1.Clinical Efficacy and Mechanisms of Qigui Didang Decoction in Treatment of Stage Ⅲ-Ⅳ Diabetic Kidney Disease with Kidney Collateral Stasis Syndrome in Real World
Yingchao WANG ; Jiaqi WANG ; Zongjiang ZHAO ; Hua ZHANG ; Jiannan ZHOU ; Jiangteng LIU ; Zhichao RUAN ; Weijun HUANG ; Jinxi ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):162-169
ObjectiveTo investigate the clinical efficacy and mechanisms of Qigui Didang decoction in the treatment of kidney collateral stasis syndrome in patients with stage Ⅲ-Ⅳ diabetic kidney disease (DKD) in a real-world setting. MethodsPatients with stage Ⅲ-Ⅳ DKD with kidney collateral stasis syndrome admitted to Beijing Aerospace General Hospital from January 2022 to December 2024 were selected for clinical study. According to treatment methods, patients were divided into the Qigui Didang decoction group (Qigui Didang decoction + conventional treatment) and the control group (conventional treatment alone). A 1∶1 propensity score matching (PSM) method was used to reduce bias caused by confounding factors. Clinical efficacy, traditional Chinese medicine (TCM) symptom scores, renal function indicators, mRNA expression related to pathway mechanisms, glycolipid metabolism indices, and adverse reactions were compared between the two groups. ResultsA total of 120 patients with stage Ⅲ-Ⅳ DKD with kidney collateral stasis syndrome were included, including 62 cases in the Qigui Didang Decoction group and 58 cases in the control group. Before matching, there were statistically significant differences between the two groups in DKD stage, baseline urinary albumin-to-creatinine ratio (UACR), 24-hour urine total protein (24 h-UTP), and estimated glomerular filtration rate (eGFR) (P<0.05). After matching, 47 cases were included in each group, and there was no statistically significant difference in baseline data between the two groups. After matching, the total clinical effective rate of the Qigui Didang decoction group was significantly higher than that of the control group (χ2=4.681, P<0.05). Compared with data before treatment, the scores of primary and secondary TCM symptoms in the Qigui Didang decoction group were significantly decreased (P<0.05). Compared with data before treatment, serum creatinine (SCr), 24 h-UTP, and UACR levels were significantly decreased, while eGFR was significantly increased in the Qigui Didang decoction group (P<0.05). Compared with data before treatment, the mRNA expression of silent information regulator 1 (Sirt1) was significantly upregulated, while the mRNA expression of nuclear factor-kappa B (NF-κB) and tumor suppressor protein p53 (p53) was significantly downregulated in the Qigui Didang decoction group (P<0.05). Compared with data before treatment, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (2 hPG), glycated hemoglobin A1c (HbA1c), total cholesterol (TC), triglycerides (TG), and low-density lipoprotein cholesterol (LDL-C) levels were decreased, while high-density lipoprotein cholesterol (HDL-C) levels were increased (P<0.05). There was no statistically significant difference in adverse reactions between the two groups. ConclusionQigui Didang decoction combined with conventional treatment can significantly improve renal function, glycolipid metabolism, and TCM syndromes in patients with stage Ⅲ-Ⅳ DKD with kidney collateral stasis syndrome, with good safety. The mechanism may be related to the regulation of the Sirt1/NF-κB/p53 signaling pathway.
2.Clinical Efficacy and Mechanisms of Qigui Didang Decoction in Treatment of Stage Ⅲ-Ⅳ Diabetic Kidney Disease with Kidney Collateral Stasis Syndrome in Real World
Yingchao WANG ; Jiaqi WANG ; Zongjiang ZHAO ; Hua ZHANG ; Jiannan ZHOU ; Jiangteng LIU ; Zhichao RUAN ; Weijun HUANG ; Jinxi ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):162-169
ObjectiveTo investigate the clinical efficacy and mechanisms of Qigui Didang decoction in the treatment of kidney collateral stasis syndrome in patients with stage Ⅲ-Ⅳ diabetic kidney disease (DKD) in a real-world setting. MethodsPatients with stage Ⅲ-Ⅳ DKD with kidney collateral stasis syndrome admitted to Beijing Aerospace General Hospital from January 2022 to December 2024 were selected for clinical study. According to treatment methods, patients were divided into the Qigui Didang decoction group (Qigui Didang decoction + conventional treatment) and the control group (conventional treatment alone). A 1∶1 propensity score matching (PSM) method was used to reduce bias caused by confounding factors. Clinical efficacy, traditional Chinese medicine (TCM) symptom scores, renal function indicators, mRNA expression related to pathway mechanisms, glycolipid metabolism indices, and adverse reactions were compared between the two groups. ResultsA total of 120 patients with stage Ⅲ-Ⅳ DKD with kidney collateral stasis syndrome were included, including 62 cases in the Qigui Didang Decoction group and 58 cases in the control group. Before matching, there were statistically significant differences between the two groups in DKD stage, baseline urinary albumin-to-creatinine ratio (UACR), 24-hour urine total protein (24 h-UTP), and estimated glomerular filtration rate (eGFR) (P<0.05). After matching, 47 cases were included in each group, and there was no statistically significant difference in baseline data between the two groups. After matching, the total clinical effective rate of the Qigui Didang decoction group was significantly higher than that of the control group (χ2=4.681, P<0.05). Compared with data before treatment, the scores of primary and secondary TCM symptoms in the Qigui Didang decoction group were significantly decreased (P<0.05). Compared with data before treatment, serum creatinine (SCr), 24 h-UTP, and UACR levels were significantly decreased, while eGFR was significantly increased in the Qigui Didang decoction group (P<0.05). Compared with data before treatment, the mRNA expression of silent information regulator 1 (Sirt1) was significantly upregulated, while the mRNA expression of nuclear factor-kappa B (NF-κB) and tumor suppressor protein p53 (p53) was significantly downregulated in the Qigui Didang decoction group (P<0.05). Compared with data before treatment, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (2 hPG), glycated hemoglobin A1c (HbA1c), total cholesterol (TC), triglycerides (TG), and low-density lipoprotein cholesterol (LDL-C) levels were decreased, while high-density lipoprotein cholesterol (HDL-C) levels were increased (P<0.05). There was no statistically significant difference in adverse reactions between the two groups. ConclusionQigui Didang decoction combined with conventional treatment can significantly improve renal function, glycolipid metabolism, and TCM syndromes in patients with stage Ⅲ-Ⅳ DKD with kidney collateral stasis syndrome, with good safety. The mechanism may be related to the regulation of the Sirt1/NF-κB/p53 signaling pathway.
3.Psychological Stress-induced Immune Dysregulation: The Key Factor Undermining Aerobic Exercise’s Antagonism Against Tumor Progression
Xin ZHOU ; Hua ZHANG ; Jing-Jing LIU ; Hui-Xin PAN ; Jing ZHANG ; Qing-Lu WANG
Progress in Biochemistry and Biophysics 2026;53(6):1656-1671
Cancer is one of the most lethal and burdensome diseases worldwide. Its progression not only causes irreversible damage to the body, but also imposes a substantial psychological burden on patients due to its complex prognosis. Immune imbalance, a hallmark of the tumor microenvironment (TME), accelerates tumor invasion and metastasis by impairing the function of effector immune cells, promoting the abnormal infiltration of immunosuppressive cells, and disrupting cytokine homeostasis, thereby constituting a major barrier to the efficacy of cancer immunotherapy. Compared with conventional chemotherapy and radiotherapy, aerobic exercise has shown considerable potential in antagonizing tumor progression through relatively mild but effective immunomodulatory mechanisms. On the one hand, regular aerobic exercise enhances the number and activity of key effector immune cells, such as CD8+ T cells, thereby strengthening their ability to recognize and eliminate tumor cells and alleviate immune imbalance. On the other hand, aerobic exercise promotes tumor vascular normalization, improves vascular maturity, and stimulates the secretion of irisin and other anti-inflammatory myokines, thereby remodeling the TME and relieving its immunosuppressive state to delay tumor progression. However, psychological stress following a cancer diagnosis can not only act as an independent disruptive factor that exacerbates immune imbalance within the TME, but also amplify the effects of other detrimental factors, such as reduced treatment adherence, thereby further weakening the antagonistic effect of aerobic exercise on tumor growth. Psychological stress, as a chronic stressor, promotes the excessive secretion of emotion-related hormones, including glucocorticoids (GCs) and norepinephrine (NE), which further suppress the activation and effector functions of antitumor immune cells such as CD8+ T cells and natural killer (NK) cells, while facilitating the recruitment of protumor immune cells such as regulatory T cells (Tregs). These changes ultimately disrupt immune homeostasis in the TME, promote tumor immune evasion, accelerate tumor invasion and metastasis, and offset the beneficial effects of aerobic exercise on tumor control. In addition, psychological stress induces hyperactivation of the hypothalamic-pituitary-adrenal (HPA) axis and abnormal excitation of the sympathetic nervous system (SNS), thereby maintaining elevated levels of GCs, NE, and related stress hormones, suppressing inflammatory chemokine expression and immune cell recruitment, and further disturbing immune homeostasis in the TME, which accelerates tumor progression. More importantly, prolonged psychological stress can also disrupt the homeostasis of central neurotransmitters, such as 5-hydroxytryptamine (5-HT) and glutamate (Glu). This not only directly inhibits the activation and effector functions of antitumor immune cells and promotes the establishment of an immunosuppressive microenvironment, but also impairs cellular energy metabolism and continuously provides energy for tumor cells through metabolic reprogramming, thereby sustaining rapid tumor growth and adaptation to a hostile TME. Ultimately, these alterations contribute to the dysregulation of “neuro-endocrine-immune” axis and weaken the protective effect of aerobic exercise against tumor progression. Therefore, this review focuses on the interaction between psychological stress and the “neuro-endocrine-immune” axis, with particular emphasis on the mechanisms by which psychological stress induces immune imbalance and weakens the antagonistic effect of aerobic exercise on tumor progression. We further highlight the important role of psychological stress in tumor progression and propose that combining psychotropic interventions, aerobic exercise, and clinical antitumor immunotherapy may help restore the tumor-killing capacity of the immune system. Such a multimodal strategy may exert synergistic effects at multiple levels, including psychological stress relief, neuroendocrine regulation, and reconstruction of immune homeostasis, thereby providing new perspectives for identifying therapeutic targets in solid tumors, enhancing the efficacy of cancer immunotherapy, and improving patient prognosis.
4.Clinical Efficacy and Radiographic Outcomes of Manipulative Reduction Combined with Small Splint Fixation for Distal Radius Fractures:A Retrospective Multicenter Study with Propensity Score Matching
Mao WU ; Guoda DAI ; Yang SHAO ; Shaoshuo LI ; Zhen HUA ; Hengyan CUI ; Tingchen ZHU ; Dipeng LI ; Jintao LIU ; Ming ZHOU ; Peimin WANG ; Liyong ZHANG ; Jianwei WANG
Journal of Traditional Chinese Medicine 2026;67(10):1086-1092
ObjectiveTo observe the clinical efficacy and radiographic outcomes of manipulative reduction combined with small splint fixation in the treatment of distal radius fractures. MethodsThe clinical data of 1051 patients with distal radius fractures were retrospectively collected from five hospitals included in the Jiangsu Diagnosis and Treatment Data Platform for Traditional Chinese Medicine(TCM) Dominant Diseases. Propensity score matching at a 1∶4 ratio was applied, resulting in 580 cases selected for final analysis, which comprised 448 patients in the TCM group(manipulative reduction plus small splint fixation) and 132 in the surgical treatment group(open reduction and internal fixation). Each group was further stratified into type A, B, and C subgroups based on AO fracture classification. Radiographic indicators including palmar tilt, radial inclination, and radial height were compared between groups before treatment and 1 day, 1 week, and 4-6 weeks after treatment, and pain visual analog scale(VAS) scores before treatment and 1 week and 4-6 weeks after treatment were also compared. Wrist joint function was assessed 12 weeks after treatment, using the Dienst wrist function score and the Gartland and Werley(G-W) wrist function score. Additionally, the radiographic indicators at different timepoints and the 12-week wrist function levels were compared between groups across different fracture types. ResultsNo statistically significant difference was observed in radiographic indicators and VAS scores at all timepoints before and after treatment, as well as wrist joint function grades assessed by the Dienst score and the G-W score at 12 weeks after treatment (P>0.05). Compared to those before treatment, both groups showed increased palmar tilt, radial inclination, and radial height 1 week and 4-6 weeks after treatment, and decreased VAS scores (P<0.05). Compared to those 1 week after treatment, both groups showed a decrease in palmar tilt, an increase in radial inclination and radial height, and a reduction in VAS score 4-6 weeks after treatment(P<0.05). In type A and B subgroups, the surgical treatment group had a higher radial inclination than the TCM group 4-6 weeks after treatment, while in the type C subgroup, a higher radial height was shown in the surgical treatment group than in the TCM group 4-6 weeks after treatment(P<0.05). In type C subgroup, there was significant difference between groups in the wrist joint function by G-W scores 12 weeks after treatment(P<0.05). ConclusionManipulative reduction combined with small splint fixation can maintain fracture alignment and alleviate pain in treating distal radius fractures, which achieves therapeutic outcomes comparable to surgical treatment. It is particularly suitable for type A and B fractures and can be considered an effective treatment option for distal radius fractures.
5.Construction and Clinical Validation of a Deep Learning-Based Automatic Measurement Model for Palmar Tilt and Radial Inclination in Distal Radius Fractures
Guoda DAI ; Jianwei WANG ; Mao WU ; Bin KANG ; Yang SHAO ; Hengyan CUI ; Shaoshuo LI ; Tingchen ZHU ; Zhen HUA ; Zhongming SHEN ; Jintao LIU ; Ming ZHOU
Journal of Traditional Chinese Medicine 2026;67(10):1093-1100
ObjectiveTo construct an automatic measurement model for palmar tilt and radial inclination suitable for traditional Chinese medicine (TCM) clinical scenarios, and to validate its accuracy and efficiency in TCM manipulative reduction settings. MethodsData on anteroposterior (AP) and lateral X-rays of distal radius fractures were collected from patients admitted to 18 TCM/ integrated TCM and western medicine hospitals in Jiangsu province between September 1st, 2023, and September 1st, 2024, via the Jiangsu Diagnosis and Treatment Big Data Platform for TCM Dominant Diseases. A medical image segmentation framework based on multi-scale feature fusion and edge-awareness was employed, combined with anatomical knowledge specific to TCM orthopedics, to optimize the feature extraction strategy of an artificial intelligence (AI) model. This framework enabled automatic segmentation of fracture regions and measurement of distal radius palmar tilt and radial inclination. The accuracy of the AI model in measuring radial inclination and volar tilt was validated, and the measurement time and average time gain rate of the AI model were compared to those of manual measurement. ResultsA total of 15,444 AP and lateral X-ray images of distal radius fractures were collected, and were divided into a training set (11,144 images, 5066 AP and 6078 lateral), a validation set (3700 images, 1840 AP and 1860 lateral), and an independent test set (600 images, 300 AP and 300 lateral) after preprocessing. In the measurement of 300 AP X-rays in the independent test set for radial inclination, when the degree error between AI measurement and manual measurement was <3° and <5°, AI measurement accuracy was 83% and 93%, respectively. In 300 lateral X-rays in the test set for palmar tilt, when AI measurements had an error of <3° and <5° compared to manual measurements, corresponding accuracy rate was 78% and 90%, respectively. For 50 X-ray images, AI measurement time was (1.37±0.05) min for radial inclination while manual measurement time was (22.57±2.52) min (P<0.001); in terms of palmar tilt, the AI measurement time was (1.33±0.14) min, shorter than (23.70±2.80) min for manual measurement time (P<0.001). Average time gain rates for manual and AI measurements were 93.93% and 94.39% respectively. ConclusionAn automatic measurement model for palmar tilt and radial inclination in distal radius fractures has been established, enabling more accurate and efficient assessment as well as providing a tool to support the quantitative evaluation of the efficacy of TCM manipulative reduction and large-sample clinical research.
6.Three cases of acquired ocular toxoplasmosis
Rui-rui LI ; Shu ZHOU ; Hua LIU ; Bo ZHOU ; Yu-zhang HU
Acta Parasitologica et Medica Entomologica Sinica 2026;33(1):66-68
In this study, there were three toxoplasmosis patients, two of whom developed symptoms in both eyes. One patient had a slight deviation of the lesion from the central fovea, which had a minor impact on vision. The diagnosis of this disease requires not only a close pet contact history and typical clinical manifestations, but also serology and the gold standard Goldmann-Witmer coefficient(GWC). However, the GWC of some patients cannot be detected at the initial stage, such as the first patient′s GWC, which did not meet the standard. All three patients underwent metagenomic testing to assist with diagnosis.
7.Analysis and prevention strategies for abnormal blood waste events in blood collection and supply processes
Kaiqiang LIU ; Huayou DAI ; Minyu HUA ; Tingting HU ; Weifei QIN ; Jixia ZHOU ; Xiaojing LIU ; Huaying CAI ; Chenghui LUO ; Shoubing ZHU ; Yanhua SHI ; Xi DENG ; Xia HUANG
Chinese Journal of Blood Transfusion 2026;39(8):1061-1066
Objective: To analyze the characteristics and key risk factors of abnormal blood disposal throughout the 2024-2025 blood collection and supply process based on nationwide multi-site monitoring data, develop a comprehensive prevention and control strategy across the entire chain, reduce preventable blood waste, and ensure clinical blood safety. Methods: According to the Guidelines for Haemovigilance (T/CSBT 001-2026), we extracted 74 cases of abnormal blood disposal events reported by the China Blood Transfusion Association′s Blood Safety Monitoring System from January 1 2024, to December 31 2025, and conducted descriptive statistical analysis on the distribution of events, types of deviations, root causes, and classifications of disposal manifestations. Results: A total of 664 adverse events related to blood collection and supply were reported over two years, with 74 cases involving discarded abnormal blood units, accounting for 11.1% of the total. Among these, blood component preparation (40.5%) and blood collection (37.8%) remained traditional high-risk stages. The proportion of blood waste occurring during storage, distribution, and transportation increased from 7.7% in 2024 to 34.3% in 2025. Deviations from standard operating procedures (SOP) by personnel were the primary cause, accounting for 74.3% of cases. Discarded blood units were categorized into four types: compromised closed blood bag systems (40 cases), mainly due to inadequate heat sealing, physical damage, or dropped bags; blood out of the cold chain (12 cases), primarily resulting from blood being left at work sites; imbalanced proportion of preservation solution (10 cases), mostly caused by blood collection volumes exceeding the standard capacity of blood bags; and other causes (12 cases). Conclusion: Human operational errors are the core cause of abnormal blood waste. The collection and preparation stages have long been at high-risk, and the risks in the storage and transportation stages have been increasing year by year. We should focus on standardizing personnel management, improving specialized operation norms such as heat sealing, transportation, and storage, establishing a full-process intelligent cold chain monitoring and multi-node visual verification mechanism, and systematically reducing the occurrence rate of abnormal blood waste through a closed-loop quality intervention system, thereby improving the utilization efficiency of voluntary blood donation resources.
8.Effects of Zuogui Pill (左归丸) Decoction on Cerebral Perfusion and Corticospinal Tract Remodeling in Patients With Ischemic Stroke of the Liver-Kidney Yin Deficiency Syndrome
Xinyu XU ; Dan WU ; Xiaohui YAN ; Hao HUA ; Siqi MEI ; Zihan ZHOU ; Jinglin ZHAO ; Shiyu HE ; Xiaoyu FEI ; Yangfan LIU ; Yue SU ; Li LI ; Wenlei LI
Journal of Traditional Chinese Medicine 2026;67(21):2302-2310
ObjectiveTo evaluate the clinical efficacy of Zuogui Pill (左归丸,ZGP) decoction on neurological function, motor function, and activities of daily living in patients with ischemic stroke (IS) of liver-kidney yin deficiency syndrome, and to assess its potential mechanisms from the perspectives of cerebral perfusion and corticospinal tract (CST) remodeling. MethodsA total of 108 patients with IS of liver-kidney yin deficiency syndrome and onset time ≤14 days were enrolled and randomly divided into a control group and a treatment group, with 54 cases in each group. The control group received conventional western medicine, while the treatment group received ZGP decoction (one dose per day) in addition to the conventional treatment. Both groups were treated for 90 days. The National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), modified Barthel Index (MBI), Fugl-Meyer Assessment (FMA), and Chinese medicine syndrome score (CMS) were evaluated before treatment and after (90±3) days of treatment. Three-dimensional arterial spin labeling (3D-ASL) and diffusion tensor imaging (DTI) were performed to obtain ipsilesional cerebral blood flow (CBF) in the unaffected and affected hemispheres, relative CBF (rCBF), and fractional anisotropy (FA) of the CST. Nodal analysis of FA values along the CST was also conducted. Correlation analysis was used to assess the relationships between post-treatment cerebral perfusion parameters (CBF and rCBF), and FA values with clinical neurological function scores. ResultsAfter treatment, both groups showed significantly decreased NIHSS, mRS and CMS scores, together with significantly increased FMA and MBI scores (P<0.01). Intergroup comparison showed that NIHSS, mRS, and CMS scores in the treatment group were significantly lower than those in the control group , while MBI and FMA scores were significantly higher (P<0.01). The 3D-ASL results revealed that CBF and rCBF values in the affected hemisphere significantly increased in both groups after treatment, and the treatment group had significantly higher values (P<0.01). DTI showed that the FA value of the CST on the affected side in the treatment group was significantly higher than that in the control group after treatment (P<0.05). Nodal analysis along the CST further demonstrated that the continuity of FA values at lesion-related nodes 45~99 in the treatment group was significantly better than that in the control group (P<0.01), with significant increases at nodes 65~71 and 76~81 compared with baseline (P<0.05 or P<0.01), whereas the control group showed a decreasing trend at nodes 80~93 (P<0.05). Correlation analysis indicated that CBF and rCBF values in the affected hemisphere were negatively correlated with NIHSS and mRS scores and positively correlated with MBI score (P<0.05). FA value of the CST on the affected side, both before and after treatment, were negatively correlated with NIHSS score and positively correlated with FMA score (P<0.05 or P<0.01). ConclusionZGP decoction can effectively improve neurological function, motor function, and activities of daily living in IS patients with liver-kidney yin deficiency syndrome, and its mechanism may be related to enhanced cerebral perfusion in the affected hemisphere and corticospinal tract structural remodeling.
9.Triglyceride-glucose index and homocysteine in association with the risk of stroke in middle-aged and elderly diabetic populations
Xiaolin LIU ; Jin ZHANG ; Zhitao LI ; Xiaonan WANG ; Juzhong KE ; Kang WU ; Hua QIU ; Qingping LIU ; Jiahui SONG ; Jiaojiao GAO ; Yang LIU ; Qian XU ; Yi ZHOU ; Xiaonan RUAN
Shanghai Journal of Preventive Medicine 2025;37(6):515-520
ObjectiveTo investigate the triglyceride-glucose (TyG) index and the level of serum homocysteine (Hcy) in association with the incidence of stroke in type 2 diabetes mellitus (T2DM) patients. MethodsBased on the chronic disease risk factor surveillance cohort in Pudong New Area, Shanghai, excluding those with stroke in baseline survey, T2DM patients who joined the cohort from January 2016 to October 2020 were selected as the research subjects. During the follow-up period, a total of 318 new-onset ischemic stroke patients were selected as the case group, and a total of 318 individuals matched by gender without stroke were selected as the control group. The Cox proportional hazards regression model was used to adjust for confounding factors and explore the serum TyG index and the Hcy biochemical indicator in association with the risk of stroke. ResultsThe Cox proportional hazards regression results showed that after adjusting for confounding factors, the risk of stroke in T2DM patients with 10 μmol·L⁻¹
10.Safety of teriflunomide in Chinese adult patients with relapsing multiple sclerosis: A phase IV, 24-week multicenter study.
Chao QUAN ; Hongyu ZHOU ; Huan YANG ; Zheng JIAO ; Meini ZHANG ; Baorong ZHANG ; Guojun TAN ; Bitao BU ; Tao JIN ; Chunyang LI ; Qun XUE ; Huiqing DONG ; Fudong SHI ; Xinyue QIN ; Xinghu ZHANG ; Feng GAO ; Hua ZHANG ; Jiawei WANG ; Xueqiang HU ; Yueting CHEN ; Jue LIU ; Wei QIU
Chinese Medical Journal 2025;138(4):452-458
BACKGROUND:
Disease-modifying therapies have been approved for the treatment of relapsing multiple sclerosis (RMS). The present study aims to examine the safety of teriflunomide in Chinese patients with RMS.
METHODS:
This non-randomized, multi-center, 24-week, prospective study enrolled RMS patients with variant (c.421C>A) or wild type ABCG2 who received once-daily oral teriflunomide 14 mg. The primary endpoint was the relationship between ABCG2 polymorphisms and teriflunomide exposure over 24 weeks. Safety was assessed over the 24-week treatment with teriflunomide.
RESULTS:
Eighty-two patients were assigned to variant ( n = 42) and wild type groups ( n = 40), respectively. Geometric mean and geometric standard deviation (SD) of pre-dose concentration (variant, 54.9 [38.0] μg/mL; wild type, 49.1 [32.0] μg/mL) and area under plasma concentration-time curve over a dosing interval (AUC tau ) (variant, 1731.3 [769.0] μg∙h/mL; wild type, 1564.5 [1053.0] μg∙h/mL) values at steady state were approximately similar between the two groups. Safety profile was similar and well tolerated across variant and wild type groups in terms of rates of treatment emergent adverse events (TEAE), treatment-related TEAE, grade ≥3 TEAE, and serious adverse events (AEs). No new specific safety concerns or deaths were reported in the study.
CONCLUSION:
ABCG2 polymorphisms did not affect the steady-state exposure of teriflunomide, suggesting a similar efficacy and safety profile between variant and wild type RMS patients.
REGISTRATION
NCT04410965, https://clinicaltrials.gov .
Humans
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Crotonates/adverse effects*
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Toluidines/adverse effects*
;
Nitriles
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Hydroxybutyrates
;
Female
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Male
;
Adult
;
ATP Binding Cassette Transporter, Subfamily G, Member 2/genetics*
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Middle Aged
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Multiple Sclerosis, Relapsing-Remitting/genetics*
;
Prospective Studies
;
Young Adult
;
Neoplasm Proteins/genetics*
;
East Asian People


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