1.Treatment Principles and Paradigm of Diabetic Microvascular Complications Responding Specifically to Traditional Chinese Medicine
Anzhu WANG ; Xing HANG ; Lili ZHANG ; Xiaorong ZHU ; Dantao PENG ; Ying FAN ; Min ZHANG ; Wenliang LYU ; Guoliang ZHANG ; Xiai WU ; Jia MI ; Jiaxing TIAN ; Wei ZHANG ; Han WANG ; Yuan XU ; .LI PINGPING ; Zhenyu WANG ; Ying ZHANG ; Dongmei SUN ; Yi HE ; Mei MO ; Xiaoxiao ZHANG ; Linhua ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(5):272-279
To explore the advantages of traditional Chinese medicine (TCM) and integrative TCM-Western medicine approaches in the treatment of diabetic microvascular complications (DMC), refine key pathophysiological insights and treatment principles, and promote academic innovation and strategic research planning in the prevention and treatment of DMC. The 38th session of the Expert Salon on Diseases Responding Specifically to Traditional Chinese Medicine, hosted by the China Association of Chinese Medicine, was held in Beijing, 2024. Experts in TCM, Western medicine, and interdisciplinary fields convened to conduct a systematic discussion on the pathogenesis, diagnostic and treatment challenges, and mechanism research related to DMC, ultimately forming a consensus on key directions. Four major research recommendations were proposed. The first is addressing clinical bottlenecks in the prevention and control of DMC by optimizing TCM-based evidence evaluation systems. The second is refining TCM core pathogenesis across DMC stages and establishing corresponding "disease-pattern-time" framework. The third is innovating mechanism research strategies to facilitate a shift from holistic regulation to targeted intervention in TCM. The fourth is advancing interdisciplinary collaboration to enhance the role of TCM in new drug development, research prioritization, and guideline formulation. TCM and integrative approaches offer distinct advantages in managing DMC. With a focus on the diseases responding specifically to TCM, strengthening evidence-based support and mechanism interpretation and promoting the integration of clinical care and research innovation will provide strong momentum for the modernization of TCM and the advancement of national health strategies.
2.Interpretation of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Wenxi PENG ; Meng QIAO ; Lianxin WANG ; Yuanyuan LI ; Xiuhui LI ; Xin CUI ; Zijia CHEN ; Xinyi CHEN ; Yi DENG ; Yanming XIE ; Zhifei WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):152-160
The Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines (hereinafter referred to as the Guidelines) is first specialized in the field of drug safety for oral Chinese patent medicines (OCPMs) in China. Rooted in China's healthcare context, the Guidelines address the unique usage patterns and risk characteristics of OCPMs, filling a regulatory gap in the pharmacovigilance framework specific to this category. To facilitate accurate understanding and effective implementation of the Guidelines, and to promote the standardized development of pharmacovigilance practices for OCPMs, this study offered a systematic interpretation based on its three core components. In the domain of risk monitoring and reporting, the paper analyzed the rationale for multi-source information integration and clarified the criteria for identifying key products and target populations for intensive monitoring. Regarding risk assessment, the Guidelines were examined from three dimensions of formulation components, medication behaviors, and population to address complex safety issues arising from medicinal constituents, irrational use, and individual susceptibility. In the area of risk control, the analysis focused on context-based interventions and dynamic closed-loop management strategies, exploring practical pathways to shift from passive response to proactive risk mitigation. Furthermore, this paper evaluated the applied value of the Guidelines and identified implementation challenges, such as insufficient capacity at the primary-care level and limited digital infrastructure. In response, the study proposed optimization strategies including establishing a dynamic updating mechanism, strengthening training at the grassroots level, and incorporating artificial intelligence to enhance pharmacovigilance capacity. This interpretation aims to provide actionable insights for marketing authorization holders (including manufacturers), pharmaceutical distributors, healthcare institutions, and research organizations, ultimately supporting the establishment and refinement of a full lifecycle pharmacovigilance system for OCPMs.
3.Effect evaluation of pharmaceutical service based on root cause analysis combined with KAP theory on decreasing the protocol violations of investigational medicinal products rate in pediatric clinical trials
Chunyan GUO ; Yi ZHANG ; Yuxin YANG ; Yuguang LIANG ; Qian DING ; Qian WANG ; Chengyue ZHANG ; Yu SUN ; Peng GUO
China Pharmacy 2026;37(9):1206-1210
OBJECTIVE To investigate the effect of pharmaceutical services guided by root cause analysis (RCA) in a problem-oriented manner combined with knowledge-attitude-practice (KAP) theory on reducing the incidence of protocol violations of investigational medicinal products in pediatric clinical trials. METHODS A total of 617 participants from 69 drug clinical trial projects conducted in our hospital from January 2016 to December 2020 were selected as the control group, and 868 participants from 72 drug clinical trial projects from January 2022 to December 2025 as the observation group. RCA was performed on the protocol violations of investigational medicinal product in the control group to identify the types and underlying causes. The control group received routine pharmaceutical services for drug clinical trials, while the observation group was provided with precision pharmaceutical services from the three dimensions of knowledge, attitude and practice on the basis of routine pharmaceutical services, according to the root causes identified by RCA. The occurrence of investigational medicinal products protocol violations was compared between the two groups. RESULTS The total incidence of protocol violations of investigational medicinal products, as well as the incidences of minor and major protocol violations, were all significantly lower in the observation group than in the control group ( P <0.001). The main types of protocol violations in both groups included missed/under-/over-dosing of medications, non-adherence to administration time, failure to adjust dosage as required, and combined medication/vaccination in violation of the protocol. Regarding the responsible subjects of protocol violations, the incidences of protocol violations attributed to participants and their guardians as well as investigators and accidental factors were significantly lower in the observation group than in the control group ( P <0.001, P <0.001, P =0.025). However, there were no statistically significant differences in the incidences of protocol violations caused by sponsor-related reasons between the two groups ( P >0.05). CONCLUSIONS Pharmaceutical services led by pharmacists, based on problem-oriented RCA and combined with KAP theory, can effectively reduce the protocol violations of investigational medicinal products rate in pediatric clinical trials, thereby safeguarding the safety and rights of study participants.
4.Neoadjuvant Sintilimab Combined with Gemcitabine and Cisplatin for Muscle-Invasive Bladder Cancer Patients Followed by Selective Bladder Sparing Surgery: A Phase 2 Trial
Zhou TONG ; Guanghou FU ; Feng ZHOU ; Xiaoyan LIU ; Xing XUE ; Hangyu ZHANG ; Yimin WANG ; Xudong ZHU ; Yang GAO ; Lulu LIU ; Xuanwen BAO ; Yi ZHENG ; Weijia FANG ; Peng ZHAO ; Baiye JIN
Cancer Research and Treatment 2026;58(2):581-590
Purpose:
This study aimed to evaluate the safety and efficacy of gemcitabine and cisplatin (GP) regimen in combination with immune checkpoint inhibitor sintilimab as neoadjuvant therapy for muscle-invasive bladder cancer (MIBC) patients and the feasibility of the following selective bladder sparing surgery.
Materials and Methods:
Patients with histopathologically confirmed urothelial carcinoma without distant metastases (T2-4a, N ≤ 1, M0, American Joint Committee of Cancer 8th) and with adequate organ function will be enrolled. The therapeutic regimen was sintilimab 200 mg once on day 8, gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 once on days 1 and 8, every 21 days for four cycles. The primary endpoint was pathologic complete response (pCR, pT0N0) rate. The secondary end points were ypT < 2 rate, R0 resection rate, event-free survival, and safety.
Results:
From May 4, 2020, to May 20, 2023, 55 patients were enrolled. Forty-six patients were evaluated for efficacy. Among the 42 patients who underwent surgery, 16 patients (38.0%) achieved pCR. Thirty-three patients (78.6%) achieved pT < 2. With a median follow-up of 15.7 months, the 1-year event-free survival was 91.3%. Notwithstanding the poor pathological baseline characteristic of a high T3-T4a proportion (39.1%), a promising bladder preservation (including 22 patients transurethral resection of bladder tumor, 5 patients partial cystectomy, and 4 surveillances) rate was achieved (67.4%). The most common grade ≥ 3 treatment-related adverse events was neutropenia (n=15, 27.3%), which was related to chemotherapy. There were no grade 3 immune-related adverse events.
Conclusion
Neoadjuvant GP plus sintilimab is a promising regimen for MIBC patients, with relatively high pT < 2 rate and triggering the emerging roles for the multi-disciplinary team decision-making for bladder sparing surgery.
5.Expert consensus on the application of artificial intelligence in lung cancer screening, diagnosis, and treatment (2026 edition)
Wenzhao ZHONG ; Haibo WANG ; Yi HU ; Hao ZHANG ; Jigang DAI ; Junqiang FAN ; Guibin QIAO ; Fan YANG ; Jian HU ; Fengwei TAN ; Xuening YANG ; Qiang PU ; Zihao CHEN ; Hongxia TIAN ; Lunxu LIU ; Hecheng LI ; Xiaolong YAN ; Zongyang YU ; Zhenbin QIU ; Yihua SUN ; Jing HU ; Yuhang SHI ; Zhifei GUO ; Peng ZHANG ; Kezhong CHEN ; Shugeng GAO ; Yilong WU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(06):848-856
With the continuous deepening of the concept of precision diagnosis and treatment for lung cancer, how to achieve higher efficiency and accuracy in the screening, diagnosis, and treatment pathways in clinical practice has become an important issue that urgently needs to be overcome. The current clinical difficulty lies in the fact that despite continuous advancements in imaging and molecular diagnostic technologies, there are still limitations in manual efficiency and subjective experience when it comes to massive data analysis and multi-scale feature extraction. Artificial intelligence (AI), especially algorithm systems based on deep learning, is an innovative technology capable of deeply empowering medical big data. This method utilizes algorithms such as convolutional neural networks, combined with radiomics, pathomics, and multi-modal data fusion analysis, demonstrating immense potential in early precise detection and benign-malignant differentiation of pulmonary nodules, digital pathological subtype recognition and non-invasive prediction of driver genes, precise 3D surgical planning and automatic delineation of radiotherapy target volumes, as well as dynamic risk warning during follow-up. This innovative technology provides a brand-new solution for realizing intelligent and individualized lung cancer diagnosis and treatment models. This consensus, based on the latest evidence from evidence-based medicine and combined with the development trends in the AI field and real-world clinical needs, was ultimately formed by gathering the consensus opinions of multidisciplinary experts in radiology, pathology, thoracic surgery, and other fields. The main content covers the application specifications of AI in the three core scenarios of lung cancer screening, diagnosis, and treatment, the technical standards for data collection and algorithm validation, as well as the ethical and regulatory challenges faced at the current stage. It aims to clarify the applicable boundaries of AI as a clinical auxiliary decision support tool, providing scientific guidance and standardized exploration directions for peers currently engaged in or planning to carry out AI-assisted clinical diagnosis, treatment, and translation of lung cancer.
6.Spousal correlations of blood lipid based on a family design
Yixin LI ; Huangda GUO ; Hexiang PENG ; Tianjiao HOU ; Hanyu ZHANG ; Yinxi TAN ; Yi ZHENG ; Mengying WANG ; Yiqun WU ; Xueying QIN ; Jin LI ; Ying YE ; Tao WU ; Dafang CHEN ; Yonghua HU ; Liming LI
Journal of Peking University(Health Sciences) 2025;57(3):423-429
Objective:To explore the spousal correlations of total cholesterol(TC),total triglyceride(TG),low-density lipoprotein cholesterol(LDL-C),and high-density lipoprotein cholesterol(HDL-C),and to investigate the reasons behind these spousal correlations.Methods:Participants and data were from the baseline survey of family-based cohort studies in Fangshan,Beijing and Tulou,Fujian.The ori-gin of spousal correlations were explored from perspectives of convergence,assortative mating,social ho-mogamy.Pearson's correlation and generalized linear models(GLM)were used to estimate the spousal correlation.Convergence was assessed by Pearson's correlation between the phenotypic differences be-tween couples and the duration of marriage,with GLM used for further validation.Pearson's correlation of genetic risk scores(GRS)and couple-specific Mendelian randomization(MR)were calculated to assess the genetic correlation and possible causal relationships between spouses.Two-independent-sample t-tests were used to compare GRS consistency across subgroups divided by education attainment,couple-specific MR and Q statistics used to test assortative mating in subgroups and intergroup differences.Results:In the study,342 couples(287 couples from Fangshan and 55 couples from Fujian)were included,with the average age of(64.91±8.76)years.Spousal correlations of TC,TG,HDL-C,and LDL-C showed statistically significant associations both before and after adjusting for covariates,with effect sizes of 0.229(95%CI:0.125-0.327),0.257(95%CI:0.155-0.354),0.179(95%CI:0.074-0.280),and 0.181(95%CI:0.076-0.282).For convergence,for each additional year of marriage,ΔTC increased by 0.016 mmol/L(95%CI:0.001-0.033 mmol/L),and ΔLDL-C increased by 0.017 mmol/L(95%CI:0.002-0.031 mmol/L).For assortative mating,GRS correlations and results of couple specific MR didn't show any statistical significance.For social homogamy,no differences in GRS or assortative mating were found between subgroups stratified by education attainment.Conclusion:The blood lipid in participants exhibit spousal phenotypic correlations,however,no effects of convergence,assortative mating or social homogamy were observed.More independent studies with larger sample sizes are warranted to further validate these findings in the future.
7.Study on Mechanism of Xuefu Zhuyu Decoction in Interfering Oxidative Stress Injury in Rats with Heart Blood Stasis Syndrome of Coronary Heart Disease Based on Keap1/Nrf2 Signaling Pathway
Huifang KUANG ; Jing LI ; Peng TIAN ; Chang SU ; Yi LIU ; Mingyun WANG ; Qiuyan ZHANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(7):104-111
Objective To investigate the effects and mechanism of Xuefu Zhuyu Decoction in oxidative stress in coronary heart disease model rats with heart blood stasis syndrome based on Keap1/Nrf2 signaling pathway.Methods The rats were divided into normal group,sham-operation group,model group,Xuefu Zhuyu Decoction group and trimetazidine group.The rat model of coronary heart disease with heart blood stasis syndrome was established by ligation of the left anterior descending branch of the coronary artery.Xuefu Zhuyu Decoction group and trimetazidine group were administrated with the corresponding drugs at the dosages of 14.04 g/kg and 5.4 mg/kg,respectively,and normal group,sham-operation group and model group were administrated with the same volume of normal saline for 14 days.The general state of rats was observed,body mass was recorded and electrocardiogram was collected.Echocardiography was used to examine cardiac functions(LVEF,LVFS,LVIDd,LVIDs);the morphology of myocardial tissue was observed by HE staining,serum malondialdehyde(MDA),superoxide dismutase(SOD),glutathione peroxidase(GSH-Px)and total antioxidant capacity(T-AOC)were detected by ELISA,the positive expressions of Keap1,Nrf2,HO-1 and NQO1 in myocardial tissue were detected by immunohistochemistry.Results Compared with the normal group and sham-operation group,the rats in the model group showed signs of mental fatigue,reduced activity,dull fur,purple claws,and a significant decrease in body mass(P<0.01);the ST segment in lead Ⅱ of the electrocardiogram was significantly elevated,LVEF and LVFS were significantly reduced,and LVIDd and LVIDs significantly increased(P<0.01),with severe degeneration and necrosis of myocardial cells,disappearance of striated structures,disordered arrangement of myocardial fibers,infiltration of inflammatory cells;the serum MDA content significantly increased,while the activities of SOD,GSH-Px and T-AOC significantly decreased(P<0.01);the positive expressions of Keap1 and Nrf2 in myocardial tissue significantly increased,while the positive expression of HO-1 and NQO1 significantly decreased(P<0.01).Compared with the model group,the rats in Xuefu Zhuyu Decoction group and trimetazidine group showed improvement in their mental state,increased activity,shiny fur,rosy nails,and significantly increased body mass(P<0.01);the ST segment of the electrocardiogram decreased to varying degrees,with significant increases in LVEF and LVFS,and significant decreases in LVIDd and LVIDs(P<0.01);a large number of myocardial cells survived,the arrangement of myocardial fibers was relatively regular,and the infiltration of inflammatory cells was significantly reduced;the serum MDA content was significantly reduced,while the activities of SOD,GSH-Px and T-AOC significantly increased(P<0.01);the positive expression of Keap1 in myocardial tissue significantly decreased,while the positive expressions of Nrf2,HO-1 and NQO1 significantly increased(P<0.01).Conclusion Xuefu Zhuyu Decoction may inhibit oxidative stress by activating Keap1/Nrf2 signaling pathway to improve the pathological morphology and structural damage of myocardial tissue and promote the recovery of cardiac functions in rats with heart blood stasis syndrome of coronary heart disease.
8.Study on the Application of Ultrasound Bone Knife Bone Window Technology Combined with Viscous Bone in Mandibular Cysts
Tian-yi LI ; Xin-feng ZHANG ; Ya-meng SI ; Xin-yu ZHANG ; Peng KOU ; Xuan WANG
Progress in Modern Biomedicine 2025;25(12):2024-2033
Objective:To investigate the clinical effect of ultrasound bone knife bone window technique combined with viscous bone in mandibular cysts and its impact on postoperative bone defect repair.Methods:60 patients with mandibular cysts who visited our hospital from January 2024 to June 2024 were selected as the study subjects,they were randomly divided into control group(30 cases)and experimental group(30 cases).The control group underwent traditional scraping surgery(without the use of bone defect repair materials).The experimental group used ultrasound bone knife bone window technology combined with adhesive bone treatment.The surgical time,postoperative visual pain simulation(VAS)score,intraoperative blood loss,postoperative swelling degree,and incidence of postoperative complications between the two groups were observed and compared.Bone defect repair was evaluated by cone beam computed tomography(CBCT)at 3 and 6 months postoperatively.Results:There was no significant difference in surgical time,intraoperative blood loss,postoperative swelling degree,and incidence of postoperative complications between the two groups(P>0.05).The VAS scores of both groups at 3 and 7 d postoperative were lower than those at 1 d postoperative(P<0.05),and the VAS score at 7 d postoperative was lower than that 3 d postoperative(P<0.05).The VAS scores in the experimental group were significantly lower than those in the control group at 1,3 and 7 d postoperative(P<0.05).The HU values and bone repair area ratio in the experimental group at 3 and 6 months postoperative were significantly higher than those in the control group(P<0.05),and the HU values and bone repair area ratio in the control group and experimental group at 6 months postoperative were significantly increased compared to those at 3 months postoperative(P<0.05).Conclusion:The combination of ultrasound bone knife bone window technology and adhesive bone treatment for mandibular cysts can significantly reduce postoperative pain,accelerate bone defect repair,and improve bone density and repair quality.Compared with traditional scraping surgery,the use of sticky bone has significant advantages in postoperative bone regeneration and does not significantly increase the risk of complications,making it of high clinical application value.
9.Prevalence and molecular characterization of Shiga toxin-producing Esch-erichia coli in domestic goats in the Chengkou District of Chongqing
Jing-jing PENG ; Bin HU ; Xi YANG ; Yi LI ; Hai HUANG ; Wen-shuang LIU ; Yu MENG ; Li-jun WANG ; Yan-wen XIONG ; Yi YUAN ; Pei-bin HOU
Chinese Journal of Zoonoses 2025;41(5):529-536
This study investigated the infection status,drug resistance,and molecular characteristics of Shiga toxin-producing Escherichia coli(STEC)in domestic goats in Chengkou county,Chongqing.In August 2023,283 fecal samples were collected from households in Chengkou county.After enrichment with EC broth and inoculation onto selective media,samples that tested positive for stx1/stx2 were selected for further isolation.The positive strains were investigated with antimicrobial susceptibility testing and whole genome sequencing.According to the whole genomic sequences,the stx subtypes,serotypes,multi-locus sequence types,virulence genes,drug resistance genes,and phylogenetic relationships of the STEC strains were analyzed.Forty-six strains of STEC were isolated from 283 goat fecal samples,thus resulting in a detection rate of 16.25%.The 46 STEC strains were categorized into 12 O∶H serotypes,among which O76∶H19 and O8∶H7 predominated,each represented by 9 strains.Five STEC strains were identified as serotype O157∶H7.The 46 STEC strains were categorized into 11 sequence types(STs),among which ST675 and ST196 predominated,each represented by nine strains,accounting for a 19.57%proportion.The strains were categorized into 7 stx subtypes,among which stx1c(26/46,56.52%),followed by stx2k(9/46,19.57%)predominated.All nine Stx2k-STEC strains were identified as serotype O8∶H7 and sequence type ST196.In antimicrobial susceptibility testing,2 STEC strains were resistant to ampicillin,one strain was resistant to ampicillin/sulbactam,one strain was resistant to cefazolin,and one strain was resistant to cefoxitin.Nine Stx2k-STEC strains were found to carry the beta-lactam resistance gene blaEC-18.Antimicrobial sensitivity tests revealed that the nine Stx2k-STEC strains were sensitive to all 15 tested antibiotics.Moreover,phylogenetic analysis indicated that the 9 Stx2k-STEC strains were remarkably similar but showed high genetic diversity with respect to that of the Stx2k-STEC strains isolated from other regions in China.Goatsare an important animal reservoir for STEC in theChengkou district of Chongqing,and novel sequence type Stx2k-STEC strains distinct from those found in other regions of China were identified in this region.
10.Effects of lumbar lordosis on spinal sagittal balance after Roussouly type Ⅱ spinal lumbar fusion
Journal of Clinical Surgery 2025;33(8):865-869
Objective The aim of this study was to explore the effects of lumbar lordosis on spinal sagittal balance after Roussouly type Ⅱ spinal lumbar fusion.Methods In the experiment,96 patients undergoing Roussouly type Ⅱ spinal lumbar fusion in Laohekou First Hospital were enrolled as the research objects between January 2022 and December 2023.According to random number table method,they were divided into control group(intraoperative maintaining of the original lumbar lordosis,n=48)and study group(intraoperative increasing of lumbar lordosis by 5°,n=48).The clinical symptoms[numerical rating scale(NRS),Oswestry disability index(ODI)],spinal and pelvic sagittal parameters[pelvic incidence(PI),sacral slope(SS),pelvic tilt(PT),lumbar lordosis(LL),thoracic kyphosis(TK)],rehabilitation status[Japanese Orthopaedic Association(JOA),Berg balance scale(BBS)]and postoperative complications were compared between the two groups.Results The experiment results showed that at 6 months after surgery,scores of NRS and ODI were decreased in both groups,which were lower in study group than control group(P<0.05).At 6 months after surgery,PI,SS,PT and LL in study group were(48.48±1.62)°,(35.42±5.39)°,(16.75±1.84)°and(39.36±3.72)°,higher than those in control group[(47.51±2.32)°,(28.83±4.46)°,(13.95±1.77)°,(30.78±3.64),P<0.05],while TK was lower than that in control group[(11.72±1.08)°vs.(14.26±1.23)°,P<0.05].At 6 months after surgery,scores of JOA and BBS were increased in both groups,which were higher in study group than control group(P<0.05).There was no significant difference in incidence of postoperative complications between study group and control group(12.50%vs.14.58%,P>0.05).Conclusion It can be concluded that appropriate increase of lumbar lordosis can significantly improve spinal sagittal balance,promote the remission of clinical symptoms and rehabilitation process in patients after Roussouly type Ⅱ spinal lumbar fusion.

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