1.The effect of body mass index and inferior pulmonary ligament division on the residual lung expansion after right upper lobectomy: A retrospective cohort study in a single center
Guang MU ; Wenhao ZHANG ; Hongchang WANG ; Yan GU ; Chenghao FU ; Wentao XUE ; Shiyuan XIE ; Tong WANG ; Ke WEI ; Yang XIA ; Liang CHEN ; Jun WANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(02):261-266
Objective To analyze the effect of releasing the lower pulmonary ligament on right residual lung expansion after right upper lobe resection under different body mass index (BMI) levels. Methods The clinical data of patients who underwent thoracoscopic right upper lobe resection in the First Affiliated Hospital with Nanjing Medical University from 2021 to 2022 were retrospectively analyzed. Patients were divided into a group A (17 kg/m2<BMI≤23 kg/m2), a group B (23 kg/m2<BMI≤29 kg/m2) and a group C (BMI>29 kg/m2) according to BMI. The presence of residual cavity was judged by chest X-ray at 7-10 days after operation, the degree of compensation change of the right main bronchus angle was measured, and the changes in lung volume were determined by CT three-dimensional reconstruction. Results A total of 157 patients who underwent thoracoscopic right upper lobe resection were included, including 71 males and 86 females, with an average age of (59.7±11.2) years. There were 50 patients in the group A, 75 patients in the group B, and 32 patients in the group C. In the group A, compared with those without releasing the lower pulmonary ligament, patients with releasing had a lower incidence of postoperative residual cavity (P=0.016), greater changes in bronchus angle (P<0.001), and smaller changes in lung volume (P<0.001). In the group B and C, there was no significant effect of releasing the lower pulmonary ligament on postoperative residual cavity, bronchus angle, and lung volume changes (P>0.05). Conclusion For patients with thin and long body shape and low BMI, releasing the lower pulmonary ligament is helpful to promote the expansion of the residual lung after right upper lobe resection and reduce the occurrence of postoperative residual cavity in patients.
2.Severity Assessment Parameters and Diagnostic Technologies of Obstructive Sleep Apnea
Zhuo-Zhi FU ; Ya-Cen WU ; Mei-Xi LI ; Ping-Ping YIN ; Hai-Jun LIN ; Fu ZHANG ; Yu-Xiang YANG
Progress in Biochemistry and Biophysics 2025;52(1):147-161
Obstructive sleep apnea (OSA) is an increasingly widespread sleep-breathing disordered disease, and is an independent risk factor for many high-risk chronic diseases such as hypertension, coronary heart disease, stroke, arrhythmias and diabetes, which is potentially fatal. The key to the prevention and treatment of OSA is early diagnosis and treatment, so the assessment and diagnostic technologies of OSA have become a research hotspot. This paper reviews the research progresses of severity assessment parameters and diagnostic technologies of OSA, and discusses their future development trends. In terms of severity assessment parameters of OSA, apnea hypopnea index (AHI), as the gold standard, together with the percentage of duration of apnea hypopnea (AH%), lowest oxygen saturation (LSpO2), heart rate variability (HRV), oxygen desaturation index (ODI) and the emerging biomarkers, constitute a multi-dimensional evaluation system. Specifically, the AHI, which measures the frequency of sleep respiratory events per hour, does not fully reflect the patients’ overall sleep quality or the extent of their daytime functional impairments. To address this limitation, the AH%, which measures the proportion of the entire sleep cycle affected by apneas and hypopneas, deepens our understanding of the impact on sleep quality. The LSpO2 plays a critical role in highlighting the potential severe hypoxic episodes during sleep, while the HRV offers a different perspective by analyzing the fluctuations in heart rate thereby revealing the activity of the autonomic nervous system. The ODI provides a direct and objective measure of patients’ nocturnal oxygenation stability by calculating the number of desaturation events per hour, and the biomarkers offers novel insights into the diagnosis and management of OSA, and fosters the development of more precise and tailored OSA therapeutic strategies. In terms of diagnostic techniques of OSA, the standardized questionnaire and Epworth sleepiness scale (ESS) is a simple and effective method for preliminary screening of OSA, and the polysomnography (PSG) which is based on recording multiple physiological signals stands for gold standard, but it has limitations of complex operations, high costs and inconvenience. As a convenient alternative, the home sleep apnea testing (HSAT) allows patients to monitor their sleep with simplified equipment in the comfort of their own homes, and the cardiopulmonary coupling (CPC) offers a minimal version that simply analyzes the electrocardiogram (ECG) signals. As an emerging diagnostic technology of OSA, machine learning (ML) and artificial intelligence (AI) adeptly pinpoint respiratory incidents and expose delicate physiological changes, thus casting new light on the diagnostic approach to OSA. In addition, imaging examination utilizes detailed visual representations of the airway’s structure and assists in recognizing structural abnormalities that may result in obstructed airways, while sound monitoring technology records and analyzes snoring and breathing sounds to detect the condition subtly, and thus further expands our medical diagnostic toolkit. As for the future development directions, it can be predicted that interdisciplinary integrated researches, the construction of personalized diagnosis and treatment models, and the popularization of high-tech in clinical applications will become the development trends in the field of OSA evaluation and diagnosis.
3.Research progress on the structural modification of isosteviol and the biological activities of its derivatives
Li-jun ZHAO ; You-fu YANG ; Tong-sheng WANG ; Yan-li ZHANG ; Ya WU
Acta Pharmaceutica Sinica 2025;60(1):22-36
Isosteviol is a tetracyclic diterpenoid compound obtained by hydrolysis of natural stevia glycoside under acidic conditions. It has many pharmacological activities, such as anti-tumor, hypoglycemic, anti-inflammatory and antibacterial. Due to its low water solubility, low activity and low bioavailability, isosteviol has poor performance. In order to overcome these shortcomings, scholars have obtained a large number of isosteviol derivatives with novel structures and excellent activity. In this paper, we review the recent progress in the research on the structure modification, biological activity, structure-activity relationship and microbial transformation of isosteviol, in order to provide a reference for the development of new drugs of isosteviol and its derivatives.
4.Research progress on indirect energy measurement in guiding energy and nutritional application in nutritional support therapy for critically ill patients.
Yinqiang FAN ; Jun YAN ; Ning WEI ; Jianping YANG ; Hongmei PAN ; Yiming SHAO ; Jun SHI ; Xiuming XI
Chinese Critical Care Medicine 2025;37(8):794-796
Nutritional support therapy is one of the extremely important treatment methods for patients in the intensive care unit. Timely and effective nutritional support regimens can improve patients' immune function, reduce complications, and optimize clinical outcomes. Energy expenditure is influenced by multiple factors, including patients' baseline characteristics (such as physical condition, gender, age) and dynamic changes in indicators (such as body temperature, nutritional support regimens, and therapeutic interventions). The currently recognized "gold standard" for accurately assessing energy metabolism in clinical practice is the indirect calorimetry system, also known as the metabolic cart. This device monitors carbon dioxide production and oxygen consumption in real time and uses specific algorithms to estimate the metabolic proportions of the three major nutrients (carbohydrates, fats, and proteins) in energy expenditure. An appropriate nutrient ratio helps maintain the balance between supply and demand in the body's nutritional metabolism. In the management of critically ill patients, the application of the metabolic cart enables personalized nutritional therapy, avoiding over- or under-supply of energy and optimizing the use of medical resources. Furthermore, with real-time, quantitative data support from the energy metabolism monitoring system, clinicians can develop more precise nutritional intervention strategies, thereby improving patient prognosis. This article provides a systematic review of the technical features of the metabolic cart and its application value in various critical care scenarios, aiming to offer a reference for indirect calorimetry in clinical practice.
Humans
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Critical Illness/therapy*
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Nutritional Support
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Energy Metabolism
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Calorimetry, Indirect
5.Diagnostic Techniques and Risk Prediction for Cardiovascular-kidney-metabolic (CKM) Syndrome
Song HOU ; Lin-Shan ZHANG ; Xiu-Qin HONG ; Chi ZHANG ; Ying LIU ; Cai-Li ZHANG ; Yan ZHU ; Hai-Jun LIN ; Fu ZHANG ; Yu-Xiang YANG
Progress in Biochemistry and Biophysics 2025;52(10):2585-2601
Cardiovascular disease (CVD), chronic kidney disease (CKD), and metabolic disorders are the 3 major chronic diseases threatening human health, which are closely related and often coexist, significantly increasing the difficulty of disease management. In response, the American Heart Association (AHA) proposed a novel disease concept of “cardiovascular-kidney-metabolic (CKM) syndrome” in October 2023, which has triggered widespread concern about the co-treatment of heart and kidney diseases and the prevention and treatment of metabolic disorders around the world. This review posits that effectively managing CKM syndrome requires a new and multidimensional paradigm for diagnosis and risk prediction that integrates biological insights, advanced technology and social determinants of health (SDoH). We argue that the core pathological driver is a “metabolic toxic environment”, fueled by adipose tissue dysfunction and characterized by a vicious cycle of systemic inflammation and oxidative stress, which forms a common pathway to multi-organ injury. The at-risk population is defined not only by biological characteristics but also significantly impacted by adverse SDoH, which can elevate the risk of advanced CKM by a factor of 1.18 to 3.50, underscoring the critical need for equity in screening and care strategies. This review systematically charts the progression of diagnostic technologies. In diagnostics, we highlight a crucial shift from single-marker assessments to comprehensive multi-marker panels. The synergistic application of traditional biomarkers like NT-proBNP (reflecting cardiac stress) and UACR (indicating kidney damage) with emerging indicators such as systemic immune-inflammation index (SII) and Klotho protein facilitates a holistic evaluation of multi-organ health. Furthermore, this paper explores the pivotal role of non-invasive monitoring technologies in detecting subclinical disease. Techniques like multi-wavelength photoplethysmography (PPG) and impedance cardiography (ICG) provide a real-time window into microcirculatory and hemodynamic status, enabling the identification of early, often asymptomatic, functional abnormalities that precede overt organ failure. In imaging, progress is marked by a move towards precise, quantitative evaluation, exemplified by artificial intelligence-powered quantitative computed tomography (AI-QCT). By integrating AI-QCT with clinical risk factors, the predictive accuracy for cardiovascular events within 6 months significantly improves, with the area under the curve (AUC) increasing from 0.637 to 0.688, demonstrating its potential for reclassifying risk in CKM stage 3. In the domain of risk prediction, we trace the evolution from traditional statistical tools to next-generation models. The new PREVENT equation represents a major advancement by incorporating key kidney function markers (eGFR, UACR), which can enhance the detection rate of CKD in primary care by 20%-30%. However, we contend that the future lies in dynamic, machine learning-based models. Algorithms such as XGBoost have achieved an AUC of 0.82 for predicting 365-day cardiovascular events, while deep learning models like KFDeep have demonstrated exceptional performance in predicting kidney failure risk with an AUC of 0.946. Unlike static calculators, these AI-driven tools can process complex, multimodal data and continuously update risk profiles, paving the way for truly personalized and proactive medicine. In conclusion, this review advocates for a paradigm shift toward a holistic and technologically advanced framework for CKM management. Future efforts must focus on the deep integration of multimodal data, the development of novel AI-driven biomarkers, the implementation of refined SDoH-informed interventions, and the promotion of interdisciplinary collaboration to construct an efficient, equitable, and effective system for CKM screening and intervention.
6.Improvement effects of fecal microbiota transplantation on chemotherapy-induced diarrhea in mice
Qiu-Yu YANG ; Meng-Tian TAN ; Jing BAI ; Xing REN ; Jun-Qi ZHANG ; Yong YANG ; Yu-Hang SUN ; Lei LI ; Ze-Xian FU
Medical Journal of Chinese People's Liberation Army 2025;50(3):261-268
Objective To investigate the improvement effects of homogeneous fecal microbiota transplantation(FMT)on chemotherapy-induced diarrhea(CID)in mice.Methods Fifteen C57BL/6N mice were divided into control group,CID model group and CID+FMT group according to the random number distribution and remainder grouping method,with 5 mice per group.Control group received no intervention,and their feces were used to prepare fecal bacteria suspension.CID model group was injected intraperitoneally with fluorouracil(65 mg/kg)for 5 consecutive days to construct the CID mouse model,followed by gavage with 0.1 ml of saline on alternate days.CID+FMT group was given 0.1 ml fecal bacteria suspension gavage on alternate days for one week,followed by intraperitoneal injection of fluorouracil(65 mg/kg)for 5 consecutive days to construct the CID mouse model,with the experiment ending on the 14th day.During the experiment,the mice's food intake and body weight were recorded.At the end of the experiment,the mice were euthanized with deep carbon dioxide anesthesia,and the mice colonic specimens from cecum to anus were collected for hematoxylin and eosin(HE)staining and histopathological examination.Fecal samples were collected for 16S rRNA gene sequencing.Shannon index,Simpson index and Chao1 algorithm were used to analyze the α-diversity species of the intestinal flora in each group of mice.Similarity analysis(Anosim)was used to perform non-parametric on the inter-group differences of intestinal flora among the mice.Linear discriminate analysis size effect(LEfSe)and nonmetric multidimensional scaling(NMDS)were employed to analyze the intestinal dominant flora and the similarity classification relationships in each group of mice.Results The colonic specimen's length from cecum to anus in CID model group was significantly shorter than that in control group(P<0.05),while there was no significant difference between CID+FMT group and CID model group(P>0.05).The weight of mice in CID model group decreased by 42.04%,while control group mice gained 10.24%,with a significant difference between the two groups(P<0.05).The weight of mice in CID+FMT group decreased by 8.12%,which was significantly improved compared to CID model group(P<0.05).HE staining results revealed the intestinal mucosal structure in CID model group was severely damaged,with atrophy and deformation,accompanied by inflammatory cell infiltration,and the pathological score was higher than that of control group(P<0.05).Compared with CID model group,the intestinal mucosal integrity and crypt cells in the CID+FMT group were improved,with less damage,and the pathological score was lower than that of CID model group,but the difference was not statistically significant(P>0.05).The α-diversity analysis showed that there were significant differences in the Shannon,Simpson and Chao1 indices among the three groups(P<0.05).ANOSIM and NMDS analysis revealed that the intestinal flora in CID+FMT group was closer to the normal intestinal flora compared to CID model group.LEfSe analysis showed that the intestinal flora in CID model group was enriched in famliy_Bacteroidaceae,and the intestinal flora in CID+FMT group was similar to that of control group,with an enrichenment of familiy_Enterobacteriaceae.Conclusion Homogeneous FMT can improve the abundance of intestinal flora in CID mice,making it more similar to normal intestinal flora,thereby protecting intestinal mucosa,reducing damage and alleviating the severity of CID.
7.Protective effect of dexmedetomidine on intestinal mucosal injury in rats with enterogenous sepsis and its mechanism
Kun YANG ; Qianyao FU ; Yongqiang SUN ; Kun YANG ; Jun MENG
Journal of Jilin University(Medicine Edition) 2025;51(4):855-865
Objective:To discuss the protective effect of dexmedetomidine(DEX)on intestinal function in rats with enterogenous sepsis,and to clarify its potential mechanism based on E2F transcription factor 1(E2F1)/nuclear factor kappa B(NF-κB)signaling pathway.Methods:Sixty SD rats were selected,among which 50 rats were used to establish enterogenous sepsis models by cecal ligation and puncture(CLP),and the remaining 10 rats were used as sham operation group(only cecal separation without ligation or puncture).The 40 successfully modeled rats were randomly divided into model group,low dose of DEX group,medium,doses of DEX group,and high dose of DEX group,with 10 rats in each group.The rats in low,medium,and high dose of DEX groups were intraperitoneally injected with 20,40 and 60 μg·kg-1 DEX immediately after modeling,while the rats in sham operation group and model group were intraperitoneally injected with the same volume of saline.After 24 h of administration,the intestinal myoelectric activities of the rats in various groups were detected;the colony counts of Escherichia coli,Lactobacillus and Bifidobacterium in cecal contents of the rats in various groups were detected;the pathomorphology of small intestinal tissue of the rats was observed by HE staining;the levels of secretory immunoglobulin A(sIgA)in supernatant of small intestinal tissue homogenate and the levels of diamine oxidase(DAO)and D-lactic acid in serum of the rats in various groups were detected by kit;real-time fluorescence quantitative PCR(RT-qPCR)method was used to detect the mRNA expression levels of macrophage polarization markers in small intestinal tissues of the rats in various groups;Western blotting method was used to detect the protein expression levels of macrophage polarization markers,E2F1,phosphorylated NF-κB p65(p-NF-κB p65),and NF-κB p65 in small intestinal tissue of the rats in various groups.Results:Compared with sham operation group,the slow wave frequency and amplitude of intestinal smooth muscle of the rats in model group were decreased(P<0.05);compared with model group,the slow wave amplitude of intestinal smooth muscle of the rats in low dose of DEX groups was increased(P<0.05),the slow wave frequency and amplitude of intestinal smooth muscle of the rats in medium and high doses of DEX groups were increased(P<0.05);compared with low dose of DEX group,the slow wave frequency and amplitude of the rats in medium and high doses of DEX groups were increased(P<0.05);compared with medium dose of DEX group,the slow wave frequency and amplitude of intestinal smooth muscle of the rats in high dose of DEX group were increased(P<0.05).Compared with sham operation group,the colony count of Escherichia coli in intestinal tract of the rats in model group was increased(P<0.05),while the colony counts of Bifidobacterium and Lactobacillus were decreased(P<0.05);compared with model group,the colony count of Bifidobacterium in intestinal tract of the rats in low dose of DEX group was decreased(P<0.05),the colony count of Escherichia coli in intestinal tract of the rats in medium,and high doses of DEX groups was decreased(P<0.05),while the colony counts of Bifidobacterium and Lactobacillus were increased(P<0.05);compared with low dose of DEX group,the colony count of Escherichia coli in intestinal tract of the rats in medium and high dose of DEX groups was decreased(P<0.05),while the colony counts of Bifidobacterium and Lactobacillus were increased(P<0.05);compared with medium dose of DEX group,the colony count of Escherichia coli in intestinal tract of the rats in high dose of DEX group was decreased(P<0.05),while the colony counts of Bifidobacterium and Lactobacillus were increased(P<0.05).The HE staining results showed that the small intestinal mucosal structure in sham operation group was normal and intact;the small intestinal mucosal epithelial cells in model group were necrotic,with damaged,collapsed and disordered villi;Compared with model groups,the pathological changes of small intestinal tissues in low,medium,and high doses of DEX groups were improved.Compared with sham operation group,the level of sIgA in supernatant of small intestinal tissue homogenate of the rats in model group was decreased(P<0.05),while the protein expression levels of DAO and D-lactic acid in serum were increased(P<0.05);compared with model group,the level of DAO in serum of the rats in low dose of DEX groups was decreased(P<0.05),the level of sIgA in supernatant of small intestinal tissue homogenate of the rats in medium and high doses of DEX groups was increased(P<0.05),while the protein expression levels of DAO and D-lactic acid in serum were decreased(P<0.05);compared with low dose of DEX group,the level of sIgA in supernatant of small intestinal tissue homogenate of the rats in medium and high doses of DEX groups was increased(P<0.05),while the protein expression levels of DAO and D-lactic acid in serum were decreased(P<0.05);compared with medium dose of DEX group,the level of sIgA in supernatant of small intestinal tissue homogenate of the rats in high dose of DEX group was significantly increased(P<0.05),while the protein expression levels of DAO and D-lactic acid in serum were decreased(P<0.05).The RT-qPCR results and Western blotting results showed that compared with sham operation group,the mRNA and protein expression levels of CD86,monocyte chemoattractant protein-1(MCP-1),and CD80 in small intestinal tissue of the rats in model group were increased(P<0.05),while the mRNA and protein expression levels of CD206,interleukin-4(IL-4)and,CD163 were decreased(P<0.05);compared with model group,the expression levels of CD80 mRNA,CD86 protein and MCP-1 protein in small intestinal tissue of the rats in low dose of DEX group were decreased(P<0.05),and the expression levels of IL-4 mRNA,CD163 mRNA,CD206 protein,and CD163 protein were decreased(P<0.05),the mRNA and protein expression levels of CD86,MCP-1,and CD80 in small intestinal tissue of the rats in medium and high doses of DEX groups were decreased(P<0.05),while the mRNA and protein expression levels of CD206,IL-4 and CD163 were increased(P<0.05);compared with low dose of DEX group,the mRNA and protein expression levels of CD86,MCP-1,and CD80 in small intestinal tissue of the rats in medium and high doses of DEX groups were decreased(P<0.05),while the mRNA and protein expression levels of CD206,IL-4,and CD163 were increased(P<0.05);compared with medium dose of DEX group,the mRNA and protein expression levels of CD86,MCP-1,and CD80 in small intestinal tissue of the rats in high dose of DEX group were decreased(P<0.05),while the mRNA and protein expression levels of CD206,IL-4,and CD163 were increased(P<0.05).The Western blotting results showed that compared with sham operation group,the protein expression level of E2F1 in small intestinal tissue of the rats in model group was decreased(P<0.05),while the ratio of p-NF-κB p65/NF-κB p65 was increased(P<0.05);compared with model group,the protein expression levels of E2F1 and ratio of p-NF-κB p65/NF-κB p65 in small intestinal tissue of the rats in low,medium and high doses of DEX groups were decreased(P<0.05);compared with low dose of DEX group,the protein expression level of E2F1 in small intestinal tissue of the rats in medium and high doses of DEX groups was increased(P<0.05),while the ratio of p-NF-κB p65/NF-κB p65 was decreased(P<0.05);compared with medium dose of DEX group,the protein expression level of E2F1 in small intestinal tissue of the rats in high dose of DEX group was increased(P<0.05),while the ratio of p-NF-κB p65/NF-κB p65 was decreased(P<0.05).Conclusion:DEX can improve the small intestinal mucosal injury in the rats with enterogenous sepsis and promote the polarization of macrophages to M2 type in small intestinal tissues,and its mechanism may be related to the regulation of E2F1/NF-κB signaling pathway by DEX.
8.Simultaneous Determination of 21 Kinds of Aconitum Alkaloids in Biological Specimens and Herbal Wines Using Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry
Ju YANG ; Guo-Jun LI ; Xian-Mou FAN ; Rui-Bin ZHAO ; Shao-Ming SU ; Xu-Xian FU ; En-Jin ZHU ; Qi-Lin HUANG ; Yao QIN ; Li-Na LI
Chinese Journal of Analytical Chemistry 2025;53(8):1391-1401,后插1-后插6,封3
A method for simultaneous determination of 21 kinds of Aconitum alkaloids(ATS)in biological specimens and infused liquor using ultra-performance liquid chromatography-tandem mass spectrometry(UPLC-MS/MS)was developed.The biological samples were pretreated with methanol-acetonitrile(1∶2,V/V)for protein precipitation,while infused liquors were diluted 100-fold with acetonitrile,followed by centrifugation,and filtration by a 0.22-μm membrane.Chromatographic separation was carried out on an EC-C18 column using gradient elution with the mixture of 10 mmol/L ammonium acetate and 0.2%formic acid as mobile phase A and acetonitrile as mobile phase B.With this method,all the analytes were separated within 9.5 min.The samples were detected in positive ESI mode with dynamic multiple reaction monitoring(MRM)and quantified via external standard calibration.The results showed that the concentrations of the analytes in the range of 2-1000 ng/mL had excellent linearity(R2>0.9992)with the peak area.The developed method was successfully used for detection of 21 kinds of aconitum alkaloids,with limits of detection of 0.5-2 ng/mL,quantification limits of 2-6 ng/mL,intra/inter-day precision≤6.0%,spiked recoveries of 89.4%-100.9%,extraction recoveries of 74.2%-104.4%,and matrix effects ranging from-11.1%to 9.2%in blood/urine.The method was applied to detection of 12 samples from 4 fatal aconite poisoning cases,and all 21 kinds of ATS with total alkaloid concentrations of 0.04-4.18 μg/mL in blood and 154.96-422.83 μg/mL in medicinal liquors were detected.Tissue distribution revealed that the order of concentrations from highest to lowest is as follows:urine(157.22 μg/mL)>gastric contents(51.37 μg/mL)>kidney(21.6 μg/g)>whole blood(4.18 μg/mL)>liver(0.03 μg/g).This method showed many advantages such as simple pretreatment,low detection limits,accurate quantification,broad analyte coverage,and superior anti-interference capability in complex matrices,proving ideal for forensic and toxicological analysis of aconitum alkaloids.
9.Interpretation of"Guideline 9213 for validation,verification,and transfer of microbiological analytical methods"in Chinese Pharmacopoeia 2025 Edition
Yan YANG ; Hong SHAO ; Shujuan WANG ; Rong FU ; Qian YANG ; Junhao CHEN ; Zhen SHEN ; Chunyan AN ; Yiling FAN ; Meicheng YANG ; Jun ZHANG ; Changqin HU
Drug Standards of China 2025;26(5):462-467
The Chinese Pharmacopoeia 2025 Edition added the 9213 Guideline for validation,verification,and transfer of microbiological analytical methods.Based on the characteristics of pharmaceutical microbiological analyt-ical methods and practical applications,it specified definitions of relevant terms and application scenarios,estab-lished technical indicators and acceptance criteria for methodological evaluation,and introduced key statistical tools and evaluation principles.This article systematically elaborates on the drafting background and process of the Guideline,and interprets its key content,aiming to offer theoretical guidance and practical reference for relevant practitioners in applying this guideline.This guideline strengthens the foundation of pharmaceutical microbial analytical methods in China and enhances the scientificity and accuracy of the pharmaceutical microbial standards system.
10.Predictive Value of Residual Quantitative Flow Ratio for Long-term Vessel-oriented Composite Endpoints
Rui ZHANG ; Yanpu SHI ; Changdong GUAN ; Yanyan ZHAO ; Shengxian TU ; Bo YU ; Guosheng FU ; Yujie ZHOU ; Jian'an WANG ; Yundai CHEN ; Jun PU ; Kefei DOU ; Weixian YANG ; Yongjian WU ; Shubin QIAO ; Lei SONG
Chinese Circulation Journal 2025;40(9):862-869
Objectives:To explore the predictive value of residual Murray's law-based quantitative flow ratio(μQFR)on long-term vessel-oriented composite endpoints(VoCE).Methods:This retrospective study included 3 510 patients from the FAVOR Ⅲ China trial.Offline residual μQFR analysis was performed on all vessels(diameter≥2.5 mm)with 50%-90%stenotic lesions.Patients were stratified into high-,intermediate-,and low-risk groups based on residual μQFR tertiles.The primary endpoint was 3-year VoCE,defined as a composite of cardiac death related to the target vessel,target vessel-related spontaneous myocardial infarction,and ischemia-driven target vessel revascularization.Results:Offline analysis was performed on 5 256 vessels from 3 510 patients.The mean residual μQFR was 0.92±0.75.The high-risk group(residual μQFR≤0.91)with 1 554 patients(1 958 vessels);the intermediate-risk group(residual μQFR 0.92-0.96)with 1 211 patients(1 906 vessels);and the low-risk group(residual μQFR>0.96)with 745 patients(1 392 vessels).Over 3-year follow-up,VoCE occurred in 227 vessels(4.3%).The 3-year VoCE incidence was significantly higher in the high-risk group compared to the intermediate-and low-risk groups(6.2%vs.4.1%vs.2.5%,log-rank P<0.001),primarily driven by ischemia-driven target vessel revascularization(5.0%vs.3.0%vs.1.6%,log-rank P<0.001).Hypertension(OR=0.83,95%CI:0.72-0.96),hypercholesterolemia(OR=0.84,95%CI:0.73-0.97),bifurcation lesions(OR=0.72,95%CI:0.63-0.83),moderate/severe calcification(OR=0.70,95%CI:0.57-0.84),and tandem lesions(OR=0.59,95%CI:0.47-0.75)were independent predictors of lower residual μQFR values.Conclusions:Lower residual μQFR is significantly associated with increased VoCE risk during the 3-year follow up period.

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