1.Effect of Jianpi Qinghua Granules on Blood Glucose Fluctuations and Skeletal Muscle Mass and Function in Newly Diagnosed Overweight/Obese Type 2 Diabetes Patients with Qi-Yin Deficiency Syndrome
Yuan CHEN ; Qiuyue GUO ; Yanyan XIAO ; Hao LU ; Chi CHEN ; Junfei XU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(11):218-224
ObjectiveTo investigate the effects of Jianpi Qinghua granules on blood glucose fluctuations in patients with newly diagnosed overweight/obese type 2 diabetes mellitus (T2DM) and Qi-Yin deficiency syndrome from the perspective of skeletal muscle mass and function, while providing new insights for the treatment of diabetes. MethodsThis study employed a randomized, double-blind, placebo-controlled design. A total of 110 newly diagnosed overweight/obese T2DM patients meeting the inclusion criteria were randomly assigned to either the traditional Chinese medicine (TCM) group (54 cases) or the control group (56 cases). Patients in the TCM group received Jianpi Qinghua Granules, while those in the control group received a placebo. Both groups underwent dietary and exercise guidance. After 12 weeks of intervention, blood glucose fluctuations were assessed using the following parameters: time in the target blood glucose range (TIR), mean daily blood glucose (MBG), standard deviation of mean daily blood glucose (SDBG), mean amplitude of glycemic excursions (MAGE), coefficient of variation of blood glucose (CV), glycated hemoglobin (HbA1c) achievement rate, fasting plasma glucose (FPG), and 2 hour postprandial glucose (2 hPG). Skeletal muscle mass was measured by dual-energy X-ray absorptiometry (DXA), while skeletal muscle function was evaluated using a handheld dynamometer for distal muscle strength and a 5-time sit-to-stand test for lower limb function. Additionally, pancreatic islet function and TCM syndrome scores were analyzed. ResultsNo significant differences were observed in baseline data between the two groups before intervention, ensuring comparability. After treatment, compared to the control group, the TCM group showed a significant increase in TIR (P<0.01). While the SDBG and CV decreased, and MBG and MAGE increased in the TCM group, these differences were not statistically significant. Notably, the TCM group exhibited significant reductions in 2 hPG (P<0.01) and HbA1c (P<0.05), though the decrease in FPG was not statistically significant. The HbA1c achievement rate in the TCM group was significantly higher than that in the control group (χ2=45.498, P<0.01). In terms of skeletal muscle mass and function, the TCM group demonstrated a significant increase in handgrip strength (P<0.01) and a significant reduction in the 5-time sit-to-stand duration (P<0.05). However, although body fat percentage increased, leading to a decrease in skeletal muscle mass and the ratio of skeletal muscle to fat, these changes were not statistically significant. For pancreatic islet function, the TCM group showed significant reductions in fasting insulin (FINS) and homeostasis model assessment of insulin resistance (HOMA-IR) (P<0.01). Additionally, the TCM syndrome score in the TCM group was significantly reduced (P<0.01). ConclusionJianpi Qinghua granules may reduce blood glucose fluctuations in newly diagnosed overweight/obese T2DM patients with Qi-Yin deficiency syndrome by enhancing skeletal muscle function, improving pancreatic islet function, and ameliorating related TCM syndromes.
2.Effect of Slicing Angle and Initial Water Content on Water Migration and Effective Ingredient Content in Drying Process of Salviae Miltiorrhizae Radix et Rhizoma
Guohong YANG ; Bingqian ZHOU ; Heng LU ; Xiao WANG ; Lanping GUO ; Wei LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(4):208-216
ObjectiveTo explore the effects of angle and original moisture content on the moisture distribution, migration and contents of effective components in the drying process of sliced Salviae Miltiorrhizae Radix et Rhizoma(SMRR). MethodsSet the slicing angles of SMRR at 30°, 45°, and 90°. Cut the fresh samples, 1/3 dehydrated samples, and 2/3 dehydrated samples, dry them in an oven at 40 ℃ and take samples at the set time points. Low-field nuclear magnetic resonance(LF-NMR) and magnetic resonance imaging(MRI) were used to analyze the changes in transverse relaxation time(T2) of SMRR samples in 9 treatment groups at specific times, as well as the distribution and migration of water in the samples. The contents of tanshinone ⅡA, tanshinone Ⅰ, cryptotanshinone, and salvianolic acid B in samples from 9 different treatment groups were determined by high performance liquid chromatography(HPLC), and the best processing technology of SMRR was screened by combining with One-way ANOVA, Duncan multiple comparison and principal component analysis(PCA). ResultsThe moisture content of dry basis of SMRR in each treatment group decreased with the extension of drying time. The drying rate of fresh cut group decreased slowly at first, while the drying rate of water loss group showed a trend of increasing at first and then decreasing. The internal water of SMRR could be divided into three states, including bound water, non flowing water and free water. During the drying process, the water migration law showed that the free water of fresh cut group disappeared after drying for 12 h, the content of bound water gradually decreased, and the overall fluidity deteriorated. In the water loss group, part of the free water was transformed into more cohesive and non flowing water after drying for 3 h, and the three kinds of water basically disappeared after drying for 12 h. The MRI results showed that the entire dehydration process slowly moved from the outer side to the center, and the internal water eventually dissipated. In terms of the contents of active ingredients, the order of the effect of slicing angle on the total content of active ingredients in SMRR was 30°>45°>90°. The content of tanshinones was ranked as 1/3 dehydrated group>2/3 dehydrated group>fresh cut group, and the content of salvianolic acid B was ranked as 1/3 dehydrated group>fresh cut group>2/3 dehydrated group. Combined with the results of PCA and comprehensive scoring results, the overall level of effective component content in SMRR was the highest when cut at 30° after 1/3 of water loss. ConclusionAfter comprehensive evaluation, SMRR can be sliced at 30° after 1/3 of water loss. It is not only easy to cut, but also the surface and cross-sectional colors remain basically unchanged after drying, which is similar to the color under traditional processing, and the effective ingredients are preserved the highest. This study can provide a basis for the optimization of processing technology of SMRR.
3.A practice guideline for therapeutic drug monitoring of mycophenolic acid for solid organ transplants.
Shuang LIU ; Hongsheng CHEN ; Zaiwei SONG ; Qi GUO ; Xianglin ZHANG ; Bingyi SHI ; Suodi ZHAI ; Lingli ZHANG ; Liyan MIAO ; Liyan CUI ; Xiao CHEN ; Yalin DONG ; Weihong GE ; Xiaofei HOU ; Ling JIANG ; Long LIU ; Lihong LIU ; Maobai LIU ; Tao LIN ; Xiaoyang LU ; Lulin MA ; Changxi WANG ; Jianyong WU ; Wei WANG ; Zhuo WANG ; Ting XU ; Wujun XUE ; Bikui ZHANG ; Guanren ZHAO ; Jun ZHANG ; Limei ZHAO ; Qingchun ZHAO ; Xiaojian ZHANG ; Yi ZHANG ; Yu ZHANG ; Rongsheng ZHAO
Journal of Zhejiang University. Science. B 2025;26(9):897-914
Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Therapeutic drug monitoring (TDM) enhances treatment outcomes through tailored approaches. This study aimed to develop an evidence-based guideline for MPA TDM, facilitating its rational application in clinical settings. The guideline plan was drawn from the Institute of Medicine and World Health Organization (WHO) guidelines. Using the Delphi method, clinical questions and outcome indicators were generated. Systematic reviews, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence quality evaluations, expert opinions, and patient values guided evidence-based suggestions for the guideline. External reviews further refined the recommendations. The guideline for the TDM of MPA (IPGRP-2020CN099) consists of four sections and 16 recommendations encompassing target populations, monitoring strategies, dosage regimens, and influencing factors. High-risk populations, timing of TDM, area under the curve (AUC) versus trough concentration (C0), target concentration ranges, monitoring frequency, and analytical methods are addressed. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug-drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety.
Mycophenolic Acid/administration & dosage*
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Drug Monitoring/methods*
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Humans
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Organ Transplantation
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Immunosuppressive Agents/administration & dosage*
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Delphi Technique
4.Granulocyte colony-stimulating factor in neutropenia management after CAR-T cell therapy: A safety and efficacy evaluation in refractory/relapsed B-cell acute lymphoblastic leukemia.
Xinping CAO ; Meng ZHANG ; Ruiting GUO ; Xiaomei ZHANG ; Rui SUN ; Xia XIAO ; Xue BAI ; Cuicui LYU ; Yedi PU ; Juanxia MENG ; Huan ZHANG ; Haibo ZHU ; Pengjiang LIU ; Zhao WANG ; Yu ZHANG ; Wenyi LU ; Hairong LYU ; Mingfeng ZHAO
Chinese Medical Journal 2025;138(1):111-113
5.Exploration and Practice of Artificial Intelligence Empowering Case-based Teaching in Biochemistry and Molecular Biology
Ying-Lu HU ; Yi-Chen LIN ; Jun-Ming GUO ; Xiao-Dan MENG
Progress in Biochemistry and Biophysics 2025;52(8):2173-2184
In recent years, the deep integration of artificial intelligence (AI) into medical education has created new opportunities for teaching Biochemistry and Molecular Biology, while also offering innovative solutions to the pedagogical challenges associated with protein structure and function. Focusing on the case of anaplastic lymphoma kinase (ALK) gene mutations in non-small-cell lung cancer (NSCLC), this study integrates AI into case-based learning (CBL) to develop an AI-CBL hybrid teaching model. This model features an intelligent case-generation system that dynamically constructs ALK mutation scenarios using real-world clinical data, closely linking molecular biology concepts with clinical applications. It incorporates AI-powered protein structure prediction tools to accurately visualize the three-dimensional structures of both wild-type and mutant ALK proteins, dynamically simulating functional abnormalities resulting from conformational changes. Additionally, a virtual simulation platform replicates the ALK gene detection workflow, bridging theoretical knowledge with practical skills. As a result, a multidimensional teaching system is established—driven by clinical cases and integrating molecular structural analysis with experimental validation. Teaching outcomes indicate that the three-dimensional visualization, dynamic interactivity, and intelligent analytical capabilities provided by AI significantly enhance students’ understanding of molecular mechanisms, classroom engagement, and capacity for innovative research. This model establishes a coherent training pathway linking “fundamental theory-scientific research thinking-clinical practice”, offering an effective approach to addressing teaching challenges and advancing the intelligent transformation of medical education.
6.Correlation between residual cholesterol and hearing loss in noise-exposed workers
Jing QIAN ; Aichu YANG ; Minghui XIAO ; Danyan CAO ; Jijun GUO ; Xiufeng LU
China Occupational Medicine 2025;52(1):40-44
Objective To analyze the effect of residual cholesterol (RC) on hearing loss in noise-exposed workers. Methods A total of 3 412 workers engaged in noise operation work in an underground railway enterprise were selected as the research subjects using the judgment sampling method. Their occupational health examination data were collected to analyze the relationship between RC and hearing loss. Results The noise intensity of workplace in the underground rail enterprise was 80.0-85.0 (81.4±3.2) dB(A). The detection rate of hearing loss was 20.2% (691/3 412). The rates of abnormal total cholesterol, triacylglycerol, high density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol were 35.6%, 25.7%, 9.5% and 42.4%, respectively. The median and the 25th and 75th percentiles [M(P25,P75)] of RC level were 0.24 (0.15, 0.37) mmol/L. The levels of total cholesterol, triacylglycerol and RC of workers in hearing loss group were higher than those in normal hearing group [M(P25,P75): 4.91(4.37, 5.58) vs 4.84(4.30, 5.46) mmol/L, 1.29(0.91, 1.93) vs 1.16(0.82, 1.67) mmol/L, 0.26(0.16, 0.41) vs 0.24(0.14, 0.37) mmol/L, all P<0.05]. The detection rate of hearing loss in abnormal triglyceride group was higher than that in normal triglyceride group (24.8% vs 18.7%, P<0.01), and the detection rate of hearing loss in abnormal HDL-C group was higher than that in normal HDL-C group (25.0% vs 19.8%, P<0.05). The higher the serum RC level, the higher the detection rate of hearing loss (P<0.01). Multivariate logistic regression result showed that individual with older age, longer work time and higher serum RC level had higher risk of hearing abnormality (all P<0.05), and the risk of hearing abnormality was higher in patients with abnormal fasting blood glucose than patients with normal faseing blood glucose (P<0.05) after controlling for confounding factors such as gender, alcohol consumption, body mass index, and elevated blood pressure. However, abnormal triacylglycerol and HDL-C levels were not significantly related to the risk of hearing abnormality (both P>0.05). Conclusion Serum RC levels are an independent risk factor for hearing loss among noise-exposed workers exposed to noise level of 80.0-85.0 dB(A) in the workplace.
7.Comparison of efficacy and safety of crisaborole ointment 2% versus pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children: a multicenter, randomized, controlled clinical trial
Xing XIAO ; Shan WANG ; Huan YANG ; Hong SHU ; Yanping GUO ; Jinping CHEN ; Yao LU ; Qinfeng LI ; Yuan LIANG ; Mutong ZHAO ; Xiaoyan LUO ; Limin MIAO ; Rui XU ; Xuemei LI ; Sha LAI ; Jianhong LI ; Zhen LUO ; Lu YU ; Lu XING ; Meitan WANG ; Xiaoli LI ; Haitao XU ; Ping LI ; Hua WANG ; Lin MA
Chinese Journal of Dermatology 2025;58(5):425-430
Objective:To compare the efficacy and safety of crisaborole ointment 2% versus pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children aged 2 years or older.Methods:A multicenter, randomized, open-label, controlled clinical trial was conducted. A total of 120 pediatric patients aged 2 - 17 years with mild to moderate atopic dermatitis were enrolled from departments of dermatology of 8 hospitals in China between March 2022 and February 2023. The participants were randomly assigned in a 1∶1 ratio to the crisaborole group and the pimecrolimus group, and received the treatment with crisaborole ointment 2% and pimecrolimus cream 1% respectively, twice a day for 4 weeks. Visits were scheduled at baseline/on day 1, as well as on days 8, 15, and 29. The primary efficacy outcome was the percentage of patients achieving the Investigator's Static Global Assessment (ISGA) success (defined as clear [0] or almost clear [1] on the ISGA scale, combined with ≥ 2‐grade improvement from baseline) on day 29. The secondary efficacy outcomes included changes in the Eczema Area and Severity Index (EASI) total scores from baseline to day 29, percentages of patients achieving ISGA improvement (defined as clear [0] or almost clear [1] on the ISGA scale), as well as changes in the Peak Pruritus Numerical Rating Scale (NRS) scores, Dermatology Life Quality Index (DLQI) /Infants' Dermatology Life Quality Index (IDLQI) /Children's Dermatology Life Quality Index (CDLQI) scores, and in the Dermatitis Family Impact (DFI) scores. Drug safety was evaluated according to the incidence of adverse events. Categorical data were compared using the chi-square test. Since measurement data did not follow a normal distribution, the rank sum test was used for comparisons of measurement data between groups.Results:A total of 106 children with mild to moderate atopic dermatitis were included in the per-protocol analysis set, with 52 in the crisaborole group (26 males and 26 females) and 54 in the pimecrolimus group (27 males and 27 females). There were no significant differences in age, disease duration, ISGA and EASI scores at baseline between the two groups (all P > 0.05). On day 29, 22 patients (42.31%) in the crisaborole group and 25 (46.30%) in the pimecrolimus group achieved ISGA success, with no significant difference between the two groups ( χ2 = 0.17, P = 0.68) ; 35 patients (67.31%) in the crisaborole group and 45 (83.33%) in the pimecrolimus group achieved ISGA improvement, also with no significant difference between the two groups ( χ2 = 3.68, P = 0.06) ; additionally, there were no significant differences in the EASI, pruritus NRS, DLQI/IDLQI/CDLQI, or DFI scores between the two groups (all P > 0.05). Adverse reactions to the two topical agents were mainly local reactions such as mild to moderate pain, itching, or worsening of itching, and no obvious systemic adverse reactions occurred. The incidence of drug-related adverse reactions was 46.15% (24 cases) in the crisaborole group and 37.04% (20 cases) in the pimecrolimus group, with no significant difference between the two groups ( χ2 = 0.91, P = 0.34) . Conclusion:The efficacy of crisaborole ointment 2% was comparable to that of pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children aged ≥ 2 years, and it yielded early and rapid improvement in the quality of life of patients and their families, with good safety and tolerability profiles.
8.Guideline for Adult Weight Management in China
Weiqing WANG ; Qin WAN ; Jianhua MA ; Guang WANG ; Yufan WANG ; Guixia WANG ; Yongquan SHI ; Tingjun YE ; Xiaoguang SHI ; Jian KUANG ; Bo FENG ; Xiuyan FENG ; Guang NING ; Yiming MU ; Hongyu KUANG ; Xiaoping XING ; Chunli PIAO ; Xingbo CHENG ; Zhifeng CHENG ; Yufang BI ; Yan BI ; Wenshan LYU ; Dalong ZHU ; Cuiyan ZHU ; Wei ZHU ; Fei HUA ; Fei XIANG ; Shuang YAN ; Zilin SUN ; Yadong SUN ; Liqin SUN ; Luying SUN ; Li YAN ; Yanbing LI ; Hong LI ; Shu LI ; Ling LI ; Yiming LI ; Chenzhong LI ; Hua YANG ; Jinkui YANG ; Ling YANG ; Ying YANG ; Tao YANG ; Xiao YANG ; Xinhua XIAO ; Dan WU ; Jinsong KUANG ; Lanjie HE ; Wei GU ; Jie SHEN ; Yongfeng SONG ; Qiao ZHANG ; Hong ZHANG ; Yuwei ZHANG ; Junqing ZHANG ; Xianfeng ZHANG ; Miao ZHANG ; Yifei ZHANG ; Yingli LU ; Hong CHEN ; Li CHEN ; Bing CHEN ; Shihong CHEN ; Guiyan CHEN ; Haibing CHEN ; Lei CHEN ; Yanyan CHEN ; Genben CHEN ; Yikun ZHOU ; Xianghai ZHOU ; Qiang ZHOU ; Jiaqiang ZHOU ; Hongting ZHENG ; Zhongyan SHAN ; Jiajun ZHAO ; Dong ZHAO ; Ji HU ; Jiang HU ; Xinguo HOU ; Bimin SHI ; Tianpei HONG ; Mingxia YUAN ; Weibo XIA ; Xuejiang GU ; Yong XU ; Shuguang PANG ; Tianshu GAO ; Zuhua GAO ; Xiaohui GUO ; Hongyi CAO ; Mingfeng CAO ; Xiaopei CAO ; Jing MA ; Bin LU ; Zhen LIANG ; Jun LIANG ; Min LONG ; Yongde PENG ; Jin LU ; Hongyun LU ; Yan LU ; Chunping ZENG ; Binhong WEN ; Xueyong LOU ; Qingbo GUAN ; Lin LIAO ; Xin LIAO ; Ping XIONG ; Yaoming XUE
Chinese Journal of Endocrinology and Metabolism 2025;41(11):891-907
Body weight abnormalities, including overweight, obesity, and underweight, have become a dual public health challenge in Chinese adults: overweight and obesity lead to a variety of chronic complications, while underweight increases the risks of malnutrition, sarcopenia, and organ dysfunction. To systematically address these issues, multidisciplinary experts in endocrinology, sports science, nutrition, and psychiatry from various regions have held multiple weight management seminars. Based on the latest epidemiological data and clinical evidence, they expanded the guideline to include assessment and intervention strategies for underweight, in addition to the core content of obesity management. This guideline outlines the etiological mechanisms, evaluation methods, and multidimensional management strategies for overweight and obesity, covering key areas such as diagnosis and assessment, medical nutrition therapy, exercise prescription, pharmacological intervention, and psychological support. It is intended to provide a scientific and standardized approach to weight management across the adult population, aiming to curb the rising prevalence of obesity, mitigate complications associated with abnormal body weight, and improve nutritional status and overall quality of life.
9.Staging system for renal tuberculosis and prognostic analysis of treatment at different stages
Chenhao GUO ; Xiao LU ; Yuyang ZHANG ; Rui ZHANG ; Wei QIN ; Linping QI ; Xiumei LI ; Panfeng SHANG
Chinese Journal of Urology 2025;46(8):581-586
Objective:To investigate the staging criteria of renal tuberculosis,and to analyze the diagnostic and therapeutic characteristics as well as prognostic outcomes at different stages.Methods:A retrospective analysis was conducted on the clinical data of 134 patients with renal tuberculosis who were admitted to the Second Hospital of Lanzhou University between January 2019 and December 2023.The study cohort included 62 males and 72 females,with a mean age of(46.63 ± 13.52)years and a mean body mass index(BMI)of(22.85 ± 3.73)kg/m 2. A total of 107 patients resided in rural areas. Sixty patients had a history of pulmonary tuberculosis. Tuberculous lesions were located in the left kidney in 72 cases and in the right kidney in 62 cases. The main presenting complaints included irritative lower urinary tract symptoms in 85 patients and systemic symptoms in 92 patients. Ureteral involvement was observed in 97 patients,bladder involvement in 32 patients,and genital involvement in 9 patients. Based on computed tomography(CT)findings,the number,extent,and degree of renal destruction caused by tuberculous lesions were comprehensively evaluated in axial,coronal,and sagittal planes. The primary staging criteria included lesion diameter(2 cm)and the proportion of renal volume involved by the lesion(one-third,one-half,and two-thirds). Renal tuberculosis was classified into three stages and six subtypes:Stage Ⅰa,a solitary lesion with a diameter ≤ 2 cm;Stage Ⅰb,a solitary lesion >2 cm or multiple lesions confined within one-third of the renal volume;Stage Ⅱa,lesions involving more than one-third but confined within one-half of the renal volume;Stage Ⅱb,lesions involving more than one-half but confined within two-thirds of the renal volume;Stage Ⅲa,lesions involving more than two-thirds of the renal volume with a glomerular filtration rate(GFR)of the affected kidney <10 ml/min;and Stage Ⅲb,complete renal calcification,presenting as an “autonephrectomy”. Among the 134 patients included in this study,7 were classified as Stage Ⅰa,17 as Stage Ⅰb,20 as Stage Ⅱa,19 as Stage Ⅱb,62 as Stage Ⅲa,and 9 as Stage Ⅲb. The severity of hydronephrosis was graded as follows:mild,renal pelvic separation <2 cm;moderate,2-3 cm;and severe,>3 cm. Prior to treatment,the mean renal pelvic separation was(1.76 ± 0.92)cm in Stage Ⅰa,(1.69 ± 0.81)cm in Stage Ⅰb,and(1.10 ± 0.82)cm in Stage Ⅱa,corresponding to mild to moderate hydronephrosis. All 7 patients in Stage Ⅰa underwent ureteroscopic examination and double-J stent placement,combined with a 6-month short-course anti-tuberculosis regimen consisting of isoniazid,rifampicin,pyrazinamide,and ethambutol for 2 months(intensive phase),followed by isoniazid and rifampicin for 4 months(continuation phase). Among the 17 patients in Stage Ⅰb,13 presented with hydronephrosis and underwent ureteroscopic examination and double-J stent placement in combination with 6 months of anti-tuberculosis therapy,while 4 patients with isolated renal tuberculosis received anti-tuberculosis therapy alone for 6 months.Of the 20 patients in Stage Ⅱa,4 with hydronephrosis underwent ureteroscopic examination and double-J stent placement plus 6 months of anti-tuberculosis therapy,whereas 16 underwent nephroureterectomy. All 19 patients in Stage Ⅱb underwent nephroureterectomy. Among the 62 patients in Stage Ⅲa,60 underwent nephroureterectomy,while 2 refused surgery and were treated with the 6-month short-course anti-tuberculosis regimen. Of the 9 patients in Stage Ⅲb,8 underwent nephroureterectomy;in 1 patient,surgery was not performed due to severe adhesions in the operative field,and the patient received the 6-month short-course anti-tuberculosis regimen instead. Follow-up assessments included clinical symptoms,erythrocyte sedimentation rate(ESR),serum creatinine,degree of renal pelvic separation,and imaging findings from urinary tract CT. Efficacy was evaluated according to the following criteria:Cure was defined as clinical stability with all of the following conditions:① improvement of systemic symptoms,including absence of flank pain,fever,and lower urinary tract irritative symptoms,with normalization of erythrocyte sedimentation rate(ESR);② negative urine culture for Mycobacterium tuberculosis;and ③ complete calcification of renal lesions and/or no evidence of tuberculous lesions at other sites. Stable disease was defined as no change in the size or extent of renal tuberculosis lesions. Progressive disease was defined as enlargement or increase in the number of tuberculous lesions or involvement of additional sites. Results:Among the 7 patients in Stage Ⅰa,follow-up imaging after treatment showed a mean renal pelvic separation of(0.44 ± 0.56)cm,which was significantly reduced compared with baseline( t = 3.909, P = 0.008). Five patients achieved cure,1 remained stable,and 1 showed disease progression and subsequently underwent nephroureterectomy,resulting in postoperative cure. In Stage Ⅰb,among 13 patients with hydronephrosis,post-treatment imaging showed a mean renal pelvic separation of(0.8 ± 0.75)cm,a statistically significant improvement from baseline( t = 5.633, P < 0.01). Six patients were cured,4 remained stable,and 3 experienced disease progression and underwent nephroureterectomy. Of the 4 patients with isolated renal tuberculosis,2 were controlled,and 2 progressed and underwent nephroureterectomy. In Stage Ⅱa,among 4 patients with tuberculous hydronephrosis,post-treatment renal pelvic separation was(1.20±0.98)cm,with no significant difference from baseline( t = -1.675, P = 0.193);these patients underwent nephroureterectomy 1-2 years later. The remaining 16 patients without hydronephrosis underwent nephroureterectomy and were cured. All 19 patients in Stage Ⅱb underwent nephroureterectomy;17 were cured,and 2 developed ipsilateral perirenal fluid collections 3 months postoperatively,which resolved spontaneously with the standard 6-month anti-tuberculosis regimen. Among 62 patients in Stage Ⅲa,60 underwent nephroureterectomy. Of these,54 were cured;1 developed a urinary tract infection within 2 weeks postoperatively;3 showed contralateral renal disease progression at 3 months;and 1 developed ipsilateral perirenal fluid at 3 months,which resolved spontaneously with standard anti-tuberculosis therapy. One patient developed solitary kidney failure 7 months postoperatively and underwent ureteral stent placement,with disease remaining stable thereafter. Two patients refused surgery and received only anti-tuberculosis therapy;during follow-up,1 patient experienced disease progression and died of disseminated tuberculosis after 1 year,while the other developed contralateral renal involvement at 3 months and received standard 6-month therapy,with disease remaining stable. Among 9 patients in Stage Ⅲb,8 underwent nephroureterectomy and were cured. One patient,with severe adhesions precluding surgery,received anti-tuberculosis therapy alone,and disease remained stable over a 2-year follow-up. Conclusions:The CT-based staging system for renal tuberculosis proposed in this study(three stages and six subtypes)effectively reflects the severity of renal lesions and clearly delineates the clinical characteristics and prognostic outcomes at each stage. Stage Ⅰ patients treated with anti-tuberculosis drugs combined with double-J stent placement demonstrated favorable outcomes and high renal preservation rates. In contrast,Stages Ⅱ and Ⅲ patients showed poor responses to anti-tuberculosis therapy combined with drainage,with a higher risk of disease progression and relatively worse prognosis,highlighting the recommendation for early nephroureterectomy of the affected kidney.
10.Pharmacokinetics and anti-inflammatory activity of cannabidiol/ γ-polyglutamic acid-g-cholesterol nanomicelles.
Rui LI ; Li-Yan LU ; Chu XU ; Rui HAO ; Xiao YU ; Rui GUO ; Jue CHEN ; Wen-Hui RUAN ; Ying-Li WANG
China Journal of Chinese Materia Medica 2025;50(2):534-541
In this study, the pharmacokinetic characteristics and tissue distribution of cannabidiol(CBD)/γ-polyglutamic acid-g-cholesterol(γ-PGA-g-CHOL) nanomicelles [CBD/(γ-PGA-g-CHOL)NMs] were investigated by pharmacokinetic experiments, and the effect of CBD/(γ-PGA-g-CHOL)NMs on the lipopolysaccharide(LPS)-induced inflammatory damage of cells was evaluated by cell experiments. CBD/(γ-PGA-g-CHOL)NMs were prepared by dialysis. The CBD concentrations in the plasma samples of male SD rats treated with CBD and CBD/(γ-PGA-g-CHOL)NMs were investigated, and the pharmacokinetic parameters were calculated and compared. UPLC-MS/MS was employed to determine the concentration of CBD in tissue samples. The heart, liver, spleen, lung, kidney, and muscle samples were collected at different time points to explore the tissue distribution of CBD and CBD/(γ-PGA-g-CHOL)NMs. The Caco-2 cell model of LPS-induced inflammation was established, and the cell viability, transepithelial electrical resistance(TEER), and secretion levels of inflammatory cytokines were determined to compare the anti-inflammatory activity between the two groups. The results showed that CBD/(γ-PGA-g-CHOL)NMs had the average particle size of(163.1±2.3)nm, drug loading of 8.78%±0.28%, and encapsulation rate of 84.46%±0.35%. Compared with CBD, CBD/(γ-PGA-g-CHOL)NMs showed increased peak concentration(C_(max)) and prolonged peak time(t_(max)) and mean residence time(MRT_(0-t)). Within 24 h, the tissue distribution concentration of CBD/(γ-PGA-g-CHOL)NMs was higher than that of CBD. In addition, both CBD and CBD/(γ-PGA-g-CHOL)NMs significantly enhanced Caco-2 cell viability and TEER, lowered the secretion levels of inflammatory cytokines, and alleviated inflammation. Moreover, CBD/(γ-PGA-g-CHOL)NMs demonstrated stronger anti-inflammatory effect. It can be inferred that γ-PGA-g-CHOL blank nanomicelles are good carriers of CBD, being capable of prolonging the circulation time of CBD in the blood, improving the bioavailability and tissue distribution concentration of CBD, and protecting against LPS-induced inflammatory injury. The findings can provide an experimental basis for the development and clinical application of oral CBD preparations.
Animals
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Cannabidiol/administration & dosage*
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Polyglutamic Acid/analogs & derivatives*
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Humans
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Male
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Rats
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Rats, Sprague-Dawley
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Anti-Inflammatory Agents/administration & dosage*
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Micelles
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Caco-2 Cells
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Cholesterol/pharmacokinetics*
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Tissue Distribution
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Nanoparticles/chemistry*

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