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OBJECTIVE To explore the whole-process pharmaceutical care model of iodine contrast medium and promote the rational clinical use of iodine contrast medium. METHODS Clinical Professional Committee on Rational Drug Use of China Medical Education Association and Expert Committee on Drug Evaluation and Clinical Research of Guangdong Pharmaceutical Association organized domestic experts to establish a working group on the Consensus on the whole-process pharmaceutical care for iodine contrast medium. The working group conducted literature searches， evidence-based analysis， and discussions on the development process， indications， contraindications， adverse drug reactions， drug interactions， drug use for special population， pharmaceutical care， and other key topics to summarize the content and process of the whole-process pharmaceutical care for iodine contrast medium. This consensus was ultimately formed. RESULTS The consensus on whole-process pharmaceutical care for iodine contrast medium included an evaluation of the patient， renal function， combined drug use， and hydration regimen before examination， the presence of contrast agent extravasation or suspected acute adverse reactions during examination， observation time points and follow-up after examination， and the presentation of specific work in each stage through pharmaceutical care flowchart. The medication monitoring record form was also formed to record the work situation. CONCLUSIONS The consensus has established a whole-process pharmaceutical care system for iodine contrast medium， providing scientific evidence for clinical physicians and nursing staff in the rational use of such special drugs， and also serving as a reference for pharmacists in providing related pharmaceutical care.
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At present， there is no consensus on the diagnosis， treatment， and management of pulmonary nodules with integrated traditional Chinese and Western Medicine in China. To establish the clinical management strategy of pulmonary nodules with integrated medicine， a consensus was formed after full discussion by the experts from the Cancer Committee of Chinese Association of Integrative Medicine and the Cancer Committee of Beijing Association of Chinese Medicine according to the guidelines for pulmonary nodules issued in recent years and the clinical practice of multiple hospitals in the treatment of cancers with integrated Chinese and Western medicine. This consensus involves the existing clinical management guidelines of pulmonary nodules and the intervention methods of traditional Chinese medicine （TCM）. Considering the therapeutic positioning and value of TCM， this consensus standardizes the whole-process management of pulmonary nodules with integrated traditional Chinese and Western medicine， which will help more patients.
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Objective:Under the background of "new medical science", to construct a whole-process education path with "education as the driving force - moral cultivation as the core", and to provide a decision-making basis for the reform, innovation, and development of humanistic quality education in medical colleges.Methods:Five-year clinical medical students (freshman to fifth graders) from Qiqihar Medical University were selected as the research objects. The evaluation model and questionnaire of humanistic quality of clinical medical students were constructed by literature analysis. The Questionnaire Star platform was used to investigate and collect data by random sampling of clinical medical undergraduates, and the data results were analyzed by SPSS 26.0 to explore the path of building the whole-process education.Results:The empirical research on the cultivation of humanistic quality of medical students showed that the average humanistic attitude score of medical students was (3.47±0.75) points. From the perspective of gender, the scores of humanistic cognition, attitude, and behavior of male students were 2.81, 3.68, and 3.22 points, respectively, which were all significantly higher than those of female students (2.52, 3.22, and 2.95 points, respectively) ( P<0.05). The data from freshmen to the fifth graders showed that humanistic cognition, attitude, and behavior scores all presented an increasing trend with the grade. Using the "Knowledge, Attitude/Belief, Practice" model, it was found that the cognitive rate of humanistic quality of medical students was relatively ideal, and the awareness rate of medical students in different grades was different. The cross analysis showed that the effect of ideological morality and political literacy education on medical students in medical colleges had a significant cross-relationship with multiple choice questions. Conclusion:The humanistic quality of clinical medical students needs to be improved, and the cultivation of medical humanistic quality should run through the whole process from the first year to the fifth year, so as to improve the comprehensive training of professional ability and promote the all-round development of medical students.
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The standardized residency training is an important stage in the training of physicians. Shanghai East Hospital has explored the system of the whole-process tutor management in the residency training. To explore the specific methods of carrying out the whole-process tutor training for residents in the whole hospital, gradually the whole-process tutor system is built with qualification certification, mutual selection of teachers and students, tutor empowerment, plan implementation and assessment and evaluation. Meanwhile, a supporting informatization platform is being developed to provide necessary tool support for the implementation and promotion of the whole-process tutor of residency training. And information tools are used to carry out implementation management, process optimization and quality monitoring, so as to form a closed management loop.
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Objective:In the context of China′s increasing standardized management requirements of clinical research, this article aims to explore the management methods of investigator-initiated trials in the new period, to provide possible reference for other medical institutions dedicated to clinical research.Methods:According to the requirements set forth by the＂Administrative Measures for Investigator-Initiated Trials in Medical and Health Institutions (Trial)", combined with the hospital management practice, experiences regarding the research management system construction and implementation, management system construction and its implementation effects are summarized and analyzed.Results:By exploring and summarizing the connotation of high-quality clinical research under the New Policy, tailored clinical research management system in our hospital was developed and implemented. And the hospital′s clinical research capability and level have been greatly improved, which enhancing the hospital academic influence, as well as its competence for serving the development of national and regional clinical research.Conclusions:Along with the rapid progress of clinical research, hospitals need to assure the compliance of national laws and regulations, and develop appropriate and applicable institutional management measures to empower the conduct of high quality clinical research.
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The global efforts aimed at preventing and controlling HIV infections have made remarkable progress. With the continuous accumulation of clinical evidence and the development of antiviral drugs, the treatment of HIV/AIDS has entered an era of chronic disease management. However, it has also brought about many challenges. Currently, some areas in prevention, control and management of HIV infection need to be further improved, and the long-term management model currently in use need to be further refined in China. The comprehensive whole-course management mode for HIV/AIDS, which is proved as effective and efficient means, should be widely recognized and vigorously promoted in order to provide reference and assistance for the clinical management of HIV infection in China.
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Objective:To explore the effect of whole-process management mode based on "Internet + nursing service" in the management of children with concealed penis.Methods:This study adopted a quasi-experimental research method. A total of 383 children with concealed penis who were hospitalized in the Third Department of Urology of Hunan Provincial People′s Hospital from January 2018 to August 2021 were convenient selected. According to the sequence of admission, 195 children admitted from January 2018 to May 2020 were set as the control group, and 188 children admitted from June 2020 to August 2021 were set as the observation group. The control group was received conventional treatment and nursing, but the observation group was received whole-process management mode based on "Internet + nursing service". The length of hospitalization, incidence of complications after discharge, anxiety of the children′s parents and satisfaction of the doctors, the specialist & nurse sharing and the children′s parents were compared between the two groups.Results:Finally, 186 and 193 children were included in the observation group and the control group, respectively After the intervention, in the observation group, the length of hospitalization, anxiety score of the children′s parents, difference of anxiety score of the children′s parents, satisfaction content of the doctors, satisfaction effect of the doctors, satisfaction content of the specialist & nurse sharing, satisfaction effect of the specialist & nurse sharing, satisfaction content of the children′s parents and satisfaction effect of the children′s parents were (4.30 ± 1.35) d, (35.08 ± 3.17) points, (19.14 ± 4.35) points,(4.57 ± 0.54) points, (4.71 ± 0.49) points, (4.75 ± 0.50) points, (5.00 ± 0.00) points, (4.60 ± 0.49) points, (4.65 ± 0.49) points; in the control group, the scores were (5.50 ± 1.41) d, (44.79 ± 3.30) points, (9.22 ± 3.67) points, (3.71 ± 0.49) points, (4.00 ± 0.58) points, (3.50 ± 0.58) points, (3.25 ± 0.50) points, (3.54 ± 0.59) points, (3.64 ± 0.67) points. The differences between the two groups were statistically significant ( t values were -23.94-29.19, all P<0.05). The complication rates of the observation group and the control group were not statistically significant ( χ2=0.64, P>0.05). Conclusions:The whole-process management mode based on "Internet + nursing service" is beneficial to shorten the length of hospitalization, relieve the degree to anxiety of the children′s parents, improve the satisfaction of the doctors, the specialist & nurse sharing and the children′s parents, and accelerate the rehabilitation of children, which is worthy of clinical promotion.
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In order to promote the rational clinical use of gadolinium-based contrast agents （GBCA） and to provide a reference for physicians to prescribe such contrast agents and for pharmacists to review prescriptions， the consensus working group launched the preparation project of “Consensus on whole-process pharmaceutical care for GBCA” according to domestic and foreign guidelines and consensus. The Zhujiang Hospital of Southern Medical University took the lead and cooperated with clinical experts and pharmaceutical experts from several domestic medical institutions to discuss and summarize the basic pharmacological effect of GBCA， types， pharmacokinetics， pharmacodynamics， indications， contraindications， precautions， usage and dosage， adverse drug reactions， and finally forms the consensus. The main contents of this consensus include an overview of various types of GBCA， rational clinical use of drugs， security management and whole-process pharmaceutical care process， etc.， for reference by physicians and pharmacists in medical institutions at all levels.
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Chinese patent medicines(CPMs) are unique therapeutic drugs in China. Establishing and improving the evaluation criteria is an important measure to promote the high-quality development of CPMs. Based on the "evaluation criteria of high-grade CPMs with quality as the core index" established by our group in 2018, the "high-quality evaluation criteria for CPMs based on whole process control" was proposed in the present study in 2022. The scope of application and basic principles of the new criteria were clarified. A quality evaluation scoring table was established in the new criteria, including five parts: raw material selection, production process, quality control, efficacy evaluation, and brand building. The technical evaluation indexes involved have increased from 20% in the original criteria to 70% in the new criteria, and efficacy evaluation has been added in the new criteria. The subjective evaluation indicators account for a large proportion in the original criteria, which is prone to bias. The improved criteria overcome this shortcoming. It is expected that the new criteria as a basis can play a better role in the selection of high-quality products of CPMs, guide enterprises and institutions to participate actively in the evaluation and research of high-quality CPMs, and promote the high-quality development of CPMs.
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Medicine, Chinese Traditional , Drugs, Chinese Herbal/therapeutic use , Nonprescription Drugs , Chlorobenzenes , ChinaABSTRACT
Quality control is pivotal in the research and development of traditional Chinese medicine, whose connotation is not limi-ted to the qualitative or quantitative detection of an indicator component, but extends to the establishment of a whole process quality control system from the perspective of pharmaceutical product lifecycle management. This study discussed the quality control strategy of Chinese medicine based on the concept of pharmaceutical product lifecycle management, and proposed the following suggestions:(1) to focus on the "holistic view" and "phased" characteristics of quality control and strengthen the establishment of quality control strategy based on top-level design;(2) to strengthen the research on quality control of Chinese medicine based on quality risk management, focus on the correlations of quality control indicators with the safety and effectiveness of traditional Chinese medicine, and establish a quality evaluation system consistent with the characteristics of traditional Chinese medicine;(3) to consider the characteristics of different registration classifications in the establishment of quality control strategy;(4) to highlight the quality correlation research, strengthen the quality transfer research, ensure the quality traceability, and establish a sound quality management system;(5) to strengthen the quality research on marketed drugs to achieve dynamic quality improvement.
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Medicine, Chinese Traditional , Drugs, Chinese Herbal/therapeutic use , Quality ControlABSTRACT
Objective To evaluate the effectiveness of a whole-process health education model among inpatients with ascites type of advanced schistosomiasis. Methods A “admission-hospitalization-discharge” whole-process health education model was created, 101 inpatients with ascites type of advanced schistosomiasis were given the whole-process health education. The scores of schistosomiasis control knowledge, attitudes towards schistosomiasis control and healthy behaviors, and awareness of schistosomiasis control knowledge, correct rate of attitudes towards schistosomiasis control and correct rate of healthy behaviors were compared among inpatients with ascites type of advanced schistosomiasis before and after implementation of the whole-process health education. Results The scores of schistosomiasis control knowledge, schistosomiasis control attitudes and healthy behaviors were all significantly higher among inpatients with ascites type of advanced schistosomiasis after implementation of the whole-process health education than before implementation (Z = −7.688, −3.576 and −4.328, all P values < 0.01). In addition, the awareness of schistosomiasis control knowledge increased from 54.3% to 82.7% (χ2 = 188.886, P < 0.01), and the correct rate of attitudes towards schistosomiasis control increased from 88.4% to 98.0% (χ2 = 22.001, P < 0.01), while the correct rate of healthy behaviors increased from 48.2% to 59.7% (χ2 = 11.767, P < 0.01). Conclusions The whole-process health education model may remarkably improve the awareness of schistosomiasis control knowledge and promote the formation of positive attitudes towards schistosomiasis control and correct behaviors among inpatients with ascites type of advanced schistosomiasis, which is of great significance to facilitate patients’ cure.
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OBJECTIVE@#The national requirements for the fund management of scientific research projects are becoming more stringent, so that it is convenient to carry out scientific research work and can strengthen the regulation of scientific research reagent procurement, so this study explores the standardization of the whole process of the procurement of scientific research reagent supplies in hospitals and new modes of management.@*METHODS@#By exploring the implementation of the centralized procurement management platform, we engage in full process supervision before, during, and after the event.@*RESULTS@#Introduction of centralized procurement management platform for scientific research reagent supplies can normalize the procurement process, ensure the quality of procurement and improve the procurement efficiency on the basis of ensuring the quality of scientific research.@*CONCLUSIONS@#The new model of centralized procurement of full process management based on one-stop service for scientific research reagent supplies is an important part of improving the fine scale management of public hospitals, and it is of great significance in improving the level of scientific research in China and avoiding scientific research corruption.
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Indicators and Reagents , Hospitals, Public , ChinaABSTRACT
Focusing on the development and quality improvement strategy of the traditional Chinese medicine(TCM) industry, the scientific and technological innovation of the new engineering of TCM should be paid attention to solve the "stuck neck" dilemma. Under the background of the ecological and industrial revolution of the scientific and technological innovation system, the super-scale information interaction and multi-dimensional integration will inevitably lead to profound changes in the manufacturing mode of TCM. Manufacturing measurement of TCM is formed on the basis of the reliability engineering theory of process control of TCM production. It is the development extension of system theory and system science ideas and a cross-fertilization discipline that combines theory with practice and adheres to the "four-oriented" re-epistemology improvement of the TCM discipline. In response to the problems of complex raw material sources, coarse process technology, unclear material basis, and poor applicability of equipment and technology in the manufacture of TCM, the transformation research mode of "aiming at the integration of pharmaceutical industry-developing intelligent production line-enabling industrial transformation" has been developed. This paper proposed the four key engineering technical problems, i.e., the identification of critical quality attributes(CQA) in the manufacture of TCM, the quality by design(QbD) and product development of the manufacturing process of TCM, the quality transfer principle and multivariate process capability index of TCM manufacturing, and the development of measurement technology and equipment of the manufacturing measurement of TCM, to achieve the systematization of quality control indicators, real-time process control, digitalization of manufacturing process, transparency of quality transfer, and intelligent whole-process control. In this paper, the new concepts, new theories, and new technologies provide a reference for the industrialization of TCM.
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Medicine, Chinese Traditional , Reproducibility of Results , Commerce , Drug Industry , Quality ControlABSTRACT
After the completion of the pilot work of traditional Chinese medicine formula granules （TCMFGs）， the national and provincial medical products administrations have published and implemented about 440 varieties of TCMFGs standards. Based on the previous work， this paper analyzed technical problems encountered in the review and evaluation of Shandong TCMFGs standards， mainly involving the executive standards and distinguishing technologies of raw materials， the adding process of excipients in the procedure item， the rationality of quality control methods， the information content and reproducibility of characteristic chromatograms， the nomenclature and accessibility of reference materials， etc. The common problems such as the coverage of standards， specification differences， and the integrity of quality control items of current TCMFGs standards were discussed deeply. It is proposed to promote the upgrading of provincial standards to national standards， accelerate the research and development of reference materials， advocate the use of high-quality raw materials， explore the evaluation methods of high-quality products， and strengthen the quality supervision of the whole process. Suggestions of this paper is hoped to provide references for the formulation of national and provincial TCMFGs standards， promote the continuous improvement of TCMFGs standard system， and ensure the healthy and orderly development of the TCMFGs industry.
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Liver transplantation is one of the best approaches for the treatment of hepatocellular carcinoma. The concept of transplant oncology could shed light on the whole process management of hepatocellular carcinoma patients. The success rate of operation and perioperative safety were the major concerns in the past, whereas the focus of treatment is gradually shifting to cancer treatment and improving patient survival and quality of life, with the promotion of neoadjuvant and postoperative adjuvant therapy for hepatocellular carcinoma. The prognosis of different group of patients might be heterogeneous. Therefore, refined stratification should be carried out for heterogeneous patients before and after liver transplantation to achieve the best prognosis. The present study classified patients for three clusters: primary hepatocellular carcinoma patients within the transplant criteria, hepatocellular carcinoma recurrence after liver resection, and patients after down-staging or neoadjuvant therapy. Fine stratified management are essential for the whole process management in the new era of transplant oncology.
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Sichuan province is extremely rich in Chinese herbal medicine resources，and the Chinese herbal medicine industry is an integral part of the "10+3" industrial system of modern agriculture. However，it has been long constrained by factors such as hilly terrain and scattered planting patterns，which hinders the mechanization development of the Chinese herbal medicine planting industry. Committed to promoting the application and development of the whole-process mechanization of Chinese herbal medicine production， the research group investigated the current situation and mechanization application of the Chinese herbal medicine planting industry in Sichuan province，and clarified the core advantages of the industry in Sichuan province and the urgent need for mechanization production. The current situation of mechanization of key links in producing rhizome-type Chinese herbal medicines such as planting，fertilization，pest and weed controlling，harvesting，and primary processing in production areas were analyzed. The key factors and existing problems in the whole-process mechanization development as well as the key future research directions were discussed，and the mechanization development trend of Ophiopogonis Radix，Chuanxiong Rhizoma and other herbal medicines in the Chinese herbal medicine planting areas of Chengdu Plain were forecasted. This paper focused on the bottleneck of the mechanization application in producing Chinese herbal medicines in Sichuan province，and introduced key technologies and equipment for the whole-process mechanization of rhizome-type Chinese herbal medicine production，which is conducive to transforming and upgrading the Chinese herbal medicine production industry，accelerating the application of high-tech information technology，and promoting the mechanization and intelligentization of the planting industry.
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【Objective】 To develop and implement a precise and efficient telephone recruitment strategy for apheresis platelet donors based on the information management of blood collection and supply process. 【Methods】 A telephone recruitment strategy based on the whole process information management of apheresis platelet donors (hereinafter referred to as telephone recruitment) was formulated From January 1, 2019, apheresis platelet donors in Hangzhou, registered in the intelligent blood donor recruitment system(hereinafter referred to as the recruitment system), were recruited by telephone calls or (and) SMS reminders to inform re-donation interval, key points of recruitment consultation, blood donation appointment time and other precautions. Response rate, pass rate and blood donation rate of donors before(in 2018) and after( in 2019) the implementation of telephone recruitment, as well as the above three rates during the COVID-19 epidemic in 2020 in Hangzhou were collected and analyzed by χ2 test. 【Results】 The response rate, pass rate, and blood donation rate of apheresis platelet donors in Hangzhou before /after the implementation of telephone recruitment and during the COVID-19 epidemic were 28.52%(3 901/13 678)vs 30.52%(4 429/14 511)vs 39.36%(4 064/10 326), 73.80%(2 879/3 901)vs 77.83%(3 447/4 429)vs 78.20%(3 178/4 064)and 6.77%(2 879/42 553)vs 7.77%(3 447/44 366)vs 8.13%(3 178/39 077, respectively(P<0.05). In 2020, 85.94%(3 178/3 698) of apheresis donors were recruited by telephone(P<0.05). The proportion of apheresis donations successfully recruited by telephone in 2018 and 2019 accounted for 11.74% (2 879/24 519) and 12.48% (3 447/27 628), respectively(P<0.05), contributing 10.59% (4 030 U/38 040 U) and 11.38% (4 875 U/42 853 U) of units(P<0.05) that issued to the clinical. Due to the COVID-19 epidemic, the number of blood donors recruited by telephone and its proportion in 2020 decreased significantly as compared with those before the implementation of telephone recruitment (2019). 【Conclusion】 The telephone recruitment strategy based on the whole-process information management (system) of blood collection and supply can effectively improve the targeted recruitment of apheresis platelet donors and enhance its proportion of apheresis collection that issued to the clinical.
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As a Chinese saying goes， "good Chinese medicinal material makes good medicine"， the traceability of Chinese medicinal materials is closely related to the high-quality development of Chinese medicine industry. This article intends to analyze the "new era of smarter food safety blueprint" and Proposed Rule for Food Traceability related to food traceability of the U.S. Food and Drug Administration （FDA）， including food traceability list， critical tracking events， and examples of exemptions. By studying the process and consideration of the construction of the FDA food traceability system， as well as the specific traceability requirements of fresh herbs， vegetables and fruits in the FDA food traceability system that are related to Chinese medicinal materials， on the one hand， it provides research materials for the communication and discussion of Chinese medicinal materials traceability， on the other hand， it also provides reference for the construction of food traceability system in China. To sort out the idea of constructing a traceability system for Chinese medicinal materials suitable for the current development status of traditional Chinese medicine， the contents to be considered are as follows：①To determine the traceability list of Chinese medicinal materials based on the risk control of Chinese medicinal materials. ②Determine the critical tracking links and information in the Chinese medicinal materials industry chain， and standardize the traceability information of Chinese medicinal materials. ③The quality information of Chinese medicinal materials should be reflected in the traceability of Chinese medicinal materials. ④Within the scope of the traceability list of Chinese medicinal materials， enterprises should be encouraged to make voluntary traceability by selecting Chinese medicinal materials with a good foundation of traceability work.
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With the deepening of China′s healthcare reform, cost control of medical consumables has become an important means to alleviate the problem of " high medical cost" . Through analysis of the difficulties of medical consumables cost control and mechanism loopholes in such control, the authors proposed a whole-process control practice, in terms of assessment, procurement, use, supervision, assessment and evaluation, and recommend on formulating whole-process cost control measures at both government and hospital levels.
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We retrospectively analyzed the clinical characteristic of one patient with metastatic prostate cancer and the relative literatures were reviewed. A 40-year-old man was admitted and diagnosed as prostate cancer on March 20, 2018(T 4N 1M 1a) with prostate-specific antigen (PSA) at 47.99 ng/ml. The first 68Ga-PSMA PET/CT showed multiple nodular lesions in the bilateral peripheral bands of the prostate, multiple nodular lesions in the right apex, abnormal uptake of nuclides in multiple lymph nodes in the abdominal aortic wandering zone, the abdominal aortic bifurcation zone, and the bilateral iliac artery wandering zone at the level of the lumbar 2-5 vertebral body, and metastasis was considered. The patient was treated with six cycles of drug castration combined with antiandrogenic treatment and pre-operative system chemotherapy(docetaxel). Six months later, the PSA decreased to 0.225ng/ml. Robot-assisted laparoscopic prostatectomy and expanded pelvic lymph node dissection was performed. Postoperative total androgen blocking therapy was maintained, and PSA slowly increased. Ten months after operation, salvage radiotherapy for enlarged lymph nodes was performed in pelvic extension field, prostate tumor bed area and pelvic cavity. PSA remained stable for 7 months postradiotherapy, and then increased. The patient developed castration-resistant prostate cancer and was treated with triptorelin combined with abiraterone. PSA was decreased, and local radiotherapy was performed for new lymph node metastases in the neck. 68Ga-PSMA PET/CT could provide a decision-making basis for accurate clinical staging, therapeutic effect evaluation and distant metastatic lesions location with guiding value for the formulation of individualized treatment plans.