1.A comparative study on the conversion treatment of the sirolimus quadruple regimen for expanded criteria donor kidney transplantation versus the control group from the same donors
Hua YANG ; Rui XIONG ; Lisong WAN ; Tongzhang CHEN ; Jinran YANG ; Wenfeng LUO ; Xinzhang LI
Organ Transplantation 2026;17(2):243-249
Objective To explore the efficacy and safety of converting the triple immunosuppressive regimen of tacrolimus (Tac) + mycophenolate mofetil (MMF) + prednisone (Pred) to a quadruple regimen of low-dose sirolimus (SRL) + low-dose Tac + MMF + Pred at 3 to 6 months after expanded criteria donor (ECD) kidney transplantation. Methods A single-center, retrospective, donor-matched controlled study included 22 ECD kidney transplant recipients from September 2021 to June 2024. Two recipients from the same donor kidneys were respectively assigned to the SRL group and the conventional triple regimen control group. The main outcome measures were the differences in serum creatinine (Scr), estimated glomerular filtration rate (eGFR), and adverse events before the regimen conversion and after conversion during the 1, 3, 6, and 12-month follow-up. Results There were no statistically significant differences in baseline characteristics between the two groups. In the SRL group, Scr decreased and eGFR increased starting from 3 months after conversion, and this was superior to the control group starting from 6 months(all P < 0.05). There were no statistically significant differences in the incidence of rejection reactions, pulmonary infections, hyperlipidemia and proteinuria between the two groups after conversion and during the 12-month follow-up (all P > 0.05). Conclusions For ECD kidney transplant recipients, converting the triple regimen to the SRL quadruple regimen at 3 to 6 months after transplantation may improve the function of the transplanted kidney without increasing the risk of adverse events.
2.Compilation Instruction and Key Point Interpretation for Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration
Wenzhe LI ; Rui MA ; Xiaoxiao ZHAO ; Hong HUA ; Xin CUI ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):260-266
To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems, including insufficient safety information in package inserts, amplified medication risks in special populations, and non-standard clinical practices, thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China (2019 revision) and the GB/T 1.1—2020 standard, a systematic search was performed in the Chinese Pharmacopoeia (2020 edition), the Catalog of Medicines Covered by Medical Insurance (2022 edition), Chinese databases [China Network of Knowledge Infrastructure (CNKI), Wanfang Data (Wanfang), and VIP journal resource integration service platform (VIP)], and international databases (Cochrane Library, PubMed, and EMbase). Guideline outlines were developed through questionnaire surveys, expert interviews, and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine (TCM) incompatibility, as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia (2020 edition) and 58 from the Catalog of Medicines Covered by Medical Insurance (2022 edition). Safety-related items in the corresponding package inserts were collected, and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting, and opinions from 61 external experts were solicited. A pharmacovigilance framework was established, covering the full chain of "monitoring, identification, assessment, and control". Based on seven anatomical sites, including nasal, ocular, and oral mucosa, a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions", "Contraindications", and "Precautions", clinical procedure standardization in healthcare institutions, risk control, and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration, filling the current gap in international pharmacovigilance standards in this field, while offering technical support for safety management across the full life cycle of medicines for mucosal administration.
3.Compilation Instruction and Key Point Interpretation for Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration
Wenzhe LI ; Rui MA ; Xiaoxiao ZHAO ; Hong HUA ; Xin CUI ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):260-266
To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems, including insufficient safety information in package inserts, amplified medication risks in special populations, and non-standard clinical practices, thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China (2019 revision) and the GB/T 1.1—2020 standard, a systematic search was performed in the Chinese Pharmacopoeia (2020 edition), the Catalog of Medicines Covered by Medical Insurance (2022 edition), Chinese databases [China Network of Knowledge Infrastructure (CNKI), Wanfang Data (Wanfang), and VIP journal resource integration service platform (VIP)], and international databases (Cochrane Library, PubMed, and EMbase). Guideline outlines were developed through questionnaire surveys, expert interviews, and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine (TCM) incompatibility, as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia (2020 edition) and 58 from the Catalog of Medicines Covered by Medical Insurance (2022 edition). Safety-related items in the corresponding package inserts were collected, and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting, and opinions from 61 external experts were solicited. A pharmacovigilance framework was established, covering the full chain of "monitoring, identification, assessment, and control". Based on seven anatomical sites, including nasal, ocular, and oral mucosa, a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions", "Contraindications", and "Precautions", clinical procedure standardization in healthcare institutions, risk control, and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration, filling the current gap in international pharmacovigilance standards in this field, while offering technical support for safety management across the full life cycle of medicines for mucosal administration.
4.Application of ''Sensation and Response'' Theory in Syndrome Differentiation and Treatment of Lung Cancer
Ayidana MAOLAN ; Qiujun GUO ; Runzhi QI ; Rui LIU ; Baojin HUA
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(2):261-268
Lung cancer still ranks first among malignant tumors in the world and China. Although surgery, radiotherapy, chemotherapy, and other treatments can delay patients' lives, thorny problems remain to be solved, such as adverse reactions after intervention, patient resistance to treatment, and the economic burden of treatment. Traditional Chinese medicine (TCM) featuring a holistic view advocates macro interventions throughout the entire disease cycle, which has the advantages of reducing toxicity, improving efficiency, and enhancing patients' quality of life. The theory of ''sensation and response'' was first recorded in the book of I-Ching. This is the natural law of mutual induction, influence, and interaction among all things in nature. According to the theory of ''Qi monism'' and the proposal of regulating Qi movement and removing toxin by Professor Hua Baojin, we re-examine lung cancer from the primitive thinking in TCM and explain the relevance of Qi movement changes to the occurrence, progression, and treatment of lung cancer. The core pathogeneses of lung cancer are the deficiency of healthy Qi and invasion of deficiency pathogen resulting in the formation of cancer and the internal generation of cancer toxin leading to intermediate dysfunction. Six excesses and Yin pathogen invade and gradually accumulate in the lung and spleen, leading to the generation of cancer toxin, which eventually evolve into lung cancer. The treatment can be based on the theories of five elements and visceral manifestation from three aspects. First, on the basis of syndrome differentiation, medicinal materials of different flavors can be used. Specifically, pungent medicinal materials can be used for dredging and sweet medicinal materials can be used for tonifying. Second, medicinal materials with similar morphology or origin to that in the human body can be used for treating the diseases in corresponding sites. Finally, corrigent medicinal materials can be combined for two-way regulation. These measures can be applied in lung cancer treatment to optimize the prevention and treatment strategies and provide new research directions for TCM diagnosis and treatment of tumors.
5.Characteristics of brain glymphatic system changes in patients with amnestic mild cognitive impairment based on perivascular spaces and DTI-ALPS index assessment
Xiaoqin CHENG ; Guoqiang FEI ; Shen ZHAO ; Rui HUA ; Feng SHI ; Xiaoli PAN ; Ziyi HE ; Sirui LIU
Chinese Journal of Clinical Medicine 2026;33(3):479-485
Objective To explore the characteristics and correlation between perivascular spaces (PVS) and diffusion tensor image analysis along perivascular spaces (DTI-ALPS) index in patients with amnestic mild cognitive impairment (aMCI). Methods A retrospective study was conducted on a total of 118 participants, including cognitive normal (CN) healthy controls and aMCI patients, recruited from the Department of Neurology, Zhongshan Hospital, Fudan University from September 2020 to September 2022. All participants underwent structural magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI). An automatic segmentation algorithm was used to quantify PVS metrics in the brain, and DTI-ALPS index was calculated based on DTI. Differences in DTI-ALPS index and PVS metrics between the CN and aMCI groups were compared. Multivariate logistic regression was used to identify independent factors influencing aMCI. Correlation analysis was performed to assess relationships among DTI-ALPS index, PVS metrics, and cognitive scores. Results A total of 80 CN healthy controls and 38 aMCI patients were included. The DTI-ALPS index was significantly lower in the aMCI group compared with the CN group (1.28±0.18 vs 1.37±0.21, P=0.018), while differences in PVS metrics between groups were not statistically significant. Multivariate logistic regression analysis indicated that DTI-ALPS index was an independent factor affecting aMCI (OR=0.097, 95%CI 0.011–0.833, P=0.033). Correlation analysis revealed a positive relationship between DTI-ALPS index and MMSE score (r=0.210, P=0.023) as well as PVS length in the centrum semiovale (r=0.216, P=0.019). Conclusions The DTI-ALPS index may serve as an imaging biomarker for identifying early cognitive impairment, and patients with aMCI exhibit abnormal DTI-ALPS indices, suggesting that brain glymphatic system dysfunction may occur prior to morphological changes.
6.Three cases of acquired ocular toxoplasmosis
Rui-rui LI ; Shu ZHOU ; Hua LIU ; Bo ZHOU ; Yu-zhang HU
Acta Parasitologica et Medica Entomologica Sinica 2026;33(1):66-68
In this study, there were three toxoplasmosis patients, two of whom developed symptoms in both eyes. One patient had a slight deviation of the lesion from the central fovea, which had a minor impact on vision. The diagnosis of this disease requires not only a close pet contact history and typical clinical manifestations, but also serology and the gold standard Goldmann-Witmer coefficient(GWC). However, the GWC of some patients cannot be detected at the initial stage, such as the first patient′s GWC, which did not meet the standard. All three patients underwent metagenomic testing to assist with diagnosis.
7.Dual Targeting of TBK1 and JAK-STAT1 Pathways by (-)-epigallocatechin-3-gallate Suppresses Type I Interferon-driven Inflammation
Liang LI ; Qi-Huan SHENG ; Huan LIU ; Wen-Hao YANG ; Jia-Lin SHI ; Ying-Jie SUN ; Rui JING ; Wei-Hua MAI ; Zhi-Min LI ; Xiao-Li XIE
Progress in Biochemistry and Biophysics 2026;53(7):1969-1983
ObjectiveType I interferon (IFN-I) signaling is essential for antiviral innate immunity, yet its sustained or excessive activation contributes to the pathogenesis of several autoimmune diseases and interferonopathies, such as systemic lupus erythematosus and Aicardi-Goutières syndrome. Current strategies targeting this pathway, exemplified by JAK inhibitors, act mainly on downstream signal transduction and provide limited direct control over upstream IFN-I production, while also carrying the risk of broad immunosuppression. Phyllanthus emblica L. has long been used in traditional medicine for inflammatory disorders, but the bioactive constituent responsible for its regulation of IFN-I signaling and the underlying molecular mechanism have not been clearly defined. This study aimed to identify the active anti-inflammatory component of P. emblica and to characterize its mechanism of action on the IFN-I pathway in macrophages. MethodsActive components ofP. emblica and their candidate targets were screened by network pharmacology using the TCMSP and DrugBank databases (oral bioavailability≥30%, drug-likeness≥0.18) and intersected with inflammation-related genes retrieved from public databases. The predicted interaction between EGCG and IFN-I pathway proteins (TBK1, IRF3, STAT1) was evaluated by molecular docking, with BX795 and GSK8612 used as reference TBK1 inhibitors. Mechanistic experiments were performed in THP-1-derived macrophages and primary bone marrow-derived macrophages (BMDM). Upstream signaling was activated by transfection of the nucleic acid analogs poly(I∶C) and poly(dA∶dT) or by lipopolysaccharide (LPS) stimulation, whereas downstream signaling was activated by exogenous IFN-β. An siRNA-mediated TREX1 knockdown model was used to mimic endogenous nucleic acid-driven interferonopathy. Expression of IFN-β1 and interferon-stimulated genes (ISGs) was measured by RT-qPCR, protein phosphorylation by Western blot, and IFN-β secretion by ELISA. Cellular thermal shift assay (CETSA) and drug affinity responsive target stability (DARTS) were used to probe the interactionbetween EGCG and IRF3. ResultsNetwork pharmacology identified (-)-epigallocatechin-3-gallate (EGCG) as a candidate IFN-I-suppressive constituent of P. emblica, with predicted binding to TBK1, IRF3, and STAT1. Molecular docking yielded binding energies of -9.2, -7.2, and -8.2 kcal/mol for TBK1, IRF3, and STAT1, respectively, indicating an affinity for TBK1 comparable to that of the reference inhibitors BX795 (-5.7 kcal/mol) and GSK8612 (-6.4 kcal/mol). EGCG suppressed IFN-β1 and ISG mRNA expression under poly (I∶C), poly (dA∶dT), and LPS stimulation in both THP-1 macrophages and BMDM. At the protein level, EGCG reduced the phosphorylation of TBK1 and IRF3 without affecting the levels of the upstream sensors cGAS and RIG-I, and lowered IFN-β secretion in a concentration-dependent manner. CETSA and DARTS showed that EGCG did not enhance the thermal stability or protease resistance of IRF3, indicating that its effect on IRF3 is indirect. Following IFN-β stimulation, prolonged EGCG treatment reduced STAT1 phosphorylation in a time-dependent manner without an apparent change in IRF9, and partially attenuated ISG transcription; this effect was not monotonicly concentration-dependent, and CXCL10 showed the most consistent suppression. In TREX1-knockdown cells, the elevated mRNA levels of ISG15, ISG56, and CXCL10 were reduced by EGCG. ConclusionEGCG suppresses IFN-I responses by concurrently inhibiting TBK1-IRF3-dependent IFN‑β production and JAK-STAT1-mediated downstream transcription. These in vitro findings provide a mechanistic basis for the anti-inflammatory use of P. emblica in traditional medicine and identify EGCG as a candidate for further evaluation in interferon-driven autoimmune disease models.
8.Effects of Modified Guomin Decoction (加味过敏煎) on Traditional Chinese Medicine Syndromes and Quality of Life in Patients with Mild to Moderate Atopic Dermatitis of Heart Fire and Spleen Deficiency Pattern:A Randomized,Double-Blind,Placebo-Controlled Trial
Jing NIE ; Rui PANG ; Lingjiao QIAN ; Hua SU ; Yuanwen LI ; Xinyuan WANG ; Jingxiao WANG ; Yi YANG ; Yunong WANG ; Yue LI ; Panpan ZHANG
Journal of Traditional Chinese Medicine 2025;66(10):1031-1037
ObjectiveTo observe the clinical efficacy and safety of Modified Guomin Decoction (加味过敏煎, MGD) in patients with mild to moderate atopic dermatitis (AD) of the traditional Chinese medicine (TCM) pattern of heart fire and spleen deficiency, and to explore its possible mechanisms. MethodsIn this randomized, double-blind, placebo-controlled study, 72 patients with mild to moderate AD and the TCM pattern of heart fire and spleen deficiency were randomly divided into a treatment group and a control group, with 36 cases in each group. The treatment group received oral MGD granules combined with topical vitamin E emulsion, while the control group received oral placebo granules combined with topical vitamin E treatment. Both groups were treated twice daily for 4 weeks. Clinical efficacy, TCM syndrome scores, Visual Analogue Scale (VAS) for pruritus, Dermatology Life Quality Index (DLQI) scores, Scoring Atopic Dermatitis (SCORAD) and serum biomarkers, including interleukin-33 (IL-33), interleukin-1β (IL-1β), immunoglobulin E (IgE), and tumor necrosis factor-α (TNF-α) were compared before and after treatment. Safety indexes was also assessed. ResultsThe total clinical effective rates were 77.78% (28/36) in the treatment group and 38.89% (14/36) in the control group, with cure rates of 19.44% (7/36) and 2.78% (1/36), respectively. The treatment group showed significantly better clinical outcomes compared to the control group (P<0.05). The treatment group exhibited significant reductions in total TCM syndrome scores, including erythema, edema, papules, scaling, lichenification, pruritus, irritability, insomnia, abdominal distension, and fatigue scores, as well as reductions in VAS, DLQI, SCORAD, and serum IgE and IL-33 levels (P<0.05 or P<0.01). Compared to the control group, the treatment group had significantly better improvements in all indicators except for insomnia (P<0.05). No adverse events occurred in either group. ConclusionMGD is effective and safe in treating mild to moderate AD patients with heart fire and spleen deficiency pattern. It significantly alleviates pruritus, improves TCM syndromes and quality of life, and enhances clinical efficacy, possibly through modulation of immune responses.
9.Literature analysis of tislelizumab-induced Stevens-Johnson syndrome and toxic epidermal necrolysis
Rui HAN ; Mingxi SHEN ; Hua YANG ; Zhaoshuai JI
China Pharmacy 2025;36(16):2046-2050
OBJECTIVE To analyze the clinical characteristics of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) induced by tislelizumab, providing evidence for clinical medication safety. METHODS Case reports of tislelizumab-related SJS/TEN were retrieved from CNKI, VIP, Wanfang Data, PubMed, ScienceDirect, and Embase. Descriptive analysis was performed. RESULTS Seventeen cases from 17 publications were included (SJS 4 cases, TEN 13 cases). Among them, there were 10 males and 7 females. Twelve patients were aged between 70 and 79 years. The predominant tumor type was lung cancer (10 cases). Thirteen patients received combination therapy with chemotherapeutic drugs. The median onset time of SJS/ TEN was 26 (4, 104) days. Nine patients developed SJS/TEN after the first administration of the drug. Sixteen patients exhibited prodromal rash symptoms, primarily characterized by severe skin damage such as skin detachment, accompanied by mucosal injury. Sixteen patients improved after symptomatic treatment, while one patient died. CONCLUSIONS Tislelizumab-associated SJS/TEN risk is higher in elderly patients, males, those with lung cancer and those receiving combination chemotherapy. Mucosal lesions and atypical rashes may indicate the early onset of SJS/TEN. During clinical use, pharmaceutical care can be carried out through measures such as identifying high-risk populations, closely monitoring skin symptoms from the first administration to the fifth treatment cycle, and enhancing patient education. When relevant symptoms occur, the medication should be promptly discontinued and symptomatic treatment should be administered to ensure the patient’s medication safety.
10.Medication Rules of Professor Hua Baojin in Treatment of Subsolid Pulmonary Nodules Based on Data Mining
Huibo YU ; Yue LI ; Yue LUO ; Hongyuan LIU ; Xiyuan ZHANG ; Jiaqi HU ; Rui LIU ; Baojin HUA
Cancer Research on Prevention and Treatment 2025;52(8):682-691
Objective To explore the medication rules of Professor Hua Baojin in the treatment of subsolid pulmonary nodules through retrospective analysis and data mining techniques. Methods The prescriptions of patients with subsolid pulmonary nodules who were diagnosed and treated by Professor Hua Baojin at Guang’anmen Hospital of the Chinese Academy of Chinese Medical Sciences from January 1, 2021 to December 31, 2024 were retrospectively collected. Data were imported into the Ancient and Modern Medical Case Cloud Platform for analysis of drug frequency, four natures and five flavors, meridian tropism, drug association, and hierarchical clustering. Results A total of 455 prescriptions were included, containing 205 kinds of traditional Chinese medicines, with a total frequency of


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