2.An adaptive Bayesian randomized controlled trial of traditional Chinese medicine in progressive pulmonary fibrosis: Rationale and study design.
Cheng ZHANG ; Yi-Sen NIE ; Chuan-Tao ZHANG ; Hong-Jing YANG ; Hao-Ran ZHANG ; Wei XIAO ; Guang-Fu CUI ; Jia LI ; Shuang-Jing LI ; Qing-Song HUANG ; Shi-Yan YAN
Journal of Integrative Medicine 2025;23(2):138-144
Progressive pulmonary fibrosis (PPF) is a progressive and lethal condition with few effective treatment options. Improvements in quality of life for patients with PPF remain limited even while receiving treatment with approved antifibrotic drugs. Traditional Chinese medicine (TCM) has the potential to improve cough, dyspnea and fatigue symptoms of patients with PPF. TCM treatments are typically diverse and individualized, requiring urgent development of efficient and precise design strategies to identify effective treatment options. We designed an innovative Bayesian adaptive two-stage trial, hoping to provide new ideas for the rapid evaluation of the effectiveness of TCM in PPF. An open-label, two-stage, adaptive Bayesian randomized controlled trial will be conducted in China. Based on Bayesian methods, the trial will employ response-adaptive randomization to allocate patients to study groups based on data collected over the course of the trial. The adaptive Bayesian trial design will employ a Bayesian hierarchical model with "stopping" and "continuation" criteria once a predetermined posterior probability of superiority or futility and a decision threshold are reached. The trial can be implemented more efficiently by sharing the master protocol and organizational management mechanisms of the sub-trial we have implemented. The primary patient-reported outcome is a change in the Leicester Cough Questionnaire score, reflecting an improvement in cough-specific quality of life. The adaptive Bayesian trial design may be a promising method to facilitate the rapid clinical evaluation of TCM effectiveness for PPF, and will provide an example for how to evaluate TCM effectiveness in rare and refractory diseases. However, due to the complexity of the trial implementation, sufficient simulation analysis by professional statistical analysts is required to construct a Bayesian response-adaptive randomization procedure for timely response. Moreover, detailed standard operating procedures need to be developed to ensure the feasibility of the trial implementation. Please cite this article as: Zhang C, Nie YS, Zhang CT, Yang HJ, Zhang HR, Xiao W, Cui GF, Li J, Li SJ, Huang QS, Yan SY. An adaptive Bayesian randomized controlled trial of traditional Chinese medicine in progressive pulmonary fibrosis: Rationale and study design. J Integr Med. 2025; 23(2): 138-145.
Female
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Humans
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Male
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Bayes Theorem
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Disease Progression
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Drugs, Chinese Herbal/therapeutic use*
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Medicine, Chinese Traditional/methods*
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Pulmonary Fibrosis/therapy*
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Quality of Life
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Randomized Controlled Trials as Topic
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Research Design
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Adaptive Clinical Trials as Topic
3.Clinical practice guidelines for the diagnosis and treatment of atopic dermatitis with integrative traditional Chinese and Western medicine.
Xin-Ran DU ; Meng-Yi WU ; Mao-Can TAO ; Ying LIN ; Chao-Ying GU ; Min-Feng WU ; Yi CAO ; Da-Can CHEN ; Wei LI ; Hong-Wei WANG ; Ying WANG ; Yi WANG ; Han-Zhi LU ; Xin LIU ; Xiang-Fei SU ; Fu-Lun LI
Journal of Integrative Medicine 2025;23(6):641-653
Traditional Chinese medicine (TCM) is a well-accepted therapy for atopic dermatitis (AD). However, there are currently no evidence-based guidelines integrating TCM and Western medicine for the treatment of AD, limiting the clinical application of such combined approaches. Therefore, the China Association of Chinese Medicine initiated the development of the current guideline, focusing on key issues related to the use of TCM in the treatment of AD. This guideline was developed in accordance with the principles of the guideline formulation manual published by the World Health Organization. A comprehensive review of the literature on the combined use of TCM and Western medicine to treat AD was conducted. The findings were extensively discussed by experts in dermatology and pharmacy with expertise in both TCM and Western medicine. This guideline comprises 23 recommendations across seven major areas, including TCM syndrome differentiation and classification of AD, principles and application scenarios of TCM combined with Western medicine for treating AD, outcome indicators for evaluating clinical efficacy of AD treatment, integration of TCM pattern classification and Western medicine across disease stages, daily management of AD, the use of internal TCM therapies and proprietary Chinese medicines, and TCM external treatments. Please cite this article as: Du XR, Wu MY, Tao MC, Lin Y, Gu CY, Wu MF, Cao Y, Chen DC, Li W, Wang HW, Wang Y, Wang Y, Lu HZ, Liu X, Su XF, Li FL. Clinical practice guidelines for the diagnosis and treatment of atopic dermatitis with integrative traditional Chinese and Western medicine. J Integr Med. 2025; 23(6):641-653.
Dermatitis, Atopic/drug therapy*
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Humans
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Medicine, Chinese Traditional/methods*
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Integrative Medicine
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Drugs, Chinese Herbal/therapeutic use*
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Practice Guidelines as Topic
4.Construction and characterization of lpxC deletion strain based on CRISPR/Cas9 in Acinetobacter baumannii
Zong-ti SUN ; You-wen ZHANG ; Hai-bin LI ; Xiu-kun WANG ; Jie YU ; Jin-ru XIE ; Peng-bo PANG ; Xin-xin HU ; Tong-ying NIE ; Xi LU ; Jing PANG ; Lei HOU ; Xin-yi YANG ; Cong-ran LI ; Lang SUN ; Xue-fu YOU
Acta Pharmaceutica Sinica 2024;59(5):1286-1294
Lipopolysaccharides (LPS) are major outer membrane components of Gram-negative bacteria. Unlike most Gram-negative bacteria,
5.The role of endoplasmic reticulum stress in gut-pancreas axis dysfunction in type 2 diabetes
Li-ran LEI ; Ya-xin FU ; Quan LIU ; Jia-yu ZHAI ; Zhu-fang SHEN ; Hui CAO ; Shuai-nan LIU
Acta Pharmaceutica Sinica 2024;59(12):3189-3198
Type 2 diabetes mellitus (T2DM) is a complex metabolic disorder characterized by chronic hyperglycemia, hyperlipidemia, and peripheral insulin resistance. Endoplasmic reticulum stress (ERS), a response to cellular stress, is activated across various tissues during the progression of T2DM, leading to disruptions in protein synthesis. Notably, epithelial and endocrine cells with hormone-secreting functions are particularly vulnerable to functional impairments induced by ERS. The gut-pancreas axis is essential for regulating metabolism and the progression of T2DM. Intestinal epithelial L cells, integral to the intestinal barrier, can secrete the glucagon-like peptide-1 (GLP-1). This hormone promotes insulin secretion from pancreatic
6.Correlation Between Hyperbaric Oxygen Therapy Course and Reduction of Clonazepam in Patients with Paroxysmal Sympathetic Hyperactivity: A Retrospective Cohort Study
Sujuan LIU ; Yong WANG ; Ran LI ; Haidong LI ; Jie LIU
Medical Journal of Peking Union Medical College Hospital 2024;16(2):386-392
To analyze the correlation between the duration of hyperbaric oxygen (HBO) therapy and oral medication clonazepam reduction in patients with paroxysmal sympathetic hyperactivity (PSH). Clinical data of patients with secondary PSH after severe brain injury at Capital Medical University Affiliated Fuxing Hospital from September 2017 to July 2023 were retrospectively included, covering general information, etiology, lesion location, comorbidities, vital signs at admission, PSH attack characteristics, HBO treatment frequency, PSH treatment drugs and dosage. According to the number of HBO treatments, PSHpatients were divided into HBO short course group (10 treatments) and HBO long course group (>10 treatments). Multiple logistic regression and rank correlation analysis were used to investigate the correlation between the duration/frequency of HBO treatment and the reduction of clonazepam. A total of 75 PSH patients who met the inclusion and exclusion criteria were selected, including 38 cases (50.7%) who received reduced doses of clonazepam. There were 32 cases (42.7%) in the HBO short course group and 43 cases (52.3%) in the HBO long course group. The reduction rate of clonazepam in the HBO short course group was lower than that in the HBO long course group[31.3% (10/32) vs.65.1% (28/43), crude Long course HBO treatment was positively correlated with oral reduction of clonazepam in PSH patients, which may help reduce the side effects caused by clonazepam and become a non- pharmacological treatment option for PSH.
7.A Case Report of Mitochondrial Diabetes Mellitus Caused by Large FragmentDeletion of Mitochondrial Gene and Literature Review
Ran LI ; Jinhao LIAO ; Hanhui FU ; Hui PAN ; Yuxiu LI ; Jiangfeng MAO ; Hongbo YANG ; Huabing ZHANG
Medical Journal of Peking Union Medical College Hospital 2024;16(3):634-640
Mitochondrial diabetes mellitus (MDM) is a genetically heterogeneous disorder caused by mitochondrial DNA (mtDNA) or nuclear DNA mutations, characterized by multi-system involvement and diverse clinical phenotypes. We report a pediatric case presenting with growth retardation followed by subsequent development of diabetes mellitus. Systematic evaluation revealed concurrent bilateral sensorineural hearing loss, bilateral basal ganglia calcification, and electroencephalographic abnormalities. A post-exercise lactate test demonstrated significant elevation of serum lactate levels immediately after physical exertion. Genetic analysis identified a large-scale mitochondrial DNA deletion spanning from m.8649 to m.16084. This case report is complemented by a literature review focusing on the pathogenesis, genetic characteristics, and therapeutic approaches of mitochondrial diabetes, with particular emphasis on mitochondrial disorders exhibiting large-scale mtDNA deletions alongside diabetic manifestations. Our comprehensive analysis aims to enhance clinical understanding and inform diagnostic strategies for this complex disease entity.
8.Carnosine attenuates OGD/R damage to BV2 cells by inhibiting ROS/NLRP3/GSDMD-mediated pyroptosis
Rui-Li RAN ; Yu-Tong WANG ; Jun-Qiu SONG ; Jiang BIAN ; De-Wei WANG ; Xiao-Han JIANG ; Fu-Lin YOU ; Jing YANG
Chinese Pharmacological Bulletin 2024;40(11):2150-2158
Aim To investigate the protective effect of carnosine on BV2 cell damage induced by oxygen-glu-cose deprivation/reperfusion(OGD/R)and its role in mediating pyrodeath through the ROS/NLRP3/GSDMD pathway.Methods BV2 cells were randomly divided into the control group(Con),model group(OGD/R),carnosine group(OGD/R+CAR),inhibitor group(OGD/R+MCC950),and carnosine+inhibitor group(OGD/R+CAR+MCC950).The cell survival rate was detected by MTT assay.The release rate of lactate dehydrogenase(LDH)in cell supernatant was detected by microenzyme labeling method.Cell damage was as-sessed using Hoechst 33342/SYTOX Green staining.ROS levels in cells were detected by DCFH-DA.The nucleation level of NF-κB p65 was observed by immu-nofluorescence.The protein expression levels of NLRP3,ASC,cleaved caspase-1,and GSDMD-N were detected by Western blot.The levels of IL-1 β and IL-18 in the supernatant were detected by ELISA.Results Com-pared with Con group,the survival rate of cells in the OGD/R group was significantly reduced,LDH release was significantly raised,cell morphology was damaged,and the positive rate of SYTOX Green was significantly elevated with ROS level in cells.The fluorescence in-tensity of NF-κB p65 in the nucleus increased,and the protein expression levels of NLRP3,ASC,cleaved caspase-1,GSDMD-N increased significantly,and the levels of IL-1 β and IL-18 in the cell superserum in-creased significantly.Compared with the OGD/R group,the survival rate of cells in other groups in-creased significantly,the LDH release rate significantly decreased,and the cell damage was improved to a cer-tain extent.The positive rate of SYTOX Green and ROS production in cells significantly decreased,and the fluorescence intensity of NF-κB p65 in nucleus markedly decreased.The expression levels of related proteins and the levels of IL-1 β and IL-18 in cell super-natant significantly decreased.Conclusion Carnosine can protect BV2 cells from OGD/R-induced damage by inhibiting oxidative stress and NF-κB activation,then inhibiting NLRP3/GSDMD signaling pathway.
9.Comparative study of different optimization methods in craniospinal irradiation
Li-Li LIU ; Shan XU ; Fu-Rong RAN ; Qiang LIU
Chinese Medical Equipment Journal 2024;45(9):62-66
Objective To compare the differences in dosimetric parameters between gradient optimization(GO)method and dynamic multi leaf collimator automatic optimization(dMLC-AO)method in craniospinal irradiation(CSI)to provide references for enhancing the feasibility of CSI planning of Monaco treatment planning system.Methods Fifteen patients undergoing CSI at some hospital were retrospectively selected,and a GO plan(enrolled into a GO group)and a dMLC-AO plan(enrolled into a dMLC-AO group)were designed for volumetric modulated arc therapy for each patient by the Monaco treatment planning system.The two groups were compared in terms of the dosimetric parameters of the planning target volume,dose transition zone and organ at risk.SPSS 24.0 statistical software was used for data analysis.Results The dMLC-AO group behaved slightly better than the GO group in D98% and homogeneity index,with the differences being significant(P<0.05),while the two groups were not different statistically in D2%,D50%and conformity index(P>0.05).There were no significant differences between the two groups in radiation doses to the organs at risk except intestinal Dmean(P>0.05).The GO group gained advantages over the dMLC-AO group in dose distribution conformity at the drop zone,and the target volume length covered by the 36 Gy isodose line for the intermdediate-section plan of the GO group was significantly longer than that of the dMLC-AO group.Conclusion GO method behaves better than dMLC-AO method in controlling effectively the dose drop at the dose transition zone of CSI plan.[Chinese Medical Equipment Journal,2024,45(9):62-66]
10.Novel antibacterial drug target against Gram-negative bacteria: lipopolysaccharide transport protein LptDE and its inhibitors
Yue LI ; Guo-qing LI ; Yuan-yuan TIAN ; Cong-ran LI ; Xin-yi YANG ; Kai-hu YAO ; Xue-fu YOU
Acta Pharmaceutica Sinica 2024;59(2):279-288
The outer membrane composed predominantly of lipopolysaccharide (LPS) is an essential biological barrier for most Gram-negative (G-) bacteria. Lipopolysaccharide transport protein (Lpt) complex LptDE is responsible for the critical final stage of LPS transport and outer membrane assembly. The structure and function of LptDE are highly conserved in most G- bacteria but absent in mammalian cells, and thus LptDE complex is regarded as an attractive antibacterial target. In recent 10 years, the deciphering of the three-dimensional structure of LptDE protein facilities the drug discovery based on such "non

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