1.Myocardial Metabolomics Reveals Mechanism of Shenfu Injection in Ameliorating Energy Metabolism Remodeling in Rat Model of Chronic Heart Failure
Xinyue NING ; Zhenyu ZHAO ; Mengna ZHANG ; Yang GUO ; Zhijia XIANG ; Kun LIAN ; Zhixi HU ; Lin LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(5):178-186
ObjectiveTo examine the influences of Shenfu injection on the endogenous metabolic byproducts in the myocardium of the rat model exhibiting chronic heart failure, thus deciphering the therapeutic mechanism of the Qi-reinforcing and Yang-warming method. MethodsSD rats were randomly allocated into a control group and a modeling group. Chronic heart failure with heart-Yang deficiency syndrome in rats was modeled by multi-point subcutaneous injection of isoproterenol, and the rats were fed for 14 days after modeling. The successfully modeled rats were randomized into model, Shenfu injection (6.0 mL·kg-1), and trimetazidine (10 mg·kg-1) groups and treated with corresponding agents for 15 days. The control group and the model group were injected with equal doses of normal saline, and the samples were collected after the intervention was completed. Cardiac color ultrasound was performed. Hematoxylin-eosin (HE) staining was used to observe histopathological morphology, and the serum level of N-terminal pro-brain natriuretic peptide (NT-proBNP) was assessed by enzyme-linked immunosorbent assay (ELISA). The mitochondrial morphological and structural changes of cardiomyocytes were observed by transmission electron microscopy, and the metabolic profiling was carried out by ultra high performance liquid chromatography-quantitative exactive-mass spectrometry (UHPLC-QE-MS). Differential metabolites were screened and identified by orthogonal partial least squares-discriminant analysis (OPLS-DA) and other methods, and then the MetaboAnalyst database was used for further screening. The relevant biological pathways were obtained through pathway enrichment analysis. The receiver operating characteristic (ROC) curve was established to evaluate the diagnostic value of each potential biomarker for myocardial injury and the evaluation value for drug efficacy. ResultsThe results of color ultrasound showed that Shenfu Injection improved the cardiac function indexes of model rats (P<0.05). The results of HE staining showed that Shenfu injection effectively alleviated the pathological phenomena such as myocardial tissue structure disorder and inflammatory cell infiltration in model rats. The results of ELISA showed that Shenfu injection effectively regulated the serum NT-proBNP level in the model rats. Transmission electron microscopy (TEM) showed that Shenfu injection effectively restored the mitochondrial morphological structure. The results of metabolomics showed that the metabolic phenotypes of myocardial samples presented markedly differences between groups. Nine differential metabolites could be significantly reversed in the Shenfu injection group, involving three metabolic pathways: pyruvate metabolism, histidine metabolism, and citric acid cycle (TCA cycle). The results of ROC analysis showed that the area under the curve (AUC) values of all metabolites were between 0.75 and 1.0, indicating that the differential metabolites had high diagnostic accuracy for myocardial injury, and the changes in their expression levels could be used as potential markers for efficacy evaluation. ConclusionShenfu injection significantly alleviated the damage of cardiac function, myocardium, and mitochondrial structure in the rat model of chronic heart failure with heart-Yang deficiency syndrome by ameliorating energy metabolism remodeling. Reinforcing Qi and warming Yang is a key method for treating chronic heart failure with heart-Yang deficiency syndrome.
2.The first record of Anopheles messeae (Diptera: Culicidae) parasitized by water mites in China
Xue-ru CHEN ; Wen-zhen YAO ; Yu-hao LI ; Gui-chang LI ; Tao MENG ; Qun-ling FENG ; Xin-hui LIU ; Li-hong QIAO ; Xiang-ting WU ; Xue-feng ZHANG ; Cheng-lin LI ; Xue-cheng DONG ; Da-wei WANG ; Xiao-yan SI ; Yu-hong GUO
Acta Parasitologica et Medica Entomologica Sinica 2026;33(1):53-57
Objective This study reports on the obligatory parasitism of water mites Arrenurus sp. on Anopheles messeae at the Manzhouli Port, Inner Mongolia, China. Methods Duing July 2024, a survey on the mosquito diversity was conducted at the Manzhouli Port. Captured mosquitoes and their ectoparasites were identified to species level. Results A total of 1840 adult mosquitoes were collected, representing species from three genera: Culex(Cx. modestus, Cx. pipiens pallens), Aedes(Ae. dorsalis, Ae. flavidorsalis, Ae. flavescens), and Anopheles (An. messeae). Among all the mosqutioes specimens,3 out of 150 captured An. messeae were found to carry ectoparasitic mites, with number of 2,4,27 mites separately. Morphological and molecular identification reached the same result as water mites(Hydrachnidiae, Hydracrina). COI gene sequence showed 94% similarity with the closest species Arrenurus truncatellus. Conlusions Literature review suggests water mites are host-specific parasitism of mosquito species and herein with the first record of Arrenurus sp. parasiting on An. Messeae in the most high-latitude region globally.
3.Corrective Effects of Three-Stage Structured Tai Chi on Abnormal Neck and Shoulder Posture:A Biomechanics-Based Randomized Controlled Trial
Yulei RAN ; Jing ZHANG ; Chao YANG ; Liyuan ZHANG ; Tingting HAN ; Weibiao LI ; Xiang GUO ; Xianhui GUO
Journal of Traditional Chinese Medicine 2026;67(16):1752-1758
ObjectiveTo evaluate the corrective effects of a three-stage structured Tai Chi training program on abnormal neck and shoulder posture from a biomechanical perspective. MethodsEighty-two participants with abnormal neck and shoulder posture were randomly assigned to a treatment group and a control group, with 41 participants in each group. The treatment group received three-stage structured Tai Chi training six times per week, while the control group received online health education once per week. Both interventions lasted for 12 weeks. The primary outcome cervical postural deviation angle, and the secondary outcomes including cervical loading and bilateral shoulder horizontal deviation angle, were assessed before intervention, after 6 weeks and 12 weeks of intervention. Safety was also evaluated. ResultsUltimately, 40 participants from each group were included in the analysis. In the treatment group, cervical postural deviation angle and cervical spine loading were significantly reduced after 12 weeks of intervention compared with baseline and after 6 weeks of intervention. The bilateral shoulder horizontal deviation angle decreased significantly after both 6 and 12 weeks of intervention compared with baseline (P<0.05). In the control group, cervical spine loading was reduced after 6 and 12 weeks of intervention compared with baseline (P< 0.05). After 12 weeks of intervention, the treatment group showed lower cervical postural deviation angle and bilateral shoulder horizontal deviation angle than the control group, whereas cervical loading was higher in the treatment group after 6 weeks of intervention (P<0.05). Significant differences were observed between groups in the changes from baseline to week 12 for cervical postural deviation angle and bilateral shoulder horizontal deviation angle, as well as in the changes from baseline to week 6 for cervical loading and bilateral shoulder horizontal deviation angle (P< 0.05). No significant adverse events occurred in either group during the intervention period. ConclusionThree-stage structured Tai Chi can effectively improve abnormal neck and shoulder posture, demonstrating good safety and feasibility.
4.Integrated effects of climate, land use, and their interactive driving mechanisms on the spatiotemporal dynamics of Oncomelania hupensis density: a case study of Yunnan Province
Jiangling XIANG ; Suying GUO ; Qiang WANG ; Lijuan ZHANG ; Jiayu SUN ; Yi DONG ; Jing XU
Chinese Journal of Schistosomiasis Control 2026;38(3):260-267
Objective To examine the impact of climate, land use and their interaction effect on the population density of Oncomelania hupensis. Methods O. hupensis snail surveillance data in Yunnan Province from 2013 to 2022 were obtained from the National Information System for Parasitic Diseases Prevention and Control of Chinese Information System for Disease Control and Prevention, and the density of living snails was calculated in each county-level administrative district. Climate data were obtained from the China Meteorological Forcing Dataset version 2.0, and land use data were captured from the China Land Cover Dataset. The raster climate data and land use data were clipped to the administrative border of Yunnan Province in the R package version 4.5, and the climate data were resampled to a spatial resolution of 30 m × 30 m consistent with the land use data using bilinear interpolation. Annual meteorological indicators were extracted from each county-level schistosomiasis surveillance administrative area in Yunnan Province from 2013 to 2022, including average temperature, maximum temperature, minimum temperature, temperature difference, average precipitation rate, maximum precipitation rate, minimum precipitation rate, downward shortwave radiation flux, downward longwave radiation flux, air pressure, wind speed, specific humidity and relative humidity. Annual land use structure and landscape pattern index in each county-level schistosomiasis surveillance administrative area in Yunnan Province from 2013 to 2022 were extracted and calculated, including the proportion of areas occupied by each type of land use, patch density, largest patch index, landscape separation index, landscape fragmentation index, landscape segmentation index, contagion index, patch cohesion index, edge density, and shape index. Land use entropy index was introduced to represent the degree of habitat fragmentation and ecological niche breadth. The density of living snails and environmental factors were subjected to rank correlation analysis, and variables with no statistically significant correlation (P>0.1) were excluded. Then, a correlation coefficient matrix was constructed, and |rs| of 0.85 and greater was defined as the threshold of high collinearity. For highly correlated variables in each group, indicators with a more biological explanatory power or a better statistical efficiency were retained. A generalized additive model (GAM) was constructed with O. hupensis snail density as a response variable and screened environmental variables as independent variables, and the model performance was evaluated using the variance explained. Results The area occupied by O. hupensis snail habitats was 1 056 to 1 680 hm2 in Yunnan Province from 2013 to 2022, appearing an overall tendency towards a decline; however, the density of living snails appeared a tendency towards a slight rise. Based on the correlation coefficient matrix, 14 core explanatory variables were retained, including farmland, water bodies, bare land, impervious surface, landscape separation index, landscape fragmentation index, edge density, shape index, land use entropy index, downward longwave radiation flux, downward shortwave radiation flux, maximum temperature, minimum precipitation rate and specific humidity. Two types of GAM were constructed, including the main-effects model without interaction terms and the interaction model with interaction terms. The corrected Akaike information criterion (AICc) of the optimal main-effects model was −285.223, and the core variables included bare land, impervious surface, landscape separation index, edge density, shape index, land use entropy index and downward shortwave radiation flux. Following introduction of second-order interaction terms, the AICc value of the optimal interaction model was −345.526, and the significant interaction combinations included: farmland × impervious surface, farmland × landscape separation index, farmland × shape index, farmland × land use entropy index, impervious surface × landscape separation index, impervious surface × edge density, and shape index × downward shortwave radiation flux. The proportion of the main-effects model explaining the variation of O. hupensis snail density was 39.8%, and the explanatory power of GAM increased to 79.0% following introduction of interaction terms. Conclusion Landscape separation index, edge density, shape index and other landscape pattern indicators pose significant impacts on the intensity and direction of changes in O. hupensis snail density in Yunnan Province.
5.Sclera Vessel Segmentation Based on Fusion Filtering and Reflection Suppression
Ming-Xuan FAN ; Zong-Qing MA ; Chu-Xiang GAO ; Yi-Xuan SHI ; Zi-Hang ZHANG ; Zhe-Xuan JIA ; Fan FAN ; Guo-Liang HUANG ; Jiang ZHU
Progress in Biochemistry and Biophysics 2026;53(5):1195-1206
ObjectiveIn traditional Chinese medicine (TCM), the foundational doctrine that the eyes reflect the essence of the internal viscera establishes ocular observation as a cornerstone of diagnostic practice. Specifically, the morphological characteristics and coloration variations of the scleral microvasculature serve as critical clinical indicators for assessing the dynamic balance of Qi and Blood, as well as the pathological status of internal organs. Historically, however, TCM eye diagnosis has relied predominantly on the subjective clinical experience and visual acuity of individual practitioners, leading to inherent challenges in standardization and reproducibility. While automated computer-aided diagnostic systems offer a promising solution, existing vessel segmentation algorithms encounter significant domain-specific bottlenecks when applied to scleral imagery. These challenges primarily stem from the highly reflective and moist nature of the ocular surface, which generates severe reflective interference. Furthermore, the inherent low contrast of fine capillary networks against complex background textures, compounded by non-uniform illumination, frequently results in high false-positive rates, misdetections, and severe vessel fragmentation. To address these critical limitations and advance the objective quantification of TCM diagnostics, this paper proposes a novel, highly robust sclera vessel segmentation framework that innovatively integrates Frangi-Sato dual-filter adaptive enhancement with pixel-level reflection detection. MethodsThe proposed methodology systematically addresses the segmentation pipeline through three synergistic stages. First, to overcome the structural limitations of single-filter approaches, a multi-scale weighted fusion strategy is meticulously designed to harness the complementary extraction capabilities of both Frangi and Sato filters. This adaptive enhancement optimally balances the preservation of main vessel trunk continuity with the heightened sensitivity required for delineating delicate, low-contrast peripheral capillaries. Second, to tackle the persistent issue of reflective highlights, a sophisticated multi-feature synergistic reflection detection module is introduced. By jointly analyzing local information entropy, gradient field variations, and intensity statistical distributions, this module achieves precise, pixel-level identification and elimination of reflective artifacts without compromising the underlying vascular structures. Finally, a dual-level adaptive thresholding strategy, featuring an innovative “core protection” mechanism, is implemented. This critical step effectively suppresses complex background noise while rigorously preserving the structural and topological integrity of the intricate vessel network, preventing the structural breaks often seen in conventional binarization methods. ResultsThe efficacy of the proposed framework was rigorously evaluated using both self-constructed clinical datasets specifically acquired for TCM research and standardized public datasets. Extensive experimental results demonstrate that the proposed method consistently outperforms state-of-the-art traditional approaches and contemporary deep learning models. Specifically, the proposed method achieves a Dice similarity coefficient of approximately 0.71 on the private clinical dataset, and secures the best performance across the majority of quantitative metrics on both datasets. Notably, the framework exhibits exceptional robustness and generalization capabilities in highly challenging scenarios characterized by intense reflective interference, low signal-to-noise ratios, and cross-domain image variations. ConclusionThis study successfully realizes the high-integrity, automated segmentation of scleral vessel networks under complex clinical imaging conditions. By overcoming the fundamental algorithmic challenges of reflection interference and micro-vessel loss, the proposed methodology provides potential support for the digitization, objective standardization, and intelligent advancement of modern TCM eye diagnosis systems.
6.Sclera Vessel Segmentation Based on Fusion Filtering and Reflection Suppression
Ming-Xuan FAN ; Zong-Qing MA ; Chu-Xiang GAO ; Yi-Xuan SHI ; Zi-Hang ZHANG ; Zhe-Xuan JIA ; Fan FAN ; Guo-Liang HUANG ; Jiang ZHU
Progress in Biochemistry and Biophysics 2026;53(5):1195-1206
ObjectiveIn traditional Chinese medicine (TCM), the foundational doctrine that the eyes reflect the essence of the internal viscera establishes ocular observation as a cornerstone of diagnostic practice. Specifically, the morphological characteristics and coloration variations of the scleral microvasculature serve as critical clinical indicators for assessing the dynamic balance of Qi and Blood, as well as the pathological status of internal organs. Historically, however, TCM eye diagnosis has relied predominantly on the subjective clinical experience and visual acuity of individual practitioners, leading to inherent challenges in standardization and reproducibility. While automated computer-aided diagnostic systems offer a promising solution, existing vessel segmentation algorithms encounter significant domain-specific bottlenecks when applied to scleral imagery. These challenges primarily stem from the highly reflective and moist nature of the ocular surface, which generates severe reflective interference. Furthermore, the inherent low contrast of fine capillary networks against complex background textures, compounded by non-uniform illumination, frequently results in high false-positive rates, misdetections, and severe vessel fragmentation. To address these critical limitations and advance the objective quantification of TCM diagnostics, this paper proposes a novel, highly robust sclera vessel segmentation framework that innovatively integrates Frangi-Sato dual-filter adaptive enhancement with pixel-level reflection detection. MethodsThe proposed methodology systematically addresses the segmentation pipeline through three synergistic stages. First, to overcome the structural limitations of single-filter approaches, a multi-scale weighted fusion strategy is meticulously designed to harness the complementary extraction capabilities of both Frangi and Sato filters. This adaptive enhancement optimally balances the preservation of main vessel trunk continuity with the heightened sensitivity required for delineating delicate, low-contrast peripheral capillaries. Second, to tackle the persistent issue of reflective highlights, a sophisticated multi-feature synergistic reflection detection module is introduced. By jointly analyzing local information entropy, gradient field variations, and intensity statistical distributions, this module achieves precise, pixel-level identification and elimination of reflective artifacts without compromising the underlying vascular structures. Finally, a dual-level adaptive thresholding strategy, featuring an innovative “core protection” mechanism, is implemented. This critical step effectively suppresses complex background noise while rigorously preserving the structural and topological integrity of the intricate vessel network, preventing the structural breaks often seen in conventional binarization methods. ResultsThe efficacy of the proposed framework was rigorously evaluated using both self-constructed clinical datasets specifically acquired for TCM research and standardized public datasets. Extensive experimental results demonstrate that the proposed method consistently outperforms state-of-the-art traditional approaches and contemporary deep learning models. Specifically, the proposed method achieves a Dice similarity coefficient of approximately 0.71 on the private clinical dataset, and secures the best performance across the majority of quantitative metrics on both datasets. Notably, the framework exhibits exceptional robustness and generalization capabilities in highly challenging scenarios characterized by intense reflective interference, low signal-to-noise ratios, and cross-domain image variations. ConclusionThis study successfully realizes the high-integrity, automated segmentation of scleral vessel networks under complex clinical imaging conditions. By overcoming the fundamental algorithmic challenges of reflection interference and micro-vessel loss, the proposed methodology provides potential support for the digitization, objective standardization, and intelligent advancement of modern TCM eye diagnosis systems.
7.Establishment and application of a determination method for plasma concentrations of venetoclax,busulfan and voriconazole in patients with acute myeloid leukemia
Zhenhua ZHANG ; Mengru ZHANG ; Aoxiang GUO ; Hui CHEN ; Shijian XIANG ; Benjie ZHOU ; Bingchen GE
China Pharmacy 2026;37(10):1323-1328
OBJECTIVE To establish a method for simultaneous determination of venetoclax, busulfan and voriconazole in plasma of patients with acute myeloid leukemia (AML), and apply it clinically. METHODS Plasma samples were subjected to protein precipitation using acetonitrile and subsequently analyzed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) using venetoclax-D 8 , busulfan-D 8 and posaconazole as internal standards. The separation was performed on a Phenomenex Kinetex ® C 18 column with a mobile phase composed of 0.1% formic acid solution (2 mmol/L ammonium acetate)-0.1% formic acid in acetonitrile (gradient elution) at a flow rate of 0.8 mL/min. The column temperature was set at 40 ℃, the sample size was 5 μL, and the total run time was 3.10 min. An electrospray ionization source was employed, and positive ion scanning was conducted using multiple reaction monitoring mode. The ion pairs used for quantitative analysis included m/z 868.4→636.3 (venetoclax), m/z 264.1→151.1 (busulfan), and m/z 350.1→224.0 (voriconazole). The above LC-MS/MS method was adopted to determine plasma concentrations of venetoclax and voriconazole in 10 AML patients, as well as plasma concentration of busulfan in 5 patients undergoing conditioning treatment for allogeneic hematopoietic stem cell transplantation. RESULTS The linear ranges of venetoclax, busulfan and voriconazole were 50-10 000, 15-3 000 and 50-10 000 ng/mL, respectively ( R 2 ≥0.999 0), with lower limits of quantification of 50, 15 and 50 ng/mL, respectively. The RSDs of intra-day and inter-day precision tests for all three analytes were all less than 10%, with accuracy (relative errors) ranging from -10.00% to 12.96%. The average extraction recovery ranged from 92.54% to 100.95%, and the average matrix effect was 89.98%-101.49%. Dilution reliability covered all dilution factors used in the test samples, and the absolute values of relative errors in stability tests were all≤16.25%. The plasma concentrations of venetoclax, busulfan and voriconazole in enrolled patients were 496.20-4 250.45, 233.48-2 002.28 and 475.51-5 710.18 ng/mL, respectively. CONCLUSIONS The LC-MS/MS method established in this study is rapid, sensitive and easy to operate, and can be used for the therapeutic drug monitoring of venetoclax, busulfan and voriconazole.
8.Clinical features and multimodal quantitative radiological features of primary liver cancer patients with different traditional Chinese medicine syndrome types
Feng WU ; Muqing LUO ; Wantingting WEN ; Ziwei CAI ; Yinqi LIU ; Jian XIANG ; Xiaona ZHOU ; Qian GUO ; Kun ZHANG
Journal of Clinical Hepatology 2026;42(5):1093-1100
ObjectiveTo investigate the association of the traditional Chinese medicine (TCM) syndrome types of primary liver cancer (PLC) with clinical features and multimodal quantitative radiological features on computed tomography (CT) and magnetic resonance imaging (MRI), and to provide a reference for the objectification of TCM syndrome differentiation and precise diagnosis and treatment. MethodsA retrospective analysis was performed for the clinical data of 312 patients who were diagnosed with PLC in The First Affiliated Hospital of Hunan University of Chinese Medicine from March 2020 to June 2025, and according to the TCM syndrome type, they were divided into stagnation of liver Qi group with 40 patients, stagnation of liver Qi and spleen deficiency group with 109 patients, Qi stagnation and blood stasis group with 62 patients, dampness-heat toxin amassment group with 81 patients, and liver-kidney Yin deficiency group with 20 patients. Clinical features and multimodal quantitative radiological features were compared between the patients with different TCM syndrome types. A one-way analysis of variance was used for comparison of normally distributed continuous data between multiple groups, and the least significant difference t-test was used for further comparison between two groups; the Kruskal-Wallis H test was used for comparison of non-normally distributed continuous data between multiple groups, and the Dunn’s multiple test was used for further comparison between two groups; the chi-square test was used for comparison of categorical data between groups, and the Bonferroni method was used for further comparison between two groups. ResultsThere were significant differences between the patients with different TCM syndrome types in China liver cancer staging (CNLC), Child-Pugh class, alanine aminotransferase, aspartate aminotransferase, albumin, direct bilirubin, total bilirubin, prothrombin time, neutrophil, and albumin-bilirubin score (all P<0.05). In the stagnation of liver Qi group, the patients with Child-Pugh class A accounted for 75.00%; among the patients with CNLC stage I PLC, the patients with stagnation of liver Qi accounted for 60.00%, and those with Qi stagnation and blood stasis syndrome accounted for 59.68%, while among the patients with CNLC stage IV PLC, the distribution proportion of dampness-heat toxin amassment (27.16%) and liver-kidney Yin deficiency (30.00%) was significantly higher than that of stagnation of liver Qi (2.50%) (all P<0.05). Radiological examination showed that there were significant differences between the patients with different TCM syndrome types in the number of tumors, ascites, venous tumor thrombus, maximum tumor diameter, intrahepatic metastasis, and lymph node metastasis in the hepatic hilar and retroperitoneal regions (all P<0.05). Compared with the patients with stagnation of liver Qi, the patients with liver depression and spleen deficiency or liver-kidney Yin deficiency were more likely to develop intrahepatic metastasis; the patients with liver depression and spleen deficiency, dampness-heat toxin amassment, or liver-kidney Yin deficiency were more likely to develop lymph node metastasis in the hepatic hilar and retroperitoneal regions; the patients with liver-kidney Yin deficiency were more likely to experience multiple tumors; the patients with liver depression and spleen deficiency or dampness-heat toxin amassment were more likely to develop ascites (all P<0.05). Compared with the patients with Qi stagnation and blood stasis syndrome, the patients with liver depression and spleen deficiency had a significantly longer maximum tumor diameter and a significantly higher proportion of patients with venous tumor thrombus (both P<0.05). Furthermore, among the 184 patients with MRI diffusion-weighted imaging sequences, the patients with dampness-heat toxin amassment or Qi stagnation and blood stasis syndrome had significantly higher ADC values and relative ADC values than those with stagnation of liver Qi (all P<0.05). ConclusionThere are significant differences in CT/MRI radiological features and clinical features between PLC patients with different TCM syndrome types, among whom the patients with liver depression and spleen deficiency, dampness-heat toxin amassment, and liver-kidney Yin deficiency tend to exhibit progressive radiological features, and those with dampness-heat toxin amassment or Qi stagnation and blood stasis syndrome tend to have higher ADC values. These findings provide an objective basis for TCM syndrome differentiation in PLC.
9.Clinical efficacy and safety of a domestic calcipotriol/betamethasone dipropionate ointment in the treatment of stable plaque psoriasis: a multicenter, randomized, double-blind, controlled study
Lixin XIA ; Guang XIANG ; Qingchun DIAO ; Kun HUANG ; Shoumin ZHANG ; Shanshan LI ; Yumei LI ; Zhiqiang SONG ; Qing SUN ; Xiumin YANG ; Meng PAN ; Yuling SHI ; Shuping GUO ; Huiping WANG ; Tiechi LEI ; Xiaoyong ZHOU ; Songmei GENG ; Suchun HOU ; Juan SU ; Yong CUI ; Rixin CHEN ; Yanyan FENG ; Hongxia FENG ; Rushan XIA ; Zudong MENG ; Fang YIN ; Jingjing WANG ; Xinghua GAO
Chinese Journal of Dermatology 2025;58(11):1020-1026
Objective:To evaluate the clinical equivalence between a domestic calcipotriol/betamethasone dipropionate ointment and the originator product in the treatment of stable plaque psoriasis.Methods:A multicenter, randomized, double-blind, three-arm, parallel-group, active- and placebo-controlled study was conducted, and 449 patients aged 18 - 65 years with stable plaque psoriasis were enrolled from 25 hospitals (such as the First Affiliated Hospital of China Medical University). Eligible patients had a baseline physician's global assessment (PGA) score of ≥ 3 points, baseline body surface area (BSA) involvement of 5% - 30%, and a target lesion psoriasis area and severity index (TL-PASI) for plaque elevation of ≥ 3 points. Participants were randomly assigned in a 2:2:1 ratio to the test group ( n = 179), reference group ( n = 180), and placebo group ( n = 90), and applied the domestic calcipotriol/betamethasone dipropionate ointment, originator product, and ointment base respectively, once daily in the evening for 4 weeks. Efficacy and safety were assessed at weeks 1, 2, and 4. The primary efficacy endpoints were the treatment success rates and clinical success rates in each group at week 4. The per-protocol set (PPS) was used for the primary efficacy analysis, and the intention-to-treat (ITT) set for supplementary efficacy analysis. Equivalence between the test and reference preparations was tested using the Cochran-Mantel-Haenszel method adjusted for randomization strata. Superiority of the test and reference preparations over the placebo was also tested. Measurement data were compared among the 3 groups using analysis of variance or non-parametric tests, while treatment success rates, clinical success rates, and incidence rates of adverse reactions were compared using the chi-square test. Results:The ITT, PPS, and safety sets included 447, 420, and 448 patients, respectively. In the ITT set, patients were aged 43.6 ± 12.8 years, including 320 (71.6%) males and 127 (28.4%) females, and the disease duration was 11.21 ± 9.05 years; 316 (70.7%) had a PGA score of 3 points and 131 (29.3%) had a PGA score of 4 - 5 points. No significant differences in the baseline characteristics (including age, sex, disease duration and disease severity) were observed among the 3 groups (all P > 0.05). Based on the PPS analysis, the treatment success rates were 57.9% (99/171) in the test group, 50.3% (86/171) in the reference group, and 7.7% (6/78) in the placebo group, and the clinical success rates were 57.9% (99/171), 50.3% (86/171), and 10.3% (8/78), respectively; both the test and reference groups were superior to the placebo group in both treatment and clinical success rates (all P < 0.001) ; the rate differences for treatment success (90% confidence interval [ CI]: -1.3% - 16.4%) and clinical success (90% CI: -1.3% - 16.3%) between the test and reference groups were entirely within the pre-defined equivalence margin (-20% - 20%). Subgroup analyses by baseline PGA scores: for patients with a baseline PGA score of 3 points, the treatment success rates in the test, reference, and placebo groups were 60.8% (73/120), 52.1% (62/119), and 11.1% (6/54), respectively, and the corresponding clinical success rates were 61.7% (74/120), 53.8% (64/119), and 13% (7/54), respectively; the test and reference groups did not differ significantly in treatment or clinical success rates (both P > 0.05), but both showed higher success rates than the placebo group (all P < 0.001) ; the results of statistical comparisons among the 3 groups in patients with a baseline PGA score of 4 - 5 points were consistent with those observed in patients with a baseline PGA score of 3 points. The percentage reductions in PGA and TL-PASI scores from baseline to weeks 1, 2, and 4 showed significant differences among the 3 groups, which were significantly higher in the test and reference groups than in the placebo group (all P < 0.001), but did not differ between the test and reference groups (all P > 0.05). The primary adverse reactions were local skin reactions, such as pruritus, pain, and erythema. The incidence rates of adverse reactions were 8.9% (16/179) in the test group, 7.3% (13/179) in the reference group, and 7.8% (7/90) in the placebo group, with no significant difference among the 3 groups ( P > 0.05) . Conclusions:The domestic calcipotriol/betamethasone dipropionate ointment demonstrated clinical equivalence to the originator product in the treatment of stable plaque psoriasis, and the two agents exhibited comparable efficacy for patients with varying degrees of disease severity, and were comparable in the speed and degree of clinical improvement, with similar favorable safety profiles.
10.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.


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