1.Exploring on Quality Evaluation Methods of Clinical Case Reports in Traditional Chinese Medicine Based on China Clinical Cases Library of Traditional Chinese Medicine
Kaige ZHANG ; Feng ZHANG ; Bo ZHOU ; Haimin CHEN ; Yong ZHU ; Changcheng HOU ; Liangzhen YOU ; Weijun HUANG ; Jie YANG ; Guoshuang ZHU ; Shukun GONG ; Jianwen HE ; Yang YE ; Yuqiu AN ; Chunquan SUN ; Qingjie YUAN ; Buman LI ; Xingzhong FENG ; Kegang CAO ; Hongcai SHANG ; Jihua GUO ; Xiaoxiao ZHANG ; Zhining TIAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(1):271-276
As the core vehicle for preserving and transmitting traditional Chinese medicine(TCM) academic thought and clinical experience, the establishment of a robust quality evaluation system for TCM clinical case reports is a crucial component in the current standardization and modernization of TCM. Based on the practical experience of constructing the China Clinical Cases Library of Traditional Chinese Medicine by the China Association of Chinese Medicine, this study conducted a comprehensive analysis of critical challenges, including insufficient authenticity and unfocused evaluation criteria. It proposed a three-dimensional evaluation framework grounded in the structure-process-outcome logic, encompassing three dimensions of authenticity and standardization, characteristics and advantages, application and translational impact. This framework integrated 12 key evaluation indicators in a systematic manner. The model preserved the academic characteristics of TCM syndrome differentiation and treatment, while aligning with modern scientific research standards, achieving a balance between individualized TCM experience and standardized evaluation. Concurrently, this study provided theoretical foundations and methodological guidance for evaluating the quality of TCM clinical cases, contributing significantly to the inheritance of TCM knowledge, evidence-based practice, and the reform of talent evaluation mechanisms.
2.Clinical Advantages of Traditional Chinese Medicine in Treatment of Childhood Simple Obesity: Insights from Expert Consensus
Qi ZHANG ; Yingke LIU ; Xiaoxiao ZHANG ; Guichen NI ; Heyin XIAO ; Junhong WANG ; Liqun WU ; Zhanfeng YAN ; Kundi WANG ; Jiajia CHEN ; Hong ZHENG ; Xinying GAO ; Liya WEI ; Qiang HE ; Qian ZHAO ; Huimin SU ; Zhaolan LIU ; Dafeng LONG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):238-245
Childhood simple obesity has become a significant public health issue in China. Modern medicine primarily relies on lifestyle interventions and often suffers from poor long-term compliance, while pharmacological options are limited and associated with potential adverse effects. Traditional Chinese Medicine (TCM) has a long history in the prevention and management of this condition, demonstrating eight distinct advantages, including systematic theoretical foundation, diversified therapeutic approaches, definite therapeutic efficacy, high safety profile, good patient compliance, comprehensive intervention strategies, emphasis on prevention, and stepwise treatment protocols. Additionally, TCM is characterized by six distinctive features: the use of natural medicinal substances, non-invasive external therapies, integration of medicinal dietetics, simple exercise regimens, precise syndrome differentiation, and diverse dosage forms. By combining internal and external treatments, TCM facilitates individualized regimen adjustment and holistic regulation, demonstrating remarkable effects in improving obesity-related metabolic indicators, regulating constitutional imbalance, and promoting healthy behaviors. However, challenges remain, such as inconsistent operational standards, insufficient high-quality clinical evidence, and a gap between basic research and clinical application. Future efforts should focus on accelerating the standardization of TCM diagnosis and treatment, conducting multicenter randomized controlled trials, and fostering interdisciplinary integration, so as to enhance the scientific validity and international recognition of TCM in the prevention and treatment of childhood obesity.
3.Effect of Pibai Yucuo Formula (枇柏愈痤方) on Inflammatory Response in Lesional Tissue and Skin Barrier Damage in Acne Model Mice
Yunni LIU-TANG ; Yutong DENG ; Gaiying HE ; Huishang FENG ; Xuewen REN ; Yimei FANG ; Xuewan WANG ; Yatong LI ; Lingling CAI ; Yuanwen LI
Journal of Traditional Chinese Medicine 2026;67(11):1211-1219
ObjectiveTo investigate the possible mechanism of Pibai Yucuo Formula (枇柏愈痤方, PYF) in treating acne from the perspective of skin barrier damage. MethodsThirty-two mice were randomly divided into blank group, model group, minocycline group, and PYF group, with 8 mice in each group. Except for the blank group, mice were induced by intradermal injection of Cutibacterium acnes (C.acnes) combined with topical application of artificial sebum to establish acne model. The blank group and model group received intragastric administration of 0.2 ml of distilled water, while the PYF group received intragastric administration of 22.75 g/(kg·d)of PYF, and the minocycline group received 0.013 g/(kg·d)of minocycline suspension, all once daily for 5 consecutive days. On day 0 and day 6 of the experiment, the body weight of mice in each group was recorded, and the absolute value of the body weight difference during the experiment was calculated. Skin conditions were assessed with multifunctional skin imaging system on the 2nd, 4th and 6th day of the experiment. Skin barrier function indicators including transepidermal water loss (TEWL), and the water content of the stratum corneum and epidermis on day 0, 2, 4 and 6 of the experiment. Optical coherence tomography (OCT) was used to observe stratum corneum and skin thickness on the 1st, 3rd and 5th day of the experiment. Hematoxylin-eosin (HE) staining was performed to observe histopathological changes, while ELISA was used to detect interleukin-17A (IL-17A) levels, and immunofluorescence staining was used to assess skin barrier-related proteins filaggrin (FLG) and loricrin (LOR) levels of skin lesions on day 6 of the experiment. ResultsCompared to the blank group, the model group showed a decrease in body weight on day 6, and an increase in the absolute value of the difference in body weight before and after the experiment (P<0.05). On day 4 and 6, TEWL values increased, while water content in the skin stratum corneum and epidermis decreased (P<0.05), accompanied by elevated IL-17A level and reduced immunofluorescence intensity of FLG and LOR proteins (P<0.05). The model group mice showed papules or pustules at the skin modeling site with progressively worsening desquamation under multifunctional skin imaging system. OCT revealed focal epidermal protrusions, blurred epidermal-dermal boundaries, and disorganized structural layers. HE staining showed significant epidermal hyperkeratosis and incomplete keratinization in the skin, with keratin plug formation in hair follicles and glandular lumens, thickened stratum corneum, hyperplasia of the stratum spinosum, as well as dense dermal inflammatory cell infiltration, and capillary dilation. Compared to the model group, both the minocycline group and the PYF group showed a reduced difference in body weight before and after experiment (P<0.05). On day 4 and 6, the TEWL value decreased, and water content of the skin stratum corneum increased (P<0.05); on day 6, the IL-17A level in the skin lesions decreased and immunofluorescence intensity of FLG and LOR proteins increased (P<0.05). On day 4 and 6, the severity of the skin lesions and range of redness and swelling were lighter than those in the model group, with reverted epidermal thickness, smoother surface and clearer epidermis-dermis boundary. HE staining showed that the degree of skin keratinization was reduced, and the inflammatory infiltration and vascular dilation in the dermis were improved compared to the model group. The PYF group showed better results than the minocycline group in reducing TEWL value on day 4 (P<0.05). ConclusionPYF may improve inflammation and skin barrier damage by downregulating IL-17A levels in lesion tissue and increasing skin barrier-related proteins, which could be one of the potential mechanism of action on acne.
4.Evaluation of CARIFS Score and Negative Antigen Conversion Rate of Qingxuan Daozhi Formula in Treatment of Influenza in Children (Heat Accumulation in Lung and Stomach Syndrome):A Multi-center Randomized Controlled Clinical Study
Jing WANG ; Liqun WU ; Tiegang LIU ; Yongning CAO ; Jing QIU ; Jing LI ; Huaqing TAN ; Ying ZHANG ; Xulei GOU ; Jia WANG ; Jing LI ; Haipeng CHEN ; Xueying QIN ; Yuanshuo TIAN ; Yang WANG ; Chen BAI ; Zhendong WANG ; Qianqian LI ; He YU ; Xueyan MA ; Fei DONG ; Lin JIANG ; Yingqi XU ; Jianping LIU ; Xiaohong GU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(13):188-196
ObjectiveThis paper aims to observe the syndrome improvement and negative antigen conversion rate of Qingxuan Daozhi formula in the treatment of influenza in children (heat accumulation in the lung and stomach syndrome). MethodsThrough a multi-center randomized controlled methodology design,confirmed influenza cases were collected from October 2022 to April 2023 in the pediatrics department of eight hospitals,such as Dongfang Hospital of Beijing University of Chinese Medicine. A total of 180 children with influenza and heat accumulation in the lung and stomach syndrome conforming to the standard were recruited through the clinic. The sick children meeting the inclusion criteria were randomly divided into groups by a block-randomized method. The children in the experimental group were treated with Qingxuan Daozhi formula for five days,and those in the control group were treated with Oseltamivir Phosphate Granules for five days. The primary efficacy indicator was the negative conversion rate of influenza antigen detection. Secondary efficacy indicators were the Canadian acute respiratory illness and flu scale (CARIFS) and the incidence of complications,severe cases, and critical cases. Follow-up observation was conducted on the day of enrollment,48 hours after medication,72 hours after medication, and (6+1) d after medication. ResultsOne hundred and eighty participants were randomly assigned to the experimental group (90 cases) or the control group (90 cases). All participants were followed up during the study. Comparison of influenza antigen detection results in the primary efficacy indicators showed that the average time of negative influenza antigen conversion in the experimental group was (5.29±1.25) d,and that in the control group was (5.40±1.68) d,without a statistically significant difference. After five days of intervention,52 cases in the experimental group and 51 cases in the control group converted to negative,without a statistically significant difference. CARIFS score results in the secondary efficacy indicators showed that during 72 hours after intervention,there were statistically significant differences between the experimental group and the control group in three dimensions, including headache,muscle soreness, and the need for extra care (P<0.05). On the (6+1) days after the intervention,the differences in both the experimental group and the control group were statistically significant in 10 dimensions, including sore throat,bad sleep,uncomfortable feeling,poor spirit and fatigue,crying more than usual,the need for extra care,symptom,function,influence on parents,and total score (P<0.05). The comparison results within the group in the dimensional scores of symptom, function, and influence on parents,as well as the CARIFS total score showed that with the delay of follow-up time,scores of both groups decreased significantly,with a statistically significant difference (P<0.01). Inter-group comparison results showed that the mean score of the experimental group was higher than that of the control group at the time of enrollment. With the progress of intervention,the score of the experimental group was significantly decreased compared with that of the control group. At the end of follow-up,the mean score of the experimental group was lower than that of the control group,with no statistically significant difference. In terms of the incidence of complications,severe cases, and critical cases, there were no complications,severe cases, and critical cases in the two groups,without a statistically significant difference. ConclusionThe symptom improvement effect and negative antigen conversion rate of Qingxuan Daozhi formula in the treatment of influenza in children (heat accumulation in the lung and stomach syndrome) are not inferior to Oseltamivir Phosphate granules, and children's acceptance is better. It can be more widely used in clinical treatment of influenza in children (heat accumulation in the lung and stomach syndrome).
5.Sanjie Quban Prescription Affects Proliferation, Apoptosis, Migration, and Invasion of Human Keloid Fibroblasts via AhR/CYP1A1 Signaling Pathway
Zhihong HE ; Fengchuan ZHANG ; Dingquan YANG ; Chuhan HUANG ; Zhihan WANG ; Yatong WU ; Qingwu LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(17):164-174
ObjectiveTo investigate the effects of Sanjie Quban prescription (SJQB)-containing serum on the proliferation, apoptosis, migration, and invasion of human keloid fibroblasts (KFs) and to elucidate its underlying mechanism, with a focus on the aryl hydrocarbon receptor (AhR)/cytochrome P450 family 1 subfamily A member 1 (CYP1A1) signaling pathway. MethodsPrimary human KFs were cultured in vitro and assigned to the following groups: control (KFs+blank serum), asiaticoside (KFs+asiaticoside-containing serum), SJQB (KFs+SJQB-containing serum), AhR agonist (KFs+β-naphthoflavone), AhR inhibitor (KFs+CH223191), and AhR inhibitor+SJQB (KFs+CH223191+SJQB-containing serum). The optimal intervention concentrations were determined through the cell counting kit-8 (CCK-8) assay. Cell proliferation, apoptosis, migration, and invasion were evaluated by the EdU assay, flow cytometry, wound healing assay, and Transwell assay, respectively. The expression of transforming growth factor-β1 (TGF-β1) and α-smooth muscle actin (α-SMA) was visualized by immunofluorescence. The mRNA and protein levels of AhR, CYP1A1, TGF-β1, and α-SMA were measured by Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) and Western blot, respectively. ResultsCompared with the control group, the SJQB, asiaticoside, and AhR agonist groups demonstrated inhibited cell proliferation, migration, and invasion, along with an increased apoptosis rate (P<0.01). The AhR inhibitor group showed enhanced proliferation, migration, and invasion together with a reduced apoptosis rate in comparison with the AhR agonist group (P<0.01). The AhR inhibitor+SJQB group exhibited increased proliferation, migration, and invasion as well as decreased apoptosis compared with the SJQB group (P<0.05, P<0.01). At the molecular level, compared with the control group, the SJQB, asiaticoside, and AhR agonist groups presented upregulated protein and mRNA levels of AhR and CYP1A1 (P<0.05, P<0.01), while the SJQB and AhR agonist groups showed downregulated TGF-β1 and α-SMA expression at both protein and mRNA levels (P<0.05, P<0.01), and the asiaticoside group displayed decreased protein level of TGF-β1 and mRNA level of α-SMA (P<0.05, P<0.01). Compared with both the AhR agonist and control groups, the AhR inhibitor group exhibited decreased AhR and CYP1A1 expression but increased TGF-β1 and α-SMA expression at protein and mRNA levels (P<0.01). In comparison with the SJQB group, the AhR inhibitor+SJQB group demonstrated reduced AhR and CYP1A1 expression (P<0.01) and elevated TGF-β1 and α-SMA expression (P<0.05, P<0.01) at both protein and mRNA levels. ConclusionSJQB may activate the AhR/CYP1A1 signaling pathway to downregulate TGF-β1 and α-SMA expression, thereby suppressing the proliferation, migration, and invasion and inducing the apoptosis of KFs.
6.Construction and Validation of Integrated Traditional Chinese and Western Medicine Risk Prediction Model for Carotid Artery Plaques in 3 009 Individuals with High-risk of Stroke
Shuqi QIN ; Xiangyu GUO ; Weihao YANG ; Yang CHEN ; Ying YU ; Limin HE ; Jialin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):242-250
ObjectiveTo construct a risk prediction model for carotid artery plaques in high-risk populations of stroke based on five machine learning methods. MethodsThe clinical information of the high-risk population of stroke was collected. Factor analysis and statistical analysis of syndrome elements were conducted on their traditional Chinese medicine (TCM) symptoms and tongue and pulse manifestations. On the basis of the results of factor analysis and variable screening, five machine learning methods-classification and regression tree (CART) decision tree, support vector machine (SVM), back propagation(BP) neural network, logistic regression, and random forest-were used to construct the risk prediction model for carotid artery plaques. ResultsThe most common TCM syndrome elements in the high-risk population of stroke was Qi deficiency. The scores of Qi deficiency, Yin deficiency, and Yang deficiency in the population with carotid artery plaques were higher than those without carotid artery plaques (P<0.05). The CART decision tree, SVM, logistic regression, BP neural network, and random forest models showed the areas under the receiver operating characteristic (ROC) curves of 0.71, 0.75, 0.76, 0.76, and 0.75, the accuracy rates of 68.94%, 69.27%, 69.44%, 70.10%, and 69.60%, the precision rates of 68.56%, 68.53%, 68.75%, 69.74%, and 69.42%, the recall rates of 68.91%, 67.93%, 67.92%, 68.10%, and 67.31%, and the F1 values of 0.69, 0.68, 0.68, 0.68, and 0.68, respectively. ConclusionAmong the high-risk population of stroke, the most frequently distributed TCM syndrome element is Qi deficiency, with the rest mainly being fire heat, Yin deficiency, Yang deficiency, phlegm dampness, blood stasis, and Qi stagnation. Deficiency syndrome may be a major factor leading to carotid artery plaques in the high-risk population of stroke. The BP neural network model demonstrates better performance in predicting the risk of carotid artery plaques in the high-risk population of stroke. People with carotid artery plaques are more likely to present with symptoms such as a heavy head, dizziness, headache, and thready pulse. The primary community benefits more widely when the BP neural network model is adopted to predict the risk of carotid artery plaques in the high-risk population of stroke over 40 years old.
7.Construction and Validation of Integrated Traditional Chinese and Western Medicine Risk Prediction Model for Carotid Artery Plaques in 3 009 Individuals with High-risk of Stroke
Shuqi QIN ; Xiangyu GUO ; Weihao YANG ; Yang CHEN ; Ying YU ; Limin HE ; Jialin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):242-250
ObjectiveTo construct a risk prediction model for carotid artery plaques in high-risk populations of stroke based on five machine learning methods. MethodsThe clinical information of the high-risk population of stroke was collected. Factor analysis and statistical analysis of syndrome elements were conducted on their traditional Chinese medicine (TCM) symptoms and tongue and pulse manifestations. On the basis of the results of factor analysis and variable screening, five machine learning methods-classification and regression tree (CART) decision tree, support vector machine (SVM), back propagation(BP) neural network, logistic regression, and random forest-were used to construct the risk prediction model for carotid artery plaques. ResultsThe most common TCM syndrome elements in the high-risk population of stroke was Qi deficiency. The scores of Qi deficiency, Yin deficiency, and Yang deficiency in the population with carotid artery plaques were higher than those without carotid artery plaques (P<0.05). The CART decision tree, SVM, logistic regression, BP neural network, and random forest models showed the areas under the receiver operating characteristic (ROC) curves of 0.71, 0.75, 0.76, 0.76, and 0.75, the accuracy rates of 68.94%, 69.27%, 69.44%, 70.10%, and 69.60%, the precision rates of 68.56%, 68.53%, 68.75%, 69.74%, and 69.42%, the recall rates of 68.91%, 67.93%, 67.92%, 68.10%, and 67.31%, and the F1 values of 0.69, 0.68, 0.68, 0.68, and 0.68, respectively. ConclusionAmong the high-risk population of stroke, the most frequently distributed TCM syndrome element is Qi deficiency, with the rest mainly being fire heat, Yin deficiency, Yang deficiency, phlegm dampness, blood stasis, and Qi stagnation. Deficiency syndrome may be a major factor leading to carotid artery plaques in the high-risk population of stroke. The BP neural network model demonstrates better performance in predicting the risk of carotid artery plaques in the high-risk population of stroke. People with carotid artery plaques are more likely to present with symptoms such as a heavy head, dizziness, headache, and thready pulse. The primary community benefits more widely when the BP neural network model is adopted to predict the risk of carotid artery plaques in the high-risk population of stroke over 40 years old.
8.Effect of Roxadustat and rHuEPO on novel inflammatory immune indices in non-dialysis diabetic nephropathy anemia patients
Zhouxia XIANG ; Dan PENG ; Dongfang ZHAO ; Meng HE ; Shunian GUO ; Shu RONG
Clinical Medicine of China 2025;41(2):127-132
Objective:To investigate the effects of Roxadustat and recombinant human erythropoietin (rHuEPO) on novel inflammatory immune indices in anemic patients with non-dialysis type 2 diabetes mellitus combined with chronic kidney disease (CKD).Methods:A retrospective case-control study was performed in this study. Patients with non-dialysis type 2 diabetes mellitus combined with CKD admitted to Shanghai First People's Hospital from December 2015 to December 2023 were selected. Among those patients, 252 cases were treated with rHuEPO (rHuEPO group) and 103 cases were treated with Roxadustat (Roxadustat group). Both group had a course of treatment over three months. The baseline data and novel inflammatory immunity indices, systemic immuno-inflammation index (SII), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) were compared between the two groups of patients before and after 3 months of treatment.Results:The differences in gender, age, body mass index, systolic blood pressure, diastolic blood pressure, history of cardiovascular and cerebrovascular disease, history of hypertension, estimated glomerular filtration rate, and use of hypoglycemic, antihypertensive, and lipid-lowering medications were not statistically significant when compared between the two groups of patients (all P>0.05). Before treatment, the differences in NLR, PLR, SII, and LMR between the two groups were not statistically significant (all P>0.05); after 3 months of treatment, NLR, PLR, SII, and LMR were lower in both groups than before treatment [rHuEPO group: (2.3±0.8)% vs. (2.8±0.8)%, (83±33)% vs. (160±49)%, (2.3±0.8)% vs. (3.1±0.7)%, (476±227)% vs. (594±243)%, with t values of 9.25, 23. 20, 26.67, and 9.62, respectively, all P<0.001; Roxadustat group: (1.7±0.6)% versus (2.9±1.0)%, (72±30)% versus (162±47)%, (2.0±0.8)% versus (3.1±0.9)%, (408±151)% versus (605±267)%, with t values of 8. 38, 14.27, 8.62, and 5.97, respectively, all P<0.001], and NLR, PLR, and SII were lower in the Roxadustat group than in the rHuEPO group ( t=5.00, P<0.001, t=2.44, P=0.015, t=2.09, P=0.040). Conclusion:In patients with anemia in non-dialysis type 2 diabetes mellitus associated with CKD,Roxadustat had similar ability of reducing the level of novel inflammatory markers compared to rHuEPO.
9.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*
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Humans
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Medicine, Chinese Traditional/methods*
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Practice Guidelines as Topic
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Drugs, Chinese Herbal/therapeutic use*
10.Glucocorticoid Discontinuation in Patients with Rheumatoid Arthritis under Background of Chinese Medicine: Challenges and Potentials Coexist.
Chuan-Hui YAO ; Chi ZHANG ; Meng-Ge SONG ; Cong-Min XIA ; Tian CHANG ; Xie-Li MA ; Wei-Xiang LIU ; Zi-Xia LIU ; Jia-Meng LIU ; Xiao-Po TANG ; Ying LIU ; Jian LIU ; Jiang-Yun PENG ; Dong-Yi HE ; Qing-Chun HUANG ; Ming-Li GAO ; Jian-Ping YU ; Wei LIU ; Jian-Yong ZHANG ; Yue-Lan ZHU ; Xiu-Juan HOU ; Hai-Dong WANG ; Yong-Fei FANG ; Yue WANG ; Yin SU ; Xin-Ping TIAN ; Ai-Ping LYU ; Xun GONG ; Quan JIANG
Chinese journal of integrative medicine 2025;31(7):581-589
OBJECTIVE:
To evaluate the dynamic changes of glucocorticoid (GC) dose and the feasibility of GC discontinuation in rheumatoid arthritis (RA) patients under the background of Chinese medicine (CM).
METHODS:
This multicenter retrospective cohort study included 1,196 RA patients enrolled in the China Rheumatoid Arthritis Registry of Patients with Chinese Medicine (CERTAIN) from September 1, 2019 to December 4, 2023, who initiated GC therapy. Participants were divided into the Western medicine (WM) and integrative medicine (IM, combination of CM and WM) groups based on medication regimen. Follow-up was performed at least every 3 months to assess dynamic changes in GC dose. Changes in GC dose were analyzed by generalized estimator equation, the probability of GC discontinuation was assessed using Kaplan-Meier curve, and predictors of GC discontinuation were analyzed by Cox regression. Patients with <12 months of follow-up were excluded for the sensitivity analysis.
RESULTS:
Among 1,196 patients (85.4% female; median age 56.4 years), 880 (73.6%) received IM. Over a median 12-month follow-up, 34.3% (410 cases) discontinued GC, with significantly higher rates in the IM group (40.8% vs. 16.1% in WM; P<0.05). GC dose declined progressively, with IM patients demonstrating faster reductions (median 3.75 mg vs. 5.00 mg in WM at 12 months; P<0.05). Multivariate Cox analysis identified age <60 years [P<0.001, hazard ratios (HR)=2.142, 95% confidence interval (CI): 1.523-3.012], IM therapy (P=0.001, HR=2.175, 95% CI: 1.369-3.456), baseline GC dose ⩽7.5 mg (P=0.003, HR=1.637, 95% CI: 1.177-2.275), and absence of non-steroidal anti-inflammatory drugs use (P=0.001, HR=2.546, 95% CI: 1.432-4.527) as significant predictors of GC discontinuation. Sensitivity analysis (545 cases) confirmed these findings.
CONCLUSIONS
RA patients receiving CM face difficulties in following guideline-recommended GC discontinuation protocols. IM can promote GC discontinuation and is a promising strategy to reduce GC dependency in RA management. (Trial registration: ClinicalTrials.gov, No. NCT05219214).
Adult
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Aged
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Female
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Humans
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Male
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Middle Aged
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Arthritis, Rheumatoid/drug therapy*
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Glucocorticoids/therapeutic use*
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Medicine, Chinese Traditional
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Retrospective Studies

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