Objective To evaluate the feasibility of process scale-up for the production of human prothrombin complex concentrate(PCC) by comparing the quality parameters of PCC samples obtained at different stages of process scale-up.Methods The PCC production process was scaled up sequentially through bench scale, pilot scale and production scale.Samples were collected at critical process control points across the three scales for comparative quality analysis. The final PCC products from each scale were tested in accordance with the Chinese Pharmacopoeia(VolumeⅢ, 2020 edition) to assess process stability and regulatory compliance during scale-up.Results After the first ultrafiltration step, no statistically significant differences were observed in the potency of human coagulation factor Ⅸ(FⅨ) or protein content among samples from the three scales(F = 1. 066 and 0. 590, respectively, each P > 0. 05). The FⅨ recovery rates were(69. 3 ± 10. 3)%,(73. 9 ±11. 1)%, and(69. 8 ± 7. 3)%, respectively, with no significant difference( F = 0. 330, P > 0. 05). Following solvent/detergent(S/D) treatment, the pH remained stable, and no significant differences were observed in FⅨ potency or protein content(F =1. 414 and 0. 542, respectively, each P > 0. 05). After the secondary ion-exchange chromatography step, no significant differences were found in FⅨ potency or specific activity(F = 0. 437 and 0. 201, respectively, each P > 0. 05), with FⅨ recovery rates of(90. 6 ± 6. 7)%,(82. 6 ± 4. 6)% and(87. 2 ± 6. 1)%, respectively, with no significant difference(F = 2. 513, P > 0. 05).At the bulk solution stage, no significant differences were observed in FⅨ potency or specific activity(F = 0. 187 and 0. 135,respectively, each P > 0. 05) with stable pH, and FⅨ recovery rates were(90. 6 ± 7. 5)%,(97. 2 ± 8. 3)%, and(92. 2 ± 6. 4)%,respectively, with no significant difference(F = 1. 016, P > 0. 05). After dry-heat virus inactivation, no significant differences were noted in the potency of factorsⅡ, Ⅶ, Ⅸ, and Ⅹ(F = 0. 11, 0. 473, 0. 818, and 0. 244, respectively, each P > 0. 05).The critical quality attributes of final PCC products from all three scales were consistent and complied with the requirements of Chinese Pharmacopoeia(Volume Ⅲ, 2020 edition).Conclusion The established PCC production process is stable, reliable, and reproducible, demonstrating the feasibility of process scale-up.

ObjectiveTo analyze the differences in color， odor and volatile components of Citri Reticulatae Pericarpium（CRP） before and after being stir-fried with Halloysitum Rubrum， and to explore the material basis of enhancing the effect of strengthening spleen after processing and the scientific connotation of decoction pieces processed with Halloysitum Rubrum as the auxiliary material. MethodsThe volatile components of the samples before and after processing were identified and relatively quantified by headspace gas chromatography-mass spectrometry（HS-GC-MS）， and the volatile components were analyzed by principal component analysis（PCA） and orthogonal partial least squares-discriminant analysis（OPLS-DA）. According to the principle of variable importance in the projection（VIP） value>1.5， volatile differential components before and after processing were screened. And combined with intelligent sensory technologies such as colorimeter and electronic nose， the chroma and odor information of CRP before and after being stir-fried with Halloysitum Rubrum were identified. Pearson correlation analysis was used to explore the correlation between volatile differential components and chroma values. ResultsA total of 112 volatile components were identified from CRP and CRP stir-fried with Halloysitum Rubrum， of which 84 were from CRP and 97 were from CRP stir-fried with Halloysitum Rubrum. And 7 differential components were selected， including α-pinene， β-myrcene， linalool， sabinene， ocimene isomer mixture， A-ocimene， and δ-elemene. After being processed with Halloysitum Rubrum， the brightness value（L^*）， yellow-blue value（b^*） and total chromatic value（E^*_ab） of CRP were decreased（P<0.01）， and red-green value（a^*） was increased（P<0.01）， the response values of S4， S5， S10 and S13 sensors were significantly increased（P<0.05）， and the response values of S3 and S8 sensors were significantly decreased（P<0.05）. Correlation analysis showed that α-pinene and β-myrcene were negatively correlated with L^* and E^*_ab， but positively correlated with a^*. Sabinene was positively correlated with L^* and E^*_ab. Linalool was positively correlated with L^* and E^*_ab， and negatively correlated with a^*. The ocimene isomer mixture was positively correlated with the L^*. ConclusionAfter being processed with Halloysitum Rubrum， the appearance color， odor and volatile components of CRP change significantly， and α-pinene， β-myrcene， sabinene， linalool and A-ocimene are the characteristic volatile components before and after processing， which can provide references for the quality evaluation and clinical application of CRP and its processed products.

ObjectiveTo analyze the differences in color， odor and volatile components of Citri Reticulatae Pericarpium（CRP） before and after being stir-fried with Halloysitum Rubrum， and to explore the material basis of enhancing the effect of strengthening spleen after processing and the scientific connotation of decoction pieces processed with Halloysitum Rubrum as the auxiliary material. MethodsThe volatile components of the samples before and after processing were identified and relatively quantified by headspace gas chromatography-mass spectrometry（HS-GC-MS）， and the volatile components were analyzed by principal component analysis（PCA） and orthogonal partial least squares-discriminant analysis（OPLS-DA）. According to the principle of variable importance in the projection（VIP） value>1.5， volatile differential components before and after processing were screened. And combined with intelligent sensory technologies such as colorimeter and electronic nose， the chroma and odor information of CRP before and after being stir-fried with Halloysitum Rubrum were identified. Pearson correlation analysis was used to explore the correlation between volatile differential components and chroma values. ResultsA total of 112 volatile components were identified from CRP and CRP stir-fried with Halloysitum Rubrum， of which 84 were from CRP and 97 were from CRP stir-fried with Halloysitum Rubrum. And 7 differential components were selected， including α-pinene， β-myrcene， linalool， sabinene， ocimene isomer mixture， A-ocimene， and δ-elemene. After being processed with Halloysitum Rubrum， the brightness value（L^*）， yellow-blue value（b^*） and total chromatic value（E^*_ab） of CRP were decreased（P<0.01）， and red-green value（a^*） was increased（P<0.01）， the response values of S4， S5， S10 and S13 sensors were significantly increased（P<0.05）， and the response values of S3 and S8 sensors were significantly decreased（P<0.05）. Correlation analysis showed that α-pinene and β-myrcene were negatively correlated with L^* and E^*_ab， but positively correlated with a^*. Sabinene was positively correlated with L^* and E^*_ab. Linalool was positively correlated with L^* and E^*_ab， and negatively correlated with a^*. The ocimene isomer mixture was positively correlated with the L^*. ConclusionAfter being processed with Halloysitum Rubrum， the appearance color， odor and volatile components of CRP change significantly， and α-pinene， β-myrcene， sabinene， linalool and A-ocimene are the characteristic volatile components before and after processing， which can provide references for the quality evaluation and clinical application of CRP and its processed products.

Objective To compare the quality and centrifugal efficiency of human plasma cryoprecipitates extracted by GQ142 high-speed tube centrifuge and BKB45 continuous flow centrifuge and the differences in the production process of human coagulation factor Ⅷ(FⅧ).Methods The main functions, parameters and work efficiency of GQ142 high-speed tube centrifuge and BKB45 continuous flow centrifuge were compared. Cryoprecipitates were extracted for FⅧ production,sampling and testing, comparing the quality, yield, and virus safety of cryoprecipitates, as well as the quality and virus safety of FⅧ production process and finished products.Results Compared with GQ142 high-speed tube centrifuge, BKB45 continuous flow centrifuge had more perfect functions and higher working efficiency. The appearance of the cryoprecipitates extracted by both centrifuges was normal, the virus safety was in accordance with the internal quality control standard, and there was no statistically significant difference in cryoprecipitates yield(t = 1. 507, P > 0. 05). The recovery rates of FⅧactivity were(48. 7 ± 4. 2)% and(49. 2 ± 5. 4)%, respectively, with no statistically significant difference(t =-0. 250, P >0. 05). There was no statistically significant difference in FⅧ potency, protein content and FⅧ specific activity among cryoprecipitate solution, post chromatographic products and ultrafiltration products(t =-1. 466,-2. 084,-0. 998,-1. 701,-1. 973, 0. 472,-0. 975, 1. 116, and-1. 215, respectively, each P > 0. 05). The recovery rates of FⅧ activity of post chromatographic products were(38. 0 ± 4. 4)% and(38. 7 ± 5. 6)%, respectively, with no statistically significant difference(t =-0. 275, P > 0. 05). The pH of ultrafiltration products was stable. The appearance of the finished products was normal, and the virus safety indicators, FⅧ potency, moisture, pH, protein content and FⅧ specific activity were all in accordance with the quality standards of Chinese Pharmacopoeia(Vol Ⅲ, 2020 edition).Conclusion Compared with GQ142 high-speed tube centrifuge, BKB45 continuous flow centrifuge can significantly improve production efficiency while ensuring the quality of cryoprecipitates and FⅧ, making it suitable for large-scale production.

Objective To compare the quality and centrifugal efficiency of human plasma cryoprecipitates extracted by GQ142 high-speed tube centrifuge and BKB45 continuous flow centrifuge and the differences in the production process of human coagulation factor Ⅷ(FⅧ).Methods The main functions, parameters and work efficiency of GQ142 high-speed tube centrifuge and BKB45 continuous flow centrifuge were compared. Cryoprecipitates were extracted for FⅧ production,sampling and testing, comparing the quality, yield, and virus safety of cryoprecipitates, as well as the quality and virus safety of FⅧ production process and finished products.Results Compared with GQ142 high-speed tube centrifuge, BKB45 continuous flow centrifuge had more perfect functions and higher working efficiency. The appearance of the cryoprecipitates extracted by both centrifuges was normal, the virus safety was in accordance with the internal quality control standard, and there was no statistically significant difference in cryoprecipitates yield(t = 1. 507, P > 0. 05). The recovery rates of FⅧactivity were(48. 7 ± 4. 2)% and(49. 2 ± 5. 4)%, respectively, with no statistically significant difference(t =-0. 250, P >0. 05). There was no statistically significant difference in FⅧ potency, protein content and FⅧ specific activity among cryoprecipitate solution, post chromatographic products and ultrafiltration products(t =-1. 466,-2. 084,-0. 998,-1. 701,-1. 973, 0. 472,-0. 975, 1. 116, and-1. 215, respectively, each P > 0. 05). The recovery rates of FⅧ activity of post chromatographic products were(38. 0 ± 4. 4)% and(38. 7 ± 5. 6)%, respectively, with no statistically significant difference(t =-0. 275, P > 0. 05). The pH of ultrafiltration products was stable. The appearance of the finished products was normal, and the virus safety indicators, FⅧ potency, moisture, pH, protein content and FⅧ specific activity were all in accordance with the quality standards of Chinese Pharmacopoeia(Vol Ⅲ, 2020 edition).Conclusion Compared with GQ142 high-speed tube centrifuge, BKB45 continuous flow centrifuge can significantly improve production efficiency while ensuring the quality of cryoprecipitates and FⅧ, making it suitable for large-scale production

Objective Based on 25 indicators including immune factors, cell count classification, and smear results of the knee joint fluid, machine learning models were established to distinguish between osteoarthritis (OA) and rheumatoid arthritis (RA). Methods 100 OA and 40 RA patients scheduled for total knee arthroplasty were enrolled respectively. Each patient's knee joint fluid was collected preoperatively. Nucleated cells were counted and classified. The expression levels of immune factors, including tumor necrosis factor alpha (TNF-α), interleukin-1 beta (IL-1β), IL-6, IL-8, IL-15, matrix metalloproteinase 3 (MMP3), MMP9, MMP13, rheumatoid factor (RF), serum amyloid A (SAA), C-reactive protein (CRP), and others were measured. Smears and microscopic classification of all the immune factors were performed. Independent influencing factors for OA or RA were identified using univariate binary logistic regression, Lasso regression, and multivariate binary logistic regression. Based on the independent influencing factors, three machine learning models were constructed which are logistic regression, random forest, and support vector machine. Receiver operating characteristic curve (ROC), calibration curve and decision curve analysis (DCA) were used to evaluate and compare the models. Results A total of 5 indicators in the knee joint fluid were screened out to distinguish OA and RA, which were IL-1β(odds ratio(OR)=10.512, 95× confidence interval (95×CI) was 1.048-105.42, P=0.045), IL-6 (OR=1.007, 95×CI was 1.001-1.014, P=0.022), MMP9 (OR=3.202, 95×CI was 1.235-8.305, P=0.017), MMP13 (OR=1.002, 95× CI was 1-1.004, P=0.049), and RF (OR=1.091, 95×CI was 1.01-1.179, P=0.026). According to the results of ROC, calibration curve and DCA, the accuracy (0.979), sensitivity (0.98) and area under the curve (AUC, 0.996, 95×CI was 0.991-1) of the random forest model were the highest. It has good validity and feasibility, and its distinguishing ability is better than the other two models. Conclusion The machine learning model based on immune factors in the knee joint fluid holds significant value in distinguishing OA and RA. It provides an important reference for the clinical early differential diagnosis, prevention and treatment of OA and RA.
Humans ; Arthritis, Rheumatoid/metabolism* ; Machine Learning ; Male ; Female ; Middle Aged ; Aged ; Synovial Fluid/immunology* ; Osteoarthritis, Knee/metabolism* ; Knee Joint/metabolism* ; ROC Curve ; Diagnosis, Differential

Objective To analyze the tumor characteristics associated with achieving pathological complete response(pCR) and tumor prognosis in the patients undergoing laparoscopic rectal cancer surgery after neoadjuvant chemoradiotherapy(nCRT). Methods A retrospective review was conducted on clinical and pathological data of locally advanced rectal cancer(LARC) patients who underwent nCRT at Renji Hospital from January 2017 to January 2024. Factors influencing the achievement of pCR were analyzed, and the patients prognosis of pCR group and non-pCR group was compared. Results Univariate analysis, multivariate Logistic regression analysis, and receiver operating characteristic (ROC) curve analysis showed that tumor length less than 5 cm(cutoff value 5.24 cm) and baseline carcinoembryonic antigen(CEA) less than 5 μg/L(cutoff value 5.33 μg/L) were independent predictors of achieving pCR after nCRT in LARC patients. Prognostic survival analysis showed that the 3-year overall survival(OS) rate for pCR group and non-pCR group were 92.86% and 82.46%, respectively (P=0.193), and the 3-year disease-free survival (DFS) rate were 85.71% and 70.18%, respectively (P=0.141), with no statistically significant differences between the two groups. Conclusions Tumor length and baseline CEA level are independent predictors for achieving pCR after nCRT in LARC patients. Additionally, there were no statistically significant differences in 3-year OS and DFS between pCR group and non-pCR group.

Objective To analyze the prevalence status,influencing factors,and differences among different school age groups of myopia in children and adolescents in Ningxia Hui Autonomous Region.Methods From September to De-cember 2019,inYinchuan,Wuzhong,Shizuishan,Guyuan and Zhongwei of Ningxia,8 primary schools,6 junior high schools,6 senior high schools and 4 universities were randomly selected by stratified cluster random sampling.Five classes were se-lected from each grade of primary school,and four classes were selected from each grade of junior high school to university.All students in the selected classes were included in the study.A total of 14 211 students were selected for questionnaire sur-vey,physical examination and visual acuity measurement.The influencing factors of myopia in children of different grades were analyzed using the least absolute shrinkage and selection operator(LASSO)and logistic regression,and the model with the smallest Bayesian information criterion(BIC)was selected as the optimal model.Results The detection rate of myopia in children and adolescents in Ningxia Hui Autonomous Region was 70.3％.The detection rate of myopia in girls was higher than that in boys,and that in cities was higher than that in towns,with statistically significant differences(both P＜0.001).Compared with primary school students,the detection rate of myopia in junior high school students,senior high school students and college students gradually increased,and that in the college students was the highest,with statistically signifi-cant differences among different grades(all P＜0.001).The LASSO-logistic regression analysis of the influencing factors of myopia showed that urban and rural areas,gender,age,whether or not to wear glasses at present,the number of daily break exercises,whether or not to actively participate in physical activities,and whether or not to maintain regular exercises in the past 6 months were the influencing factors of myopia in primary school students(all P＜0.05).Gender and whether or not to wear glasses at present were the influencing factors of myopia in junior high school students and senior high school students(all P＜0.05).Whether or not to wear glasses at present was the influencing factor of myopia in college students(P＜0.05).Conclusion The detection rate of myopia in children and adolescents in Ningxia Hui Autonomous Region is high,and there are significant differences in the influencing factors of myopia among different age groups of children and adolescents.Wear-ing glasses is a protective factor to control myopia.Targeted health education on vision should be provided based on the aca-demic stage of children and adolescents to enhance their awareness of health care and improve their visual health.

Objective:To explore the relationship between the expression of long chain non coding ribonucleic acid (LncRNA) small nucleolar RNA host gene 1 (LncRNA SNHG1) and microRNA (miR)-143-3p in nasopharyngeal squamous cell carcinoma (HSCC) tissue and clinical pathological features and prognosis.Methods:A prospective selection was made from 97 HSCC patients admitted to the Handan Central Hospital from March 2016 to March 2018. Surgical resection of HSCC tissue and normal mucosa tissue adjacent to cancer were taken, and real-time fluorescence quantitative polymerase chain reaction (qRT-PCR) was used to detect the expression of LncRNA SNHG1 and miR-143-3p. The patient′s survival status was followed up after leaving the hospital. We compared the differences in the expression of LncRNA SNlHG1 and miR-143-3p in HSCC tissues with different clinical pathological parameters, analyzed the correlation between LncRNA SNHG1 and miR-143-3p expression, and the relationship between LncRNA SNHG1 and miR-143-3p expression and the prognosis of HSCC patients.Results:The expression of LncRNA SNHG1 in HSCC tissue was higher than that in normal mucosa tissue adjacent to cancer ( P<0.05), and the expression of miR-143-3p was lower than that in normal mucosa tissue adjacent to cancer ( P<0.05). The expression of LncRNA SNHG1 in cancer tissues of HSCC patients with tumor node metastasis (TNM) stage Ⅲ, low to medium differentiation, and lymph node metastasis was higher than that of HSCC patients with TNM stage Ⅰ-Ⅱ, high differentiation, and no lymph node metastasis (all P<0.05), and the expression of miR-143-3p was lower than that of HSCC patients with TNM stage Ⅰ-Ⅱ, high differentiation, and no lymph node metastasis (all P<0.05). The expression of LncRNA SNHG1 in HSCC tissues is negatively correlated with the expression of miR-143-3p ( r=-0.522, P<0.05). The 5-year cumulative survival rate of HSCC patients with high expression of LncRNA SNHG1 was lower than that of HSCC patients with low expression of LncRNA SNHG1 ( P<0.05), and the 5-year cumulative survival rate of HSCC patients with low expression of miR-143-3p was lower than that of HSCC patients with high expression of miR-143-3p ( P<0.05). Multivariate Cox regression analysis showed that TNM stage Ⅲ and high expression of LncRNA SNHG1 were risk factors for poor prognosis in HSCC patients (all P<0.05), while high expression of miR-143-3p was a protective factor ( P<0.05). Conclusions:The expression of LncRNA SNHG1 is upregulated and miR-143-3p is downregulated in HSCC tissues, with a negative correlation between the two, which is related to the malignant pathological characteristics and poor prognosis of HSCC.

Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.