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.

Objective: To explore the effects of different anesthesia maintenance programs on the efficacy of laparoscopic hysterectomy. Methods: Eighty-two patients undergoing elective laparoscopic hysterectomy were randomly divided into a control group and a study group with 41 cases each. Anesthesia was intraoperatively maintained with propofol combined with remifentanil in the control group and sevoflurane combined with remifentanil in the study group. The quality of anesthesia, stress response indexes [cortisol (Cor), 5-hydroxytryptamine (5-HT)], cognitive function [mini-mental state examination (MMSE) score] and the incidence of postoperative adverse reactions were compared between the two groups. Results: Postoperatively, the time to spontaneous breathing, awakening and extubating were shorter, the levels of Cor, 5-HT and the incidence of adverse reactions were lower, and the MMSE score was higher in the study group than the control group (P<0.05). Conclusion: Compared with propofol combined with remifentanil, maintenance anesthesia with sevoflurane combined with remifentanil in patients undergoing laparoscopic total hysterectomy can improve the quality of awakening, reduce the stress response, and induce the recovery of cognitive function with fewer adverse effects.

The distal femoral fracture is a common fracture in clinic. With the development of internal fixation devices and the improvement of treatment concepts and techniques, the treatment of distal femoral fractures has made new progress. In this paper, we make a summery including the anatomical structure of the anatomical basis of distal femur, the occurrence mechanism and classification, clinical diagnosis, historical evolution of treatment, and reasearch prospects of distal femoral fracture.

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.

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.

Objective: To improve the synthetic route of Janus kinase inhibitor baricinib (1). Methods: 3- (cyanomethylene) azocyclobutane-1-carboxylic acid tert-butyl ester (2) was deprotected to obtain the intermediate 2-(3-azocyclobutanylidene) acetonitrile hydrochloride (3), which was then subjected to sulfonation reaction to obtain 2-[1-(ethylsulfonyl)-3-azocyclobutanylidene] acetonitrile (4), followed by Michael addition reaction to obtain 1-(ethylsulfonyl)-3-[4-(4,5,5-tetramethyl-1,3,2-dioxocyclopentane-2-yl)-1H-pyrazole-1-yl]-3-azocyclobutane acetonitrile (5). Finally, a coupling reaction was carried out with 4-chloro-7H-pyrrolo[2,3-d] pyrimidine to obtain 1. Results & Conclusion: The total yield was 63.6% with the purity 99.9% (HPLC area normalization method). The structures of the target end product and key intermediates were confirmed to be correct by MS and ¹H-NMR. The starting materials used in this method are inexpensive and readily available and the post-treatment of the reaction is simple. The new route has a high overall yield and is suitable for large-scale preparation, and can provide reference for the production of baricitinib and the synthesis research of its derivatives.

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 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.

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.

Objective: To investigate the effect of aspirin combined with etipatide on the treatment prognosis of acute stage of cerebral infarction. Methods: Sixty patients with acute cerebral infarction admitted to our hospital from March 2021 to March 2022 were collected and the random number table method was used to divide the patients into a control group and an observation group with 30 cases in each group. The control group took aspirin 100 mg/time, once a day, for two consecutive weeks, and the observation group added the first dose of etibatide 135 μg/kg, intravenous injection on this basis, then 0.75 μg·kg^-1·min^-1 micro pump injection for 12~72 hours. The prognosis, adverse reactions, hemorheology indexes, coagulation function indexes, national institutes of health stroke scale(NIHSS) scores and activity of daily living scale(ADL) scores of the two groups were compared before and after treatment. Results: After 2 weeks of treatment, the total effective rate in the observation group was 93.33%(28/30), which was higher than that of the control group 73.33%(22/30, P<0.05). After treatment, the results of erythrocyte sedimentation rate(ESR) and erythrocyte aggregation index(EAI) in the observation group were lower than those in the control group(P<0.05); the results of activated partial thromboplastin time(APTT) in the observation group were higher than those in the control group, while the results of D-dimer(D-D) and fibrinogen(FIB) were lower than those in the control group(P<0.05). After treatment, the NIHSS score in the observation group was lower than that in the control group, and the ADL score was higher than that in the control group(P<0.05). The total incidence of adverse reactions in the observation group was 13.33%(4/30), and there was no significant difference compared with 10.00%(3/30) in the control group(P>0.05). Conclusion: Aspirin combined with etibatide can improve the treatment prognosis of acute stage of cerebral infarction, neurological function and daily living ability of patients, which is worthy of clinical recommendation.

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.

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.

Objective: To establish a method for the determination of rhEGF content in rhEGF (recombinant human epidermal growth factor) eye drops and perform method validation. Methods: The content of rhEGF in eye drops was determined using a commercial kit Quantikine by enzyme-linked immuno sorbent assay (ELISA). Results: The linear range of the standard curve was 20-200 pg/mL. The relative standard deviation (RSD) of intermediate precision was 14.98% (n=9). The average recoveries of low, medium, and high concentrations of samples were 94.08%, 100.46% and 104.89% with RSD 11.03%, 9.85%, 8.75% (n=3), respectively. The RSD for 10 replicates was 5.58%. Conclusion: The ELISA method established in this study has a good specificity, precision, accuracy and stability, and is suitable for the determination of the content of rhEGF in rhEGF eye drops.

The number of investigator-initiated trial (IIT) has increased continuously in our country and meanwhile the quality of their studies is gradually becoming prominent. How to construct and optimize quality management system (QMS) of IIT and improve IIT quality has become one of the focuses of managers in the medical and health institutions. This article sorts out international and domestic quality management standards including principles, requirements and methods, analyzes the application in the IIT-QMS construction, and proposes applicability, reference significance and specificity of the quality management standards for IIT-QMS construction. These standards would guide medical and health institutions to construct the effective QMS in order to ensure the rights and safety of subjects and the authenticity and reliability of research data.

Objective: To observe the effectiveness of Tongxinluo combined with atorvastatin in the treatment of carotid atherosclerosis in H-type hypertension. Methods:One hundred patients with carotid artery atherosclerosis in H-type hypertension were randomly divided into an observation group (n=50) and a control group (n=50). Both groups were treated with oral amlodipine tablets, and then atorvastatin tablets were additionally given in the control group, while the observation group was treated with Tongxinluo capsule besides atorvastatin tablets. Blood pressure, blood lipids, carotid intima-media thickness (IMT), carotid plaque Crouse’s score, blood biochemical indexes, clinical efficacy and treatment safety were evaluated in the two groups. Results:The total clinical efficacy rate of the observation group was higher than that of the control group (P<0.05). After treatment, the levels of systolic blood pressure, diastolic blood pressure, TG, TC, LDL-C, IMT, carotid plaque Crouse score, endolipids, Hcy, IL-1β, TNF-α, hs-CRP were lower and the levels of HDL-C, L-PGDS were higher in the observation group than the control group (all P<0.05). No serious adverse reactions occurred in both groups. Conclusion:Tongxinluo combined with atorvastatin can help to maintain the stability of carotid plaques in patients with carotid atherosclerosis of H-type hypertension, and the therapeutic effect is better.

Objective: To investigate the clinical efficacy of the application of acupuncture combined with Ganmai Dazao Tang in the treatment of patients with diabetes mellitus (DM) complicated with anxiety and depressive states. Methods: Sixty patients with DM combined with anxiety and depressive states were randomly divided into a control group and an observation group with 30 cases each. The control group was treated with oral haloperidol melittin tablets, and the observation group was treated with acupuncture combined with Ganmai Dazao Tang on the base of the control group, and the treatment was lasted for four weeks. The clinical efficacy, blood glucose levels, mood indicators and adverse reactions were compared between the two groups. Results: The total clinical effectiveness rate was higher, and the levels of fasting blood glucose and 2-hour postprandial plasma glucose and the scores of the Hamilton anxiety scale and Hamilton depression scale were lower in the observation group than the control group (P<0.05). The differences in the incidence of adverse reactions between the two groups were not statistically significant (P>0.05). Conclusion: The application of acupuncture combined with Ganmai Dazao Tang in the treatment of patients with DM complicated with anxiety and depressive states can improve the blood glucose level and anxiety and depressive states with good effect and safety, and has a certain clinical value.

Objective: To collect idiopathic membranous nephropathy (IMN) case samples, determine the expression level of TIPE2 and study its association with macrophage polarization-associated cytokines and IL-17/IL-10 induced by IMN. Methods: Sixty cases of patients with IMN were selected as a IMN group, and 50 cases of healthy subjects were recruited as a control group. The level of TIPE2 were determined by a literature method, while the contents of TNF-α, IL-2, IL-17 and IL-10 by ELISA. Results: Serum and urinary β₂-microglobulin contents and urinary protein indexes were higher and creatinine content was lower in the IMN group than the control group (P<0.001), and TIPE2, TNF-α, IL-2 levels and IL-17/IL-10 value were significantly higher in the IMN group than the control group (P<0.001). TIPE2 level was positively correlated with the TNF-α, IL-2 levels and IL-17/IL-10 ratio (P<0.001). Conclusion: This study can provide a new direction for clinical treatment and drug development and a basis for immune regulation involving basic molecules.

Protein drugs have the advantages of strong targeting, clear mechanism of action and fewer adverse reactions, so they have great application prospects in clinic. The stability of protein is one of the most important properties of protein drugs, which is crucial for drugs’ efficacy, safety and stability. In recent years, protein engineering assisted by artificial intelligence (AI) has been developed into an efficient strategy for protein molecular design, and has been widely used in protein stability prediction, drug design and antibody optimization. In this paper, we introduce several major methods of AI-assisted protein stability optimization, discuss their advantages and disadvantages and their applications in protein drug design and optimization. We also discuss the challenges and prospects of AI in protein stability design. We hope this paper will provide new ideas for researchers to develop more stable and efficient protein drugs.

With the advancement of bioscience technology and pharmaceutical manufacturing process, the mRNA vaccines have entered a stage of rapid development under the background of COVID-19, which have the advantages of short R&D cycle, rapid production and high clinical effectiveness. However there are various technical difficulties in the field of their development and production. How the drug regulatory agencies can implement the quality control of the entire chain of mRNA vaccines has also become a research hotspot. The WHO released technical guidelines on mRNA vaccines in 2021. This article summarizes the key points of WHO guideline, discusses the regulatory concerns based on the actual situation in China and prospects the technical guidelines system in the future.

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.

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.

A patient with liver cirrhosis complicated with Mycoplasma pneumoniae pneumonia had poor effect on azithromycin to control the infection and the clinical pharmacist recommended to adjust to levofloxacin considering the factors such as bacterial resistance and the patient’s pathophysiology and so on. The resistance rate of azithromycin to adult community-acquired Mycoplasma pneumoniae in China is high, while azithromycin may increase the risk of acute liver injury and mortality in patients with liver cirrhosis. Levofloxacin may be one of the drugs of choice for Mycoplasma pneumoniae pneumonia in adults and the patients with decompensated liver function do not require dosage reduction.

Objective: To synthesize the impurities WF-Z1-WF-Z6 produced in the production process of warfarin sodium. Methods: Using 2′-hydroxyacetophenone (SM-1) as a starting material, 4-hydroxy-chromen-2-one (WF-1) was synthesized by condensation reaction with dimethyl carbonate (SM-2). Subsequently, Michael addition reaction with 4-phenyl-3-buten-2-one (SM-3) was carried out to obtain 3-(α-acetoneylbenzyl)-4-hydroxycoumarin (WF), and finally the corresponding target impurities WF-Z1-WF-Z6 were synthesized by reaction with methanol, ethanol or isopropanol under acidic conditions. Results: The chemical structure of these impurities were identified by LCMS, ¹H NMR, ¹³C NMR. Conclusion: The synthesized impurities can be used as a reference material for the quality control of warfarin sodium and moreover, the starting materials used in this synthetic route are cheap and easy to obtain and it is expected to be used in industrial production.

Objective: To analyze the effect of blended teaching mode based on flipped classroom in the undergraduate courses of orthopedics. Methods: Twenty-four “eight-year” students and 25 “4+4” students in clinical medicine who participated in orthopedics courses were selected as the study subjects, in which “eight-year” students received traditional teaching (as a control group) and the “4+4” students received blended teaching mode based on flipped classroom (as the observation group). The total score, theory test score, internship test score and students’ satisfaction rate were compared between the two groups. Results: The total score of the observation group was higher than that of the control group, but there were no statistical differences. There were also no statistical differences between the two groups in theory scores and internship test score. The overall satisfaction rate of the students was comparable in the two groups, but the “very satisfied” rate in the observation group was significantly higher than that in the control group (P=0.03). Conclusion: The application of the blended teaching mode based on flipped classroom in the undergraduate teaching of orthopedics can improve students’ learning effect, cultivate their independent learning ability, and be recognized by both students and teachers.

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.

Clinical studies can only be conducted with the methodological support of epidemiology. Epidemiology is based on multidisciplinary medical knowledge, using observation and questioning to investigate the disease and health status of social populations, describing the frequency and distribution of diseases, proposing etiological hypotheses through generalization, synthesis and analysis, and then applying analytical studies to verify the established etiological hypotheses, and finally confirming them further through experimental studies. Descriptive study, also known as descriptive epidemiological research, refers to a realistic portrayal and narrative treatment of the distribution of a disease or health condition using specialized survey data or existing information grouped according to different regions and time or population characteristics. Descriptive study is the most basic step in revealing the causal relationship of diseases. By analyzing and comparing the possible causes leading to the differences in the distribution of diseases or health conditions, it can propose the direction of further research or the conception of preventive and control strategies, and lay the foundation for the subsequent development of analytical research or experimental research. This article begins with the categorization of descriptive clinical studies, introduces the concepts of case reports, case series studies, current studies, longitudinal studies, ecological studies, and screening tests, and focuses on the key points of the design and implementation of prevalence studies, so as to provide researchers with reference for conducting descriptive clinical studies.

Objective: An inductively coupled plasma mass spectrometer (ICP-MS) was developed for simultaneous determination of 24 elements in normal saline as required by ICH Q3D. Methods: Using mixed acid solution as solvent system, according to the maximum daily dose of the product and the allowable daily exposure of elements (PDE), an ICP-MS method was established for the determination of Cd, Pb, As, Hg, Co, V, Ni, Tl, Au, Pd, Ir, Os, Rh, Ru, Se, Ag, Pt, Li, Sb, Ba, Mo, Cu, Sn, Cr in normal saline. Results: The linear relationships of the calibration curves were good in the range of 0.2-100 mg/L with recoveries 72.0%-118.6%. Conclusion: The method was simple and reliable and has good sensitivity, accuracy and precision, and can meet the requirements of the determination of various elements in sodium chloride injection.

The gut-brain axis and gut microbiota play an important role in maintaining homeostasis and the bidirectional communication between the gut and the brain, respectively. Therefore, scholars established the concept of a gut microbiota-gut-brain axis. Gut microbiota may affect the host through neural, immune, neuroendocrine, and metabolic pathways, including nerve development, transmission and behavior, and participates in the occurrence and development of a variety of neuropsychiatric diseases. In this review, we discussed the interaction among gut microbiota, gut and brain, the role of gut microbiota-gut-brain axis in the occurrence and development of neuropsychiatric diseases including depression, anxiety, autism spectrum disorders, Alzheimer’s disease, Parkinson’s disease and irritable bowel syndrome, and the intervention strategy of gut-brain axis with gut microbiota as therapeutic target for neuropsychiatric diseases based on the current research progress at home and abroad and the clinical experience of the center, so as to provide some new ideas and methods for the treatment of neuropsychiatric diseases.

Objective: To observe the effect of the community comprehensive intervention to promote glycaemic control of the elderly patients with diabetes after medical compliance. Methods: The elderly patients with diabetes in several residential communities under the jurisdiction of petrochemical community were selected, and 30 patients were recruited according to different age groups(60-69 years old, 70-79 years old, and 80 years old above), respectively and the patients who actively cooperated with this study were a total of 90 ones. All patients received a 9-month community comprehensive intervention (strengthening health education; reasonable diet and control energy intake; medication on time and in quantity; exercise training, weight control; psychological care; strengthening self-monitoring). The self-made questionnaires were used to conduct the survey, including disease cognition, life behavior, medication use, monitoring blood glucose frequency, quality of life evaluation, etc. Results: All patients had significant improvements in blood glucose monitoring on time, good lifestyle habits, good medication compliance, and correct blood glucose monitoring compared with intervention before(P<0.05); the quality of life satisfaction of patients in the 60-69 year old group was significantly higher than that in the group over 80 years old(70.0% P<0.05); the FBG, PBG and HbAlc of patients in the 60-69 and 70-79 years old groups were significantly improved compared with those before intervention(P<0.05); the PBG in the patients over 80 years old group was significantly improved after intervention compared with that before intervention(P<0.05); the FBG compliance rate after intervention was significantly higher than that before intervention(P<0.05). Conclusion: Community comprehensive intervention can improve patients’ self-management, compliance behavior, and glycaemic control.

Objective: To study the common problems in the review and supplement of the filing data of the validity period and storage conditions of the listed chemical drugs in Hubei Province, and to provide references for the drug marketing authorization holders (MAH) to change the validity period and storage conditions of the products and improve the product quality. Methods: Taking the change record data submitted by the MAH of listed chemical drugs through the drug business application system of the National Medical Products Administration as the research object, the common problems in the review and supplement of the record data were analyzed and summarized by the method of summary and induction. Results: The integrity of the record data of the change of validity period and storage conditions of the MAH, the rationality of the change reasons, the formulation of the stability test plan, the selection of test conditions, the inspection indicator, the data integrity and other aspects of the deficiencies and problems still exist. Conclusion: MAH should study the new regulations and guiding principles in depth, strengthen communication with review regulators, accurately capture the requirements for post-listing filing data changes, and effectively fulfil their own responsibilities to ensure the truthfulness, completeness and traceability of the filing data.

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.

Depression is the most common mental disorder characterized by persistent and significant low mood state. In China, the incidence of depression is increasing year by year. This article reviews and summarizes the research focus on the correlation between unsaturated fatty acids and depression at home and abroad in recent years. Studies have shown that the lower serum polyunsaturated fatty acids (mainly omega-3 fatty acids) are associated with the severity of depressive symptoms, and the higher level of serum polyunsaturated fatty acids is associated with the lower incidence of depression and the lower scores of depressive symptom. Monounsaturated fatty acids (omega-9 fatty acids) seem to have no correlation with depression. Lower omega-6/omega-3 fatty acids ratio may predict a better prognosis. Serum polyunsaturated fatty acid levels may be used as reference for predicting the incidence of depression and the severity of depressive symptoms.

Bronchial asthma (asthma) is a chronic inflammatory airway disease mediated by various immune cells, of which type 2 asthma is the main phenotype of asthma. The traditional drugs for asthma include glucocorticoids, β₂ receptor agonists, leukotriene receptor antagonists and so on. However, some patients with severe asthma do not respond well to these drugs or cannot use them for a long time due to adverse effects. The research and development of the targeted drugs for type 2 inflammation has achieved great success in recent years. This review aimed to briefly introduce the research progress of targeted drugs for the treatment of asthma.