial by NCCN. With this informative report, we aimed to raise awareness on the importance of rare tumor investigations and guarantee a bright future for rare tumor patients.

Effectiveness analysis of the clinical research coordinators management carried out by drug clinical trial institutions / 中华医学科研管理杂志

Objective:To analyze the problems existing in the management mode of clinical research coordinator (CRC) in the new context, propose improvement measures and analyze the effectiveness of improvement.Methods:Four types of stakeholders related to CRC, including investigators, clinical research associates(CRA), institutional managers and human subjects were investigated in regular monthly questionnaire survey on the basis of CRC management comparasionat home and abroad. The new CRC management countermeasures implemented by our institution in July 2020 were taken as the time node, and the data from January to June 2020 were taken as the pre-implementation group, and the data from July to December 2020 were taken as the post-implementation group. Compare the monthly scores of CRCs′ work effect for 30 projects in the institution before and after the implementation of such countermeasures.Results:The scores of CRCs′ working effectiveness were improved after the implementation of CRC management countermeasures, whcih including standardizing the entry of CRC, updating of the training and assessment mechanisms, conducting regular communication meetings and developing reward and punishment measures. The scores from investigators increased by 20.17%, scores from CRAs increased by 11.54%, scores from institutional managers increased by 14.26%, scores from subjects increased by 10.64%, and the total scores increased by 14.13%( P<0.01). Conclusions:Countermeasures to optimize CRC management taken by drug clinical trial institutions can significantly improve CRCs′ working effectiveness in multiple dimensions.

Establishment and effectiveness evaluation of clinical pharmacist diabetes chronic disease management model / 药学实践杂志

Objective To evaluate the role of clinical pharmacists on the pharmacological monitoring and management of diabetic patients. Methods 406 adult outpatients with diabetes in outpatient were selected as research object. The patients were given the questionnaire and intervened with diabetes education and management by the clinical pharmacist regularly. The patient’s knowledge of the diabetes medication before and after intervention, blood glucose and glycosylated hemoglobin values, treatment compliance, non-reserved outpatient visit, emergency, hospitalization, etc. were compared and statistically analyzed. Results After pharmacy intervention, the patients' knowledge of diabetes and drug-related information, treatment compliance, blood glucose and glycosylated hemoglobin were better than before intervention, P<0.01. Non-reserved outpatient visits and emergency cases were better than before intervention, P<0.05. There are significant differences. Conclusion Clinical pharmacists carry out diabetes chronic disease management and build a clinical pharmacist-led chronic disease management model, which helps to promote standardized treatment, improve patient compliance, promote rationalized medication, achieve the goal of controlling blood sugar and reduce complications.

Content Determination of Itraconazole and Its Metabolit Hydroxy-itraconazole in Rabbit Plasma by HPLC-Fluorometric Methods / 中国药房

OBJECTIVE: To establish a high-performance liquid chromatographic(HPLC)-fluorometric method for the concentration determination of itraconazole (ITZ) and its metabolite hydroxy-itraconazole(HITZ) in rabbit plasma simultaneously.METHODS: Separation was achieved with Agilent Eclipse C18,the mobile phase consisted of acetonitrile(adjusted to pH=2.5 with 85% phosphoric acid)-water(63∶37),and the flow rate was 1.0 mL?min-1.The excitation and emission wavelengths were 260 nm and 365 nm.The analysis was performed at room temperature..RESULTS: The linear concentration range of ITZ and HITZ were 7.4～296 0 ng?mL-1(r=0.999 1)and 5.4～216 0 ng?mL-1(r=0.999 3), respectively.The limit of detection was 0.518 and 0.318 ng?mL-1,respectively.The extraction and method recovery rate of ITZ and HITZ were more than 80%.The intra-day and inter-day RSD of ITZ and HITZ were less than 4.47%. CONCLUSIONS: The method is simple,sensitive,accurate and reliable for monitoring ITZ and HITZ in rabbit plasma and pharmacokinetic studies.