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.Effect of Sacubitril/Valsartan on serum agglutinin and SIRT6 in patients with coronary atherosclerotic heart disease complicated with acute heart failure
Hao WANG ; Yi ZHANG ; Peng ZHOU
Immunological Journal 2025;41(11):786-792
Objective To investigate the effects of Sacubitril/Valsartan(SV)on serum agglutinin and Silent Information Regulator Transporter 6(SIRT6)in patients with coronary atherosclerotic heart disease(CAHD)complicated with acute heart failure(AHF).Methods One hundred and twenty-two patients with CAHD complicated with AHF admitted from January 2023 to May 2024 were selected and divided into control group(n=61)and observation group(n=61)by random number table method.Both groups were given conventional treatment,the control group was given Candesartan Cilexetil tablets,and the observation group was given SV.The clinical efficacy,disease-related indicators,cardiac function indicators[left ventricular ejection fraction(LVEF),left ventricular end-diastolic diameter(LVEDD),left ventricular end-systolic diameter(LVESD)],myocardial injury indicators[N-terminal pro-B-type natriuretic peptide(NT-proBNP),high-sensitivity C reactive protein(hs-CRP)],agglutinin levels,SIRT6 levels,adverse reactions and major adverse cardiovascular events(MACE)were compared between the two groups.Results The total effective rate of the observation group[96.72%(59/61)]was higher than that of the control group[86.89%(53/61)](P<0.05).At 7 d after treatment,compared with the control group,the heart rate,systolic blood pressure and diastolic blood pressure in the observation group were lower,and the urine volume was higher(P<0.01).At 3 months after treatment,LVEDD,LVESD,NT-proBNP,hs-CRP,and agglutinin were lower,while LVEF and SIRT6 were higher in the observation group than in the control group(P<0.01).There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).After 3 months of follow-up,the incidence of MACE in the observation group was lower than that in the control group(P<0.05).Conclusion The early application of SV demonstrates a significant efficacy in patients with CAHD complicated with AHF,which can improve the hemodynamic status of the body,inhibit ventricular remodeling,regulate the levels of agglutinin and SIRT6,reduce myocardial injury,and reduce the risk of MACE,with a favorable safety profile.
5.Preliminary application study of robot-assisted pelvic exenteration in the treatment of low locally advanced or recurrent rectal cancer
Yu TAO ; Yunsheng CHAI ; Junnan CHEN ; Huan PENG ; Yi WANG ; Jian ZHANG ; Houshan YAO
Chinese Journal of Gastrointestinal Surgery 2025;28(8):895-901
Objective:To explore the feasibility and preliminary clinical experience of robot-assisted pelvic exenteration (PE) in the treatment of locally advanced (LARC) and recurrent (LRRC) rectal cancer.Method:A descriptive case series research method was adopted. Inclusion criteria included: (1) Age 18-80 years old; (2) Preoperative puncture biopsy performed through endoscopy, and a pathological diagnosis of rectal malignant tumor; (3) Preoperative imaging examinations confirming locally advanced (cT4b stage) or locally recurrent rectal cancer, with tumor location in the pelvic cavity; (4) Physical condition: ECOG score ≤1 point, and radical resection being feasible after assessment. The data for five patients with LARC or LRRC who underwent pelvic exenteration (PE) using the da Vinci robotic surgical system in the Department of Anorectal Surgery, the Second Affiliated Hospital of Naval Medical University (Shanghai Changzheng Hospital) from January, 2024 to January, 2025 were collected retrospectively. The mean age was (46.8±7.7) years, with 3 males and 2 females, who comprised 2 cases of LARC and 3 cases of LRRC. Two patients received preoperative radiotherapy, and 4 patients received preoperative chemotherapy. The average body mass index was (21.5±2.7) kg/m2. According to the American Society of Anesthesiologists (ASA) classification, 2 cases were grade II and 3 cases were grade III.Results:All patients with LARC or LRRC successfully underwent robot-assisted PE. The average operation time was (496.4±139.5) minutes; the average intraoperative blood loss was (72.0±29.5) ml; the average postoperative exhaust time was (50.0 ±13.6) hours; and the average postoperative defecation time was(64.2±15.3) hours. Mean early postoperative VAS pain scores was (3.6±1.5) points. Three patients underwent primary intestinal anastomosis, and 2 patients underwent colonic single-lumen ostomy. All 5 patients underwent urinary system reconstruction, among which 2 underwent ureterovesical reimplantation, 1 underwent percutaneous ureterostomy, 1 underwent ileal conduit replacement of bladder, and 1 underwent direct bladder suture. After surgery, except for 1 case of pelvic infection with effusion (Clavien-Dindo grade IIIa), there were no obvious postoperative complications. Postoperative pathological results showed that all patients achieved R0 resection, including 1 case of T4a stage and 4 cases of T4b stage (all involving urogenital organs or tissues), and 3 cases of N0 stage and 2 cases of N1 stage, with a maximum tumor diameter of (4.7±1.9) cm. The median postoperative follow-up time was 11 (range 7 to 17) months, and no patient experienced local recurrence.Conclusion:The above short-term preliminary results of robot-assisted PE in the treatment of LARC or LRRC within the pelvic cavity indicate that it is both safe and feasible.
6.Effect of Vericiguat combined with Sacubitril/Valsartan on ventricular remodeling and serum miR-133a and miR-433 in elderly patients with dilated cardiomyopathy and heart failure
Hao WANG ; Yi ZHANG ; Peng ZHOU
Immunological Journal 2025;41(10):703-709
Objective To investigate the efficacy of Vericiguat combined with Sacubitril/Valsartan(Sac/Val)in the treatment of heart failure in elderly patients with dilated cardiomyopathy(DCM).Methods From January 2023 to January 2024,96 elderly patients with DCM and heart failure were selected and randomly divided into two groups by the random number table method,with 48 patients in each group.The control group was treated with Sac/Val,while the combination group was treated with Vericiguat combined with Sac/Val for a course of 3 months.The clinical efficacy,adverse reactions,parameters of cardiac structure and function[left atrial diameter(LAD),left ventricular end-diastolic diameter(LVEDD),left ventricular ejection fraction(LVEF),stroke volume(SV)],myocardial injury indicators[N-terminal pro-brain natriuretic peptide(NT-proBNP),troponin I(cTnI),creatine kinase isoenzyme(CK-MB)],and serum miR-133a and miR-433 expression levels before and after treatment were compared between the two groups.The patients were followed up for 6 months to statistically analyze the occurrence of major adverse cardiovascular events(MACE).Results Compared with 77.08%(37/48)in the control group,the total effective rate of the combination group was significantly increased to 93.75%(45/48)after treatment(P<0.05).Compared with the control group,SV and LVEF increased,while LAD and LVEDD decreased in the combination group after treatment(P<0.05).Compared with the control group,the levels of serum NT-proBNP,cTnI,CK-MB and the expression levels of serum miR-133a and miR-433 in the combination group decreased after treatment(P<0.05).During the treatment period,there was no significant difference in the total incidence of adverse reactions between the two groups(P>0.05).After a 6-month follow-up,there was no significant difference in the incidence of MACE between the two groups(P>0.05).Conclusion Vericiguat combined with Sac/Val has a definite therapeutic effect in the treatment of heart failure in elderly patients with DCM,which can reduce the levels of myocardial injury markers in patients,improve cardiac structure and function,and has favorable safety profile.It may be related to the regulation of miR-133a and miR-433 expression.
7.Construction of a prognostic model for pancreatic ductal adenocarcinoma based on m6A-and m5C-related lncRNAs and its relationship with the immune microenvironment
Jie WANG ; Junxi LIAO ; Yi QIU ; Yuanna JIANG ; Yuxin SHI ; Jie PENG
Chinese Journal of General Surgery 2025;34(3):475-484
Background and Aims:Pancreatic ductal adenocarcinoma(PDAC)is a highly malignant digestive system tumor with an inferior prognosis,and its early diagnosis and treatment remain significant challenges.In recent years,RNA methylation modifications(such as m6A and m5C)have attracted considerable attention for their roles in tumor development;however,their regulatory mechanisms and clinical significance in PDAC remain unclear.This study was conducted to identify prognosis-related long noncoding RNAs(lncRNAs)associated with m6A and m5C in PDAC,construct a reliable prognostic prediction model,and explore their relationship with the tumor immune microenvironment.Methods:Based on RNA-seq data from the TCGA-PDAC cohort,differentially expressed lncRNAs(DElncRNAs)related to m6A and m5C were identified through differential expression analysis and Pearson correlation analysis.The samples were randomly divided into a training set(n=89)and a validation set(n=89).Key DElncRNAs were selected using LASSO-Cox regression to construct a prognostic model,and patients were categorized into high-and low-risk groups based on risk scores.Kaplan-Meier survival analysis,ROC curves,and multivariate Cox regression were used to evaluate the model's predictive performance.Furthermore,CIBERSORT and ESTIMATE scores were used to analyze immune cell infiltration characteristics and tumor microenvironment(TME)differences between the high-and low-risk groups.Results:To construct the prognostic model,four m6A-and m5C-related DElncRNAs(LINC00857,LINC02038,TSPOAP1-AS1,and TRPC7-AS1)were identified.Patients in the high-risk group had significantly lower overall survival than those in the low-risk group(P<0.05),and the risk score was an independent prognostic factor for PDAC(HR=1.551,95%CI=1.297-1.854,P<0.001).ROC curve analysis showed that the risk score model exhibited high predictive efficiency in both the training and validation sets(AUC values for 1,3,and 5 years:0.766,0.875,0.879;0.685,0.711,0.792,respectively).Immune analysis revealed increased infiltration of M0 macrophages with lower TME scores in the high-risk group(all P<0.05),suggesting an immunosuppressive microenvironment.Conclusion:This study successfully established a PDAC prognostic model based on m6A-and m5C-related DElncRNAs and confirmed its independent predictive value.High-risk patients exhibited M0 macrophage enrichment and immunosuppressive microenvironment characteristics,possibly contributing to poor prognosis.
8.Acute extensive anterior myocardial infarction after medullary infarction:a case report
Pei-xun HE ; Yan-ming LIU ; Yi SUN ; Peng WU ; Lan WANG ; Xue-yong LI ; Jun-jie YANG ; Wei-nan ZHAO
Chinese Journal of Interventional Cardiology 2025;33(9):536-540
The medulla oblongata,situated at the caudal portion of the brainstem,serves as a critical regulatory center responsible for maintaining fundamental vital functions including respiratory and cardiovascular homeostasis.As a pivotal hub within the autonomic nervous system,it orchestrates the coordinated control of afferent and efferent neural pathways.Dysfunction of this region may precipitate life-threatening cardiorespiratory arrest,associated with substantial mortality rates.This case report presents a patient who developed acute extensive anterior myocardial infarction during treatment with dual antiplatelet therapy and moderate-intensity statins following acute medullary infarction.It is hypothesized that the pathogenesis may involve the acceleration of plaque erosion by the stroke-heart syndrome.This clinical case provides valuable insights into the complex neurocardiac interplay,particularly highlighting the imperative for enhanced recognition of brain-heart axis interactions in cerebrovascular pathology.
9.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.
10.A suspected outbreak of carbapenem-resistant Acinetobacter baumannii in respiratory intensive care unit:a survey by whole genome sequencing
Xianming QIU ; Peng XU ; Xiutao DONG ; Yi XU ; Xuan GUO ; Binghao BIAN ; Lili WANG
Chinese Journal of Infection Control 2025;24(9):1300-1306
Objective To investigate and analyze the epidemiological characteristics and the causes of a suspected outbreak of carbapenem-resistant Acinetobacter baumannii(CRAB)infection,and provide basis for healthcare-asso-ciated infection(HAI)prevention and control.Methods Information of 3 patients with CRAB positive culture from the respiratory intensive care unit(RICU)of a hospital in May 2024 was collected.Microbiological sampling was performed in patients' ward environment,and the specimens were cultured and strains were identified.CRAB strains detected from the environment and patients were performed whole genome sequencing(WGS).Multiple de-partments jointly formulated and implemented comprehensive infection control measures,and the effectiveness were evaluated.Results CRAB was cultured from specimens of sputum and bedside office mice of 3 patients.WGS de-tection showed that ST2158 and ST1791 resistance genes were detected from both sputum and bedside office mice of 2 patients.After comprehensive assessment,2 patients were confirmed with HAI and 1 patient was confirmed with colonization,ruling out an outbreak of HAI.A total of 24 environmental specimens were taken for environmental hygiene monitoring,with a CRAB detection rate of 58.33%.CRAB detected from bedside mice and patients' spu-tum specimen had consistent CRAB drug susceptibility testing results.After implementing measures such as in-creasing the frequency of cleaning and disinfection of ward environment,strengthening the implementation of hand hygiene,and enhancing the supervision of department personnel as well as HAI prevention and control training,HAI was effectively controlled.Conclusion The possible transmission route of this suspected CRAB outbreak in RICU is the contamination of office mice,which caused healthcare workers carrying CRAB in their hands,leading to cross infection due to poor hand hygiene implementation of healthcare workers.Strengthening the cleaning and dis-infection of environmental surface and the management of hand hygiene of healthcare workers are key measures to prevent CRAB HAI.

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