The Chinese Pharmacopoeia 2025 Edition is about to be officially released. Based on multiple meetings and extensive consultations the vaccine products professional committee of the 12th pharmacopoeia commission, has revised and formed the general chapter 0237 for the preparation of national biological reference standards in Chinese Pharmacopoeia 2025 Edition volume Ⅲ. General chapter 0237, integrating the cutting-edge concepts from WHO’s related guidelines and the practical experience of biological reference standards both domestically, has revised the names of this chapter, updated and improved the technical requirements for candidate reference materials, collaborative calibration and value assignment, as well as stability research and monitoring. It also newly proposes the calculation of uncertainty of biological reference materials and emphasizes to pay attention to commutability. The implementation of general chapter 0237 will play a guiding role in improving the research and application level of biological reference materials in China. This article, by interpreting the revised content of general chapter 0237, aims to provide a reference for the researchers of biological reference materials.

Objective　To analyze the in vitro yeast-phase drug susceptibility testing of 82 Talaromyces marneffei (TM) strains isolated at Yunnan Infectious Disease Hospital and their association with patient therapeutic outcomes. The study aims to investigate the antifungal resistance breakpoint for TM through in vitro susceptibility tests, evaluate the stability of the susceptibility testing methods, and assess the correlation between in vitro susceptibility test results and different clinical outcomes in HIV/AIDS patients with TM. This research provides a theoretical basis for the clinical selection of highly effective and low-toxicity antifungal drugs in treating HIV/AIDS with TM infection and aims to improve the clinical treatment quality. Methods　Clinical data from 82 HIV/AIDS patients co-infected with TM from 2017 to 2021 were retrospectively collected. The minimum inhibitory concentration (MIC) of TM strains from these patients was tested using the microdilution method at Yunnan Provincial Infectious Disease Hospital. Patients were divided into two groups based on therapeutic outcomes: good and poor. Statistical analyses were performed on epidemiological data, clinical characteristics, laboratory data, and treatment regimens between the two groups. Correlations between different MIC results and therapeutic outcomes were analyzed, and independent risk factors affecting prognosis were identified using multivariate logistic regression. The predictive value of the diagnostic indicators was assessed using the Receiver Operating Characteristic (ROC) curves. Results　Clinical efficacy: Out of the 82 patients, 38 had good outcomes and 44 had poor outcomes. Univariate analysis showed statistically significant differences (P<0.05) in abnormal imaging features, CD4+T lymphocyte count, duration of antifungal therapy, white blood cell (WBC) count, total protein (TP), albumin (ALB), and use of itraconazole. Patients who received itraconazole had better outcomes, with statistically significant differences (P<0.05). In vitro susceptibility testing: MICs for 82 TM strains were <4 to 4 mg/L for 5-fluorocytosine, <0.5 to 0.5 mg/L for amphotericin B, <1 to 8 mg/L for fluconazole, <0.125 mg/L for itraconazole, and <0.06 to 0.06 mg/L for voriconazole. There were no statistical differences in efficacy among patients with different susceptibility results for the same drug. Prognostic model: A significantly reduced CD4+T cell count was an independent risk factor for poor TM treatment outcomes, with a ROC curve area under the curve (AUC) of 0.983 (95%CI: 0.963-1.000), specificity of 0.955, and sensitivity of 0.919. Conclusion　The tested TM strains showed good sensitivity to all five antifungal drugs. Sequential treatment with itraconazole can improve patient prognosis, and CD4+T cell count is an independent risk factor affecting the prognosis of patients with TM infection.

Objective To compare the stability of multi-rod structures with double-headed screws and traditional connectors in posterior three-column osteotomy of the spine using finite element analysis.Methods A finite element model of the T3-L4 thoracolumbar spine was constructed based on postoperative computed tomography(CT)data of patients with severe kyphosis.Based on the patient's standard two-rod model(2R),a double-headed screw multi-rod structure model(4R-DHS)and a traditional connector multi-rod structure model(4R-TC)were constructed.The two models were evaluated under 300 N follower load and 7.5 N-m moment load,and the stability,maximum von Mises stresses on the main rods,and stress distributions of the two multi-rod structures were analyzed.Results There was little difference in the stability between the two multi-rod structures.Compared with 4R-TC,4R-DHS showed a decrease in the maximum von Mises stresses on the main rods during all motions(the stress decreased by 7.2％,8.8％,8.7％,18.5％,and 16.9％during flexion,left lateral bending,right lateral bending,left axial rotation,and right axial rotation,respectively)and more uniform stress distribution,except for a slight increase in the maximum von Mises stresses on the main rods during post-extension.Conclusions The double-headed screw multi-rod structure can reduce the maximum stress on the main rod compared with the traditional connector multi-rod structure,and there is no problem with stress concentration on the main rod near the connector,which can more effectively reduce the risk of internal fixation failure.

Objective: To investigate the differences of clinicopathological features, diagnosis, treatment and prognosis between patients with extra-gastrointestinal stromal tumors (EGIST) and duodenal gastrointestinal stromal tumors (DGIST). Methods: A retrospective case - control study was performed. Case inclusion criteria: (1) tumor confirmed by histology and pathology; (2) primary tumor locating in the extra - gastrointestinal tract or duodenum; (3) without other synchronous tumors; (4) complete clinical and pathological data. Clinical data of 20 EGIST patients and 32 DGIST patients from March 2011 to September 2016 at Department of Gastrointestinal Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine were retrospectively collected and analyzed. The observational parameters included clinicopathological characteristics, treatment and prognosis conditions. Continuous data of abnormal distribution were expressed as median (range) and compared using the Mann-Whitney U-test. Survival curves were drawn by the Kaplan-Meier method and compared with the Log-rank test. Results: Of the 20 EGIST patients, 8 were males and 12 were females with age of 61.0 (30.0 to 86.0) years and of the 32 DGIST patients, 12 were males and 20 were females with age of 55.5 (27.0 to 70.0) years. Compared with DGIST patients, EGIST patients were older (U=188.000, P=0.012], had larger tumor size [10.0 (3.0 to 29.0) cm vs. 4.0 (1.5 to 10.0) cm, U=98.500, P<0.001] and higher ratio of high risk classification [85.0% (17/20) vs. 12.5% (4/32), χ²=26.870, P<0.001]. Among the 20 EGIST patients, 5 were diagnosed with distal metastasis and received imatinib (400 mg/d), and the other 15 patients underwent radical resection who were included in survival analysis. All the 32 DGIST patients underwent radical resection. The median follow-up of whole group was 43 (14 to 76) months. The 3-year recurrence/metastasis-free survival rate of 15 cases undergoing radical resection in the EGIST group was 85.6%, which was lower than that of the DGIST group (88.6%), and the difference was not statistically significant (P=0.745). There was no significant difference in the 3-year overall survival rate between the EGIST group (92.9%) and the DGIST group (100%) (P=0.271). Conclusions As compared to DGIST, EGIST mostly occurs in those with older age, larger tumor size and higher risk grade. The prognosis of EGIST patients after radical resection is similar to that of DGIST patients.

Objective To investigate the differences of clinicopathological features, diagnosis, treatment and prognosis between patients with extra?gastrointestinal stromal tumors (EGIST) and duodenal gastrointestinal stromal tumors (DGIST). Methods A retrospective case?control study was performed. Case inclusion criteria: (1) tumor confirmed by histology and pathology; (2) primary tumor locating in the extra?gastrointestinal tract or duodenum; (3) without other synchronous tumors; (4) complete clinical and pathological data. Clinical data of 20 EGIST patients and 32 DGIST patients from March 2011 to September 2016 at Department of Gastrointestinal Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine were retrospectively collected and analyzed. The observational parameters included clinicopathological characteristics, treatment and prognosis conditions. Continuous data of abnormal distribution were expressed as median (range) and compared using the Mann?Whitney U?test. Survival curves were drawn by the Kaplan?Meier method and compared with the Log?rank test. Results Of the 20 EGIST patients, 8 were males and 12 were females with age of 61.0 (30.0 to 86.0) years and of the 32 DGIST patients, 12 were males and 20 were females with age of 55.5 (27.0 to 70.0) years. Compared with DGIST patients, EGIST patients were older (U=188.000, P=0.012], had larger tumor size [10.0 (3.0 to 29.0) cm vs. 4.0 (1.5 to 10.0) cm, U=98.500, P<0.001] and higher ratio of high risk classification [85.0% (17/20) vs. 12.5% (4/32), χ2=26.870, P<0.001]. Among the 20 EGIST patients, 5 were diagnosed with distal metastasis and received imatinib (400 mg/d), and the other 15 patients underwent radical resection who were included in survival analysis. All the 32 DGIST patients underwent radical resection. The median follow?up of whole group was 43 (14 to 76) months. The 3?year recurrence/metastasis?free survival rate of 15 cases undergoing radical resection in the EGIST group was 85.6%, which was lower than that of the DGIST group (88.6%), and the difference was not statistically significant (P=0.745). There was no significant difference in the 3?year overall survival rate between the EGIST group (92.9%) and the DGIST group (100%) (P=0.271). Conclusions As compared to DGIST, EGIST mostly occurs in those with older age, larger tumor size and higher risk grade. The prognosis of EGIST patients after radical resection is similar to that of DGIST patients.

Objective To investigate the differences of clinicopathological features, diagnosis, treatment and prognosis between patients with extra?gastrointestinal stromal tumors (EGIST) and duodenal gastrointestinal stromal tumors (DGIST). Methods A retrospective case?control study was performed. Case inclusion criteria: (1) tumor confirmed by histology and pathology; (2) primary tumor locating in the extra?gastrointestinal tract or duodenum; (3) without other synchronous tumors; (4) complete clinical and pathological data. Clinical data of 20 EGIST patients and 32 DGIST patients from March 2011 to September 2016 at Department of Gastrointestinal Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine were retrospectively collected and analyzed. The observational parameters included clinicopathological characteristics, treatment and prognosis conditions. Continuous data of abnormal distribution were expressed as median (range) and compared using the Mann?Whitney U?test. Survival curves were drawn by the Kaplan?Meier method and compared with the Log?rank test. Results Of the 20 EGIST patients, 8 were males and 12 were females with age of 61.0 (30.0 to 86.0) years and of the 32 DGIST patients, 12 were males and 20 were females with age of 55.5 (27.0 to 70.0) years. Compared with DGIST patients, EGIST patients were older (U=188.000, P=0.012], had larger tumor size [10.0 (3.0 to 29.0) cm vs. 4.0 (1.5 to 10.0) cm, U=98.500, P<0.001] and higher ratio of high risk classification [85.0% (17/20) vs. 12.5% (4/32), χ2=26.870, P<0.001]. Among the 20 EGIST patients, 5 were diagnosed with distal metastasis and received imatinib (400 mg/d), and the other 15 patients underwent radical resection who were included in survival analysis. All the 32 DGIST patients underwent radical resection. The median follow?up of whole group was 43 (14 to 76) months. The 3?year recurrence/metastasis?free survival rate of 15 cases undergoing radical resection in the EGIST group was 85.6%, which was lower than that of the DGIST group (88.6%), and the difference was not statistically significant (P=0.745). There was no significant difference in the 3?year overall survival rate between the EGIST group (92.9%) and the DGIST group (100%) (P=0.271). Conclusions As compared to DGIST, EGIST mostly occurs in those with older age, larger tumor size and higher risk grade. The prognosis of EGIST patients after radical resection is similar to that of DGIST patients.

OBJECTIVEDust sample mass gain is too smaller to satisfy the limit of detection (LOD) even in most cases during dust sampling at workplaces nowdays, especially for respirable fraction. Therefore, it is aimed to solve the problem by increasing sample load with high flow rate samplers.

METHODSIn A and B two shipyards respirable welding fume was sampled by high flow rate cyclone samplers of FSP-10 (10 L/min) for 2-2.5 hours and normal flow rate FSP-2 (2 L/min) for 3-4 hours with a stratigy of parallele sampling at the same workpalce, in order to compare their mass gain, coincidence rate with LOD, and airborn dust concentration.

RESULTSSample mass gain of 0.97±0.40 mg and 1.61±0.86 mg respectively in the two factories by FSP-10 was significantly higher than that of 0.29±0.12 mg and 0.51±0.27 mg by FSP-2 (t-test, P<0.05 in both cases) , increasing herewith the coincidence rate with LOD from 26.8% (when sampling with FSP-2, calculated together with samples of the two factories) to 89.7%. However there was no significant difference in dust concentrations by the two different samplers, 0.53±1.88 vs 0.73±1.61 mg/m(3) by FSP-2 and FSP-10 in the shipyard A and 1.14±1.78 vs 1.01±1.63 mg/m(3) in the factory B (t-test, P>0.05 in every case) . In addtion, sample loading by FSP-2 was found to be correlated to sampling time (R(2)=0.7906, y=0.002 6x) , therefore, it has to sample for ≥192.3 min to meet the LOD (0.5 mg) in case of normal flow rate.

CONCLUSIONBy using of high flow rate cyclone FSP-10 the problem of LOD could be solved, along with increased sample mass and similar respirable dust concentration by the two samplers. Some techincal improvements of FSP-10 and increasing of LOD coincidence rate by other methods was also disscussed.

Air Pollutants, Occupational ; analysis ; Construction Industry ; Dust ; analysis ; Environmental Monitoring ; instrumentation ; Occupational Exposure ; Ships ; Workplace

OBJECTIVETo investigate the role of calcium activated-potassium channels (KCa) in the injury to rat alveolar macrophages induced by quartz.

METHODSThe experiments were conducted on a rat alveolar macrophage cell line (NR8383) in vitro, where crystal silica (100 üg/ml) and amorphous silica (100 üg/ml) were used as the test substances and the cells without any treatment as negative controls. At first the effects of two kinds of quartz were compared. Then KCa special inhibitors (Paxilline for BK, Tram-34 for IK, Apamin for SK) were added in different doses to the in vitro test system with 100 üg/ml crystal quartz as matrix, to observe the function of such channels. Cell viability, lactate dehydrogenase (LDH), interleukin-1β (IL-1β) and tumor necrosis factor-a (TNF-α) were tested.

RESULTSComparing to the negative control group, cell viability reduced, LDH leakage, IL-1β and TNF-α release increased significantly in the amorphous quartz group, furthermore, the effects by crystal quartz were much more serious than those by amorphous quartz, with a statistical significance (P < 0.01). Comparing to the crystal quartz group, IK blockers (Tram-34) led to increase in cell viability significantly, with a statistical significance (P < 0.01); all the KCa specific blockers (Paxilline, Tram-34, Apamin) could reduce LDH leakage and IL-1β release, with a statistical significance (P < 0.05); meanwhile, BK and IK blockers (Paxilline,Tram-34) were able to reduce TNF-α release,with a statistical significance (P < 0.05).Reduction of IL-1β and TNF-α by Tram-34 was dose-dependent, but not so in the other two blockers.

CONCLUSIONBlocking calcium-activated potassium channels (KCa) could reduce cell membrane damage as well as IL-1β and TNF-α release induced by crystal quartz in the rat alveolar macrophages cell line in vitro, which might serve as a signal in the early regulation of inflammatory responses by quartz.

Animals ; Calcium ; metabolism ; Cell Line ; Interleukin-1beta ; metabolism ; Macrophages, Alveolar ; cytology ; metabolism ; Potassium Channels, Calcium-Activated ; metabolism ; Quartz ; toxicity ; Rats ; Tumor Necrosis Factor-alpha ; metabolism

There are actually no sufficient data for lifting technique assessment. A laboratory study was undertaken to determine the effect of 3 regular lifting techniques on erector muscle activation, cardiovascular strain and subjective response. Thirty student volunteers participated in the study, and were required to lift a weight with different techniques. Stoop-, squat-, semi-squat-lifting resulted in 3, 2 and 1 time of the highest percentage of the maximum voluntary electrical activation (MVE%) respectively. In the same order, the lowest median frequency (MF) existed 1, 1 and 2 times. Muscle fatigue was 4 times in squat, 36 in semi-squat and 43 in stoop lifting. Heart rate was the highest in squat and lowest in stoop respectively, with a middle level in semi-squat lifting. It may be recommended to adopt mainly the semi-squat technique for daily lifting works. For heavy lifting, it should use the squat technique. Stoop lifting may also be used alternatively but for light things.
Adult ; Biomechanical Phenomena ; physiology ; Female ; Humans ; Lifting ; Male ; Muscle Fatigue ; physiology ; Muscle, Skeletal ; physiology ; Young Adult

There are actually no sufficient data for lifting technique assessment. A laboratory study was undertaken to determine the effect of 3 regular lifting techniques on erector muscle activation, cardiovascular strain and subjective response. Thirty student volunteers participated in the study, and were required to lift a weight with different techniques. Stoop-, squat-, semi-squat-lifting resulted in 3, 2 and 1 time of the highest percentage of the maximum voluntary electrical activation (MVE%) respectively. In the same order, the lowest median frequency (MF) existed 1, 1 and 2 times. Muscle fatigue was 4 times in squat, 36 in semi-squat and 43 in stoop lifting. Heart rate was the highest in squat and lowest in stoop respectively, with a middle level in semi-squat lifting. It may be recommended to adopt mainly the semi-squat technique for daily lifting works. For heavy lifting, it should use the squat technique. Stoop lifting may also be used alternatively but for light things.