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.Epidemiological characteristics and risk factors of chronic kidney disease in patients with 10 years of hypertension
RUN GUO ; Wen SI ; Yaoyao CUI ; Yiqing CHEN ; Qiao LIU
Journal of Public Health and Preventive Medicine 2025;36(2):39-42
Objective To analyze the epidemiological characteristics and risk factors of chronic kidney disease in patients with 10 years of hypertension. Methods A total of 350 patients with 10 years or longer course of hypertension who underwent physical examination in the Second Affiliated Hospital of Air Force Medical University from June 2021 to June 2024 were selected. General information of the patients was collected through questionnaires. Renal function related indicators and imaging results were obtained through relevant laboratory tests and imaging examinations. Based on the results of renal function related indicators, the epidemiological characteristics of chronic kidney disease in hypertensive patients with 10 years of hypertension, as well as risk factors for chronic kidney disease in the hypertensive patients were identified. Results Among the 350 patients enrolled in this study, there were 71 (20.29%) with proteinuria, 32 (9.14%) with hematuria, and 40 (11.43%) with decreased renal function. A total of 80 (22.86%) cases with structural variations such as kidney stones and cysts were detected by renal B-mode ultrasound. There were 121 (34.57%) patients with hypertension and chronic kidney disease. There were statistically significant differences in gender, age, diabetes, hyperlipidemia and hyperuricemia between patients with chronic kidney disease and those without (P<0.05). Multivariate logistic regression analysis results showed that gender, age, diabetes, hyperlipidemia, and hyperuricemia were the risk factors for chronic kidney disease in patients with hypertension (P<0.05). Conclusion Patients with 10 years of hypertension have a high risk of chronic kidney disease, and the risk factors include gender, age, diabetes, hyperuricemia, and hyperlipidemia.
3.The Relationship Between Atherogenic Index of Plasma and Rapid Progression of Coronary Non-target Lesions
Wei WANG ; Haobo XU ; Juan WANG ; Jiansong YUAN ; Weixian YANG ; Rong LIU ; Shubin QIAO ; Jingang CUI
Chinese Circulation Journal 2025;40(11):1076-1080
Objectives:The study assessed the relationship between atherogenic index of plasma(AIP)and the rapid progression of coronary non-target lesions.Methods:A total of 1 247 patients with coronary artery disease who underwent two coronary angiography examinations at Fuwai Hospital,Chinese Academy of Medical Sciences between January 2010 and September 2014 were enrolled in this retrospective study.The AIP is defined as the base 10 logarithm of the ratio of the concentrations of triglyceride to high-density lipoprotein cholesterol.Patients were divided into the high AIP group(n=623)and the low AIP group(n=624)based on the median value of AIP.Lesion rapid progression is defined as an increase of more than 10%in the lumen stenosis of the lesion with a stenosis rate of more than 50%,or an increase of more than 30%in the lumen stenosis rate of the lesion with a stenosis rate of less than 50%,or a progression to total occlusion within 2 years.Results:Median AIP was 0.39(0.23-0.56)in this patient cohort.Rapid progression of non-target lesions occurred in 65(5.21%),including 42(6.74%)in the high AIP group.The Kaplan-Meier curve showed that the cumulative incidence of rapid progression of non-target lesions was higher in the high AIP group than in the low AIP group(HR=1.751,95%CI:1.053-2.912,log-rank P=0.028).In univariate cox analysis,the AIP and high AIP correlated with rapid progression of non-target lesions.After multivariate adjustment,AIP was an independent risk factor for rapid progression of non-target lesions(adjusted HR=2.731,95%CI:1.090-6.844,P=0.032).Conclusions:AIP is an independent risk factor for rapid progression of non-target lesions.AIP should be considered as a biomarker for estimating the risk of cardiovascular disease,along with other traditional risk factors.
5.The impact of early enteral nutrition on intestinal function in patients with complicated intra-abdominal infection
Shuang-Shuang QIU ; Yan-Hua WANG ; Qiao-Hong HONG ; Cui-Ping ZENG ; Jian-Ting CHEN ; Jian-She SHI
Parenteral & Enteral Nutrition 2025;32(2):95-100
Objective:To investigate the effect of early enteral nutrition on intestinal function in patients with complicated intra-abdominal infection.Methods:In this study,a prospective single-center randomized controlled trial was used to select 88 patients with severe abdominal infections in the surgical intensive care ward from January 2021 to December 2023.Among them,65 patients were eligible and were randomly divided into 33cases in the intervention group(who received early enteral nutrition),and 32cases in the control group(who did not receive early enteral nutrition).The clinical baseline characteristics of the two groups,conditions such as abdominal distension and diarrhea during enteral nutrition,intra-abdominal pressure,the time to reach the standard of complete enteral nutrition,and the indexes of pre-albumin,CRP,and leukocyte count on the third and the seventh day postoperative day were observed.The t-test was used to compare between groups for normally distributed measures.The Mann-Whitney U test was used to compare between groups for skewed measures.The χ2 test or continuity-corrected χ2 test was used to compare the count data between groups.Repeated measures data were analyzed by repeated measures ANOVA.Results:The clinical baseline characteristics of the two groups were completely matched;There were significant differences in the changes of intra-abdominal pressure over time between the two groups(Fgroup=9.665,P=0.004),There were significant differences in the changes of intra-abdominal pressure over time between the two intervention group(Ftime=64.124,P<0.001)and the control group.and the trend of intra-abdominal pressure reduction in the intervention group was more significant than that in the control group(Finteractive=3.938,P=0.023);The time required for the recovery of bowel sounds was significantly shorter in the experimental group than in the control group[(19.5±3.5)h vs(35.3±4.5)h,P<0.001,t=15.829];there was no significant difference in the frequency of abdominal distention,vomiting and aspiration between the two groups(P>0.05),and the difference in the frequency of diarrhea was statistically significant(P=0.003);The time to reach the standard of enteral nutrition in the intervention group was shorter than that in the control group[(6.3±1.2)d vs(7.4±1.5)d,P=0.002];The total hospital stay of the intervention group was significantly shorter than that of the control group[(11±3.2)d vs(14±4.1)d,P=0.007].The prealbumin(0.21±0.2,0.28±0.2)g/L,CRP(175.5±23.6,45.4±14.5)mg/L,and white blood cell count(11.7±2.9,9.1±3.5)109/L of the intervention group on the 3rd and 7th days after surgery were significantly improved compared with those of the control group(P<0.05).Conclusion:Early enteral nutrition can effectively promote the recovery of intestinal function in patients with complicated intra-abdominal infection.
6.Meta-analysis of pathogen distribution and drug resistance trends in elderly patients with stroke-associated pneumonia in China
Bin CUI ; Zhiyuan TIAN ; Chennian XU ; Rui QIAO
Journal of Shenyang Medical College 2025;27(4):375-379
Objective:To investigate the trends of pathogen distribution and drug resistance in elderly patients with stroke-associated pneumonia(SAP)in China,providing references for clinical antibiotic selection and application.Methods:A meta-analysis was conducted to comprehensively evaluate changes in resistance rates of major pathogens isolated from elderly SAP patients to key clinical antibiotics over the past 10 years.The trends of antimicrobial resistance were analyzed.Results:A total of 12 qualified articles were screened out,involving 1 202 cases of pulmonary infections and 1 315 pathogenic isolates.Gram-negative bacilli accounted for 951 strains(72.32%),Gram-positive cocci for 278 strains(21.14%),and fungi for 86 strains(6.54%).The top five pathogens were Klebsiella pneumoniae,Pseudomonas aeruginosa,Acinetobacter Baumannii,Staphylococcus aureus and Escherichia coli.The resistance rates to various antibiotics showed minor fluctuations across years.Conclusions:Gram-negative bacilli dominate pulmonary infections in elderly stroke patients,with a high proportion of multidrug-resistant strains.Strengthened pathogen surveillance and rational antibiotic use are critical in clinical practice.
7.Clinical analysis of six cases of TAFRO syndrome
Sumiao LIU ; Qianyu GUO ; Pengyan QIAO ; Yinfeng CUI ; Ke XU ; Liyun ZHANG
Chinese Journal of Rheumatology 2025;29(2):118-122
Objective:The clinicalpathological features of TAFRO syndrome were analyzed to clarify the similarities and differences between TAFRO syndrome and autoimmune diseases and to establish differential diagnosis.Methods:Six patients diagnosed with TAFRO syndrome in Shanxi Bethune Hospital from January 2014 to March 2022 were collected. The clinical, examination, pathology and treatment of TAFRO syndrome were analyzed and compared with autoimmune diseases, especially systemic lupus erythematosus and Sj?gren′s syndrome.Results:Among the 6 patients, 4 were males and 2 were females, with an average age of (57.5 ±9.8) years. All the 6 patients had fever, edema (including chest and abdominal effusion and systemic edema), thrombocytopenia (3 main criteria) and more than 2 secondary criteria.ESR and CRP were significantly elevated in 6 patients. There were 1 case of elevated IgA and IgG (IgA 4.10 g/L, IgG19.05 g/L), 1 case of elevated igg (IgG 19.33 g/L), 3 cases of normal and 1 case of undetected. Serum IgG4 was negative in 4 cases and undetected in 2 cases. Autoantibodies: 4 cases were ANA positive, including 1 case with anti-SSA/Ro52(+), anti-SSA/Ro60(+), anti-SSB (+), 1 case with anti-SSA /Ro60(+), and 2 untested. Bone marrow cytological examination was performed in 6 cases, all of which showed active hyperplasia, 2 cases showed elevated megakaryocytes, and 1 case was accompanied by interstitial fibrosis. Pathological examination of lymph nodes: 5 cases were consistent with Castleman′s disease, and 1 case was suggestive of reactive hyperplasia of lymph nodes. Conclusion:Although the diagnostic criteria of TAFRO syndrome should exclude autoimmune diseases, TAFRO syndrome and autoimmune diseases can coexist, and the connective tissue disease complicated with TAFRO syndrome has its specific clinical characteristics and treatment plan, which needs to be identified clinically.
8.DeepSeek's Enabling Applications and Compliance Pathway in Hospital Management
Xiwei CUI ; Yangyang QIAO ; Hongli WANG
Chinese Hospital Management 2025;45(8):57-60
Based on the medical AI solution system constructed by the DeepSeek series of large models(including but not limited to the R1/V3 versions),the innovative application of the DeepSeek in the medical field and its transformative impact on hospital management were systematically explored.Focusing mainly on the practical utility of this technology in medical process optimization,auxiliary decision and diagnosis and treatment support,and operation management.It deeply analyzes the practical application and compliance development path of DeepSeek in the field of hospital management.It aims to provide reference suggestions and guidance plans for optimizing and enhancing the DeepSeek in empowering hospital management.
9.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.
10.Factors related to inpatient rehabilitation costs at a general hospital in Northwest China
Lisha WANG ; Xiaoting YAN ; Na LI ; Yanchao CUI ; Peng LI ; Mingfeng ZEN ; Jin QIAO
Chinese Journal of Physical Medicine and Rehabilitation 2025;47(7):631-637
Objective:To analyze the changes in the costs of hospital rehabilitation after the reform of health insurance payments in the past 6 years, and to identify relevant factors which can provide a reference for the reform of the health insurance payment system in rehabilitation department.Methods:Information on 16, 827 patients hospitalized in the rehabilitation department of The First Affiliated Hospital of Xi′an Jiaotong University between May 2018 and May 2024 was collected and subjected to non-parametric analysis.Results:The average hospitalization cost of rehabilitation department patients over the six years was Y14, 574.92±10, 524.79. During that time the proportion of the cost attributable to Western medicine decreased from 17.1% in 2018 to 7.6% in 2024. The proportion of the patients with hypertension was 51.94%, followed by diabetes mellitus (20.10%). Those with infections had the highest total hospitalization costs. Motor disorders were the most common dysfunction (59.02%), followed by speech disorders (17.45%). Patients with swallowing disorders had the highest hospitalization costs. After the payment system shifted from fee-for-service (FFS) to payment by diagnosis-related group (DRG) in 2023, the average daily inpatient expenditures for rehabilitation patients with all types of diseases gradually declined, reaching its lowest level in 2024.Conclusions:After the health insurance payments shifted from FFS to DRG, the proportion of in patients′ total drug costs decreased annually, and the average daily costs of patients with different types of diseases also decreased significantly, but the comprehensive service fee and diagnostic costs increased.


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