1.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.
2.Brain-heart Axis in Neurodegenerative and Cardiovascular Comorbidity: Oxidative Stress, Inflammation, and Biomarkers
Xu-Lin LIU ; Ying-Ao XIE ; Yun-Fei WANG ; Jing CHENG ; Qiao-Qiao LI
Progress in Biochemistry and Biophysics 2026;53(10):2558-2582
Neurodegenerative diseases (NDs), particularly Alzheimer’s disease (AD) and Parkinson’s disease (PD), and cardiovascular diseases (CVDs), including heart failure (HF) and coronary artery disease (CAD), are major chronic disorders associated with population aging. Their frequent coexistence in clinical practice suggests that they may not progress independently, but may instead be linked through bidirectional pathological communication within the brain-heart axis. Epidemiological evidence underscores this clinical burden: systematic reviews and meta-analyses have reported pooled relative risks for dementia of approximately 1.27 among individuals with a history of CAD and 1.60 among those with HF, while the pooled prevalence of cognitive impairment and dementia in patients with HF has been estimated at approximately 41.42% and 19.79%, respectively. This review synthesizes current evidence on the mechanistic links, disease-state manifestations, biomarkers, and potential therapeutic strategies involved in the comorbidity between NDs and CVDs from the perspective of the brain-heart axis. The brain and heart communicate through autonomic, neuroendocrine, neuroimmune, vascular, and humoral pathways. Sympathetic activation, parasympathetic withdrawal, vagal dysfunction, cerebral hypoperfusion, endothelial injury, blood-brain barrier (BBB) alterations, peripheral immune activation, and circulating inflammatory mediators may jointly contribute to cross-organ pathological signaling. Oxidative stress and inflammatory response are not specific to the brain-heart axis; rather, they may act as candidate amplifying processes within this network. Mitochondrial dysfunction and NADPH oxidase activation can increase the generation of reactive oxygen species and reactive nitrogen species, which may activate nuclear factor-κB, the NLRP3 inflammasome, and mitogen-activated protein kinase/c-Jun N-terminal kinase signaling. These pathways can promote the release of interleukin-1β, interleukin-6, tumor necrosis factor‑α, and other inflammatory mediators, which may in turn aggravate mitochondrial injury, endothelial dysfunction, immune cell activation, and further oxidant generation. Cytokines, chemokines, oxidized lipids, mitochondrial DNA, damage-associated molecular patterns, and extracellular vesicles may transmit these signals between the cardiovascular and central nervous systems, whereas autonomic reflexes provide an additional route for bidirectional amplification. Distinct disease states illustrate different manifestations of this network. The association between AD and CVDs may involve vascular risk factors, impaired amyloid-β clearance, abnormal cholesterol homeostasis, cerebral microvascular injury, neuroinflammation, and endothelial dysfunction. HF-related cognitive impairment may be linked to reduced cardiac output, recurrent cerebral hypoperfusion, hypoxia-related signaling, BBB dysfunction, circulating inflammation, and impaired autonomic feedback. In PD, cardiovascular autonomic dysfunction and abnormalities in heart rate and blood pressure regulation may interact with vascular injury, reduced cerebral perfusion, inflammation, and oxidative stress. However, the relationship between PD and CAD remains heterogeneous and may be modified by age, ethnicity, medication use, metabolic factors, and coexisting diseases. Biomarker evaluation should therefore move beyond isolated indicators. Traditional markers, including malondialdehyde, superoxide dismutase, glutathione, C-reactive protein, and interleukin-6, reflect systemic oxidative or inflammatory burden but lack sufficient specificity to distinguish primary neurodegeneration, cardiovascular injury, or a comorbid state involving both. Greater clinical value may be obtained from cross-system panels that combine oxidative stress and inflammatory markers with cardiac stress or injury biomarkers, such as N-terminal pro-B-type natriuretic peptide; glial or neuronal biomarkers, such as glial fibrillary acidic protein and neurofilament light chain; BBB- or endothelial injury-related biomarkers; and omics-derived candidates, including microRNAs, long non-coding RNAs, DNA methylation signatures, metabolites, and proteins. Multi-omics integration and artificial intelligence-assisted analysis may support risk stratification, disease monitoring, and prediction of treatment response. However, these approaches require standardized analytical platforms, validation in independent cohorts, and careful distinction between associative findings and causal mechanisms. Potential interventions include antioxidant, anti-inflammatory, mitochondria-targeted, and multi-target combination strategies, together with emerging approaches such as nanodelivery, CRISPR/Cas9- or CRISPR/dCas9-based regulation, mesenchymal stem cell-mediated mitochondrial transfer, and ergothioneine supplementation. Nevertheless, most available evidence is indirect, preclinical, or derived from other disease indications, and no single drug or technology can currently be regarded as specific to brain-heart axis comorbidity. The clinical relevance of these strategies will depend on whether they can be matched to dominant pathological phenotypes and improve both neurological and cardiovascular outcomes. Overall, comorbidity between NDs and CVDs is more appropriately understood as a heterogeneous cross-organ regulatory network than as a disorder driven by a single pathway. Future research should prioritize multicenter longitudinal cohorts, standardized clinical phenotyping, validation of cross-system biomarker panels, and mechanism-guided interventions in clearly defined patient subgroups, with integrated assessment of cognitive function, cardiovascular events, quality of life, long-term safety, and treatment response.
3.The relationship between chromosomal karyotypes and reproductive factor levels in peripheral blood and adverse pregnancies in women
International Journal of Laboratory Medicine 2025;46(13):1603-1607
Objective To investigate the relationship between chromosomal karyotypes and reproductive factor levels in peripheral blood and adverse pregnancies in women.Methods A total of 105 pregnant women who received prenatal care and delivered at Yulin Hospital,the First Affiliated Hospital of Xi'an Jiaotong Uni-versity and Yulin Traditional Chinese Medicine Hospital from January 2020 to June 2024 were selected as the research subjects.Through the follow-up observation of pregnant women,there were 29 cases of pregnant women with adverse pregnancies(adverse pregnancy group)and 76 cases of pregnant and parturient women with normal pregnancies(good pregnancy group).The karyotypes of peripheral blood chromosomes and the levels of reproductive factors,as well as their correlations with adverse pregnancy outcomes,were analyzed re-spectively in the adverse pregnancy group and the good pregnancy group.Results There was a statistically significant difference in the proportion of autosomes and sex chromosomes in the number and structure of pe-ripheral blood between the adverse pregnancy group and the good pregnancy group(P<0.05).The anti-Müllerian hormone(AMH)level in the adverse pregnancy group was higher than that in the good pregnancy group,while estradiol(E2)and progesterone(P)levels were lower than those in the good pregnancy group,and the differences were statistically significant(P<0.05).Abnormalities in autosomal number,autosomal structure,sex chromosome number,sex chromosome structure,and AMH were all positively correlated with adverse pregnancy outcomes(r=0.369,0.445,0.528,0.665,0.785,P<0.05).E2 and P were negatively cor-related with adverse pregnancy outcomes(r=-0.865,—0.562,P<0.05).Conclusion Peripheral blood chromosomal karyotypes and reproductive factor levels are related to adverse pregnancies in women.By under-standing the relationship between these biomarkers and chromosomal abnormalities,adverse pregnancy out-comes can be better predicted and managed,and the accuracy of fertility treatment can be improved.
4.Clinical efficacy of sulbactam-durlobactam in treating patients with carbapenem-resistant Acinetobacter baumannii pulmonary infection and drug concentration surveillance
Yue CHEN ; Lin QIAO ; Zhongyao XIE ; Wenqian CHEN ; Dongjie GUO ; Pengmei LI
Chinese Journal of Nosocomiology 2025;35(20):3105-3109
OBJECTIVE To evaluate the efficacy of sulbactam-durlobactam combined with meropenem in treating carbapenem-resistant Acinetobacter baumannii(CRAB)pulmonary infection.METHODS A total of 16 patients treated at China-Japan Friendship Hospital from Jan.1,2025 to Jun.1,2025 were included.Retrospective analy-sis was conducted on patients'basic situation,preliminary treatment regimens,infection-related diagnoses,etiolo-gy and clinical outcomes.Therapeutic drug monitoring(TDM)for sulbactam was also performed.RESULTS By the end of the treatment course,13 patients achieved etiological eradication of CRAB and clinical improvement,while 1 patient experienced CRAB recurrence within one month.Three patients showed treatment failure.TDM for sulbactam was performed in 13 patients.Except for one slightly lower,all achieved trough plasma concentra-tions above the minimum inhibitory concentration(MIC)(100%T>MIC,MIC=4 mg/L based on clinical breakpoints).Dosage adjustments based on plasma concentrations were made for 4 patients,with 3 receiving re-duced doses and 1 receiving an increased dose.CONCLUSIONS Sulbactam-durlobactam combined with meropenem demonstrates superior efficacy in treating CRAB compared to other regimens.Under the recommended dosage,all patients can achieve the PK/PD target for sulbactam.
5.Severe malnutrition during pregnancy complicated with acute pyelonephritis causing sepsis,refractory septic shock and multiple organ failure:A case report
Fangfei XIE ; Hong QIAO ; Boya LI ; Cui YUAN ; Fang WANG ; Yu SUN ; Shuangling LI
Journal of Peking University(Health Sciences) 2025;57(1):202-207
This study reports the diagnosis and treatment of a 26-year-old pregnant woman with severe malnutrition combined with acute pyelonephritis causing sepsis,refractory septic shock and multiple organ failure.A female patient,26 years old,was admitted to hospital mainly due to"menelipsis for more than 19 weeks,nausea and vomiting for 20 days,fever with fatigue for 3 days".At the end of 19 weeks of in-trauterine pregnancy,the patient presented with fever accompanied by urinary tract irritation.Laboratory tests showed elevated inflammatory indicators,and ultrasonography showed bilateral pelvicalyceal dila-tion.She was diagnosed with acute pyelonephritis,sepsis,acute kidney injury(AKI)and severe malnu-trition.After a whole-hospital consultation,the patient was treated with meropenem and vancomycin as antimicrobial therapy,and bilateral nephrostomy drainage was performed simultaneously.After that,the patient suffered a sudden decrease in blood pressure,blood oxygen saturation,and rapid heart rate.Sep-tic shock with multiple organ dysfunction was considered,and she was transferred to intensive care unit(ICU)immediately.After the patient was transferred to ICU,emergency tracheal intubation and ventila-tor-assisted ventilation were performed.Rapid fluid resuscitation was administered for the patient.While pulse indicator continuous cardiac output(PICCO)monitoring was performed,norepinephrine,terlipres-sin,and methylene blue were administered to maintain peripheral vascular resistance.Since the patient developed septic cardiomyopathy and cardiogenic shock later,levosimendan and epinephrine were admi-nistered to improve cardiac function.While etiological specimens were delivered,meropenem,teicoplanin and caspofungin were given as initial empiric antimicrobial therapy.Unfortunately,the intrauterine fetal death occurred on the night of admission to ICU.On the 3rd day of ICU admission,a still-born child was delivered vaginally with 1/5 defect of the fetal membrane.On the 6th day of ICU admission,the patient had fever again with elevated inflammatory indicators.After excluding infection in other parts,intrau-terine infection caused by incomplete delivery of fetal membrane was considered.Then emergency uterine curettage was performed and the infection gradually improved.Later the laboratory results showed that the nephrostomy drainage was cultured for Escherichia coli and uterine,cervical and vaginal secretions were cultured for Candida albicans.Due to severe infection and intrauterine incomplete abortion,the patient developed disseminated intravascular coagulation(DIC).Active antimicrobial therapy and blood product supplement were given.However,the patient was critically ill with significant decrease in hemoglobin and platelets combined with multiple organ failure.Thrombotic microangiopathy(TMA)was not excluded yet,so plasma exchange was performed for the patient in order not to delay treatment.The patient under-went bedside continuous renal replacement therapy(CRRT)for AKI.The patient was complicated with acute liver injury,and the liver function gradually returned to normal after liver protection,antimicrobial therapy and other treatments.Due to the application of large doses of vasoactive drugs,the extremities of the patient gradually developed cyanosis and ischemic necrosis.Local dry gangrene of the bilateral toes remained at the time of discharge.In general,the patient suffered from septic shock,cardiogenic shock,combined with DIC and multiple organ dysfunction.After infection source control,antimicrobial therapy,uterine curettage,blood purification treatment,nutritional and metabolic support,the patient was dis-charged with a better health condition.
6.The application of liquid biopsy techniques in cervical cancer diagnosis, prediction and therapeutic surveillance
Jia JIANG ; Libo LI ; Cui ZHANG ; Can YANG ; Yunmeng DAI ; Yanping CHEN ; Yisidan HUANG ; Lu XIE ; Yang XIANG ; Jia YUAN ; Yuting ZENG ; Qiao WANG ; Yuncong LIU ; Hanqun ZHANG ; Yong LI
Journal of Gynecologic Oncology 2025;36(6):e121-
Cervical cancer (CC) is a significant cause of cancer-related deaths in women and ranks as the fourth most common malignant tumor worldwide. Cervical histopathology is currently the primary diagnostic method for confirming the presence of CC. Tumor markers and imaging techniques play crucial roles in monitoring treatment effectiveness and prognostic follow-up. Unfortunately, these traditional examination methods are invasive and often lack sensitivity and accuracy. Therefore, there is a need for a less invasive and more sensitive test to facilitate early diagnosis, efficacy evaluation, and prognostic monitoring of CC. In recent years, liquid biopsy has been developed as a new detection method. It involves analyzing tumor components released into the peripheral circulation, such as cell-free RNA, circulating tumor DNA, circulating tumor cells, tumor-educated platelets, and exosomes. Liquid biopsy offers advantages such as being less invasive, highly reproducible, and capable of real-time monitoring. Moreover, liquid biopsy can play a crucial role in the early diagnosis of CC, guiding targeted therapy, assessing prognosis, and evaluating treatment effectiveness.This review focuses on the value of liquid biopsy application in CC, detection markers, and detection methods. It also explores how liquid biopsy can be used in the detection, prognosis, and monitoring the progression of CC. The advantages and limitations of liquid biopsy in CC are analyzed to promote its application and improve the diagnosis and treatment of the disease.
7.Expert consensus on intraoperative repositioning for patients with spine fracture and dislocation (version 2025)
Dongmei BIAN ; Ke SUN ; Ningbo CHEN ; Caixia BAI ; Miao WANG ; Yafeng QIAO ; Fei WANG ; Hong WANG ; Feng TIAN ; Mei YAN ; Meng BAI ; Linjuan ZHANG ; Liyan ZHAO ; Yaqing CUI ; Xue JIANG ; Leling FENG ; Ning NING ; Junqin DING ; Lan WEI ; Yonghua ZHAI ; Yu ZENG ; Zengmei ZHANG ; Jiqun HE ; Fenggui BIE ; Hong CHEN ; Zengyan WANG ; Li LI ; Li ZHANG ; Yaying ZHOU ; Bing SHAO ; Ying WANG ; Caixia XIE ; Yanfeng YAO ; Jingjing AN ; Wen SHI ; Xiongtao LIU ; Xiaoyan AN ; Ning NAN ; Lan LI ; Xiaohui GOU ; Qiaomei LI ; Xiuting WU ; Yuqin ZHANG ; Jing LIU ; Fusen XIANG ; Xu XU ; Na MEI ; Jiao ZHOU ; Shan FAN ; Qian WANG ; Shuixia LI
Chinese Journal of Trauma 2025;41(2):138-147
Spine fracture and dislocation are common traumatic spinal conditions that often require surgical intervention due to compromised spinal stability. Surgical approaches include anterior, posterior, and combined anterior-posterior spinal procedures. According to the specific surgical requirements, patients may be placed in the prone position or repositioned between prone and supine positions during surgery. Intraoperative repositioning has become an essential step in patient positioning. However, during repositioning, patients with spinal fracture and dislocation are at increased risk for complications such as hemodynamic instability, nerve injury, and pressure injuries to the skin and soft tissue. Notably, due to the instability of the spinal cord, even minor manipulations can further exacerbate the damage, potentially leading to severe outcomes like paraplegia. Although the current clinical guidelines provide instructive recommendations for standard position, there remains no specific protocols for intraoperative repositioning in patients with spine fracture and dislocation. With a concern for the lack of clinical studies on positioning techniques, risk prevention, and operational norms for special patients, no applicable guidelines or standards are available. A consensus was required to provide clinical reference, meet the requirements of surgical treatment, and minimize the safety risks of patients caused by improper placement of positions. Professional Committee of Operating Room Nursing of Shaanxi Nursing Association organized experts in nursing management and operating room nursing from major hospitals across China to formulate Expert consensus on intraoperative repositioning for patients with spinal fracture and dislocation ( version 2025). The consensus provides 11 recommendations covering pre-repositioning preparation, intraoperative maneuvers, and post-repositioning observation, aiming to provide references for clinical standardization of the intraoperative repositioning process and protection of patients′ safety.
8.Development and validation of nomogram models for poor short-term response to recombinant human growth hormone treatment in children with short stature
Xuyang GONG ; Mengxing PAN ; Qianshuai LI ; Shuai ZHU ; Xinjing LIU ; Tianfang WANG ; Xulong LI ; Yanshuang CUI ; Yijing XIE ; Yi SONG ; Linlin ZHAO ; Jinqin WANG ; Yawei ZHANG ; Na XU ; Qiao REN ; Linqi DIAO ; Guijun QIN ; Yanyan ZHAO
Chinese Journal of Endocrinology and Metabolism 2025;41(6):467-475
Objective:To develop and validate clinical predictive models for identifying poor short-term response to recombinant human growth hormone(rhGH) treatment in children with short stature.Methods:A retrospective analysis was conducted on 118 children diagnosed with growth hormone deficiency or idiopathic short stature who were treated at the First Affiliated Hospital of Zhengzhou University and two other hospitals between January 1, 2020, and January 1, 2024. A poor response to rhGH was defined as a height increase of less than 0.2 standard deviation score(SDS) after 6 months of rhGH treatment. LASSO regression was used to identify predictive variables from baseline and follow-up data. Two logistic regression models were conducted: Model A(incorporating baseline variables only) and model B(incorporating both baseline and follow-up variables), and nomograms were created for visualization. External data and internal resampling were used for dual validation of the models, and their performance was compared.Results:A total of 118 children with short stature were included. Six baseline predictive variables(diagnosis, initial height SDS, bone age, bone age-chronological age difference, rhGH dose, and gender) and one follow-up variable(height SDS after 3 months of rhGH treatment) were identified. Area under the curve values for Model A and Model B were 0.753(95% CI 0.696-0.811) and 0.930(95% CI 0.891-0.975), respectively. Calibration curves, decision curve analysis, and other evaluation metrics demonstrated good discrimination and clinical utility for both models. Model B, incorporating the 3-month follow-up variable, showed superior predictive performance compared to Model A. Conclusions:The clinical prediction models developed in this study(Model A and Model B) are practical and reliable tools for quantitatively, conveniently, and intuitively identifying children with short stature at risk of poor response to rhGH treatment.
9.Expert Consensus on Optimisation of Emergency Management Procedure for Hand Injury in Microsurgery (2025)
Ziqing ZHANG ; Jianxi HOU ; Kelie WANG ; Jian QI ; Rongfeng ZHANG ; Dong HUANG ; Xiaoju ZHENG ; Muwei LI ; Qiqiang DONG ; Xianyou ZHENG ; Shuqiang XIE ; Qiao HOU ; Gangyi LIU ; Jian LIN ; Jihui JU ; Huaqiao WANG ; Liqiang GU
Chinese Journal of Microsurgery 2025;48(4):361-372
Standardised emergency management protocols for hand injury in microsurgery is critical, as it directly determines ultimate clinical outcomes. This consensus consolidates expert insights regarding diagnostic and treatment procedure for hand injury in microsurgery, emergency support protocols and key points of emergency workflow optimisation. It summarises the opinions of experts and puts forward standardised recommendations to guide clinical practice in microsurgical treatment process, so as to further improve the quality of treatment for hand injury in microsurgery and maximise the protection of limb function and quality of life of patients.
10.Investigation on the quality standard of pharmaceutical excipient steviol glycosides
Yongfang LI ; Qing YANG ; Cancan DING ; Qiao ZHANG ; Zhizhou JIANG ; Yongfu XIE ; Yuanyuan LI ; Shuai HUANG
Drug Standards of China 2025;26(5):527-532
Objective:To propose suggestions for the revision of quality standard of steviol glycosides through research on its major manufacturer's products.Methods:The inspection items in the current quality standards were inspected,with domestic and international quality standard of steviol glycosides.Results:Specific rotation was from-33.39° to-39.50°,pH was from 5.3 to 6.7,impurity absorbency was lower than 0.096 0,while the contents of weight loss on drying were lower than 5.0%,residue on ignition were lower than 0.043%,methanol residual were lower than 0.01%,ethanol residual were lower than 0.06%,residue on arsenic were lower than 0.000 054%,lead wasn't detected.The content of rebaudioside A and 13 kinds of steviol glycosides were 8.23%-68.48%and 85.78%-96.13%.Conclusion:The main components of the commercial steviol glycosides products were rebaudioside A and stevioside,with low safety risk of elemental impurities and solvent residues.It provided suggestions for the revision of quality standard of steviol glycosides in the Chinese Pharmacopoeia.

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