1.Randomized, double-blind, parallel-controlled, multicenter, equivalence clinical trial of Jiuwei Xifeng Granules(Os Draconis replaced by Ostreae Concha) for treating tic disorder in children.
Qiu-Han CAI ; Cheng-Liang ZHONG ; Si-Yuan HU ; Xin-Min LI ; Zhi-Chun XU ; Hui CHEN ; Ying HUA ; Jun-Hong WANG ; Ji-Hong TANG ; Bing-Xiang MA ; Xiu-Xia WANG ; Ai-Zhen WANG ; Meng-Qing WANG ; Wei ZHANG ; Chun WANG ; Yi-Qun TENG ; Yi-Hui SHAN ; Sheng-Xuan GUO
China Journal of Chinese Materia Medica 2025;50(6):1699-1705
Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent
;
Child
;
Child, Preschool
;
Female
;
Humans
;
Male
;
Double-Blind Method
;
Drugs, Chinese Herbal/therapeutic use*
;
Tic Disorders/drug therapy*
;
Treatment Outcome
2.Mechanism of Yishen Jiangtang Decoction in regulating endoplasmic reticulum stress-mediated NLRP3 inflammasome to improve renal damage in diabetic nephropathy db/db mice.
Yun-Jie YANG ; Bin-Hua YE ; Chen QIU ; Han-Qing WU ; Bo-Wei HUANG ; Tong WANG ; Shi-Wei RUAN ; Fang GUO ; Jian-Ting WANG ; Ming-Qian JIANG
China Journal of Chinese Materia Medica 2025;50(10):2740-2749
This study aims to explore the mechanism through which Yishen Jiangtang Decoction(YSJTD) regulates endoplasmic reticulum stress(ERS)-mediated NOD-like receptor thermal protein domain associated protein 3(NLRP3) inflammasome to improve diabetic nephropathy(DN) in db/db mice. Thirty db/db mice were randomly divided into the model group, YSJTD group, ERS inhibitor 4-phenylbutyric acid(4-PBA) group, with 10 mice in each group. Additionally, 10 db/m mice were selected as the control group. The YSJTD group was orally administered YSJTD at a dose of 0.01 mL·g~(-1), the 4-PBA group was orally administered 4-PBA at a dose of 0.5 mg·g~(-1), and the control and model groups were given an equal volume of carboxylmethyl cellulose sodium. The treatments were administered once daily for 8 weeks. Food intake, water consumption, and body weight were recorded every 2 weeks. After the intervention, fasting blood glucose(FBG), glycosylated hemoglobin(HbA1c), urine microalbumin(U-mALB), 24-hour urine volume, serum creatinine(Scr), and blood urea nitrogen(BUN) were measured. Inflammatory markers interleukin-1β(IL-1β) and interleukin-18(IL-18) were detected using the enzyme-linked immunosorbent assay(ELISA). Renal pathology was assessed through hematoxylin-eosin(HE), periodic acid-Schiff(PAS), and Masson staining, and transmission electron microscopy(TEM). Western blot was used to detect the expression levels of glucose-regulated protein 78(GRP78), C/EBP homologous protein(CHOP), NLRP3, apoptosis-associated speck-like protein containing CARD(ASC), cysteinyl aspartate-specific proteinase(caspase-1), and gasdermin D(GSDMD) in kidney tissues. The results showed that compared to the control group, the model group exhibited poor general condition, increased weight and food and water intake, and significantly higher levels of FBG, HbA1c, U-mALB, kidney index, 24-hour urine volume, IL-1β, and IL-18. Compared to the model group, the YSJTD and 4-PBA groups showed improved general condition, increased body weight, decreased food intake, and lower levels of FBG, U-mALB, kidney index, 24-hour urine volume, and IL-1β. Specifically, the YSJTD group showed a significant reduction in IL-18 levels compared to the model group, while the 4-PBA group exhibited decreased water intake and HbA1c levels compared to the model group. Although there was a decreasing trend in water intake and HbA1c in the YSJTD group, the differences were not statistically significant. No significant differences were observed in BUN, Scr, and kidney weight among the groups. Renal pathology revealed that the model group exhibited more severe renal damage compared to the control group. Kidney sections from the model group showed diffuse mesangial proliferation in the glomeruli, tubular edema, tubular dilation, significant inflammatory cell infiltration in the interstitium, and increased glycogen staining and blue collagen deposition in the basement membrane. In contrast, the YSJTD and 4-PBA groups showed varying degrees of improvement in renal damage, glycogen staining, and collagen deposition, with the YSJTD group showing more significant improvements. TEM analysis indicated that the model group had extensive cytoplasmic edema, homogeneous thickening of the basement membrane, fewer foot processes, and widening of fused foot processes. In the YSJTD and 4-PBA groups, cytoplasmic swelling of renal tissues was reduced, the basement membrane remained intact and uniform, and foot process fusion improved.Western blot results indicated that compared to the control group, the model group showed upregulation of GRP78, CHOP, GSDMD, NLRP3, ASC, and caspase-1 expression. In contrast, both the YSJTD and 4-PBA groups showed downregulation of these markers compared to the model group. These findings suggest that YSJTD exerts a protective effect against DN by alleviating NLRP3 inflammasome activation through the inhibition of ERS, thereby improving the inflammatory response in db/db DN mice.
Animals
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Endoplasmic Reticulum Stress/drug effects*
;
Diabetic Nephropathies/metabolism*
;
NLR Family, Pyrin Domain-Containing 3 Protein/genetics*
;
Drugs, Chinese Herbal/administration & dosage*
;
Mice
;
Inflammasomes/drug effects*
;
Male
;
Kidney/pathology*
;
Endoplasmic Reticulum Chaperone BiP
;
Humans
;
Interleukin-18/genetics*
;
Mice, Inbred C57BL
3.Challenges and management strategies of anti-tumor treatment for renal insufficiency in elderly patients with malignant tumors
Chengyu ZENG ; Wei QIU ; Hua SONG ; Xinying GUO ; Hongyan YING
Basic & Clinical Medicine 2025;45(10):1262-1269
The incidence of malignant tumors among elderly patients is increasing.Influenced by multiple factors such as aging,tumor,and drug,this population exhibits a high prevalence of renal insufficiency.However,there remains a scarcity of research data and significant challenges in clinical management.This article systematically an-alyzes the challenges faced in administering anti-tumor therapies to elderly patients with renal insufficiency and pro-poses management strategies.Optimization approaches include precise assessment of renal function,selection of nephrotoxicity-sparing medications,appropriate dose adjustments,implementation of preventive measures,and em-phasis on comprehensive geriatric assessment and multidisciplinary collaboration.Renal injury management should be individualized,with considerations for special populations such as renal transplant recipients and dialysis pa-tients.Future efforts should focus on biomarker discovery and the development of low-nephrotoxicity therapeutic agents to address these complex clinical challenges.
4.Research progress of airway epithelial cell senescence mechanism in chronic obstructive pulmonary disease
Zhao-liang LI ; Lue-li WANG ; Qian YI ; Ruo-qiu MA ; Rong GUO ; Chang-li XU ; Xiao-hua DU ; Wei-min YANG
Chinese Pharmacological Bulletin 2025;41(5):805-810
As the first defense of respiratory system,airway epi-thelial cells(AECs)play an important role in separating the re-spiratory internal and external environment.They are essential for the natural immune function.Small airway lesions are an im-portant early pathology of chronic obstructive pulmonary disease(COPD),when AECs are exposed to harmful particles or gases for a long time,the epithelial barrier is damaged,and the signa-ling pathways which involved in differentiation,repair,and in-flammatory are disordered,resulting in epithelial cell cycle stag-nation and accelerated aging.A number of studies have sugges-ted that AECs of COPD patients express high levels of aging markers,suggesting that senescence of AECs is closely related to COPD.This review discusses the potential mechanisms of AECs senescence in COPD,the impact of AECs senescence on the de-velopment and severity of the disease,and highlights potential targets for modulating cellular senescence in airway epithelium as a therapeutic approach in COPD.
5.Design and application of a combination dressing for open-window central venous catheters
Ting ZHOU ; Lei JIANG ; Lin HUA ; Yuan QIU ; Yinying HE ; Youquan ZHOU ; Yuxuan GUO ; Chunrui FAN ; Changwen WU
Chinese Journal of Practical Nursing 2025;41(8):601-607
Objective:To explore the safety, economic benefits, and clinical application effect of the new practical patent open window central venous catheter combination dressing (Patent No.ZL 202121652858.8).Methods:From October 2022 to October 2023, a randomized controlled trial was conducted. A total of 120 tumor patients in Yunnan Cancer Hospital with indwelling central venous catheters who met the inclusion and exclusion criteria were randomly divided into three groups at a ratio of 1∶1∶1 with random digit table, with 40 patients in each group: control group 1, control group 2, and the experimental group. In control group 1, Smith & Nephew IV 3000 dressing was used, in control group 2, 3M transparent dressing was used; and in the experimental group, the self - developed fenestrated central venous catheter combined dressing by the researchers was used for catheter maintenance. The skin surface bacterial colonization, the occurrence of medical adhesive-related skin injuries, catheter maintenance time, and maintenance costs were compared among the three groups.Results:In control group 1, there were 21 males and 19 females, with an average age of (51.53 ± 12.01) years. In control group 2, there were 22 males and 18 females, with an average age of (54.00 ± 11.03) years. In the experimental group, there were 19 males and 21 females, with an average age of (53.60 ± 9.41) years. During the 72 - hour observation period, 1, 3, and 2 cases of bacterial colonization occurred in control group 1, control group 2, and the experimental group respectively, and there was no significant difference among the three groups ( χ2 = 1.10, P = 0.577). No medical adhesive - related skin injury occurred in the experimental group, and there was a significant difference compared with the 4 cases in control group 2 ( χ2 = 4.21, P = 0.040). The average catheter maintenance time and maintenance cost in the experimental group were (15.20 ± 1.56) minutes and (8.11 ± 1.35) yuan respectively. Compared with (21.05 ± 3.31) minutes and (13.16 ± 1.03) yuan in control group 1, the differences were statistically significant ( t = 5.85, 5.05, both P<0.001). Compared with (21.08 ± 3.00) minutes and (15.17 ± 1.63) yuan in control group 2, the differences were also statistically significant ( t = 5.88, 7.06, both P<0.001). Conclusions:The open-window central venous catheter combination dressing designed in this study can effectively reduce the incidence of medical adhesive-related skin injury, and also has a better role in saving maintenance time and reducing maintenance costs, especially for patients who need repeated dressing changes at the puncture point for treatment with the advantages of, convenience, economy, speed, firm fixation and safety.
6.Conserved translational control in cardiac hypertrophy revealed by ribosome profiling.
Bao-Sen WANG ; Jian LYU ; Hong-Chao ZHAN ; Yu FANG ; Qiu-Xiao GUO ; Jun-Mei WANG ; Jia-Jie LI ; An-Qi XU ; Xiao MA ; Ning-Ning GUO ; Hong LI ; Zhi-Hua WANG
Acta Physiologica Sinica 2025;77(5):757-774
A primary hallmark of pathological cardiac hypertrophy is excess protein synthesis due to enhanced translational activity. However, regulatory mechanisms at the translational level under cardiac stress remain poorly understood. Here we examined the translational regulations in a mouse cardiac hypertrophy model induced by transaortic constriction (TAC) and explored the conservative networks versus the translatome pattern in human dilated cardiomyopathy (DCM). The results showed that the heart weight to body weight ratio was significantly elevated, and the ejection fraction and fractional shortening significantly decreased 8 weeks after TAC. Puromycin incorporation assay showed that TAC significantly increased protein synthesis rate in the left ventricle. RNA-seq revealed 1,632 differentially expressed genes showing functional enrichment in pathways including extracellular matrix remodeling, metabolic processes, and signaling cascades associated with pathological cardiomyocyte growth. When combined with ribosome profiling analysis, we revealed that translation efficiency (TE) of 1,495 genes was enhanced, while the TE of 933 genes was inhibited following TAC. In DCM patients, 1,354 genes were upregulated versus 1,213 genes were downregulated at the translation level. Although the majority of the genes were not shared between mouse and human, we identified 93 genes, including Nos3, Kcnj8, Adcy4, Itpr1, Fasn, Scd1, etc., with highly conserved translational regulations. These genes were remarkably associated with myocardial function, signal transduction, and energy metabolism, particularly related to cGMP-PKG signaling and fatty acid metabolism. Motif analysis revealed enriched regulatory elements in the 5' untranslated regions (5'UTRs) of transcripts with differential TE, which exhibited strong cross-species sequence conservation. Our study revealed novel regulatory mechanisms at the translational level in cardiac hypertrophy and identified conserved translation-sensitive targets with potential applications to treat cardiac hypertrophy and heart failure in the clinic.
Animals
;
Humans
;
Cardiomegaly/physiopathology*
;
Ribosomes/physiology*
;
Protein Biosynthesis/physiology*
;
Mice
;
Cardiomyopathy, Dilated/genetics*
;
Ribosome Profiling
7.Structural equation analysis and modeling of fect and ankles WMSDs and its adverse ergonomic factors
Xi ZHANG ; Ning JIA ; Xin SUN ; Meibian ZHANG ; Qing XU ; Huadong ZHANG ; Ruijie LING ; Yimin LIU ; Gang LI ; Yan YIN ; Hua SHAO ; Hengdong ZHANG ; Yanmin QI ; Bing QIU ; Tiebing LIU ; Dayu WANG ; Qiang ZENG ; Yan YE ; Bin XIAO ; Hua ZOU ; Jianchao CHEN ; Dongxia LI ; Yongquan LIU ; Jixiang LIU ; Enfei JIANG ; Jun QI ; Liangying MEI ; Tianlai LI ; Mimi YANG ; Xinwei GUO ; Zhongxu WANG
Chinese Journal of Industrial Hygiene and Occupational Diseases 2025;43(2):101-109
Objective:To explore the structural equation model to explore the levels of work-related musculoskeletal disorders (WMSDs) and various risk factors in the feet and ankle of China's occupational population, providing scientific basis for for preventing WMSDs in feet and ankles.Methods:Data of 73497 national occupational epidemiological cases were selected from June 2018 to December 2023 used the Chinese version of the Electronic Questionnaire on Musculoskeletal Disorders. The adverse ergonomic factors and their source classification standard and confirmatory factor analysis were used to investigate foot and ankle WMSDs and their related risk factors (including individual factors, work organization, work posture, work type, fatigue, etc.) in key occupational groups in China, and structural equation model hypothesis, fitting, verification, and path and intermediary effect analysis were carried out. The model fit evaluation indexes included Chi-square specific degrees of freedom ( χ2/ df), gauge fit index (NFI), Tucker Lewis index (TLI), goodness of Fit index (GFI), adjusted Goodness of Fit index (AGFI) and approximate root mean square error (RMSEA) . Results:A total of 73497 occupational workers were surveyed, with local muscle fatigue and WMSDs incidence rates in the feet and ankles being 17.17% and 12.06%, respectively. The fitting index of the adjusted structural equation model basically meets the standard (GFI=1, AGFI=1, RMESA=0.042, NFI=0.716, TLI=0.663). The top three factors affecting feet and ankle WMSDs are feet and ankle muscle fatigue, work type, and work organization, with standardized path coefficients of 0.221, 0.105, and 0.095, respectively. The top two factors affecting feet and ankle muscle fatigue are work organization and work type, with standardized path coefficients of 0.548 and 0.383, respectively. Feet and ankle muscle fatigue, work type, work organization, and work posture have a direct effect on feet and ankle WMSDs, with effect values of 0.221, 0.105, 0.095, and 0.077, respectively. The organization and type of work can also have indirect effects through feet and ankle muscle fatigue, with effect values of 0.121 and 0.084, respectively.Conclusion:Feet and ankle muscle fatigue has a direct impact on WMSDs, and plays a mediating role between ankle and ankle WMSDs caused by work organization and work type. Feet and ankle muscle fatigue is an important pathway leading to feet and ankle WMSDs. It is recommended that employers and managers detect job fatigue early and take corresponding prevention and intervention measures, which can play a key role in preventing feet and ankle WMSDs.
8.Structural equation analysis and modeling of upper limb WMSDs and their adverse ergonomic factors
Siwu ZHONG ; Ning JIA ; Xin SUN ; Meibian ZHANG ; Qing XU ; Huadong ZHANG ; Ruijie LING ; Yimin LIU ; Gang LI ; Yan YIN ; Hua SHAO ; Jue LI ; Hengdong ZHANG ; Bing QIU ; Dayu WANG ; Qiang ZENG ; Rugang WANG ; Yan YE ; Bin XIAO ; Hua ZOU ; Jianchao CHEN ; Dongxia LI ; Yongquan LIU ; Qinghua SHI ; Jixiang LIU ; Enfei JIANG ; Jun QI ; Liangying MEI ; Xianfeng ZHAO ; Mimi YANG ; Xinwei GUO ; Zhi WANG ; Zhongxu WANG
Chinese Journal of Industrial Hygiene and Occupational Diseases 2025;43(4):254-263
Objective:To explore the structural relationship between WMSDs in the upper limbs and various risk factors in the occupational population in China, based on a large sample epidemiological survey and structural equation analysis, and to establish a structural equation model, so as to lay a foundation for the prevention and control of such diseases.Methods:The Chinese version of the Musculoskeletal Disorders Electronic Questionnaire was used to conduct a nationwide survey on the prevalence of WMSDs in the upper extremity. Six factors related to WMSDs in the upper extremity were extracted by the classification standard of adverse ergonomic factors and their source and confirmatory factor analysis, including work organization, work type, upper extremity work posture, individual factors, upper extremity fatigue and upper extremity WMSDs. The structural equation analysis was carried out and the structural equation model was established.Results:The incidence of WMSDs and fatigue in the upper limbs was 24.44% and 43.76%, respectively. The adjusted structural equation model fitting indicators were generally up to the standard (GFI=1.000, AGFI=1.000, RMSEA=0.043, NFI=0.808, TLI=0.784) . The four exogenous latent variables of work organization, work type, upper limb work posture and individual factors were correlated. There was a strong positive correlation between job type and upper limb work posture ( r=0.865) , a moderate positive correlation between work organization and job type and upper limb work posture ( r=0.570, 0.490) , and a weak negative correlation between individual factors and the other three exogenous latent variables. Upper limb work posture and individual factors had direct effects on upper limb WMSDs, and the effect coefficients were 0.10 and 0.06, respectively. Upper limb fatigue played a mediating role between work organization, work type, upper limb work posture and upper limb WMSDs. The effect coefficient was 0.46, and the composition ratios of indirect effects were 100.0%, 100.0%, and 38.3%, respectively. The direct path effect of upper limb work posture, individual factors and upper limb WMSDs was weaker than the mediating path through upper limb fatigue. Conclusion:When carrying out the prevention and control of upper limbWMSDs, it is necessary to comprehensively consider the pathogenesis path of upper limb muscle fatigue and upper limb WMSDs caused by work organization, work type, and upper limb work posture, so as to provide theoretical reference for improving the prevention and control level of such diseases.
9.Research progress of airway epithelial cell senescence mechanism in chronic obstructive pulmonary disease
Zhao-liang LI ; Lue-li WANG ; Qian YI ; Ruo-qiu MA ; Rong GUO ; Chang-li XU ; Xiao-hua DU ; Wei-min YANG
Chinese Pharmacological Bulletin 2025;41(5):805-810
As the first defense of respiratory system,airway epi-thelial cells(AECs)play an important role in separating the re-spiratory internal and external environment.They are essential for the natural immune function.Small airway lesions are an im-portant early pathology of chronic obstructive pulmonary disease(COPD),when AECs are exposed to harmful particles or gases for a long time,the epithelial barrier is damaged,and the signa-ling pathways which involved in differentiation,repair,and in-flammatory are disordered,resulting in epithelial cell cycle stag-nation and accelerated aging.A number of studies have sugges-ted that AECs of COPD patients express high levels of aging markers,suggesting that senescence of AECs is closely related to COPD.This review discusses the potential mechanisms of AECs senescence in COPD,the impact of AECs senescence on the de-velopment and severity of the disease,and highlights potential targets for modulating cellular senescence in airway epithelium as a therapeutic approach in COPD.
10.Design and application of a combination dressing for open-window central venous catheters
Ting ZHOU ; Lei JIANG ; Lin HUA ; Yuan QIU ; Yinying HE ; Youquan ZHOU ; Yuxuan GUO ; Chunrui FAN ; Changwen WU
Chinese Journal of Practical Nursing 2025;41(8):601-607
Objective:To explore the safety, economic benefits, and clinical application effect of the new practical patent open window central venous catheter combination dressing (Patent No.ZL 202121652858.8).Methods:From October 2022 to October 2023, a randomized controlled trial was conducted. A total of 120 tumor patients in Yunnan Cancer Hospital with indwelling central venous catheters who met the inclusion and exclusion criteria were randomly divided into three groups at a ratio of 1∶1∶1 with random digit table, with 40 patients in each group: control group 1, control group 2, and the experimental group. In control group 1, Smith & Nephew IV 3000 dressing was used, in control group 2, 3M transparent dressing was used; and in the experimental group, the self - developed fenestrated central venous catheter combined dressing by the researchers was used for catheter maintenance. The skin surface bacterial colonization, the occurrence of medical adhesive-related skin injuries, catheter maintenance time, and maintenance costs were compared among the three groups.Results:In control group 1, there were 21 males and 19 females, with an average age of (51.53 ± 12.01) years. In control group 2, there were 22 males and 18 females, with an average age of (54.00 ± 11.03) years. In the experimental group, there were 19 males and 21 females, with an average age of (53.60 ± 9.41) years. During the 72 - hour observation period, 1, 3, and 2 cases of bacterial colonization occurred in control group 1, control group 2, and the experimental group respectively, and there was no significant difference among the three groups ( χ2 = 1.10, P = 0.577). No medical adhesive - related skin injury occurred in the experimental group, and there was a significant difference compared with the 4 cases in control group 2 ( χ2 = 4.21, P = 0.040). The average catheter maintenance time and maintenance cost in the experimental group were (15.20 ± 1.56) minutes and (8.11 ± 1.35) yuan respectively. Compared with (21.05 ± 3.31) minutes and (13.16 ± 1.03) yuan in control group 1, the differences were statistically significant ( t = 5.85, 5.05, both P<0.001). Compared with (21.08 ± 3.00) minutes and (15.17 ± 1.63) yuan in control group 2, the differences were also statistically significant ( t = 5.88, 7.06, both P<0.001). Conclusions:The open-window central venous catheter combination dressing designed in this study can effectively reduce the incidence of medical adhesive-related skin injury, and also has a better role in saving maintenance time and reducing maintenance costs, especially for patients who need repeated dressing changes at the puncture point for treatment with the advantages of, convenience, economy, speed, firm fixation and safety.

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