1.Study of the evaluation methods for evidence and recommendation in Chinese expert consensus on off-label use of drugs
Mingyue ZHANG ; Nan CHEN ; Ling XU ; Zhenggang BAI ; Likai LIN
China Pharmacy 2025;36(6):641-647
OBJECTIVE To provide reference for optimizing or formulating unified evaluation methods for evidence and recommendation in expert consensus on off-label use of drugs. METHODS Retrieved from CNKI, Wanfang data, VIP, CBM, PubMed and Web of Science, Chinese expert consensuses on off-label use of drugs involving evaluation methods for evidence and recommendations were collected from the inception to August 1, 2024. After screening the literature and extracting relevant data, descriptive statistical analysis was conducted. RESULTS & CONCLUSIONS Among the 32 articles included, 14 articles (43.8%) used Micromedex’s Thomson grading system, only 7 articles (21.9%) considered economic factors when forming recommendations, 10 articles (31.3%) reported the conflicts of interest; only 2 articles (6.3%) involved experts in the field of evidence-based medicine methodology. There were differences in the sources of evidence, factors considered in forming recommendations, and the grading standards for evidence and recommendations among different expert consensus evidence evaluation methods. There were also differences in evidence levels and recommendation strength of the same drug off-label use in different expert consensus. It is recommended that in future consensus-building processes, greater attention should be paid to potential conflicts of interest among participants, collaboration with methodological experts should be enhanced, and efforts should be expedited to establish unified standards for evaluating evidence and recommendation methodologies.
2.Single-cell transcriptomics identifies PDGFRA+ progenitors orchestrating angiogenesis and periodontal tissue regeneration.
Jianing LIU ; Junxi HE ; Ziqi ZHANG ; Lu LIU ; Yuan CAO ; Xiaohui ZHANG ; Xinyue CAI ; Xinyan LUO ; Xiao LEI ; Nan ZHANG ; Hao WANG ; Ji CHEN ; Peisheng LIU ; Jiongyi TIAN ; Jiexi LIU ; Yuru GAO ; Haokun XU ; Chao MA ; Shengfeng BAI ; Yubohan ZHANG ; Yan JIN ; Chenxi ZHENG ; Bingdong SUI ; Fang JIN
International Journal of Oral Science 2025;17(1):56-56
Periodontal bone defects, primarily caused by periodontitis, are highly prevalent in clinical settings and manifest as bone fenestration, dehiscence, or attachment loss, presenting a significant challenge to oral health. In regenerative medicine, harnessing developmental principles for tissue repair offers promising therapeutic potential. Of particular interest is the condensation of progenitor cells, an essential event in organogenesis that has inspired clinically effective cell aggregation approaches in dental regeneration. However, the precise cellular coordination mechanisms during condensation and regeneration remain elusive. Here, taking the tooth as a model organ, we employed single-cell RNA sequencing to dissect the cellular composition and heterogeneity of human dental follicle and dental papilla, revealing a distinct Platelet-derived growth factor receptor alpha (PDGFRA) mesenchymal stem/stromal cell (MSC) population with remarkable odontogenic potential. Interestingly, a reciprocal paracrine interaction between PDGFRA+ dental follicle stem cells (DFSCs) and CD31+ Endomucin+ endothelial cells (ECs) was mediated by Vascular endothelial growth factor A (VEGFA) and Platelet-derived growth factor subunit BB (PDGFBB). This crosstalk not only maintains the functionality of PDGFRA+ DFSCs but also drives specialized angiogenesis. In vivo periodontal bone regeneration experiments further reveal that communication between PDGFRA+ DFSC aggregates and recipient ECs is essential for effective angiogenic-osteogenic coupling and rapid tissue repair. Collectively, our results unravel the importance of MSC-EC crosstalk mediated by the VEGFA and PDGFBB-PDGFRA reciprocal signaling in orchestrating angiogenesis and osteogenesis. These findings not only establish a framework for deciphering and promoting periodontal bone regeneration in potential clinical applications but also offer insights for future therapeutic strategies in dental or broader regenerative medicine.
Receptor, Platelet-Derived Growth Factor alpha/metabolism*
;
Humans
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Neovascularization, Physiologic/physiology*
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Dental Sac/cytology*
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Single-Cell Analysis
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Transcriptome
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Mesenchymal Stem Cells/metabolism*
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Bone Regeneration
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Animals
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Dental Papilla/cytology*
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Periodontium/physiology*
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Stem Cells/metabolism*
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Regeneration
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Angiogenesis
3.Association of Body Mass Index with All-Cause Mortality and Cause-Specific Mortality in Rural China: 10-Year Follow-up of a Population-Based Multicenter Prospective Study.
Juan Juan HUANG ; Yuan Zhi DI ; Ling Yu SHEN ; Jian Guo LIANG ; Jiang DU ; Xue Fang CAO ; Wei Tao DUAN ; Ai Wei HE ; Jun LIANG ; Li Mei ZHU ; Zi Sen LIU ; Fang LIU ; Shu Min YANG ; Zu Hui XU ; Cheng CHEN ; Bin ZHANG ; Jiao Xia YAN ; Yan Chun LIANG ; Rong LIU ; Tao ZHU ; Hong Zhi LI ; Fei SHEN ; Bo Xuan FENG ; Yi Jun HE ; Zi Han LI ; Ya Qi ZHAO ; Tong Lei GUO ; Li Qiong BAI ; Wei LU ; Qi JIN ; Lei GAO ; He Nan XIN
Biomedical and Environmental Sciences 2025;38(10):1179-1193
OBJECTIVE:
This study aimed to explore the association between body mass index (BMI) and mortality based on the 10-year population-based multicenter prospective study.
METHODS:
A general population-based multicenter prospective study was conducted at four sites in rural China between 2013 and 2023. Multivariate Cox proportional hazards models and restricted cubic spline analyses were used to assess the association between BMI and mortality. Stratified analyses were performed based on the individual characteristics of the participants.
RESULTS:
Overall, 19,107 participants with a sum of 163,095 person-years were included and 1,910 participants died. The underweight (< 18.5 kg/m 2) presented an increase in all-cause mortality (adjusted hazards ratio [ aHR] = 2.00, 95% confidence interval [ CI]: 1.66-2.41), while overweight (≥ 24.0 to < 28.0 kg/m 2) and obesity (≥ 28.0 kg/m 2) presented a decrease with an aHR of 0.61 (95% CI: 0.52-0.73) and 0.51 (95% CI: 0.37-0.70), respectively. Overweight ( aHR = 0.76, 95% CI: 0.67-0.86) and mild obesity ( aHR = 0.72, 95% CI: 0.59-0.87) had a positive impact on mortality in people older than 60 years. All-cause mortality decreased rapidly until reaching a BMI of 25.7 kg/m 2 ( aHR = 0.95, 95% CI: 0.92-0.98) and increased slightly above that value, indicating a U-shaped association. The beneficial impact of being overweight on mortality was robust in most subgroups and sensitivity analyses.
CONCLUSION
This study provides additional evidence that overweight and mild obesity may be inversely related to the risk of death in individuals older than 60 years. Therefore, it is essential to consider age differences when formulating health and weight management strategies.
Humans
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Body Mass Index
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China/epidemiology*
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Male
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Female
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Middle Aged
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Prospective Studies
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Rural Population/statistics & numerical data*
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Aged
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Follow-Up Studies
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Adult
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Mortality
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Cause of Death
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Obesity/mortality*
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Overweight/mortality*
4.An excerpt of EASL-EASD-EASO clinical practice guidelines on the management of metabolic dysfunction-associated steatotic liver disease in 2024
Wenjing NI ; Nan GENG ; Xue BAI ; Jie LI
Journal of Clinical Hepatology 2024;40(8):1567-1574
In June 2024,the European Association for the Study of the Liver,the European Association for the Study of Diabetes,and the European Association for the Study of Obesity jointly released the latest edition of clinical practice guidelines on the management of metabolic dysfunction-associated steatotic liver disease(MASLD),which comprehensively elaborates on the definition,prevalence rate,natural disease history,screening,diagnosis,and treatment of MASLD and proposes 33 statements and 72 recommendations.This article gives an excerpt of the key points in this document.
5.Exploration and construction of an evaluation indicator framework for clinical research benefits in China
Aiyi ZHANG ; Hu CHEN ; Aijuan SHENG ; Nan BAI ; Yanfen CHEN ; Zhongguang YU
Chinese Medical Ethics 2024;37(4):448-452
Objective:The aim is to construct an evaluation framework for clinical research benefits,and provide a reference for the formulate of evaluation standards for clinical research benefits.Methods:The Delphi method was used to carry out expert consultation,and the mean,score of importance,coefficient of variation and coordination,etc.of evaluation indicators were summarized and calculated,to screen evaluation indicators for clinical research benefits.Results:Twenty-three experts in this field were selected for correspondence,and their enthusiasm was 100%in both rounds,the authority coefficients were≥0.90,and Kendall's coefficients of concordance were<0.25(P<0.001).By referring to the mean and coefficient of variation of the indicators,as well as combining them with expert suggestions,an evaluation framework for clinical research benefits was ultimately formed with 2 primary indicators,5 secondary indicators,and 8 tertiary indicators.Conclusion:The evaluation framework for clinical research benefits constructed in this paper can comprehensively evaluate the research benefits,as well as provide a basis for reasonably determining the research risk-benefit ratio and developing quantitative evaluation tools for clinical research benefits.
6.New requirements and reflections on ethics review in the 2022 version of Good Clinical Practice for Medical Devices
Qiansu YANG ; Nan BAI ; Jiyin ZHOU
Chinese Medical Ethics 2024;37(8):919-925
The National Medical Products Administration issued a new version of the"Good Clinical Practice for Medical Devices(GCP)"in March 2022,which deleted specific requirements for the constitution and operation of the ethics committee and simplified the processes of submitting initial review documents and reporting serious adverse events in clinical trials.Firstly,the new requirements for ethics committees were sorted out and analyzed,including responsibilities,compositions,qualifications and training of members and secretaries,as well as the management of archives.Secondly,it elaborated on the new requirements for ethical initial reviews,including submission of materials,contents,methods,and conclusions of the review,as well as the learning curve risk management of drug-device combination medical devices and medical devices during use.It emphasized the compliance and validity of informed consent,strictly limited the conditions for exemption from informed consent,and redefined the organizations and individuals allowed to access trial data.Finally,it elaborated on the new requirements for follow-up review of serious adverse events,device defects,and new requirements for the correction clinical trial data after project the completion.The new version of the GCP is more operational and puts forward higher requirements for the review quality and efficiency of the ethics committee.The ethics committee should improve the review efficiency on the premise of ensuring the quality of the review,to effectively protect the safety,rights and interests of the subjects.
7.Research advances on the roles of metabolic remodeling and protein acylation modification in keloids
Zelan MU ; Yongxiang TENG ; Jian ZHANG ; Nan BAI ; Yanjie FU
Chinese Journal of Burns 2024;40(6):589-593
Keloid is a common skin disease, and the mechanism of its occurrence is not fully understood. There is evidence to show that multiple factors such as genetics, race, age, gender, hormones, infection, immunity, and oxidative stress, etc. may be related to the occurrence of keloids. Metabolic remodeling and protein acylation modification, as two important biological processes, play important roles in various skin related diseases. Based on this, this article reviews the roles of metabolic remodeling and protein acylation modification in keloids and the interrelationship between the two biological processes, and explores the application prospects of targeting the two biological processes in the prevention and treatment of keloids.
8.Management of retroactive signing of economic contracts in a public hospital
Xu ZHANG ; Zhuang MIAO ; Nan HONG ; Diange ZHOU ; Minghao BAI
Chinese Journal of Hospital Administration 2024;40(9):723-726
Retroactive signing of economic contracts poses significant economic risks and potential hazards, and may harm the interests of the hospital and trigger corruption risks. A certain tertiary public hospital analyzed 41 backdated contracts out of 282 economic contracts signed from January to June 2023 to determine the reasons for contract retrosigning, and proposed targeted countermeasures in terms of personnel management, emergency procurement project management, and management of project initiation, contract drafting, approval, and signing. Since September 2023, by improving relevant management systems, optimizing and standardizing various processes, and strengthening the application of performance assessments, the issue of economic contracts retrosigning has been effectively resolved, reducing the risk hazards in the hospital′s economic activities, which can provide a reference for the economic contract management of public hospitals.
9.Analysis on the Medication Law of Bai Changchuan in the Treatment of Chronic Gastritis Based on Data Mining
Lili ZHANG ; Rui YU ; Minghua NAN ; Tingting JIANG ; Ming KANG ; You YU ; Changchuan BAI
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(6):39-46
Objective To summarize the medication law and prescription thinking of Professor Bai Changchuan in the treatment of chronic gastritis.Methods Effective medical records of chronic gastritis treated by Professor Bai Changchuan from January 2017 to December 2022 were selected.Frequency statistics,hidden structure model,association rules were used for data mining.Interview of Professor Bai Changchuan for the treatment of chronic gastritis was analyzed from the aspects of basic principles,core prescriptions and prescription thinking.Results Totally 328 medical cases were included,involving 1 128 prescriptions,among which 904 prescription were HP positive,209 prescription were bile reflux,268 prescriptions were located in the cardia,9 prescriptions in the gastric body,and 896 prescriptions in the gastric antrum.The pathological changes were erosion in 524 prescriptions,atrophy in 354 prescriptions,and intestinal metaplasia in 208 prescriptions.108 kinds of Chinese materia medica were involved.The properties were mainly warm,cold,and mild,the tastes were mainly bitter,sweet and pungent,and the main meridians were spleen meridian,lung meridian,and stomach meridian,involving 20 kinds of efficacy.20 hidden variables were obtained from the hidden structure model of high-frequency Chinese materia medica.There were 210 association rules high-frequence between Chinese materia medica.The core combination was ginger Pinelliae Rhizoma-Codonopsis Radix-Citri Reticulatae Pericarpium-Poria-Glycyrrhizae Radix et Rhizoma Praeparata cum Melle-fried Atractylodis Macrocephalae Rhizoma.Different etiology,disease location and pathological changes were associated with Liujunzi Decoction.The association of HP-Pogostemonis Herba,Amomi Fructus,fried Coicis Semen;bile reflux-Magnoliae Officinalis Corte,Aurantii Fructus Immaturu,Aucklandiae Radix,Galli Gigerii Endothelium Corneumm,Bupleuri Radix,fried Crataegi Fructus;gastric antrum-Pogostemonis Herba,Cyperi Rhizoma,Linderae Radix,Typhae Pollen;cardia-Fritillariae Thunbergii Bulbus,Nelumbinis Folium,Curcumae Radix,Aurantii Fructus Immaturu,Magnoliae Officinalis Corte;erosion-Fritillariae Thunbergii Bulbus,Sepiae Endoconcha,Magnoliae Officinalis Corte,Aurantii Fructus Immaturu,Aucklandiae Radix,fried Paeoniae Radix Alba,Catechu;atrophy-Aucklandiae Radix,Magnoliae Officinalis Corte,Fritillariae Thunbergii Bulbus,Cinnamomi Ramulus,Ophiopogonis Radix;intestinal transformation-Aucklandiae Radix,Magnoliae Officinalis Corte,Aurantii Fructus Immaturu,Galli Gigerii Endothelium Corneumm,Fritillariae Thunbergii Bulbus,Linderae Radix,Faeces Trogopterori,Typhae Pollen also had clinical significance.Conclusion Professor Bai Changchuan treats chronic gastritis with a combination of cold and warm,treating both symptoms and root causes,and applying both attack and tonics.The basic principle is to"promote spleen and stomach circulation,eliminate accumulation and stagnation",and the core prescription is Liujunzi Decoction.Combined with microscopic syndrome differentiation,he selects appropriate drugs for treatment.
10.Efficacy of unilateral percutaneous kyphoplasty combined with posterior medial branch block of the contralateral spinal nerve in the treatment of lumbar osteoporotic vertebral compression fracture in the elderly
Peiwu ZHANG ; Hua GUO ; Jie PANG ; Hanghang BAI ; Ligang FAN ; Wenyan LI ; Nan WU ; Xianyu SHE ; Yuan HE
Chinese Journal of Trauma 2024;40(8):684-691
Objective:To compare the efficacy of unilateral percutaneous kyphoplasty (PKP) and unilateral PKP combined with posterior medial branch block of the contralateral spinal nerve in the treatment of lumbar osteoporotic vertebral compression fracture (OVCF) in the elderly.Methods:A retrospective cohort study was conducted to analyze the clinical data of 161 aged patients with newly developed lumbar OVCF, admitted to Xi′an Central Hospital Affiliated to Xi′an Jiaotong University School of Medicine from January 2019 to January 2023, including 58 males and 103 females, aged 61-88 [(72.9±6.3)years]. All the patients were diagnosed with type II compression fracture based on acute symptomatic osteoporotic thoracolumbar fracture classification (ASOTLF). Seventy-eight patients underwent unilateral PKP (PKP group), while the other 83 patients underwent unilateral PKP combined with posterior medial branch block of the contralateral spinal nerve (PKP+contralateral block group). The operation time, intraoperative blood loss, and length of hospital stay were recorded. Beck index of the injured vertebra, Cobb angle of lumbar lordosis, Roland-Morris disability (RMD) score, visual analogue scale (VAS), and Oswestry disability index (ODI) were evaluated before operation, at 1 day, 1 week, 1 month, 3 months after operation, and at the last follow-up. The incidence of complications such as cement leakage was recorded as well.Results:All the patients were followed up for 6-8 months [(6.7±0.6)months]. There were no significant differences between the two groups in the operation time, intraoperative blood loss, or length of hospital stay ( P>0.05). The Beck index of the injured vertebra and Cobb angle of lumbar lordosis were not significantly different between the two groups before operation, at 1 day, 1 week, 1 month, 3 months after operation, and at the last follow-up ( P>0.05). The RMD score of the injured vertebra, VAS score, and ODI were not significantly different between the two groups before operation ( P>0.05). At 1 day, 1 week, 1 month, 3 months after operation, and at the last follow-up, the RMD scores in the PKP+contralateral block group were (11.23±1.05)points, (10.90±1.11)points, (10.10±1.06)points, (9.94±1.06)points, and (9.60±0.83)points respectively, which were all lower than (17.55±0.71)points, (15.78±0.86)points, (13.42±0.92)points, (10.67±0.78)points, and (9.78±0.72)points in the PKP group ( P<0.05 or 0.01); the VAS scores in the PKP+contralateral block group were (3.02±0.60)points, (2.96±0.55)points, (2.92±0.57)points, (2.88±0.61)points, and (2.70±0.51)points respectively, which were all lower than (3.60±0.57)points, (3.47±0.55)points, (3.32±0.46)points, (2.99±0.47)points, and (2.77±0.42)points in the PKP group ( P<0.05 or 0.01); the ODI values in the PKP+contralateral block group were 14.43±1.29, 14.54±1.24, 14.63±1.32, 14.37±1.31, and 13.42±1.45 respectively, which were all lower than 16.72±1.64, 16.09±1.49, 14.82±1.53, 14.74±1.46, and 13.69±1.75 in the PKP group ( P<0.05 or 0.01). The bone cement leakage rate was 12.0% (10/83) in the PKP+contralateral block group, similar to 11.5% (9/78) in the PKP group ( P>0.05). No other complications such as neurovascular injury, pulmonary embolism or adjacent vertebral fracture were found in either groups. Conclusion:In the treatment of lumbar OVCF in the elderly, unilateral PKP combined with posterior medial branch block of the contralateral spinal nerve is similar to unilateral PKP in terms of the operation time, intraoperative blood loss, length of hospital stay, effectiveness of reduction, and incidence of complications, but it can achieve better pain relief and more satisfactory functional recovery.

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