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ObjectiveTo explore the comprehensive clinical value of Qianlieping capsules in the treatment of chronic prostatitis with damp-heat stasis syndrome， and to provide evidence for the decision-making of clinical basic drug management. MethodBased on the "Guidelines for Comprehensive Clinical Evaluation of Drugs （Trial Version 2021）"， this study systematically reviewed the existing research on the treatment of chronic prostatitis with damp-heat stasis syndrome by Qianlieping capsules. Based on evidence-based medicine， clinical epidemiology， clinical medicine， evidence-based pharmacy， pharmacoeconomics， health statistics， health technology assessment， and other disciplines， the multi-criteria decision analysis model （MCDA） and CSC 2.0 software were used. The six dimensions of safety， effectiveness， economy， innovation， suitability， and accessibility of drugs， as well as traditional Chinese medicine（TCM） characteristics， were comprehensively evaluated qualitatively and quantitatively. ResultIn terms of safety， based on the spontaneous reporting system （SRS） of the National Center for ADR Monitoring， safety literature analysis， pharmacological and toxicological experiment report， and other evidence， the safety grade of Qianlieping capsules was evaluated as grade A， with good safety. In terms of effectiveness， based on the results of pharmacological and pharmacodynamic studies and Meta-analysis， and combined with the value and quality of the evidence for efficacy， the final efficacy grade of Qianlieping capsules was rated as B. In terms of economy， Qianlieping capsules was a class B drug of national medical insurance. Compared with those of similar Chinese patent medicines， the average daily cost of Qianlieping capsules was moderate， and there was no related cost increase during the administration process. Economic research showed that Qianlieping capsules combined with α-receptor blockers were more economical than α-receptor blockers alone. Based on the quality evaluation of economic evidence and the value evaluation of economic evidence， the economic grade of Qianlieping capsules was rated as B. In terms of innovation， Qianlieping capsules were a combination of cold and warm drugs， focusing on clearing heat， detoxifying， removing blood stasis， and relieving pain， with non-toxic medicinal materials. They obtained a number of invention patents. The enterprise service system was perfect， and the quality standard was higher than the international and Chinese standards. The innovation grade of Qianlieping capsules was rated as B. In terms of suitability， the results of the questionnaire survey showed that it had relatively good suitability for clinicians， nurses， pharmacists， and patients who used Qianlieping capsules. The information on Chinese patent medicines was complete and met the requirements of national standards. The suitability grade of Qianlieping capsules was rated as A. In terms of accessibility， Qianlieping capsules were moderately priced and affordable， with sufficient resources of medicinal materials， no shortage of medicinal materials， and good availability. The accessibility grade of Qianlieping capsules was rated as B. In terms of TCM medicine characteristics， the prescription of Qianlieping capsules was derived from Danshen Huoxue Decoction. The original prescription was used for the treatment of chronic prostatitis with blood stasis syndrome. The whole formula was recorded in The Complete Compendium of Fine Formulas （《良方大全》） published by Beijing Publishing Group Co.， Ltd. in 1991 and has been used for more than 30 years. The formula was a combination of warm and cold drugs， attacking pathogens without hurting healthy Qi. The grade of TCM characteristics of Qianlieping capsules was rated as B. ConclusionBased on the above "6+1" dimensions， the comprehensive evaluation result of Qianlieping capsules in the treatment of chronic prostatitis with damp-heat and blood stasis syndrome is grade B， and it is recommended to convert it into the relevant policy results of basic clinical drug management according to the conditions.
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This study overviewed equivalence demonstration, the principles for the selection of comparative devices, the difficulties in equivalence demonstration, and the equivalence demonstration of special medical devices. In addition, the concept of equivalence demonstration was adopted for the products exempted from clinical evaluation, and there were many confusion in actual use. The operation points and difficult points of equivalence demonstration for the products exempted from clinical evaluation were introduced in order to provide reference for medical device colleagues.
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The real-world data of Hainan Boao Lecheng International Tourism Pilot Zone has the advantage of supporting pre-market clinical evaluation of medical devices. Based on the relevant requirements of clinical evaluation of medical devices and based on the practical experience of pilot devices in the early stage, the application of Boao Lecheng real-world data in the pre-market clinical evaluation path of medical devices from the perspective of review is discussed. At the same time, the elements that should be considered in real-world study design and the way of data quality evaluation are proposed. Expect to provide a reference in order to allow registration applicants to use real world data wisely to help declare device registration for marketing.
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Device Approval , Marketing , Research DesignABSTRACT
To provide proof of the evidence-based medicine and decision-making information for the clinical decision of functional gastrointestinal disorders(FGIDs), this study evaluated and compared the efficacy, safety, and economy of four oral Chinese patent medicines(CPMs) in the treatment of FGIDs using the method of rapid health technology assessment. The literature was systematically retrieved from CNKI, Wanfang, VIP, SinoMed, EMbase, PubMed, Cochrane Library and ClinicalTrials.gov from the establishment of the databases to May 1, 2022. Two evaluators screened out the literature, extracted data, evaluated the quality of the literature, and descriptively analyzed the results according to the prepared standard. Eventually, 16 studies were included, all of which was rando-mized controlled trial(RCT). The results showed that Renshen Jianpi Tablets, Renshen Jianpi Pills, Shenling Baizhu Granules, and Buzhong Yiqi Granules all had certain effects on the treatment of FGIDs. Renshen Jianpi Tablets treated FGIDs and persistent diarrhea. Shenling Baizhu Granules treated diarrhea with irritable bowel syndrome and FGIDs. Buzhong Yiqi Granules treated diarrhea with irritable bowel syndrome, FGIDs, and chronic diarrhea in children. Renshen Jianpi Pills treated chronic diarrhea. The four oral CPMs all have certain effects on the treatment of FGIDs and have specific advantages for specific patients. Compared with other CPMs, Renshen Jianpi Tablets have higher clinical universality. However, there are problems such as insufficient clinical research evidence, generally low quality of evidence, lack of comparative analysis among medicines, and lack of academic evaluation. More high-quality clinical research and the economic research should be carried out in the future, so as to provide more evidence for the evaluation of the four CPMs.
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Child , Humans , Irritable Bowel Syndrome , Technology Assessment, Biomedical , Gastrointestinal Diseases , DiarrheaABSTRACT
At present， many antidepressant drug categories have been marketed in China， but still lack a scientific and standardized system for drug comprehensive clinical evaluation. To guide and promote medical institutions to standardize the comprehensive clinical evaluation of antidepressant drugs， 19 clinical， pharmacy and evidence-based medicine experts from China were organized by the China Population Welfare Foundation to evaluate 11 drugs in 5 categories， including sertraline/escitalopram/ paroxetine/fluvoxamine/citalopram/fluoxetine/venlafaxine/duloxetine/vortioxetine/agomelatine/mirtazapine， through seminars and interviews， concerning clinical real-world data and evidence-based medicine， and to form the first draft of Expert Consensus on Comprehensive Clinical Evaluation of Antidepressant drugs， which is finalized after peer review by 18 clinical and pharmacy experts. The evaluation system of this expert consensus adopts the quantitative evaluation system of percentile and carries out a systematic evaluation from 6 dimensions of effectiveness， safety， economy， suitability， accessibility and innovativeness， while the evaluation dimensions are more detailed， with the operability of the drug evaluation system and the characteristics of drugs in the field of antidepressants. It aims to provide a theoretical basis for the rational use of drugs in the field of psychiatric disorders in medical institutions and help improve the quality of pharmacy services to better meet the needs of the people for medication.
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ObjectiveTo systematically review the existing studies on Xueshuantong for injection（lyophilized） in the treatment of acute cerebral infarction（ACI）， and to clarify the clinical value of Xueshuantong for injection（lyophilized） through comprehensive clinical evaluation， so as to promote clinical rational drug use and relevant policy transformation. MethodEvidence of Xueshuantong for injection（lyophilized） in terms of safety， effectiveness， economy， innovation， suitability， accessibility， traditional Chinese medicine（TCM） characteristics（6+1 dimensions） and information service was comprehensively collected. Evidence-based medicine， questionnaire survey， health technology assessment， pharmacoeconomic evaluation and other research methods were used， and the multi-criteria decision analysis model was used to measure each dimension， in order to comprehensively evaluate the clinical value of Xueshuantong for injection（lyophilized）. ResultSpontaneous reporting system， Meta-analysis of adverse reactions， and active safety monitoring study showed that the main adverse reactions of Xueshuantong for injection（lyophilized） were rash， pruritus， chest tightness， headache， dizziness and other general adverse reactions， the incidence of serious adverse reactions was judged to be rare， the known risk was small， the evidence was sufficient， and the safety evaluation was grade A. The results of Meta-analysis showed that Xueshuantong for injection（lyophilized） combined with conventional treatment for ACI was superior to conventional treatment in terms of improving neurological deficit score， improving daily activity score and clinical efficacy， and the effectiveness evaluation was grade B. The results of pharmacoeconomic evaluation showed that Xueshuantong for injection（lyophilized） combined with conventional treatment was relatively economic compared with conventional treatment alone， with the total clinical effective rate as the effect parameter， but the incremental effect was not significant， the economic evaluation was grade B. In addition to ACI and unstable angina of coronary heart disease， the drug also had good clinical efficacy in central retinal vein occlusion， and had a wider range of indications and awarded 16 patents， and its innovation evaluation was grade B. The suitability of medical personnel and patients was good without special technical and management requirements， and the suitability was evaluated as grade B. Xueshuantong for injection（lyophilized） had reasonable price， good affordability， certain prescription restrictions and general availability， the accessibility evaluation was grade B. Since the drug is an injection of effective parts of TCM， no grade evaluation of its TCM characteristics is conducted. The legal and non-legal information evaluation results of Xueshuantong for injection（lyophilized） showed that all the information was complete and in accordance with the requirements of national standards. Based on the grade scores of the 6 dimensions， the clinical comprehensive evaluation of Xueshuantong for injection（lyophilized） in the treatment of ACI was calculated as category B by CSC 2.0. ConclusionThe clinical value of Xueshuantong for injection（lyophilized） is good， and it is suggested that it can be directly translated into relevant policy outcomes for basic clinical medication management.
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@#The concept of extracellular vesicles(EV) was proposed in 2011 by the International Society for Extracellular Vesicles(ISEV),and EV can be widely used in various fields of disease treatment as therapeutic drugs and drug delivery carriers.The therapy based on EV may become a new model of disease treatment in addition to traditional drug therapy and cell therapy-EV cell-free therapy.As a vector,compared with viral vector and synthetic non viral vector,EV have unique advantages and great potential.However,EV have some challenges in clinical transformation because of their unique biological properties.Moreover,this field is relatively new,and there are no relevant policies and regulations specifically for EV therapy.By collecting information from ClinicalTrials.gov platform,this paper summarized the research progress based on EV therapy,put forward suggestions for the existing regulatory system,discussed the general principles of EV non clinical research,pharmaceutical research,pharmacodynamics and pharmacokinetics research,safety evaluation and other non clinical evaluation strategies,so as to provide reference for the formulation of non clinical evaluation research scheme based on EV therapy.
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Intraductal papillary mucinous neoplasm (IPMN) is one of the precancerous lesions of the pancreas. Currently there is controversial over the management and follow-up strategy of IPMN, including the timing of surgery. The core problem lies in the accurate preoperative assessment of the nature of the lesions and the risk of malignant transformation. Cumulation of high-quality evidence and development of efficient evaluation methods are vital for the establishment of standardized decision-making system and the improvement of clinical benefits to patients. This review aims to summarize the consensus and controversies on surgical evaluation standards in the latest guidelines and representative literatures, and to look forward to the development direction of IPMN diagnosis and treatment decisions in combination with the progress of related evaluation techniques.
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Objective:To investigate the application of mind map combined with daily mini-clinical evaluation exercise in standardized training of gynecological residents.Methods:A total of 100 trainees who received standardized training in Department of Gynecology, Women and Children's Hospital of Chongqing Medical University, were selected as subjects, and they were divided into control group (traditional teaching) and observation group (mind map combined with daily mini-clinical evaluation exercise) according to the order by which they entered the department for training, with 50 trainees in each group. After teaching, the two groups were compared in terms of assessment results of clinical practice exercise and degree of satisfaction with teaching. SPSS 22.0 statistical software was used for the t-test. Results:After the application of mind map combined with daily mini-clinical evaluation exercise in the standardized training of gynecological residents, compared with the control group, the observation group had significantly higher assessment results of inquiry ability, specialized physical examination, clinical diagnosis, diagnosis and treatment regimen, clinical practice ability, communication ability, clinical thinking ability, decision-making ability for clinical issues, and overall performance ( P<0.05). Compared with the control group, the observation group had significantly higher levels of mastery of clinical inquiry ability, specialized physical examination, development of diagnosis and treatment regimen, doctor-patient communication ability, and clinical practice ability, as well as a significantly higher overall teaching satisfaction score ( P<0.05). Conclusion:Mind map combined with daily mini-clinical evaluation exercise is a simple and feasible teaching method and can help to improve the comprehensive clinical practice ability of trainees receiving standardized residency training, and therefore, it holds promise for application in teaching.
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Objective:To investigate the application effect of Mini-Clinical Evaluation Exercise (Mini-CEX) combined with direct observation of procedural skills (DOPS) in standardized training of emergency medicine guided by professional physician qualification examination.Methods:Based on the time of emergency medicine teaching reform in Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, 32 standardized training residents in Emergency Department before September 2020 were included as control group and were given traditional teaching, and 32 standardized training residents after September 2020 were included as observation group and were given Mini-CEX combined with DOPS teaching under the guidance of professional physician qualification examination. The two groups were compared in terms of Mini-CEX score, DOPS score, assessment score of comprehensive emergency skills, pass rate of professional physician qualification examination, and comprehensive teaching quality. SPSS 25.00 was used to perform the t-test and the chi-square test. Results:Compared with the control group after training, the observation group had significantly higher scores of Mini-CEX, DOPS, and comprehensive emergency skill assessment ( P<0.05). There were no significant differences between the two groups in the pass rates of theoretical and practical examinations in professional physician qualification examination, and the observation group had a significantly higher total pass rate than the control group ( P<0.05). The observation group had significantly higher comprehensive teaching quality scores than the control group ( P<0.05). Conclusion:Mini-CEX combined with DOPS guided by professional physician qualification examination can help to improve the teaching effectiveness of standardized training residents in emergency, enhance their comprehensive skills and emergency professional skills, achieve a relatively high pass rate of professional physician qualification examination, and improve their post competency, and thus it holds promise for clinical application.
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Objective:To investigate the application of modified mini-clinical evaluation exercise (Mini-CEX) in the probationary teaching of dermatology and venereology for eight-year program students.Methods:From 2019 to 2020, a modified Mini-CEX was used to grade 58 eight-year program students at the Third Affiliated Hospital of Sun Yat-Sen University at the early, middle, and late stages of the probationary teaching of dermatology and venereology. The modifications included refining various evaluation indicators. Specifically, medical history collection involved dynamic changes in rashes, negative symptoms with differential diagnostic significance, past history/personal history/family history, and other important medical history; physical examination involved the specialized condition of rashes, systematic physical examination, and negative signs with differential diagnostic significance; humanistic care involved caring for patients, health education, and privacy protection; clinical judgment involved principles of diagnosis, differential diagnosis, and treatment; communication skills involved proficiency, prioritization, and body language; organizational effectiveness involved time allocation, patient compliance, and preparation work; overall performance involved calmness and fluency, neat writing, and preliminary clinical thinking. SPSS 20.0 was used to perform the t test. Results:Compared with the early stage of probation, the 58 eight-year program students improved their scores in clinical comprehensive ability evaluation and scores in each specific evaluation at the middle and late stages of probation ( P < 0.001). The dynamic changes in rashes and the specialized situation of rashes (identification and description of rashes) were specific to this discipline. Conclusion:The modified Mini-CEX is an objective, comprehensive, concise, and efficient assessment tool, which meets the needs of teaching reform and practice of dermatology and venereology.
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The modern era has undergone tremendous change in the educational system especially in evaluation methodology of students. One such evaluator measure is the Objective Structured Clinical Examination (OSCE). This study was undertaken to explore the perceptions of students on OSCE, assess their level of satisfaction and identify their feedback. A descriptive survey design was adopted for the study and it was conducted at Baby memorial College of Nursing, Kerala among 46 nursing students who had attended OSCE as a part of their practical examination. Consecutive sampling technique was used to identify the subjects. The results showed that there were diverse degrees of perception among students towards OSCE and majority (43%) of them were highly satis ed with the OSCE. The subjects opined OSCE as a good method of evaluation which was stress-free and time-bound and helped to improve practical skills and knowledge. The subjects also found that OSCE was helpful in identifying the weakest areas of their competencies and was more exible. Few of the subjects suggested that it was very hard to communicate with dummies and clinical examination would be better than OSCE.
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Background and Aim of Study: Early childhood caries is a multifactorial disease process affecting children below 71 months of age and continues to be a global health problem. Stainless steel crowns (SSCs) are widely used and are very popular in pediatric dentistry due to its superiority and durability when compared with multisurface amalgam restorations. However, one of the major disadvantages with these crowns is the poor esthetics. Parents often request for a more esthetic alternative to the SSC. Zirconia crowns are one of the tooth-colored full crown restorations currently available for use in primary teeth. These are available as both preformed and custom-made crowns and show excellent esthetics. However, these require extensive tooth preparation with a subgingival finish lines, which would cause gingival trauma and bleeding during the preparation. The present study uses intraoral scanners for making the custom-made zirconia crowns, which will avoid the conventional impressions. Currently, there are no studies available in pediatric dentistry regarding CAD-CAM crowns. Hence, there is a need for the study. Aim: The aim of this study is to clinically evaluate the performance of preformed SSCs and custom-made zirconia crowns in primary molars. To elicit parental and patient satisfaction with respect to preformed SSCs and custom made zirconia crowns and to radiographically compare the interproximal bone height for 1 year. Methods: The patients were selected with purposive sampling. The tooth of interest was prepared according to the crown it would receive. The upper and the lower arch of the tooth receiving custom-made zirconia crown was scanned using an intraoral scanner. The crowns were cemented using Type 1 glass ionomer cement (GIC) (SSC) and resin modified GIC (custom-made zirconia crown). After the crown placement, the patient and the parent's satisfaction was scaled regarding the time taken, comfort, cost of crown, appearance of crown, etc., using a 5-point Likert scale. A baseline radiograph was taken after crown placement. The patient was recalled every 3 months till 1 year for evaluation (loss of retention, loss of proximal contact, gingival inflammation, opposing tooth wear, and marginal integrity). At the end of 1 year, radiographs were taken to check the interproximal bone. Results: After 1 year evaluation of custom-made zirconia crowns and preformed SSCs in primary molars, it was shown that both SSC and zirconia crowns showed good gingival scores but zirconia crown was better than SSC in improving the gingival health. SSCs showed better results with respect to the opposing tooth wear and marginal adaptability. Parents as well as patients preferred a tooth-colored crown as a treatment option. Conclusion: Custom-made zirconia crowns are comparable to the preformed SSCs and they show better gingival scores and excellent color match.
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Objective:To explore the effect of mini-clinical evaluation exercise (Mini-CEX) combined with simulation teaching + case-based learning (CBL) in pediatric clinical teaching.Methods:A total of 60 medical students who practiced in Department of Pediatrics, Affiliated Hospital of Jining Medical College from August 2019 to August 2020 were selected as the research objects. According to different teaching methods, they were divided into control group ( n=30) and observation group ( n=30). The control group received traditional teaching, and the observation group received Mini-CEX combined with simulated teaching + CBL. The assessment results, comprehensive ability of medical interview, critical thinking ability and teaching satisfaction of the two groups were compared. SPSS 20.0 was performed for t-test and Chi-square test. Results:The test scores and total scores of the observation group were significantly higher than those of the control group ( P<0.05). After teaching, the Mini-CEX scores, the CTDI-CV (critical thinking disposition inventory Chinese version) scores and the total scores of the two groups increased significantly, and the above scores were significantly higher in the observation group than the control group ( P<0.05). The scores of the teaching program satisfaction questionnaire in the observation group were significantly higher than those in the control group ( P<0.05). Conclusion:The application of Mini-CEX combined with simulation teaching + CBL in pediatric clinical teaching can help to cultivate the medical interview ability, clinical practice ability and critical thinking ability of interns, improve the examination results, and improve the teaching satisfaction.
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Objective:To explore the application of typical case combined with practice teaching in the pediatric clinical teaching.Methods:A total of 80 clinical interns majoring in pediatrics who practiced in the Affiliated Hospital of Jining Medical University between September 2019 and January 2020 were selected as the research subjects, and they were randomly divided into observation group ( n=41) and control group ( n=39). The control group adopted conventional teaching while the observation group were given typical case combined with practice teaching model. After 16 weeks of training, the theoretical knowledge, practical operation [direct observation of procedural skill (DOPS) evaluation, and mini-clinical evaluation exercise (Mini-CEX)] and overall performance were analyzed in the two groups of students. SPSS 19.0 was used for t test, chi-square test and rank sum test. Results:After the internship, the theoretical scores of common pediatric diseases, clinical disease characteristics, etiopathogenesis, treatment regimen and complications were enhanced in the two groups, and the above scores in observation group were higher than those in control group ( P<0.05). Besides, the DOPS scores and Mini-CEX scores of the two groups were increased, and the scores were higher in observation group than in control group ( P<0.05). Furthermore, the overall excellent rate of the observation group was 87.80% (36/41), which was higher than 69.23% in control group (27/39). Survey found that the number of interns who believed that the teaching regimen could deepen the knowledge mastery degree, increase the internship interest and improve the comprehensive ability, internship efficiency and clinical thinking ability was more in observation group than in control group. Conclusion:Typical case combined with practice teaching can effectively deepen the interns' understanding of theoretical knowledge of clinical pediatrics, improve the practical operation ability and arouse the interest in learning.
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Objective:To investigate the application effects of flipped classroom combined with mini-clinical evaluation exercise (Mini-CEX) evaluation on the cultivation of clinical ability of professional postgraduates majoring in clinical medicine.Methods:A total of 32 trainees, the professional postgraduates majoring in clinical medicine integrated with standardized residency training who rotated in the Department of Neurology, The Southwest Hospital of Army Medical University from January 2019 to January 2020 were selected and divided into control group and the experimental group, with 16 ones in each group. The control group were taught with the traditional standardized residency training program, while the experimental group were assessed by Mini-CEX evaluation once every two weeks combined with flipped classroom in stages on the basis of the control group. At the end of the training, the application effects of these two teaching methods were evaluated by theoretical knowledge and clinical comprehensive ability (including 7 aspects of medical history collection, physical examination, clinical diagnosis, treatment plan, medical ethics, doctor-patient communication and overall evaluation). SPSS 22.0 was used for t test. Results:At the end of the training, the scores of theoretical knowledge in the experimental group were higher than those in the control group [(89.83±3.93) points vs. (85.75±5.34) points], with statistical differences ( P<0.05). For the clinical comprehensive ability, the scores of history collection, physical examination, clinical diagnosis, treatment plan, doctor-patient communication and overall evaluation were higher in the experimental group than in the control group ( P<0.05), except for the medical ethics. Conclusion:The application of flipped classroom combined with Mini-CEX evaluation improves the teaching quality and strengthens the clinical comprehensive ability of students, which is worth promoting in clinical practice.
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Objective:To compare the laboratory diagnostic methods of Mycoplasma pneumonia(MP) and evaluate its clinical value.Methods:A prospective study.Throat swabs and double sera of children with MP infection were collected from December 2016 to January 2017 in Shengjing Hospital Affiliated to China Medical University; throat swab samples of healthy children aged 3 to 5 in Chaoyang District, Beijing were collected from March to May 2017.Passive agglutination (PA) was used to detect the double serum.Taking the 4-fold increase or decrease of the specific antibody titer of the double serum as the gold standard, the receiver operating characteristic curve (ROC) was drawn, and the laboratory methods for detecting MP infection were compared and evaluated.Results:(1)A total of 93 children with MP infection were clinically diagnosed, including 42 males (45.2%) and 51 females (54.8%), with an average age of 5.5 years.Sixty cases (64.5%) of MP infection were diagnosed.There were 349 healthy children, 198 males and 151 females, with an average age of 4.3 years.The positive rate of throat swab culture was 0.6% (2 cases), and the positive rate of fluorescent quantitative PCR(qPCR) was 18.9% (66 cases). (2) The culture specificity was the highest (100.0%) and the sensitivity was the lowest (65.0%). PA and enzyme linked immunosorbent assay (ELISA) were used to detect a single serum in the acute phase, the sensitivity was 71.7% and 86.5% respectively.ROC curve suggested that the current clinical diagnostic threshold MP specific antibody IgM ≥ 1∶160 was not the best diagnostic threshold.Molecular biological diagnostic methods were the most sensitive, RNA simultaneous and testing (SAT) was 85.0% and qPCR was 93.0%; while the specificity was low, 75.7% (SAT) and 63.6% (qPCR), respectively.(3) At the same time, MP nucleic acid (SAT, PCR) of throat swabs and a single serum (ELISA, PA) of children in acute phase were detected, the sensitivity was increased to 95.0%-100.0%, and the specificity was 63.6%-75.7%.Conclusions:Molecular biology is highly sensitive in diagnosing MP infection.It has asymptomatic infection or is carried after infection.Whether it needs treatment needs to be combined with clinical practice, when MP detection is positive.The detection of a single serum in the acute phase with a course of about 1 week has high sensitivity and is of reference value for the diagnosis of MP infection, but the diagnosis needs to be combined with clinical practice.The sensitivity and accuracy of detecting MP infection by single serological test combined with SAT in acute phase are higher than that by single application.
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ObjectiveTo evaluate the safety， efficacy， and economy of the four Chinese patent medicines （CPMs）， including Simotang oral liquid， Liuwei Anxiao capsule， Baohe pill， and Jianwei Xiaoshi oral liquid in the treatment of functional dyspepsia （FD） by a rapid health technology assessment （RHTA）， thus providing evidence support for clinical decision making. MethodChina National Knowledge Infrastructure （CNKI）， WanFang Database， VIP Chinese Technology Periodical Database （VIP）， China Biology Medicine disc （CBMdisc）， PubMed， EMBASE， Cochrane Library， and Web of Science were searched by computer from inception to March 2022. After literature screening， data extraction， and quality evaluation， the descriptive analysis of the results combined with visual charts was performed. Nineteen studies were included， involving 18 randomized controlled trials （RCTs） and 1 Meta-analysis. Neither economic studies nor health technology assessment （HTA） reports were retrieved. ResultThe four CPMs were safe and effective in the treatment of FD， but economic research was lacking. Among them， Simotang oral liquid could be used for children with FD and FD caused by qi and food stagnation， liver and spleen disharmony， and liver and spleen stagnation. Liuwei Anxiao capsule could be used for adult patients with FD caused by food stagnation. Baohe pill could be used for the elderly with FD. Jianwei Xiaoshi oral liquid could be used for children with FD caused by spleen and stomach weakness. ConclusionThe four CPMs have their advantages in the treatment of FD. Among them， the clinical universality of Simotang oral liquid is higher. However， the quality of clinical evidence is generally low， and comparative analysis among drug dosage forms is lacking. In the future， it is necessary to improve， apply， and promote RHTA for rapid evidence production while carrying out a more standardized and scientific evidence-based demonstration of the comprehensive clinical efficacy of CPMs.
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Objective:To explore the effect of visual mind mapping based on Mini-CEX evaluation combined with case-based learning (CBL) on improving the learning ability and teaching satisfaction of nursing students in department of general surgery.Methods:A total of 120 nurses rotating in the Department of General Surgery, Panzhihua Central Hospital (Clinical Medical College of Panzhihua University) from September 2019 to July 2020 were selected as research objects, and randomly divided into a control group and a study group, with 60 nurses in each group. The control group used traditional teaching, and the study group used visual mind mapping based on Mini-CEX evaluation combined with CBL. After the training, the clinical comprehensive ability of the nurses was evaluated by theoretical and practical assessment, and the self-learning ability and teaching satisfaction of the nurses were analyzed through self-made questionnaire survey. SPSS 22.0 was used for t test and chi-square test. Results:The theoretical and practical assessment scores of nursing students in the study group were significantly higher than those in the control group[(95.01±3.52) vs. (83.26±4.05); (96.14±3.22) vs. (81.17±4.30)] ( P=0.001). Before the rotation training, there was no statistical difference between the study group and the control group in the scores of self-motivation beliefs, task analysis, self-monitoring and adjustment, and self-evaluation ( P>0.05). After the rotation training, the scores of above 4 aspects were significantly higher in study group than the control group ( P<0.05). The nurse trainees in the study group were significantly superior to those in control group in the following 7 aspects: reasonable arrangement of the teaching plan, novelty of the teaching mode, improvement of clinical nursing skills, improvement of the nurse-patient communication ability, improvement of the emergency response ability, and overall teaching satisfaction ( P=0.001). Conclusion:Visual mind mapping based on Mini-CEX evaluation combined with CBL applied to clinical teaching training of nursing students in the department of general surgery can effectively improve the effectiveness of nursing teaching and teaching satisfaction, improve the learning ability of nurses, and improve the nursing level of nursing students in the department of general surgery.
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The evolution throughout the whole supervision history of Class II/III safety and effectiveness related NMPA submission dossier requirements was studied in this study, meanwhile elaborating the revolution progress of clinical evaluation domestically. The relationship between submission dossier requirements and Essential Principles of Safety and Performance of Medical Devices as well as IMDRF relevant documents was deeply analyzed and illustrated, in order to comprehensively understanding the background and future reform direction of NMPA submission dossier requirements under the background of the government's deepening reform of medical device evaluation and approval system strategy.