1.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
;
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
2.Effects of Modified Guomin Decoction (加味过敏煎) on Traditional Chinese Medicine Syndromes and Quality of Life in Patients with Mild to Moderate Atopic Dermatitis of Heart Fire and Spleen Deficiency Pattern:A Randomized,Double-Blind,Placebo-Controlled Trial
Jing NIE ; Rui PANG ; Lingjiao QIAN ; Hua SU ; Yuanwen LI ; Xinyuan WANG ; Jingxiao WANG ; Yi YANG ; Yunong WANG ; Yue LI ; Panpan ZHANG
Journal of Traditional Chinese Medicine 2025;66(10):1031-1037
ObjectiveTo observe the clinical efficacy and safety of Modified Guomin Decoction (加味过敏煎, MGD) in patients with mild to moderate atopic dermatitis (AD) of the traditional Chinese medicine (TCM) pattern of heart fire and spleen deficiency, and to explore its possible mechanisms. MethodsIn this randomized, double-blind, placebo-controlled study, 72 patients with mild to moderate AD and the TCM pattern of heart fire and spleen deficiency were randomly divided into a treatment group and a control group, with 36 cases in each group. The treatment group received oral MGD granules combined with topical vitamin E emulsion, while the control group received oral placebo granules combined with topical vitamin E treatment. Both groups were treated twice daily for 4 weeks. Clinical efficacy, TCM syndrome scores, Visual Analogue Scale (VAS) for pruritus, Dermatology Life Quality Index (DLQI) scores, Scoring Atopic Dermatitis (SCORAD) and serum biomarkers, including interleukin-33 (IL-33), interleukin-1β (IL-1β), immunoglobulin E (IgE), and tumor necrosis factor-α (TNF-α) were compared before and after treatment. Safety indexes was also assessed. ResultsThe total clinical effective rates were 77.78% (28/36) in the treatment group and 38.89% (14/36) in the control group, with cure rates of 19.44% (7/36) and 2.78% (1/36), respectively. The treatment group showed significantly better clinical outcomes compared to the control group (P<0.05). The treatment group exhibited significant reductions in total TCM syndrome scores, including erythema, edema, papules, scaling, lichenification, pruritus, irritability, insomnia, abdominal distension, and fatigue scores, as well as reductions in VAS, DLQI, SCORAD, and serum IgE and IL-33 levels (P<0.05 or P<0.01). Compared to the control group, the treatment group had significantly better improvements in all indicators except for insomnia (P<0.05). No adverse events occurred in either group. ConclusionMGD is effective and safe in treating mild to moderate AD patients with heart fire and spleen deficiency pattern. It significantly alleviates pruritus, improves TCM syndromes and quality of life, and enhances clinical efficacy, possibly through modulation of immune responses.
3.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.
4.Study on the protective mechanism of Bawei chenxiang powder containing serum on H9c2 cells injured by oxygen-glucose deprivation
Baihui GONG ; Dongfang YUE ; Caixia LI ; Min GUAN ; Yongfang LI
China Pharmacy 2023;34(1):40-46
OBJECTIVE To study the protective mechanism of Bawei chenxiang powder containing serum on H9c2 cells injured by oxygen-glucose deprivation (OGD). METHODS H9c2 cells were divided into blank group, model group and Bawei chenxiang powder low-dose, medium-dose and high-dose groups (the dose of drug containing serum 2.5, 8, 12 g/kg). H9c2 cells were cultured in vitro to establish OGD model. After intervention with drug-containing serum, survival rate of cell was detected. The cell morphology was observed; the levels of lactate dehydrogenase (LDH), creatine kinase (CK), superoxide dismutase (SOD), catalase (CAT), respiratory chain complexⅠ (ComplexⅠ), glutathione peroxidase (GSH-Px) and malondialdehyde (MDA) were detected. The contents of reactive oxygen species (ROS), mitochondrial membrane potential and apoptosis were also detected. The expressions of oxidative stress-related proteins [Kelch ECH association protein 1 (Keap1), nuclear factor erythroid 2- related factor 2 (Nrf2), heme oxygenase 1 (HO-1), NADH oxidoreductase coenzyme 10 (Ndufa10), thioredoxin (Trx)] and apoptosis-related proteins [B-cell lymphoma 2 (Bcl-2), Bcl-2 associated X protein (Bax), Caspase-3 and cytochrome C (Cytc)] were detected. RESULTS Compared with blank group, the cell morphology of model group was damaged; the levels of LDH, CK and MDA were significantly increased (P<0.01), while the levels of CAT, ComplexⅠ, SOD and GSH-Px and mitochondrial membrane potential were significantly decreased (P<0.01). The content of intracellular ROS and apoptotic rate were significantly increased (P<0.01); the expressions of oxidative stress-related proteins (Keap1, Nrf2, HO-1, Ndufa10 and Trx) and pro- apoptosis proteins (Bax, Caspase-3 and Cytc) were significantly increased (P<0.05), while the expression of anti-apoptotic protein Bcl-2 was significantly decreased (P<0.05). After administration of Bawei chenxiang powder containing serum, the cell morphology improved, and most of the above indexes were significantly reversed (P<0.05 or P<0.01).CONCLUSIONS Bawei chenxiang powder containing serum E-mail:345783110@qq.com has a good protective effect on H9c2 cells damaged by OGD,the mechanism of which is related to the reduction of oxidative damage and inhibition of cell apoptosis.
6.Mechanisms of Ersi Decoction on Rheumatoid Arthritis Rats Induced by Bovine Type Ⅱ Collagen-solution
Tian-yue MA ; Yi-mei FANG ; Gan-lin GUO ; Jia-xi YANG ; Bin YANG ; Yi-kun YANG ; Qiu-ai KOU
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(5):38-45
ObjectiveTo observe that effect of Ersi decoction on rats with rheumatoid arthritis (RA) induced by using the complete Freund's adjuvant emulsion containing bovine type Ⅱ collagenand and elucidate underlying menchanisms involving to inhibit inflammation and joint synovial angiogenesis. MethodThe rat model of RA was established by immune induction with complete Freund's adjuvant emulsion containing bovine type Ⅱ collagen. All male SD rats were randomly divided into blank group, RA model group, methotrexate group(1.0 mg·kg-1), and low-, medium- and high-dose group(30,15,7.0 g·kg-1·d-1)of Ersi decoction, with 8 rats in each group. Except the blank group, rats in the methotrexate group and Ersi decoction groups were given corresponding doses of methotrexate and Ersi decoction after establishment of RA induced by strengthen immunity,respectively,and those in the model group and blank group received normal saline of equivalent volume,once a day for 28 days. After the administration, the degree of joint swelling of rats in each group was analyzed by joint swelling volume and index. The small animal ultrasound imaging system was used to detect the score and area of synovial hyperplasia of knee joint in right lower limb of rats and hematoxylin-eosin(HE)staining to observe the histomorphological changes in joint synovium of rats. The levels of tumor necrosis factor-α(TNF-α) and interleukin-1β(IL-1β) were measured by enzyme-linked immunosorbent assay(ELISA). Immunohistochemistry was employed to analyze the expression of CD31 and vascular endothelial growth factor receptor 2(VEGFR2) in in joint synovium. ResultCompared with the blank group, the model group demonstrated significant increase in joint swelling volume and index, inflammatory cytokines including TNF-α and IL-1β in serum, the score and area of synovial hyperplasia of knee joint in right lower limb, obvious pathological changes in the synovium and the expression of CD31 and VEGFR2 in joint synovium. Medium and high-dose Ersi decoction significantly alleviated the pathological changes of synovium tissue, attenuated joint swelling volume and index and decreased the expression of CD31 and VEGFR2 in joint synovium as compared with the model group. Moreover, high-dose Ersi decoction showed significantly lower levels of TNF-α and IL-1β in serum, and the score and area of synovial hyperplasia of knee joint in right lower limb. But medium-dose Ersi decoction only showed lower levels of TNF-α and area of synovial hyperplasia of knee joint. ConclusionErsi decoction could reduce synovial inflammation and hyperplasia through inhibiting synovial angiogenesis in rats with RA induced by bovine type Ⅱ collagen for achieving the effect of reducing RA joint damage, which provides an important reference for anti-RA of Ersi decoction in clinical application.
7.Effect of Huoxue Jiedu Runzao Prescription on Expression of Apoptosis Inhibitor Survivin in Submandibular Gland Cells of Sjögren's Syndrome Mice
Fang-kai LI ; Yue-lan ZHU ; Xiu-juan HOU ; Yu-ting ZHANG ; Xin-yi GU ; Hai-bo WANG ; Qian SHEN
Chinese Journal of Experimental Traditional Medical Formulae 2021;27(24):84-91
Objective:To investigate the effect of Huoxue Jiedu Runzao prescription on the morphology, apoptosis, and function of submandibular gland in the mouse model of Sjögren's syndrome (SS) and its functioning mechanism, we analyzed the expression of the apoptosis inhibitor Survivin in the submandibular gland cells of SS mice. Method:Female BALB/c57 mice were selected as the normal group. The naive non-obese diabetic (NOD/Ltj) female mice were selected as the SS model, which were randomly assigned into the model group, Paeoniae Radix Alba total glucosides capsule (0.234 g·kg-1) group, and low-, medium-, and high-dose (15.6, 31.2, 62.4 g·kg-1, respectively) Huoxue Jiedu Runzao prescription groups. Each group had 15 mice. The morphological and functional changes of submandibular gland and the Survivin expression were observed and measured after 8 weeks of drug intervention. Survivin expression was determined by immunohistochemistry (IHC), Western blot, and reverse transcription-polymerase chain reaction (RT-PCR). Result:Compared with normal group, salivary flow and submandibular gland index in model group were significantly decreased (
8.Regulation of Naoxin'an Capsule on Glial Cell Activation and Inflammatory Response in Rats with Chronic Cerebral Hypoperfusion-induced Vascular Cognitive Impairment
Guang-hui HAN ; Dong-yue LI ; Hong-ni YU ; Wei-zhe ZHEN ; Tao MA
Chinese Journal of Experimental Traditional Medical Formulae 2021;27(19):46-55
Objective:To investigate the protective effect of Naoxin'an capsule (NC) against glial cell activation and inflammatory damage in brain of rats with chronic cerebral hypoperfusion-induced vascular cognitive impairment (VCI). Method:One hundred and fifty rats were randomly divided into a sham operation group (
9.Expert Consensus on Otorhinolaryngology Head and Neck Diseases Responding Specifically to Traditional Chinese Medicine
Wei WU ; Yong-zhang SUN ; Da-xin LIU ; Jing-jing YUAN ; Sheng LIN ; Yue LIU ; Li-dong ZHAO ; Wei FENG ; Wen-yu SHE ; Lin-e WANG ; Lei LI ; Yong-gang LIU ; Ming-xia ZHANG ; Yan-jun WANG ; Lei DING ; Ling-yan JIANG ; Jin QIAO ; Man WANG ; Yong ZHU ; Zhan-feng YAN ; Xiao-xiao ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2021;27(14):208-214
Traditional Chinese medicine (TCM) and western medicine have their respective advantages and limitations in the diagnosis and treatment of common otorhinolaryngology head and neck diseases. Although the integrated TCM and western medicine exhibits definite curative effects, there is no consensus on the otorhinolaryngology head and neck diseases responding specifically to TCM or integrated TCM and western medicine, as well as the diagnosis and treatment schemes. The China Association of Chinese Medicine (CACM) thus organized the otorhinolaryngology head and neck specialists of both TCM and western medicine to discuss the etiology, pathogenesis, and clinical diagnosis and treatment methods of common otorhinolaryngology head and neck diseases with the results of multiple clinical trials taken into account. The acute pharyngitis, chronic pharyngolaryngitis, paraesthesia pharyngis, hysterical aphasia, allergic rhinitis, subjective tinnitus, and otogenic vertigo were confirmed to respond specifically to TCM or integrated TCM and western medicine. Then a mutually agreed diagnosis and treatment scheme and recommendation with integrated TCM and western medicine was formulated as a reference for clinical practice, thus benefiting more patients.
10.Chinese Expert's Perspectives on Andrological Diseases Responding Specifically to Traditional Chinese Medicine
Yue-qing LI ; Hai-song LI ; Yong-zhang SUN ; Sheng LIN ; Bao-xing LIU ; Jia-you ZHAO ; Jian-wu SHEN ; Hong-ming LIU ; Jing-shang WANG ; Yuan TANG ; Shao-ming LIU ; Hai WANG ; Yu-tian ZHU ; Yong ZHU ; Yong YANG ; Xiao-xiao ZHANG ; Bin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2021;27(12):182-188
In recent years, the incidence rate of andrological diseases has shown a significant growth trend. Considering the unavailability of a perfect theoretical system for andrology in traditional Chinese medicine (TCM) and the complex pathogenesis despite of the limited types of andrological diseases, it is necessary to improve the clinical efficacy of andrological diseases so as to satisfy the needs of patients. Therefore, the China Association of Chinese Medicine (CACM) organized the andrologists of TCM and western medicine and the outstanding young clinicians to discuss the andrological diseases responding specifically to TCM or integrated TCM and western medicine, such as chronic prostatitis, male infertility, benign prostatic hyperplasia, erectile dysfunction, and premature ejaculation, determine their diagnostic criteria in western medicine, and standardize the specifications for TCM diagnosis and treatment based on syndrome differentiation, thus formulating recognized and integrated diagnosis and treatment protocols. Apart from proposing suggestions on the treatment of such andrological diseases with TCM and western medicine, the experts have also figured out the andrological diseases responding specifically to TCM, the optimal intervention time of TCM and western medicine, and the suitable measures including surgery. The resulting consensus helps to better guide the formulation of accurate, personalized, and optimized treatment plans in clinical practice and improve the diagnosis and treatment effects of andrological diseases by giving full play to the advantages of TCM, which will in turn contribute to further innovation and development of TCM.


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