1.Effect and mechanism of Wnt5a knockdown on the efficacy of M1 bone marrow-derived macrophage in treatment of liver cirrhosis
Feifei XING ; Danyang WANG ; Xinrui ZHENG ; Yannan XU ; Shihao ZHANG ; Junyi ZHAN ; Wei LIU ; Gaofeng CHEN ; Jiamei CHEN ; Ping LIU ; Yongping MU
Journal of Clinical Hepatology 2026;42(3):618-628
ObjectiveTo observe the effect of M1 bone marrow-derived macrophages (M1-BMDM) with Wnt5a knockdown on liver fibrosis and regeneration in a rat model of liver cirrhosis, and to investigate its gain-of-function effect compared with unmodified M1-BMDM. MethodsPrimary bone marrow-derived macrophages were isolated from rats and were polarized to M1 phenotype to construct M1-BMDMWnt5a-KD cells. A rat model of liver cirrhosis induced by CCl4/2-AAF was established, and at the end of week 8, rats were randomly divided into model group, M1-BMDM group, M1-BMDM Wnt5a-knockdown empty vector group (M1-BMDMKD-EV group), and M1-BMDM Wnt5a-knockdown group (M1-BMDMWnt5a-KD group), with 6 rats in each group. On the first day of week 9, the rats in each group were given a single injection of the corresponding cells via the caudal vein, along with an intraperitoneal injection of a CCR2 inhibitor. Six rats without any treatment were used as normal control group. Samples were collected at the end of week 12 to assess liver histopathology, serum liver function parameters, hepatic stellate cell activation, and the expression levels of mature hepatocyte markers. A one-way analysis of variance was used for comparison of continuous data between multiple groups, and the least significant difference t-test was used for further comparison between two groups. ResultsCompared with the model group, all cell treatment groups had significant alleviation of liver inflammatory response and significant reductions in the activities of alanine aminotransferase and aspartate aminotransferase (AST) in serum (all P<0.01), and the M1-BMDMWnt5a-KD group had a significantly lower serum level of AST than the M1-BMDM group (P<0.05). The semi-quantitative analysis based on immunohistochemical staining showed that compared with the model group, all cell treatment groups had a significant reduction in the percentage of CD68-positive area (all P<0.05), and compared with the M1-BMDMKD-EV group, the M1-BMDMWnt5a-KD group had a significant reduction in the percentage of CD68-positive area and a significant increase in the percentage of CD163-positive area (both P<0.05). Compared with the model group, all cell treatment groups had significant reductions in the mRNA expression levels of CD68 and tumor necrosis factor-α (all P<0.05) and the protein expression level of CD68 (all P<0.01); compared with the M1-BMDMKD-EV group, the M1-BMDMWnt5a-KD group had significant increases in the protein and mRNA expression levels of CD163 (both P<0.05), significant reductions in the protein and mRNA expression levels of CD68 (both P<0.05), and a significant reduction in the protein expression level of tumor necrosis factor-α (P<0.01). Sirius Red collagen staining and alpha-smooth muscle actin (α-SMA) immunohistochemical staining showed that compared with the model group, all cell treatment groups had significant alleviation of liver collagen deposition and α-SMA-positive area, with the most significant changes in the M1-BMDMWnt5a-KD group, and compared with the M1-BMDMKD-EV group, the M1-BMDMWnt5a-KD group had significantly smaller Sirius Red-positive area and α-SMA-positive area and a significantly lower content of hydroxyproline in liver tissue (all P<0.05). Compared with the M1-BMDMKD-EV group, the M1-BMDMWnt5a-KD group had significant reductions in the protein and mRNA expression levels of α-SMA and the mRNA expression level of COL-I and TGF-β (all P<0.05). Compared with the model group, all cell treatment groups had a significant increase in the protein expression level of HNF-4α in liver tissue (all P<0.05), and the M1-BMDMWnt5a-KD group had significantly higher protein and mRNA expression levels of HNF-4α and hepatocyte specific antigen than the M1-BMDMKD-EV group (both P<0.05). The M1-BMDMWnt5a-KD group had a significantly higher serum level of albumin than the M1-BMDMKD-EV group (P<0.01). Immunofluorescence co-staining showed that compared with the model group, all cell treatment groups had a significant increase in the number of cells stained positive for HNF and HNF-4α and Ki67 (all P<0.01), and the M1-BMDMWnt5a-KD group had a significantly higher number of such cells than the M1-BMDMKD-EV group (P<0.05). ConclusionInhibition of Wnt5a expression enhances the therapeutic effect of M1-BMDM on rats with liver cirrhosis induced by CCl4/2-AAF, which provides new ideas for enhancing the anti-cirrhotic effect of M1-BMDM through genetic modification.
2.Reflections on Status Quo and Development Pathways of Traditional Chinese Medicine Technology Transfer in Context of Digital-intelligent Transformation
Jie ZHANG ; Jing XU ; Guangwei ZHENG ; Huayu ZHANG ; Chang LIU ; Xiaoxiao WEN ; Xishui PAN ; Bin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(4):235-240
As a distinctive resource of Chinese civilization, traditional Chinese medicine (TCM) technology transfer faces significant opportunities under the background of digital and intelligent transformation, while also being constrained by unique challenges such as the complexity of its theoretical system, lengthy industrial chains, and multidimensional policy restrictions, resulting in a "high-value-high-threshold" paradox. At present, TCM technology transfer is deeply trapped in a "threefold reluctance" dilemma, i.e., unwillingness to transfer, inability to transfer, and lack of capacity to transfer. Specifically, the disconnection between scientific research evaluation systems and market demand leads to low conversion rates of research achievements, unclear ownership and compliance risks suppress innovation incentives, and the absence of professional services intensifies supply-demand mismatches. This article systematically analyzes the specific characteristics of TCM technology transfer and proposes a breakthrough pathway centered on full-chain digital and intelligent transformation. By integrating technologies such as intelligent sorting systems, blockchain-based traceability, and AI diagnostic models, the TCM ecosystem spanning "cultivation-production-service" can be reconstructed. In terms of standardization, promoting the progression from "experience-based data conversion" to "data standardization" and further to "intelligent standardization" is advocated to resolve quality control challenges. For example, a "three-no-one-full" certification system can strengthen quality trust. Policy coordination should focus on optimizing mechanisms for the transformation of scientific and technological achievements, while exploring intellectual property securitization and risk-sharing models to stimulate research momentum. In terms of internationalization, reliance on the Belt and Road Initiative platform to promote the export of geo-authentic medicinal material brands and standards is recommended to build a dual-driven model of "technology plus culture". Looking ahead, through the construction of national-level databases, the cultivation of interdisciplinary talent, and the mutual recognition of international standards, a new paradigm of "scientific intelligent manufacturing" can be formed, providing systematic solutions for the modernization of TCM and global health governance.
3.Mechanism of Traditional Chinese Medicine in Comorbidity of Parkinson's Disease and Depression: A Review
Qi ZHENG ; Xiaomin XU ; Simeng WANG ; Shumin LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(4):268-276
Parkinson's disease (PD) is a neurodegenerative disorder primarily characterized by motor dysfunction. Traditionally, its main clinical features include resting tremor, muscular rigidity, bradykinesia, and postural balance disorders. However, an increasing number of studies have shown that its non-motor symptoms (NMS) exert an even greater impact on patients' quality of life than motor symptoms, severely affecting daily functioning and increasing the burden on families and society. Among these, depression is one of the most common and most debilitating NMS, with statistics indicating that the incidence of depression among PD patients reaches as high as 40%-50%. The pathological mechanisms are complex, involving the interplay between degenerative changes in dopaminergic neurons and disruptions in emotional regulatory circuits, which poses a substantial challenge to clinical treatment. Traditional Chinese medicine (TCM), characterized by holistic regulation and multi-target intervention, has demonstrated significant advantages in the treatment of PD and depression, offering new insights for managing PD-depression comorbidity. This study integrates research extracted from multiple databases, including PubMed, Web of Science, Google Scholar, and China National Knowledge Infrastructure (CNKI), that investigates the potential mechanisms of PD and depression as well as TCM-based treatments for these conditions. The aim is to elucidate the shared pathological mechanisms underlying PD and depression and to explore the therapeutic potential of TCM in effectively combating PD-depression comorbidity through these shared mechanisms, thereby providing valuable insights for the development of targeted therapies.
4.Standardization Challenges in Outcome Evaluation Systems of Animal Experiments and Considerations for Core Outcome Set Construction Strategies
Qingyong ZHENG ; Yongjia ZHOU ; Tengfei LI ; Jianguo XU ; Chen TIAN ; Hui LIU ; Min TIAN ; Ziyu ZHOU ; Caihua XU ; Yating CUI ; Junfei WANG ; Jinhui TIAN
Laboratory Animal and Comparative Medicine 2026;46(1):138-148
Animal experimentation constitutes a critical link between basic research and clinical application, making its research quality and translational efficiency paramount. Although considerable progress has been made in standardizing operational procedures and ethical guidelines, the standardization of outcome evaluation systems has significantly lagged, creating a key bottleneck that constrains the quality of biomedical research and evidence synthesis. This deficiency is manifested by pronounced heterogeneity in outcome selection across similar studies, incomplete methodological reporting, and disparate criteria for result interpretation, which severely impairs the comparability of findings and the evidence integration. To cope with this challenge, this paper systematically introduces a mature methodological tool from clinical research–the core outcome set (COS)–and explores its construction strategies and application potential in the field of animal experimentation. Given the extensive diversity of animal experiments, a pragmatic strategy of "focusing on key areas, implementing phased pilots, and promoting gradual expansion" should be adopted. This approach prioritizes the development of domain-specific COS for disease areas characterized by high research volume, urgent translational needs, and well-established animal models. A multi-source integration pathway for COS development is detailed, comprising systematic literature searches, methodological appraisals, and expert consensus, with the feasibility of leveraging artificial intelligence (AI) to enhance efficiency also being examined. The development and promotion of such COS are not intended to restrict scientific exploration; rather, they aim to establish a new, tiered evaluation paradigm consisting of "core outcomes" (mandatory), "recommended outcomes" (encouraged), and "exploratory outcomes" (optional). This framework is expected not only to enhance research quality through standardization and to adhere to the "3R" principles but also to accelerate the accumulation of high-quality evidence. This, in turn, provides a solid foundation for higher-level evidence synthesis, ultimately facilitating the effective translation of basic research findings into clinical practice and providing an essential methodological framework for scientific advancement in relevant disciplines.
5.Exploring Mechanism of Xiaoqinglongtang Against High Altitude Pulmonary Edema Based on Integrative Pharmacology Model
Rongrong WANG ; Chuchu WANG ; Qi XU ; Qin JIAN ; Junzhi LIN ; Ruli LI ; Chuan ZHENG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):137-148
ObjectiveTo explore the potential mechanism of Xiaoqinglongtang(XQL) in the prevention and treatment of high altitude pulmonary edema(HAPE) by network pharmacology, molecular docking, and molecular dynamics simulation, and to verify it by in vivo animal model. MethodsIn this study, the active ingredients, drug targets, and HAPE-related targets of XQL were collected from BATMAN-TCM, GeneCards, and Online Mendelian Inheritance in Man(OMIM) databases. The protein-protein interaction(PPI) network was constructed by using intersection targets, and the core targets were screened and visualized by Cytoscape software. Functional annotation and pathway analysis of the intersection targets were performed by gene ontology (GO) and Kyoto encyclopedia of genes and genomes (KEGG) functional enrichment. AutoDock and GROMACS were used to evaluate the binding ability of active ingredients to key targets. In the experimental verification part, a mouse model of HAPE induced by hypobaric hypoxia(simulated 6 000 m altitude for 48 h) was established. The control effect was evaluated by hematoxylin-eosin(HE) staining, lung tissue water content, lung tissue wet/dry weight ratio, real-time quantitative polymerase chain reaction(Real-time PCR) detection of gene expression levels, and immunohistochemistry and Western blot detection of key protein expression. ResultsA total of 355 active ingredients of XQL, 2 142 targets, 716 HAPE-related targets, and 236 intersection targets were obtained by network pharmacology analysis. Key core targets such as interleukin (IL)-6, tumor necrosis factor (TNF), protein kinase B1 (Akt1), and hypoxia-inducible factor-1α (HIF-1α) were screened. The results of GO analysis of common targets involved 738 biological processes(BP), 72 cellular components(CC), and 135 molecular functions(MF). KEGG analysis effectively enriched two important signaling pathways: Phosphoinositol 3-kinase (PI3K)/Akt and HIF-1α. The results of molecular docking and molecular dynamics simulation showed that the screened active ingredients had good binding ability with key targets. In the HAPE model induced by hypobaric hypoxia(6 000 m, 48 h), the lung tissue water content, lung tissue wet/dry weight ratio, and pathological injury score of the model group were significantly increased(P<0.01), accompanied by exudation of a large number of red blood cells in the alveoli and alveolar interstitium, a significant increase in inflammatory cells, a significant widening of the alveolar septum, and mutual fusion between the alveoli. The XQL administration group significantly improved the above pathological changes(P<0.01). The results of inflammatory factor expression showed that compared with the control group, the model group showed significantly up-regulated expression of TNF-α, IL-6, and IL-1β in the lung tissue(P<0.01). Compared with the model group, the XQL administration group had significantly decreased expression of inflammatory factors(P<0.05, P<0.01). The mRNA expression of key pathway related genes PI3K, Akt1, mammalian target of rapamycin(mTOR), and HIF-1α was significantly increased in the model group(P<0.01), and decreased in a concentration-dependent manner after XQL administration(P<0.05, P<0.01). The expression levels of key proteins PI3K, phosphorylation(p)-PI3K, Akt1, p-Akt1, mTOR, p-mTOR, and HIF-1α in lung tissue were analyzed by immunohistochemistry and Western blot. Compared with the blank group, the model group showed increased expression of key proteins(P<0.05, P<0.01). Compared with the model group, the XQL administration group exhibited decreased expression of key proteins(P<0.05, P<0.01). ConclusionXQL can reduce lung inflammation and improve HAPE. The mechanism may be related to the regulation of PI3K/Akt/mTOR and HIF-1α pathways. This study provides a new idea and a theoretical basis for the treatment of HAPE with XQL.
6.Exploring Mechanism of Xiaoqinglongtang Against High Altitude Pulmonary Edema Based on Integrative Pharmacology Model
Rongrong WANG ; Chuchu WANG ; Qi XU ; Qin JIAN ; Junzhi LIN ; Ruli LI ; Chuan ZHENG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):137-148
ObjectiveTo explore the potential mechanism of Xiaoqinglongtang(XQL) in the prevention and treatment of high altitude pulmonary edema(HAPE) by network pharmacology, molecular docking, and molecular dynamics simulation, and to verify it by in vivo animal model. MethodsIn this study, the active ingredients, drug targets, and HAPE-related targets of XQL were collected from BATMAN-TCM, GeneCards, and Online Mendelian Inheritance in Man(OMIM) databases. The protein-protein interaction(PPI) network was constructed by using intersection targets, and the core targets were screened and visualized by Cytoscape software. Functional annotation and pathway analysis of the intersection targets were performed by gene ontology (GO) and Kyoto encyclopedia of genes and genomes (KEGG) functional enrichment. AutoDock and GROMACS were used to evaluate the binding ability of active ingredients to key targets. In the experimental verification part, a mouse model of HAPE induced by hypobaric hypoxia(simulated 6 000 m altitude for 48 h) was established. The control effect was evaluated by hematoxylin-eosin(HE) staining, lung tissue water content, lung tissue wet/dry weight ratio, real-time quantitative polymerase chain reaction(Real-time PCR) detection of gene expression levels, and immunohistochemistry and Western blot detection of key protein expression. ResultsA total of 355 active ingredients of XQL, 2 142 targets, 716 HAPE-related targets, and 236 intersection targets were obtained by network pharmacology analysis. Key core targets such as interleukin (IL)-6, tumor necrosis factor (TNF), protein kinase B1 (Akt1), and hypoxia-inducible factor-1α (HIF-1α) were screened. The results of GO analysis of common targets involved 738 biological processes(BP), 72 cellular components(CC), and 135 molecular functions(MF). KEGG analysis effectively enriched two important signaling pathways: Phosphoinositol 3-kinase (PI3K)/Akt and HIF-1α. The results of molecular docking and molecular dynamics simulation showed that the screened active ingredients had good binding ability with key targets. In the HAPE model induced by hypobaric hypoxia(6 000 m, 48 h), the lung tissue water content, lung tissue wet/dry weight ratio, and pathological injury score of the model group were significantly increased(P<0.01), accompanied by exudation of a large number of red blood cells in the alveoli and alveolar interstitium, a significant increase in inflammatory cells, a significant widening of the alveolar septum, and mutual fusion between the alveoli. The XQL administration group significantly improved the above pathological changes(P<0.01). The results of inflammatory factor expression showed that compared with the control group, the model group showed significantly up-regulated expression of TNF-α, IL-6, and IL-1β in the lung tissue(P<0.01). Compared with the model group, the XQL administration group had significantly decreased expression of inflammatory factors(P<0.05, P<0.01). The mRNA expression of key pathway related genes PI3K, Akt1, mammalian target of rapamycin(mTOR), and HIF-1α was significantly increased in the model group(P<0.01), and decreased in a concentration-dependent manner after XQL administration(P<0.05, P<0.01). The expression levels of key proteins PI3K, phosphorylation(p)-PI3K, Akt1, p-Akt1, mTOR, p-mTOR, and HIF-1α in lung tissue were analyzed by immunohistochemistry and Western blot. Compared with the blank group, the model group showed increased expression of key proteins(P<0.05, P<0.01). Compared with the model group, the XQL administration group exhibited decreased expression of key proteins(P<0.05, P<0.01). ConclusionXQL can reduce lung inflammation and improve HAPE. The mechanism may be related to the regulation of PI3K/Akt/mTOR and HIF-1α pathways. This study provides a new idea and a theoretical basis for the treatment of HAPE with XQL.
7.Study on Reducing Hepatotoxicity and Retaining Anti-osteoporosis Activity of Psoraleae Fructus Though Salt Processing Based on Zebrafish
Yiqi LIU ; Xuan WANG ; Qiqi FAN ; Zehua CHANG ; Shuo FAN ; Na WANG ; Zheng LI ; Xinfang XU ; Chongjun ZHAO ; Xiangri LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(9):79-90
ObjectiveTo investigate the mechanism of salt processing of Psoraleae Fructus (PF) through modern analytical techniques and biotechnology, focusing on its effects related to hepatotoxicity and anti-osteoporosis activity. MethodsThe zebrafish model was utilized to evaluate the impact of PF and salt-processed Psoraleae Fructus (SPF) on the hepatotoxicity (using 134.17 , 178.89, 268.34 mg·L-1 as low, medium, and high dose groups of PF, 135.04, 180.06, 270.08 mg·L-1 as low, medium, and high dose groups of SPF, respectively) and anti-osteoporotic activity (using 33.54 , 67.08 and 134.17 mg·L-1 as low, medium, and high dose groups of PF, 33.76, 67.52, 135.04 mg·L-1 as low, medium, and high dose groups of SPF, respectively), which was using alizarin red skull staining of zebrafish as an indicator of different batches of PF. The specific dosage of a batch of PF was taken as an example. Then ultra-performance liquid chromatography-quadrupole-time of flight-mass spectrometry(UPLC-Q-TOF-MS) analysis was employed to identify the chemical composition of PF before and after salt processing, and PCA, OPLS-DA, and independent sample t-test were used to elucidating the compositional changes associated with the effects of salt processing on hepatotoxicity and anti-osteoporosis activity. ResultsUnder specific conditions, PF induced notable hepatotoxicity in zebrafish while simultaneously demonstrating protective effect against prednisolone-induced osteoporosis. In comparison to PF, SPF showed alleviated hepatotoxicity while retaining significant anti-osteoporosis activity. UPLC-Q-TOF-MS analysis revealed that after salt processing, the overall chemical composition of PF showed a downward trend, with 69 components showing a decrease in content, represented by psoralen, and 13 components showing an increase, represented by 4′-O-methyl psoralen B. Further multivariate statistical analysis revealed 11 key differential components before and after salt processing of PF, including psoralen and bakuchiol. ConclusionSalt processing effectively diminishes hepatotoxicity without impairing therapeutic efficacy against osteoporosis of PF, which may be related to the compositional changes before and after salt processing of PF and provides key evidence to reveal the scientific significance of salt processing of PF.
8.Evaluation of the public health governance capacity in Jiangsu Province
Peiyu FENG ; Anning MA ; Peiwu SHI ; Qunhong SHEN ; Chaoyang ZHANG ; Zheng CHEN ; Chuan PU ; Lingzhong XU ; Zhaohui GONG ; Tianqiang XU ; Panshi WANG ; Chao HAO ; Zhi HU ; Mo HAO ; Hua WANG ; Chengyue LI
Shanghai Journal of Preventive Medicine 2026;38(2):146-152
ObjectiveTo evaluate the public health governance capacity in Jiangsu Province and provide an optimized pathway for the construction of a “strong, rich, beautiful, and high-quality” new Jiangsu. MethodsA total of 806 policy documents, 658 public information reports, and 148 research literatures related to public health governance capacity in Jiangsu Province from January 1995 to December 2023 were collected. The status of current public health goverance was assessed based on the evaluation criteria suitable for public health systems, and the strengths and the weaknesses of the system were identified. ResultsThe public health governance capability of Jiangsu Province was scored at 738.3 points, ranking 3rd nationally. Maternal health care and emergency response capacities achieved leading positions nationwide, both ranking 2nd. Jiangsu had exhibited a standardized guidance in the strategic level, a well-established management mechanism, an extensive coverage in information collection, and a scientifically established health targets setting. However, bottlenecks remained, including an unclear division of responsibilities across organizational departments, an insufficient public-health workforce, the absence of a stable growth mechanism for government funding investment, and difficulties in promptly identifying public needs. ConclusionJiangsu’s public-health system demonstrates leading nationally, yet several components remain underdeveloped. Future efforts should consolidate advantages while addressing weaknesses, further diversify content and forms, establish a stable funding increase mechanism, and clarify departmental functions, thereby providing solid health support for realizing the developmental goals of a “strong, rich, beautiful and high-quality” new Jiangsu.
9.Evaluation of public health governance capacity in Zhejiang Province
Haiyan LI ; Ting CHEN ; Chengyue LI ; Huihui HUANGFU ; Wei WANG ; Qunhong SHEN ; Chaoyang ZHANG ; Zheng CHEN ; Chuan PU ; Lingzhong XU ; Anning MA ; Zhaohui GONG ; Tianqiang XU ; Panshi WANG ; Hua WANG ; Chao HAO ; Zhi HU ; Peiwu SHI ; Mo HAO
Shanghai Journal of Preventive Medicine 2026;38(2):153-158
ObjectiveTo systematically assess the public health governance capacity in Zhejiang Province, to conduct an in-depth analysis of its strengths and weaknesses, so as to provide scientific basis and strategic recommendations for further enhancement. MethodsA systematic collection of policy documents, public information reports, and research literature related to public health governance capacity in Zhejiang Province from 2002 to 2023 was conducted (encompassing a total of 1 263 policy documents, 138 pieces of information reports and 631 research articles). Based on the evaluation criteria suitable for public health systems previously developed by the research team, the basic status and magnitude of change in public health governance capacity in Zhejiang Province was evaluated. Additionally, normative gap analyses were employed to identify the strengths and weaknesses. ResultsZhejiang Province ranked 4th nationwide in terms of public health governance capacity with a score of 733.4 points (1 000.0-point maximum). The province has effectively implemented the principle of health first (scoring 698.5 points in the assessment of health-first strategy implementation) and attached sufficient importance to health-related goals (scoring 658.2 points in the scientific rationality of goal setting). However, the implementation of inter-departmental coordination and incentive mechanisms only scored 178.7 points, the feasibility of management and monitoring mechanisms scored even lower at only 144.0 points, and the coverage of incentive mechanisms scored 286.0 points. ConclusionZhejiang Province has effectively implemented its health first strategy and attached great importance to health targets, but still needs to strengthen cross-departmental coordination mechanisms and health-oriented incentives.
10.Efficacy and safety of Babaodan Capsule in patients with chronic hepatitis B virus infection comorbid with gallbladder polyps
Qianqian NIU ; Huan CHEN ; Ying ZHENG ; Chunyan GOU ; Chen XU ; Li LI ; Xinxin WANG ; Jianping LIU ; Zhaolan LIU ; Xiuhui LI
Journal of Clinical Hepatology 2026;42(2):304-311
ObjectiveTo investigate the efficacy and safety of Babaodan Capsule (BBD) in the treatment of patients with chronic hepatitis B virus (HBV) infection with damp-heat in the liver and gallbladder comorbid with gallbladder polyps. MethodsA randomized, double-blinded, placebo-controlled single-center trial was conducted among 120 patients with chronic HBV infection who were admitted to Beijing YouAn Hospital, Capital Medical University, from August 2020 to April 2023, and they were divided into treatment group (BBD) and control group (placebo), with 60 patients in each group. The course of treatment was 24 weeks, and follow-up assessments were conducted every 4 weeks. The primary outcome measures were the number and maximum diameter of gallbladder polyps (assessed by ultrasound), and the secondary outcome measures included traditional Chinese medicine (TCM) syndrome score, blood lipid levels, and liver function parameters. The independent-samples t test or the Wilcoxon rank-sum test was used for comparison of continuous data between two groups, and the chi-square test or the Fisher’s exact test was used for comparison of categorical data between two groups; the Wilcoxon rank-sum test was used for comparison of ranked data between two groups; the generalized estimating equation was used to analyze repeated measures data. ResultsAfter 8 weeks of treatment, the treatment group had a significantly smaller diameter of polyps and a significantly lower number of polyps than the control group (Z=-1.76 and -1.80, both P<0.05), and after 24 weeks of treatment, the treatment group had a significantly higher polyp reduction rate than the control group (30.51% vs 10.91%, P<0.05). The subgroup analysis showed that patients receiving combined antiviral therapy, male patients, patients with a diameter of polyps of <5 mm, and patients with multiple polyps tended to achieve significantly greater benefits. At week 8 of treatment, the treatment group had a significantly better TCM syndrome score than the control group (Z=-2.35, P<0.05); after treatment, compared with the control group, the treatment group had a significantly greater increase in high-density lipoprotein (Z=-1.85, P<0.05) and significantly lower levels of alanine aminotransferase (Z=-2.06, P <0.05), aspartate aminotransferase (Z=-2.13, P<0.05), total bilirubin (Z=-2.12, P<0.05), and direct bilirubin (Z=-3.09, P<0.05). No serious adverse events were reported in either group. ConclusionBBD can effectively reduce the size of gallbladder polyps, improve TCM syndrome score, and reduce the level of bilirubin in patients with chronic HBV infection with damp-heat in the liver and gallbladder, with a favorable safety profile, and it may be more suitable for patients receiving combined antiviral therapy and specific subgroups (male patients, patients with a diameter of polyps of <5 mm, and patients with multiple polyps.

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