With the development of nuclear medicine, nuclear technology and molecular biology, radioligand therapy has become an important development direction of precision medicine. In China, radioligand therapy drugs are usually called radionuclide drug conjugates (RDC). These drugs deliver radionuclides to specific tumor sites by coupling targeted ligand molecules to realize different functions of diagnosis or treatment. This article analyzes the research progress of RDC and the issues faced at the level of technical evaluation, and puts forward relevant reflections and research paths, aiming to provide reference for China's drug regulatory authorities to formulate corresponding policies and measures.
In recent years, the massive accumulation of health and medical data driven by the development of medical informatization has propelled the medical field into the era of big data. The construction and application of disease-specific databases have gradually become an important way to improve clinical diagnosis and treatment levels and promote the development of clinical research. This paper aims to provide reference for the construction of disease-specific databases in the future by reviewing relevant literature, summarizing key parts, technologies and the main applications of disease-specific databases, and proposing future development suggestions.
The taste of drugs can significantly affect the clinical application effect. The traditional evaluation methods for the taste of drugs include human mouth test, animal preference test, and in vitro analysis methods such as in vitro dissolution test. A new tool for drug taste evaluation, electronic tongue, was introduced in this paper. Electronic tongue is an in vitro bionics technology, which can output the taste of drugs with the overall taste information of samples. It has good objectivity and fast detection speed, and can avoid the potential safety risks and subjective factors in human mouth test. This paper introduces the development of electronic tongue and its application in drug taste evaluation, and puts forward some suggestions for further application and development of electronic tongue.
Stem cells refer to a class of cells with self-renewal and multi-directional differentiation potential, which have broad application prospects in the field of regenerative medicine. In 2018, Stemirac was conditionally approved as an autologous bone marrow mesenchymal stem cell therapy product in Japan. This article introduces the regulatory system and approval standards for mesenchymal stem cell products in Japan, analyzes and studies the review report of Stemirac, aiming to provide ideas and reference for the research and development, clinical trials and evaluation of mesenchymal stem cell products in China.
In recent years, postbiotics, a new concept related to probiotics, has been used to describe some certain inactivated microorganisms or sterile extracts, which may provide host health benefits through distinct biological activities from those of probiotics. A series of studies have shown that some postbiotics have anti-inflammatory, immunomodulatory, antioxidant and antibacterial activities, which have been used in the adjuvant treatment of metabolic syndrome, anxiety, depression, and even corona virus disease 2019, although their mechanisms and the signaling pathways involved have not been fully elucidated. With the deepening of the research and development of postbiotics, it is expected to be widely used in the healthy food industry and medical health care field in the future.
Rosacea is a chronic inflammatory skin condition that primarily affects the central face, its clinical manifestations are diverse and it is prone to recurrence, which can significantly impact the quality of life and mental health of patients. Accurate assessment of the severity and treatment efficacy of rosacea is crucial for long-term management. This article reviews the tools for assessing rosacea based on domestic and international expert consensus and clinical research. We outline the methods, advantages and disadvantages of these tools and summarize the scales for ocular and phymatous rosacea. Additionally, we discuss the evaluation methods of life quality and mental health in rosacea patients so as to assist dermatologists in better selecting and utilizing these assessment tools.
In clinical research, it is often necessary to construct regression models to analyze the relationship between independent variables and dependent variables. However, most regression models require a linear association of the independent variables with the dependent variable. When the independent variable and the dependent variable do not satisfy these conditions, transforming continuous variables into categorical variables will result in the loss of some information and may introduce new biases. Therefore, in this case, it is necessary to construct a spline regression to directly fit the nonlinear relationship between the independent variable and the dependent variable, and a common method for this analysis is the restricted cubic spline. This article starts with the concept of how to apply a restricted cubic spline to fit the nonlinear relationship between the independent variable and the dependent variable when analyzing clinical research data, so as to provide reference for clinical medical personnel to conduct clinical research.
The penetration of active ingredients in cosmetics through the skin barrier is a hot topic in the cosmetics industry. Microneedle technology creates microchannels on the skin surface using tiny needles, which can facilitate the penetration of active ingredients from cosmetics into the deeper layers of the skin, bringing innovation to traditional skincare methods. This article reviews the pathways of transdermal absorption and methods to enhance transdermal absorption, as well as the research progress of microneedle technology in transdermal absorption of cosmetics. The development prospects and challenges of microneedle technology in the cosmetics industry are discussed so as to provide references for future research and development.
Following the announcement by China of the adoption of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) on “Continuous manufacturing of drug substances and drug products. Q13”, the implementation of this guidance has become a widespread concern in the pharmaceutical industry. The residence time distribution (RTD) and its mode serve as crucial tools outlined in the guidance designed for facilitating material traceability and support diversion strategies in continuous manufacturing. This article begins by introducing the concepts of residence time, RTD and its mode and then details the draft process of this guidance. The relevant sections on RTD are also summarized, aiming to enhance comprehension of the guidance and their associated requirements and thereby to aid in the successful implementation of continuous manufacturing technology in China.
The practical nature of medicine and the individuality of diseases have led to high misdiagnosis rates, and clinical decision support system (CDSS) based on artificial intelligence and medical big data can provide decision support for doctors in the diagnosis of diseases, which has become an important means of solving such problems, and has now also achieved certain results. However, despite the potential advantages of CDSS in improving the accuracy and efficiency of medical decision making, there are a series of problems in its implementation that may affect the reliability, usability and safety of CDSS. This paper summarizes and analyses the current status of the application of diagnostic CDSS, the challenges it faces, and the future development trend, with a view to providing reference for the development of CDSS towards intelligence and knowledge in China.
In recent years, real world study as an important type of clinical research has gradually attracted the attention of medical professionals. Hospital health information system (HIS)/laboratory information system (LIS) stores a huge amount of real patient diagnosis and treatment data, therefore, how to conduct standardized clinical research based on these data from HIS/LIS is a hot topic. Starting from the concept of real world research, this article focuses on the characteristics of hospital HIS/LIS data, as well as the key aspects and points of real world clinical research so as to provide a reference basis for clinicians and researchers.
Objective: To summarize the application of personalized traditional Chinese medicine (TCM) preparation in our hospital, with a view to continuous quality improvement. Methods: We selected and analyzed the prescription data of TCM in our hospital from May 2021 to December 2022, and used questionnaires to collect feedback on patients’ knowledge and use. Results: The proportion of personalized TCM preparation in our hospital was on the rise, accounting for (1.40±0.49)% of Chinese medicine prescription. The top three departments were cardiology, endocrinology and hepatology, and its use in pediatrics accounted for only 0.05%. The age distribution of its use in the patients was similar to that of the use of tablets, with 21-80 years old accounting for more than 80%, and ≤10 years old only 0.13%. The flavors of the medicines were mostly 21-30. The expense of the medicines was mostly RMB 501-2 000, which was less than 50% of the formula granules. The awareness rate of the patients about the personalized TCM preparation was only 24.51%, and those who had used it were 100% satisfied with its quality and appearance, and no adverse reactions were observed. Conclusion: The personalized TCM preparation has become an important supplement to the Chinese medicine dispensing in our hospital, with a high degree of patient satisfaction and a good value for application and promotion, but there are still problems such as low awareness rate, high processing costs and out-of-pocket expenses and inconvenience in the production of pediatric prescriptions.
The gut microbiota-host metabolic axis is defined as a group of high-speed multi-disciplinary, interactive chemical signal pathways that link a specific host cell pathway to a series of gut microbiome species, subecosystems and metabolic activities. Many diseases are related to intestinal microbiota disorders (alterations of the composition or functions of the intestinal microbiota). The present article focus on the gut flora dysfunction classification, the causes and consequences of the dysfunction of intestinal metabolites, as well as their roles in the molecular etiology of various intestinal diseases. Meanwhile, novel diagnostic and therapeutic approaches targeting microbiota and its metabolites are also discussed.
Herpes zoster (HZ) is a common skin disease, whose incidence has been increasing year by year, and is more common in the middle-aged and elderly as well as people with immunosuppression or immunodeficiency. Zoster-associated pain in the acute phase and postherpetic neuralgia has a significant impact on the quality of life. Therefore, the accurate assessment of the intensity, properties and changes of pain in HZ patients and estimation of the impact of symptoms on the quality of life are of benefit to carrying out appropriate therapeutic measures or to adjusting the therapeutic regimen timely in the process of clinical diagnosis and treatment, which are crucial for treatment efficacy and rehabilitation process of patients. At present, there are a variety of clinical scales used to evaluate the condition of HZ patients, mainly to assess pain and quality of life. Based on the latest version of the expert consensus on herpes zoster-related pain, this review summarizes the specific content and advantages and disadvantages of the commonly used scales so as to provide better selection for their clinical application.
Sponsor, drug clinical trial institution, regulation are all important for the quality management (QM) of drug clinical trials. Sponsor is ultimately responsible for the quality of drug clinical trial. Drug clinical trial institution is responsible for the operation management of drug clinical trial. Regulation is responsible for the supervision of drug clinical trials. Meanwhile, sponsor and drug clinical trial institution are also important evaluated objects for their QM. At present, the development of scientific methods for QM evaluation of drug clinical trial is attracting increasing interests. However, at present, the studies mainly focus on evaluating hardware construction levels other than managing abilities, partially due to the complexity of drug clinical trials. In this study, existing QM theories were summarized, the existing strategies were reviewed, and the evaluating challenges for QM were discussed. In the view of evidence-based decision-making, potential evaluation strategies were discussed based on the concept of quality management system in drug related fields.
Objective: To compare the extraction process of highland barley seeds to maximize their antioxidant activities. Methods: Three methods, namely, biofermentation, aqueous extraction and alcohol extraction, were used to comparatively analyze the extraction efficiency of β-glucan and total phenols from barley seed grain extract. The antioxidant capacity of the three barley seed extracts was detected by ferric reducing antioxidant power (FRAP), 2,2'-binamine-di-3-ethylbenzothiazolin-6-sulfonic acid (ABTS) and 1,1-diphenyl-2-picrylhydrazyl (DPPH) free radical scavenging assay. Meanwhile, the identification of metabolite from the extracts was performed using high performance liquid chromatography with tandem mass spectrometry (LC-MS/MS). Results: The alcoholic extraction method showed optimal extraction, yielding 2.03 µg/mL β-glucan and 8.88 µg/mL gallic acid equivalent of total phenols, and the strongest antioxidant activity in all the three antioxidant activity assays, FRAP, ABTS, and DPPH. Twenty-five compounds were screened out by metabolite analysis, 23 of which possessed antioxidant properties. Conclusion: This study reveals the metabolic composition of highland barley seed extract and its antioxidant activity, which provides a scientific basis for an in-depth understanding of the nutritional properties of barley and its potential health benefits, as well as theoretical support for the application of barley in the development of pharmaceuticals and nutraceuticals.
The reliability and validity test is the final step before a scale is developed or standardized and put into formal use, and can effectively test whether the questions on the scale reflect the true level of the theoretical variable being measured, and whether the scale is effective in measuring what it is intended to measure. This article starts from the method of scale reliability and validity evaluation, introduces the definition and calculation of reliability evaluation indexes (retest reliability, split-half reliability, Cronbach α coefficient) and validity evaluation indexes (content validity, validity scale correlation validity, structural validity), and take the Chinese version of the development and psychometric properties of the shared decision making questionnaire-physician version (SDM-Q-Doc) in the field of medical aesthetics as an example for reliability and validity evaluation to demonstrate the operation of SPSS statistical software, so as to provide reference for the reliability and validity evaluation of the scale or the Chinese scale after the researcher compiles the scale.
Psychiatric clinical pharmacist training is pre-job professional training. The Pharmacy Management Committee of the Chinese Hospital Association has established requirements for training bases and teachers. Psychiatric clinical pharmacist training theoretical courses and practical skills training have their own characteristics. As a training base for psychiatric clinical pharmacists, Shanghai Mental Health Center has established an information-based clinical pharmacy work and teaching path based on the requirements of the training syllabus to enable trainees to master pharmaceutical service methods as soon as possible while learning theories and skills, improve clinical thinking ability, and become a qualified psychiatric clinical pharmacist. Driven by the reform of the three-medicine linkage, the work of psychiatric clinical pharmacists will be increasingly recognized and valued by hospitals and society.
Drug abuse can cause a range of psychotic and psychological problems and is a serious social hazard. China and most countries in the world exercise strict control over narcotic drugs and other psychoactive drugs. However, it is difficult to establish timely legal control over some psychoactive drugs and chemical variants of controlled substances, which has led to the emergence of new psychoactive substance abuse. It caused great harm, especially to the youth population. This review provides an overview of the types and characteristics of new psychoactive substance abuse among adolescents and young people in China in recent years and recommends basic principles for intervention.
Objective: To observe the characteristics of basement membrane barrier damage caused by UVB irradiation in cell models and isolated skin tissues. Methods: HaCaT cells were irradiated with 40 mJ/cm2 UVB, and the expression characteristics of basement membrane barrier-related genes were analyzed by RNA-seq data. In addition, transmission electron microscopy and immunofluorescence staining were used to observe the changes of basement membrane structure and key barrier protein content in three groups of isolated skin tissues after continuous irradiation with 50 mJ/cm2 UVB for 3 days. Results: Eighteen genes related to basement membrane were found, of which the expression of 17 genes were down-regulated. The expression levels of COL4A4, COL4A5, COL4A6, ITGB1, ITGA3, ITGA4, ITGA6 and LAMA5 was down-regulated by more than 1.5 times (P<0.05), while the expression level of HPSE was up-regulated by 2.4 times (P<0.000 1). In the in vitro skin tissue experiment, the transparent layer and dense layer of the basement membrane were observed to be broken after UVB irradiation, the hemidesmosomes were destroyed and their integrity and continuity were damaged, and the integrin protein content was decreased (P<0.05). Conclusion: UVB irradiation can down-regulate the expression of genes related to the structure of the basement membrane barrier, up-regulate the expression of heparanase gene, cause the disorder of the basement membrane structure and the degradation of the key barrier protein of the basement membrane, and damage the basement membrane.
With the improvement of people’s living standards and the continuous penetration of intelligent technology into the elderly care services, ordinary nursing beds have been unable to meet the care and rehabilitation needs of bedridden patients. Research and development can solve the problems of nursing and rehabilitation for the long-term bedridden patients, intelligent multifunctional nursing beds that reduce the labor intensity of caregivers have become a research hotspot at home and abroad. This article summarizes the research status of the intelligent multifunctional nursing bed from four aspects: body position adjustment, stool and urine care, physiological parameter monitoring, and bed rehabilitation training facing to the research hotspot at home and abroad.
Depression is now the most common psychological disorder, and there are a wide variety of drugs for the treatment of depression. This article reviews the research progress of pharmacoeconomics in the treatment of depression and analyzes the pharmacoeconomic research within or between different classes of drugs based on the relevant literature available at home and abroad in the past decade, with the results of cost-effectiveness analysis as the main basis. The article summarizes the differences in the economics of different classes of therapeutic drugs so as to provide reference for clinicians to select safe, effective and economical therapeutic regimens.
In the context of the Healthy China Initiative, early diagnosis and early treatment of diseases are new goals and requirements for health management. This article analyzes the key issues of early disease screening in China, such as small disease coverage and low population coverage and finds that the disease selection method of China’s disease screening projects is not yet perfect, and there is still a lack of connection in fund payment. Accordingly, it is suggested that the disease screening scheme can be optimized from the aspects of disease screening criteria and screening process and meanwhile, the basic medical insurance fund and public health service fund can adopt the “secondary classification method” to implement different payment strategies for different types of diseases, strengthen the payment connection and provide financial support for early disease screening.
Objective: To explore the effects of lyophilized essence of compound traditional Chinese medicine extracts on scalp tissue aging. Methods: Normal human scalp tissues cultured in vitro were selected as the experimental subjects, which were divided into a control group and an extracts essence treatment group. The tissues were cultured in William's complete medium, and the effects of the extracts essence on the key proteins associated with scalp aging were evaluated by enzyme-linked immunosorbent assay and immunofluorescence detection. Results: In scalp tissues cultured in vitro, the extracts essence could significantly reduce the expression level of interleukin 6 to below 1% of the baseline at the concentrations of x/5, x/3, and x/2. In addition, the extracts essence could decrease the expression levels of 8-hydroxy-2'-deoxyguanosine (8-OHdG) by 25%, versican by 48% and myelin protein zero-like 3 (MPZL3) by 19% at a concentration of x/10 (all P<0.01), and the expression of 8-OHdG by 24%, versican by 24% and MPZL3 by 33% at a concentration of x/5 (all P<0.01), respectively. Conclusion: The lyophilized essence of compound Chinese medicine extracts has anti-inflammatory, antioxidant and anti-aging effects on human scalp tissues cultured in vitro and a value of further clinical research.
Objective: To systematically evaluate the difference in efficacy and safety of duloxetine and agomelatine in the treatment of patients with first-episode depression. Methods: The head-to-head clinical randomized controlled studies of two drugs in patients with first-episode depression were included by searching in the National Knowledge Infrastructure Database (CNKI), VIP, Wanfang, PubMed, Web of Science and other databases, the data on the efficacy and safety were extracted, and meta-analysis was performed using RevMan 5.4. Results: A total of 6 papers were included. Meta-analysis showed that there were significant differences in the HAMD-17 scores (P<0.05) and effective rate between the agomelatine group and the duloxetine group after treatment (P=0.002), however, the difference in cure rate (P=0.10) and the incidence of total adverse reactions (P=0.11) were not statistically significant. Conclusion: Agomelatine for the treatment of first-episode depression has comparable safety and superior efficacy compared with duloxetine.
In recent years, with the continuous advancement of technology and the increasing focus on health and beauty, the cosmetics industry has been facing new challenges and opportunities. One of them is how to better penetrate the effective components of cosmetics into the skin to maximize their effectiveness. Deuterium-depleted water may be an effective transdermal agent and has now attracted widespread attention. This study examines the solubility, permeability of deuterium-depleted water, and its potential application as a new transdermal strategy in cosmetics.
Disease diagnosis is the basis and premise of clinical treatment and intervention, so diagnostic tests are an important part of clinical research. Correct understanding of the design points, evaluation principles and precautions of diagnostic tests can not only strengthen the knowledge of the connotation of diagnostic tests, but also avoid their wrong application. In addition, the application of clinical epidemiological methods to evaluate diagnostic tests helps to correctly recognize the value of diagnostic tests, scientifically interpret the results of diagnostic tests, and thus improve the diagnostic level of clinicians. This article starts with the concept of diagnostic tests, explains the design points and specifications of diagnostic tests, the basic principles of evaluation, the evaluation indexes of authenticity, reliability and clinical application value, and the methods to improve the effect of diagnostic tests, so as to provide reference for researchers to apply their diagnostic tests.
Objective: To establish a special disease database based on clinical diagnosis and treatment data of pediatric allergic diseases so as to provide data support for multidisciplinary diagnosis and treatment and maximize the role of information technology in promoting the improvement of clinical diagnosis and treatment level and medical research progress. Methods: Based on the clinical diagnosis and treatment data of children with allergic diseases in Shanghai Children’s Hospital from January 2013 to July 2018, the clinical data was uniformly cleaned and stored using the extract-transform-load technology. The structured indicators in the original business system were mapped and standardized, while the unstructured content was manually labelled. Natural language processing technology was then applied for post-structured governance to create a specialized disease data model, which was used to build a dedicated pediatric allergic disease database. Results & Conclusion: The special disease database consists of 6 thematic data modules, including 16 items and 60 fields. We have achieved the collection and standardization of clinical diagnosis and treatment data for 333 029 children with allergic diseases, and further explored the distribution of diseases. The establishment of a special database for pediatric allergic diseases has enabled the storage, mining, and analysis of massive clinical data in the real world, providing support for the subsequent expansion of database based specialized management and decision-making assistance.
Objective: To evaluate the anti-inflammatory effects of Zigui lip balm both in vitro and in vivo. Methods: The model of inflammation was established using lipopolysaccharide-induced RAW 264.7 cells to detect the impact of Zigui alcohol extract on nitric oxide production. The model of atopic dermatitis-like mice induced by capsaicin was established to study the effects of Zigui lip balm on ear skin thickness, severity of ear skin inflammation, histopathology, and safety. Results: Zigui alcohol extract at 25-200 μg/mL could significantly promote the growth of RAW 264.7 cells and reduce nitric oxide levels. Meanwhile, Zigui lip balm could also significantly reduce ear thickness, eczema area and severity index (EASI) scores, inflammatory cell infiltration and decrease epidermal thickening and improve inflammation of the atopic dermatitis-like mice ear skin and in addition, Zigui lip balm had no effect on the liver, spleen, and kidneys of mice with capsaicin-induced atopic dermatitis. Conclusion: Zigui lip balm exhibits significant anti-inflammatory effects and is safe for use.
Objective: To explore the application of the resource-based relative value scale (RBRVS) in hospital performance allocation. Methods: A comprehensive performance evaluation system was constructed by sorting out the diagnostic and treatment items, determining the scoring principles and organizing expert interviews, and the application effect was evaluated using descriptive analysis method. Results: A collection scale including 5 800 diagnostic and treatment items and 520 nursing items was constructed, and a performance management system based on RBRVS was determined. Conclusion: The evaluation system can scientifically reflect the labor value of medical staff and mobilize their enthusiasm, and the trend of various operational data in this hospital is improving.
Objective: To establish high-voltage leak detection and microbiological challenge test (microbial ingress method) to determine the package integrity of the injection vial. Methods: The package integrity of the injection vial was determined using the high-voltage leak detection and microbiological challenge test (microbial ingress method). Results: The positive detection rates of 1, 3, 5 and 10 μm laser-bored hole samples were 0%, 30%, 60% and 70% by microbiological challenge test (microbial ingress method), respectively and 100% by high-voltage leak detection method. The sensitivity of positive rate was 1.4 μm by the microbial ingress method, and 1 μm by the high-voltage leak detection, and the later was higher than the former. Conclusion: Both the high-voltage leak detection and microbiological challenge test (microbial ingress method) can be used to evaluate the container closure integrity of injection vials.
Objective: To comprehensively evaluate the soothing effects of a novel efficacy complex (referred to as “Penta-Ring essence”) on the skin of individuals with oily sensitivity. Methods: An in vivo experimental approach with 34 healthy female subjects aged 18-60 years with oily skin from the Shanghai area was employed. The soothing effect of a long-term use of Penta-Ring essence on oily and sensitive skin was evaluated by a method of autologous before-and-after control. Results: A number of physiological indicators of the skin were significantly improved after the Penta-Ring essence was continuously used for 4 weeks, including 13.29% increase in the water content of the stratum corneum, 11.72% decrease transepidermal water loss, 1.91% decrease in skin temperature, 21.21% decrease in skin sebum, 7.70% decrease in skin E value, 4.54% decrease in M value, 5.84% decrease in skin chroma a* value, 5.68% increase in skin chroma L* value and 58.16% decrease in the score after 2.5 min lactate irritation (all P<0.01). Conclusion: For oily and sensitive skin, the Penta-Ring essence can effectively increase skin hydration, reduce oil secretion and pigmentation, relieve inflammation, brighten skin tone with minimal irritation and significantly improve skin barrier function, which demonstrate its efficacy in skin soothing and repair.
