1.Development and evaluation of classification system for drug-related problems in China
Shuang ZOU ; Tingting LU ; Lei BAO ; Yun LIAO ; Ling LI ; Ping ZHANG
China Pharmacy 2026;37(3):371-376
OBJECTIVE To establish a Chinese drug-related problem (DRP) classification system applicable to pharmacist-led pharmaceutical care in China, providing pharmacists with an effective and practical tool for pharmaceutical care. METHODS A multi-stage process was employed to construct the DRP classification system, including literature review and analysis, comparison of existing classification systems, refinement of classification items and framework development, two rounds of standard case validation, expert discussion, and system revision. The Fleiss′ kappa test was used to calculate the consistency coefficient κ, assessing the reliability of pharmacists participating in evaluating the classification system. An electronic questionnaire comprising six items was employed to evaluate the system’s applicability. RESULTS The constructed Chinese DRP classification system comprised six sections [problem(including potential problems), DRP evaluation, cause (including possible causes of potential problems), intervention, acceptance of intervention and DRP status], with 24 primary codes and 96 secondary codes. In the first round of case validation, κ values exceeded 0.4 for all sections except “intervention” and “DRP status”. In the second round, κ values exceeded 0.4 for all sections. In the applicability evaluation of the classification system, positive ratings (“strongly agree” or “agree”) exceeded 85% for all items. Specifically, positive ratings for“the classification system can provide appropriate category selection”,“ the classification system is comprehensive”,“ the classification system is convenient to use” and “the classification system is highly satisfactory” exceeded 92%. CONCLUSIONS The Chinese DRP classification system developed demonstrates both high reliability and applicability, providing an effective and practical classification tool for pharmacists in China to conduct pharmaceutical care.
2.Forty Cases of Mid-Stage Diabetes Kidney Disease Patients of Blood Stasis Syndrome Treated with Huayu Tongluo Formula (化瘀通络方) as an Adjunct Therapy: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial
Yun MA ; Kaishuang WANG ; Shuang CAO ; Bingwu ZHAO ; Lu BAI ; Su WU ; Yuwei GAO ; Xinghua WANG ; Dong BIAN ; Zhiqiang CHEN
Journal of Traditional Chinese Medicine 2025;66(6):588-595
ObjectiveTo evaluate the clinical efficacy of Huayu Tongluo Formula (化瘀通络方, HTF) in patients with mid-stage diabetic kidney disease of blood stasis syndrome and explore its potential mechanisms. MethodsA multi-center, randomized, double-blind, placebo-controlled clinical trial was conducted. Ninety patients of mid-stage diabetic kidney disease of blood stasis syndrome were divided into a control group of 46 cases and a treatment group of 44 cases. Both groups received conventional western medicine treatment, the treatment group additionally taking HTF, while the control group taking a placebo of the formula. The treatment was administered once daily for 24 weeks. The primary outcomes included 24-hour urine total protein (24 h-UTP), serum albumin (Alb), glycated hemoglobin (HbA1c), and serum creatinine (Scr).The secondary outcomes included changes in levels of endothelin-1 (ET-1), nitric oxide (NO), vascular endothelial growth factor (VEGF), and traditional Chinese medicine (TCM) syndrome scores before and after treatment. Clinical efficacy was evaluated based on TCM syndrome scores and overall disease outcomes. Adverse reactions and endpoint events were recorded. ResultsIn the treatment group after treatment, 24 h-UTP, ET-1, and VEGF levels significantly decreased (P<0.05), Alb and NO levels significantly increased (P<0.05); while the TCM syndrome scores for edema, lumbar pain, numbness of limbs, dark purple lips, dark purple tongue or purpura, and thin, rough pulse all significantly decreased (P<0.05). In the control group, no significant changes were observed in any of the indicators after treatment (P>0.05).Compared with the control group, the treatment group showed significant reductions in 24 h-UTP, ET-1, and VEGF levels, and increases in Alb and NO levels (P<0.05). The TCM syndrome scores for edema, lumbar pain, dark purple tongue or purpura, and thin, rough pulse were all lower in the treatment group than in the control group (P<0.05). The total effective rate of TCM syndrome in the treatment group was 59.09% (26/44), and the overall clinical effective rate was 45.45% (20/44). In the control group, these rates were 15.22% (7/46) and 8.7% (4/46), respectively, with the treatment group showing significantly better outcomes (P<0.05). A total of 7 adverse events occurred across both groups, with no significant difference (P>0.05). No endpoint events occurred during the study. ConclusionOn the basis of conventional treatment of Western medicine, HTF can further reduce urinary protein levels and improve clinical symptoms in patients with mid-stage diabetic kidney disease of blood stasis syndrome. The mechanism may be related to its effects on endothelial function.
3.Graphene-based Heterostructure Modified Glassy Carbon Electrode for Sensitive Detection of Catechol
Peng LEI ; Peng-Jia WEI ; Ni WU ; Ming-Lu LI ; Shao-Min SHUANG
Chinese Journal of Analytical Chemistry 2025;53(1):65-73
Catechol(CC)is a highly toxic phenolic pollutant,and its sensitive detection holds significant importance for environmental monitoring.Herein,graphene was used as a template to prepare graphdiyne/graphene(GDY/GR)heterogeneous materials,serving as high-performance electrochemical sensing materials for CC determination.GR played the role of an epitaxial template during the growth of GDY.The electrochemical experiment results demonstrated that the glassy carbon electrode(GCE)modified with GDY/GR showed excellent electrochemical response to CC,with a wide linear detection range(1-900 μmol/L)and a low detection limit(0.11 μmol/L).Meanwhile,GDY/GR/GCE also exhibited good anti-interference ability,stability and reproducibility.More importantly,the practicality of GDY/GR/GCE was evaluated and satisfactory results were obtained in actual water samples,which showed significant potential for practical applications in environmental monitoring.
4.Application Progress of Metal-Organic Frameworks in Electrochemical Sensing of Antibiotics Residues
Lin WANG ; Shuang HAN ; Ji-Ping CHEN ; Xian-Bo LU
Chinese Journal of Analytical Chemistry 2025;53(4):535-546
Antibiotics are widely used in clinical treatment of bacterial infection diseases and in the breeding of livestock,poultry and aquatic products.However,the irrational and excessive use of antibiotics not only leads to the emergence of drug-resistant superbugs,but also the antibiotics discharged into the environment pose a significant threat to the environment and human health.Antibiotics have been included in the list of key new pollutants to be controlled.Therefore,the detection of residual antibiotics in environmental media and food is of vital importance for protecting the environment and public health.Among various antibiotic detection methods,electrochemical sensors have attracted extensive attention due to their high sensitivity,low cost,simplicity and rapidity.Appropriate modification of the electrode surface can enhance the sensitivity of electrochemical sensors,reduce interference and expand the detection range.Metal-organic frameworks(MOFs)materials have the advantages of rich types,adjustable structure and activity,high specific surface area and high porosity,and show great application potential in the field of electrochemical sensing.This paper first introduces the synthesis methods of MOFs,reviews the research progress of MOFs-modified electrodes for detection of common antibiotics by electrochemical sensors,and finally looks forward to their future development trends in the field of rapid antibiotic detection.
5.A predictive model for poor outcome of lower extremity motor function after acute ischemic stroke
Shuang XU ; Liming LU ; Zhaowei LI
International Journal of Cerebrovascular Diseases 2025;33(3):168-172
Objective:To develop and evaluate a nomogram prediction model for poor outcome of lower extremity motor function in patients with acute ischemic stroke (AIS) at 90 days after onset.Methods:Patients with AIS admitted to Guangzhou Province Hospital of Chinese Medicine from January to October 2024 were included retrospectively. At 90 days after onset, Functional Ambulation Category (FAC) was used for outcome evaluation. ≥4 was defined as good outcome and <4 was defined as poor outcome. Multivariate logistic regression analysis was used to identify the independent predictive factors for poor outcome of lower extremity motor function, and develop a nomogram prediction model. The area under the receiver operating characteristic curve, calibration curve, and clinical decision curve were used to evaluate the predictive model. Results:A total of 325 patients with AIS were enrolled, including 214 males (65.8%), median aged 62 years (interquartile range, 54-71 years); 158 patients (48.6%) had poor outcome of lower extremity motor function. Multivariate logistic regression analysis showed that older age (odds ratio [ OR] 1.037, 95% confidence interval [ CI] 1.011-1.065]; P=0.007) and a higher baseline National Institutes of Health Stroke Scale (NIHSS) score ( OR 1.472, 95% CI 1.336-1.637; P<0.001) were the independent predictors of poor outcome, while intravenous thrombolysis ( OR 0.195, 95% CI 0.080-0.443; P<0.001) and early rehabilitation intervention ( OR 0.444, 95% CI 0.231-0.850; P=0.014) were the independent predictors of good outcome. The area under the receiver operating characteristic curve of the nomogram prediction model developed using the above factors was 0.906 (95% CI 0.872-0.940), indicating that the model had good discriminability. The calibration curve fits well with the ideal curve. The clinical decision curve showed that the model had stronger clinical practicality. Conclusion:The nomogram developed by age, intravenous thrombolysis, early rehabilitation intervention, and baseline NIHSS score can effectively predict the risk of poor outcome of lower extremity motor function in patients with AIS and has higher clinical value.
6.The SMILE study: Study of long-term methotrexate and iguratimod combination therapy in early rheumatoid arthritis.
Fang DU ; Qing DAI ; Jialin TENG ; Liangjing LU ; Shuang YE ; Ping YE ; Zhiqian LIN ; Hong DING ; Min DAI ; Chunde BAO
Chinese Medical Journal 2025;138(14):1705-1713
BACKGROUND:
Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by chronic inflammation and joint destruction. Iguratimod (IGU) is a novel conventional synthetic disease-modifying antirheumatic drugs (csDMARD) with good efficacy and safety for the treatment of active RA in China and Japan. However, the long-term effects of IGU on the progression of bone destruction or radiographic progression in patients with active RA remain unknown. We aimed to investigate the efficacy and safety of iguratimod (IGU), a combination of methotrexate (MTX) and IGU, and IGU in patients with active rheumatoid arthritis (RA) who were naïve to MTX.
METHODS:
This multicenter, double-blind, randomized, non-inferiority clinical trial was conducted at 28 centers for over 52 weeks in China. In total, 911 patients were randomized (1:1:1) to receive MTX monotherapy (10-15 mg weekly, n = 293), IGU monotherapy (25 mg twice daily, n = 297), or IGU + MTX (10-15 mg weekly for MTX and 25 mg twice daily for IGU, n = 305) for 52 weeks. The patients' clinical characteristics, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), disease activity score in 28 joints-C-reactive protein (DAS28-CRP) level, and disease activity score in 28 joints-erythrocyte sedimentation rate (DAS28-ESR) were assessed at baseline. The primary endpoints were the proportion of patients with ≥20% improvement according to the American College of Rheumatology (ACR20) response and changes in the van der Heijde-modified total Sharp score (vdH-mTSS) at week 52.
RESULTS:
The proportions of patients achieving an ACR20 response at week 52 were 77.44%, 77.05 %, and 65.87% for IGU monotherapy, IGU + MTX, and MTX monotherapy, respectively. The non-inferiority of IGU monotherapy to MTX monotherapy was established with the ACR20 (11.57%; 95% confidence interval [CI], 4.35-18.79%; P <0.001) and vdH-mTSS (-0.37; 95% CI, -1.22-0.47; P = 0.022). IGU monotherapy was also superior to MTX monotherapy in terms of ACR20 ( P = 0.002) but not the vdH-mTSS. The superiority of IGU + MTX over MTX monotherapy was confirmed in terms of the ACR20 (11.18%; 95% CI, 3.99-18.37%; P = 0.003), but not in the vdH-mTSS (-0.68; 95% CI, -1.46-0.11; P = 0.091). However, the difference in the incidence rates of adverse events was not statistically significant.
CONCLUSIONS:
IGU monotherapy/IGU + MTX showed a more favorable clinical response than did MTX monotherapy. IGU may have some clinical benefits over MTX in terms of radiographic progression, implying that IGU may be considered as an initial therapeutic option for patients with active RA.
TRIAL REGISTRATION
https://classic.clinicaltrials.gov/ , NCT01548001.
Adult
;
Aged
;
Female
;
Humans
;
Male
;
Middle Aged
;
Antirheumatic Agents/therapeutic use*
;
Arthritis, Rheumatoid/drug therapy*
;
Chromones/adverse effects*
;
Double-Blind Method
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Drug Therapy, Combination
;
Methotrexate/adverse effects*
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Treatment Outcome
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Sulfonamides
7.CAR-based cell therapies for systemic lupus erythematosus.
Yiyang WANG ; Liangjing LU ; Shuang YE ; Qiong FU
Chinese Medical Journal 2025;138(5):523-530
The remarkable efficacy of chimeric antigen receptor (CAR) T cell therapy in hematological malignancies has provided a solid basis for the therapeutic concept, wherein specific pathogenic cell populations can be eradicated by means of targeted recognition. During the past few years, CAR-based cell therapies have been extensively investigated in preclinical and clinical research across various non-tumor diseases, with particular emphasis in the treatment of autoimmune diseases (ADs), yielding significant advancements. The recent deployment of CD19-directed CAR T cells has induced long-lasting, drug-free remission in patients with systemic lupus erythematosus (SLE) and other systemic ADs, alongside a more profound immune reconstruction of B cell repertoire compared with conventional immunosuppressive agents and B cell-targeting biologics. Despite the initial success achieved by CAR T cell therapy, it is critical to acknowledge the divergences in its application between cancer and ADs. Through examining recent clinical studies and ongoing research, we highlight the transformative potential of this therapeutic approach in the treatment of SLE, while also addressing the challenges and future directions necessary to enhance the long-term efficacy and safety of CAR-based cell therapies in clinical practice.
Humans
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Lupus Erythematosus, Systemic/immunology*
;
Receptors, Chimeric Antigen/metabolism*
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Immunotherapy, Adoptive/methods*
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Cell- and Tissue-Based Therapy/methods*
;
Animals
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T-Lymphocytes/immunology*
9.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
;
Immunosuppressive Agents/administration & dosage*
;
Delphi Technique
10.Application of palatopharyngeal arch staging system in assessing the severity of obstructive sleep apnea and airway collapse.
Zhenzhang LU ; Shuang WANG ; Xiaodan XU ; Wenqian ZHONG ; Jing TAO ; Guohui NIE ; Beiping MIAO
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(9):824-829
Objective:To investigate the relationship between the Palatopharyngeal Arch Staging System(PASS) and the severity of Obstructive Sleep Apnea(OSA), as well as the patterns of airway collapse, while further assessing its clinical applicability. Methods:A total of 98 patients diagnosed with OSA at the Department of Otorhinolaryngology Head and Neck Surgery, Shenzhen University Affiliated Shenzhen Hospital, were recruited for this study. Data collected included basic demographic information, oropharyngeal laryngoscopy videos, results from awake laryngoscopy Muller tests, and indicators from sleep respiratory monitoring. The distribution of each PASS stage among patients with varying severities of OSA was compared. Additionally, both objective and subjective sleep indicators along with occurrences of airway collapse in OSA patients across different PASS stages were analyzed. Results:In total, 98 patients participated in this study. Statistically significant differences were observed in neck circumference, weight, Body Mass Index(BMI), tongue position, and PASS stage when comparing mild-to-moderate OSA patients to those with severe OSA(P<0.05). Furthermore, there were statistically significant variations in Apnea-Hypopnea Index(AHI), minimum blood oxygen saturation levels, average blood oxygen saturation levels, oxygen desaturation index values, and total oxygen desaturation indices among OSA patients categorized by different PASS stages. Multiple comparisons revealed statistically significant differences in AHI as well as minimum and average blood oxygen saturation levels between patients at PASS 1 versus those at PASS 3(P<0.05). Additionally, notable differences regarding oropharyngeal collapse rates among OSA patients across various PASS stages were identified; specifically between those at PASS stage 1 and those at PASS stage 3. Conclusion:The proportion of PASS stages for OSA varies across different severity levels. The severity of OSA and the degree of airway collapse in patients with varying PASS stages also exhibit significant differences. Patients classified as PASS 3 demonstrate a more severe form of OSA compared to those at PASS 1, with stage 3 being more susceptible to oropharyngeal collapse than its stage 1 counterpart. This assessment system is anticipated to address the current limitations in evaluating the lateral pharyngeal wall within the oropharynx.
Humans
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Sleep Apnea, Obstructive/pathology*
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Male
;
Severity of Illness Index
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Female
;
Middle Aged
;
Polysomnography
;
Adult
;
Pharynx/physiopathology*
;
Aged

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