1.A Randomized Controlled,Double-Blind Study on Huaban Jiedu Formulation (化斑解毒方) in the Treatment of Psoriasis Vulgaris with Blood-Heat Syndrome
Xuewen REN ; Yutong DENG ; Huishang FENG ; Bo HU ; Jianqing WANG ; Zhan CHEN ; Xiaodong LIU ; Xinhui YU ; Yuanwen LI
Journal of Traditional Chinese Medicine 2025;66(16):1679-1686
ObjectiveTo evaluate the clinical efficacy and safety of Huaban Jiedu Formulation (化斑解毒方, HJF) in treating psoriasis vulgaris with blood-heat syndrome. MethodsA randomized, double-blind, placebo-controlled study was conducted with 60 patients diagnosed with psoriasis vulgaris of blood-heat syndrome. Patients were randomly assigned to either a treatment group or a control group, with 30 cases in each. The treatment group received HJF granules orally, one dose a day, combined with topical Qingshi Zhiyang Ointment (青石止痒软膏), while the control group received placebo granules, one dose a day, combined with the same topical ointment. Both groups were topically treated twice daily of 28 days treatment cours. Psoriasis area and severity index (PASI), visual analogue scale for pruritus (VAS), traditional Chinese medicine (TCM) syndrome scores, dermatology life quality index (DLQI), and psoriasis life stress inventory (PLSI) were assessed before treatment and on day 14 and day 28. Response rates for PASI 50 (≥50% reduction) and PASI 75 (≥75% reduction), as well as overall clinical efficacy, were compared between groups. Serum levels of interleukin-6 (IL-6) and interleukin-17 (IL-17) were measured before and after 28 days of treatment. Adverse reactions during treatment were recorded. ResultsAfter 28 days of treatment, both groups showed significant reductions in PASI total score, lesion area score, erythema, scaling, and infiltration scores, pruritus VAS score, TCM syndrome score, DLQI, PLSI, and serum IL-6 and IL-17 levels (P<0.05). Compared to the control group, the treatment group had significantly greater improvements in PASI total score and erythema score, TCM syndrome score, serum IL-6 and IL-17 levels, and PASI 50 response rate after 28 days (P<0.05). Between-group comparisons of score differences before and after 28-day treatment revealed that the treatment group showed significantly better improvements in PASI total, lesion area score, erythema score, TCM syndrome score, DLQI, PLSI, and inflammatory markers (P<0.05 or P<0.01). The total effective rate on day 14 and day 28 was 40.00% (12/30) and 83.33% (25/30) in the treatment group, versus 6.90% (2/29) and 41.38% (12/29) in the control group, respectively. The clinical efficacy in the treatment group was significantly superior to that in the control group (P<0.05). Mild gastric discomfort occurred in 3 patients in the treatment group and 1 in the control group. ConclusionHJF can effectively improve skin lesions and TCM symptoms relieve pruritus, enhance quality of life, and reduce inflammatory markers IL-6 and IL-17, in patients with blood-heat syndrome of psoriasis vulgaris, with a good safety profile.
2.Expert consensus on the positioning of the "Three-in-One" Registration and Evaluation Evidence System and the value of orientation of the "personal experience"
Qi WANG ; Yongyan WANG ; Wei XIAO ; Jinzhou TIAN ; Shilin CHEN ; Liguo ZHU ; Guangrong SUN ; Daning ZHANG ; Daihan ZHOU ; Guoqiang MEI ; Baofan SHEN ; Qingguo WANG ; Xixing WANG ; Zheng NAN ; Mingxiang HAN ; Yue GAO ; Xiaohe XIAO ; Xiaobo SUN ; Kaiwen HU ; Liqun JIA ; Li FENG ; Chengyu WU ; Xia DING
Journal of Beijing University of Traditional Chinese Medicine 2025;48(4):445-450
Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.
3.Survey on pharmacovigilance functions and operational models in 66 tertiary medical institutions in China
Xuelin SUN ; Dongfang QIAN ; Wenjing ZHAO ; Chunting WANG ; Xin HU ; Yatong ZHANG
China Pharmacy 2025;36(21):2711-2717
OBJECTIVE To provide practical basis and policy recommendations for improving the pharmacovigilance (PV) system construction in medical institutions across China. METHODS A questionnaire survey was conducted using a mixed sampling strategy of “online random sampling+offline supplementary sampling” to distribute questionnaires among pharmaceutical professionals in tertiary medical institutions nationwide. The questionnaire covered aspects such as the construction of PV systems, job position settings, information system support, operational practices, and multi-stakeholder collaboration. The data were analyzed using descriptive methods and SPSS 20.0 statistical software. RESULTS A total of 70 valid questionnaires were collected from 66 medical institutions, primarily Class A tertiary hospitals. The survey found that 90.00% had designated PV personnel and 74.29% routinely conducted PV activities. However, there were notable disparities in resource allocation and information system capacity, with less than 50% of the institutions conducting post-marketing drug re-evaluation. PV activities were primarily focused on the collection and reporting of adverse drug reactions, with limited capabilities in signal detection and risk assessment. CONCLUSIONS Among the surveyed tertiary hospitals, PV systems have begun to take shape. However, challenges persist in terms of system establishment, resource allocation, risk assessment, and inter-organizational coordination. Policy efforts should focus on strengthening regulatory frameworks, improving information sharing mechanisms, enhancing professional training, and strengthening collaboration between hospitals and market authorization holders to ensure the effective implementation of PV in medical institutions.
4.Acupuncture combined with blade needle therapy for knee osteoarthritis:a randomized controlled trial.
Xiao LI ; Yujie CUI ; Wenjin YANG ; Yuanyuan LI ; Xiao GUO ; Di LIU ; Mengyun YU ; Hui HU ; Hua LI
Chinese Acupuncture & Moxibustion 2025;45(11):1571-1576
OBJECTIVE:
To observe the clinical efficacy and safety of acupuncture combined with blade needle therapy for knee osteoarthritis (KOA).
METHODS:
A total of 60 patients with KOA were randomly divided into an observation group and a control group, 30 cases each group. The control group received acupuncture at Neixiyan (EX-LE4),Dubi (ST35), Yinlingquan (SP9), Liangqiu (ST34), Xuehai (SP10), Yanglingquan (GB34) and Zusanli (ST36) on the affected side, once every other day, 3 times a week. The observation group received blade needle therapy on the basis of the treatment in the control group, once every 3 days, 2 times a week. Both groups were treated for 4 weeks. Before treatment, after 2, 4 weeks of treatment, and after 1 month of treatment completion (in follow-up), the scores of pain visual analogue scale (VAS), Western Ontario and McMaster Universities osteoarthritis index (WOMAC) and Lequesne index were observed in the two groups, and the clinical efficacy and safety were evaluated.
RESULTS:
After 2, 4 weeks of treatment and in follow-up, the pain VAS scores, Lequesne index scores, and pain, stiffness, function scores of WOMAC in both groups were decreased compared with those before treatment (P<0.05), and the VAS scores, Lequesne index scores and pain, function scores of WOMAC in the observation group were lower than those in the control group (P<0.05). The effective response rate in the observation group was 76.7% (23/30), while that in the control group was 70.0% (21/30), there was no statistically significant difference in the effective response rates between the two groups (P>0.05). No adverse reactions were observed in either group.
CONCLUSION
Acupuncture combined with blade needle therapy could alleviate pain and promote functional recovery in KOA patients, and achieve long-lasting improvements.
Humans
;
Osteoarthritis, Knee/physiopathology*
;
Acupuncture Therapy/instrumentation*
;
Male
;
Female
;
Middle Aged
;
Aged
;
Acupuncture Points
;
Treatment Outcome
;
Adult
;
Needles
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Combined Modality Therapy
5.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
;
Biomechanical Phenomena
;
Orthopedics
;
Traumatology
;
Software
;
Medicine, Chinese Traditional
;
Musculoskeletal System
;
Models, Biological
6.International clinical practice guideline on the use of traditional Chinese medicine for functional dyspepsia (2025).
Sheng-Sheng ZHANG ; Lu-Qing ZHAO ; Xiao-Hua HOU ; Zhao-Xiang BIAN ; Jian-Hua ZHENG ; Hai-He TIAN ; Guan-Hu YANG ; Won-Sook HONG ; Yu-Ying HE ; Li LIU ; Hong SHEN ; Yan-Ping LI ; Sheng XIE ; Jin SHU ; Bin-Fang ZENG ; Jun-Xiang LI ; Zhen LIU ; Zheng-Hua XIAO ; Jing-Dong XIAO ; Pei-Yong ZHENG ; Shao-Gang HUANG ; Sheng-Liang CHEN ; Gui-Jun FEI
Journal of Integrative Medicine 2025;23(5):502-518
Functional dyspepsia (FD), characterized by persistent or recurrent dyspeptic symptoms without identifiable organic, systemic or metabolic causes, is an increasingly recognized global health issue. The objective of this guideline is to equip clinicians and nursing professionals with evidence-based strategies for the management and treatment of adult patients with FD using traditional Chinese medicine (TCM). The Guideline Development Group consulted existing TCM consensus documents on FD and convened a panel of 35 clinicians to generate initial clinical queries. To address these queries, a systematic literature search was conducted across PubMed, EMBASE, the Cochrane Library, China National Knowledge Infrastructure (CNKI), VIP Database, China Biology Medicine (SinoMed) Database, Wanfang Database, Traditional Medicine Research Data Expanded (TMRDE), and the Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS). The evidence from the literature was critically appraised using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. The strength of the recommendations was ascertained through a consensus-building process involving TCM and allopathic medicine experts, methodologists, pharmacologists, nursing specialists, and health economists, leveraging their collective expertise and empirical knowledge. The guideline comprises a total of 43 evidence-informed recommendations that span a range of clinical aspects, including the pathogenesis according to TCM, diagnostic approaches, therapeutic interventions, efficacy assessments, and prognostic considerations. Please cite this article as: Zhang SS, Zhao LQ, Hou XH, Bian ZX, Zheng JH, Tian HH, Yang GH, Hong WS, He YY, Liu L, Shen H, Li YP, Xie S, Shu J, Zeng BF, Li JX, Liu Z, Xiao ZH, Xiao JD, Zheng PY, Huang SG, Chen SL, Fei GJ. International clinical practice guideline on the use of traditional Chinese medicine for functional dyspepsia (2025). J Integr Med. 2025; 23(5):502-518.
Dyspepsia/drug therapy*
;
Humans
;
Medicine, Chinese Traditional/methods*
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Practice Guidelines as Topic
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Drugs, Chinese Herbal/therapeutic use*
7.Progress in the application of deep learning in prognostic models for non-small cell lung cancer
Ruikang ZHONG ; Jinghua LI ; Ximing LIN ; Xueni FANG ; Kaiwen HU ; Tian ZHOU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(09):1345-1350
Non-small cell lung cancer is one of the cancers with the highest incidence and mortality rate in the world, and precise prognostic models can guide clinical treatment plans. With the continuous upgrading of computer technology, deep learning as a breakthrough technology of artificial intelligence has shown good performance and great potential in the application of non-small cell lung cancer prognosis model. The research on the application of deep learning in survival and recurrence prediction, efficacy prediction, distant metastasis prediction, and complication prediction of non-small cell lung cancer has made some progress, and it shows a trend of multi-omics and multi-modal joint, but there are still shortcomings, which should be further explored in the future to strengthen model verification and solve practical problems in clinical practice.
8.Promotion of rational medication use in elderly patients with Parkinson's disease through drug use risk management
Xuelin SUN ; Dongfang QIAN ; Wenjing ZHAO ; Xi WANG ; Yatong ZHANG ; Xin HU
Chinese Journal of Geriatrics 2024;43(11):1496-1501
Parkinson's disease(PD)is a prevalent condition among the elderly, with its incidence increasing with age and significantly affecting the quality of life in this demographic.Given the unique characteristics of older adults, such as comorbidities, polypharmacy, and reduced sensitivity to treatment regimens, it is essential to not only focus on the efficacy of medications used in PD treatment but also to carefully evaluate the associated drug risks.This article examines a drug risk management approach for treating elderly patients with PD, emphasizing the importance of gathering comprehensive drug information, identifying potential risks associated with drug selection, procurement, storage, prescription, and dispensing, and addressing specific considerations pertinent to the elderly population.Furthermore, the article proposes management strategies aimed at standardizing risk management in the treatment of elderly patients with PD, enhancing clinical pharmacy services in this area, and promoting rational drug use among this vulnerable group.
9.Unilateral laminotomy for bilateral decompression under unilateral biportal endoscopy and uniportal endoscopy to treat lumbar spinal stenosis
Yutong HU ; Haoyan XU ; Dongfang YANG ; Hao FU ; Honglin TENG ; Weibing XU
Chinese Journal of Orthopaedics 2023;43(2):89-96
Objective:To compare the clinical efficacy of unilateral biportal endoscopy (UBE) and uniportal endoscopy (UE) for unilateral laminotomy for bilateral decompression (ULBD) in the treatment of lumbar spinal stenosis.Methods:Data of 82 patients with lumbar spinal stenosis treated by ULBD under UBE or UE from January 2020 to June 2021 in Dalian Central Hospital affiliated to Dalian Medical University and the First Hospital affiliated to Wenzhou Medical University were retrospectively analyzed, including 36 males and 46 females, aged 63.3±7.5 years (range, 47-81 years). According to the surgical procedure, they were divided into UBE group (42 cases), including 20 males and 22 females; aged 63.2±7.6 years (range, 47-81 years) and UE group (40 cases), including 16 males and 24 females; aged 63.5±7.5 years (range, 48-80 years). Operation time, hospital stay and surgical complications were compared between the two groups. Visual analogue scale (VAS) of low back and leg pain before surgery, 1 day, 7 d, 1 month and 6 months after surgery, and Oswestry disability index (ODI) before surgery, 1 month and 6 months after surgery were compared. Dural sac area before and after surgery, resection angle of ipsilateral facet joint, decompression rate of disc space and bone lateral recess were calculated.Results:All patients were operated successfully. In the UBE group, the operation time was 63.1±7.0 min, and the hospital stay was 3.9±0.9 d. The UE group was 61.2±6.2 min and 3.7±0.9 d, respectively ( t=1.31, P=0.195; t=1.24, P=0.217). The VAS of back and legs pain in UBE group decreased from 7.19±0.97 before operation to 3.43±0.63 points at postoperative 1 day, 1.71±0.60 at postoperative 7 d, 1.33±0.48 at postoperative 1 month and 1.36±0.48 points at postoperative 6 months ( F=352.29, P<0.001). The VAS score of the UE group decreased from 6.85±0.89 points before operation to 2.45±0.75 points at postoperative 1 day, 1.75±0.59 points at postoperative 7 d, 1.33±0.47 points at postoperative 1 month and 1.28±0.45 points at postoperative 6 months ( F=291.44, P<0.001). The VAS of low back and leg pain was higher in the UBE group than in the UE group at 1 day postoperatively ( t=6.41, P<0.001), and the difference was not statistically significant at 7 d postoperatively ( t=-0.27, P=0.786). The ODI of UBE group decreased from 66.62%±4.98% before operation to 21.81%±2.61% at postoperative 1 month and 11.62%±2.31% at postoperative 6 months ( F=1991.35, P<0.001). The ODI score of UE group decreased from 64.35%±5.16% before operation to 22.85%±3.26% at postoperative 1 month and 11.15%±2.86% at postoperative 6 months ( F=1931.18, P<0.001). The postoperative dural sac area of the UBE and UE groups was 135.1±10.0 mm 2 and 120.9±10.4 mm 2 ( t=6.30, P<0.001). The resection angle of ipsilateral facet joint was 69.3°±4.9° and 94.3°±4.1° in the two groups, respectively, with a statistically significant difference ( t=-25.00, P<0.001). The decompression rate of ipsilateral disk-flavum space was 39.0%±3.0% and 38.7%±3.3% in the two groups ( t=1.52, P=0.314). On the contralateral side was 41.6%±3.3% and 22.8%±3.2% ( t=26.32, P<0.001), respectively. The ipsilateral osseous side fossa decompression rate in the two groups were 70.0%±4.8% and 59.3%±3.9% ( t=15.64, P<0.001), the contralateral were 73.0%±3.4% and 48.4%±4.3% ( t=28.86, P<0.001). There was no significant difference in the decompression rate of ipsilateral disco-flavum space or bony lateral recess between the UBE group and the contralateral group ( t=-1.40, P=0.174; t=-1.72, P=0.096), while the decompression rate of discoflavum space and bony side recess on the ipsilateral side of UE group were higher than those on the contralateral side ( t=28.51, P<0.001; t=13.95, P<0.001). Conclusion:Both UE-ULBD and UBE-ULBD have good short-term clinical efficacy in patients with lumbar spinal stenosis. UB is better than UBE in early postoperative pain relief. However, UBE shows better imaging performance in decompression effect and better retention of facet joints.
10.Effect of Zishenwan on Intestinal Barrier and Transcriptome of Skeletal Muscle of db/db Diabetic Mice
You WU ; Yuan CHEN ; Yaomu HU ; Boju SUN ; Xiaoyuan GUO ; Lingling QIN ; Tonghua LIU ; Lili WU
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(16):22-32
ObjectiveTo explore the effect of Zishenwan on glucose and lipid metabolism in spontaneous type 2 diabetes (db/db) mice and investigate the underlying mechanism for improving diabetes based on intestinal barrier function and skeletal muscle transcriptome sequencing results. MethodLiquid chromatography-tandem mass spectrometry (LC-MS/MS) was used to analyze the components of Zishenwan. Sixteen 6-week-old db/db mice were divided into a model group and a Zishenwan group, while eight wild-type mice were assigned to the normal group. The Zishenwan group received oral administration of drugs for six weeks, during which fasting blood glucose, body weight, and food intake were measured. Serum total cholesterol (TC) and triglyceride (TG) levels were determined, and fasting insulin levels were measured to calculate the homeostatic model assessment of insulin resistance (HOMA-IR). After the treatment, skeletal muscle and ileum tissues were collected, followed by hematoxylin-eosin (HE) staining. Immunohistochemistry was used to detect the expression of tight junction proteins occludin and zonula occludens-1 (ZO-1) in the ileum. Transcriptome sequencing was performed to detect the skeletal muscle transcriptome, and enrichment analysis was conducted for differentially expressed genes. ResultMultiple active components were identified in Zishenwan. Compared with the normal group, the model group showed increased fasting blood glucose, body weight, TC, TG, and HOMA-IR (P<0.01). Compared with the model group, Zishenwan significantly reduced fasting blood glucose, body weight, TC, TG, and HOMA-IR in db/db mice (P<0.01), while there was no statistically significant difference in food intake. Compared with the normal group, the model group exhibited lipid deposition in skeletal muscle, as well as structural changes in the ileum, with significant decreases in the protein expression levels of intestinal occludin and ZO-1 (P<0.01). Compared with the model group, Zishenwan improved the pathological changes in skeletal muscle and ileum, and increased the protein expression of occludin and ZO-1 in the ileum (P<0.01). Transcriptome analysis suggested that Zishenwan might improve skeletal muscle metabolism and increase insulin sensitivity in mice. ConclusionZishenwan can improve glucose and lipid metabolism in db/db mice, and this effect may be related to its protection of intestinal barrier function and transcriptional regulation of skeletal muscle metabolism-related genes.


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