The methods of sample size estimation is an important part of the design of a randomized controlled clinical trial according to the Consolidated Standards of Reporting Trials (CONSORT) statement and PICO design guidelines. A reasonable sample size is an important safeguard for obtaining evidence from high-level clinical research. Too small a sample size cannot guarantee reliable research conclusions, while too large a sample size can result in unnecessary waste of human, material and financial resources, as well as increase the difficulty of the research. This article starts from the parameters affecting the sample size, points out that the sample size should be estimated based on the main efficacy evaluation indicators of clinical trial research, and clarifies the ways to obtain the indicators of “quantitative variables” and “qualitative variables”. The methods of sample size estimation for differential clinical research designs, superiority clinical research designs, non-inferiority clinical research designs and equivalence clinical research designs are introduced by way of examples so as to provide reference for researchers to conduct optimal scale regression analysis in the future.

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 development of a statistical analysis plan (SAP) is an important part of clinical trial and also an executive document for the analysis of clinical trial data. The SAP of clinical trial provides detailed descriptions of the purpose, study design, data collection, quality control, statistical analysis methods and result presentation of clinical trial and also an important basis and reference for statistical analysis. This article focuses on the content and core elements of SAP starting from the concept of clinical study SAP, and provides an SAP verification checklist and helps research teams verify the completeness of content writing after completing SAP, so as to timely check the gaps and improve the clinical trial SAP.

This guideline is developed according to the methodology and steps of evidence-based guidelines so as to standardize the diagnosis and treatment of ankylosing spondylitis (AS), in which 54 recommendations on 13 areas of concern to clinicians are involved. Therefore AS patients can be treated reasonably and effectively and their quality of life and prognosis can be also improved.

Cohort study is an important type of study in analytical epidemiology, which is essentially observational in nature. In a cohort study, the researcher cannot treat or intervene in the study as his or her envisions. Usually, the study subjects should be divided into different groups according to whether they are currently or at some time in the past exposed to the factors under study or different levels of exposure, such as exposed and non-exposed groups, high-dose exposure groups and low-dose groups, and then, by collecting relevant information and following up and observing for a period of time, observe and register the occurrence of the outcome events in the different exposed populations, and compare the rates of the outcomes in each group, so as to evaluate and test the relationship between risk factors and outcomes. This article starts from the basic concepts of cohort study and introduces the classification of cohort study, sample size estimation, key points of cohort study design and its application so as to provide reference for clinical medical personnel working on the design of cohort study.

Proteins, the intricate “molecular machines” that orchestrate life’s processes, hold immense potential for therapeutic applications. However, the designing and engineering of these proteins towards desired properties and functions remain a formidable challenge due to the complex interplay between the amino acid sequence, the three dimensional structure, and biological function. Artificial intelligence (AI) has been making transformative strides in various fields and its combination with protein engineering techniques offers a powerful toolkit in generating novel proteins for synthetic biology and therapeutics development. In this review, we will discuss the advancements and applications of AI in protein modeling and design and highlight the challenges and outlook of its applications.

Objective: To ensure that products with good quality and stability can be prepared on commercial production lines by optimizing the preparation process of clevidipine butyrate emulsion for injection. Methods: The preparation process of clevidipine butyrate emulsion for injection suitable for commercial production was screened out by the optimization of method for the addition of egg yolk lecithin, the investigation of the crude emulsion feeding sequence, homogenization parameters and pH adjustment steps. Results: A better quality clevidipine butyrate emulsion for injection could be obtained by adding egg yolk lecithin to the oil phase, mixing oil and water in a fixed proportion, setting the homogenization pressure at 50-70 MPa, maintaining the temperature of the liquid at 40-60 ℃, homogenizing the liquid for 5-12 times and adjusting the pH to 7.0-8.0. Conclusion: It is possible to prepare a good quality and stable clevidipine butyrate emulsion for injection using the optimized process parameters on a commercial production line.

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.

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.

In the past two decades, synthetic biology has made breakthroughs in the construction of biocircuits, the standardization of biological elements and the development of various genomic/metabolic engineering tools and approaches. Its rapid development is changing the industrial layout of biotechnology industry. At present, synthetic biotechnology has been widely used in many fields such as natural product synthesis, medicine, energy and industry. Pharmaceutical demands have also driven its development, including the application of in vitro catalytic technology in the green manufacturing of chiral pharmaceutical chemicals and the integration of heterologous pathways into designer cells to efficiently produce medicines and so on. Synthetic biology, with its more economical and environmentally friendly features, will subvert some traditional pharmaceutical manufacturing methods. This article reviews the applications of synthetic biology in the green manufacturing of chiral pharmaceutical chemicals and the biological manufacturing of natural plant products.

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.

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.

Traditional Chinese medicine, primarily based on medicinal plants, has been used for thousands of years in China and has made significant contributions to the health and proliferation of the Chinese nations. The bioactive compounds are the pharmaceutical basis for Chinese medicine. The identification of the composition of active components in Chinese medicine and the establishment of their green, low-cost manufacturing technoogies would play key roles in the promotion of the modernization of Chinese medicine. The recent development of synthetic biology not only provides new avenues for the green, low-cost and large-scale production of bioactive components of Chinese medicine but also offers technical support and necessary compounds for clarifying the composition of active components and their pharmacological mechanisms. This article reviews the development and application of synthetic biology in the production of bioactive components of Chinese medicine, such as artemisinin, ginsenosides and icaritin, and the potential roles of synthetic biology in promoting the modernization of Chinese medicine.

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.

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.

The design of a clinical trial protocol is the primary aspect of clinical research. A well-written clinical research protocol can clarify the purpose of the research and guide the standardization of clinical trial research. The design of a clinical research protocol is also a scientific and rigorous task and must comply with the statistical requirements of the specifications while meeting the clinical treatment needs. With reference to the Uniform Standards for Reporting of Randomized Controlled Trials (CONSORT) statement, PICO principles and China’s Good Clinical Practice, the clinical study design types were introduced, including statistical elements in clinical study protocol design such as randomization protocols, control settings, replication, blinding, endpoint indicators, analysis sets, data monitoring and management committees, missing data and data filling methods, statistical analysis and subgroup analysis, so as to provide reference for researchers to write clinical study protocols.

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.

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.

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.

Objective: To compare the safety and efficacy of temperature-sensitive liquid embolic agent (TSLEA) with traditional embolic materials in the treatment of gastrointestinal bleeding (GIB), and to analyze the value of its application. Methods: The clinical data from GIB patients were retrospectively analyzed, and the patients were divided into two groups according to whether or not they used TSLEA intraoperatively and the differences were compared between the two groups. Results: There were 10 cases with 14 responsible vessels in the TSLEA group and 24 cases with 31 responsible vessels in the non-TSLEA group. The technical success rate of both groups was 100%, and the average postoperative follow-up time was 16.07 months. The clinical success rate was 91.67% with the incidence of postoperative complication 8.33% in the non-TSLEA group and 90.00% without significant complications in the TSLEA group. The differences of the incidence of complication and the clinical success rate between the two groups showed no statistical significance (P=0.888, P=0.837). Conclusion: TSLEA has similar technical and clinical success rates and complication incidence compared with traditional embolic materials, but it can pass through twisted and slender duty vessels and is a good material for embolization.

A case-control study is the most basic and important type of study in analytical epidemiology. This type of study is essentially observational in nature, in which the researcher cannot treat or intervene in the study according to his or her own conception, but only groups the subjects according to whether they have the outcome event of interest to the researcher, and then retrospectively collects information on previous exposures of the subjects of the two groups, and then explores the “cause and effect” relationship between the exposures and the outcomes. This article begins with the basic concepts of case-control studies, introduces the classification of case-control studies, sample size estimation of case-control studies, and the key points and applications of case-control study design, with a view to providing a reference for the design of subsequent case-control studies conducted by clinical medical personnel.

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.

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.

Decision tree model is a supervised machine learning method and its classification rules usually take the form of IF-THEN, the analysis results are often presented in the form of tree diagrams, with the advantages of solid interpretability and ease understanding, and it has been widely used in the fields of disaster prediction, environmental monitoring, clinical diagnosis and treatment decision-making. This article starts from the concept of decision tree model, introduces the general construction steps of decision tree model, the application of classification and regression tree (CART) decision tree model in the analysis of clinical research data, and the construction process and realization method of CART decision tree model using the SPSS software example, so as to provide a better solution for clinical researchers to use decision tree model for data analysis.

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.

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.

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.

Function of female pelvic floor is to support the vagina, urethra, rectum and other pelvic organs to maintain a normal anatomical position. Pelvic floor dysfunction disease(PFD) is a common disease after delivery that affecting the physical and mental health of women, which should not be ignored. There are high risk factors of PFD during pregnancy and delivery. PFD has become a social public health problem. This study reviewed the influencing factors, assessment measures and the rehabilitation treatments of postpartum PFD in order to provide more basis and reference for community medical institutions to carry out postpartum pelvic floor rehabilitation training plans in the future.

Cardiovascular disease is one of the leading causes of death worldwide. The comprehensive rehabilitation intervention for patients with heart disease is a major clinical challenge. Traditional Chinese medicine has unique advantages in the rehabilitation of this disease, but currently there is no integrated rehabilitation plan for heart disease in China. The Muscle and Skeleton Integrated Traditional Chinese and Western Medicine Rehabilitation Professional Committee of the Shanghai Rehabilitation Medicine Association has organized experts in relevant fields to combine relevant clinical guidelines in recent years and developed “Guidelines for Integrated the Traditional Chinese and Western Medicine Rehabilitation of Heart Diseases” after repeated discussions with experts in related fields, aiming to guide and standardize the practice of integrated traditional Chinese and Western medicine rehabilitation of heart diseases.

Clinical research is an important form of scientific research based on the scientific questions raised by clinical practice, and is an important source of funding for medical personnel engaged in scientific research, which has had a wide impact in recent years in China, especially in the “Beijing, Shanghai, Guangzhou, Shenzhen” and other regions. Just as engineers need design drawings to construct a building, medical personnel need a reference to carry out clinical research, and this reference is the clinical research project application. Clinical project application writing is the main way to apply for scientific research projects; a good project application is a stepping stone to open the door to scientific research, and it is also the first step on the road to clinical research. The clinical research project application usually includes the applicant’s basic information, the body of the project, the project opinion, and other parts. The main body is the focus of the clinical research project application, usually including the basis of the project, research content, technical route, research objectives, innovation, expected results, funding budget, project team members and other content. This article started with the selection of clinical research topics and focused on the details of each part of the project application in order to provide a reference for clinical medical personnel to write clinical research project applications.

Objective: To prepare high purity monomers from polymyxin B by reversed-phase preparative liquid chromatography. Methods: The suitable conditions for the preparation of polymyxin B monomers were screened out by selecting different specifications of preparative chromatographic columns and loading amount and adjusting the gradient elution procedure of mobile phase. Six high-purity monomers with purity greater than 96% were obtained by multiple times of purification, vacuum concentration and freeze-drying of eluates and confirmed by mass spectrometry. Results: The purities of the obtained units were over 96%. Conclusion: The method established in this study can quickly, efficiently and economically prepare multiple monomers of polymyxin B.