1.Expert consensus on evaluation index system construction for new traditional Chinese medicine(TCM) from TCM clinical practice in medical institutions.
Li LIU ; Lei ZHANG ; Wei-An YUAN ; Zhong-Qi YANG ; Jun-Hua ZHANG ; Bao-He WANG ; Si-Yuan HU ; Zu-Guang YE ; Ling HAN ; Yue-Hua ZHOU ; Zi-Feng YANG ; Rui GAO ; Ming YANG ; Ting WANG ; Jie-Lai XIA ; Shi-Shan YU ; Xiao-Hui FAN ; Hua HUA ; Jia HE ; Yin LU ; Zhong WANG ; Jin-Hui DOU ; Geng LI ; Yu DONG ; Hao YU ; Li-Ping QU ; Jian-Yuan TANG
China Journal of Chinese Materia Medica 2025;50(12):3474-3482
Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards*
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Humans
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Consensus
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Drugs, Chinese Herbal/therapeutic use*
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Surveys and Questionnaires
2.Modified Sini Powder in treating mild to moderate generalized anxiety disorder in patients with syndrome of liver depression transforming into fire: a single-center, randomized, double-blind, dose-controlled trial.
Jia-Xin XU ; Hong-Jun YANG ; Hong-Wei WU ; Li-Jun MAO ; Jian-Xin WANG ; Zong-Liang YU ; Yang ZHAO ; Xiao-Nan HAO ; Rui GAO
China Journal of Chinese Materia Medica 2025;50(14):4063-4070
A single-center, randomized, double-blind, dose-controlled trial of modified Sini Powder in treating mild to moderate generalized anxiety disorder(GAD) in the patients with syndrome of liver depression transforming into fire was conducted at Xiyuan Hospital, China Academy of Chinese Medical Sciences. A total of 80 patients with mild to moderate GAD and the syndrome of liver depression transforming into fire were included. Patients were assigned by the central randomization system at a ratio of 3∶1 into an observation group(n=60, receiving a conventional-dose of granules of modified Sini Powder) and a control group(n=20, receiving low-dose granules with the active ingredients being 50% of that in observation group). Assessments were conducted before treatment(baseline), after 2 weeks of introduction, after 2/4/8 weeks of treatment, and after 4 weeks of follow-up. The results were summarized as follows. In terms of primary outcome indicators, the observation group(62.2%) showed higher total response rate than the control group(26.6%)(P<0.05), and greater Hamilton anxiety scale(HAMA) score reduction after 8 weeks of treatment(P<0.05). In terms of secondary outcome indicators, the HAMA score(somatic anxiety score), traditional Chinese medicine(TCM) syndrome scores, Pittsburgh sleep quality index(PSQI) scale, and clinical global impression(CGI) scale score in the observation group showed a significant compared to the control group at each visit points(P<0.05). Adverse events occurred in 10 cases, including 9(16.9%) cases in the observation group and 1(6.6%) case in the control group. No adverse reaction was observed. In conclusion, conventional-dose modified Sini Powder demonstrated superior efficacy and favorable safety for mild and moderate GAD in the patients with the syndrome of liver depression transforming into fire over low-dose treatment.
Humans
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Male
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Female
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Adult
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Middle Aged
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Double-Blind Method
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Drugs, Chinese Herbal/administration & dosage*
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Anxiety Disorders/drug therapy*
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Treatment Outcome
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Young Adult
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Powders
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Aged
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Liver/drug effects*
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Generalized Anxiety Disorder
3.Research progress in mechanisms of kidney-tonifying traditional Chinese medicine in promoting healing of osteoporotic fractures.
Jun WU ; Ou-Ye LI ; Ken QIN ; Xuan WAN ; Wang-Bing XU ; Yong LI ; Jia-Wei ZHONG ; Yong-Xiang YE ; Rui XU
China Journal of Chinese Materia Medica 2025;50(15):4166-4177
Osteoporotic fractures(OPF) refer to the fractures caused by minor violence in the state of osteoporosis, seriously threatening the life and health of elderly patients. Drug and surgical therapies have limitations such as single targets, diverse adverse reactions, and poor prognosis. Kidney-tonifying traditional Chinese medicine(TCM) has good potential in the treatment of OPF. TCM can promote the healing of OPF by promoting angiogenesis in the early stage of bone healing, promoting osteogenic differentiation of bone marrow mesenchymal stem cells in the stage of bone repair, maintaining the balance of osteogenic and osteoclastic system in the stage of bone remodeling, and regulating the oxidative stress responses throughout the process of OPF healing. TCM can alleviate the pathological state of osteoporosis and promote fracture healing in OPF patients via multiple pathways and targets, demonstrating the advantages and potential of biphasic regulation.
Humans
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Drugs, Chinese Herbal/therapeutic use*
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Osteoporotic Fractures/metabolism*
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Animals
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Fracture Healing/drug effects*
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Medicine, Chinese Traditional
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Kidney/metabolism*
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Osteogenesis/drug effects*
4.Preparation of baicalin-berberine complex nanocrystal enteric microspheres and pharmacodynamic evaluation of ulcerative colitis treatment in rats.
Xiao-Chao HUANG ; Yi-Wen HU ; Peng-Yu SHEN ; Rui-Hong JIAN ; Dong-Li QI ; Zhi-Dong LIU ; Jia-Xin PI
China Journal of Chinese Materia Medica 2025;50(15):4263-4274
To enhance the therapeutic efficacy of the baicalin-berberine complex(BA-BBR) in the treatment of ulcerative colitis(UC), BA-BBR nanocrystal microspheres(BA-BBR NC MS) were prepared using the dropping method. The microspheres were characterized in terms of morphology, particle size, differential scanning calorimetry(DSC), and powder X-ray diffraction(XRD). The release profiles of BA and BBR from the microspheres were measured, and the drug release mechanism was investigated. A rat model of UC was induced by 5% dextran sodium sulfate(DSS) and treated continuously for 7 days to evaluate the therapeutic effects of different formulations. The results showed that the prepared BA-BBR MS and BA-BBR NC MS were uniform gel spheres with particle sizes of(1.77±0.16) mm and(1.67±0.08) mm, respectively. After drying, the gels collapsed inward and exhibited a rough surface. During the preparation process, the BA-BBR nanocrystals(BA-BBR NC) were uniformly encapsulated within the microspheres. The release profiles of the microspheres followed a first-order kinetic model, and the 12-hour cumulative release of BA and BBR from BA-BBR NC MS was higher than that from BA-BBR MS. Compared with BA-BBR, BA-BBR NC, and BA-BBR MS, BA-BBR NC MS further alleviated UC symptoms in rats, most significantly reducing the levels of TNF-α, IL-1β, IL-6, and MPO, while increasing the level of IL-4 in colon tissues. These results indicate that BA-BBR NC MS, based on a "nano-in-micro" design, can deliver BA-BBR to the intestine and exert significant therapeutic effects in a UC rat model, suggesting it as a promising new strategy for the treatment of UC.
Animals
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Colitis, Ulcerative/metabolism*
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Rats
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Nanoparticles/chemistry*
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Microspheres
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Male
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Berberine/administration & dosage*
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Flavonoids/administration & dosage*
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Rats, Sprague-Dawley
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Drugs, Chinese Herbal/administration & dosage*
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Humans
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Particle Size
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Tumor Necrosis Factor-alpha/immunology*
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Drug Liberation
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Drug Compounding
5.Clinical Characteristics and Risk Factors of Coronary Artery Disease in Patients with Hypertension and Persistent Atrial Fibrillation.
Jia-Qi BAI ; Yi-Ning LIU ; Rui-Zhe LI ; Zong-Bin LI
Chinese Medical Sciences Journal 2025;40(3):171-179
BACKGROUND AND OBJECTIVE: Hypertension (HT) and atrial fibrillation (AF) are highly prevalent cardiovascular conditions that frequently coexist. Coronary artery disease (CAD) is a major global cause of mortality. The co-occurrence of HT, AF, and CAD presents significant management challenges. This study aims to explore the clinical characteristics and risk factors associated with CAD in patients with HT and persistent AF (HT-AF). METHODS: In this retrospective cross-sectional study, data were collected from 384 hospitalized HT-AF patients at the People's Liberation Army General Hospital between January 2010 and December 2019. CAD diagnosis was confirmed by coronary angiography or computed tomography angiography. Clinical characteristics and comorbidities were compared between patients with and without CAD. Multivariate logistic regression analyses were performed to identify independent risk factors associated with CAD development. RESULTS: The prevalence of CAD among HT-AF patients was 66.41% (255/384). Cardiovascular complications, particularly heart failure (44.7% vs 25.6%, P < 0.05), were significantly more prevalent in the CAD group than in the non-CAD group. Only age was identified as an independent risk factor for CAD (adjusted OR: 1.047; 95% CI: 1.022-1.073; P = 0.000). Of all HT-AF patients, 54.7% had a CHA2DS2-VASc score of ≥4, indicating high stroke risk. There was a slightly higher anticoagulant usage rate in the CAD group than those without CAD (8.6% vs 4.7%, P = 0.157), and the overall anticoagulant usage remained low. CONCLUSION: There is a high prevalence of CAD among hospitalized HT-AF patients, among whom age is the sole independent risk factor for CAD. Despite a high stroke risk, the utilization of oral anticoagulants is alarmingly low.
Humans
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Atrial Fibrillation/epidemiology*
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Coronary Artery Disease/etiology*
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Hypertension/epidemiology*
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Male
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Female
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Risk Factors
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Middle Aged
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Retrospective Studies
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Cross-Sectional Studies
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Aged
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Prevalence
6.Application of OpenSim musculoskeletal model in biomechanics research of orthopedics and traumatology.
Rui LI ; Yang LIU ; Zhao-Jie ZHANG ; Xin-Wei ZHANG ; Yan-Zhen ZHANG ; Yan-Qi HU ; Can YANG ; Shu-Shi MAO ; Jia-Ming QIU
China Journal of Orthopaedics and Traumatology 2025;38(3):319-324
OpenSim is an open source, free motion simulation and gait analysis software, which can be used to dynamically simulate and analyze the complex motion of the human body, and is widely used in human biomechanical research. Since OpenSim can analyze multi-dimensional motion data such as muscle strength, joint torque, and muscle synergistic activation during human movement, it can be used to study the biomechanical mechanism of musculoskeletal imbalance diseases and various treatment methods in TCM orthopedics, and has a broad application prospect in the field of TCM orthopedics. By the analysis of the basic characteristics, elements, analysis process, and application prospects of OpenSim, it is concluded that OpenSim musculoskeletal model has a large application space in the field of traditional Chinese medicine orthopedic, which is helpful to explain the pathogenesis and mechanism of diseases, and promote the precision diagnosis and treatment of orthopedics diseases;the application of OpenSim musculoskeletal model can solve the problem that the previous research paid attention to the bone malalignment and not enough attention to the tendon, and provide a new method for the research of orthopedic diseases. At present, there are still problems in the promotion and application of OpenSim, such as large equipment requirements and high operation threshold. Therefore, multidisciplinary cooperation, clinical research, and data sharing are the basic research strategies in this field.
Humans
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Biomechanical Phenomena
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Orthopedics
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Traumatology
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Software
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Medicine, Chinese Traditional
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Musculoskeletal System
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Models, Biological
7.Mechanism exploration and basic research on the repair of diabetic foot ulcer.
Hong-Rui WANG ; Kang WU ; Jia-Dong ZHANG ; Yong HU ; Xian LI
China Journal of Orthopaedics and Traumatology 2025;38(9):964-968
Diabetic foot ulcer (DFU) is one of the common chronic complications in diabetic patients. Its course is complex and the therapeutic effect is limited, which seriously affects the quality of life of patients. In recent years, significant progress has been made in the research on the mechanism of DFU wound repair. Studies have found that dysregulation of the inflammatory microenvironment, vascular dysfunction, obstruction of re-epithelialization, insufficient collagen deposition, and formation of wound biofilms are the core factors affecting healing. Intervention strategies targeting these mechanisms have become research hotspots. For instance, hydrogel scaffolds could provide an appropriate healing microenvironment, immune regulation strategies could promote inflammation resolution and tissue remodeling, and stem cell exosomes and growth factors have shown good potential in cell migration, angiogenesis, and matrix remodeling. Various natural compounds, such as components from Chinese herbal medicines, are also applied in diabetic foot ulcers. And it demonstrates excellent anti-inflammatory and restorative capabilities. However, existing research still faces obstacles in clinical translation, such as the immaturity of individualized treatment strategies and the difficulty of animal models in simulating complex clinical situations. By systematically summarizing the latest research progress on the repair mechanism of DFU, it is expected to provide theoretical support for precise treatment.
Humans
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Diabetic Foot/drug therapy*
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Wound Healing
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Animals
8.Observation on the therapeutic effect of a modified Devine procedure with subcutaneous sliding fixation method for concealed penis.
Mohammed Abdulkarem AL-QAISI ; Hai-Fu TIAN ; Jia-Jin FENG ; Ke-Ming CHEN ; Jin ZHANG ; Yun-Shang TUO ; Xue-Hao WANG ; Bin-Cheng HUANG ; Muhammad Arslan Ul HASSAN ; Rui HE ; Guang-Yong LI
Asian Journal of Andrology 2025;27(4):470-474
To evaluate the therapeutic effect of a modified Devine procedure with a subcutaneous sliding fixation method for the treatment of congenital concealed penis, we retrospectively selected 45 patients with congenital concealed penises who were admitted to General Hospital of Ningxia Medical University (Yinchuan, China) between September 2020 and November 2023. In all cases, the penis was observed to be short, and retracting the skin at the base revealed a normal penile body, which immediately returned to its original position upon release. All patients underwent the modified Devine procedure with subcutaneous sliding fixation and completed a 12-week postoperative follow-up. A statistically significant increase in penile length was observed postoperatively, with the median length increasing from 4.0 (interquartile range [IQR]: 3.5-4.8; 95% confidence interval [CI]: 3.9-4.4) cm to 8.0 (IQR: 7.8-8.0; 95% CI: 7.7-7.9) cm, with P < 0.001. The parents were satisfied with the outcomes, including increased penile length, improved hygiene, and enhanced esthetics. Except for mild foreskin edema in all cases, no complications (such as infections, skin necrosis, or penile retraction) were observed. The edema was resolved within 4 weeks after the operation. This study demonstrates that the modified Devine procedure utilizing the subcutaneous sliding fixation method yields excellent outcomes with minimal postoperative complications, reduced penile retraction, and high satisfaction rates among patients and their families.
Humans
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Male
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Penis/abnormalities*
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Retrospective Studies
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Urologic Surgical Procedures, Male/methods*
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Treatment Outcome
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Child
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Plastic Surgery Procedures/methods*
9.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
10.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

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