1.Quality Evaluation and Analysis of Key Problems in Rukuaixiao Preparations
Rong CHEN ; Chao ZHANG ; Shuisheng ZHONG ; Wei CHEN ; Enyun TU ; Yaqiong WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):146-155
		                        		
		                        			
		                        			ObjectiveBased on multi-index and multi-method detection, the quality of Rukuaixiao preparations was systematically evaluated from the perspective of characteristic components, and the existing problems were analyzed. MethodsLiquid chromatography-mass spectrometry(LC-MS) for the determination of 16 characteristic components was established to evaluate the quality of 129 batches of Rukuaixiao preparations. High performance liquid chromatography(HPLC) was established to determine the contents of salvianolic acids and tanshinones, investigate the rationality of quality control index of Salviae Miltiorrhizae Radix et Rhizoma in the standard for Rukuaixiao preparations in the 2020 edition of Pharmacopoeia of the People's Republic of China(hereinafter referred to as Chinese Pharmacopoeia) (volume Ⅰ), and trace the causes of significant difference among different batches. The processing and different extraction methods of Vaccariae Semen were tested, analyzing the impact of formulation changes across different editions of Chinese Pharmacopoeia. The LC-MS was established for determining the changes in the ratio of toosendanin and isotoosendanin after water extraction of Toosendan Fructus. The contents of active components in different parts of Gleditsiae Spina were determined to identify the reason of the low contents of characteristic components in some enterprises. ResultsBased on the comprehensive analysis of the samples from different dosage forms, the contents of characteristic components of Vaccariae Semen and Gleditsiae Spina in tablets from manufacturer B and granules from manufacturer D were significantly higher than those in tablets from manufacturer A, and tablets and capsules from manufacturer C. The contents of tanshinones in some batches of products from manufacturer A were abnormally high, potentially linked to the use of 70% ethanol reflux during extraction of Salviae Miltiorrhizae Radix et Rhizoma. All samples from manufacturer C exhibited abnormally high proportions of salvianic acid A and 3,4-dihydroxybenzaldehyde(salvianolic acid degradation products) to the total seven phenolic acids, indicating a risk of blindly pursuing tanshinol content and neglecting more effective components. The extraction rate of the characteristic components from Vaccariae Semen by decocting with water was obviously higher than that by reflux extraction with 70% ethanol. However, using the stir-fried Vaccariae Semen could reduce the loss of ingredients. The content ratio of toosendanin and isotoosendanin decreased from the crude herb to the prepared medicine when Toosendan Fructus was prepared by water decoction. The reason for the low component content of Gleditsiae Spina may be attributed to manufacturers using excessive non-medicinal parts in their formulations. ConclusionIt is suggested that enterprises should ensure the quality of raw material inputs, especially those without quality-control items in the standard, reduce the use of non-medicinal parts, and prohibit arbitrary alterations to manufacturing methods or processes. It is also recommended that Vaccariae Semen in Rukuaixiao capsules and granules should be changed to the stir-fried processed products. Isotoosendanin should be taken into consideration in the drug supervision when Toosendan Fructus is prepared into medicine by water decoction. Salvianolic acid B should be set as a quality control index for Salviae Miltiorrhizae Radix et Rhizoma when revising the pharmacopoeia standard of Rukuaixiao preparations. 
		                        		
		                        		
		                        		
		                        	
2.Quality Evaluation and Analysis of Key Problems in Rukuaixiao Preparations
Rong CHEN ; Chao ZHANG ; Shuisheng ZHONG ; Wei CHEN ; Enyun TU ; Yaqiong WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):146-155
		                        		
		                        			
		                        			ObjectiveBased on multi-index and multi-method detection, the quality of Rukuaixiao preparations was systematically evaluated from the perspective of characteristic components, and the existing problems were analyzed. MethodsLiquid chromatography-mass spectrometry(LC-MS) for the determination of 16 characteristic components was established to evaluate the quality of 129 batches of Rukuaixiao preparations. High performance liquid chromatography(HPLC) was established to determine the contents of salvianolic acids and tanshinones, investigate the rationality of quality control index of Salviae Miltiorrhizae Radix et Rhizoma in the standard for Rukuaixiao preparations in the 2020 edition of Pharmacopoeia of the People's Republic of China(hereinafter referred to as Chinese Pharmacopoeia) (volume Ⅰ), and trace the causes of significant difference among different batches. The processing and different extraction methods of Vaccariae Semen were tested, analyzing the impact of formulation changes across different editions of Chinese Pharmacopoeia. The LC-MS was established for determining the changes in the ratio of toosendanin and isotoosendanin after water extraction of Toosendan Fructus. The contents of active components in different parts of Gleditsiae Spina were determined to identify the reason of the low contents of characteristic components in some enterprises. ResultsBased on the comprehensive analysis of the samples from different dosage forms, the contents of characteristic components of Vaccariae Semen and Gleditsiae Spina in tablets from manufacturer B and granules from manufacturer D were significantly higher than those in tablets from manufacturer A, and tablets and capsules from manufacturer C. The contents of tanshinones in some batches of products from manufacturer A were abnormally high, potentially linked to the use of 70% ethanol reflux during extraction of Salviae Miltiorrhizae Radix et Rhizoma. All samples from manufacturer C exhibited abnormally high proportions of salvianic acid A and 3,4-dihydroxybenzaldehyde(salvianolic acid degradation products) to the total seven phenolic acids, indicating a risk of blindly pursuing tanshinol content and neglecting more effective components. The extraction rate of the characteristic components from Vaccariae Semen by decocting with water was obviously higher than that by reflux extraction with 70% ethanol. However, using the stir-fried Vaccariae Semen could reduce the loss of ingredients. The content ratio of toosendanin and isotoosendanin decreased from the crude herb to the prepared medicine when Toosendan Fructus was prepared by water decoction. The reason for the low component content of Gleditsiae Spina may be attributed to manufacturers using excessive non-medicinal parts in their formulations. ConclusionIt is suggested that enterprises should ensure the quality of raw material inputs, especially those without quality-control items in the standard, reduce the use of non-medicinal parts, and prohibit arbitrary alterations to manufacturing methods or processes. It is also recommended that Vaccariae Semen in Rukuaixiao capsules and granules should be changed to the stir-fried processed products. Isotoosendanin should be taken into consideration in the drug supervision when Toosendan Fructus is prepared into medicine by water decoction. Salvianolic acid B should be set as a quality control index for Salviae Miltiorrhizae Radix et Rhizoma when revising the pharmacopoeia standard of Rukuaixiao preparations. 
		                        		
		                        		
		                        		
		                        	
3.Hepatitis E virus infection among blood donors in Zhengzhou
Hongna ZHAO ; Yueguang WEI ; Lumin YAN ; Tiantian TU ; Shumin WANG ; Yihui WEI ; Yifang WANG ; Lei ZHAO ; Mingjun CHEN
Chinese Journal of Blood Transfusion 2025;38(1):13-18
		                        		
		                        			
		                        			[Objective] To analyze the infection status of hepatitis E virus (HEV) among blood donors in Zhengzhou, so as to provide data support for formulating local blood screening strategies. [Methods] Random samples from blood donors from January to December 2022 were tested for HEV RNA using PCR technology. Reactive samples were sequenced for gene analysis, and the donors were followed up. [Results] Among 21 311 samples, 3(0.14‰) were reactive for HEV RNA, all of whom were male. Genetic sequencing results revealed that one strong positive sample was genotype 4, while sequencing failed for the other two due to low viral load. A follow-up of 25 strong positive donors showed that ALT significantly increased on day 7 after donation, anti-HEV IgM and anti-HEV IgG turned positive. On day 21, ALT returned to normal, and on day 35, HEV RNA turned negative. Notably, anti-HEV IgM and anti-HEV IgG persisted until day 482. [Conclusion] There is HEV infection among blood donors in Zhengzhou, and it is necessary to expand the screening scope to comprehensively explore the prevalence and genotype distribution of HEV among blood donors.
		                        		
		                        		
		                        		
		                        	
4.Outcome after spleen-preserving distal pancreatectomy by Warshaw technique for pancreatic body cancer
Endi ZHOU ; Guodong SHI ; Hongyuan SHI ; Kai ZHANG ; Jishu WEI ; Min TU ; Zipeng LU ; Feng GUO ; Jianmin CHEN ; Kuirong JIANG ; Wentao GAO
Annals of Hepato-Biliary-Pancreatic Surgery 2025;29(2):177-186
		                        		
		                        			 Background:
		                        			s/Aims: Distal pancreatectomy with splenectomy (DPS) is a common surgical procedure for pancreatic body cancer.However, spleen-preserving distal pancreatectomy (SPDP) utilizing the Warshaw technique (WT) in malignancies is generally not favored due to concerns about inadequate resection. This study aims to assess the feasibility and oncologic outcomes of employing SPDP with WT in pancreatic body cancer. 
		                        		
		                        			Methods:
		                        			We conducted a retrospective analysis comparing 21 SPDP patients with 63 DPS patients matched by propensity score from January 2018 to November 2022. Clinical outcomes and follow-up data were analyzed using R. 
		                        		
		                        			Results:
		                        			Both groups exhibited similar demographic, intraoperative, and pathological characteristics, with the exception of a reduced number of total lymph nodes (p = 0.006) in the SPDP group. There were no significant differences in the rates of postoperative complications, recurrence, or metastasis. Local recurrence predominantly occurred in the central region as opposed to the spleen region.There were no cases of isolated recurrences in the splenic region. Median overall survival and recurrence-free survival times were 51.5 months for SPDP vs 30.5 months for DPS and 18.7 months vs 16.8 months, respectively (p > 0.05). The incidence of partial splenic infarction and left-side portal hypertension in the SPDP group was 28.6% (6/21) and 9.5% (2/21), respectively, without necessitating splenic abscess puncture, splenectomy, or causing bleeding from perigastric varices. 
		                        		
		                        			Conclusions
		                        			SPDP did not negatively impact local recurrence or survival rates in selected pancreatic body cancer patients. Further studies are necessary for validation. 
		                        		
		                        		
		                        		
		                        	
5.Outcome after spleen-preserving distal pancreatectomy by Warshaw technique for pancreatic body cancer
Endi ZHOU ; Guodong SHI ; Hongyuan SHI ; Kai ZHANG ; Jishu WEI ; Min TU ; Zipeng LU ; Feng GUO ; Jianmin CHEN ; Kuirong JIANG ; Wentao GAO
Annals of Hepato-Biliary-Pancreatic Surgery 2025;29(2):177-186
		                        		
		                        			 Background:
		                        			s/Aims: Distal pancreatectomy with splenectomy (DPS) is a common surgical procedure for pancreatic body cancer.However, spleen-preserving distal pancreatectomy (SPDP) utilizing the Warshaw technique (WT) in malignancies is generally not favored due to concerns about inadequate resection. This study aims to assess the feasibility and oncologic outcomes of employing SPDP with WT in pancreatic body cancer. 
		                        		
		                        			Methods:
		                        			We conducted a retrospective analysis comparing 21 SPDP patients with 63 DPS patients matched by propensity score from January 2018 to November 2022. Clinical outcomes and follow-up data were analyzed using R. 
		                        		
		                        			Results:
		                        			Both groups exhibited similar demographic, intraoperative, and pathological characteristics, with the exception of a reduced number of total lymph nodes (p = 0.006) in the SPDP group. There were no significant differences in the rates of postoperative complications, recurrence, or metastasis. Local recurrence predominantly occurred in the central region as opposed to the spleen region.There were no cases of isolated recurrences in the splenic region. Median overall survival and recurrence-free survival times were 51.5 months for SPDP vs 30.5 months for DPS and 18.7 months vs 16.8 months, respectively (p > 0.05). The incidence of partial splenic infarction and left-side portal hypertension in the SPDP group was 28.6% (6/21) and 9.5% (2/21), respectively, without necessitating splenic abscess puncture, splenectomy, or causing bleeding from perigastric varices. 
		                        		
		                        			Conclusions
		                        			SPDP did not negatively impact local recurrence or survival rates in selected pancreatic body cancer patients. Further studies are necessary for validation. 
		                        		
		                        		
		                        		
		                        	
6.Outcome after spleen-preserving distal pancreatectomy by Warshaw technique for pancreatic body cancer
Endi ZHOU ; Guodong SHI ; Hongyuan SHI ; Kai ZHANG ; Jishu WEI ; Min TU ; Zipeng LU ; Feng GUO ; Jianmin CHEN ; Kuirong JIANG ; Wentao GAO
Annals of Hepato-Biliary-Pancreatic Surgery 2025;29(2):177-186
		                        		
		                        			 Background:
		                        			s/Aims: Distal pancreatectomy with splenectomy (DPS) is a common surgical procedure for pancreatic body cancer.However, spleen-preserving distal pancreatectomy (SPDP) utilizing the Warshaw technique (WT) in malignancies is generally not favored due to concerns about inadequate resection. This study aims to assess the feasibility and oncologic outcomes of employing SPDP with WT in pancreatic body cancer. 
		                        		
		                        			Methods:
		                        			We conducted a retrospective analysis comparing 21 SPDP patients with 63 DPS patients matched by propensity score from January 2018 to November 2022. Clinical outcomes and follow-up data were analyzed using R. 
		                        		
		                        			Results:
		                        			Both groups exhibited similar demographic, intraoperative, and pathological characteristics, with the exception of a reduced number of total lymph nodes (p = 0.006) in the SPDP group. There were no significant differences in the rates of postoperative complications, recurrence, or metastasis. Local recurrence predominantly occurred in the central region as opposed to the spleen region.There were no cases of isolated recurrences in the splenic region. Median overall survival and recurrence-free survival times were 51.5 months for SPDP vs 30.5 months for DPS and 18.7 months vs 16.8 months, respectively (p > 0.05). The incidence of partial splenic infarction and left-side portal hypertension in the SPDP group was 28.6% (6/21) and 9.5% (2/21), respectively, without necessitating splenic abscess puncture, splenectomy, or causing bleeding from perigastric varices. 
		                        		
		                        			Conclusions
		                        			SPDP did not negatively impact local recurrence or survival rates in selected pancreatic body cancer patients. Further studies are necessary for validation. 
		                        		
		                        		
		                        		
		                        	
7.Improvement effect and mechanism of total flavonoids from Rosa multiflora root on vascular injury in rheumatoid arthritis model rats
Kaiyan LI ; Fei ZHANG ; Ping TIAN ; Dan YANG ; Wei ZHANG ; Xiaoli WANG ; Wanqian TU ; Yifei LIU
China Pharmacy 2024;35(8):931-935
		                        		
		                        			
		                        			OBJECTIVE To study the improvement effect of total flavonoids from Rosa multiflora root on vascular injury in rheumatoid arthritis (RA) model rats and its potential mechanism. METHODS Female Wistar rats were randomly divided into normal control group, model group, aspirin group (positive control, 30 mg/kg), low-dose and high-dose groups of total flavonoids from R. multiflora root (4.15, 8.30 g/kg, by crude drug), with 10 rats in each group. Except for the normal control group, the RA model was induced in other groups by collagen induction and high-fat diet. After 14 days of modeling, they were given corresponding drug solution/0.5% sodium carboxymethyl cellulose solution intragastrically, once a day, for 36 consecutive days. The total body score, arthritis index (AI) and swollen joint count (SJC) of the rats were evaluated regularly. After the last medication, serum levels of interleukin-6 (IL-6), intercellular adhesion molecule-1 (ICAM-1) and vascular cell adhesion molecule- 1 (VCAM-1) were determined. The pathological morphological changes in the vascular tissue of thoracic aorta were observed; the protein expression of Toll-like receptor 4 (TLR4) and the protein phosphorylation levels of Janus kinase 2 (JAK2) and signal transduction and activator of transcription 3 (STAT3) in vascular tissue of thoracic aorta were measured. RESULTS Compared with the normal control group, serum levels of IL-6, ICAM-1 and VCAM-1, protein expression of TLR4, and the protein phosphorylation levels of JAK2 and STAT3 in vascular tissue of thoracic aorta were increased significantly in model group (P< 0.01). The atherosclerotic plaque (atheroma), cholesterol crystal, lymphocyte infiltration and a small number of unbroken foam cell aggregation could be seen in the vascular tissue of thoracic aorta. Compared with the model group, total body score (except for the low-dose group), AI and SJC were decreased significantly in groups of total flavonoids from R. multiflora root on the 28th day (P<0.05 or P<0.01); total body score,AI and SJC were decreased significantly in low-dose group of total flavonoids from R. multiflora root on the 49th day (P<0.05 or P<0.01); the other quantitative indicators in serum and vascular tissue were significantly reversed in groups of total flavonoids from R. multiflora root (P<0.05 or P<0.01), and pathological damage of vascular tissue was significantly relieved. CONCLUSIONS Total flavonoids from R. multiflora root can significantly improve vascular injury in RA model rats, and its mechanism may be related to reducing the protein expression of TLR4 in vascular tissue and inhibiting the activation of IL-6/JAK2/ STAT3 signaling pathway.
		                        		
		                        		
		                        		
		                        	
8.Inhibitory Effect of Sesquiterpenoid M36 from Myrrha on Growth of Human Hepatoma Cells
Dongxiao LIU ; Yaxin LIU ; Huiming HUANG ; Lishan OUYANG ; Chaochao WANG ; Jinxin XIE ; Longyan WANG ; Xuejiao WEI ; Peng TAN ; Pengfei TU ; Jun LI ; Zhongdong HU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(5):80-87
		                        		
		                        			
		                        			ObjectiveThe antitumor activity of sesquiterpenoid M36 isolated from Myrrha against human hepatoma HepG2 cells was investigated in this study. MethodHepG2 cells were treated with M36 at different concentrations (0, 2, 4, 6, 8, 10 μmol·L-1). Firstly, the effects of M36 on the proliferation of human hepatoma HepG2 cells were detected by methyl thiazolyl tetrazolium (MTT), colony formation assay, and EdU proliferation assay. Hoechst staining, flow cytometry analysis, and Western blot were used to explore the effect of M36 on the apoptosis of human hepatoma HepG2 cells. Acridine orange staining and western blotting were used to examine the effect of M36 on autophagy in HepG2 cells. Finally, Western blot was used to detect protein expression of cancer-related signaling pathways. ResultCompared with the blank group, M36 treatment significantly inhibited the proliferation of human hepatoma HepG2 cells (P<0.01), and the half inhibitory concentration (IC50) value of M36 for 48 h was 5.03 μmol·L-1, in a dose- and time-dependent manner. M36 was also able to induce apoptosis and autophagy in human hepatoma HepG2 cells. After treatment with 8 μmol·L-1 M36 for 48 hours, the apoptosis rate of HepG2 cells was (42.03±9.65)% (P<0.01). Compared with the blank group, HepG2 cells treated with 4 and 8 μmol·L-1 M36 for 48 h had a significant increase in cleaved poly ADP-ribose polymerase (cleaved-PARP) protein levels (P<0.01). Acridine orange staining showed that autophagy was significantly activated in HepG2 cells treated with 4 and 8 μmol·L-1 M36 for 48 h compared with the blank group (P<0.01), which was further verified by the up-regulation of microtubule-associated protein 1 light chain 3 Ⅱ (LC3 Ⅱ). Western blot results showed that compared with the blank group, the levels of phosphorylated extracellular regulated protein kinase (p-ERK), phosphorylated p38 mitogen-activated protein kinase (p-p38 MAPK), phosphorylated c-Jun N-terminal kinase (p-JNK), and its downstream nuclear transcription factors c-Jun and p-c-Jun protein were significantly increased in M36 group (P<0.05, P<0.01). The mechanism may be related to the up-regulation of MAPK signaling pathway. ConclusionThe sesquiterpenoid M36 isolated from Myrrha inhibits the proliferation of human hepatoma HepG2 cells and promotes apoptosis and autophagy, which may be related to the activation of the MAPK signaling pathway. 
		                        		
		                        		
		                        		
		                        	
9.Discovery of a normal-tension glaucoma-suspect rhesus macaque with craniocerebral injury: Hints of elevated translaminar cribrosa pressure difference.
Jian WU ; Qi ZHANG ; Xu JIA ; Yingting ZHU ; Zhidong LI ; Shu TU ; Ling ZHAO ; Yifan DU ; Wei LIU ; Jiaoyan REN ; Liangzhi XU ; Hanxiang YU ; Fagao LUO ; Wenru SU ; Ningli WANG ; Yehong ZHUO
Chinese Medical Journal 2024;137(4):484-486
10.Machine learning to analyze risk factors for postoperative failure of proximal humeral fractures with medial column instability
Daxing XU ; Muqiang JI ; Zesong TU ; Weipeng XU ; Weilong XU ; Wei NIU
Chinese Journal of Tissue Engineering Research 2024;33(33):5295-5301
		                        		
		                        			
		                        			BACKGROUND:Internal fixation and open reduction with locking plate is the main treatment for proximal humeral fractures with medial column instability.However,reduction failure is one of the main postoperative complications,and accurate risk factor assessment is beneficial for screening high-risk patients and clinical decision selection. OBJECTIVE:To construct four types of prediction models by different machine learning algorithms,compare the optimal model to analyze and sort the risk variables according to their weight scores on the impact of outcome,and explore their significance in guiding clinical diagnosis and treatment. METHODS:262 patients with proximal humeral fractures with medial column instability,aged(60.6±10.2)years,admitted to Foshan Hospital of Traditional Chinese Medicine between June 2012 and June 2022 were included.All patients underwent open reduction with locking plate surgery.According to the occurrence of reduction failure at 5-month follow-up,the patients were divided into a reduction failure group(n=64)and a reduction maintenance group(n=198).Clinical data of patients were collected,and model variables and their classification were determined.The data set was randomly divided into a training set and a test set according to a 7:3 ratio,and the optimal hyperparameters were obtained in the training set according to a 5-fold cross-over test.Four machine learning prediction models of logistic regression,random forest,support vector machine,and XGBoost were constructed,and the performance of different algorithms was observed in the test set using AUC,correctness,sensitivity,specificity,and F1 scores,so as to comprehensively evaluate the prediction performance of the models.The best-performing model was evaluated using SHAP to assess important risk variables and to evaluate its clinical guidance implications. RESULTS AND CONCLUSION:(1)There were significant differences between the two groups in deltoid tuberosity index,fracture type,fracture end with varus deformity before operation,fragment length of inferior metaphyseal of humerus,postoperative reduction,cortical support of medial column of proximal humerus,and insertion of calcar screw(P<0.05).(2)The best-combined performance of the four machine models was XGBoost.The AUC,accuracy,and F1 scores were 0.885,0.885,and 0.743,respectively;followed by random forest and support vector machine,with both models performing at approximately equal levels.Logistic regression had the worst combined performance.The SHAP interpretation tool was used in the optimal model and results showed that deltoid tuberosity index,medial humeral column cortical support,fracture type,fracture reduction quality,and the status of the calcar screw were important influencing fators for postoperative fracture reduction failure.(3)The accuracy of using machine learning to analyze clinical problems is superior to that of traditional logistic regression analysis methods.When dealing with high-dimensional data,the machine learning approach can solve multivariate interaction and covariance problems well.The SHAP interpretation tool can not only clarify the importance of individual variables but also obtain detailed information on the impact of dummy variables in each variable on the outcome.
		                        		
		                        		
		                        		
		                        	
            
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