OBJECTIVE To sort out the evaluation mechanism and methodology of published cases of comprehensive clinical evaluation of drugs in China， and provide a reference for promoting standardized comprehensive clinical evaluation of drugs and strengthening policy transformation in China. METHODS Clinical comprehensive evaluation cases of drugs published in China from CNKI， Wanfang Data， PubMed and Web of Science were systematically searched， and the retrieval time was from the inception to December 31st， 2023. The summary and analysis were performed from the aspects of theme selection， indicator system construction， evaluation methods， comprehensive decision-making， quality control， etc. RESULTS A total of 143 pieces of literature were ultimately included from 2014 to 2023. The number of publications has shown a rapid upward trend since 2019. The subjects of the evaluation cases were mainly pediatric drugs， Chinese patent medicines， cardiovascular drugs and anti-tumor drugs. The evaluation dimensions were between 3-8， all involving safety and effectiveness dimensions. Most cases adopted rapid evaluation methods based on literature review and expert interviews/questionnaire surveys with less emphasis on real-world research. Most cases did not involve comprehensive decision-making， quality control， or policy transformation. CONCLUSIONS The clinical comprehensive evaluation of drugs in China has made rapid progress under the guidance of national policies. However， there are still issues and challenges such as incomplete evaluation methods and standards， few cases of evaluation results being converted into decision-making， and a lack of quality control mechanisms. It is suggested that standardized evaluation paths and quality control mechanisms should be explored； when the evidence-based basis is insufficient， real-world research should be conducted as much as possible， so as to accelerate the policy transformation of evaluation results.

OBJECTIVE To sort out the evaluation mechanism and methodology of published cases of comprehensive clinical evaluation of drugs in China， and provide a reference for promoting standardized comprehensive clinical evaluation of drugs and strengthening policy transformation in China. METHODS Clinical comprehensive evaluation cases of drugs published in China from CNKI， Wanfang Data， PubMed and Web of Science were systematically searched， and the retrieval time was from the inception to December 31st， 2023. The summary and analysis were performed from the aspects of theme selection， indicator system construction， evaluation methods， comprehensive decision-making， quality control， etc. RESULTS A total of 143 pieces of literature were ultimately included from 2014 to 2023. The number of publications has shown a rapid upward trend since 2019. The subjects of the evaluation cases were mainly pediatric drugs， Chinese patent medicines， cardiovascular drugs and anti-tumor drugs. The evaluation dimensions were between 3-8， all involving safety and effectiveness dimensions. Most cases adopted rapid evaluation methods based on literature review and expert interviews/questionnaire surveys with less emphasis on real-world research. Most cases did not involve comprehensive decision-making， quality control， or policy transformation. CONCLUSIONS The clinical comprehensive evaluation of drugs in China has made rapid progress under the guidance of national policies. However， there are still issues and challenges such as incomplete evaluation methods and standards， few cases of evaluation results being converted into decision-making， and a lack of quality control mechanisms. It is suggested that standardized evaluation paths and quality control mechanisms should be explored； when the evidence-based basis is insufficient， real-world research should be conducted as much as possible， so as to accelerate the policy transformation of evaluation results.

Background Air pollution and meteorological factors exert complex nonlinear effects on acute symptoms in the population, with intricate interactions among these factors. Traditional statistical methods struggle to simultaneously address complex nonlinear relationships and multicollinearity issues. Objective To delineate the dynamic effects of air pollutants and meteorological parameters on acute symptoms in three distinct populations with the multicollinearity being addressed and to generate reliable scientific evidence for prevention and control of health risk factors. Methods A time-series study design was employed to collect data on air pollution (daily mean temperature, daily precipitation, daily mean relative humidity, and daily mean wind speed), meteorological factors [Air Quality Index (AQI), fine particulate matter (PM_2.5), inhalable particulate matter (PM₁₀), sulfur dioxide (SO₂), nitrogen dioxide (NO₂), carbon monoxide (CO), and 8-hour maximum ozone (O₃)], and acute symptoms such as fever, cough, and sore throat in Jinan from June to December 2023. Key variables were selected using least absolute shrinkage and selection operator (LASSO) regression, followed by generalized additive mixed modeling (GAMM) to analyze the health effects of combined environmental exposures to air pollution and meteorological factors. Linear variables were modeled using linear mixed-effects function, nonlinear variables were smoothed using thin-plate regression splines, and variables with interaction effects were smoothed using low-rank scale-invariant tensor product splines. Fluctuations in independent variables following a normal distribution were treated as sampling errors and incorporated as random effects in the GAMM. Results For fever, the daily mean temperature, daily mean relative humidity, daily mean wind speed, and ambient SO₂ were statistically significant (P<0.05), with daily mean wind speed being a linear influencing factor. When the daily mean temperature was below 3 °C, each 10 °C increase corresponded to a relative risk (RR) of 2.64 (95%CI: 2.50, 2.79). When the daily mean temperature was ≥3 °C, each 10 °C increase corresponded to an RR of 0.86 (95%CI: 0.83, 0.89). Each 10% increase in daily mean relative humidity was associated with an RR of 0.93 (95%CI: 0.89, 0.97). Each 1 m·s⁻¹ increase in daily mean wind speed corresponded to an RR of 1.06 (95%CI: 1.02, 1.10). Within the concentration ranges of <10 μg·m⁻³, 10–<12.5 μg·m⁻³, and ≥12.5 μg·m⁻³, each 1 μg·m⁻³ increase in ambient SO₂ corresponded to RR values of 1.01 (95%CI: 0.98, 1.05), 1.21 (95%CI: 1.17, 1.24), and 0.97 (95%CI: 0.94, 0.99), respectively. For cough, the daily mean temperature, daily mean relative humidity, PM₁₀, and SO₂ were statistically significant (P<0.001), with PM₁₀ being a linear influencing factor. When the daily mean temperature was below 1 °C, each 10 °C increase corresponded to an RR of 1.47 (95%CI: 1.42, 1.52). When the daily mean temperature was ≥1 °C, each 10 °C increase corresponded to an RR of 0.85 (95%CI: 0.82, 0.87). Each 10% increase in daily mean relative humidity was associated with an RR of 0.95 (95%CI: 0.92, 0.98). Each 50 μg·m⁻³ increase in PM₁₀ concentration corresponded to an RR of 1.05 (95%CI: 1.02, 1.08). Within the concentration ranges of <10 μg·m⁻³, 10–<12.5 μg·m⁻³, and ≥ 12.5 μg·m⁻³, each 1 μg·m⁻³ increase in ambient SO₂ corresponded to RR values of 1.00 (95%CI: 0.97, 1.03), 1.12 (95%CI: 1.09, 1.16), and 0.98 (95%CI: 0.95, 1.00), respectively. For sore throat, the daily mean temperature, daily mean relative humidity, daily mean wind speed, PM₁₀, and SO₂ were statistically significant (P<0.05), with daily mean wind speed and PM₁₀ being linear influencing factors. When the daily mean temperature was below 2 °C, each 10 °C increase corresponded to an RR of 1.82 (95%CI: 1.69, 1.96). When the daily mean temperature was ≥2 °C, each 10 °C increase corresponded to an RR of 0.81 (95%CI: 0.77, 0.87). Each 10% increase in daily mean relative humidity was associated with an RR of 0.94 (95%CI: 0.88, 1.00). Within the concentration ranges of <10 μg·m⁻³, 10–<12.5 μg·m⁻³, and ≥12.5 μg·m⁻³, each 1 μg·m⁻³ increase in ambient SO₂ corresponded to RR values of 1.02 (95%CI: 0.97, 1.08), 1.13 (95%CI: 1.08, 1.19), and 0.98 (95%CI: 0.94, 1.02), respectively. Each 1 m·s⁻¹ increase in daily mean wind speed and each 50 μg·m⁻³ increase in PM₁₀ concentration were associated with RR values of 1.06 (95%CI: 1.00, 1.12) and 1.04 (95%CI: 0.98, 1.10), respectively. An interaction effect was observed between daily mean wind speed and PM₁₀: increasing daily mean wind speed non-linearly reduced the impact of PM₁₀, on sore throat whereas PM₁₀ had no significant effect on wind speed. Conclusion This study, by combining LASSO and GAMM, largely eliminates the multicollinearity among selected variables. It reveals complex non-linear effects and interactions between air pollutants, meteorological factors, and acute symptoms in different population groups in Jinan. The symptoms like fever, cough, and sore throat are non-linearly associated with daily mean temperature and SO₂ concentration, while PM₁₀ and wind speed show a linear relationship or interactive effects. These findings provide a new basis for the precise prevention and control of health risk factors.

OBJECTIVE To explore standardized evaluation process for clinical comprehensive evaluation of blood lipid- regulating drugs and perform rapid assessment of clinical comprehensive evaluation of blood lipid-regulating drugs with different mechanisms so as to provide reference for the drug catalogue selection and rational drug use of medical institutions. METHODS Referring to guidelines and consensus such as the guideline for the management of comprehensive clinical evaluation of drugs， the methods such as literature research， expert interviews， and Delphi expert consultation were used to establish a multi-dimensional and multi-criteria clinical comprehensive evaluation index system and quantitative scoring table for blood lipid-regulating drugs around the two main lines of technical evaluation and policy evaluation. Then 13 blood lipid-regulating drugs with different mechanisms in 21 third-grade class-A medical institutions from five provinces and regions of Northwest China were scored from both technical and policy dimensions to form a comprehensive evaluation result. RESULTS The clinical comprehensive evaluation index system and corresponding rapid evaluation quantitative scoring table were constructed for blood lipid-regulating drugs in the five northwest provinces and regions. The technicalevaluation section included 6 primary indicators， 13 secondary indicators， and 34 tertiary indicators， totaling 110 points. The policy evaluation section included 4 primary indicators and 6 secondary indicators， with a total score of 40 points （30 points for some drugs） and a total score of 150 points （or 140 points）. The scoring results showed that the highest score was atorvastatin， followed by rosuvastatin and simvastatin. CONCLUSIONS Statins are still the cornerstone of drug therapy for patients with dyslipidemia； the rapid evaluation quantitative scoring table constructed in this study is comprehensive， systematic and operable. The evaluation process in this study can provide empirical references for other groups to exploring the standardized path and quality control mechanism of clinical comprehensive evaluation of drugs.

According to a document issued by the General Office of National Health Commission, "one person, one diagnosis, and one room" is required in the process of outpatient consultation. However, the patient will need to go to another room for dressing change after the doctor checks the wound if sticking to the conventional layout of current wound repair specialist outpatient clinic in hospitals and following the regulation of "separation of diagnosis and treatment". To allow a patient walking back and forth with the exposed wounds to different clinics or going to another clinic for dressing change with the original dressing reapplied to the wound is against the regulation of nosocomial infection control and the principle of sterility. To ensure that the layout of the outpatient clinic in the wound repair outpatient department not only conforms to the principle of "one person, one diagnosis, and one room", but also meets the characteristics of the diagnosis and treatment process of chronic wounds, this paper proposes the layout of "large space and small partition" in the wound repair clinic.

Objective:To explore the application value of flexible endoscopy and rigid endoscopy in the clinical examination of chronic sinus tract wounds with different shapes.Methods:A retrospective observational study was conducted. From January 1 to December 23, 2019, a total of 46 patients with chronic sinus tract wounds, who met the inclusion criteria were admitted to the Wound Healing Center of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, including 23 males and 23 females, aged 18-81 (48±21) years. On admission, computer tomography (CT) imaging and three-dimensional reconstruction were performed to examine the shapes of wound sinus tract and classify the wounds, with the lengths of wound sinus tract by CT imaging examination (hereinafter referred to as reference lengths) recorded. The lengths of wound sinus tract were examined and measured by rigid endoscopy and flexible endoscopy. The wounds with and without obviously curved sinus tract were classified into curve group and linear group respectively, and the deviation rates between the lengths of wound sinus tract measured by flexible endoscopy or rigid endoscopy and the reference lengths (hereinafter referred to as deviation rates of lengths) in each group were calculated. The difference between the deviation rates of lengths examined by flexible endoscopy and rigid endoscopy and the differences between the above two and the deviation rate of reference lengths (0) in each group were compared. Data were statistically analyzed with paired sample t test and Wilcoxon signed rank sum test. Results:CT imaging and three-dimensional reconstruction showed that there were 4 types of wound sinus tract, including tubular (36/46), lamellar (4/46), club-mallet (4/46), and irregular (2/46) shape. Tubular wounds were further divided into type I (23/36), type L (4/36), and type Y (9/36). Wounds with type I tubular, lamellar, and club-mallet sinus tract were classified into linear group (31/46), while those with type Y tubular, type L tubular, and irregular sinus tract were classified into curve group (15/46). In linear group, the deviation rates of lengths examined and measured by rigid endoscopy and flexible endoscopy were 0. In curve group, the deviation rate of lengths examined and measured by flexible endoscopy was 0 (0, 0.58%), which was significantly lower than 41.18% (31.68%, 48.41%) examined and measured by rigid endoscopy, Z=-3.408, P<0.01; the deviation rate of lengths examined and measured by rigid endoscopy (40±19)% was significantly higher than the deviation rate of reference lengths ( t=8.343, P<0.01), while the deviation rate of the lengths examined and measured by flexible endoscopy was similar to the deviation rate of reference lengths ( Z=-1.342, P>0.05). Conclusions:Compared with rigid endoscopy, flexible endoscopy can observe the internal characteristics of chronic sinus tract wounds in a wider range in the clinical examination of this kind of wound, especially for the exploration of curved chronic sinus tract wounds. The promotion of this method will be conducive to the diagnosis and treatment of chronic sinus tract wounds.

Objective:To analyze the distribution and drug resistance of wound pathogenic microorganisms in outpatients of wound healing center so as to provide a basis for the standardized construction of wound healing centers.Methods:A retrospective case series study was used to analyzed the data of 365 outpatients treated at Ruijin Hospital, Shanghai Jiaotong University School of Medicine from December 2017 to October 2019. There were 220 males and 145 females, aged (58.8±18.9)years (range, 18-98 years). The patients included 92 first-visit patients and 273 re-visit patients. The culture results (positive rate of pathogenic microorganisms, bacterial species, bacterial distribution) and drug sensitivity results of the wound secretions were compared and analyzed.Results:(1) Among 365 samples of wound secretions, 198 patients were positive for pathogenic microorganisms with a positive rate of 54.3%. A total of 107 strains (51.0%) of Gram-positive bacteria were detected, mainly Staphylococcus aureus (70 strains, 33.3%); 95 strains (45.2%) of Gram-negative bacteria were detected, mainly Escherichia coli (20 strains, 9.5%), followed by Pseudomonas aeruginosa (17 strains, 8.1%); 8 strains (3.8%) of fungi were detected. (2) A total of 26 (28.3%) first-visit patients were positive for pathogenic microorganisms, and 172 (63.0%) re-visit patients were positive for pathogenic microorganisms. The rate of positive microorganism detection had significant differences between first-visit and re-visit patients ( P<0.05). (3) A total of 29 strains were detected in first-visit patients, including 16 strains (55.2%) of Gram-positive bacteria, 11 strains (37.9%) of Gram-negative bacteria and 2 strains (6.9%) of fungi. A total of 181 strains were detected in re-visit patients, including 91 strains (50.3%) of Gram-positive bacteria, 84 strains (46.4%) of Gram-negative bacteria and 6 strains (3.3%) of fungi. The microbial distribution was significantly different between first-visit and re-visit patients ( P<0.05). (4) Compared with first-visit patients, the resistance of Staphylococcus aureus isolated from the re-visit patients to spenicillin, oxacillin, ciprofloxacin, tetracycline, clindamycin, moxifloxacin, erythromycin, and levofloxacin were increased variably. No vancomycin-resistant Staphylococcus aureus was detected, indicating that the staphylococcus aureus presented in the wound was highly sensitive to vancomycin. Conclusions:Staphylococcus aureus is the most common microorganism in wound secretions in outpatients of wound healing center. The rate of positive pathogenic microorganisms in wound secretions of re-visit patients is significantly higher than that of first-visit patients, and the distribution of pathogenic microorganisms of first-visited and revisited patients differs significantly. The Staphylococcus aureus detected in re-visit patients has a higher resistance to common antibiotics compared with first-visit patients. It is suggested that timely detection of pathogenic microorganisms in outpatients and effective control and supervision of outpatient infections are important contents that cannot be ignored in the construction of wound healing center.

Objective To synthesize and identify artificial antigens of lung elastin degradation peptide and for the purpose of preparation of COPD test.Methods The artificial antigens were synthesized by Sulfo-SMCC and KLH.The complete antigens were identified by ultraviolet spectrum and SDS-PAGE.Immunize Balb/c mice was used to prepare antibody.The antiserum activity was evaluated by indirect competitive ELISA.Results The artificial antigens were identified by ultraviolet spectrum and SDS-PAGE. The protein concentration was 1.181 mg/mL.The titer of antiserum was 1∶64 000,and IC50 was 13.7 ng/mL.The antiserum had no cross-reaction with nonsense peptide.Conclusion The artificial antigens were acquired successfully,which had good immunoge-nicity.The results have laid basis for COPD test.

Objective To investigate the expression of apelin and its recoptor (APJ) in myocardium in insulin-resistant CIR rats with myocardial ischemia.Methods Totally 24 male SD rats were randomly divided into three groups:IR group,IR+ischemia group,the control group (n=8 each).Rats in IR and IR+ischemia groups were fed with the high fat diet.Rats in control group were given the basic diet.The rat model of insulin resistance was assessed by fasting blood glucose (FBG),fasting insulin (Fins) and insulin resistance index (HOMA-IR).The rat model of myocardial ischemia was conducted by subcutaneous injection of isoprenaline 1 mg/kg per day in IR+ ischemia group.The other groups were injected an equal volume of saline.The expression levels of apelin and APJ mRNA in myocardium were determined by real-time-PCR.The positive expression of apelin polypeptide was detected by immunochemistry.Results Compared with the control group,the apelin average optical density was increased in IR group and was decreased in IR+ ischemia group [(0.16±0.004) vs.(0.13±0.005),(0.10±0.002) vs.(0.13±0.0050),both P＜0.05].There was a significant difference in apelin average optical density between IR group and IR+ischemia group [(0.16± 0.004) vs.(0.10±0.002),P＜0.05].Compared with the control group,the relative expression of apelin mRNA was increased in IR group [(5.89±0.36) vs.(4.40±0.24),P＜0.05]The relative expression of apelin mRNA was decreased in IR± ischemia group as compared with IR group [(2.66 ± 0.17) vs.(5.89 ± 0.36),P ＜ 0.05].The APJ mRNA relative expression was increased in IR group as compared with control group and was decreased in IR+ ischemia group as compared with IR group [(10.46±1.06) vs.(6.54±0.63),(3.31±0.31) vs.(10.46±1.06),both P＜0.05].Conclusions The expressions of apelin and APJ are inhibited in insulin-resistant rats with myocardial ischemia,which attenuates their protective effects on myocardium.