1.Correlation Between Cardiovascular Events and Traditional Chinese Medicine Syndrome in Patients with Rheumatoid Arthritis:A Cross-Sectional Study
Fuyuan ZHANG ; Quan JIANG ; Jun LI ; Yuchen YANG ; Xieli MA ; Tian CHANG ; Congmin XIA ; Jian WANG ; Xun GONG
Journal of Traditional Chinese Medicine 2025;66(15):1572-1578
ObjectiveTo explore the correlation between the occurrence of cardiovascular events in rheumatoid arthritis(RA) and traditional Chinese medicine(TCM) syndrome. MethodsThe cross-sectional study selected 6713 RA patients from 122 centres nationwide, in which general information such as name, gender, age, height, body weight, and course of disease were collected by completing a questionnaire; patients were classified into eight types of syndrome according to the information of their four examinations,i.e. wind-dampness obstruction syndrome, cold-dampness obstruction syndrome, dampness-heat obstruction syndrome, phlegm-stasis obstruction syndrome, stasis-blood obstructing collateral syndrome, qi-blood deficiency syndrome, liver-kidney insufficiency syndrome, and qi-yin deficiency syndrome. According to the occurrence of cardiovascular events, they were divided into the occurrence group and the non-occurrence group, and the condition assessment data and laboratory examination indexes were recorded. The test of difference between groups was used to analyse the possible risk factors for the occurrence of RA cardiovascular events, and binary logistic regression was used to analyse the correlation between TCM syndromes and RA cardiovascular events. ResultsA total of 6713 RA patients were included, including 256 cases in occurrence group and 6457 in non-occurrence group. There was no statistically significant difference between groups in terms of height, gender, insomnia, appetite, white blood cell(WBC), hemoglobin(HGB), platelets(PLT), rheumatoid factor(RF), anti-cyclic peptide containing citrulline(CCP), alanine aminotransferase(ALT), aspartate aminotransferase(AST), γ-glutamyl transpeptidase(GGT), urea creatinine(CREA), and glucose(GLU)(P>0.05). The TCM syndromes between groups showed significant statistic differences(P<0.05). Patients in occurrence group had longer disease duration, heavier body weight, and older age; more severe conditions such as disease activity(DAS-28), number of painful joints(TJC), number of swollen joints(SJC), health questionnaire scores(HAQ), visual analog scores(VAS), restlessness, and fatigue; higher blood sedimentation rate(ESR), low-density lipoprotein(LDL-C), triglyceride(TG), total cholesterol(TC), D-Dimer, and lower high-density lipoprotein(HDL-C)(P<0.05). The distribution of syndrome types showed that dampness-heat obstruction syndrome accounted for the largest proportion of patients in both groups and was higher in RA cardiovascular events. Logistic regression analysis showed that the occurrence of RA cardiovascular events was strongly associated with dampness-heat obstruction syndrome[OR=5.937, 95%CI (4.434, 7.949), P<0.001]. ConclusionThe occurrence of RA cardiovascular events were associated with TCM syndromes, and the probability of cardiovascular events in the RA patients with dampness-heat obstruction syndrome was 5.937 times higher than patients with other TCM syndromes.
2.Feixin Decoction Treats Hypoxic Pulmonary Hypertension by Regulating Pyroptosis in PASMCs via PPARγ/NF-κB/NLRP3 Signaling Pathway
Junlan TAN ; Xianya CAO ; Runxiu ZHENG ; Wen ZHANG ; Chao ZHANG ; Jian YI ; Feiying WANG ; Xia LI ; Jianmin FAN ; Hui LIU ; Lan SONG ; Aiguo DAI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(18):1-9
ObjectiveTo investigate the mechanism by which Feixin decoction treats hypoxic pulmonary hypertension (HPH) by regulating the peroxisome proliferator-activated receptor gamma (PPARγ)/nuclear factor-kappa B (NF-κB)/NOD-like receptor pyrin domain containing 3 (NLRP3) signaling pathway. MethodsForty-eight male SD rats were randomly allocated into normal, hypoxia, and low-, medium- and high-dose (5.85, 11.7, 23.4 g·kg-1, respectively) Feixin decoction groups, with 8 rats in each group. Except the normal group, the remaining five groups were placed in a hypoxia chamber with an oxygen concentration of (10.0±0.5)% for 8 h per day, 28 days, and administrated with corresponding drugs during the modeling process. After 4 weeks of treatment, echocardiographic parameters [pulmonary artery acceleration time (PAT), pulmonary artery ejection time (PET), right ventricular anterior wall thickness (RVAWd), and tricuspid annular plane systolic excursion (TAPSE)] were measured for each group. The right ventricular systolic pressure (RVSP) was measured by the right heart catheterization method, and the right ventricular hypertrophy index (RVHI) was calculated by weighing the heart. The pathological changes in pulmonary arterioles were observed by hematoxylin-eosin staining. The co-localization of α-smooth muscle actin (α-SMA) with NLRP3, N-terminal gasdermin D (N-GSDMD), and cysteinyl aspartate-specific proteinase-1 (Caspase-1) in pulmonary arteries was detected by immunofluorescence. The protein levels of PPARγ, NF-κB, NLRP3, apoptosis-associated speck-like protein containing a CARD (ASC), N-GSDMD, interleukin-1β (IL-1β), interleukin-18(IL-18), and cleaved Caspase-1 in the lung tissue was determined by Western blot. The ultrastructural changes in pulmonary artery smooth muscle cells (PASMCs) were observed by transmission electron microscopy. ResultsCompared with the normal group, the hypoxia group showed increased RVSP and RVHI (P<0.01), decreased right heart function (P<0.01), increased pulmonary vascular remodeling (P<0.01), increased co-localization of α-SMA with NLRP3, N-GSDMD, and Caspase-1 in pulmonary arterioles (P<0.01), up-regulated protein levels of NF-κB, NLRP3, ASC, N-GSDMD, IL-1β, IL-18, and cleaved Caspase-1 in the lung tissue (P<0.05, P<0.01), a down-regulated protein level of PPARγ (P<0.05, P<0.01), and pyroptosis in PASMCs. Compared with the hypoxia group, Feixin decoction reduced RVSP and RVHI, improved the right heart function and ameliorated pulmonary vascular remodeling (P<0.05, P<0.01), decreased the co-localization of α-SMA with NLRP3, N-GSDMD, and Caspase-1 (P<0.05, P<0.01), down-regulated the protein levels of NF-κB, NLRP3, ASC, N-GSDMD, IL-1β, IL-18, and cleaved Caspase-1 in the lung tissue (P<0.05, P<0.01), up-regulated the protein level of PPARγ (P<0.05, P<0.01), and alleviated pyroptosis in PASMCs. ConclusionFeixin decoction can ameliorate pulmonary vascular remodeling and right heart dysfunction in chronically induced HPH rats by regulating pyroptosis in PASMCs through the PPARγ/NF-κB/NLRP3 pathway.
3.Expert consensus on evaluation index system construction for new traditional Chinese medicine(TCM) from TCM clinical practice in medical institutions.
Li LIU ; Lei ZHANG ; Wei-An YUAN ; Zhong-Qi YANG ; Jun-Hua ZHANG ; Bao-He WANG ; Si-Yuan HU ; Zu-Guang YE ; Ling HAN ; Yue-Hua ZHOU ; Zi-Feng YANG ; Rui GAO ; Ming YANG ; Ting WANG ; Jie-Lai XIA ; Shi-Shan YU ; Xiao-Hui FAN ; Hua HUA ; Jia HE ; Yin LU ; Zhong WANG ; Jin-Hui DOU ; Geng LI ; Yu DONG ; Hao YU ; Li-Ping QU ; Jian-Yuan TANG
China Journal of Chinese Materia Medica 2025;50(12):3474-3482
Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards*
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Humans
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Consensus
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Drugs, Chinese Herbal/therapeutic use*
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Surveys and Questionnaires
4.Quality evaluation of Bidentis Herba based on HPLC fingerprint, multi-component content determination, and chemometrics.
Guo-Li SHI ; Xin-Feng WANG ; Wei-Qun LI ; Jian-Wei FAN ; Yong-Xia GUAN
China Journal of Chinese Materia Medica 2025;50(14):3944-3950
This study established the HPLC fingerprints and a multi-component content determination method for Bidens pilosa var. radiata and B. pilosa and conducted comprehensive evaluation by integrating fingerprint similarity comparison, cluster analysis(CA), and principal component analysis(PCA), aiming to provide a reference for the establishment of quality standards for Bidentis Herba. HPLC was launched on an Agilent Poroshell 120 EC-C_(18) chromatographic column(4.6 mm×250 mm, 4 μm) by gradient elution with a mobile phase of 0.1% aqueous phosphoric acid-acetonitrile at a flow rate of 0.7 mL·min~(-1), detection wavelength of 270 nm, column temperature of 25 ℃, and an injection volume of 5 μL. The fingerprint similarity of 20 batches of Bidentis Herba ranged from 0.775 to 0.979. A total of 20 common peaks were identified, and seven components were confirmed through comparison with reference substances: neochlorogenic acid, chlorogenic acid, isochlorogenic acid A, isochlorogenic acid B, isochlorogenic acid C, rutin, and hyperoside. These seven components exhibited good linearity within the ranges of 3.4-67.4, 33.0-660.3, 26.6-531.2, 3.5-70.5, 6.2-124.9, 2.4-48.3, and 4.6-91.5 μg·mL~(-1), respectively, with correlation coefficients(r) greater than 0.999. The average recovery rates ranged from 96.47% to 104.6%. CA and PCA classified the 20 batches of Bidentis Herba into two categories. PCA yielded two principal components, with a cumulative variance contribution rate of 80.557%. The established HPLC fingerprints and multi-component content determination method are simple and accurate, providing a scientific basis for the quality control and quality standard formulation of Bidentis Herba.
Chromatography, High Pressure Liquid/methods*
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Drugs, Chinese Herbal/chemistry*
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Quality Control
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Chemometrics/methods*
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Bidens/chemistry*
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Principal Component Analysis
5.Effects of combined use of active ingredients in Buyang Huanwu Decoction on oxygen-glucose deprivation/reglucose-reoxygenation-induced inflammation and oxidative stress of BV2 cells.
Tian-Qing XIA ; Ying CHEN ; Jian-Lin HUA ; Qin SU ; Cun-Yan DAN ; Meng-Wei RONG ; Shi-Ning GE ; Hong GUO ; Bao-Guo XIAO ; Jie-Zhong YU ; Cun-Gen MA ; Li-Juan SONG
China Journal of Chinese Materia Medica 2025;50(14):3835-3846
This study aims to explore the effects and action mechanisms of the active ingredients in Buyang Huanwu Decoction(BYHWD), namely tetramethylpyrazine(TMP) and hydroxy-safflor yellow A(HSYA), on oxygen-glucose deprivation/reglucose-reoxygenation(OGD/R)-induced inflammation and oxidative stress of microglia(MG). Network pharmacology was used to screen the effective monomer ingredients of BYHWD and determine the safe concentration range for each component. Inflammation and oxidative stress models were established to further screen the best ingredient combination and optimal concentration ratio with the most effective anti-inflammatory and antioxidant effects. OGD/R BV2 cell models were constructed, and BV2 cells in the logarithmic growth phase were divided into a normal group, a model group, an HSYA group, a TMP group, and an HSYA + TMP group. Enzyme-linked immunosorbent assay(ELISA) was used to detect the levels of inflammatory cytokines such as interleukin-1β(IL-1β), tumor necrosis factor-α(TNF-α), and interleukin-6(IL-6). Oxidative stress markers, including superoxide dismutase(SOD), nitric oxide(NO), and malondialdehyde(MDA), were also measured. Western blot was used to analyze the protein expression of both inflammation-related pathway [Toll-like receptor 4(TLR4)/nuclear factor-kappa B(NF-κB)] and oxidative stress-related pathway [nuclear factor erythroid 2-related factor 2(Nrf2)/heme oxygenase-1(HO-1)]. Immunofluorescence was used to assess the expression of proteins such as inducible nitric oxide synthase(iNOS) and arginase-1(Arg-1). The most effective ingredients for anti-inflammatory and antioxidant effects in BYHWD were TMP and HSYA. Compared to the normal group, the model group showed significantly increased levels of IL-1β, TNF-α, IL-6, NO, and MDA, along with significantly higher protein expression of NF-κB, TLR4, Nrf2, and HO-1 and significantly lower SOD levels. The differences between the two groups were statistically significant. Compared to the model group, both the HSYA group and the TMP group showed significantly reduced levels of IL-1β, TNF-α, IL-6, NO, and MDA, lower expression of NF-κB and TLR4 proteins, higher levels of SOD, and significantly increased protein expression of Nrf2 and HO-1. Additionally, the expression of the M1-type MG marker iNOS was significantly reduced, while the expression of the M2-type MG marker Arg-1 was significantly increased. The results of the HSYA group and the TMP group had statistically significant differences from those of the model group. Compared to the HSYA group and the TMP group, the HSYA + TMP group showed further significant reductions in IL-1β, TNF-α, IL-6, NO, and MDA levels, along with significant reductions in NF-κB and TLR4 protein expression, an increase in SOD levels, and elevated Nrf2 and HO-1 protein expression. Additionally, the expression of the M1-type MG marker iNOS was reduced, while the M2-type MG marker Arg-1 expression increased significantly in the HSYA + TMP group compared to the TMP or HSYA group. The differences in the results were statistically significant between the HSYA + TMP group and the TMP or HSYA group. The findings indicated that the combined use of HSYA and TMP, the active ingredients of BYHWD, can effectively inhibit OGD/R-induced inflammation and oxidative stress of MG, showing superior effects compared to the individual use of either component.
Oxidative Stress/drug effects*
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Drugs, Chinese Herbal/pharmacology*
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Animals
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Mice
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Glucose/metabolism*
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Cell Line
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Inflammation/genetics*
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Oxygen/metabolism*
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Pyrazines/pharmacology*
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Microglia/metabolism*
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NF-E2-Related Factor 2/immunology*
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NF-kappa B/immunology*
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Toll-Like Receptor 4/immunology*
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Anti-Inflammatory Agents/pharmacology*
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Humans
6.Quality evaluation of Bidentis Herba derived from different original plants based on HPLC fingerprints, characteristic chromatograms, multi-component content determination combined with chemical pattern recognition.
Guo-Li SHI ; Yun MA ; Feng-Xia SHEN ; Han-Wen DU ; Cong-Min LIU ; Rui-Xia WEI ; Yan-Fang LI ; Jian-Wei FAN ; Yong-Xia GUAN
China Journal of Chinese Materia Medica 2025;50(15):4284-4292
This study established the HPLC fingerprints, characteristic chromatograms, and a multi-component content determination method for Bidens bipinnata and B. biternata. The chemical pattern recognition analysis was then employed to clarify the characteristic indexes of quality differences between the two original plants of Bidentis Herba, providing a reference for establishing the quality standards of Bidentis Herba. HPLC was launched on an Agilent Poroshell 120 EC-C_(18) chromatographic column(4.6 mm×250 mm, 4 μm) by gradient elution with a mobile phase of 0.1% aqueous phosphoric acid-acetonitrile at a flow rate of 0.7 mL·min~(-1), detection wavelength of 270 nm, column temperature of 25 ℃, and an injection volume of 5 μL. The similarity between the fingerprints of 18 batches of Bidentis Herba samples and the common pattern(R) ranged from 0.572 to 0.933. A total of 23 chromatographic peaks were calibrated. Through comparison with the reference substances, six components(neochlorogenic acid, chlorogenic acid, isochlorogenic acid A, isochlorogenic acid B, rutin, and hyperoside) were identified and subjected to quantitative analysis. The characteristic fingerprints of B. bipinnata and B. biternata were calibrated with 20 and 17 characteristic peaks, respectively. Among them, peaks 8, 9, 22, and 23 were the characteristic peaks of B. bipinnata, and peak 7 was the characteristic peak of B. biternata, which can be used to distinguish the two original plants of Bidentis Herba. The relative standard deviation of the content of the above-mentioned six components ranged from 36% to 123%. The cluster analysis, principal component analysis, and orthogonal partial least squares-discriminant analysis(OPLS-DA) classified the 18 batches of Bidentis Herba samples into two categories. Additionally, through the analysis of variable importance in projection(VIP) under OPLS-DA, three characteristic indexes, rutin, isochlorogenic acid A, and isochlorogenic acid B, were identified. The analytical method established in this study can comprehensively evaluate the consistency of Bidentis Herba samples derived from different original plants, specifically identify the differential components between them, and effectively distinguish the two original plants of Bidentis Herba, providing a basis for the differentiation between different original plants and the quality control of Bidentis Herba.
Chromatography, High Pressure Liquid/methods*
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Drugs, Chinese Herbal/chemistry*
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Quality Control
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Bidens/chemistry*
7.Correlation between bone mass loss and incidence of knee osteoarthritis in the elderly community-based population.
Chen-Jie XIA ; Jin LI ; Xiang LI ; Ke ZHOU ; Liang FANG ; Hong-Ting JIN ; Pei-Jian TONG
China Journal of Orthopaedics and Traumatology 2025;38(4):358-363
OBJECTIVE:
To explore the epidemiological characteristics of knee osteoarthritis (KOA) among the elderly in the community, and its correlation with bone mass loss.
METHODS:
A cross-sectional study was conducted on elderly community population over 50 year old from 12 community health service centers in Zhejiang province. Their gender, age, body mass index (BMI), T value and KOA diagnosis were collected using face to face questionnaire survey. Univariate regression was used to analyze the influence of age, gender, BMI and bone loss on KOA. Logistic multivariate regression model was used to analyze the independent effect of bone mass loss on KOA.
RESULTS:
Among 4 173 subjects in this study, 1 710 of them were had a KOA. The prevalence rate was 40.9%. The mean age, the proportion of females and the mean BMI in KOA patients were (65.5±3.8) years old, 67.7%(1 158/1 710) and(24.59±1.28) kg·m-2, respectively, which were significantly higher than (58.5±3.2) years old, 51.3%(1 263/2 463), and (23.48±1.25) kg·m-2 in non-KOA subjects (P<0.001). In the population aged from 60 to 69 years old, the influence of osteopenia and osteoporosis on the prevalence of KOA was[OR=1.21, 95%CI(1.00, 1.46), P=0.053 2], [OR=1.42, 95%CI(1.14, 1.78), P=0.002 2]. The influence of male and female osteoporosis on the prevalence of KOA was [OR=1.52, 95%CI(1.16, 1.99), P=0.002 7] and [OR=1.87, 95%CI(1.51, 2.32), P<0.000 1], respectively. In the population of 24 kg·m-2≤BMI<28 kg·m-2, the influence of osteopenia and osteoporosis on the prevalence of KOA was [OR=1.47, 95%CI(1.21, 1.80), P=0.000 1], [OR=2.69, 95%CI(2.11, 3.42), P<0.000 1], respectively. After controlling the confounding factors of age, gender and BMI, compared with people with normal bone mass, the effect of osteopenia on the prevalence of KOA was [OR=1.34, 95%CI(1.08, 1.67), P=0.009 2], and the effect of osteoporosis on the prevalence of KOA was [OR=1.38, 95%CI(1.06, 1.79), P=0.017 9].
CONCLUSION
Elderly overweight women are more likely to develop KOA. Bone mass loss is an independent risk factor for KOA, which will significantly increase the prevalence of KOA in people overweight or aged 60 to 69 years old.
Humans
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Female
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Male
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Aged
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Osteoarthritis, Knee/etiology*
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Middle Aged
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Cross-Sectional Studies
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Bone Density
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Aged, 80 and over
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Incidence
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Body Mass Index
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China/epidemiology*
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Osteoporosis/epidemiology*
8.Febrile infection-related epilepsy syndrome caused by hemophagocytic lymphohistiocytosis: a case report.
Xiao-Lu DENG ; Li-Fen YANG ; Xia WANG ; Hui ZHANG ; Jian HE ; Jing PENG
Chinese Journal of Contemporary Pediatrics 2025;27(7):864-869
The patient was a girl, aged 10 years, who was admitted due to fever for 5 days and pancytopenia in peripheral blood for 2 days. Bone marrow examination showed the presence of phagocytic activity, and peripheral blood tests showed pancytopenia, an increase in ferritin, a reduction in fibrinogen, increases in triglyceride and sCD25, and a reduction in natural killer cell activity, which led to the diagnosis of hemophagocytic lymphohistiocytosis (HLH). On the day of admission, the child developed convulsions and rapidly progressed to refractory status epilepticus, which was consistent with the manifestations of febrile infection-related epilepsy syndrome. HLH was controlled after active immunotherapy, with the sequela of refractory epilepsy, and her cognitive function was essentially within normal limits. This article reports the condition of febrile infection-related epilepsy syndrome caused by HLH for the first time in China, in order to improve the awareness of this disease among clinicians.
Humans
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Lymphohistiocytosis, Hemophagocytic/complications*
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Female
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Child
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Epilepsy/etiology*
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Fever/etiology*
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Epileptic Syndromes/etiology*
9.Thiotepa-containing conditioning for allogeneic hematopoietic stem cell transplantation in children with inborn errors of immunity: a retrospective clinical analysis.
Xiao-Jun WU ; Xia-Wei HAN ; Kai-Mei WANG ; Shao-Fen LIN ; Li-Ping QUE ; Xin-Yu LI ; Dian-Dian LIU ; Jian-Pei FANG ; Ke HUANG ; Hong-Gui XU
Chinese Journal of Contemporary Pediatrics 2025;27(10):1240-1246
OBJECTIVES:
To evaluate the safety and efficacy of thiotepa (TT)-containing conditioning regimens for allogeneic hematopoietic stem cell transplantation (HSCT) in children with inborn errors of immunity (IEI).
METHODS:
Clinical data of 22 children with IEI who underwent HSCT were retrospectively reviewed. Survival after HSCT was estimated using the Kaplan-Meier method.
RESULTS:
Nine patients received a traditional conditioning regimen (fludarabine + busulfan + cyclophosphamide/etoposide) and underwent peripheral blood stem cell transplantation (PBSCT). Thirteen patients received a TT-containing modified conditioning regimen (TT + fludarabine + busulfan + cyclophosphamide), including seven PBSCT and six umbilical cord blood transplantation (UCBT) cases. Successful engraftment with complete donor chimerism was achieved in all patients. Acute graft-versus-host disease occurred in 12 patients (one with grade III and the remaining with grade I-II). Chronic graft-versus-host disease occurred in one patient. The incidence of EB viremia in UCBT patients was lower than that in PBSCT patients (P<0.05). Over a median follow-up of 36.0 months, one death occurred. The 3-year overall survival (OS) rate was 100% for the modified regimen and 88.9% ± 10.5% for the traditional regimen (P=0.229). When comparing transplantation types, the 3-year OS rates were 100% for UCBT and 93.8% ± 6.1% for PBSCT (P>0.05), and the 3-year event-free survival rates were 100% and 87.1% ± 8.6%, respectively (P>0.05).
CONCLUSIONS
TT-containing conditioning for allogeneic HSCT in children with IEI is safe and effective. Both UCBT and PBSCT may achieve high success rates.
Humans
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Retrospective Studies
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Transplantation Conditioning/methods*
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Thiotepa/therapeutic use*
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Hematopoietic Stem Cell Transplantation/adverse effects*
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Male
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Female
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Child, Preschool
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Infant
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Child
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Transplantation, Homologous
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Graft vs Host Disease
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Adolescent
10.Robot-assisted percutaneous coronary intervention: a prospective, multicenter, randomized controlled, non-inferiority clinical trial.
Yi YU ; Zheng CHEN ; Zhi-Jian WANG ; Yue-Ping LI ; Li-Xia YANG ; Jing QI ; Jing XIE ; Tao HUANG ; Dong-Mei SHI ; Yu-Jie ZHOU
Journal of Geriatric Cardiology 2025;22(8):725-735
OBJECTIVE:
To evaluate the safety and effectiveness of robot-assisted percutaneous coronary intervention (R-PCI) compared to traditional manual percutaneous coronary intervention (M-PCI).
METHODS:
This prospective, multicenter, randomized controlled, non-inferior clinical trial enrolled patients with coronary heart disease who met the inclusion criteria and had indications for elective percutaneous coronary intervention. Participants were randomly assigned to either the R-PCI group or the M-PCI group. Primary endpoints were clinical and technical success rates. Clinical success was defined as visually estimated residual post-percutaneous coronary intervention stenosis < 30% with no 30-day major adverse cardiac events. Technical success in the R-PCI group was defined as successful completion of percutaneous coronary intervention using the ETcath200 robot-assisted system, without conversion to M-PCI in the event of a guidewire or balloon/stent catheter that was unable to cross the vessel or was poorly supported by the catheter. Secondary endpoints included total procedure time, percutaneous coronary intervention procedure time, fluoroscopy time, contrast volume, operator radiation exposure, air kerma, and dose-area product.
RESULTS:
The trial enrolled 152 patients (R-PCI: 73 patients, M-PCI: 79 patients). Lesions were predominantly B2/C type (73.6%). Both groups achieved 100% clinical success rate. No major adverse cardiac events occurred during the 30-day follow-up. The R-PCI group had a technical success rate of 100%. The R-PCI group had longer total procedure and fluoroscopy times, but lower operator radiation exposure. The percutaneous coronary intervention procedure time, contrast volume, air kerma, and dose-area product were similar between the two groups.
CONCLUSIONS
For certain complex lesions, performing percutaneous coronary intervention using the ETcath200 robot-assisted system is safe and effective and does not result in conversion to M-PCI.

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