1.Establishment of graded management standards for off-label use of Shenqi fuzheng injection
Min WU ; Mei YU ; Shengnan YIN ; Dongmei LIU
China Pharmacy 2026;37(5):650-654
OBJECTIVE To establish the graded management standards for off-label use of Shenqi fuzheng injection. METHODS Systematic searches were conducted in databases including CNKI, PubMed and the Cochrane Library to retrieve guidelines/consensuses, systematic reviews/meta-analyses, and randomized controlled trials (RCTs) of Shenqi fuzheng injection. The quality of evidence was evaluated using AGREE Ⅱ, AMSTAR Ⅱ, and the Risk of Bias 1.0 tool recommended by Cochrane Collaboration, and the graded management standard for off-label use of Shenqi fuzheng injection was developed by using the Thomson grading system. RESULTS A total of 534 articles were involved, including 11 guidelines, 22 systematic reviews/meta-analysis, and 501 RCTs. They covered 79 off-label indications for Shenqi fuzheng injection: cancer-related fatigue, colorectal cancer and breast cancer, all with high-quality evidence were classified under grade A management (grade Ⅰ commendation), allowing all physicians across the hospital to prescribe relevant treatments; five diseases, such as ovarian cancer, liver cancer, leukemia, heart failure and cerebral infarction, were classified under grade B management (grade Ⅱa commendation), with prescription restricted to physicians with intermediate or higher professional titles in specific departments; eleven diseases, including sepsis, cervical cancer, esophageal cancer, etc., were classified under grade C management (grade Ⅱb commendation), requiring strict evaluation by senior physicians before prescription; the use of Shenqi fuzheng injection for other conditions was explicitly prohibited due to a lack of sufficient evidence. CONCLUSIONS Off-label use of Shenqi fuzheng injection is prevalent. The graded management standard established by evidence-based medical approach provides a scientific basis for standardizing the clinical application of traditional Chinese medicine injections and offers an operable paradigm for implementing differentiated drug use supervision in medical institutions.
2.Treatment Principles and Paradigm of Diabetic Microvascular Complications Responding Specifically to Traditional Chinese Medicine
Anzhu WANG ; Xing HANG ; Lili ZHANG ; Xiaorong ZHU ; Dantao PENG ; Ying FAN ; Min ZHANG ; Wenliang LYU ; Guoliang ZHANG ; Xiai WU ; Jia MI ; Jiaxing TIAN ; Wei ZHANG ; Han WANG ; Yuan XU ; .LI PINGPING ; Zhenyu WANG ; Ying ZHANG ; Dongmei SUN ; Yi HE ; Mei MO ; Xiaoxiao ZHANG ; Linhua ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(5):272-279
To explore the advantages of traditional Chinese medicine (TCM) and integrative TCM-Western medicine approaches in the treatment of diabetic microvascular complications (DMC), refine key pathophysiological insights and treatment principles, and promote academic innovation and strategic research planning in the prevention and treatment of DMC. The 38th session of the Expert Salon on Diseases Responding Specifically to Traditional Chinese Medicine, hosted by the China Association of Chinese Medicine, was held in Beijing, 2024. Experts in TCM, Western medicine, and interdisciplinary fields convened to conduct a systematic discussion on the pathogenesis, diagnostic and treatment challenges, and mechanism research related to DMC, ultimately forming a consensus on key directions. Four major research recommendations were proposed. The first is addressing clinical bottlenecks in the prevention and control of DMC by optimizing TCM-based evidence evaluation systems. The second is refining TCM core pathogenesis across DMC stages and establishing corresponding "disease-pattern-time" framework. The third is innovating mechanism research strategies to facilitate a shift from holistic regulation to targeted intervention in TCM. The fourth is advancing interdisciplinary collaboration to enhance the role of TCM in new drug development, research prioritization, and guideline formulation. TCM and integrative approaches offer distinct advantages in managing DMC. With a focus on the diseases responding specifically to TCM, strengthening evidence-based support and mechanism interpretation and promoting the integration of clinical care and research innovation will provide strong momentum for the modernization of TCM and the advancement of national health strategies.
3.Monitoring and improvement of disinfection procedure implementation in blood stations
Xia WANG ; Dongmei NIE ; Xinghui GU ; Qiong YU ; Caiming HE ; Guidan WU ; Xin ZHENG
Chinese Journal of Blood Transfusion 2026;39(6):762-767
Objective: To systematically evaluate the application effectiveness of the full disinfection process in blood stations, identify key optimization links, and provide a scientific evidence for the formulation of specialized disinfection and hygiene standards for blood collection and supply institutions. Methods: On-site microbiological monitoring was conducted using techniques such as the plate settling method and cotton swab method. Stratified random sampling was performed on eight key control points: including evironmental air, hand hygiene, skin disinfection, blood transport boxes, pressure steam sterilization, sewage treatment, ultraviolet disinfection, and sterile swabs. Statistical analysis was performed using SPSS 20.0. Measurement data were expressed as mean ± standard deviation(x-±s), and inter-group comparisons were conducted using t-tests or analysis of variance (ANOVA). Count data were expressed as rates, and inter-group comparisons were conducted using the χ
test. Trend analysis was performed using the Cochran-Armitage test, with a significance level of α=0.05. Results: The colony removal rate of plasma air disinfection machines (94.2%±0.8%) was significantly higher than that of the ultraviolet group (P<0.05). The qualification rate of quick-drying disinfectant hand was 100% within 30 days after opening the bottle, but decreased to 93.3% after 40 days (P<0.01). The qualification rate of disinfection for blood transport boxes using 500 mg/L chlorine-containing disinfectant (100%) was significant higher 75% alcohol (60%, P< 0.05). Skin disinfection with 2% alcoholic chlorhexidine gluconate balanced effectiveness and user experience (satisfaction score 4.8±0.3). The qualification rates for core procedures such as pressure steam sterilization and sewage treatment were both 100%. Conclusion: The current disinfection procedures in blood collection and supply institutions are reliable. The effective usage period of hand disinfectants, disinfection methods for transport boxes, and usage duration of sterile swabs are the main points for optimization. It is recommended that the opened hand disinfectants be used for ≤30 days and that chlorine-containing disinfectants be prioritized for wiping transport boxes, providing empirical support for the revision of protocols and the formulation of standards.
4.Hematopoietic stem cell and kidney transplantation from the same donor in a patient with acute myeloid leukemia and literature review
Yan YIN ; Zilin QUAN ; Li SONG ; Zhonglin FENG ; Dongmei CUI ; Liyan ZHAO ; Yuhang HU ; Qinghua ZHOU ; Xiaoli KANG ; Junjie LIAO ; Qizhen LIANG ; Suijin WU ; Hongmei WU ; Shuangxin LIU
Chinese Journal of Nephrology 2025;41(9):691-695
The paper reports a 32-year-old female acute myeloid leukemia patient who developed graft-versus-host disease after paternal hematopoietic stem cell transplantation, which subsequently led to renal thrombotic microangiopathy. She subsequently required a kidney transplant from the same donor 5 years later due to renal failure. Considering that both the bone marrow and kidney were from the same donor and the recovery of renal function was favorable, immunosuppressive therapy was discontinued after a short course of anti-rejection treatment, with maintained stable kidney function. This case suggests that under the condition of high chimerism, allogeneic hematopoietic stem cell transplantation and kidney transplantation from the same donor can achieve immune tolerance, potentially improving solid organ transplantation success rate. The findings provide a novel therapeutic approach for solid organ transplantation following allogeneic hematopoietic stem cell transplantation.
5.Clinical characteristics of juvenile dermatomyositis in anti-nuclear matrix protein 2 antibody-positive patients and risk factors for severity: a national multicenter retrospective study
Huiyuan YANG ; Wanzhen GUAN ; Ling2 YANG ; Haimei LIU ; Xiaoqing3 LI ; Haiguo YU ; Meiping LU ; Jun YANG ; Xiaohui LIU ; Hongxia ZHANG ; Wei ZHANG ; Jihong XIAO ; Xiaozhong LI ; Guomin LI ; Hong CHANG ; Sheng HAO ; Yue DU ; Daliang XU ; Ling WU ; Wenjie ZHENG ; Li LIU ; Xinhui JIANG ; Shaohui ZHU ; Dongmei ZHAO ; Xuemei TANG ; Li SUN
Chinese Journal of Pediatrics 2025;63(12):1299-1305
Objective:To investigate the clinical characteristics and independent risk factors of severe disease in patients with anti-nuclear matrix protein (NXP) 2 antibody-positive juvenile dermatomyositis (JDM).Methods:A retrospective cohort study was conducted, including 219 anti-NXP2 antibody-positive JDM patients admitted to 23 children′s hospitals across China from July 2011 to July 2023. Patients were classified into severe and non-severe groups based on classification criteria for severe dermatomyositis. Demographic characteristics, clinical manifestations, and laboratory parameters were compared between the 2 groups using independent sample t-test, Mann-Whitney U test, or χ2 test. Univariate and multivariate Logistic regression analyses were performed to identify risk factors for severe disease. The receiver operating characteristic curve was employed to calculate optimal cut-off values. Results:Among the 219 patients, 108 were male and 111 were female, with an age at onset of 6.3 (3.5, 9.4) years. The severe group comprised 69 patients, and the non-severe group 150 patients. The severe group had significantly higher rates of fever, heliotrope rash, subcutaneous edema, periorbital edema, anti-Ro52 antibody positivity, as well as elevated levels of ferritin-to-albumin ratio (FAR), creatine kinase (CK), aspartate aminotransferase (AST), and lactate dehydrogenase (LDH) (all P<0.05). Multivariate analysis identified anti-Ro52 antibody positivity ( OR=13.26, 95% CI 1.37-128.29) and elevated FAR ( OR=1.90, 95% CI 1.09-2.31) as independent risk factors for severe anti-NXP2 antibody-positive JDM (both P<0.05). Receiver operating characteristic curve analysis revealed that a FAR cutoff value of 6.82 predicted severe disease with an area under the curve of 0.87 (95% CI 0.81-0.94, P<0.001), sensitivity of 0.85, and specificity of 0.70. All patients received glucocorticoid therapy, and the severe group received higher proportions of steroid pulse therapy, cyclophosphamide, mycophenolate mofetil, intravenous immunoglobulin, biologics, and adjuvant treatments compared to the non-severe group (all P<0.05). In terms of outcomes, 2 patients (2.9%) in the severe group died (due to neurological involvement and intestinal perforation, respectively), while the remaining patients achieved complete clinical response or remission. All patients in the non-severe group achieved remission. Conclusions:The primary clinical features of anti-NXP2 antibody-positive JDM included fever, heliotrope rash, subcutaneous edema, periorbital edema, anti-Ro52 antibody positivity, and elevated levels of CK, AST, LDH, and FAR. Furthermore, anti-Ro52 antibody positivity and a FAR>6.82 were identified as independent risk factors.
6.Analysis of the efficacy and influencing factors of radiotherapy after keloid surgery
Xiaoxiao ZHOU ; Dongmei WU ; Yulong TIAN ; Qingyuan DUAN ; Minjie LI
China Modern Doctor 2025;63(2):9-11,23
Objective To explore the efficacy of hypofractionated radiotherapy at different time intervals after surgery for keloid,and to analyze the factors affecting the efficacy.Methods A total of 76 patients who underwent 20 Gy/5 postoperative radiotherapy regimen in the Fifth Affiliated Hospital of Zhengzhou University from January 2021 to June 2023 were selected as study subjects,and a total of 100 keloids were divided into effective group(n=79)and recurrence group(n=21).Regular follow-up and record of the patients after radiotherapy treatment effect and adverse effects,and multivariate Logistic was used to analyze factors of recurrence in keloid patients.Results Multivariate Logistic regression analysis found that postoperative radiotherapy time and scar incision length were related to recurrence after treatment,radiotherapy within 7h of surgery was an independent risk factor for recurrence after treatment(OR>1,P=0.022),and scar incision≤5cm was an independent protective factor for recurrence after treatment(OR<1,P=0.028).Conclusion Surgical excision combined with hypofractionated radiotherapy is one of the effective measures to prevent and treat keloid recurrence,though keloids on the trunk may need more effective treatment options.The recurrence rate of radiotherapy initiated 7-48h after surgery is relatively the lowest,and it is worthy of clinical promotion and application.
7.Effect of mechanism-based secondary preventive scheme on recurrence of intracranial arterial stenosis-related stroke cerebrovascular disease event and related factors analysis
Xirui LIU ; Xue WEI ; Linyan TONG ; Jinfang LI ; Dongmei WU ; Siyin GONG
Chongqing Medicine 2025;54(2):329-334
Objective To investigate the effect of secondary preventive scheme on recurrence rate of ce-rebrovascular event based on China ischemic stroke subclassification(CISS)of intracranial arterial stenosis is-chemic stroke(IS).Methods A total of 192 patients with intracranial arterial stenosis IS were prospectively included and the secondary preventive scheme was formulated according to whether or not based on the patho-genesis.Then the patients were divided into the personalized treatment group and conventional treatment group.The personalized group conducted the classification and was given different the secondary preventive schemes the artery-artery embolism group was given the active lipid-lowering scheme to make the low density lipoprotein(LDL)reaching the standard;the low hypoperfusion group was given the smooth pressure reduc-tion program;the carrier artery occlusion perforating artery group was given the routine secondary prevention program;the mixture mechanism group was given the corresponding schemes superposition according to dif-ferent mechanisms].The conventional treatment group was given the conventional secondary preventive scheme.The difference in the recurrence rate of cerebrovascular events on 90 d was compared between the two groups.Meanwhile the univariate and multivariate logistic regression were used to analyze the influencing fac-tors of recurrence of cerebrovascular events on 90 d in intracranial arterial stenosis IS.Results Among 192 study subjects,there were 90 cases in the personalized treatment group(20 cases of vector artery occlusion and perforator artery,44 cases of arterial-arterial embolization,6 cases of hypoperfusion and 20 cases of mixed mechanism).There were 102 cases in the conventional treatment group(16 cases of perforator artery occlu-sion of the vector artery,52 cases of arterial-arterial embolism,8 cases of hypoperfusion and 26 cases of mixed mechanism).The occurrence rate of cerebrovascular events on 90 d in the personalized treatment group was significantly decreased compared to the conventional treatment group(7.8%vs.17.6%,χ2=4.112,P=0.043).The Logistic regression analysis revealed that the active lipid-lowering scheme for LDL reaching the standard was the independent protective factor of the cerebrovascular event recurrence on 90 d(OR=0.128,95%CI:1.150-71.170).Conclusion The personalized secondary prevention scheme based on pathogenesis reduces the recurrence rate of cerebrovascular event in intracranial arterial stenosis IS,in which making the LDL reaching the standard by the active lipid-lowering scheme is the independent protective factor for cerebro-vascular event recurrence in intracranial arterial stenosis IS.
8.Electroacupuncture antagonizes morphine analgesic tolerance by inhibiting microglia activation and related mechanisms
Yu ZHAO ; Fei GAO ; Dai LI ; Dongmei WU ; Lixian XU
Academic Journal of Naval Medical University 2025;46(3):411-417
Objective To observe the effects of electroacupuncture(EA)on morphine-induced microglia activation and analgesic tolerance,and explore the potential mechanism of EA in the treatment of morphine analgesic tolerance.Methods A total of 60 clean-grade SD rats were randomly assigned to control group,morphine group,morphine+EA group,and morphine+EA+colony-stimulating factor 1(CSF1)group,with 15 rats in each group.Morphine analgesic tolerance model was established by continuous 7-d intrathecal injection of morphine in the morphine,morphine+EA and morphine+EA+CSF1 groups.EA was given in the rats of morphine+EA and morphine+EA+CSF1 groups at"Zusanli"and"Sanyinjiao"acupoints,with dilatational wave,frequency of 2/100 Hz,stimulation intensities of 0.5,1.0,and 1.5 mA(10 min per intensity),once a day,for 7 consecutive days.Rats in morphine+EA+CSF1 group were given intrathecal injection with recombinant CSF1 protein for 7 consecutive days.The effect of EA on morphine analgesic tolerance in rats was observed by mechanical withdrawal threshold(MWT).After 7 d,the rats were sacrificed,and the L4-6 spinal dorsal horn and dorsal root ganglion tissues were isolated.The expression of CSF1 protein and mRNA in the dorsal root ganglia and spinal dorsal horn was detected by Western blotting and quantitative polymerase chain reaction.The expression of ionized calcium-binding adapter molecule 1(IBA-1),a marker of microglia in the spinal dorsal horn,was detected by immunofluorescence method,and the expression of interleukin(IL)-1β,IL-6 and tumor necrosis factor(TNF)-α in the spinal cord was detected by enzyme-linked immunosorbent assay(ELISA).Results After intrathecal injection of morphine,the percentage of maximal possible potential effect(%MPE)in the morphine group was decreased progressively,indicating that the morphine analgesic tolerance model was successfully constructed.Compared with the morphine group,the%MPE in the morphine+EA group was increased after intrathecal injection at 3,5 and 7 d(all P<0.05).Compared with the morphine+EA group,the%MPE in the morphine+EA+CSF1 group was all decreased after intrathecal injection at 3,5 and 7 d(all P<0.05).Compared with the control group,the expression of CSF1 protein and mRNA in dorsal root ganglion and the expression of CSF1 protein in spinal dorsal horn in the morphine group were increased(all P<0.05).Compared with the morphine group,the expression levels of CSF1 protein and mRNA in dorsal root ganglion and CSF1 protein in spinal dorsal horn in the morphine+EA group were decreased(all P<0.05).There was no significant difference in the expression of CSF1 mRNA in the spinal dorsal horn among those groups(all P>0.05).Compared with the control group,the expression of IBA-1 in the spinal dorsal horn of the morphine group was increased(P<0.05).Compared with the morphine group,the expression of IBA-1 in the spinal dorsal horn of the morphine+EA group was decreased(P<0.05).Compared with the morphine+EA group,the expression of IBA-1 in the spinal dorsal horn of the morphine+EA+CSF1 group was increased(P<0.05).Conclusion EA can inhibit the activation of microglia in the spinal dorsal horn of rats and improve morphine analgesic tolerance in rats.The mechanism may be related to the reduction of CSF1 protein expression in the spinal dorsal horn.
9.Effects of metformin on gut microbiota and short-/medium-chain fatty acids in high-fat diet rats.
Ying SHI ; Lin XING ; Shanyu WU ; Fangzhi YUE ; Tianqiong HE ; Jing ZHANG ; Lingxuan OUYANG ; Suisui GAO ; Dongmei ZHANG ; Zhijun ZHOU
Journal of Central South University(Medical Sciences) 2025;50(5):851-863
OBJECTIVES:
Recent evidence suggests that the gut may be a primary site of metformin action. However, studies on the effects of metformin on gut microbiota remain limited, and its impact on gut microbial metabolites such as short-/medium-chain fatty acids is unclear. This study aims to investigate the effects of metformin on gut microbiota, short-/medium-chain fatty acids, and associated metabolic benefits in high-fat diet rats.
METHODS:
Twenty-four Sprague-Dawley rats were randomly divided into 3 groups: 1) Normal diet group (ND group), fed standard chow; 2) high-fat diet group (HFD group), fed a high-fat diet; 3) high-fat diet + metformin treatment group (HFD+Met group), fed a high-fat diet for 8 weeks, followed by daily intragastric administration of metformin solution (150 mg/kg body weight) starting in week 9. At the end of the experiment, all rats were sacrificed, and serum, liver, and colonic contents were collected for assessment of glucose and lipid metabolism, liver pathology, gut microbiota composition, and the concentrations of short-/medium-chain fatty acids.
RESULTS:
Metformin significantly improved HFD-induced glucose and lipid metabolic disorders and liver injury. Compared with the HFD group, the HFD+Met group showed reduced abundance of Blautia, Romboutsia, Bilophila, and Bacteroides, while Lactobacillus abundance significantly increased (all P<0.05). Colonic contents of butyric acid, 2-methyl butyric acid, valeric acid, octanoic acid, and lauric acid were significantly elevated (all P<0.05), whereas acetic acid, isoheptanoic acid, and nonanoic acid levels were significantly decreased (all P<0.05). Spearman correlation analysis revealed that Lactobacillus abundance was negatively correlated with body weight gain and insulin resistance, while butyrate and valerate levels were negatively correlated with insulin resistance and liver injury (all P<0.05).
CONCLUSIONS
Metformin significantly increases the abundance of beneficial bacteria such as Lactobacillus and promotes the production of short-/medium-chain fatty acids including butyric, valeric, and lauric acid in the colonic contents of HFD rats, suggesting that metformin may regulate host metabolism through modulation of the gut microbiota.
Animals
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Metformin/pharmacology*
;
Rats, Sprague-Dawley
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Diet, High-Fat/adverse effects*
;
Rats
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Gastrointestinal Microbiome/drug effects*
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Male
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Fatty Acids, Volatile/metabolism*
;
Fatty Acids/metabolism*
10.Ursodeoxycholic acid inhibits the uptake of cystine through SLC7A11 and impairs de novo synthesis of glutathione.
Fu'an XIE ; Yujia NIU ; Xiaobing CHEN ; Xu KONG ; Guangting YAN ; Aobo ZHUANG ; Xi LI ; Lanlan LIAN ; Dongmei QIN ; Quan ZHANG ; Ruyi ZHANG ; Kunrong YANG ; Xiaogang XIA ; Kun CHEN ; Mengmeng XIAO ; Chunkang YANG ; Ting WU ; Ye SHEN ; Chundong YU ; Chenghua LUO ; Shu-Hai LIN ; Wengang LI
Journal of Pharmaceutical Analysis 2025;15(1):101068-101068
Ursodeoxycholic acid (UDCA) is a naturally occurring, low-toxicity, and hydrophilic bile acid (BA) in the human body that is converted by intestinal flora using primary BA. Solute carrier family 7 member 11 (SLC7A11) functions to uptake extracellular cystine in exchange for glutamate, and is highly expressed in a variety of human cancers. Retroperitoneal liposarcoma (RLPS) refers to liposarcoma originating from the retroperitoneal area. Lipidomics analysis revealed that UDCA was one of the most significantly downregulated metabolites in sera of RLPS patients compared with healthy subjects. The augmentation of UDCA concentration (≥25 μg/mL) demonstrated a suppressive effect on the proliferation of liposarcoma cells. [15N2]-cystine and [13C5]-glutamine isotope tracing revealed that UDCA impairs cystine uptake and glutathione (GSH) synthesis. Mechanistically, UDCA binds to the cystine transporter SLC7A11 to inhibit cystine uptake and impair GSH de novo synthesis, leading to reactive oxygen species (ROS) accumulation and mitochondrial oxidative damage. Furthermore, UDCA can promote the anti-cancer effects of ferroptosis inducers (Erastin, RSL3), the murine double minute 2 (MDM2) inhibitors (Nutlin 3a, RG7112), cyclin dependent kinase 4 (CDK4) inhibitor (Abemaciclib), and glutaminase inhibitor (CB839). Together, UDCA functions as a cystine exchange factor that binds to SLC7A11 for antitumor activity, and SLC7A11 is not only a new transporter for BA but also a clinically applicable target for UDCA. More importantly, in combination with other antitumor chemotherapy or physiotherapy treatments, UDCA may provide effective and promising treatment strategies for RLPS or other types of tumors in a ROS-dependent manner.

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