OBJECTIVE To acquire the real-world incidence of ceftazidime-avibactam sodium(CAZ)-related ad-verse reactions of blood system among a large sample of drug medication patients based on the active monitoring system so as to provide reference for safe clinical use of drugs.METHOD With the help of'Adverse Drug Event Active Surveillance and Assessment System-Ⅱ'(ADE-ASAS-Ⅱ),the use of CAZ of the patients who were hospi-talized in Chinese PLA General Hospital from Jan.1,2020 to Dec.31,2023 were retrospectively and automatical-ly monitored,the patients who were alarmed by system were evaluated by two persons,the incidence rates of CAZ-related thrombocytopenia,hemoglobin decreased and leucopenia were calculated,and the related influencing factors were analyzed.RESULTS Among the 278 case-times(191 cases)of patients who were treated with drugs and were enrolled in the study,there were 3(1.08％)case-times of thrombocytopenia,8(2.88％)case-times of hemoglobin decreased and 19(6.83％)case-times of leucopenia;the total incidence of adverse reactions of blood system was 10.79％.Logistic regression analysis showed that age and duration of drug administration were the in-fluencing factors for the CAZ-related adverse reactions of blood system.CONCLUSIONS It is common for the CAZ-related adverse reactions of blood system.The middle-aged and elderly patients who take drug therapy for a long time period are more likely to have the blood system-related adverse reactions.It is necessary to focus on the monitoring of renal function of the patients and adjust the dosage of administration in a timely manner so as to re-duce the incidence of adverse reactions of the blood system.

Objective To explore the feasibility and corresponding implementation methods of constructing a sample resource bank based on individual-level data of completed clinical trials and using it to construct external controls for drug/device clinical trials.Methods Taking the pre-marketing clinical trial of transcatheter active valve replacement(TAVR)for the treatment of aortic valve stenosis as an example,the individual-level databases of multiple trials were standardized to form a sample bank.The original data of any trial in the sample bank were selected as the experimental group,and the remaining samples were selected as the control group.The potential confounding was handled by using the propensity score matching and stratification methods to clarify the process of constructing external controls based on the sample bank of individual-level data of clinical trials.Results This study included individual-level data of single-group trials of 4 TAVR devices,with a total of 569 subjects(59.2%male).The number of subjects in Trials 1 to 4 was 120,120,163,and 166,respectively.Propensity score matching enabled the matching of 113,117,125,and 147 subjects with comparable or similar characteristics from individual-level data from other trials,respectively,demonstrating a high matching success rate.The PS score distribution plot after stratification showed that the proportions of subjects in the experimental and control groups in strata 1 to 5 in scheme 1 were 4/103,11/103,22/92,32/87,and 51/64,respectively.For all constructed external controlled trials,a certain number of control samples with similar baseline characteristics to the experimental groups were distributed within each propensity score stratum.The results of the simulation test also reflected the potential differences between different devices in the 12-month all-cause mortality rate.Conclusions The sample bank constructed with individual-level data from clinical trials,as a high-quality data source,can serve as a source of external control for single-arm trials in the same field,and as a useful supplement to the external control scenario of real-world evidence to support drug and device development.At the same time,targeted research on research methods and bias control measures in related fields is also needed.

Objective To explore the characteristic changes in white matter microstructure in Parkinson's disease(PD)patients via automated fiber quantification(AFQ)technology,providing a basis for the identification and diagnosis of PD,and to analyze the feasibility of combining the AFQ method with support vector machine(SVM)in the diagnosis of PD.Methods Forty patients with primary PD(PD group)and 20 healthy controls(HC)(HC group)were prospectively selected.The AFQ technology was applied for white matter fiber tract analysis.Statistical analyses were performed using FSL(v6.0)software and SPSS 27.0 software.Independent-sample t-tests were conducted for comparisons between groups in AFQ analysis.The AFQ method was used to analyze the relationship between diffusion tensor imaging(DTI)parameters and Montreal Cognitive Assessment(MoCA)scores.Results(1)The results of AFQ analysis revealed that compared with the HC group,the PD group exhibited significantly lower fractional anisotropy(FA)values in the right cingulum bundle,left cingulum bundle hippocampus,and left uncinate fasciculus,with no differences in the FA values of the remaining 17 fiber tracts.Moreover,PD group demonstrated higher mean diffusivity(MD)values in the left cingulum bundle,left cingulum bundle hippocampus,left inferior frontal occipital fasciculus,left inferior longitudinal fasciculus,left superior longitudinal fasciculus,and left uncinate fasciculus.These differences were statistically significant(P<0.05),while no significant differences were found in the MD values of the remaining 14 fiber tracts.Furthermore,the MD values of the left inferior frontal occipital fasciculus,and left inferior longitudinal fasciculus were negatively correlated with the MoCA scores.(2)The classification results of SVM showed that the best results were achieved when combining the differential nodes of FA and MD as classification features,with an area under the curve(AUC)of 0.922,an accuracy of 84.81%,a sensitivity of 87.50%,and a specificity of 82.05%.Conclusion The DTI parameters in PD patients can serve as potential biomarkers for diagnosis.The AFQ methods provides an effective approach for detecting alterations white matter tract integrity,offering important insights for the identification and diagnosis of PD.The best results are achieved when combining the differential nodes of FA and MD as classification features.

OBJECTIVE To acquire the real-world incidence of ceftazidime-avibactam sodium(CAZ)-related ad-verse reactions of blood system among a large sample of drug medication patients based on the active monitoring system so as to provide reference for safe clinical use of drugs.METHOD With the help of'Adverse Drug Event Active Surveillance and Assessment System-Ⅱ'(ADE-ASAS-Ⅱ),the use of CAZ of the patients who were hospi-talized in Chinese PLA General Hospital from Jan.1,2020 to Dec.31,2023 were retrospectively and automatical-ly monitored,the patients who were alarmed by system were evaluated by two persons,the incidence rates of CAZ-related thrombocytopenia,hemoglobin decreased and leucopenia were calculated,and the related influencing factors were analyzed.RESULTS Among the 278 case-times(191 cases)of patients who were treated with drugs and were enrolled in the study,there were 3(1.08％)case-times of thrombocytopenia,8(2.88％)case-times of hemoglobin decreased and 19(6.83％)case-times of leucopenia;the total incidence of adverse reactions of blood system was 10.79％.Logistic regression analysis showed that age and duration of drug administration were the in-fluencing factors for the CAZ-related adverse reactions of blood system.CONCLUSIONS It is common for the CAZ-related adverse reactions of blood system.The middle-aged and elderly patients who take drug therapy for a long time period are more likely to have the blood system-related adverse reactions.It is necessary to focus on the monitoring of renal function of the patients and adjust the dosage of administration in a timely manner so as to re-duce the incidence of adverse reactions of the blood system.

Fermented traditional Chinese medicine(TCM) has a long history of medicinal use, such as Sojae Semen Praeparatum, Arisaema Cum Bile, Pinelliae Rhizoma Fermentata, red yeast rice, and Jianqu. Fermentation technology was recorded in the earliest TCM work, Shen Nong's Classic of the Materia Medica. Microorganisms are essential components of the fermentation process. However, the contamination of fermented TCM by toxigenic fungi and mycotoxins due to unstandardized fermentation processes seriously affects the quality of TCM and poses a threat to the life and health of consumers. In this paper, the characteristics, microbial composition, and mycotoxin profile of fermented TCM are systematically summarized to provide a theoretical basis for its quality and safety control.
Fermentation ; Mycotoxins/analysis* ; Drugs, Chinese Herbal/analysis* ; Fungi/classification* ; Bacteria/genetics* ; Drug Contamination ; Medicine, Chinese Traditional

Objective:To analyze the therapeutic efficacy and long-term outcomes of wire-assisted dynamic traction with corrective device for congenital nipple inversion.Methods:A retrospective study was conducted on 22 female patients (42 nipples) with congenital nipple inversion treated at the Department of Plastic Surgery, Peking Union Medical College Hospital from January to December 2017. The patients′ age was 18-54 (27.6±1.9) years. All patients underwent wire-assisted dynamic traction correction. Postoperative indicators including numerical rating scale (NRS) pain scores, nipple skin microcirculatory disorders, and traction duration were recorded. Follow-up assessments via telephone interviews were completed by September 20, 2022; mean follow-up time was (63.68±3.73) months. Evaluating questions included nipple retraction, fertility status and breastfeeding outcomes.Results:Pain in the operative area was non-radiating, and the pain level decreased over time. Mean NRS were (5.4±1.5) scores on surgery day, decreasing to (4.4±1.2) scores at postoperative day 1 and (3.3±1.7) scores at day 2. Microcirculatory assessments revealed Grade 0-I (intact skin) in 78.6% (33/42), Grade II (skin ulceration) in 14.3% (6/42), and Grade III (partial necrosis) in 7.1% (3/42) of the nipples, with no Grade IV necrosis observed. Successful device placement was achieved in all cases (42/42), with traction duration ranging 6-15 (9.6±0.6) months. Follow-up data from 12 patients (23 nipples) showed mild retraction in 3 nipples. Three patients subsequently delivered infants and successfully achieved breastfeeding.Conclusion:The wire-assisted dynamic traction method with corrective device demonstrates satisfactory therapeutic outcomes for congenital nipple inversion patients with favorable long-term maintenance and breastfeeding compatibility.

Stem cell treatment may enhance erectile dysfunction (ED) in individuals with cavernous nerve injury (CNI). Nevertheless, no investigations have directly ascertained the implications of varying amounts of human umbilical cord-derived mesenchymal stem cells (HUC-MSCs) on ED. We compare the efficacy of three various doses of HUC-MSCs as a therapeutic strategy for ED. Sprague-Dawley rats (total = 175) were randomly allocated into five groups. A total of 35 rats underwent sham surgery and 140 rats endured bilateral CNI and were treated with vehicles or doses of HUC-MSCs (1 × 10 6 cells, 5 × 10 6 cells, and 1 × 10 7 cells in 0.1 ml, respectively). Penile tissues were harvested for histological analysis on 1 day, 3 days, 7 days, 14 days, 28 days, 60 days, and 90 days postsurgery. It was found that varying dosages of HUC-MSCs enhanced the erectile function of rats with bilateral CNI and ED. Moreover, there was no significant disparity in the effectiveness of various dosages of HUC-MSCs. However, the expression of endothelial markers (rat endothelial cell antigen-1 [RECA-1] and endothelial nitric oxide synthase [eNOS]), smooth muscle markers (alpha smooth muscle actin [α-SMA] and desmin), and neural markers (neurofilament [RECA-1] and neurogenic nitric oxide synthase [nNOS]) increased significantly with prolonged treatment time. Masson's staining demonstrated an increased in the smooth muscle cell (SMC)/collagen ratio. Significant changes were detected in the microstructures of various types of cells. In vivo imaging system (IVIS) analysis showed that at the 1 st day, the HUC-MSCs implanted moved to the site of damage. Additionally, the oxidative stress levels were dramatically reduced in the penises of rats administered with HUC-MSCs.
Male ; Animals ; Erectile Dysfunction/metabolism* ; Rats, Sprague-Dawley ; Mesenchymal Stem Cell Transplantation/methods* ; Rats ; Penis/pathology* ; Humans ; Disease Models, Animal ; Umbilical Cord/cytology* ; Peripheral Nerve Injuries/complications* ; Mesenchymal Stem Cells ; Nitric Oxide Synthase Type III/metabolism* ; Actins/metabolism* ; Nitric Oxide Synthase Type I/metabolism*

OBJECTIVE To understand the clinical characteristics of patients with Mycoplasma pneumoniae(MP)infection,and to explore the related factors of mixed infection,to provide theoretical support for the diag-nosis and treatment of MP infection.METHODS The clinical data of patients diagnosed with MP infection in the 305th hospital of PLA from Dec.2023 to Apr.2024 were collected,and the clinical characteristics of patients in-fected with MP were analyzed.Additionally,the impacts of MP mixed infections with other pathogens on the se-verity of the disease were compared,while the relevant influencing factors of MP mixed with other pathogens were analyzed by the logistic regression model.RESULTS A total of 114 patients with MP infection were collected,both genders had 57 cases(50.00％,respectively),60(52.63％)were adults,73(64.04％)had simple MP infection and 41(35.96％)had mixed infection.The clinical manifestations of MP infection primarily included fever and cough,with most fevers being low to medium intensity.Additionally,the biochemical indexes were predominantly within normal ranges,however,the interleukin 6(IL-6)level was relatively high.The abnormalities of chest X-ray examination accounted for 84.21％of the cases.In mixed infection cases,fever,dizziness,fatigue,headache and muscle pain were more prevalent than single MP infection cases(P＜0.05),and CRP level elevated in the mixed infection group(P=0.001),whereas white blood cell level and lymphocyte count decreased compared to the single MP infection group(P＜0.05).Multivariate logistic regression analysis showed that fever(OR=4.112,95％CI:1.046-16.161)and above 46 years old(OR=8.555,95％CI:1.394-52.493)were the rele-vant influencing factors for MP mixed with other pathogens infection.CONCLUSION Clinical features of MP-infected patients are atypical,but IL-6 levels are relatively high.MP is often mixed with viral infections,and fever and above 46 years old are the risk factors for mixed MP infection.

Objective To explore the feasibility and corresponding implementation methods of constructing a sample resource bank based on individual-level data of completed clinical trials and using it to construct external controls for drug/device clinical trials.Methods Taking the pre-marketing clinical trial of transcatheter active valve replacement(TAVR)for the treatment of aortic valve stenosis as an example,the individual-level databases of multiple trials were standardized to form a sample bank.The original data of any trial in the sample bank were selected as the experimental group,and the remaining samples were selected as the control group.The potential confounding was handled by using the propensity score matching and stratification methods to clarify the process of constructing external controls based on the sample bank of individual-level data of clinical trials.Results This study included individual-level data of single-group trials of 4 TAVR devices,with a total of 569 subjects(59.2%male).The number of subjects in Trials 1 to 4 was 120,120,163,and 166,respectively.Propensity score matching enabled the matching of 113,117,125,and 147 subjects with comparable or similar characteristics from individual-level data from other trials,respectively,demonstrating a high matching success rate.The PS score distribution plot after stratification showed that the proportions of subjects in the experimental and control groups in strata 1 to 5 in scheme 1 were 4/103,11/103,22/92,32/87,and 51/64,respectively.For all constructed external controlled trials,a certain number of control samples with similar baseline characteristics to the experimental groups were distributed within each propensity score stratum.The results of the simulation test also reflected the potential differences between different devices in the 12-month all-cause mortality rate.Conclusions The sample bank constructed with individual-level data from clinical trials,as a high-quality data source,can serve as a source of external control for single-arm trials in the same field,and as a useful supplement to the external control scenario of real-world evidence to support drug and device development.At the same time,targeted research on research methods and bias control measures in related fields is also needed.

Objective To explore the characteristic changes in white matter microstructure in Parkinson's disease(PD)patients via automated fiber quantification(AFQ)technology,providing a basis for the identification and diagnosis of PD,and to analyze the feasibility of combining the AFQ method with support vector machine(SVM)in the diagnosis of PD.Methods Forty patients with primary PD(PD group)and 20 healthy controls(HC)(HC group)were prospectively selected.The AFQ technology was applied for white matter fiber tract analysis.Statistical analyses were performed using FSL(v6.0)software and SPSS 27.0 software.Independent-sample t-tests were conducted for comparisons between groups in AFQ analysis.The AFQ method was used to analyze the relationship between diffusion tensor imaging(DTI)parameters and Montreal Cognitive Assessment(MoCA)scores.Results(1)The results of AFQ analysis revealed that compared with the HC group,the PD group exhibited significantly lower fractional anisotropy(FA)values in the right cingulum bundle,left cingulum bundle hippocampus,and left uncinate fasciculus,with no differences in the FA values of the remaining 17 fiber tracts.Moreover,PD group demonstrated higher mean diffusivity(MD)values in the left cingulum bundle,left cingulum bundle hippocampus,left inferior frontal occipital fasciculus,left inferior longitudinal fasciculus,left superior longitudinal fasciculus,and left uncinate fasciculus.These differences were statistically significant(P<0.05),while no significant differences were found in the MD values of the remaining 14 fiber tracts.Furthermore,the MD values of the left inferior frontal occipital fasciculus,and left inferior longitudinal fasciculus were negatively correlated with the MoCA scores.(2)The classification results of SVM showed that the best results were achieved when combining the differential nodes of FA and MD as classification features,with an area under the curve(AUC)of 0.922,an accuracy of 84.81%,a sensitivity of 87.50%,and a specificity of 82.05%.Conclusion The DTI parameters in PD patients can serve as potential biomarkers for diagnosis.The AFQ methods provides an effective approach for detecting alterations white matter tract integrity,offering important insights for the identification and diagnosis of PD.The best results are achieved when combining the differential nodes of FA and MD as classification features.