OBJECTIVE: To evaluate the immediate effect of Kuanxiong Aerosol (KXA) on perioperative coronary microcirculation in patients with unstable angina (UA) suffering from elective percutaneous coronary intervention (PCI). METHODS: From February 2021 to July 2023, UA inpatients who underwent PCI alone in the left anterior descending (LAD) branch were included. Random numbers were generated to divide patients into the trial group and the control group at a ratio of 1:1. The index of coronary microcirculation resistance (IMR) was measured before PCI, and the trial group was given two sprays of KXA, while the control group was not given. IMR was measured again after PCI, cardiac troponin I (cTnI) and creatine kinase isoenzyme-MB (CK-MB) were detected before and 24 h after surgery, and major cardiovascular adverse events (MACEs) were recorded for 30 days. The data statistics and analysis personnel were blinded. RESULTS: Totally 859 patients were screened, and 62 of them were involved into this study. Finally, 1 patient in the trial group failed to complete the post-PCI IMR and was excluded, 30 patients were included for data analysis, while 31 patients in the control group were enrolled in data analysis. There was no significant difference in baseline data (age, gender, risk factors, previous history, biochemical index, and drug therapy, etc.) between the two groups. In addition, differences in IMR, cTnI and CK-MB were not statistically significant between the two groups before surgery. After PCI, the IMR level of the trial group was significantly lower than that of the control group (19.56 ± 14.37 vs. 27.15 ± 15.03, P=0.048). Besides, the incidence of perioperative myocardial injury (PMI) was lower in the trial group, but the difference was not statistically significant (6.67% vs. 16.13%, P=0.425). No MACEs were reported in either group. CONCLUSIONS KXA has the potential of improving coronary microvascular dysfunction. This study provides reference for the application of KXA in UA patients undergoing elective PCI. (Registration No. ChiCTR2300069831).
Humans ; Percutaneous Coronary Intervention ; Male ; Microcirculation/drug effects* ; Female ; Angina, Unstable/physiopathology* ; Pilot Projects ; Middle Aged ; Aged ; Drugs, Chinese Herbal/pharmacology* ; Aerosols ; Troponin I/blood* ; Coronary Circulation/drug effects* ; Elective Surgical Procedures

Objective:To summarize the drug resistance characteristics of clinical pathogen isolates in a tuberculosis specialized hospital from 2017 to 2023，and understand the distribution characterisitics of pathogens and their resistance to antimicrobial agents.Methods:The isolates from January 2017 to December 2023 were identified and subjected to drug susceptibility tests using the VITEK 2-compact system. The susceptibilities of the isolates to antimicrobial agents were determined by the minimum inhibitory concentration（MIC）methods according to the CLSI（2023）guideline. The data of detection of different kinds of bacteria，specimen distribution and the detection rates of major drug-resistant gram-negative bacteria in hospital antimicrobial resistance were analyzed. Chi square test were performed to analyze one or more sets of data related to detection rate or drug resistance rate by SPSS 17.0.Results:A total of 9 993 isolates were detected，among which 9 079（90.9%）were gram-negative bacteria and 914（9.1%）were gram-positive bacteria. From 2017 to 2022，among all gram-negative isolates，the top three most frequently isolated pathogens were Klebsiella pneumonia，followed by Pseudomonas aeruginosa and Acinetobacter baumannii. The overall resistance rates to carbapenems in Acinetobacter baumannii， Pseudomonas aeruginosa， Klebsiella pneumonia，and Escherichia coli were 43.7%（495/1 133），19.4%（276/1 423），8.4%（279/3 304），3.6%（19/521），respectively. The overall detection rates of ceftriaxone/ciprofloxacin-resistant Klebsiella pneumonia（CTX/CRO-R-KPN），or Escherichia coli（CTX/CRO-R-ECO），and quinolone-resistant Escherichia coli（QNR-ECO）were 19.5%（644/3 304），57.6%（300/521），77.4%（403/521），respectively. The difference in resistance rates between imipenem-resistant and imipenem-susceptible Klebsiella pneumoniae was statistically significant（ P<0.05）. Except for CTX/CRO-R-ECO（ χ2=7.9 ，P>0.05），significant differences were observed in the detection rates of other major drug-resistant gram-negative bacteria in hospital（ P<0.05）. The detection of some drug-resistant strains showed an upward trend in recent years. Carbapenem-resistant Acinetobacter baumannii， Pseudomonas aeruginosa，and Escherichia coli exhibited higher resistance rate to other antibiotics. Conclusions:The detection rates of major drug-resistant gram-negative bacteria have increased in the past two years. Carbapenem-resistant strains exhibit relatively high resistance rate to cephalosporin and quinolone antibiotics. Although carbapenem antibiotics remain effective against Enterobacteriaceae，strengthened antimicrobial resistance monitoring and control of multidrug-resistant bacteria spread are necessary.

Objective:To investigate the effect of acellular dermal matrix (ADM) combined with hydroconductive dressing (HD) on wound healing of diabetic foot.Methods:In this study, 141 admitted patients with diabetic foot from Jun 2022 to Jun 2024 were randomly divided into three groups: control group, ADM group and ADM+HD group. The clinical data of all patients were collected and the differences of each index were compared.Results:There were 47 cases in each group. After 4 weeks of treatment, there were significant differences in wound area and VAS score among the three groups ( P<0.05). The number of ADM replacement in ADM+HD group was less and the incidence of adverse reactions was lower than that in ADM group ( P<0.05). Conclusion:ADM combined with HD has significant advantages in accelerating wound healing, relieving pain, reducing the number of dressing changes and reducing the incidence of infection.

Bone grafting is a primary method for treating bone defects. Among various graft materials, xenogeneic bone substitutes are widely used in clinical practice due to their abundant sources, convenient processing and storage, and avoidance of secondary surgeries. With the advancement of domestic production and the limitations of imported products, an increasing number of bone filling or grafting substitute materials isentering clinical trials. Relevant experts have drafted this consensus to enhance the management of medical device clinical trials, protect the rights of participants, and ensure the scientific and effective execution of trials. It summarizes clinical experience in aspects, such as design principles, participant inclusion/exclusion criteria, observation periods, efficacy evaluation metrics, safety assessment indicators, and quality control, to provide guidance for professionals in the field.
Humans ; Bone Substitutes/therapeutic use* ; Randomized Controlled Trials as Topic/methods* ; Consensus ; Bone Transplantation ; Research Design

Objective:To evaluate the efficacy and safety of nebulized inhalation of recombinant human interferon (IFN) α1b injection in the treatment of respiratory syncytial virus (RSV) associated lower respiratory tract infections (pneumonia and bronchiolitis) in children.Methods:A randomized, double-blind, parallel, placebo-controlled add-on design was used.Children with pneumonia or bronchiolitis aged 2 months to 5 years who tested positive for RSV antigen within 72 hours of onset from 30 clinical trial sites including Beijing Children′s Hospital, Capital Medical University between February 2021 and December 2022 were included in this study and randomly divided into 2 groups at a ratio of 1∶1 based on a stratified-block method.Both groups received basic treatments such as cough control, asthma relieving, expectorant treatment, fever reduction, oxygen therapy, etc.The experimental group received additional nebulized inhalation of IFN α1b injection at a dose of 2.0 μg/(kg·time), twice a day.The control group received nebulized inhalation of placebo twice a day.Clinical efficacy was evaluated based on indicators such as the duration of clinical symptoms and signs, and the Kaplan-Meier method was used to calculate the median and 95% CI of the duration of clinical symptoms and signs.The Log-rank test was used to compared data between groups.Safety was assessed through the incidence of adverse reactions and laboratory tests, and the Chi-square test was used to analyze the difference between groups. Results:There were 123 children in the experimental group and 122 children in the control group.The median durations of all the 5 clinical symptoms and signs [including shortness of breath, wheezing, dyspnea (visible retractions), decreased transcutaneous oxygen saturation, and abnormal mental state] in the experimental group after treatment were slightly shortened than those in the control group [2.7 d(95% CI: 1.9-3.0 d)] vs.[2.9 d(95% CI: 2.6-3.6 d), P=0.027].The improvement in dyspnea (retractions) was especially pronounced in the experimental group, with a relief rate of 50.0% (0, 100%) on the first day of administration[compared with 0 (0, 50.0%) in the control group ( Z=2.002, P=0.025)].The median duration of dyspnea in the experimental group was nearly 1 day shorter than that in the control group [1.0 d(95% CI: 0.7-1.7 d) vs.1.8 d(95% CI: 1.0-2.5 d), P=0.046].There were no significant difference in hospital stay [6.0(5.0, 8.0) d vs.6.5(5.0, 8.0) d, Z=0.675, P=0.500], oxygen therapy duration [32.0(14.0, 96.3) h vs.39.0 (24.0, 83.2) h, Z=0.094, P=0.925], the recovery rate from clinical symptoms during treatment [(105/106, 99.1%) vs.(96/101, 95.0%)], and recurrence rate [(0/106, 0) vs.(2/101, 2.0%)] between the 2 groups (all P>0.05).However, the above-mentioned four indicators in the experimental group showed a trend of clinical benefits.The quantitative virus detection results showed that the RSV viral load in both groups decreased after treatment compared to before treatment.After 2 days of treatment, the decline rate of RSV viral load from the baseline was 0.90 lg copies/(mL·d) in the experimental group and 0.25 lg copies/(mL·d)in the control group, with a statistically significant difference ( P<0.05).Furthermore, there was no statistically significant difference in the incidence of adverse reactions between the 2 groups ( P>0.05).Importantly, no drug-related serious adverse reactions occurred in both groups. Conclusions:The nebulized inhalation therapy of IFN α1b demonstrates efficacy and safety in treating pediatric RSV associated lower respiratory tract infections.It particularly offers outstanding clinical therapeutic value for severe children.

Objective:To develop a self-efficacy scale of milk donation and test its reliability and validity, in order to provide a scientific evaluation tool for the corresponding study.Methods:According to Bandura′s self-efficacy theory and consensus-based standards for the selection of health measurement instruments, the scale was developed by means of literature search, article pool establishment and expert letter consultation. A pre-survey was conducted on 30 newborn bereaved women, a formal investigation was conducted on 231 newborn bereaved women, and 115 newborn bereaved women were selected for exploratory factor analysis. Confirmatory factor analysis was performed on 116 parturients with neonatal loss to determine the reliability and validity of the scale.Results:The final scale includes 3 dimensions and 13 items. Three common factors were extracted by exploratory factor analysis, and the cumulative variance contribution rate was 77.962%. A scale with three dimensions, included breast milk donation resilience, breast milk donation cognition and breast milk donation motivation, and 13 items was determined. Confirmatory factor analysis showed that the model fit of the scale was good ( χ2/ df = 1.390, RMSEA = 0.063, RMR = 0.046, NFI = 0.924, NNFI = 0.971, GFI = 0.924, CFI = 0.977). The content validity index was 0.835. Cronbach′s α coefficient of the total volume table was 0.919, and the coefficients of each dimension were 0.892, 0.905 and 0.844, respectively. The broken half reliability of the scale was 0.893, and the broken half reliability of each dimension was 0.857, 0.881 and 0.711, respectively. The retest reliability of the scale was 0.814, and the retest reliability of each dimension was 0.803, 0.825 and 0.767, respectively. Conclusions:The scale has good reliability and validity, and can be used to evaluate the self-efficacy of milk donation in lost newborns.

Objective:To develop a self-efficacy scale of milk donation and test its reliability and validity, in order to provide a scientific evaluation tool for the corresponding study.Methods:According to Bandura′s self-efficacy theory and consensus-based standards for the selection of health measurement instruments, the scale was developed by means of literature search, article pool establishment and expert letter consultation. A pre-survey was conducted on 30 newborn bereaved women, a formal investigation was conducted on 231 newborn bereaved women, and 115 newborn bereaved women were selected for exploratory factor analysis. Confirmatory factor analysis was performed on 116 parturients with neonatal loss to determine the reliability and validity of the scale.Results:The final scale includes 3 dimensions and 13 items. Three common factors were extracted by exploratory factor analysis, and the cumulative variance contribution rate was 77.962%. A scale with three dimensions, included breast milk donation resilience, breast milk donation cognition and breast milk donation motivation, and 13 items was determined. Confirmatory factor analysis showed that the model fit of the scale was good ( χ2/ df = 1.390, RMSEA = 0.063, RMR = 0.046, NFI = 0.924, NNFI = 0.971, GFI = 0.924, CFI = 0.977). The content validity index was 0.835. Cronbach′s α coefficient of the total volume table was 0.919, and the coefficients of each dimension were 0.892, 0.905 and 0.844, respectively. The broken half reliability of the scale was 0.893, and the broken half reliability of each dimension was 0.857, 0.881 and 0.711, respectively. The retest reliability of the scale was 0.814, and the retest reliability of each dimension was 0.803, 0.825 and 0.767, respectively. Conclusions:The scale has good reliability and validity, and can be used to evaluate the self-efficacy of milk donation in lost newborns.

Objective:To evaluate the efficacy and safety of nebulized inhalation of recombinant human interferon (IFN) α1b injection in the treatment of respiratory syncytial virus (RSV) associated lower respiratory tract infections (pneumonia and bronchiolitis) in children.Methods:A randomized, double-blind, parallel, placebo-controlled add-on design was used.Children with pneumonia or bronchiolitis aged 2 months to 5 years who tested positive for RSV antigen within 72 hours of onset from 30 clinical trial sites including Beijing Children′s Hospital, Capital Medical University between February 2021 and December 2022 were included in this study and randomly divided into 2 groups at a ratio of 1∶1 based on a stratified-block method.Both groups received basic treatments such as cough control, asthma relieving, expectorant treatment, fever reduction, oxygen therapy, etc.The experimental group received additional nebulized inhalation of IFN α1b injection at a dose of 2.0 μg/(kg·time), twice a day.The control group received nebulized inhalation of placebo twice a day.Clinical efficacy was evaluated based on indicators such as the duration of clinical symptoms and signs, and the Kaplan-Meier method was used to calculate the median and 95% CI of the duration of clinical symptoms and signs.The Log-rank test was used to compared data between groups.Safety was assessed through the incidence of adverse reactions and laboratory tests, and the Chi-square test was used to analyze the difference between groups. Results:There were 123 children in the experimental group and 122 children in the control group.The median durations of all the 5 clinical symptoms and signs [including shortness of breath, wheezing, dyspnea (visible retractions), decreased transcutaneous oxygen saturation, and abnormal mental state] in the experimental group after treatment were slightly shortened than those in the control group [2.7 d(95% CI: 1.9-3.0 d)] vs.[2.9 d(95% CI: 2.6-3.6 d), P=0.027].The improvement in dyspnea (retractions) was especially pronounced in the experimental group, with a relief rate of 50.0% (0, 100%) on the first day of administration[compared with 0 (0, 50.0%) in the control group ( Z=2.002, P=0.025)].The median duration of dyspnea in the experimental group was nearly 1 day shorter than that in the control group [1.0 d(95% CI: 0.7-1.7 d) vs.1.8 d(95% CI: 1.0-2.5 d), P=0.046].There were no significant difference in hospital stay [6.0(5.0, 8.0) d vs.6.5(5.0, 8.0) d, Z=0.675, P=0.500], oxygen therapy duration [32.0(14.0, 96.3) h vs.39.0 (24.0, 83.2) h, Z=0.094, P=0.925], the recovery rate from clinical symptoms during treatment [(105/106, 99.1%) vs.(96/101, 95.0%)], and recurrence rate [(0/106, 0) vs.(2/101, 2.0%)] between the 2 groups (all P>0.05).However, the above-mentioned four indicators in the experimental group showed a trend of clinical benefits.The quantitative virus detection results showed that the RSV viral load in both groups decreased after treatment compared to before treatment.After 2 days of treatment, the decline rate of RSV viral load from the baseline was 0.90 lg copies/(mL·d) in the experimental group and 0.25 lg copies/(mL·d)in the control group, with a statistically significant difference ( P<0.05).Furthermore, there was no statistically significant difference in the incidence of adverse reactions between the 2 groups ( P>0.05).Importantly, no drug-related serious adverse reactions occurred in both groups. Conclusions:The nebulized inhalation therapy of IFN α1b demonstrates efficacy and safety in treating pediatric RSV associated lower respiratory tract infections.It particularly offers outstanding clinical therapeutic value for severe children.

Objective:To summarize the drug resistance characteristics of clinical pathogen isolates in a tuberculosis specialized hospital from 2017 to 2023，and understand the distribution characterisitics of pathogens and their resistance to antimicrobial agents.Methods:The isolates from January 2017 to December 2023 were identified and subjected to drug susceptibility tests using the VITEK 2-compact system. The susceptibilities of the isolates to antimicrobial agents were determined by the minimum inhibitory concentration（MIC）methods according to the CLSI（2023）guideline. The data of detection of different kinds of bacteria，specimen distribution and the detection rates of major drug-resistant gram-negative bacteria in hospital antimicrobial resistance were analyzed. Chi square test were performed to analyze one or more sets of data related to detection rate or drug resistance rate by SPSS 17.0.Results:A total of 9 993 isolates were detected，among which 9 079（90.9%）were gram-negative bacteria and 914（9.1%）were gram-positive bacteria. From 2017 to 2022，among all gram-negative isolates，the top three most frequently isolated pathogens were Klebsiella pneumonia，followed by Pseudomonas aeruginosa and Acinetobacter baumannii. The overall resistance rates to carbapenems in Acinetobacter baumannii， Pseudomonas aeruginosa， Klebsiella pneumonia，and Escherichia coli were 43.7%（495/1 133），19.4%（276/1 423），8.4%（279/3 304），3.6%（19/521），respectively. The overall detection rates of ceftriaxone/ciprofloxacin-resistant Klebsiella pneumonia（CTX/CRO-R-KPN），or Escherichia coli（CTX/CRO-R-ECO），and quinolone-resistant Escherichia coli（QNR-ECO）were 19.5%（644/3 304），57.6%（300/521），77.4%（403/521），respectively. The difference in resistance rates between imipenem-resistant and imipenem-susceptible Klebsiella pneumoniae was statistically significant（ P<0.05）. Except for CTX/CRO-R-ECO（ χ2=7.9 ，P>0.05），significant differences were observed in the detection rates of other major drug-resistant gram-negative bacteria in hospital（ P<0.05）. The detection of some drug-resistant strains showed an upward trend in recent years. Carbapenem-resistant Acinetobacter baumannii， Pseudomonas aeruginosa，and Escherichia coli exhibited higher resistance rate to other antibiotics. Conclusions:The detection rates of major drug-resistant gram-negative bacteria have increased in the past two years. Carbapenem-resistant strains exhibit relatively high resistance rate to cephalosporin and quinolone antibiotics. Although carbapenem antibiotics remain effective against Enterobacteriaceae，strengthened antimicrobial resistance monitoring and control of multidrug-resistant bacteria spread are necessary.

Objective:To investigate the effect of acellular dermal matrix (ADM) combined with hydroconductive dressing (HD) on wound healing of diabetic foot.Methods:In this study, 141 admitted patients with diabetic foot from Jun 2022 to Jun 2024 were randomly divided into three groups: control group, ADM group and ADM+HD group. The clinical data of all patients were collected and the differences of each index were compared.Results:There were 47 cases in each group. After 4 weeks of treatment, there were significant differences in wound area and VAS score among the three groups ( P<0.05). The number of ADM replacement in ADM+HD group was less and the incidence of adverse reactions was lower than that in ADM group ( P<0.05). Conclusion:ADM combined with HD has significant advantages in accelerating wound healing, relieving pain, reducing the number of dressing changes and reducing the incidence of infection.