1.Study on the current status and pathway optimization of traditional Chinese medicine preparations record-filing management in medical institutions across different provinces
Chao LIN ; Chenjie SHU ; Chuchu WAN ; Yang DONG ; Mengting DI ; Huiying SHEN ; Bo ZHANG
China Pharmacy 2026;37(13):1673-1678
OBJECTIVE To provide scientific reference for perfecting the record-filing management policy of traditional Chinese medicine preparations formulated via traditional processes for medical applications (hereinafter referred to as “TCM preparations”) in medical institutions, and further promote the sound development of the research and record-filing work of such preparations. METHODS A literature review combined with cross-sectional research was carried out. We collected policy documents and preparation information related to the record-filing of TCM preparations issued by national and provincial drug administration authorities on official websites during 2018-2025. A comparative analysis was conducted on the implementation and revision of core policy documents for the registration management of TCM preparations across provinces, the scope of record-filing dosage forms, conditions for rejection of record-filing, and exemptions for registration materials. Statistical analysis on the quantity and dosage forms of record-filing preparations in each province was conducted by means of data induction and trend chart plotting, and targeted suggestions were put forward to optimize the management pathway of record-filing. RESULTS CONCLUSIONS There was obvious heterogeneity in record-filing policies among provinces. Twelve provinces refined the applicable dosage forms for record-filing, fifteen provinces supplemented conditions for rejection of record-filing (16 items in total), and nine provinces expanded the scope of material exemptions. The number of recorded preparations presented a striking regional imbalance:Qinghai had the largest quantity of 4 269 varieties, while Hainan only had 14 varieties, with a gap of more than 300 times. The recorded preparations were mainly traditional dosage forms including pills (6 928 varieties) and powders (4 360 varieties). Only 12 provinces formulated the provincial catalog for TCM preparations allocation. In most regions, preparation circulation was only permitted within medical consortia, leading to a low transformation rate of scientific and technological achievements of preparations. It is recommended to optimize the record-filing management pathway from three aspects: strengthening policy standardization while maintaining flexibility, streamlining record-filing procedures and documentary requirements, and reinforcing technical support and achievement transformation. These measures can reduce regional policy differences, improve work efficiency of record-filing, and advance the standardized development and clinical value transformation of hospital-made TCM preparations.
2.Study on the current status and pathway optimization of traditional Chinese medicine preparations record-filing management in medical institutions across different provinces
Chao LIN ; Chenjie SHU ; Chuchu WAN ; Yang DONG ; Mengting DI ; Huiying SHEN ; Bo ZHANG
China Pharmacy 2026;37(13):1673-1678
OBJECTIVE To provide scientific reference for perfecting the record-filing management policy of traditional Chinese medicine preparations formulated via traditional processes for medical applications (hereinafter referred to as “TCM preparations”) in medical institutions, and further promote the sound development of the research and record-filing work of such preparations. METHODS A literature review combined with cross-sectional research was carried out. We collected policy documents and preparation information related to the record-filing of TCM preparations issued by national and provincial drug administration authorities on official websites during 2018-2025. A comparative analysis was conducted on the implementation and revision of core policy documents for the registration management of TCM preparations across provinces, the scope of record-filing dosage forms, conditions for rejection of record-filing, and exemptions for registration materials. Statistical analysis on the quantity and dosage forms of record-filing preparations in each province was conducted by means of data induction and trend chart plotting, and targeted suggestions were put forward to optimize the management pathway of record-filing. RESULTS CONCLUSIONS There was obvious heterogeneity in record-filing policies among provinces. Twelve provinces refined the applicable dosage forms for record-filing, fifteen provinces supplemented conditions for rejection of record-filing (16 items in total), and nine provinces expanded the scope of material exemptions. The number of recorded preparations presented a striking regional imbalance:Qinghai had the largest quantity of 4 269 varieties, while Hainan only had 14 varieties, with a gap of more than 300 times. The recorded preparations were mainly traditional dosage forms including pills (6 928 varieties) and powders (4 360 varieties). Only 12 provinces formulated the provincial catalog for TCM preparations allocation. In most regions, preparation circulation was only permitted within medical consortia, leading to a low transformation rate of scientific and technological achievements of preparations. It is recommended to optimize the record-filing management pathway from three aspects: strengthening policy standardization while maintaining flexibility, streamlining record-filing procedures and documentary requirements, and reinforcing technical support and achievement transformation. These measures can reduce regional policy differences, improve work efficiency of record-filing, and advance the standardized development and clinical value transformation of hospital-made TCM preparations.
3.Effects of polylactic acid-glycolic acid copolymer/lysine-grafted graphene oxide nanoparticle composite scaffolds on osteogenic differentiation of MC3T3 cells
Shuangqi YU ; Fan DING ; Song WAN ; Wei CHEN ; Xuejun ZHANG ; Dong CHEN ; Qiang LI ; Zuoli LIN
Chinese Journal of Tissue Engineering Research 2025;29(4):707-712
BACKGROUND:How to effectively promote bone regeneration and bone reconstruction after bone injury has always been a key issue in clinical bone repair research.The use of biological and degradable materials loaded with bioactive factors to treat bone defects has excellent application prospects in bone repair. OBJECTIVE:To investigate the effect of polylactic acid-glycolic acid copolymer(PLGA)composite scaffold modified by lysine-grafted graphene oxide nanoparticles(LGA-g-GO)on osteogenic differentiation and new bone formation. METHODS:PLGA was dissolved in dichloromethane and PLGA scaffold was prepared by solvent evaporation method.PLGA/GO composite scaffolds were prepared by dispersing graphene oxide uniformly in PLGA solution.LGA-g-GO nanoparticles were prepared by chemical grafting method,and the PLGA/LGA-g-GO composite scaffolds were constructed by blending LGA-g-GO nanoparticles at different mass ratios(1%,2%,and 3%)with PLGA.The micromorphology,hydrophilicity,and protein adsorption capacity of scaffolds of five groups were characterized.MC3T3 cells were inoculated on the surface of scaffolds of five groups to detect cell proliferation and osteogenic differentiation. RESULTS AND CONCLUSION:(1)The surface of PLGA scaffolds was smooth and flat under scanning electron microscope,while the surface of the other four scaffolds was rough.The surface roughness of the composite scaffolds increased with the increase of the addition of LGA-g-GO nanoparticles.The water contact angle of PLGA/LGA-g-GO(3%)composite scaffolds was lower than that of the other four groups(P<0.05).The protein adsorption capacity of PLGA/LGA-g-GO(1%,2%,and 3%)composite scaffolds was stronger than PLGA and PLGA/GO scaffolds(P<0.05).(2)CCK-8 assay showed that PLGA/LGA-g-GO(2%,3%)composite scaffold could promote the proliferation of MC3T3 cells.Alkaline phosphatase staining and alizarin red staining showed that the cell alkaline phosphatase activity in PLGA/LGA-g-GO(2%,3%)group was higher than that in the other three groups(P<0.05).The calcium deposition in the PLGA/GO and PLGA/LGA-g-GO(1%,2%,and 3%)groups was higher than that in the PLGA group(P<0.05).(3)In summary,PLGA/LGA-g-GO composite scaffold can promote the proliferation and osteogenic differentiation of osteoblasts,and is conducive to bone regeneration and bone reconstruction after bone injury.
4.Association between atherogenic index of plasma trajectory and new-onset coronary heart disease in Chinese elderly people: a prospective cohort study.
Wan-Li HU ; Yv-Lin CHENG ; Dong-Hai SU ; Yv-Fang CUI ; Zi-Hao LI ; Ge-Fei LI ; Hai-Yun GAO ; Da-Tian GAO ; Xiao-Ke ZHANG ; Song-He SHI
Journal of Geriatric Cardiology 2025;22(10):835-843
BACKGROUND:
The atherogenic index of plasma (AIP) has been shown to be positively correlated with cardiovascular disease in previous studies. However, it is unclear whether elderly people with long-term high AIP levels are more likely to develop coronary heart disease (CHD). Therefore, the aim of this study was to investigate the relationship between AIP trajectory and CHD incidence in elderly people.
METHODS:
19,194 participants aged ≥ 60 years who had three AIP measurements between 2018 and 2020 were included in this study. AIP was defined as log10 (triglyceride/high-density lipoprotein cholesterol). The group-based trajectory model was used to identify different trajectory patterns of AIP from 2018 to 2020. Cox proportional hazards models were used to estimate the hazard ratio (HR) with 95% CI of CHD events between different trajectory groups from 2020 to 2023.
RESULTS:
Three different trajectory patterns were identified through group-based trajectory model: the low-level group (n = 7410, mean AIP: -0.25 to -0.17), the medium-level group (n = 9981, mean AIP: 0.02-0.08), and the high-level group (n = 1803, mean AIP: 0.38-0.42). During a mean follow-up of 2.65 years, a total of 1391 participants developed CHD. After adjusting for potential confounders, compared with the participants in the low-level group, the HR with 95% CI of the medium-level group and the high-level group were estimated to be 1.24 (1.10-1.40) and 1.43 (1.19-1.73), respectively. These findings remained consistent in subgroup analyses and sensitivity analyses.
CONCLUSIONS
There was a significant correlation between persistent high AIP level and increased CHD risk in the elderly. This suggests that monitoring the long-term changes in AIP is helpful to identify individuals at high CHD risk in elderly people.
5.Literature analysis of the differences in the occurrence of urinary epithelial carcinoma after kidney transplantation between northern and southern China
Pengjie WU ; Runhua TANG ; Dong WEI ; Yaqun ZHANG ; Hong MA ; Bin JIN ; Xin CHEN ; Jianlong WANG ; Ming LIU ; Yaoguang ZHANG ; Ben WAN ; Jianye WANG
Journal of Modern Urology 2025;30(5):432-437
Objective: To investigate the regional differences in the incidence of urothelial carcinoma among kidney transplant recipients between northern and southern China,so as to provide reference for early diagnosis of this disease. Methods: A comprehensive search was conducted across multiple databases,including CNKI,Wanfang,CBM,and PubMed,using the keywords “kidney transplantation” and “tumor” to collect clinical data from qualified kidney transplant centers.The latest and most complete literature data published by 17 transplant centers in northern China and 14 in southern China were included.Statistical analyses were performed to compare the incidence of post-transplant urothelial carcinoma and non-urothelial malignancies. Results: A total of 37 475 kidney transplant recipients were included,among whom 837 (2.23%) developed post-transplant malignancies,including urothelial carcinoma (366/837,43.73%),non-urothelial carcinoma (444/837,53.05%),and malignancies with unspecified pathology (27/837,3.23%).The incidence of malignancies was significantly higher in northern China than in southern China [(2.82±1.39)% vs. (1.67±0.83)%,P=0.011],with a particularly pronounced difference in the incidence of urothelial carcinoma [(1.68±1.12)% vs. (0.32±0.32)%,P<0.001].No significant difference was observed in the incidence of non-urothelial carcinoma between the two regions [(1.11±0.56)% vs. (1.35±0.65)%,P=0.279].Additionally,female transplant recipients exhibited a higher incidence of malignancies than males in both regions (southern China:2.38% vs. 1.80%; northern China:8.93% vs. 2.52%). Conclusion: The incidence of urothelial carcinoma following kidney transplantation is significantly higher in northern China than in southern China,underscoring the importance of implementing regular tumor screening for kidney transplant recipients,particularly for female patients in northern China,to facilitate early diagnosis and timely intervention.
6.Exploration and practice of a refined management model in the operating room:a case study of a terti-ary hospital
Zixia WAN ; Na REN ; Mingwei WU ; Qichao DONG ; Yan ZHOU ; Yi ZHANG ; Jiawei ZHOU ; Qiaohong ZHAO ; Fen QIAN ; Mubiao LIU
Modern Hospital 2025;25(8):1214-1218
Objective To develop a refined management model for operating rooms and assess its clinical impact on op-erational efficiency and cost control.Methods The study included 10,728 elective surgeries from January to June 2024 as the study group and 9 414 elective surgeries from January to June 2023 as the control group.The differences in operational metrics before and after implementing the refined management model were compared.The model was developed through comprehensive management by hospital leadership and multi-department collaboration,focusing on management structure,systems,processes,information technology,and resource allocation.Results In terms of efficiency,the on-time start rate of the first surgeries in the study group was significantly higher than in the control group(P<0.05).The turnover time between surgeries was shorter in the study group(P<0.01),and the rate of unexpected surgery cancellations was lower(P<0.01).The average cost per surgery for consumables,excluding the impact of centralized procurement of consumables,was approximately 971 yuan,representing an 11% reduction compared to the previous year,despite a 14% increase in surgical volume.The average daily operating cost per operating room was about 12 303 yuan,a 7% reduction.Economic benefits increased by 8.43 million yuan,a 38% year-on-year increase.Conclusion Implementing a refined management model in operating rooms can significantly enhance efficiency,re-duce costs,and achieve dual improvements in social and economic benefits.
7.Clinical efficacy and safety of CLAE regimen for refractory/relapsed T cell acute lymphoblastic leukemia/lymphoma: a prospective, multicenter, single-arm study
Yan LI ; Xian ZHANG ; Xiuhua SUN ; Jia SONG ; Rong ZHANG ; Ping YANG ; Wei WAN ; Fei DONG ; Jijun WANG ; Hongmei JING
Chinese Journal of Hematology 2025;46(11):1005-1013
Objective:To evaluate the efficacy and safety of the CLAE (cladribine + cytarabine + etoposide) regimen in refractory/relapsed T cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) .Methods:Patients with R/R T-ALL/LBL received the CLAE regimen in a prospective, multicenter, single-arm clinical study or compassionate use. From March 2019 to August 2024, data from 25 patients (18 in the study across five centers and 7 receiving compassionate treatment in Peking University Third Hospital) were collected. Outcomes included objective response rate, complete response (CR) rate, partial response (PR) rate after 1–2 cycles, bridging to allo-HSCT, progression-free survival (PFS), overall survival (OS), and treatment-related adverse effects.Results:Median age was 29 years (range, 13–63) ; 17 were male. Among the 24 evaluable patients, CR rate was 33.3% overall and 41.2% among enrolled patients. Median OS and PFS time were 199 (46–1 310) and 49 (28–1 310) days, respectively. Cumulative OS rate at 6 months, 1 year, and 2 years was (52.1±10.2) %, (29.7±9.3) %, and (27.1±9.1) %, respectively; cumulative PFS rate was (32.6±9.6) %, (24.9±8.9) %, and (23.8±8.7) %, respectively. Among patients achieving CR or PR (8 cases), median OS and PFS were not reached. Cumulative OS rate at 6 months, 1 year, and 2 years was (86.8±12.0) %, (78.3±14.6) %, and (72.9±15.7) %, respectively, and the cumulative PFS rate was (86.4±12.1) %, (74.8±15.3) %, and (72.9±15.7) %, respectively. Adverse events were mainly hematologic; no treatment-related mortality occurred. Seven patients achieving CR were bridged to allo-HSCT, with 5 remaining in continuous remission.Conclusion:The CLAE regimen is safe and effective for R/R T-ALL/LBL, facilitating CR as a bridge to allo-HSCT and potentially improving patient prognosis.
8.Real-world efficacy and safety of azvudine in hospitalized older patients with COVID-19 during the omicron wave in China: A retrospective cohort study.
Yuanchao ZHU ; Fei ZHAO ; Yubing ZHU ; Xingang LI ; Deshi DONG ; Bolin ZHU ; Jianchun LI ; Xin HU ; Zinan ZHAO ; Wenfeng XU ; Yang JV ; Dandan WANG ; Yingming ZHENG ; Yiwen DONG ; Lu LI ; Shilei YANG ; Zhiyuan TENG ; Ling LU ; Jingwei ZHU ; Linzhe DU ; Yunxin LIU ; Lechuan JIA ; Qiujv ZHANG ; Hui MA ; Ana ZHAO ; Hongliu JIANG ; Xin XU ; Jinli WANG ; Xuping QIAN ; Wei ZHANG ; Tingting ZHENG ; Chunxia YANG ; Xuguang CHEN ; Kun LIU ; Huanhuan JIANG ; Dongxiang QU ; Jia SONG ; Hua CHENG ; Wenfang SUN ; Hanqiu ZHAN ; Xiao LI ; Yafeng WANG ; Aixia WANG ; Li LIU ; Lihua YANG ; Nan ZHANG ; Shumin CHEN ; Jingjing MA ; Wei LIU ; Xiaoxiang DU ; Meiqin ZHENG ; Liyan WAN ; Guangqing DU ; Hangmei LIU ; Pengfei JIN
Acta Pharmaceutica Sinica B 2025;15(1):123-132
Debates persist regarding the efficacy and safety of azvudine, particularly its real-world outcomes. This study involved patients aged ≥60 years who were admitted to 25 hospitals in mainland China with confirmed SARS-CoV-2 infection between December 1, 2022, and February 28, 2023. Efficacy outcomes were all-cause mortality during hospitalization, the proportion of patients discharged with recovery, time to nucleic acid-negative conversion (T NANC), time to symptom improvement (T SI), and time of hospital stay (T HS). Safety was also assessed. Among the 5884 participants identified, 1999 received azvudine, and 1999 matched controls were included after exclusion and propensity score matching. Azvudine recipients exhibited lower all-cause mortality compared with controls in the overall population (13.3% vs. 17.1%, RR, 0.78; 95% CI, 0.67-0.90; P = 0.001) and in the severe subgroup (25.7% vs. 33.7%; RR, 0.76; 95% CI, 0.66-0.88; P < 0.001). A higher proportion of patients discharged with recovery, and a shorter T NANC were associated with azvudine recipients, especially in the severe subgroup. The incidence of adverse events in azvudine recipients was comparable to that in the control group (2.3% vs. 1.7%, P = 0.170). In conclusion, azvudine showed efficacy and safety in older patients hospitalized with COVID-19 during the SARS-CoV-2 omicron wave in China.
9.DiPTAC: A degradation platform via directly targeting proteasome.
Yutong TU ; Qian YU ; Mengna LI ; Lixin GAO ; Jialuo MAO ; Jingkun MA ; Xiaowu DONG ; Jinxin CHE ; Chong ZHANG ; Linghui ZENG ; Huajian ZHU ; Jiaan SHAO ; Jingli HOU ; Liming HU ; Bingbing WAN ; Jia LI ; Yubo ZHOU ; Jiankang ZHANG
Acta Pharmaceutica Sinica B 2025;15(1):661-664
10.Microbial metabolite 3-indolepropionic acid alleviated PD pathologies by decreasing enteric glia cell gliosis via suppressing IL-13Rα1 related signaling pathways.
Meiyu SHANG ; Jingwen NING ; Caixia ZANG ; Jingwei MA ; Yang YANG ; Zhirong WAN ; Jing ZHAO ; Yueqi JIANG ; Qiuzhu CHEN ; Yirong DONG ; Jinrong WANG ; Fangfang LI ; Xiuqi BAO ; Dan ZHANG
Acta Pharmaceutica Sinica B 2025;15(4):2024-2038
Although enteric glial cell (EGC) abnormal activation is reported to be involved in the pathogenesis of Parkinson's disease (PD), and inhibition of EGC gliosis alleviated gut and dopaminergic neuronal dysfunction was verified in our previous study, the potential role of gut microbiota on EGC function in PD still need to be addressed. In the present study, fecal microbiota transplantation revealed that EGC function was regulated by gut microbiota. By employing 16S rRNA and metabolomic analysis, we identified that 3-indolepropionic acid (IPA) was the most affected differential microbial metabolite that regulated EGC gliosis. The protective effects of IPA on PD were validated in rotenone-stimulated EGCs and rotenone (30 mg/kg i.g. for 4 weeks)-induced PD mice, as indicated by decreased inflammation, improved intestinal and brain barrier as well as dopaminergic neuronal function. Mechanistic study showed that IPA targeted pregnane X receptor (PXR) in EGCs, and inhibition of IL-13Rα1 involved cytokine-cytokine receptor interaction pathway, leading to inactivation of downstream JAK1-STAT6 pathway. Our data not only provided evidence that EGC gliosis was critical in spreading intestinal damage to brain, but also highlighted the potential role of microbial metabolite IPA in alleviating PD pathological damages through gut-brain axis.

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