Objective: Data on syncopal donation-related vasovagal reaction (DRVR) collected from 74 blood centers between 2020 and 2023 was statistically analyzed to provide a reference for developing preventive strategies against syncopal DRVR. Methods: Data on blood donation adverse reactions and basic information of donors from 2020 to 2023 were collected through the information management system at monitoring sentinel sites. Statistical analysis was performed on the following aspects of syncopal DRVR: characteristics of donors who experienced syncope, reported incidence, triggers, duration, presence and occurrence time of syncope-related trauma, clinical management including outpatient and inpatient treatment, and severity grading. Results: From 2020 to 2023, 45 966 donation-related adverse reactions were recorded. Of these, 1 665 (3.72%) cases were syncopal DRVR. The incidence of syncopal DRVR decreased with age, being the highest in the 18-22 age group. Incidence was significantly higher in female donors than male donors, in first-time donors than repeat donors, and in university and individual donors than group donors (all P<0.05). There was no statistically significant difference among different blood donation locations (P>0.05). The top three triggers were tension, fatigue, and needle phobia or fear of blood. Among syncopal DRVR cases, 60.36% occurred during blood collection, 87.63% lasted for less than 60 seconds, and 5.05% were accompanied by trauma. Notably, 57.14% of these traumas occurred after donor had left the blood collection site. Syncope severity was graded based on required treatment: grade 1 (fully recovered without treatment, 95.50%); grade 2 (recovered after outpatient treatment, 4.02%); and grade 3 (recovered after inpatient treatment, 0.48%). Conclusion: By analyzing the data of syncopal DRVR cases, it is possible to provide a reference for formulating blood donor safety policies.

Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.

Objective:To investigate the efficacy and safety of bendamustine combined with anti-CD20 monoclonal antibody in the first-line treatment of older patients with indolent B-cell non-Hodgkin lymphoma (B-iNHL) .Methods:The clinical data of 159 patients with B-iNHL enrolled in 16 hospitals from Jiangsu Cooperative Lymphoma Group from December 1, 2019, to April 20, 2024, were analyzed for regimen efficacy and safety. Bendamustine plus rituximab (BR) and bendamustine plus obinutuzumab (BG) were administered to 139 (87.4% ) and 20 (12.6% ) patients, respectively.Results:Among the 159 patients, 101 (63.5% ) were male and 58 (36.5% ) were female, with a median age of 69 years (range: 60–84). Efficacy could be assessed in 138 (86.8% ) patients. The efficacy assessment demonstrated that the overall response rate was 92.0% with complete and partial remissions in 75 (54.3% ) and 52 (37.7% ) cases, respectively. With a median follow-up of 24 months (range: 4–64), the progression-free survival rate was (87.5 ± 3.0) % and the overall survival rate was (83.2 ± 3.3) %. Of the 27 patients who died, 6 (22.2% ) died due to disease progression. The mean applied dose of bendamustine per cycle was 73.0 (50.8–89.7) mg/m 2 per day, administered on days 1 and 2. Adverse events of grade 3 or higher were reported in 53 (33.3% ) patients, with infection (30 cases,18.9% ) and neutropenia (24 cases, 15.1% ) demonstrating the highest incidence. Conclusion:Bendamustine combined with anti-CD20 monoclonal antibody demonstrated good efficacy and is well-tolerated in the first-line treatment of elderly patients with B-iNHL.

Objective:To assess the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of chronic hepatitis C (CHC) of various genotypes, without cirrhosis or with compensated cirrhosis.Methods:394 cases with CHC from 22 centers were collected from October 2021 to April 2023. They were randomly assigned to receive either the experimental drugs (antaitasvir phosphate 100 mg+yiqibuvir 600 mg) or placebo treatment in a 3∶1 ratio. The patients were administered drugs once a day for 12 consecutive weeks, and then followed up for 24 weeks after treatment cessation. All subjects were unblinded at the four-week follow-up following drug discontinuation, with the experimental drug group continuing to complete subsequent post-discontinuation follow-up. The placebo group was switched to receive the experimental drugs for a repeated 12-week treatment period and followed up for another 24 weeks after discontinuation of the drug (placebo delayed treatment phase).The sustained virologic response rate (SVR12) was observed for subjects in the double-blind phase and the placebo delayed-treatment phase at 12 weeks after treatment cessation.Virological resistance analysis was performed on subjects who failed treatment. The primary efficacy endpoint was SVR12. The number and percentage of subjects who achieved "HCV RNA

Objective To investigate the effectiveness and safety of infarct core resection combined with decompressive craniectomy(DC)based on corticospinal tract(CST)protection in the treatment of massive cerebral infarction(MCI)with malignant brain edema.Methods This study retrospectively enrolled MCI patients with malignant brain edema who underwent internal decompression combined with DC at Xingtai Central Hospital from January 2021 to June 2024.The enrolled patients were divided into a control group and an experimental group base on the intracranial internal decompression method used.All patients underwent CT perfusion(CTP),CT angiography(CTA),diffusion-weighted imaging(DWI),and diffusion tensor imaging(DTI)within 24 h of admission.Preoperative imaging data was automatically processed using an artificial intelligence diagnostic system.For the experimental group,the imaging data was fused within a neuro-navigation system preoperatively to visualize the spatial relationships between the infarct core,ischemic penumbra,and CST and infarct core resection combined with DC was performed while protecting the CST through neuro-navigation.The control group underwent anterior temporal lobectomy combined with DC.Baseline and clinical data were collected from both groups,including gender,age,smoking history,alcohol consumption history,diabetes,hypertension,hyperlipidemia,hyperhomocysteinemia,atrial fibrillation history,responsible occluded vessel(internal carotid artery,middle cerebral artery),preoperative infarct volume on DWI,preoperative ischemic penumbra volume,preoperative the National Institutes of Health stroke scale(NIHSS)score,time from onset to surgery,intraoperative procedure duration,intraoperative blood loss,preoperative and 1-month postoperative fraction anisotropy(FA)values of the CST on the affected side,modified Rankin scale(mRS)score at 6 months postoperatively,and surgery-related complications within 1 month postoperatively(intracranial hemorrhage[operative site oozing,hemorrhagic transformation]and intracranial infection[surgical incision site infection,empyema,brain abscess,meningitis]).6-month follow-up after surgery were conducted through outpatient visit or telephone calls and prognosis of patients was evaluated using the mRS(with mRS of 0-3 defined as good prognosis,4-6 as poor prognosis,and 6 indicating death).The effectiveness indicators included FA value of the affected CST at 1 month postoperatively,good prognosis rate after surgery at 6 months,and 6-month mortality rate after surgery.The safety indicators included the incidence rates of surgical complications(intracranial hemorrhage and infection)within 1 month postoperatively.Based on preoperative DTI images,all patients were further divided into a CST-intact(infarct core did not invade CST,CST morphology intact or deformed/shifted)and a CST-damaged(infarct core invaded CST,CST disrupted or interrupted)subgroup for analysis.Results A total of 62patients(37 males,25 females,age 49-60 years,mean[55±4]years)were enrolled in this study.With 28 patients in the experimental group and 34 in the control group.(1)No significant differences were found in baseline or clinical data between the experimental and control groups(all P＞0.05),and the reoperative FA values of the affected CST were showed no significant differences(P=0.588).(2)The efficacy and safety metrics were evaluated.For the efficacy indices,at 1 month after the surgery,FA values of the affected CST increased significantly compared to preoperative values in both groups(0.409±0.051 vs.0.312±0.052 in the experimental group,and,0.381±0.048 vs.0.319±0.049 in control group;both P＜0.05),and the FA value was significantly higher in the experimental group than that in the control group(0.409±0.051 vs.0.381±0.048,P=0.030).At the 6-month follow-ups,the good prognosis rate was significantly higher in the experimental group than that in the control group(39.3％[11/28]vs.14.7％[5/34],P=0.028).No significant difference in the 6-month mortality rate were observed between the two groups(P=0.787).For the safety indices,no significant differences were found in the incidence rates of intracranial hemorrhage or intracranial infection within 1 month postoperatively between the two groups(both P＞0.05).(3)For further subgroup analysis,no significant differences were found in baseline or clinical data between the CST-damaged subgroup and the CST-intact subgroup in both the experimental and control groups(all P＞0.05).In CST-intact subgroup,FA values of the affected CST increased significantly at 1 month postoperatively compared to preoperatively in the study group(0.428±0.047 vs.0.342±0.045,P＜0.05)and the control group(0.401±0.051 vs.0.347±0.048,P＜0.05).While in the CST-damaged subgroup,no significant differences were found in FA value of the affected CST 1 month postoperatively compared with that preoperatively in both the experimental and control groups(bothP＞0.05).A significantly higher FA values 1 month postoperatively(0.428±0.047 vs.0.401±0.051,P=0.036)and good prognosis rate(9/12 vs.4/16,P=0.020)were observed in the CST-intact subgroup of the experimental group comparing with that of the control group,while there was no statistically significant difference in the 6-month mortality rate between the groups within the CST-intact subgroup(P=1.000).There were no statistically significant differences between the experimental group and the control group in both efficacy and safety indices within the CST-damaged subgroup(all P＞0.05).Conclusions Infarct core resection combining DC with CST protection demonstrates superior neurological functional improvement in comparison with anterior temporal lobectomy combining DC in treating MCI with malignant brain edema,particularly for patients with an intact CST before surgery(as indicated in patients'preoperative imaging results).This(infarct core resection combining DC with CST protection)approach does not increase the incidence of surgical complications.Prospective large sample controlled studies are required for further validation.

Objective To investigate the clinical efficacy of internal decompression based on white matter tract preservation in the treatment of malignant middle cerebral artery infarction(MMCAI).Methods A retrospective analysis was conducted on 54 patients with MMCAI.Patients were divided into a study group(n=26)and a control group(n=28)according to the surgical approach.Patients in the study group underwent preoperative fusion of CT,CTP,DWI,and DTI imaging data within a neuronavigation system.This fusion visualized the spatial relationships between the infarct core(IC),ischemic penumbra,and the corticospinal tract(CST).Subsequently,IC resection combined with decompressive craniectomy(DC)was performed while protecting the CST.Patients in the control group underwent DC alone.Key outcome measures included:changes in fractional anisotropy(FA)within the affected CST projection area at 1 month postoperatively;and 6-month postoperative mRS score,mortality,and surgical complications at 6 months postoperatively.Results At 1 month postoperatively,FA in the affected CST projection area were significantly higher in the study group than in the control group(0.092±0.013 vs.0.082±0.008,P<0.05).At the 6-month follow-up,the postoperative mRS score in the study group was significantly lower than that in the control group[2.3(1.3,4.5)vs.3.9(2.4,5.5),P<0.05]and a lower mortality rate(11.5%vs.39.3%,P<0.05)compared to the control group.However,there were no statistically significant differences between the two groups in the incidence of postoperative intracranial hemorrhage,intracranial infection,or epilepsy(P>0.05).Conclusion Internal decompression based on white matter tract protection combined with DC can reduce mortality and contribute to improving function outcomes in patients with MMCAI.

Objective To investigate the effectiveness and safety of infarct core resection combined with decompressive craniectomy(DC)based on corticospinal tract(CST)protection in the treatment of massive cerebral infarction(MCI)with malignant brain edema.Methods This study retrospectively enrolled MCI patients with malignant brain edema who underwent internal decompression combined with DC at Xingtai Central Hospital from January 2021 to June 2024.The enrolled patients were divided into a control group and an experimental group base on the intracranial internal decompression method used.All patients underwent CT perfusion(CTP),CT angiography(CTA),diffusion-weighted imaging(DWI),and diffusion tensor imaging(DTI)within 24 h of admission.Preoperative imaging data was automatically processed using an artificial intelligence diagnostic system.For the experimental group,the imaging data was fused within a neuro-navigation system preoperatively to visualize the spatial relationships between the infarct core,ischemic penumbra,and CST and infarct core resection combined with DC was performed while protecting the CST through neuro-navigation.The control group underwent anterior temporal lobectomy combined with DC.Baseline and clinical data were collected from both groups,including gender,age,smoking history,alcohol consumption history,diabetes,hypertension,hyperlipidemia,hyperhomocysteinemia,atrial fibrillation history,responsible occluded vessel(internal carotid artery,middle cerebral artery),preoperative infarct volume on DWI,preoperative ischemic penumbra volume,preoperative the National Institutes of Health stroke scale(NIHSS)score,time from onset to surgery,intraoperative procedure duration,intraoperative blood loss,preoperative and 1-month postoperative fraction anisotropy(FA)values of the CST on the affected side,modified Rankin scale(mRS)score at 6 months postoperatively,and surgery-related complications within 1 month postoperatively(intracranial hemorrhage[operative site oozing,hemorrhagic transformation]and intracranial infection[surgical incision site infection,empyema,brain abscess,meningitis]).6-month follow-up after surgery were conducted through outpatient visit or telephone calls and prognosis of patients was evaluated using the mRS(with mRS of 0-3 defined as good prognosis,4-6 as poor prognosis,and 6 indicating death).The effectiveness indicators included FA value of the affected CST at 1 month postoperatively,good prognosis rate after surgery at 6 months,and 6-month mortality rate after surgery.The safety indicators included the incidence rates of surgical complications(intracranial hemorrhage and infection)within 1 month postoperatively.Based on preoperative DTI images,all patients were further divided into a CST-intact(infarct core did not invade CST,CST morphology intact or deformed/shifted)and a CST-damaged(infarct core invaded CST,CST disrupted or interrupted)subgroup for analysis.Results A total of 62patients(37 males,25 females,age 49-60 years,mean[55±4]years)were enrolled in this study.With 28 patients in the experimental group and 34 in the control group.(1)No significant differences were found in baseline or clinical data between the experimental and control groups(all P＞0.05),and the reoperative FA values of the affected CST were showed no significant differences(P=0.588).(2)The efficacy and safety metrics were evaluated.For the efficacy indices,at 1 month after the surgery,FA values of the affected CST increased significantly compared to preoperative values in both groups(0.409±0.051 vs.0.312±0.052 in the experimental group,and,0.381±0.048 vs.0.319±0.049 in control group;both P＜0.05),and the FA value was significantly higher in the experimental group than that in the control group(0.409±0.051 vs.0.381±0.048,P=0.030).At the 6-month follow-ups,the good prognosis rate was significantly higher in the experimental group than that in the control group(39.3％[11/28]vs.14.7％[5/34],P=0.028).No significant difference in the 6-month mortality rate were observed between the two groups(P=0.787).For the safety indices,no significant differences were found in the incidence rates of intracranial hemorrhage or intracranial infection within 1 month postoperatively between the two groups(both P＞0.05).(3)For further subgroup analysis,no significant differences were found in baseline or clinical data between the CST-damaged subgroup and the CST-intact subgroup in both the experimental and control groups(all P＞0.05).In CST-intact subgroup,FA values of the affected CST increased significantly at 1 month postoperatively compared to preoperatively in the study group(0.428±0.047 vs.0.342±0.045,P＜0.05)and the control group(0.401±0.051 vs.0.347±0.048,P＜0.05).While in the CST-damaged subgroup,no significant differences were found in FA value of the affected CST 1 month postoperatively compared with that preoperatively in both the experimental and control groups(bothP＞0.05).A significantly higher FA values 1 month postoperatively(0.428±0.047 vs.0.401±0.051,P=0.036)and good prognosis rate(9/12 vs.4/16,P=0.020)were observed in the CST-intact subgroup of the experimental group comparing with that of the control group,while there was no statistically significant difference in the 6-month mortality rate between the groups within the CST-intact subgroup(P=1.000).There were no statistically significant differences between the experimental group and the control group in both efficacy and safety indices within the CST-damaged subgroup(all P＞0.05).Conclusions Infarct core resection combining DC with CST protection demonstrates superior neurological functional improvement in comparison with anterior temporal lobectomy combining DC in treating MCI with malignant brain edema,particularly for patients with an intact CST before surgery(as indicated in patients'preoperative imaging results).This(infarct core resection combining DC with CST protection)approach does not increase the incidence of surgical complications.Prospective large sample controlled studies are required for further validation.

Objective To investigate the clinical efficacy of internal decompression based on white matter tract preservation in the treatment of malignant middle cerebral artery infarction(MMCAI).Methods A retrospective analysis was conducted on 54 patients with MMCAI.Patients were divided into a study group(n=26)and a control group(n=28)according to the surgical approach.Patients in the study group underwent preoperative fusion of CT,CTP,DWI,and DTI imaging data within a neuronavigation system.This fusion visualized the spatial relationships between the infarct core(IC),ischemic penumbra,and the corticospinal tract(CST).Subsequently,IC resection combined with decompressive craniectomy(DC)was performed while protecting the CST.Patients in the control group underwent DC alone.Key outcome measures included:changes in fractional anisotropy(FA)within the affected CST projection area at 1 month postoperatively;and 6-month postoperative mRS score,mortality,and surgical complications at 6 months postoperatively.Results At 1 month postoperatively,FA in the affected CST projection area were significantly higher in the study group than in the control group(0.092±0.013 vs.0.082±0.008,P<0.05).At the 6-month follow-up,the postoperative mRS score in the study group was significantly lower than that in the control group[2.3(1.3,4.5)vs.3.9(2.4,5.5),P<0.05]and a lower mortality rate(11.5%vs.39.3%,P<0.05)compared to the control group.However,there were no statistically significant differences between the two groups in the incidence of postoperative intracranial hemorrhage,intracranial infection,or epilepsy(P>0.05).Conclusion Internal decompression based on white matter tract protection combined with DC can reduce mortality and contribute to improving function outcomes in patients with MMCAI.

Objective:To investigate the efficacy and safety of bendamustine combined with anti-CD20 monoclonal antibody in the first-line treatment of older patients with indolent B-cell non-Hodgkin lymphoma (B-iNHL) .Methods:The clinical data of 159 patients with B-iNHL enrolled in 16 hospitals from Jiangsu Cooperative Lymphoma Group from December 1, 2019, to April 20, 2024, were analyzed for regimen efficacy and safety. Bendamustine plus rituximab (BR) and bendamustine plus obinutuzumab (BG) were administered to 139 (87.4% ) and 20 (12.6% ) patients, respectively.Results:Among the 159 patients, 101 (63.5% ) were male and 58 (36.5% ) were female, with a median age of 69 years (range: 60–84). Efficacy could be assessed in 138 (86.8% ) patients. The efficacy assessment demonstrated that the overall response rate was 92.0% with complete and partial remissions in 75 (54.3% ) and 52 (37.7% ) cases, respectively. With a median follow-up of 24 months (range: 4–64), the progression-free survival rate was (87.5 ± 3.0) % and the overall survival rate was (83.2 ± 3.3) %. Of the 27 patients who died, 6 (22.2% ) died due to disease progression. The mean applied dose of bendamustine per cycle was 73.0 (50.8–89.7) mg/m 2 per day, administered on days 1 and 2. Adverse events of grade 3 or higher were reported in 53 (33.3% ) patients, with infection (30 cases,18.9% ) and neutropenia (24 cases, 15.1% ) demonstrating the highest incidence. Conclusion:Bendamustine combined with anti-CD20 monoclonal antibody demonstrated good efficacy and is well-tolerated in the first-line treatment of elderly patients with B-iNHL.

Objective:To assess the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of chronic hepatitis C (CHC) of various genotypes, without cirrhosis or with compensated cirrhosis.Methods:394 cases with CHC from 22 centers were collected from October 2021 to April 2023. They were randomly assigned to receive either the experimental drugs (antaitasvir phosphate 100 mg+yiqibuvir 600 mg) or placebo treatment in a 3∶1 ratio. The patients were administered drugs once a day for 12 consecutive weeks, and then followed up for 24 weeks after treatment cessation. All subjects were unblinded at the four-week follow-up following drug discontinuation, with the experimental drug group continuing to complete subsequent post-discontinuation follow-up. The placebo group was switched to receive the experimental drugs for a repeated 12-week treatment period and followed up for another 24 weeks after discontinuation of the drug (placebo delayed treatment phase).The sustained virologic response rate (SVR12) was observed for subjects in the double-blind phase and the placebo delayed-treatment phase at 12 weeks after treatment cessation.Virological resistance analysis was performed on subjects who failed treatment. The primary efficacy endpoint was SVR12. The number and percentage of subjects who achieved "HCV RNA