1.Analysis of the predictive value of early fluid balance in combination with daily average fluid intake for the prognosis of patients after spontaneous intracerebral hemorrhage hematoma evacuation
Xin HE ; Yan SUN ; Xiaoqi ZHOU ; Jie CHENG ; Qiqun TANG ; Xiaohua CHENG ; Fang CHEN
Chinese Journal of Cerebrovascular Diseases 2025;22(6):403-413
Objective To investigate the predictive value of early fluid balance combined with daily average fluid intake on the prognosis of patients who received hematoma evacuation for spontaneous intracerebral hemorrhage(sICH).Methods This study retrospectively and consecutively enrolled patients who underwent hematoma evacuation for sICH admitted to the Neurosurgical Intensive Care Unit of North China University of Science and Technology Affiliated Hospital between January 2023 and January 2025.Patients'baseline and clinical data were collected,including gender,age,admission vital signs(body temperature,respiratory rate,heart rate,systolic and diastolic blood pressure),medical history(hypertension,diabetes mellitus,coronary heart disease),admission Glasgow coma scale(GCS)score,admission laboratory parameters(including white blood cell count,red blood cell count,platelet count,urine bacterial levels,urine ketones,urine pH,homocysteine),hemorrhage location,hemorrhage volume,time from ictus to surgery,and hematoma evacuation rate(hematoma evacuation rate[%]=[preoperative hematoma volume-postoperative hematoma volume]/preoperative hematoma volume × 100%).Fluid intake,output,balance,daily average intake,and cumulative fluid balance during the early postoperative period(the first to seventh 24-hour periods)were assessed and recorded.Fluid intake comprised the sum of intravenously administered fluids(crystalloids,hypertonic fluids,colloids,blood products,and parenteral nutrition),enteral nutrition(nasogastric feeding solutions and water),and renal replacement therapy fluids.Fluid output comprised the sum of urine volume,vomitus,drainage fluid,and dialysis fluid losses.Fluid balance was defined as the difference between fluid intake and output.Daily average intake was calculated as the average of the fluid intake over the first seven postoperative 24-hour periods.Cumulative fluid balance was the sum of the fluid balances over the first seven postoperative 24-hour periods.Patient outcomes were assessed at 30 days postoperatively.Discharged patients underwent outpatient review or telephone follow-up,while inpatients were evaluated by neurosurgeons.Prognosis was evaluated using the 30-day modified Rankin scale(mRS)score:mRS scores 0-3 were classified as favorable prognosis,and mRS scores 4-6 as poor prognosis.Patients were subsequently divided into favorable prognosis and poor prognosis groups based on mRS scores.Factors with P<0.05 in univariate comparisons and without collinearity(multicollinearity was defined by:tolerance<0.1 and variance inflation factor>10)were included in multivariate Logistic regression analysis to identify independent risk factors for poor 30-day prognosis after hematoma evacuation in sICH patients.Receiver operating characteristic(ROC)curve analysis was employed to evaluate the predictive value of relevant factors for poor 30-day prognosis after hematoma evacuation in sICH patients.Results A total of 320 patients who underwent hematoma evacuation for sICH were enrolled,including 192 males and 128 females,with an age range of 20-91 years(median age 62[53,68]years).Among them,144 patients were assigned to the favorable prognosis group and 176 to the poor prognosis group.The poor prognosis group exhibited significantly higher hemorrhage volume,homocysteine level,fluid intake at the 3rd,5th,6th,and 7th 24-hour periods,fluid balance at the 3rd,5th,6th,and 7th 24-hour periods,daily average intake,and cumulative fluid balance compared to the favorable prognosis group(all P<0.05).The favorable prognosis group had a significantly higher hematoma evacuation rate,GCS score,proportion of supratentorial hemorrhage and negative urine ketones than the poor prognosis group(all P<0.05).No significant differences were found in other clinical data(all P>0.05).Fluid balance over the first seven postoperative 24-hour periods displayed a rise-decline-rise pattern in the poor prognosis group and a rise-decline pattern in the favorable prognosis group.Both groups peaked at the 3rd 24-hour period.Multivariate Logistic regression analysis identified fluid balance at the 3rd 24-hour period(OR,2.013,95%CI 1.386-2.922,P<0.01)and daily average intake(OR,3.583,95%CI 1.793-7.161,P<0.01)as independent influencing factors for poor 30-day prognosis after hematoma evacuation in sICH patients.ROC curve analysis revealed that the area under the curve(AUC)for fluid balance at the 3rd 24-hour period and daily average intake in predicting poor 30-day prognosis were 0.699(95%CI 0.642-0.757)and 0.765(95%CI 0.712-0.819),respectively.The combined model of fluid balance at the 3rd 24-hour period and daily average intake achieved an AUC of 0.804(95%CI 0.756-0.853),demonstrating significantly superior predictive performance compared to either variable alone(both P<0.05).Conclusions The combination of fluid balance at the 3rd 24-hour period and daily average intake demonstrates modest predictive value for poor 30-day prognosis after hematoma evacuation in sICH patients.These findings require validation through multicenter,large-scale,prospective studies.
2.Analysis on the Construction and Development Status of Drug Clinical Trial Institutions in Jiangxi Province
Xiaohua CHENG ; Li LIN ; Huiting ZHU
Herald of Medicine 2025;44(5):829-833
Objective To investigate and analyze the construction and management status of drug clinical trial institu-tions in Jiangxi Province,and to provide a reference for institutions' standardized management and development.Methods The registered drug clinical trial institutions in Jiangxi Province were selected as the research objects in the"Drug and Medical De-vice Clinical Trial Institution Filing Management Information System",and the public data were retrieved.Questionnaires were sent to the registered medical institutions as"Questionnaire Star"to collect the questionnaire data.The data on the construction and management of drug clinical trial institutions were analyzed descriptively from multiple dimensions.Results By December 2023,52 drug clinical trial institutions and one vaccine clinical trial institution had been registered in Jiangxi Province.The organ-ization and management structure,personnel composition,hardware,and software of the registration institutions met the basic re-quirements for conducting drug clinical trials.In recent years,the number of drug clinical trial record institutions and the number of projects to undertake has increased year by year,and the management ability and comprehensive strength of clinical trial institu-tions have been continuously enhanced,and there is still a big gap compared with the developed areas of the pharmaceutical in-dustry.Conclusion There is unbalanced regional development,uneven ability of different institutions to undertake projects,a low level of clinical trial information management,and the comprehensive ability of clinical trials needs to be improved in Jiangxi Province.
3.In vivo measurement of radionuclides and radiation levels around patients after BNCT treatment
Ye CAO ; Diyun SHU ; Yufeng XIAO ; Youqun LAI ; Jinsheng CHENG ; Senxing ZHENG ; Jilong YUAN ; Xiaohua MIU ; Jianji PAN ; Yuanhao LIU
Chinese Journal of Radiological Medicine and Protection 2025;45(7):668-673
Objective:To explore the in vitro radiation levels and in vivo neutron activation after patients receiving boron neutron capture therapy (BNCT). Methods:Totally 29 BNCT treatments were performed for 21 patients with head and neck and brain cancer using the NeuPex accelerator-based boron neutron capture therapy (AB-BNCT) system in Xiamen Humanity Hospital from October, 2022 to April, 2024. The ambient dose equivalent rate around the patients was measured with an X/gamma dose rate survey meter. The gamma radiation dose rates were measured at 0, 0.5, 1.0, and 2.0 m from the irradiation position, at 0, 0.5, 1.0, and 2.0 m from the opposite side of the irradiation position, and at the navel and the affected knee, respectively. Meanwhile, a portable high-purity germanium gamma spectrometer was used to measure the spectrum of activated nuclides in the bodies of patients who had underwent the treatment, and the types of radionuclides generated by neutron activation during each BNCT treatment were analyzed.Results:The radionuclides 24Na, 38Cl, and 49Ca were mainly produced in the bodies of patients treated with BNCT. 20 minutes after BNCT treatment, the ambient dose equivalent rate at a distance of 1.0 m from the irradiation position was lower than 2.5 μSv/h. Conclusions:The dose delivered to the staff and family members by the patients undergoing BNCT is relatively low, and the resulting radiation risk is low. According to the ALARA principle, it is recommended that certain control actions be taken for patients having received BNCT treatment to minimize the exposure doses of both patients and staff as much as possible.
4.Establishment and verification of a nomogram prediction model for residual stone risk following flexible ureteroscopy lithotripsy in treating 2-3 cm renal calculi
Qi DING ; Xiaohua JIN ; Hailiang ZHU ; Cheng CAO ; Zhijiang FAN ; Wenjian TU ; Feng LI ; Bo FAN
Journal of Modern Urology 2025;30(11):967-974
Objective To develop and validate a nomogram prediction model for residual stone risk after flexible ureteroscopic lithotripsy(FURL)in patients with 2-3 cm renal calculi,so as to provide reference for treatment options.Methods Clinical data of 342 patients with renal calculi measuring 2-3 cm undergoing FURL in our hospital during Jun.2017 and Apr.2024 were retrospectively collected.At a 3∶1 randomization ratio,patients were allocated to the training cohort(n=257)and validation cohort(n=85).Patients in the training cohort were stratified into two subgroups based on postoperative stone-free status:residual stone group(n=63)and stone-free group(n=194).Logistic regression analysis was employed to identify factors influencing stone retention and construct the nomogram prediction model.Bootstrapped resampling was applied to validate the model internally,model performance was assessed with calibration curves,Hosmer-Lemeshow test was used to test the degree of fitting,receiver operating characteristic(ROC)curve was plotted to evaluate the predictive accuracy,and decision curve analysis was used to determine the clinical net benefit.The model's generalization capability was evaluated with 10-fold cross-validation of the training set.Results Multivariate logistic regression revealed that stone size,CT value,lower calyx stones,multiple stones,renal infundibulum length(RIL),and renal infundibulum width(RIW)were independent predictors of residual stones(P<0.05).The nomogram based on the above mentioned parameters demonstrated excellent discrimination,with Bootstrap-validated concordance indices of 0.876(training cohort)and 0.948(validation cohort).Hosmer-Lemeshow tests showed good calibration in both cohorts(P>0.05).ROC analysis yielded the area under the curve(AUC)of 0.876 and 0.948 for the training and validation cohorts,respectively.The optimal cutoff value was 0.253,with corresponding sensitivity of 84.13%,specificity of 78.35%,and total score of nomogram of 143.The decision curve analysis showed when the threshold probability of the training cohort and verification cohort was 0-0.81 and 0-0.97,respectively,the nomogram could obtain good clinical net benefit in predicting the risk of residual stones.The average accuracy of 10-fold cross-validation was 0.814,and the average AUC was 0.865.Conclusion The nomogram model effectively predicts residual stone risk following FURL for 2-3 cm renal calculi.It is suggested that patients with a total score of ≤143 may consider undergoing FURL.
5.Establishment and verification of a nomogram prediction model for residual stone risk following flexible ureteroscopy lithotripsy in treating 2-3 cm renal calculi
Qi DING ; Xiaohua JIN ; Hailiang ZHU ; Cheng CAO ; Zhijiang FAN ; Wenjian TU ; Feng LI ; Bo FAN
Journal of Modern Urology 2025;30(11):967-974
Objective To develop and validate a nomogram prediction model for residual stone risk after flexible ureteroscopic lithotripsy(FURL)in patients with 2-3 cm renal calculi,so as to provide reference for treatment options.Methods Clinical data of 342 patients with renal calculi measuring 2-3 cm undergoing FURL in our hospital during Jun.2017 and Apr.2024 were retrospectively collected.At a 3∶1 randomization ratio,patients were allocated to the training cohort(n=257)and validation cohort(n=85).Patients in the training cohort were stratified into two subgroups based on postoperative stone-free status:residual stone group(n=63)and stone-free group(n=194).Logistic regression analysis was employed to identify factors influencing stone retention and construct the nomogram prediction model.Bootstrapped resampling was applied to validate the model internally,model performance was assessed with calibration curves,Hosmer-Lemeshow test was used to test the degree of fitting,receiver operating characteristic(ROC)curve was plotted to evaluate the predictive accuracy,and decision curve analysis was used to determine the clinical net benefit.The model's generalization capability was evaluated with 10-fold cross-validation of the training set.Results Multivariate logistic regression revealed that stone size,CT value,lower calyx stones,multiple stones,renal infundibulum length(RIL),and renal infundibulum width(RIW)were independent predictors of residual stones(P<0.05).The nomogram based on the above mentioned parameters demonstrated excellent discrimination,with Bootstrap-validated concordance indices of 0.876(training cohort)and 0.948(validation cohort).Hosmer-Lemeshow tests showed good calibration in both cohorts(P>0.05).ROC analysis yielded the area under the curve(AUC)of 0.876 and 0.948 for the training and validation cohorts,respectively.The optimal cutoff value was 0.253,with corresponding sensitivity of 84.13%,specificity of 78.35%,and total score of nomogram of 143.The decision curve analysis showed when the threshold probability of the training cohort and verification cohort was 0-0.81 and 0-0.97,respectively,the nomogram could obtain good clinical net benefit in predicting the risk of residual stones.The average accuracy of 10-fold cross-validation was 0.814,and the average AUC was 0.865.Conclusion The nomogram model effectively predicts residual stone risk following FURL for 2-3 cm renal calculi.It is suggested that patients with a total score of ≤143 may consider undergoing FURL.
6.The safety and efficacy of boron neutron capture therapy (BNCT) in the treatment of recurrent malignant tumors
Junqiang HONG ; Xiaoyi LIN ; Youqun LAI ; Ye CAO ; Xiangquan KONG ; Yuanhao LIU ; Shuiying LUO ; Zhicheng XIONG ; Mei GONG ; Yalai LIN ; Qiaoyun CHEN ; Mingang YING ; Li HUO ; Xiaohua ZHU ; Xiaoping SUN ; Yiqiao DENG ; Diyun SHU ; Haige ZHANG ; Cheng HUANG ; Jianji PAN
Chinese Journal of Radiation Oncology 2025;34(10):985-992
Objective:To evaluate the safety and efficacy of accelerator-based boron neutron capture therapy (AB-BNCT) in the treatment of recurrent and refractory malignant tumors.Methods:The data of 14 patients admitted to Xiamen Humanity Hospital from September 2022 to April 2023 were prospectively collected, including 7 patients with primary brain malignancies and 7 patients with locally recurrent inoperable head and neck malignancies. All patients received intravenous infusion of boron drug (NBB-001, p-dihydroxyborylphe nylalanine, a patented freeze-dried formulation) at a total nominal dosage of 500 mg/kg (11 patients) or 750 mg/kg (3 patients), and were irradiated with neutrons (operating with NeuPex system). Adverse events after treatment were recorded and assessed. The primary efficacy endpoint was the 90 d objective response rate (ORR), while the secondary endpoints included progression-free survival (PFS) and complete response rate (CRR). Data were compiled and analyzed by SAS 9.4 software. The rate and 95% CI were calculated using Clopper-Pearson method. Results:The median dose delivered to 80% of the target volume (D 80%) was 16.80 GyE (range: 8.93-23.79 GyE). The most common adverse reactions were hyperamylasemia, alopecia, and hyperprolactinemia. Five patients experienced 8 cases of grade 3 or above adverse events, including 1 case of grade 4 acute kidney injury and 7 cases of grade 3 adverse events. All adverse events were recovered after observation or treatment. At 90 d after treatment, the ORR of all patients was 9/14 (64%, 95% CI: 35%-87%), disease control rate (DCR) was 10/14 (71%, 95% CI: 42%-92%), CRR was 2/14 (14%, 95% CI: 2%-42%); and the best overall response during the entire course included an ORR of 10/14 (71% ,95% CI: 42%-92%), DCR of 13/14 (93%, 95% CI: 66%-100%), and CRR of 3/14 (21% ,95% CI: 5%-51%). The 1-year survival rate for head and neck malignancies was 71.4%, and the 2-year survival rate was 42.8%. The 1-year survival rate for recurrent brain malignancies was 42.8%. Conclusion:AB-BNCT demonstrates favorable safety and promising efficacy in treating primary brain malignancies and recurrent/refractory head and neck malignancies, representing a potential therapeutic option.
7.Mechanism of mitochondrial dysfunction on immune thrombocytopenia-related fatigue based on the"excessive fire consuming healthy qi"theory
Yuxin CHENG ; Xiaohua HUANG ; Diu WEI ; Wei MA ; Xinyi CHEN ; Haiyan LANG
Journal of Beijing University of Traditional Chinese Medicine 2025;48(5):703-710
Immune thrombocytopenia(ITP)is an autoimmune disease characterized primarily by bleeding and fatigue.ITP-related fatigue can substantially affect health-related quality of life and has been recognized as a treatment indication in the latest guidelines.However,its pathogenesis remains unclear,and targeted therapies are lacking.This paper explores the theoretical foundation of the"excessive fire consuming healthy qi"theory,linking two key conceptual pairs:"excessive fire"with inflammation and"healthy qi consumption"with mitochondrial dysfunction.Chronic inflammation leads to continuous"qi consumption"and damage to mitochondrial structure and function,ultimately resulting in symptoms of qi deficiency such as tiredness and fatigue.The imbalance between qi and fire,leading to imbalance of yin and yang,is the primary pathogenesis of ITP-related fatigue,with the disease mainly affecting the spleen.Considering the etiology and pathogenesis of ITP,and relative equilibrium of yin-yang,the therapeutic approach of invigorating spleen and benefiting qi to promote the production of blood serves as a core treatment strategy.Previous research has demonstrated the clinical efficacy of Jianpi Yiqi Shexue Formula,consisting of milkvetch root,tangshen,Indian bread,largehead atractylodes rhizome,India madder root,and ass hide glue in treating patients with ITP-related fatigue.Designed to invigorate the spleen and regulate qi and blood,this formula aligns with the pathogenesis of ITP-related fatigue characterized by deficiency of spleen qi and stomach qi.The formula also modulates the expression levels of key proteins and genes involved in mitochondrial energy metabolism and alleviates the immune dysfunction.These findings highlight the potential for further research into the mechanism of ITP-related fatigue,particularly by using inflammation-mediated mitochondrial energy metabolism as a promising entry point.
8.The Analysis of SLC26A4 Gene Testing in 34 Nuclear Families
Jinge XIE ; Lin DENG ; Xiaohua CHENG ; Liping ZHAO ; Yu RUAN ; Cheng WEN ; Yiding YU ; Yue LI ; Shan GAO ; Lihui HUANG
Journal of Audiology and Speech Pathology 2025;33(1):29-33
Objective To investigate the sequencing results of the SLC26A4 gene in 34 nuclear families and the genetic diagnosis on the offspring in the nuclear families who have been screened for SLC26A4 gene single-allele mutation in the deafness genetic screening,to provide a basis for genetic consulting.Methods A retrospective anal-ysis was performed on the results of SLC26A4 gene testing in 34 nuclear families,in which the offspring with SLC26A4 gene single-allele mutation in deafness genetic screening of each nuclear family.The offspring of 34 nucle-ar families with the second mutation site detected by sequencing,their audiological results were included in the anal-ysis;and if they suffered from hearing loss,the results of temporal bone CT or inner ear MRI were also included in the analysis.Results The sequencing results of 34 nuclear families showed that there were 23 offsprings(67.65%,23/34)with SLC26A4 gene single-allele mutation,and one parent was SLC26A4 gene single-allele mutation.There were 11 offsprings(32.35%,11/34)with second site,among which 7 offsprings(63.64%,7/11)with SLC26A4 gene complex heterozygous mutations,and their parents were SLC26A4 gene single-allele mutations.Among the 7 offsprings with SLC26A4 gene complex heterozygous mutation,3 cases were with hearing loss,all of which were diagnosed as large vestibular aqueduct syndrome,and the other 4 cases were normal.While 4 offsprings(36.36%,4/11)with SLC26A4 gene double heterozygous mutation(cis mutation),and one parent was SLC26A4 gene double heterozygous mutation.The hearing 4 offsprings with SLC26A4 gene double heterozygous mutations were normal.Among the 34 nuclear families,3 pairs of parents were SLC26A4 gene single-allele mutation,and both mutation sites were pathogenic,risk of reproducing children with hereditary hearing loss was 25%.Conclusion The detec-tion sites of deafness gene chip are limited.Using gene sequencing technology to sequence the nuclear family can fur-ther clarify the gene mutation type in offspring and provide guidance for parents to reproduce.
9.Analysis of the predictive value of early fluid balance in combination with daily average fluid intake for the prognosis of patients after spontaneous intracerebral hemorrhage hematoma evacuation
Xin HE ; Yan SUN ; Xiaoqi ZHOU ; Jie CHENG ; Qiqun TANG ; Xiaohua CHENG ; Fang CHEN
Chinese Journal of Cerebrovascular Diseases 2025;22(6):403-413
Objective To investigate the predictive value of early fluid balance combined with daily average fluid intake on the prognosis of patients who received hematoma evacuation for spontaneous intracerebral hemorrhage(sICH).Methods This study retrospectively and consecutively enrolled patients who underwent hematoma evacuation for sICH admitted to the Neurosurgical Intensive Care Unit of North China University of Science and Technology Affiliated Hospital between January 2023 and January 2025.Patients'baseline and clinical data were collected,including gender,age,admission vital signs(body temperature,respiratory rate,heart rate,systolic and diastolic blood pressure),medical history(hypertension,diabetes mellitus,coronary heart disease),admission Glasgow coma scale(GCS)score,admission laboratory parameters(including white blood cell count,red blood cell count,platelet count,urine bacterial levels,urine ketones,urine pH,homocysteine),hemorrhage location,hemorrhage volume,time from ictus to surgery,and hematoma evacuation rate(hematoma evacuation rate[%]=[preoperative hematoma volume-postoperative hematoma volume]/preoperative hematoma volume × 100%).Fluid intake,output,balance,daily average intake,and cumulative fluid balance during the early postoperative period(the first to seventh 24-hour periods)were assessed and recorded.Fluid intake comprised the sum of intravenously administered fluids(crystalloids,hypertonic fluids,colloids,blood products,and parenteral nutrition),enteral nutrition(nasogastric feeding solutions and water),and renal replacement therapy fluids.Fluid output comprised the sum of urine volume,vomitus,drainage fluid,and dialysis fluid losses.Fluid balance was defined as the difference between fluid intake and output.Daily average intake was calculated as the average of the fluid intake over the first seven postoperative 24-hour periods.Cumulative fluid balance was the sum of the fluid balances over the first seven postoperative 24-hour periods.Patient outcomes were assessed at 30 days postoperatively.Discharged patients underwent outpatient review or telephone follow-up,while inpatients were evaluated by neurosurgeons.Prognosis was evaluated using the 30-day modified Rankin scale(mRS)score:mRS scores 0-3 were classified as favorable prognosis,and mRS scores 4-6 as poor prognosis.Patients were subsequently divided into favorable prognosis and poor prognosis groups based on mRS scores.Factors with P<0.05 in univariate comparisons and without collinearity(multicollinearity was defined by:tolerance<0.1 and variance inflation factor>10)were included in multivariate Logistic regression analysis to identify independent risk factors for poor 30-day prognosis after hematoma evacuation in sICH patients.Receiver operating characteristic(ROC)curve analysis was employed to evaluate the predictive value of relevant factors for poor 30-day prognosis after hematoma evacuation in sICH patients.Results A total of 320 patients who underwent hematoma evacuation for sICH were enrolled,including 192 males and 128 females,with an age range of 20-91 years(median age 62[53,68]years).Among them,144 patients were assigned to the favorable prognosis group and 176 to the poor prognosis group.The poor prognosis group exhibited significantly higher hemorrhage volume,homocysteine level,fluid intake at the 3rd,5th,6th,and 7th 24-hour periods,fluid balance at the 3rd,5th,6th,and 7th 24-hour periods,daily average intake,and cumulative fluid balance compared to the favorable prognosis group(all P<0.05).The favorable prognosis group had a significantly higher hematoma evacuation rate,GCS score,proportion of supratentorial hemorrhage and negative urine ketones than the poor prognosis group(all P<0.05).No significant differences were found in other clinical data(all P>0.05).Fluid balance over the first seven postoperative 24-hour periods displayed a rise-decline-rise pattern in the poor prognosis group and a rise-decline pattern in the favorable prognosis group.Both groups peaked at the 3rd 24-hour period.Multivariate Logistic regression analysis identified fluid balance at the 3rd 24-hour period(OR,2.013,95%CI 1.386-2.922,P<0.01)and daily average intake(OR,3.583,95%CI 1.793-7.161,P<0.01)as independent influencing factors for poor 30-day prognosis after hematoma evacuation in sICH patients.ROC curve analysis revealed that the area under the curve(AUC)for fluid balance at the 3rd 24-hour period and daily average intake in predicting poor 30-day prognosis were 0.699(95%CI 0.642-0.757)and 0.765(95%CI 0.712-0.819),respectively.The combined model of fluid balance at the 3rd 24-hour period and daily average intake achieved an AUC of 0.804(95%CI 0.756-0.853),demonstrating significantly superior predictive performance compared to either variable alone(both P<0.05).Conclusions The combination of fluid balance at the 3rd 24-hour period and daily average intake demonstrates modest predictive value for poor 30-day prognosis after hematoma evacuation in sICH patients.These findings require validation through multicenter,large-scale,prospective studies.
10.Analysis on the Construction and Development Status of Drug Clinical Trial Institutions in Jiangxi Province
Xiaohua CHENG ; Li LIN ; Huiting ZHU
Herald of Medicine 2025;44(5):829-833
Objective To investigate and analyze the construction and management status of drug clinical trial institu-tions in Jiangxi Province,and to provide a reference for institutions' standardized management and development.Methods The registered drug clinical trial institutions in Jiangxi Province were selected as the research objects in the"Drug and Medical De-vice Clinical Trial Institution Filing Management Information System",and the public data were retrieved.Questionnaires were sent to the registered medical institutions as"Questionnaire Star"to collect the questionnaire data.The data on the construction and management of drug clinical trial institutions were analyzed descriptively from multiple dimensions.Results By December 2023,52 drug clinical trial institutions and one vaccine clinical trial institution had been registered in Jiangxi Province.The organ-ization and management structure,personnel composition,hardware,and software of the registration institutions met the basic re-quirements for conducting drug clinical trials.In recent years,the number of drug clinical trial record institutions and the number of projects to undertake has increased year by year,and the management ability and comprehensive strength of clinical trial institu-tions have been continuously enhanced,and there is still a big gap compared with the developed areas of the pharmaceutical in-dustry.Conclusion There is unbalanced regional development,uneven ability of different institutions to undertake projects,a low level of clinical trial information management,and the comprehensive ability of clinical trials needs to be improved in Jiangxi Province.

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