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Objective:To explore the application of virtual patient in the reexamination of clinical medical professional masters (hereinafter referred to as "clinical masters"), and to provide reference for the reform of clinical masters reexamination.Methods:The correlation between the clinical thinking scores of 97 candidates (Western medicine) in the reexamination of clinical masters in a university in 2019, the scores of comprehensive ability of clinical medicine (Western medicine) in the initial test and the interview scores in the reexamination was analyzed, and the differences between the clinical thinking scores of current and previous candidates were compared. SPSS 21.0 software was conducted for t test, chi-square test and Pearson correlation analysis. Results:The Person correlation analysis showed that the correlation coefficient between the scores of clinical thinking and the scores of comprehensive clinical medicine (Western medicine) and the scores of interview in the reexamination were 0.09 and -0.05 respectively( P>0.05). At the same time, there was no statistically significant difference between the clinical thinking scores of current and previous candidates ( P >0.05). Conclusion:There was a poor correlation between the scores of clinical thinking and the scores of comprehensive clinical medicine (Western medicine) and the scores of interview in the reexamination. The consideration is concerned with the difference in the purpose of the three assessment forms. It can provide references for other medical colleges to optimize the evaluation content of postgraduate reexamination.
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@#Abstract: Objective To analyze the laboratory microscopic re-examination results of malaria cases in Nantong of the National Notifiable Disease Report System from 2014 to 2021 by Nantong Malaria Diagnostic Reference Laboratory, so as to evaluate the malaria diagnosis ability of Nantong Malaria Diagnostic Reference Laboratory. Methods The blood smear and blood samples of malaria cases in Nantong from 2014 to 2021 of the National Notifiable Disease Report System were collected. Nantong Malaria Diagnostic Reference Laboratory and Jiangsu Institute of Parasitic Diseases carried out the re-examination of municipal and provincial laboratories, taking the results of provincial laboratory as the standard to compare and analyze the re-examination results of Nantong Malaria Diagnostic Reference Laboratory. Results From 2014 to 2021, the two-level laboratories in Nantong city and Jiangsu Province re-examined the blood samples of 297 malaria cases. The microscopic examination and PCR re-examination results at the provincial level were the same：292 positive cases and 5 negative cases. The qualitative coincidence rate between Nantong microscopic re-examination results and the provincial re-examination results was 100% (297/297), without misjudgment and omission. The coincidence rate of Plasmodium typing was 96.23% (281/292). The coincidence rate of P. falciparum, P. vivax, P. ovale and P. malaria were 99.57% (234/235), 62.50% (5/8), 89.47% (34/38) and 72.73% (8/11) respectively. The consistency test results showed that the Kappa value of Plasmodium typing results between municipal and provincial laboratories was 0.89. The Kappa values of P. falciparum, P. vivax， P. ovale and P. malaria were 0.98, 0.58, 0.87 and 0.79 respectively. Conclusion The malaria diagnosis ability of Nantong Malaria Diagnostic Reference Laboratory is generally good, and it is necessary to improve the ability of Plasmodium typing.
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Background: Helicobacter pylori (Hp) is closely associated with peptic ulcer, gastric cancer and other gastrointestinal diseases. Eradication therapy is the main approach to prevent and treat Hp-associated diseases, and patient management is crucial for improving the efficacy of eradication therapy. Aims: To explore the effect of whole-course management on medication adherence and reexamination rate of Hp eradication therapy. Methods: Patients who received Hp eradication therapy in the Hp Specialist Clinic of the First Affiliated Hospital of Soochow University from June 2020 to November 2020 were recruited consecutively. One hundred and twelve patients who received eradication therapy between June 2020 and August 2020 were served as the control group, and 112 patients who received eradication therapy between September 2020 and November 2020 were served as the observation group. Patients in control group were informed only the medication method and reexamination time, while patients in observation group were given the whole-course management composed of informing medication method and reexamination time plus following up online by WeChat and reminding the reexamination by WeChat and by phone. Patients in both groups received a 14-day bismuth quadruple therapy, and were told to undergo
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To understand the quality of production of blood slides and laboratory personnel’s ability to microscopically examine Plasmodium at Jiangsu Province clinic inspection stations at all levels, so as to provide the evidence for the construction of malaria diagnostic laboratories and the evaluation of malaria elimination effect.After the reexamination of the negative blood slides of the examination stations of the malaria center in each county (district), the negative blood slides of the outpatient inspection station in the district and all the positive blood slides of the direct report of the network from 2011 to 2017, the staining and cleanliness of the blood smears, microscopic examination results and the coincidence rate of positive blood species were comprehensively analyzed.A total of 19 109 checked blood samples were examined. The qualified rates of blood preparation, dyeing and cleanliness were 87.5%, 89.3% and 87.6%, respectively. The quality of reexamined blood slides in different years showed statistically significant difference (all P < 0.05), by using chi-square trend test, and there was a trend of increasing year by year. There was a significant difference in the quality of the reexamined blood slides among the different cities with districts (P < 0.05). In addition, there were 1 860 blood samples from 2012 to 2017, and the total coincidence rate was 87.4% and the coincidence rate of positive blood smear examinations was 98.9%. The species coincidence rates of Plasmodium falciparum, Plasmodium vivax, Plasmodium malariae, Plasmodium ovale and mixed infection were 95.4%, 33.3%, 56.0%, 76.5% and 9.1%, respectively (P < 0.05). The total coincidence rates of blood smear reexaminations in different years were 85.0%, 90.1%, 86.0%, 85.3%, 90.0% and 87.6% from 2012 to 2017, respectively, and the difference was not statistically significant (P > 0.05).The quality of blood slides at the primary clinic inspection stations in Jiangsu Province conforms to the standard established by the provincial malaria reference laboratory; however, the ability of Plasmodium species identification is insufficient and needs to be improved.
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The ‘equivalent-or-more-but-not-the-same-data’ provision in the Regulation on the Safety and Efficacy Evaluation of New Drug in Korea has served as the de facto data exclusivity term for any drug identical to a product subject to new drug reexamination. The legal debate that occurred between Abbott Korea and Hanmi in association with the approval of their sibutramine products, i.e., Reductil® vs. Slimmer®, showed why data exclusivity plays an important role to protect intellectual property of the innovator drug when incrementally modified drugs had to rely on the safety and efficacy data of the innovator drug for approval. The regulatory science and legal issues regarding the case of Reductil® vs Slimmer® were discussed, and the importance of data exclusivity was emphasized as a useful tool to protect intellectual property besides patent.
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Intellectual Property , Korea , MesylatesABSTRACT
Objective To establish the re-examination criteria of the Sysmex XN-9000 automatic blood cell analyzer pipeline suitable for this laboratory for ensuring the accuracy of detection results .Methods A total of 2250 whole blood samples were se-lected from inpatients ,outpatients and subjects undergoing physical examination .The Sysmex XN-9000 blood cell analyzer was a-dopted to conduct the detection .With the manual microscopic examination as the golden standard ,26 items of re-examination criteria were performed the verification and evaluation .The positive predicting value ,negative predicting value ,false positive rate ,false neg-ative rate and re-examination rate were performed by the statistics .Results In compariing the instrument alarm information with the microscopic examination results ,the positive predicting value was 91 .59% ,the negative predicting value was 98 .64% ,the false positive rate was 2 .09% ,the false negative rate was 1 .02% and the re-examination rate was 24 .84% .Conclusion The formulated re-examination criteria of the Sysmex XN-9000 blood cell analyzer is in accord with the characteristics of our laboratory ,which in-creases the detection efficiency ,prevents the missing detection and false detection and has clinical guidance significance .
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Objective To study the value of clinical application of leukocyte classification alarm system (Q‐Flag ) for Sysmex XT‐1800i blood cell analyzer .Methods 394 blood samples with alarm system (Q‐Flag) and 190 ones without abnormal alarm infor‐mation detected by the Sysmex XT‐1800i blood cell analyzer were performed to observe the quantity and morphology of blood cells by manual differentiation ,and the results were compared between them .Results The alarm system of Sysmex XT‐1800i blood cell analyzer in detecting cell morphologic abnormalities was 100 .0% for sensitivity ,62 .3% for specificity ,70 .8% for positive predic‐tive value and 100 .0% for negative predictive value .Based on thegold standardof manual differentiation ,no abnormal cells were observed in those blood samples without Q‐Flag alarm information and the coincidence rate was 100% .The coincidence rate of leu‐kocyte classification was from 0 .0% to 75 .0% for blood cell analyzer when the alarm system (Q‐Flag) was between 100U and 200U ,and that was from 66 .7% to 95 .6% when the alarm system (Q‐Flag) was between 200U and 300U .Conclusion The alarm system sensitivity of leukocyte classification alarm system (Q‐Flag) is high for Sysmex XT‐1800i blood cell analyzer ,and it is nec‐essary to manually differentiate the samples with abnormal Q‐Flag in order to provide accurate and reliable clinical diagnostic infor‐mation .
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Improved medical postgraduate reexamination system is essential to the quality of students. In this study, organization of medical postgraduate reexamination was discussed from the perspectives of preliminary arrangements of medical postgraduate reexamination, fairness of reexami-nation process and improvement of the follow-up after the reexamination. Sufficient attention on the re-examination, effective supervision of the reexamination process and control of human factors were the three main factors for the successful medical postgraduate reexamination and effective guarantee for the improvement of postgraduate quality.
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Since the reexamination system of new drugs has been in place for about thirty years, it is necessary to reconsider its management. The time from the reexamination application of new drugs until issuance of the results takes several years recently. General drugs are applied during the reexamination application and are approved before reconfirmation of the efficacy and safety of new drugs. Therefore, the reexamination system is not effectively operated. Although the informations for proper use collected from post-marketing investigations and clinical trials, and spontaneous adverse reaction reports of new drugs, etc. during the reexamination period are utilized for its safety measures, the plan for effective use is not systematically managed. We propose an improved plan for a future reexamination system. Further, we propose the introduction of a risk management plan in Japan; the current one of which lags behind EU and US.