1.The Effect of Fuzheng Huaji Formula (扶正化积方) for Chronic Hepatitis B on Reduction of the Incidence of Liver Cirrhosis and Hepatocellular Carcinoma:A Retrospective Cohort Study
Simiao YU ; Jiahui LI ; Jing JING ; Tingting HE ; Yongqiang SUN ; Liping WANG ; Aozhe ZHANG ; Xiaohe XIAO ; Xia DING ; Ruilin WANG
Journal of Traditional Chinese Medicine 2025;66(3):268-274
ObjectiveTo evaluate the clinical efficacy of Fuzheng Huaji Formula (扶正化积方) for chronic hepatitis B to reduce the incidence of liver cirrhosis and hepatocellular carcinoma. MethodsA retrospective cohort study was conducted, collecting medical records of 118 patients with chronic hepatitis B and 234 patients with hepatitis B-related cirrhosis who visited the hospital between January 1, 2014, and December 31, 2018. The use of Fuzheng Huaji Formula was designated as the exposure factor. Patients receiving antiviral treatment for hepatitis B without concurrent Fuzheng Huaji Formula therapy were included in the western medicine group, while those receiving antiviral treatment combined with Fuzheng Huaji Formula for a cumulative treatment lasting longer than 3 months were included in the combined treatment group. The follow-up observation period was five years. Kaplan-Meier survival analysis was used to assess the cumulative incidence of cirrhosis in patients with chronic hepatitis B and the cumulative incidence of hepatocellular carcinoma in patients with hepatitis B-related cirrhosis. Univariate and multivariate Cox regression analyses were employed to examine the factors influencing the occurrence of cirrhosis and hepatocellular carcinoma. ResultsAmong patients with chronic hepatitis B, there were 55 cases in the combined treatment group and 63 cases in the western medicine group; among patients with hepatitis B-related cirrhosis, there were 110 cases in the combined treatment group and 124 cases in the western medicine group. Five-year follow-up outcomes for chronic hepatitis B patients showed that the cumulative incidence of cirrhosis was 5.45% (3/55) in the combined treatment group and 17.46% (11/63) in the western medicine group, with a statistically significant difference between groups (Z = 2.003, P = 0.045). Five-year follow-up outcomes for hepatitis B-related cirrhosis patients showed that the cumulative incidence of hepatocellular carcinoma was 8.18% (9/110) in the combined treatment group and 22.58% (28/124) in the western medicine group, also showing a statistically significant difference (Z = 3.007, P = 0.003). Univariate and multivariate Cox regression analyses indicated that treatment with Fuzheng Huaji Formula is an independent protective factor in preventing the progression of chronic hepatitis B to cirrhosis and the progression of hepatitis B-related cirrhosis to hepatocellular carcinoma (P<0.05). ConclusionCombining Fuzheng Huaji Formula with antiviral therapy for hepatitis B can effectively intervene in the disease progression of chronic hepatitis B, reducing the incidence of cirrhosis and hepatocellular carcinoma.
2.New insights and prospects of drug-induced liver injury in the context of chronic cholestatic liver diseases
Simiao YU ; Jiabo WANG ; Xiaohe XIAO ; Ruilin WANG
Journal of Clinical Hepatology 2025;41(2):365-369
Patients with chronic cholestatic liver diseases face numerous challenges in the detection, assessment, and management of suspected drug-induced liver injury (DILI), and in particular, it is difficult to distinguish cholestatic DILI from the progression of underlying cholestatic liver diseases clinically and histologically. Currently, there is a lack of related research and management guidelines for DILI with chronic cholestatic liver diseases. This article discusses the potential risks, causality, and classification criteria for chronic cholestatic liver diseases with DILI, in order to improve the understanding of such diseases among clinicians and provide a reference for prevention, treatment, and management strategies.
3.Meta-analysis of the efficacy and safety of rituximab in the treatment of primary Sjögren syndrome
Jigao LI ; Ruilin LIU ; Zihua WANG ; Hejun WANG ; Peipei SU ; Quan ZHOU
China Pharmacy 2025;36(5):619-623
OBJECTIVE To evaluate the efficacy and safety of rituximab (RTX) in the treatment of primary Sjögren syndrome (pSS). METHODS Randomized controlled trials (RCTs) on the effects of RTX (trial group) versus placebo (control group) in the treatment of pSS were searched from the Cochran Library, PubMed, Embase, Medline, Web of Science, VIP, CNKI, Wanfang, and other databases during the inception to February 2024. After literature screening and quality evaluation, meta-analysis was performed by using RevMan 5.3 software. RESULTS Seven RCTs were finally included, involving a total of 518 patients. Results of meta-analysis showed that European League Against Rheumatism Sjögren syndrome disease activity index (ESSDAI) score [MD=-1.17, 95%CI(-1.52, -0.82), P<0.000 01] and oral dryness visual analogue scale (VAS) score [MD=-3.97, 95%CI (-5.08, -2.86), P<0.000 01] in the trial group were significantly lower than the control group; unstimulated salivary flow rate [SMD=0.64, 95%CI(0.41, 0.87), P<0.000 01] and Schirmer score [MD=0.19, 95%CI(0.18, 0.20), P<0.000 01] were significantly higher than the control group. There was no statistical significance in response rate [RD=0.10, 95%CI(-0.04, 0.23), P=0.16], fatigue VAS score [MD=-12.50, 95%CI(-35.14, 10.15), P=0.28], European League Against Rheumatism Sjögren syndrome patient reported index (ESSPRI) score [MD=0.33, 95%CI(-0.53, 1.18), P=0.46], Short-form 36 health survey physical component summary (SF36-PCS) score [MD=0.90, 95%CI(-2.97, 4.78), P=0.65], SF-36 mental component summary (SF36-MCS) score [MD=0.11, 95%CI(-0.41, 0.63), P=0.68], total salivary gland ultrasound score [SMD=-1.91, 95%CI(-4.01, 0.19), P=0.07] or the incidence of adverse drug reactions [OR=1.15,95%CI(0.62,2.13),P=0.66] between 2 groups. CONCLUSIONS RTX has advantages in the improvement of ESSDAI score, unstimulated salivary flow rate, Schirmer score and oral dryness VAS score in pSS patients, and has a good safety profile. However, it did not exhibit significant improvement in fatigue VAS score, ESSPRI score, SF36-PCS score, SF36-MCS score or response rates.
4.Research advances in traditional Chinese medicine for the prevention and treatment of inflammation-to-cancer transformation in chronic hepatitis
Simiao YU ; Sici WANG ; Haocheng ZHENG ; Yongqiang SUN ; Jing JING ; Tingting HE ; Liping WANG ; Aozhe ZHANG ; Xin WANG ; Xia DING ; Ruilin WANG
Journal of Clinical Hepatology 2025;41(9):1888-1895
Primary liver cancer is one of the most common malignant tumors of the digestive system, and the “inflammation-to-cancer transformation” (ICT) of chronic hepatitis is the core pathological process of the progression of chronic hepatitis to liver cancer. Persistent and uncontrolled liver inflammation in patients with chronic hepatitis often leads to repeated liver tissue damage and repair, which gradually develops into liver fibrosis and cirrhosis, eventually leading to malignant transformation through the mechanisms such as gene mutation and microenvironment imbalance. ICT in chronic hepatitis is the key link between chronic hepatitis and liver cancer, and its dynamic evolution involves various pathogenic factors such as dampness, heat, deficiency, toxin, and stasis; among which damp-heat and vital energy deficiency are the initiating factors for ICT of chronic hepatitis, while intermingled stasis and toxin are the key pathological products that promote malignant transformation. Based on the concept of preventive treatment, traditional Chinese medicine can effectively delay and even block the ICT of chronic hepatitis by regulating inflammation, metabolism, and abnormal cell proliferation through multiple targets, which provides important strategies and research directions for the prevention and treatment of liver cancer.
5.Integrated evidence chain-based effectiveness evaluation of traditional Chinese medicines (Eff-iEC): A demonstration study.
Ye LUO ; Xu ZHAO ; Ruilin WANG ; Xiaoyan ZHAN ; Tianyi ZHANG ; Tingting HE ; Jing JING ; Jianyu LI ; Fengyi LI ; Ping ZHANG ; Junling CAO ; Jinfa TANG ; Zhijie MA ; Tingming SHEN ; Shuanglin QIN ; Ming YANG ; Jun ZHAO ; Zhaofang BAI ; Jiabo WANG ; Aiguo DAI ; Xiangmei CHEN ; Xiaohe XIAO
Acta Pharmaceutica Sinica B 2025;15(2):909-918
Addressing the enduring challenge of evaluating traditional Chinese medicines (TCMs), the integrated evidence chain-based effectiveness evaluation of TCMs (Eff-iEC) has emerged. This paper explored its capacity through a demonstration study that evaluated the effectiveness evidence of six commonly used anti-hepatic fibrosis Chinese patent medicines (CPMs), including Biejiajian Pill (BP), Dahuang Zhechong Pill (DZP), Biejia Ruangan Compound (BRC), Fuzheng Huayu Capsule (FHC), Anluo Huaxian Pill (AHP), and Heluo Shugan Capsule (HSC), using both Eff-iEC and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system. The recognition of these CPMs within the TCM academic community was also assessed through their inclusion in relevant medical documents. Results showed that the evidence of BRC and FHC received higher assessments in both Eff-iEC and GRADE system, while the assessments for others varied. Analysis of community recognition revealed that Eff-iEC more accurately reflects the clinical value of these CPMs, exhibiting superior evaluative capabilities. By breaking through the conventional pattern of TCMs effectiveness evaluation, Eff-iEC offers a novel epistemology that better aligns with the clinical realities and reasoning of TCMs, providing a coherent methodology for clinical decision-making, new drug evaluations, and health policy formulation.
6.Drug delivery systems based on mesoporous silica nanoparticles for the management of hepatic diseases.
Boyan LIU ; Wenshi LIU ; Miao XU ; Tongyi ZHAO ; Bingxin ZHOU ; Ruilin ZHOU ; Ze ZHU ; Xuchun CHEN ; Zhiye BAO ; Keke WANG ; Heran LI
Acta Pharmaceutica Sinica B 2025;15(2):809-833
The liver performs multiple life-sustaining functions. Hepatic diseases, including hepatitis, cirrhosis, and hepatoma, pose significant health and economic burdens globally. Along with the advances in nanotechnology, mesoporous silica nanoparticles (MSNs) exhibiting diversiform size and shape, distinct morphological properties, and favorable physico-chemical features have become an ideal choice for drug delivery systems and inspire alternative thinking for the management of hepatic diseases. Initially, we introduce the physiological structure of the liver and highlight its intrinsic cell types and correlative functions. Next, we detail the synthesis methods and physicochemical properties of MSNs and their capacity for controlled drug loading and release. Particularly, we discuss the interactions between liver and MSNs with respect to the passive targeting mechanisms of MSNs within the liver by adjusting their particle size, pore diameter, surface charge, hydrophobicity/hydrophilicity, and surface functionalization. Subsequently, we emphasize the role of MSNs in regulating liver pathophysiology, exploring their value in addressing liver pathological states, such as tumors and inflammation, combined with multi-functional designs and intelligent modes to enhance drug targeting and minimize side effects. Lastly, we put forward the problems, challenges, opportunities, as well as clinical translational issues faced by MSNs in the management of liver diseases.
7.Research advances in the treatment of arthritis from natural products (2014-present).
Ruilin WANG ; Cen JI ; Jiayao CHEN ; Xiaohan ZHANG ; Qinghua HU ; Chunxiao LIU
Chinese Journal of Natural Medicines (English Ed.) 2025;23(5):529-540
Arthritis, encompassing osteoarthritis (OA), rheumatoid arthritis (RA), and gouty arthritis (GA), is a prevalent inflammatory disease that significantly impacts quality of life. Natural products (NPs), derived from animals, plants, marine organisms, and microorganisms, have demonstrated beneficial effects in arthritis treatment both domestically and internationally. These natural compounds offer advantages in drug discovery due to their skeletal diversity, structural complexity, and multi-effect, multi-target, and low-toxicity properties compared to conventional small-molecule medicines. However, unclear mechanisms have hindered the development and clinical application of NPs. This review summarizes recent experimental studies from the past decade on natural medicine for arthritis treatment, emphasizing key NPs with therapeutic effects on OA, RA, and GA. It examines the effects and molecular mechanisms of NPs acting on different cells to treat arthritis. Furthermore, this review provides insights into the future prospects of NP research in this field, which is crucial for advancing NP-based arthritis treatments.
Humans
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Biological Products/therapeutic use*
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Animals
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Arthritis, Rheumatoid/drug therapy*
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Arthritis, Gouty/drug therapy*
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Arthritis/drug therapy*
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Osteoarthritis/drug therapy*
8.Levels and clinical significance of urinary lead in patients with nonalcoholic fatty liver disease
Journal of Clinical Hepatology 2024;40(9):1771-1777
Objective To investigate the association between urinary lead and nonalcoholic fatty liver disease(NAFLD).Methods The participants,aged≥18 years,were selected from the 2017-2020 National Health and Nutrition Examination Survey(NHANES),with the exclusion of the participants with a lack of liver transient elastography data and urinary lead markers and those with hepatitis B,hepatitis C,and significant alcohol consumption.A total of 2 492 participants were enrolled and divided into NAFLD group with 852 participants and non-NAFLD group with 1 640 participants.High-performance liquid chromatography-electrospray ionization-tandem mass spectrometry and online solid-phase extraction combined with isotope dilution were used to measure urinary lead level.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.Multivariate Logistic regression analysis,restricted cubic spline,subgroup analysis,and interaction analysis were used to investigate the association between urinary lead and NAFLD.Results The NAFLD group had a significantly higher urinary lead level than the non-NAFLD group(Z=-2.023,P=0.043).After adjustment of the covariates of age,sex,race,marital status,education,family income-to-poverty ratio,body mass index,smoking,drinking,diabetes mellitus,hypertension,and hyperlipidemia,there was a significant increase in the risk of NAFLD in the Q3 urinary lead group(odds ratio[OR]=1.360,95%confidence interval[CI]:1.019-1.817,P=0.037).There was a positive dose-response relationship between urinary lead and the risk of NAFLD(P=0.047),which was a non-linear relationship(Pnon-linear=0.037).There was a significant interaction between urinary lead and race,and for every quartile increase in urinary lead,the risk of NAFLD in Mexican-Americans was increased by 32.40%(OR=1.324,95%CI:1.017-1.632,P<0.05).Conclusion Urinary lead level is significantly associated with the risk of NAFLD.
9.Characteristics of health empowerment,perceived control and experiential avoidance in coronary heart disease patients with type D and non-type D personality
Ruilin ZHANG ; Qiumin ZHANG ; Lijuan WANG ; Wanpeng QI ; Yuping SONG ; Nengzhi JIANG ; Xiangjuan TIAN
Chinese Journal of Rehabilitation Theory and Practice 2024;30(5):570-576
Objective To investigate the differences in health empowerment,perceived control and experiential avoidance between patients with coronary heart disease(CHD)with type D personality and non-type D personality. Methods From January to October,2022,using the convenient sampling method,a questionnaire survey was conducted on 195 patients with CHD from Affiliated Hospital of Shandong Second Medical University.Assessment tools in-cluded Type D Personality Scale,Chinese Version of Patient Perception Empowerment Scale(CV-PPES),Con-trol Attitudes Scale-Revised(CAS-R)and Acceptance Action Questionnaire-Ⅱ(AAQ-Ⅱ). Results A total of 185 effective questionnaires were returned,and 68 patients with type D personality.Compared with the patients with non-type D personality,the scores of negative affectivity and social inhibition were higher(|t|>9.783,P<0.001),the total score of CV-PPES and the scores of four dimensions(information,decision,individu-al and self-management)were lower(t>5.843,P<0.001),the score of CAS-R was lower(t=2.858,P=0.005),and the score of AAQ-Ⅱ was higher(t=-9.414,P<0.001)in CHD patients with type D personality. Conclusion Compared with non-D-type patients,CHD patients with D-type personality exhibit lower levels of health empowerment and perceived control,and higher level of experiential avoidance,which may negatively impact on health behaviors.
10.Study on the Effect of Baitouweng Decoction on VVC Mice by Regulating PI3K/AKT-HIF-1α Pathway
Songxia LU ; Qiangjun DUAN ; Ruilin WANG ; Xi GUO ; Min GAO ; Rongrong HUANG
Journal of Nanjing University of Traditional Chinese Medicine 2024;40(8):804-811
OBJECTIVE To explore the mechanism Baitouweng Decoction on mice with vulvovaginal candidiasis(VVC)based on phosphoinositide 3-kinase(PI3K)/protein kinase B(AKT)-hypoxia-inducible factor-1α(HIF-1α)pathway.METHODS Female SPF-grade Kunming mice were injected subcutaneously with estradiol benzoate and vaginally inoculated with Candida albicans suspension to establish a VVC mouse model.The mice with successful modeling were randomly divided into model group,high-,me-dium-,and low-dose Baitouweng Decoction groups(23.4,11.7,and 5.85 g·kg-1),and fluconazole group(0.02 g·kg-1),with 20 mice in each group.Another 20 mice were injected with estradiol benzoate as control group.Treatment started the day after success-ful model establishment and continued for 14 days.Two hours after the last administration,the number of neutrophils in vaginal lavage fluid was examined with Papanicolaou stain.The HE staining method was used to observe the morphology of vaginal tissue.ELISA was used to measure the levels of nicotinamide adenine dinucleo-tide phosphate oxidase 2(NOX2),reactive oxygen species(ROS),su-peroxide dismutase(SOD),malondialdehyde(MDA)in the vaginal tissues.The mRNA expression levels of PI3K,AKT and HIF-1α were detected using qPCR.Western blot was employed to evaluate the protein expression of p-PI3K,PI3K,p-AKT,AKT,and HIF-1α in vaginal tissue.RESULTS Compared to the control group,the model group exhibited a significant increase in neutrophils in va-ginal lavage fluid(P<0.001);the vaginal mucosal layer was severely desquamated and a large number of inflammatory cells infiltrated.Additionally,there was an elevation in NOX2,ROS,and MDA levels in vaginal tissue(P<0.001),while SOD content decreased(P<0.001).Furthermore,the mRNA expression of PI3K,AKT and HIF-1α was reduced along with decreased protein ex-pression of p-PI3K/PI3K,p-AKT/AKT,and HIF-1α(P<0.001).In comparison to the model group,both high-dose and medi-um-dose groups treated with Baitouweng Decoction demonstrated a significant decrease in neutrophil count in lavage fluid(P<0.01,P<0.001);the condition of the vaginal mucosa improved to varying degrees.Moreover,the levels of ROS and MDA in vaginal tissue were reduced(P<0.05,P<0.01,P<0.001),the activity of NOX2 was decreased(P<0.01,P<0.001),and the activity of SOD was increased(P<0.01,P<0.001).The high-dose group showed that,the mRNA expression of PI3K,AKT,and HIF-1α in vaginal tissue was increased(P<0.001),the ratios of p-PI3K/PI3K and p-AKT/AKT,and the protein expression of HIF-1α were increased(P<0.001).CONCLUSION Baitouweng Decoction has a therapeutic effect on VVC,and its mechanism of action may be related to the PI3K/AKT-HIF-1α signal pathway.

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