1.Forty years of construction and innovative development of scientific regulation system of traditional Chinese medicine in China.
Jun-Ning ZHAO ; Zhi-Shu TANG ; Hua HUA ; Rong SHAO ; Jiang-Yong YU ; Chang-Ming YANG ; Shuang-Fei CAI ; Quan-Mei SUN ; Dong-Ying LI
China Journal of Chinese Materia Medica 2025;50(13):3489-3505
Since the promulgation of the first Drug Administration Law of the People's Republic of China 40 years ago in 1984, China has undergone four main stages in the traditional Chinese medicine(TCM) regulation: the initial establishment of TCM regulation rules(1984-1997), the formation of a modern TCM regulatory system(1998-2014), the reform of the review and approval system for new TCM drugs(2015-2018), and the construction of a scientific regulation system for TCM(2019-2024). Over the past five years, a series of milestone achievements of TCM regulation in China have been achieved in the six aspects, including its strategic objectives and the establishment of a science-based regulatory system, the reform of the review and approval system for new TCM drugs, the optimization and improvement of the TCM standard system and its formation mechanism, comprehensive enhancement of regulatory capabilities for TCM safety, international harmonization of TCM regulation and its role in promoting innovation. Looking ahead, centered on advancing TCMRS to establish a sound regulatory framework tailored to the unique characteristics of TCM, TCM regulation will evolve into new reform patterns, advancing and extending across eight critical fronts, including the legal framework and policy architecture, the review and approval system for new TCM drugs, the quality standard and management system of TCM, the comprehensive quality & safety regulation and traceability system, the research and transformation system for TCMRS, AI-driven innovations in TCM regulation, the coordination between high-quality industrial development and high-level regulation, and the leadership in international cooperation and regulatory harmonization. In this way, a unique path for the development of modern TCM regulation with Chinese characteristics will be pioneered.
Humans
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China
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Drugs, Chinese Herbal/standards*
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History, 20th Century
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History, 21st Century
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Medicine, Chinese Traditional/trends*
2.Explanation and interpretation of blood transfusion provisions for children with hematological diseases in the national health standard "Guideline for pediatric transfusion".
Ming-Yi ZHAO ; Rong HUANG ; Rong GUI ; Qing-Nan HE ; Ming-Yan HEI ; Xiao-Fan ZHU ; Jun LU ; Xiao-Jun XU ; Tian-Ming YUAN ; Rong ZHANG ; Xu WANG ; Jin-Ping LIU ; Jing WANG ; Zhi-Li SHAO ; Yong-Jian GUO ; Xin-Yin WU ; Jia-Rui CHEN ; Qi-Rong CHEN ; Jia GUO ; Ming-Hua YANG
Chinese Journal of Contemporary Pediatrics 2025;27(1):18-25
To guide clinical blood transfusion practices for pediatric patients, the National Health Commission has issued the health standard "Guideline for pediatric transfusion" (WS/T 795-2022). Blood transfusion is one of the most commonly used supportive treatments for children with hematological diseases. This guideline provides guidance and recommendations for blood transfusions in children with aplastic anemia, thalassemia, autoimmune hemolytic anemia, glucose-6-phosphate dehydrogenase deficiency, acute leukemia, myelodysplastic syndromes, immune thrombocytopenic purpura, and thrombotic thrombocytopenic purpura. This article presents the evidence and interpretation of the blood transfusion provisions for children with hematological diseases in the "Guideline for pediatric transfusion", aiming to assist in the understanding and implementing the blood transfusion section of this guideline.
Humans
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Child
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Hematologic Diseases/therapy*
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Blood Transfusion/standards*
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Practice Guidelines as Topic
3.Explanation and interpretation of the compilation of blood transfusion provisions for children undergoing hematopoietic stem cell transplantation in the national health standard "Guideline for pediatric transfusion".
Rong HUANG ; Qing-Nan HE ; Ming-Yan HEI ; Xiao-Fan ZHU ; Jun LU ; Xiao-Jun XU ; Tian-Ming YUAN ; Rong ZHANG ; Xu WANG ; Jin-Ping LIU ; Jing WANG ; Zhi-Li SHAO ; Ming-Yi ZHAO ; Yong-Jian GUO ; Xin-Yin WU ; Jia-Rui CHEN ; Qi-Rong CHEN ; Jia GUO ; Rong GUI ; Ming-Hua YANG
Chinese Journal of Contemporary Pediatrics 2025;27(2):139-143
To guide clinical blood transfusion practices for pediatric patients, the National Health Commission has issued the health standard "Guideline for pediatric transfusion" (WS/T 795-2022). Blood transfusion for children undergoing hematopoietic stem cell transplantation is highly complex and challenging. This guideline provides recommendations on transfusion thresholds and the selection of blood components for these children. This article presents the evidence and interpretation of the transfusion provisions for children undergoing hematopoietic stem cell transplantation, with the aim of enhancing the understanding and implementation of the "Guideline for pediatric transfusion".
Humans
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Hematopoietic Stem Cell Transplantation
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Child
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Blood Transfusion/standards*
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Practice Guidelines as Topic
4.Explanation and interpretation of blood transfusion provisions for critically ill and severely bleeding pediatric patients in the national health standard "Guideline for pediatric transfusion".
Rong HUANG ; Qing-Nan HE ; Ming-Yan HEI ; Ming-Hua YANG ; Xiao-Fan ZHU ; Jun LU ; Xiao-Jun XU ; Tian-Ming YUAN ; Rong ZHANG ; Xu WANG ; Jin-Ping LIU ; Jing WANG ; Zhi-Li SHAO ; Ming-Yi ZHAO ; Yong-Jian GUO ; Xin-Yin WU ; Jia-Rui CHEN ; Qi-Rong CHEN ; Jia GUO ; Rong GUI
Chinese Journal of Contemporary Pediatrics 2025;27(4):395-403
To guide clinical blood transfusion practices for pediatric patients, the National Health Commission has issued the health standard "Guideline for pediatric transfusion" (WS/T 795-2022). Critically ill children often present with anemia and have a higher demand for transfusions compared to other pediatric patients. This guideline provides guidance and recommendations for blood transfusions in cases of general critical illness, septic shock, acute brain injury, extracorporeal membrane oxygenation, non-life-threatening bleeding, and hemorrhagic shock. This article interprets the background and evidence of the blood transfusion provisions for critically ill and severely bleeding children in the "Guideline for pediatric transfusion", aiming to enhance understanding and implementation of this aspect of the guidelines. Citation:Chinese Journal of Contemporary Pediatrics, 2025, 27(4): 395-403.
Humans
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Critical Illness
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Blood Transfusion/standards*
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Child
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Hemorrhage/therapy*
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Practice Guidelines as Topic
5.Explanation and interpretation of blood transfusion provisions for children undergoing cardiac surgery in the national health standard "Guideline for pediatric transfusion".
Rong HUANG ; Qing-Nan HE ; Ming-Yan HEI ; Ming-Hua YANG ; Xiao-Fan ZHU ; Jun LU ; Xiao-Jun XU ; Tian-Ming YUAN ; Rong ZHANG ; Xu WANG ; Jing WANG ; Zhi-Li SHAO ; Ming-Yi ZHAO ; Yong-Jian GUO ; Xin-Yin WU ; Jia-Rui CHEN ; Qi-Rong CHEN ; Jia GUO ; Rong GUI ; Jin-Ping LIU
Chinese Journal of Contemporary Pediatrics 2025;27(7):778-785
To guide clinical blood transfusion practices in pediatric patients, the National Health Commission has issued the health standard "Guideline for pediatric transfusion" (WS/T 795-2022). Children undergoing cardiac surgery are at high risk of bleeding, and the causes of perioperative anemia and coagulation disorders in neonates and children are complex and varied, often necessitating the transfusion of allogeneic blood components. This guideline provides direction and recommendations for specific measures in blood management for children undergoing cardiac surgery before, during, and after surgery. This article interprets the background and evidence for the formulation of the blood transfusion provisions for children undergoing cardiac surgery, hoping to facilitate the understanding and implementation of this guideline.
Humans
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Cardiac Surgical Procedures
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Blood Transfusion/standards*
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Child
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Practice Guidelines as Topic
6.Effects of Jisuishang Formula on neurological function and ferroptosis in a rat model of cervical spondylotic myelopathy
Han-li YANG ; Ming SHI ; Chun-zhi LIU ; Shao-hu LIN ; Ming-gao HU ; Xian-zhong BU ; Yuan-ming ZHONG ; Wei XU
Chinese Traditional Patent Medicine 2025;47(10):3233-3241
AIM To investigate the effects of Jisuishang Formula on neurological function and ferroptosis in a rat model of cervical spondylotic myelopathy(CSM).METHODS The CSM rat models were established and randomly assigned to the model group,the Fer-1 group(2 g/kg Ferrostatin-1 via intraperitoneal injection),the low-dose(9.7 g/kg,intragastrically),medium-dose(19.4 g/kg,intragastrically)and high-dose(38.8 g/kg,intragastrically)Jisuishang Formula groups,and the sham operation group,with 6 rats in each group.Following 4 weeks of treatment administration,BBB locomotor scores and oblique plate test result were recorded to assess their neurological function in rats.Histopathological evaluation utilized HE staining for spinal cord tissue pathology,Nissl staining for Nissl body visualization,and Prussian blue staining for iron ion deposition analysis.Protein expressions of Nrf2,SLC7A11,GPX4,HO-1,TFRC and Cox2 in spinal cord tissues was detected by immunofluorescence and Western blot,while mRNA expressions were quantified using RT-qPCR.RESULTS Compared to the sham group,the CSM model group exhibited significantly reduced BBB locomotor scores and inclined plane test performance at 1,2 and 4 weeks post-operation(P<0.05);obvious tissue cavitation,cellular edema and Prussian blue positive iron deposition in spinal cord tissues;downregulated protein and mRNA expressions of Nrf2,SLC7A11,GPX4,HO-1(P<0.05);and upregulated protein and mRNA expressions of TFRC and Cox2(P<0.05).Compared to the model group,the Jisuishang Formula and Fer-1 intervention groups showed significantly improved BBB scores and inclined plane test result at 1,2 and 4 weeks post-operation(P<0.05);reduced tissue cavitation,attenuated cellular edema and decreased Prussian blue positive iron deposition in spinal cord tissues;upregulated protein and mRNA expression of Nrf2,SLC7A11,GPX4 and HO-1 in spinal cord tissues(P<0.05);and downregulated protein and mRNA expressions of TFRC and Cox2(P<0.05).CONCLUSION Targeting the Nrf2/SLC7A11/GPX4 signaling pathway,Jisuishang Formula potentially suppresses ferroptosis and alleviates iron accumulation in spinal cord neurons,thereby improving neurological recovery in CSM rats.
7.Postdischarge cancer and mortality in patients with coronary artery disease: a retrospective cohort study.
Yi-Hao WANG ; Shao-Ning ZHU ; Ya-Wei ZHAO ; Kai-Xin YAN ; Ming-Zhuang SUN ; Zhi-Jun SUN ; Yun-Dai CHEN ; Shun-Ying HU
Journal of Geriatric Cardiology 2025;22(6):578-586
BACKGROUND:
Our understanding of the correlation between postdischarge cancer and mortality in patients with coronary artery disease (CAD) remains incomplete. The aim of this study was to investigate the relationships between postdischarge cancers and all-cause mortality and cardiovascular mortality in CAD patients.
METHODS:
In this retrospective cohort study, 25% of CAD patients without prior cancer history who underwent coronary artery angiography between January 1, 2011 and December 31, 2015, were randomly enrolled using SPSS 26.0. Patients were monitored for the incidence of postdischarge cancer, which was defined as cancer diagnosed after the index hospitalization, survival status and cause of death. Cox regression analysis was used to explore the association between postdischarge cancer and all-cause mortality and cardiovascular mortality in CAD patients.
RESULTS:
A total of 4085 patients were included in the final analysis. During a median follow-up period of 8 years, 174 patients (4.3%) developed postdischarge cancer, and 343 patients (8.4%) died. A total of 173 patients died from cardiovascular diseases. Postdischarge cancer was associated with increased all-cause mortality risk (HR = 2.653, 95% CI: 1.727-4.076, P < 0.001) and cardiovascular mortality risk (HR = 2.756, 95% CI: 1.470-5.167, P = 0.002). Postdischarge lung cancer (HR = 5.497, 95% CI: 2.922-10.343, P < 0.001) and gastrointestinal cancer (HR = 1.984, 95% CI: 1.049-3.750, P = 0.035) were associated with all-cause mortality in CAD patients. Postdischarge lung cancer was significantly associated with cardiovascular death in CAD patients (HR = 4.979, 95% CI: 2.114-11.728, P < 0.001), and cardiovascular death was not significantly correlated with gastrointestinal cancer or other types of cancer.
CONCLUSIONS
Postdischarge cancer was associated with all-cause mortality and cardiovascular mortality in CAD patients. Compared with other cancers, postdischarge lung cancer had a more significant effect on all-cause mortality and cardiovascular mortality in CAD patients.
8.Effects of Jisuishang Formula on neurological function and ferroptosis in a rat model of cervical spondylotic myelopathy
Han-li YANG ; Ming SHI ; Chun-zhi LIU ; Shao-hu LIN ; Ming-gao HU ; Xian-zhong BU ; Yuan-ming ZHONG ; Wei XU
Chinese Traditional Patent Medicine 2025;47(10):3233-3241
AIM To investigate the effects of Jisuishang Formula on neurological function and ferroptosis in a rat model of cervical spondylotic myelopathy(CSM).METHODS The CSM rat models were established and randomly assigned to the model group,the Fer-1 group(2 g/kg Ferrostatin-1 via intraperitoneal injection),the low-dose(9.7 g/kg,intragastrically),medium-dose(19.4 g/kg,intragastrically)and high-dose(38.8 g/kg,intragastrically)Jisuishang Formula groups,and the sham operation group,with 6 rats in each group.Following 4 weeks of treatment administration,BBB locomotor scores and oblique plate test result were recorded to assess their neurological function in rats.Histopathological evaluation utilized HE staining for spinal cord tissue pathology,Nissl staining for Nissl body visualization,and Prussian blue staining for iron ion deposition analysis.Protein expressions of Nrf2,SLC7A11,GPX4,HO-1,TFRC and Cox2 in spinal cord tissues was detected by immunofluorescence and Western blot,while mRNA expressions were quantified using RT-qPCR.RESULTS Compared to the sham group,the CSM model group exhibited significantly reduced BBB locomotor scores and inclined plane test performance at 1,2 and 4 weeks post-operation(P<0.05);obvious tissue cavitation,cellular edema and Prussian blue positive iron deposition in spinal cord tissues;downregulated protein and mRNA expressions of Nrf2,SLC7A11,GPX4,HO-1(P<0.05);and upregulated protein and mRNA expressions of TFRC and Cox2(P<0.05).Compared to the model group,the Jisuishang Formula and Fer-1 intervention groups showed significantly improved BBB scores and inclined plane test result at 1,2 and 4 weeks post-operation(P<0.05);reduced tissue cavitation,attenuated cellular edema and decreased Prussian blue positive iron deposition in spinal cord tissues;upregulated protein and mRNA expression of Nrf2,SLC7A11,GPX4 and HO-1 in spinal cord tissues(P<0.05);and downregulated protein and mRNA expressions of TFRC and Cox2(P<0.05).CONCLUSION Targeting the Nrf2/SLC7A11/GPX4 signaling pathway,Jisuishang Formula potentially suppresses ferroptosis and alleviates iron accumulation in spinal cord neurons,thereby improving neurological recovery in CSM rats.
9.Explanation and interpretation of the compilation of neonatal blood transfusion in the national health standard "Guideline for pediatric transfusion".
Rong GUI ; Rong HUANG ; Ming-Hua YANG ; Xiao-Fan ZHU ; Jun LU ; Xiao-Jun XU ; Tian-Ming YUAN ; Rong ZHANG ; Xu WANG ; Jin-Ping LIU ; Jing WANG ; Zhi-Li SHAO ; Ming-Yi ZHAO ; Yong-Jian GUO ; Jia-Rui CHEN ; Qi-Rong CHEN ; Jia GUO ; Xin-Yin WU ; Ming-Yan HEI ; Qing-Nan HE
Chinese Journal of Contemporary Pediatrics 2024;26(12):1249-1254
In order to guide clinical blood transfusion practices for pediatric patients, the National Health Commission has released the health standard "Guideline for pediatric transfusion" (WS/T 795-2022). Considering the physiological particularities of the neonatal period, blood transfusion practices for neonates are more complex than those for other children, the guidelines include a separate chapter dedicated to neonatal blood transfusion. This paper interprets the background and evidence for the compilation of the neonatal blood transfusion provisions, hoping to aid in the understanding and implementation of the neonatal blood transfusion section of the guidelines.
Humans
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Infant, Newborn
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Blood Transfusion/standards*
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Practice Guidelines as Topic
10.Clinical trial of Morinda officinalis oligosaccharides in the continuation treatment of adults with mild and moderate depression
Shu-Zhe ZHOU ; Zu-Cheng HAN ; Xiu-Zhen WANG ; Yan-Qing CHEN ; Ya-Ling HU ; Xue-Qin YU ; Bin-Hong WANG ; Guo-Zhen FAN ; Hong SANG ; Ying HAI ; Zhi-Jie JIA ; Zhan-Min WANG ; Yan WEI ; Jian-Guo ZHU ; Xue-Qin SONG ; Zhi-Dong LIU ; Li KUANG ; Hong-Ming WANG ; Feng TIAN ; Yu-Xin LI ; Ling ZHANG ; Hai LIN ; Bin WU ; Chao-Ying WANG ; Chang LIU ; Jia-Fan SUN ; Shao-Xiao YAN ; Jun LIU ; Shou-Fu XIE ; Mao-Sheng FANG ; Wei-Feng MI ; Hong-Yan ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(6):815-819
Objective To observe the efficacy and safety of Morinda officinalis oligosaccharides in the continuation treatment of mild and moderate depression.Methods An open,single-arm,multi-center design was adopted in our study.Adult patients with mild and moderate depression who had received acute treatment of Morinda officinalis oligosaccharides were enrolled and continue to receive Morinda officinalis oligosaccharides capsules for 24 weeks,the dose remained unchanged during continuation treatment.The remission rate,recurrence rate,recurrence time,and the change from baseline to endpoint of Hamilton Depression Scale(HAMD),Hamilton Anxiety Scale(HAMA),Clinical Global Impression-Severity(CGI-S)and Arizona Sexual Experience Scale(ASEX)were evaluated.The incidence of treatment-related adverse events was reported.Results The scores of HAMD-17 at baseline and after treatment were 6.60±1.87 and 5.85±4.18,scores of HAMA were 6.36±3.02 and 4.93±3.09,scores of CGI-S were 1.49±0.56 and 1.29±0.81,scores of ASEX were 15.92±4.72 and 15.57±5.26,with significant difference(P<0.05).After continuation treatment,the remission rate was 54.59%(202 cases/370 cases),and the recurrence rate was 6.49%(24 cases/370 cases),the recurrence time was(64.67±42.47)days.The incidence of treatment-related adverse events was 15.35%(64 cases/417 cases).Conclusion Morinda officinalis oligosaccharides capsules can be effectively used for the continuation treatment of mild and moderate depression,and are well tolerated and safe.

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