The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections （hereinafter referred to as the Guidelines） were released by the China Association of Chinese Medicine， with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections （TCMIs）. The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， along with 30 experts in TCM pharmacovigilance， clinical practice （TCM， as well as integrated traditional Chinese and Western medicine），and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field， both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1： Rules for the structure and drafting of standardizing documents， the WHO Handbook for Guideline Development，and other methodological norms. Based on international norms，national laws and regulations，and scientific research results in the field of pharmacovigilance， methods adopted included expert interviews，literature research，nominal group technique， and Delphi method. Then， key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring"，"identification"，"assessment"，and "control". The development process of the Guidelines included project initiation， international registration， expert interviews， literature search， and evaluation. Based on the research results of these steps，a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback， the final version was formed. The Guidelines came into effect on January 8，2024，providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process，this study elucidates the background，methodological framework，and key development steps of the Guidelines.

The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections （hereinafter referred to as the Guidelines） were released by the China Association of Chinese Medicine， with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections （TCMIs）. The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， along with 30 experts in TCM pharmacovigilance， clinical practice （TCM， as well as integrated traditional Chinese and Western medicine），and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field， both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1： Rules for the structure and drafting of standardizing documents， the WHO Handbook for Guideline Development，and other methodological norms. Based on international norms，national laws and regulations，and scientific research results in the field of pharmacovigilance， methods adopted included expert interviews，literature research，nominal group technique， and Delphi method. Then， key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring"，"identification"，"assessment"，and "control". The development process of the Guidelines included project initiation， international registration， expert interviews， literature search， and evaluation. Based on the research results of these steps，a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback， the final version was formed. The Guidelines came into effect on January 8，2024，providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process，this study elucidates the background，methodological framework，and key development steps of the Guidelines.

This article systematically reviews and examines the historical evolution of Bambusae Succus as a medicinal material， covering aspects such as nomenclature， origin， geographical distribution， harvesting and processing methods， quality assessment， therapeutic effects and indications， by consulting ancient herbal texts， medical compendia， and modern literature. The aim is to provide a reference for the development and utilization of famous classical formulas containing this herb. Research indicated that Bambusae Succus was first documented in the Shennong Bencaojing during the Han dynasty， with Zhuli being the standard name used throughout history， alongside aliases like Zhuzhi， Zhuyou and Huoquan. Historically， the primary source of Bambusae Succus has been Phyllostachys nigra var. henonis（Danzhu）， although other species such as Pleioblastus amarus and Bambusa emeiensis have also been used medicinally. Ancient records predominantly noted its origin in Yizhou（present-day Chengdu and surrounding areas in Sichuan） and the Wuling region（between present-day Hunan， Guangdong， Guangxi and Jiangxi provinces）， while contemporary sources are mainly from regions south of the Yangtze River and southwestern China. Traditionally， Bambusae Succus was harvested from bamboo that had grown for exactly one year， today， it can be collected year-round without strict age requirements. Ancient preparation methods included direct fire roasting or dry distillation， whereas modern industrial production employs dry distillation， reflux extraction， and percolation. In terms of quality evaluation， ancient texts considered a sweet taste to be superior， while today， clarity and transparency are prioritized. Historically， Bambusae Succus was characterized as sweet and cold nature， targeting the lung and stomach meridians， with uses evolving from clearing heat and resolving phlegm to nourishing Yin， moistening dryness， and relaxing tendons and unblocking meridians. Modern descriptions classify it as sweet， bitter， and cold in nature， affecting the heart， liver， and lung meridians， with functions including clearing heat， resolving phlegm， and facilitating orifices. It is indicated for conditions such as stroke with phlegm confusion， lung heat with phlegm congestion， convulsions， epilepsy， excessive phlegm in febrile diseases， high fever with thirst， irritability during pregnancy， and tetanus， with more clearly defined applications. Based on the results of the research， it is recommended that when developing and utilizing famous classical formulas containing Bambusae Succus， the one-year-old Phyllostachys nigra var. Henonis， which has been highly praised throughout history， should be selected as the source material. Industrial production should adopt the dry distillation method. Furthermore， in-depth research should be conducted on the modern technological characterization of the traditional quality control indicator of sweet taste， and reasonable modern quality control standards should be established.

Ephedra can improve chronic obstructive pulmonary disease (COPD). Pseudoephedrine (PSE) is a main active ingredients of ephedra. It has anti-inflammatory pharmacological properties. Its effect on COPD and its possible mechanism have not been elucidated. The COPD rat model was constructed by systemic cigarette smoke exposure combined with lipopolysaccharide (LPS) tracheal instillation. BEAS-2B cells were treated using cigarette smoke extract; PSE was administered for treatment. The senescence level of rat lung tissue and bronchial epithelial cells was evaluated through staining, immunofluorescence and western blot.The mitochondrial damage of rats and BEAS-2B cells was detected by transmission electron microscopy, JC-1 probe, MitoSOX Red probe and kits. In addition, the lung function indexes of rats were detected by animal lung function analysis system. Hematoxylin and eosin (HE) staining analyzed the pathological damage. Enzyme-linked immunosorbent assay (ELISA), kit and immunohistochemistry were used to evaluate inflammation and oxidative stress. Western blot detected phosphoinositide 3-kinase/ protein kinase B/mammalian target of rapamycin (PI3K/AKT/mTOR) axis protein. PSE significantly reduced senescent cells, apoptosis rate and P21 level in rat lung tissue and BEAS-2B cells, significantly increased the levels of zonula occludens-1 (ZO-1) and adenosine triphosphate (ATP), restored mitochondrial structure, and visible mitochondrial cristae. It also inhibited reactive oxygen species (ROS) levels and mitochondrial excessive fission. PSE also significantly improved lung function in rats, increased mean alveolar number (MAN), reduced pro-inflammatory factors, and increased superoxide dismutase (SOD) levels. PSE markedly suppressed p-p85, p-AKT and p-mTOR protein expressions. In addition, the PI3K/AKT agonist 740Y-P weakened the effect of PSE on improving COPD. PSE inhibited PI3K/AKT/mTOR axis, improved lung tissue senescence, mitochondrial dysfunction and pathological damage, and reduced airway inflammation and oxidative stress damage, thereby alleviating COPD.

Objectives: . This study aimed to investigate the regulatory functions of gamma-aminobutyric acid (GABA)ergic neural circuits from the inferior colliculus (IC) to the medial geniculate body (MGB) in salicylate-induced tinnitus. Methods: . Mice were treated with salicylate to induce tinnitus, and tinnitus-like behaviors were evaluated via gap prepulse inhibition of acoustic startle. Using combined viral tracing methodologies, we identified and mapped the pathways and connections from the IC to the MGB. Furthermore, we employed Gq-coupled human M3 designer receptors exclusively activated by designer drugs (DREADDs) and Gi-coupled human M4 DREADDs to achieve targeted excitation or suppression of GABAergic neurons in the IC and MGB. Following the administration of clozapine N-oxide, which binds to these receptors, we modulated these neural circuits to assess their impact on tinnitus severity in a mouse model. Results: . Our findings demonstrated that mice exposed to salicylate exhibited tinnitus-like behaviors. GABAergic neurons projecting retrogradely from the MGB to the IC were primarily concentrated in the external nucleus of the IC. After clozapine N-oxide administration, chemogenetic activation of IC-MGB GABAergic neurons aggravated salicylate-induced tinnitus. Additionally, activation of GABAergic neurons between the IC and MGB induced the perception of tinnitus even without salicylate. However, chemogenetic inhibition of the IC-MGB GABAergic circuit did not reverse salicylate-induced tinnitus. Conclusion . These findings suggest that activation of the IC-MGB GABAergic neural circuit may contribute to tinnitus generation through a mechanism distinct from that of salicylate-induced tinnitus. This study provides novel insights into the mechanisms underlying tinnitus.

Objective: To explore the metabolic molecular mechanism of regulatory T cells (Tregs) resisting ferroptosis under a hypoxic stress microenvironment, and to provide scientific support for finding intervention targets to improve the immune microenvironment of oral squamous cell carcinoma (OSCC). Methods: This study was approved by the Institutional Medical Ethics Committee. Multiplex immunofluorescence was used to detect the distribution of Tregs and the localization of hypoxic regions in clinical pathological specimens from patients with OSCC tissues. Animal experiments were approved by the Laboratory Animal Ethics Committee. A tumor-bearing model was established in C57BL/6 mice. The submandibular, subscapular, inguinal, and popliteal lymph nodes were collected along with the spleen, and were homogenized to prepare single cell suspensions. C57BL/6 mouse naive CD4⁺ T cells were induced to differentiate into Tregs in vitro, and a 1% hypoxic culture model was established. Normoxia and hypoxia groups were established, and Treg viability under hypoxic conditions was assessed by flow cytometry. Transcriptomics and metabolomics were applied to analyze differentially expressed genes, metabolic pathways, and changes in cholesterol metabolites. Western blot was performed to detect the expression of emopamil-binding protein (EBP), glutathione peroxidase 4 (GPX4), ferroptosis suppressor protein 1 (FSP1), and acyl-CoA synthetase long-chain family member 4 (ACSL4). The safe concentration of the EBP inhibitor TASIN-30 was determined by the CCK-8 assay. On this basis, four groups were established: normoxia control, hypoxia, hypoxia+TASIN-30, and hypoxia+TASIN-30+7-dehydrocholesterol (7-DHC). Treg viability in each group was measured by flow cytometry; intracellular Fe2+ content, lipid peroxidation level, and reactive oxygen species (ROS) accumulation were detected by cellular immunofluorescence and flow cytometry; the reduced/oxidized glutathione (GSH/GSSG) ratio was measured using a microplate reader; and mitochondrial morphology was observed by transmission electron microscopy. In vivo tumor-inhibition experiments in C3H/HeJ mice were performed to validate the in vivo effects of EBP inhibition, and clinical prognostic survival analysis based on the TCGA-HNSC cohort was performed to evaluate the clinical prognostic value of ferroptosis resistance in Tregs. Results: Tregs were highly enriched in OSCC tissue, preferentially accumulated in hypoxic areas, and could maintain cell survival under hypoxia. The cholesterol metabolism pathway was upregulated in the hypoxic group, with increased EBP mRNA expression (P < 0.001) and 7-DHC accumulation. Compared with the hypoxic group alone, the hypoxic + TASIN-30 group showed decreased GPX4 and FSP1 expression (P < 0.001, P = 0.003); increased ACSL4 expression (P < 0.001); a decreased viable cell ratio (P < 0.001); increased Fe2+, lipid peroxidation, and ROS levels (P < 0.001); a decreased GSH/GSSG ratio (P < 0.001); and mitochondrial shrinkage. Exogenous supplementation of 7-DHC reversed the effects of EBP inhibition. In vivo inhibition of EBP significantly inhibited tumor growth (P < 0.001). Conclusion Tregs upregulate EBP and promote 7-DHC accumulation in hypoxic microenvironments, thereby inhibiting Treg ferroptosis and maintaining their survival and immunosuppressive function. Inhibition of EBP can weaken the resistance of Tregs to ferroptosis under hypoxia.

The compilation explanation for the Expert Consensus on Clinical Application of Ruyi Zhenbao pills systematically expounds the formulation methods and evidence-based basis of this consensus. In response to the weak clinical application evidence and ambiguous indications of Ruyi Zhenbao pills， the Institute of Basic Research in Clinical Medicine of China Academy of Chinese Medical Sciences， Wangjing Hospital of China Academy of Chinese Medical Sciences， and Dongzhimen Hospital of Beijing University of Chinese Medicine invited 39 experts from 31 medical institutions across China to complete the compilation through multi-disciplinary collaboration. The compilation strictly adheres to the World Health Organization （WHO） guidelines for guideline development and the GRADE evidence grading system. The work process covered the construction of clinical questions （a total of 30 clinical questions were determined based on expert voting results）， evidence retrieval （covering Chinese and English databases and gray literature）， safety assessment （integrating drug monitoring data and clinical research）， and the formation of recommendation opinions and consensus suggestions （18 recommendation opinions were reached through the GRADE grid method， and 22 consensus suggestions were reached through majority voting rules）. The results show that the consensus clearly states that this medicine is suitable for knee osteoarthritis， gouty arthritis， rheumatoid arthritis， neuropathic pain， and sequelae of stroke. In terms of safety， the adverse reactions are mainly gastrointestinal reactions such as nausea， vomiting， and abdominal pain. Pregnant women and those allergic to the ingredients of this medicine are contraindicated. The compilation process underwent three rounds of expert reviews and adopted methods such as nominal group technique and Delphi method to ensure the rigor of the consensus compilation process. It provides a paradigm for the formulation of expert consensus on clinical application of Tibetan medicine through the academic promotion and dynamic revision.

[Objective] To evaluate the efficacy and safety of sacral neuromodulation (SNM) in the treatment of patients with benign prostatic hyperplasia (BPH) complicated with underactive bladder (UAB) who respond poorly to transurethral resection of the prostate (TURP). [Methods] A retrospective analysis was performed on 10 patients with BPH and UAB treated with TURP by the same surgeon in Zhongda Hospital Southeast University during Jan.2018 and Jan.2023.The residual urine volume was not significantly relieved after operation, and the maximum urine flow rate and urine volume per discharge were not significantly improved.All patients underwent phase I SNM, and urinary diaries were recorded before and after surgery to observe the average daily frequency of urination, volume per urination, maximum urine flow rate, and residual urine volume. [Results] The operation time was (97.6±11.2) min.During the postoperative test of 2-4 weeks, if the residual urine volume reduction by more than 50% was deemed as effective, SNM was effective in 6 patients (60.0%). Compared with preoperative results, the daily frequency of urination [(20.2±3.8) times vs. (13.2±3.2) times], volume per urination [(119.2±56.7) mL vs. (246.5±59.2) mL], maximum urine flow rate [(8.7±1.5) mL/s vs. (16.5±2.6) mL/s], and residual urine volume [(222.5±55.0) mL vs. (80.8±16.0) mL] were significantly improved, with statistical significance (P<0.05). There were no complications such as bleeding, infection, fever or pain.The 6 patients who had effective outcomes successfully completed phase II surgery, and the fistula was removed.During the follow-up of 1 year, the curative effect was stable, and there were no complications such as electrode displacement, incision infection, or pain in the irritation sites.The residual urine volume of the other 4 unsuccessful patients did not improve significantly, and the electrodes were removed and the vesicostomy tube was retained. [Conclusion] SNM is safe and effective in the treatment of BPH with UAB patients with poor curative effects after TURP.

Objective:To investigate the therapeutic efficacy of autologous hematopoietic stem cell transplantation (auto-HSCT) for treatment of diffuse large B-cell lymphoma (DLBCL) and the factors affecting the prognosis.Methods:A retrospective case series study was conducted. The clinical data of 51 patients with DLBCL who underwent auto-HSCT in the First Affiliated Hospital of Xinjiang Medical University from March 2019 to January 2024 were retrospectively analyzed. Patients were divided into high-risk group (19 cases) and non-high-risk group (low-risk, low-moderate-risk and moderate-high-risk groups, 32 cases) based on different risk stratifications; patients were divided into the germinal center B-cell (GCB) group (29 cases) and non-GCB group (22 cases) based on different cellular origins; patients were divided into BEAM group (39 cases) and BeEAM group (12 cases) based on different conditioning regimens before auto-HSCT; patients were divided into auto-HSCT consolidation therapy group (41 cases) and auto-HSCT after relapsed/refractory group (10 cases) based on different transplantation timings. The Kaplan-Meier method was used for survival analysis and log-rank was used for subgroup comparison.Results:All 51 patients achieved the hematopoietic reconstitution with no transplantation-related death within 100 d. Before auto-HSCT, 39 cases achieved complete remission and 12 cases (23.5%) achieved partial remission. After auto-HSCT, all cases achieved complete remission. Follow-up was until May 31, 2024, and the median follow-up time [ M ( Q1, Q3)] of 51 DLBCL patients was 33 (8, 43) months. After 51 DLBCL patients receiving auto-HSCT, 7 patients relapsed and 6 cases died including 3 cases with relapse-related death and 3 cases with non relapse-related death. The 3-year progression-free survival (PFS) and overall survival (OS) rates were 78.5% (95% CI: 64.4%-92.6%) and 85.5% (95% CI: 73.2%-97.8%), respectively. The 3-year PFS rate was 94.7% (95% CI: 84.7%-104.7%) in the high-risk group, 82.2% (95% CI: 67.9%-96.5%) in the non-high-risk group, and the difference in the PFS was not statistically significant between the high-risk group and the non-high-risk group ( P = 0.158). The 3-year PFS rate was 80.1% (95% CI: 64.4%-95.8%) in the GCB group, 88.1% (95% CI: 72.3%-104.2%) in the non-GCB group, and the difference in PFS was not statistically significant between the 2 groups ( P = 0.803). The 3-year PFS rate was 84.9% (95% CI: 72.6%-97.2%) in BEAM group, 61.1% (95% CI: 25.0%-97.2%) in the BeEAM group, and the difference in PFS was not statistically significant between the 2 groups ( P = 0.106). The 3-year PFS rate was 85.4% (95% CI: 73.4%-97.4%) in the auto-HSCT consolidation therapy group, 64.3% (95% CI: 31.4%-96.4%) in the auto-HSCT after relapsed/refractory group, and the difference in PFS was not statistically significant between the 2 groups ( P = 0.171). Conclusions:auto-HSCT is an effective therapy method for DLBCL.