1.Clinical Observation and Mechanism Study of Xu's Shenqi Yizhu Decoction Combined with Chemotherapy in the Treatment of Cancer-related Fatigue of Stagnated-toxin Spleen Deficiency Type in Postoperative Gastric Cancer Patients
Zhixiang SHEN ; Weimin LU ; Chuan SHI ; Mengwei YE ; Mengyuan LEI ; Ziyun LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(8):143-151
		                        		
		                        			
		                        			ObjectiveTo evaluate the clinical efficacy of Xu's Shenqiyizhu (SQYZ) decoction combined with chemotherapy in the treatment of cancer-related fatigue (CRF) of stagnated-toxin spleen deficiency type after gastric cancer surgery and explore its possible mechanism. MethodsFifty postoperative gastric cancer patients with CRF of stagnated-toxin spleen deficiency type were selected and randomly divided into an experimental group and a control group by using a random number table,with 25 cases in each group. The control group was treated with FLOT chemotherapy (50 mg·m-2 docetaxel (iv drip on day 1) + 85 mg·m-2 oxaliplatin (iv drip on day 1) + 200 mg·m-2 calcium folinate (iv drip on day 1) + 2 600 mg·m-2 fluorouracil (iv drip for 24 h on day 1),once every three weeks) and basic and symptomatic supportive treatment. The experimental group was treated with Xu's SQYZ decoction (decocted twice,200 mL taken orally twice a day) in addition to the treatment of the control group. One course of treatment lasted for three weeks,with a total of four courses conducted. Observation was performed on the piper fatigue scale (PFS) scores,karnofsky performance status (KPS) scores,European Organization for Research and Treatment of cancer quality of life questionnaire (EORTC QLQ-C30) scores,traditional Chinese medicine syndrome scores,and serum levels of tumor necrosis factor-α (TNF-α),interferon-γ (IFN-γ),and interleukin-6 (IL-6)detected via enzyme linked immunosorbent assay (ELISA) before and after treatment in the two groups. The safety test results before and after treatment for the two groups of patients,as well as the occurrence of adverse events during treatment, were recorded. Transcriptome sequencing data of peripheral blood samples from gastric adenocarcinoma patients and normal individuals were downloaded from the gene expression omnibus (GEO) database,and differentially expressed genes between the tumor and normal groups were identified. Differential gene enrichment analysis was made based on the Kyoto Encyclopedia of Genes and Genomes (KEGG) and Gene Ontology (GO). The CRF relevance scores of genes were retrieved from the GeneCards database. Results① Compared with that before treatment,the total PFS score in the experimental group was significantly reduced (P<0.05). Compared with the control group after treatment,the experimental group showed significantly reduced total PFS score (P<0.05). ② Compared with that before treatment,the KPS score in the experimental group decreased significantly (P<0.05). Compared with the control group after treatment,the experimental group exhibited a significantly decreased KPS score (P<0.05). The experimental group demonstrated significantly increased functional scores (physical function,role function,emotional function,social function,and overall health) (P<0.05) and significantly reduced symptom scores (fatigue,shortness of breath,loss of appetite,constipation,and diarrhea) of the EORTC QLQ-C30 scale after treatment compared with before treatment. Compared with the control group after treatment,the experimental group presented significantly increased functional scores (physical function,emotional function,social function,and overall health) (P<0.05) and significantly reduced symptom scores (fatigue,nausea and vomiting,shortness of breath,loss of appetite,and diarrhea) of the EORTC QLQ-C30 scale (P<0.05). Compared with those before treatment,the traditional Chinese medicine syndrome scores (eating too little and poor digestion,fatigue and weakness,postprandial bloating,abnormal bowel movements,lassitude and weakness,and total score) in the experimental group were significantly reduced (P<0.05). Compared with the control group after treatment,the experimental group had significantly reduced traditional Chinese medicine syndrome scores (eating too little and poor digestion,fatigue and weakness,nausea and vomiting,and sallow complexion) (P<0.05), which indicated better efficacy in the experimental group than in the control group (χ2=7.996,P<0.05). The serum levels of TNF-α,IL-6,and IFN-γ were significantly correlated with each other (P<0.01). Compared with those before treatment,the levels of serum cytokines TNF-α,IL-6,and IFN-γ in the experimental group were significantly reduced (P<0.05). Compared with the control group after treatment,the experimental group showed significantly reduced serum levels of cytokines TNF-α,IL-6,and IFN-γ (P<0.05). ③ There were no significant intra-group and inter-group differences in the safety test results of the two groups before and after treatment. During the treatment period,there was no significant difference in the incidence of adverse reactions between the two groups of patients. ④ Compared with the normal group,the tumor group exhibited a total of 328 significantly up-regulated genes in the peripheral blood (P<0.05),and KEGG and GO analyses showed that they were significantly enriched in signaling pathways such as TNF (P<0.05). ⑤ TNF,IL6,IFNG, and other cytokine encoding genes may be key pathogenic genes for CRF. ConclusionXu's SQYZ decoction can alleviate symptoms such as fatigue in postoperative chemotherapy patients with gastric cancer and improve their functional status and quality of life. Its mechanism may be related to improving cytokine imbalance. 
		                        		
		                        		
		                        		
		                        	
2.Predictive Modeling of Symptomatic Intracranial Hemorrhage Following Endovascular Thrombectomy: Insights From the Nationwide TREAT-AIS Registry
Jia-Hung CHEN ; I-Chang SU ; Yueh-Hsun LU ; Yi-Chen HSIEH ; Chih-Hao CHEN ; Chun-Jen LIN ; Yu-Wei CHEN ; Kuan-Hung LIN ; Pi-Shan SUNG ; Chih-Wei TANG ; Hai-Jui CHU ; Chuan-Hsiu FU ; Chao-Liang CHOU ; Cheng-Yu WEI ; Shang-Yih YAN ; Po-Lin CHEN ; Hsu-Ling YEH ; Sheng-Feng SUNG ; Hon-Man LIU ; Ching-Huang LIN ; Meng LEE ; Sung-Chun TANG ; I-Hui LEE ; Lung CHAN ; Li-Ming LIEN ; Hung-Yi CHIOU ; Jiunn-Tay LEE ; Jiann-Shing JENG ;
Journal of Stroke 2025;27(1):85-94
		                        		
		                        			 Background:
		                        			and Purpose Symptomatic intracranial hemorrhage (sICH) following endovascular thrombectomy (EVT) is a severe complication associated with adverse functional outcomes and increased mortality rates. Currently, a reliable predictive model for sICH risk after EVT is lacking. 
		                        		
		                        			Methods:
		                        			This study used data from patients aged ≥20 years who underwent EVT for anterior circulation stroke from the nationwide Taiwan Registry of Endovascular Thrombectomy for Acute Ischemic Stroke (TREAT-AIS). A predictive model including factors associated with an increased risk of sICH after EVT was developed to differentiate between patients with and without sICH. This model was compared existing predictive models using nationwide registry data to evaluate its relative performance. 
		                        		
		                        			Results:
		                        			Of the 2,507 identified patients, 158 developed sICH after EVT. Factors such as diastolic blood pressure, Alberta Stroke Program Early CT Score, platelet count, glucose level, collateral score, and successful reperfusion were associated with the risk of sICH after EVT. The TREAT-AIS score demonstrated acceptable predictive accuracy (area under the curve [AUC]=0.694), with higher scores being associated with an increased risk of sICH (odds ratio=2.01 per score increase, 95% confidence interval=1.64–2.45, P<0.001). The discriminatory capacity of the score was similar in patients with symptom onset beyond 6 hours (AUC=0.705). Compared to existing models, the TREAT-AIS score consistently exhibited superior predictive accuracy, although this difference was marginal. 
		                        		
		                        			Conclusions
		                        			The TREAT-AIS score outperformed existing models, and demonstrated an acceptable discriminatory capacity for distinguishing patients according to sICH risk levels. However, the differences between models were only marginal. Further research incorporating periprocedural and postprocedural factors is required to improve the predictive accuracy. 
		                        		
		                        		
		                        		
		                        	
3.Predictive Modeling of Symptomatic Intracranial Hemorrhage Following Endovascular Thrombectomy: Insights From the Nationwide TREAT-AIS Registry
Jia-Hung CHEN ; I-Chang SU ; Yueh-Hsun LU ; Yi-Chen HSIEH ; Chih-Hao CHEN ; Chun-Jen LIN ; Yu-Wei CHEN ; Kuan-Hung LIN ; Pi-Shan SUNG ; Chih-Wei TANG ; Hai-Jui CHU ; Chuan-Hsiu FU ; Chao-Liang CHOU ; Cheng-Yu WEI ; Shang-Yih YAN ; Po-Lin CHEN ; Hsu-Ling YEH ; Sheng-Feng SUNG ; Hon-Man LIU ; Ching-Huang LIN ; Meng LEE ; Sung-Chun TANG ; I-Hui LEE ; Lung CHAN ; Li-Ming LIEN ; Hung-Yi CHIOU ; Jiunn-Tay LEE ; Jiann-Shing JENG ;
Journal of Stroke 2025;27(1):85-94
		                        		
		                        			 Background:
		                        			and Purpose Symptomatic intracranial hemorrhage (sICH) following endovascular thrombectomy (EVT) is a severe complication associated with adverse functional outcomes and increased mortality rates. Currently, a reliable predictive model for sICH risk after EVT is lacking. 
		                        		
		                        			Methods:
		                        			This study used data from patients aged ≥20 years who underwent EVT for anterior circulation stroke from the nationwide Taiwan Registry of Endovascular Thrombectomy for Acute Ischemic Stroke (TREAT-AIS). A predictive model including factors associated with an increased risk of sICH after EVT was developed to differentiate between patients with and without sICH. This model was compared existing predictive models using nationwide registry data to evaluate its relative performance. 
		                        		
		                        			Results:
		                        			Of the 2,507 identified patients, 158 developed sICH after EVT. Factors such as diastolic blood pressure, Alberta Stroke Program Early CT Score, platelet count, glucose level, collateral score, and successful reperfusion were associated with the risk of sICH after EVT. The TREAT-AIS score demonstrated acceptable predictive accuracy (area under the curve [AUC]=0.694), with higher scores being associated with an increased risk of sICH (odds ratio=2.01 per score increase, 95% confidence interval=1.64–2.45, P<0.001). The discriminatory capacity of the score was similar in patients with symptom onset beyond 6 hours (AUC=0.705). Compared to existing models, the TREAT-AIS score consistently exhibited superior predictive accuracy, although this difference was marginal. 
		                        		
		                        			Conclusions
		                        			The TREAT-AIS score outperformed existing models, and demonstrated an acceptable discriminatory capacity for distinguishing patients according to sICH risk levels. However, the differences between models were only marginal. Further research incorporating periprocedural and postprocedural factors is required to improve the predictive accuracy. 
		                        		
		                        		
		                        		
		                        	
4.Predictive Modeling of Symptomatic Intracranial Hemorrhage Following Endovascular Thrombectomy: Insights From the Nationwide TREAT-AIS Registry
Jia-Hung CHEN ; I-Chang SU ; Yueh-Hsun LU ; Yi-Chen HSIEH ; Chih-Hao CHEN ; Chun-Jen LIN ; Yu-Wei CHEN ; Kuan-Hung LIN ; Pi-Shan SUNG ; Chih-Wei TANG ; Hai-Jui CHU ; Chuan-Hsiu FU ; Chao-Liang CHOU ; Cheng-Yu WEI ; Shang-Yih YAN ; Po-Lin CHEN ; Hsu-Ling YEH ; Sheng-Feng SUNG ; Hon-Man LIU ; Ching-Huang LIN ; Meng LEE ; Sung-Chun TANG ; I-Hui LEE ; Lung CHAN ; Li-Ming LIEN ; Hung-Yi CHIOU ; Jiunn-Tay LEE ; Jiann-Shing JENG ;
Journal of Stroke 2025;27(1):85-94
		                        		
		                        			 Background:
		                        			and Purpose Symptomatic intracranial hemorrhage (sICH) following endovascular thrombectomy (EVT) is a severe complication associated with adverse functional outcomes and increased mortality rates. Currently, a reliable predictive model for sICH risk after EVT is lacking. 
		                        		
		                        			Methods:
		                        			This study used data from patients aged ≥20 years who underwent EVT for anterior circulation stroke from the nationwide Taiwan Registry of Endovascular Thrombectomy for Acute Ischemic Stroke (TREAT-AIS). A predictive model including factors associated with an increased risk of sICH after EVT was developed to differentiate between patients with and without sICH. This model was compared existing predictive models using nationwide registry data to evaluate its relative performance. 
		                        		
		                        			Results:
		                        			Of the 2,507 identified patients, 158 developed sICH after EVT. Factors such as diastolic blood pressure, Alberta Stroke Program Early CT Score, platelet count, glucose level, collateral score, and successful reperfusion were associated with the risk of sICH after EVT. The TREAT-AIS score demonstrated acceptable predictive accuracy (area under the curve [AUC]=0.694), with higher scores being associated with an increased risk of sICH (odds ratio=2.01 per score increase, 95% confidence interval=1.64–2.45, P<0.001). The discriminatory capacity of the score was similar in patients with symptom onset beyond 6 hours (AUC=0.705). Compared to existing models, the TREAT-AIS score consistently exhibited superior predictive accuracy, although this difference was marginal. 
		                        		
		                        			Conclusions
		                        			The TREAT-AIS score outperformed existing models, and demonstrated an acceptable discriminatory capacity for distinguishing patients according to sICH risk levels. However, the differences between models were only marginal. Further research incorporating periprocedural and postprocedural factors is required to improve the predictive accuracy. 
		                        		
		                        		
		                        		
		                        	
5.Combining balloon catheter expansion with swallowing training can better improve the swallowing of tracheotomy patients after pontine hemorrhage
Fangzhen CAO ; Min LIU ; Chunhua ZHANG ; Wei LU ; Shanshan WANG ; Chuan HU ; Xin WANG
Chinese Journal of Physical Medicine and Rehabilitation 2024;46(1):13-16
		                        		
		                        			
		                        			Objective:To observe any effect of supplementing basic swallowing training with balloon catheter dilation on the swallowing function of tracheostomy patients with pontine hemorrhage.Methods:A total of 40 pontine hemorrhage patients with tracheostomy and swallowing disorders were divided randomly into an observation group and a control group, each of 20. Both groups were given nutritional neurodrugs and basic swallowing training, but the observation group also received 25 minutes of balloon catheter dilation, five times a week for 6 weeks. Before and after the 6 weeks of treatment one swallowing therapist evaluated the feeding ability and leakage-aspiration status of each subject assigning functional oral intake (FOIS) ratings and Rosenbek Leakage/Aspiration Rating Scale (PAS) ratings double-blinded. The Watian water swallowing test was also applied.Results:After the treatment the average FOIS and PAS scores of both groups had improved significantly, with those of the observation group then significantly better than among the control group on average. The total treatment effectiveness rate was 70% in the observation group, significantly better than the 30% in the control group.Conclusion:Supplementing swallowing training with balloon catheter dilation can better improve the swallowing of patients recovering from a tracheotomy after pontine hemorrhage.
		                        		
		                        		
		                        		
		                        	
6.Robot-assisted virtual scenario training combined with scalp acupuncture can relieve cognitive impairment among stroke survivors
Pan LIU ; Xiuyan LU ; Xin WANG ; Wei LU ; Chuan HU
Chinese Journal of Physical Medicine and Rehabilitation 2024;46(3):242-246
		                        		
		                        			
		                        			Objective:To explore any effect of combining robot-assisted virtual scenario training of the upper limbs with scalp acupuncture on post-stroke cognitive impairment.Methods:Ninety patients with post-stroke cognitive impairment (PSCI) were divided at random into a control group, a scalp acupuncture group and a comprehensive group, each of 30. In addition to routine health education and rehabilitation training, the scalp acupuncture group was given scalp acupuncture, while the comprehensive group was treated with scalp acupuncture and virtual scenario training with an upper limb robot. Before and after 4 weeks of the treatment, the subjects′ cognitive functioning was assessed using the Mini-mental State Examination (MMSE) and the Montreal Cognitive Assessment scale (MoCA). Ability in the activities of daily living (ADL) was quantified using the Modified Barthel Index (MBI).Results:After the intervention, significant improvement was observed in the average MMSE, MoCA and MBI scores of all three groups. The average MMSE and MBI scores of the scalp acupuncture group were then significantly higher than the control group′s averages, while the average MMSE, MoCA and MBI scores of the comprehensive group were all significantly better than those of the other two groups.Conclusion:Robot-assisted virtual scenario upper limb training combined with scalp acupuncture can significantly improve the cognition and ADL ability of PSCI patients.
		                        		
		                        		
		                        		
		                        	
7.Exploring the mechanism of pre-electroacupuncture at"Neiguan"(PC6)and"Jianshi"(PC5)acupoints on learning,memory,and locus coeruleus-hippocampal neural circuit in Alzheimer's disease-like rats via the β2AR/β-arrestin2/NF-κB pathway
Chuan HE ; Li WANG ; Xiaoli PAN ; Chaochao YU ; Juan XIAO ; Zhenkun LU ; Xiangyu LI ; Yanjun DU ; Feng SHEN
Journal of Beijing University of Traditional Chinese Medicine 2024;47(11):1612-1622
		                        		
		                        			
		                        			Objective To investigate the effects of pre-electroacupuncture(EA)on spatial learning and memory,the locus coeruleus-hippocampal neural circuit,and neuroinflammation in Alzheimer's disease(AD)-like rats,and to explore the possible mechanism of pre-EA in preventing and treating AD.Methods Thirty-six male SD rats were divided into the normal,model,EA,and sham EA groups using the random number table method,with nine rats per group.An AD-like rat model was prepared through intraperitoneal injection of 120 mg/(kg·d)D-galactose for eight consecutive weeks.After daily intraperitoneal injection,the rats in the EA group underwent EA stimulation at the"Neiguan"(PC6)and"Jianshi"(PC5)acupoints with a continuous wave,frequency of 50 Hz,and a current of 1 mA for 20 min once a day for 8 weeks.The sham EA group was only superficially punctured to the subcutaneous tissue at the"Neiguan"(PC6)and"Jianshi"(PC5)acupoints without electricity,and the rest of the operations were the same as those in the EA group.The Morris water maze experiment was then used to evaluate the spatial learning and memory of the rats.Immunofluorescence labeling was used to detect dopamine β hydroxylase and c-Fos co-localization in the locus coeruleus of noradrenergic neurons,as well as glial fibrillary acidic protein and tumor necrosis factor-α(TNF-α)co-localization in the CA1 area of the hippocampus of astrocytes.Western blotting was used to measure the protein expressions of norepinephrine(NE),β2-adrenergic receptor(β2AR),β-inhibitory protein 2(β-arrestin2),nuclear transcription factor-κB(NF-κB)inhibitory factor protein α(IκBα),and NF-κB in the hippocampus of rats.An enzyme-linked immunosorbent assay was used to detect the TNF-α,interleukin-1β(IL-1β),and interleukin-6(IL-6)contents in hippocampal tissue.Results Compared with the normal group,the average escape latency of the model group rats was prolonged,and the times of crossing platform and exploration time in the target quadrant were reduced(P<0.01),while the EA intervention can shorten the average escape latency and increase the times of crossing platform and exploration time in the target quadrant(P<0.01).Compared with the normal group,the expression of co-located noradrenergic neurons in the model group decreased,co-located astrocytes increased(P<0.01);NE,β2AR,β-arrestin2,and IκBα protein expression decreased(P<0.01),NF-κB protein expression increased(P<0.01);the contents of TNF-α,IL-1β,and IL-6 increased(P<0.01).Compared with the model group,the EA group showed an increase in the expression of co-located noradrenergic neurons,a decrease in co-located astrocytes(P<0.01),an increase in NE,β2AR,β-arrestin2,and IκBα protein expressions(P<0.01),a decrease in NF-κB protein expression(P<0.01),and a decrease in TNF-α,IL-1β,and IL-6 levels(P<0.01).No significant difference was observed in the above indicators between the model and sham EA groups.Conclusion Pre-EA at"Neiguan"(PC6)and"Jianshi"(PC5)can alleviate learning and memory dysfunction,alleviate noradrenergic neuronal loss in the locus coeruleus,inhibit astrocyte activation,protect the locus coeruleus-hippocampal neural circuit,and may be associated with inhibiting β2AR/β-arrestin2/NF-κB inflammatory pathway activation.
		                        		
		                        		
		                        		
		                        	
8.Exploring the mechanism of pre-electroacupuncture at"Neiguan"(PC6)and"Jianshi"(PC5)acupoints on learning,memory,and locus coeruleus-hippocampal neural circuit in Alzheimer's disease-like rats via the β2AR/β-arrestin2/NF-κB pathway
Chuan HE ; Li WANG ; Xiaoli PAN ; Chaochao YU ; Juan XIAO ; Zhenkun LU ; Xiangyu LI ; Yanjun DU ; Feng SHEN
Journal of Beijing University of Traditional Chinese Medicine 2024;47(11):1612-1622
		                        		
		                        			
		                        			Objective To investigate the effects of pre-electroacupuncture(EA)on spatial learning and memory,the locus coeruleus-hippocampal neural circuit,and neuroinflammation in Alzheimer's disease(AD)-like rats,and to explore the possible mechanism of pre-EA in preventing and treating AD.Methods Thirty-six male SD rats were divided into the normal,model,EA,and sham EA groups using the random number table method,with nine rats per group.An AD-like rat model was prepared through intraperitoneal injection of 120 mg/(kg·d)D-galactose for eight consecutive weeks.After daily intraperitoneal injection,the rats in the EA group underwent EA stimulation at the"Neiguan"(PC6)and"Jianshi"(PC5)acupoints with a continuous wave,frequency of 50 Hz,and a current of 1 mA for 20 min once a day for 8 weeks.The sham EA group was only superficially punctured to the subcutaneous tissue at the"Neiguan"(PC6)and"Jianshi"(PC5)acupoints without electricity,and the rest of the operations were the same as those in the EA group.The Morris water maze experiment was then used to evaluate the spatial learning and memory of the rats.Immunofluorescence labeling was used to detect dopamine β hydroxylase and c-Fos co-localization in the locus coeruleus of noradrenergic neurons,as well as glial fibrillary acidic protein and tumor necrosis factor-α(TNF-α)co-localization in the CA1 area of the hippocampus of astrocytes.Western blotting was used to measure the protein expressions of norepinephrine(NE),β2-adrenergic receptor(β2AR),β-inhibitory protein 2(β-arrestin2),nuclear transcription factor-κB(NF-κB)inhibitory factor protein α(IκBα),and NF-κB in the hippocampus of rats.An enzyme-linked immunosorbent assay was used to detect the TNF-α,interleukin-1β(IL-1β),and interleukin-6(IL-6)contents in hippocampal tissue.Results Compared with the normal group,the average escape latency of the model group rats was prolonged,and the times of crossing platform and exploration time in the target quadrant were reduced(P<0.01),while the EA intervention can shorten the average escape latency and increase the times of crossing platform and exploration time in the target quadrant(P<0.01).Compared with the normal group,the expression of co-located noradrenergic neurons in the model group decreased,co-located astrocytes increased(P<0.01);NE,β2AR,β-arrestin2,and IκBα protein expression decreased(P<0.01),NF-κB protein expression increased(P<0.01);the contents of TNF-α,IL-1β,and IL-6 increased(P<0.01).Compared with the model group,the EA group showed an increase in the expression of co-located noradrenergic neurons,a decrease in co-located astrocytes(P<0.01),an increase in NE,β2AR,β-arrestin2,and IκBα protein expressions(P<0.01),a decrease in NF-κB protein expression(P<0.01),and a decrease in TNF-α,IL-1β,and IL-6 levels(P<0.01).No significant difference was observed in the above indicators between the model and sham EA groups.Conclusion Pre-EA at"Neiguan"(PC6)and"Jianshi"(PC5)can alleviate learning and memory dysfunction,alleviate noradrenergic neuronal loss in the locus coeruleus,inhibit astrocyte activation,protect the locus coeruleus-hippocampal neural circuit,and may be associated with inhibiting β2AR/β-arrestin2/NF-κB inflammatory pathway activation.
		                        		
		                        		
		                        		
		                        	
9.Construction of rehabilitation nursing program for stroke patients based on international classification of functioning, disability and health
Weiwei LI ; Guozhen SUN ; Jianying SHEN ; Qian LU ; Chuan HE ; Meiyan LU
Journal of Clinical Medicine in Practice 2024;28(8):138-141
		                        		
		                        			
		                        			Objective To construct a rehabilitation nursing program for stroke patients based on the international classification of functioning, disability and health (ICF). Methods The relevant domestic and foreign literatures were systematically searched, and a draft of the rehabilitation nursing program for stroke patients based on the 17 functional items in the four dimensions of ICF functional evaluation was constructed. The Delphi method was used to consult experts to further improve the program. Results A total of 16 experts completed two rounds of expert consultation. The expert authority coefficients of the first and second rounds of consultation were 0.897 and 0.897, respectively, with coefficient of variations ranging from 0.05 to 0.27 and 0.05 to 0.19, respectively. The Kendall's W coefficients were 0.384 and 0.452 (
		                        		
		                        	
10.Discrete element modeling and breakage behavior analysis of oral solid dosage form particles
Lin-xiu LUO ; Tian-bing GUAN ; An-qi LUO ; Zeng LIU ; Yu-ting WANG ; Yan-ling JIANG ; Zheng LU ; Jing-cao TANG ; Shuang-kou CHEN ; Hui-min SUN ; Chuan-yun DAI
Acta Pharmaceutica Sinica 2024;59(4):1057-1066
		                        		
		                        			
		                        			 The breakage pattern of unit particles during the production of oral solid dosage forms (OSD) is closely related to the quality of intermediate or final products. To accurately characterize the particles and study the evolution law of particle breakage, the Bonding model of the discrete element method (DEM) was used to investigate the breakage patterns of model parameters, particle shape and process conditions (loading mode and loading rate) on the dynamic breakage, force-time curve, breakage rate, maximum breakage size ratio and fracture strength of particles. The results showed that the particle breakage force was positively correlated with normal strength and bonded disk scale, negatively correlated with normal stiffness per unit area and tangential stiffness per unit area, and weakly correlated with tangential strength. The particle breakage rate was negatively correlated with the aspect ratio of the particles, and the maximum breakage size ratio was positively correlated with the aspect ratio of the particles; among the three loading modes, the breakage rate of compression breakage model was the largest, the breakage rate of shear breakage model was the second largest, and the breakage rate of wear breakage model was the smallest; the maximum breakage size ratio was positively correlated with the loading rate, the loading mode and the loading rate had no mutual influence on particle breakage rate, but had mutual influence on the maximum breakage size ratio. The research results will provide a theoretical basis for the shift of OSD from batch manufacturing to advanced manufacturing. 
		                        		
		                        		
		                        		
		                        	
            

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