1.A randomized,double-blind,placebo-controlled,multicenter clinical study of Shengxuebao Mixture in treating cancer-related anemia
Zhu LIU ; Xiangrong LI ; Xiaojun DAI ; Yanjun WANG ; Xiao LI ; Keqiong WANG ; Tao WU ; Miaowen ZHONG ; Hongjiang YU ; Ji FENG ; Zuowei HU ; Kainan LI ; Shaowei CHEN ; Chunhua LI ; Zhengchuan FU ; Rui ZHANG ; Yongfa CHEN ; Hongyu XU ; Tao REN ; Yibo YAO ; Jianxu JIN ; Pengyin WANG ; Zhijiang HE ; Jian SHEN ; Lei WANG ; Min LI ; Wenming CHANG ; Xinyi CHEN ; Li HOU
Journal of Beijing University of Traditional Chinese Medicine 2025;48(10):1447-1459
Objective We aimed to evaluate the efficacy and safety of Shengxuebao Mixture in the treatment of cancer-related anemia(CRA)presenting with syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood.Methods A randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted.Eligible patients with malignant tumors meeting the inclusion and exclusion criteria were enrolled from 26 hospitals,including Dongzhimen Hospital,Beijing University of Chinese Medicine,Xiaogan Central Hospital,and Yangzhou Hospital of Traditional Chinese Medicine,from June 1,2022,to September 30,2024.Patients were allocated 1:1 to either the experimental group receiving Shengxuebao Mixture or the control group receiving its simulator(placebo)using a block randomization method under double-blind conditions.Both groups received 15 mL orally three times daily for 28 consecutive days.The primary efficacy indicators included the hemoglobin(Hb)improvement rate(RHb)and the traditional Chinese medicine(TCM)syndrome improvement rate(RTCM)at week 4 of treatment.The secondary efficacy indicators encompassed Hb and red blood cell(RBC)count,Karnofsky Performance Status(KPS)score,TCM syndrome score,individual TCM symptom scores,and changes in each of these indicators compared to the baseline period at weeks 2,4,and 6 of treatment.Safety evaluations were conducted at week 4 of treatment.Results A total of 239 patients were enrolled,with 225 cases included in the Full Analysis Set(FAS)(109 in the experimental group vs.116 control group),163 in the Per Protocol Set(PPS)(77 vs.86),and 225 in the Safety Set(SS)(109 vs.116).Baseline characteristics between groups showed no significant differences.Significant differences were observed between the experimental and control groups in RHb at week 4(FAS:49.51%vs.35.24%,P<0.05;PPS:53.25%vs.36.05%,P<0.05)and RTCM at week 4(FAS:61.54%vs.39.62%,P<0.01;PPS:64.94%vs.40.70%,P<0.01).At weeks 2,4,and 6,the experimental group showed greater improvements in Hb and RBC counts than the control group.Additionally,the TCM syndrome scores were lower in the experimental group than in the control group at these time points.Except for week 2 in PPS,the KPS improvement was better in the experimental group than in the control group(P<0.05).The experimental group also demonstrated a greater reduction in scores for individual TCM symptoms such as spiritlessness and weakness,poor appetite and reduced food intake at weeks 4 and 6 compared to the control group(P<0.05,P<0.01).Furthermore,the reduction in vertigo score was more pronounced in the experimental group at week 6(P<0.01).For the score of pale and lusterless complexion,only in the PPS was the reduction from baseline more significant in the experimental group than in the control group at weeks 4 and 6(P<0.05).No significant differences were observed between the experimental and control groups in the incidence of all adverse events or drug-related adverse reactions.Conclusion Shengxuebao Mixture demonstrates significant efficacy in patients with CRA presenting syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood,effectively increasing Hb levels,ameliorating TCM syndromes,alleviating clinical symptoms,and enhancing functional status,with no significant difference in adverse drug reactions compared to the placebo.
2.Clinical study of self-help inflatable balloon for refractory benign upper digestive tract stricture
Qianqian DONG ; Wenbo LI ; Qun LI ; Zengyi MA ; Wenming WU ; Minghui WANG ; Jing WANG ; Feifei FAN ; Kuilin SUN ; Xiaofeng LIU
China Journal of Endoscopy 2025;31(4):80-85
Objective To investigate the efficacy and safety of self-help inflatable balloon in the treatment of refractory benign upper digestive tract stricture.Methods From November 2022 to February 2024,10 patients with refractory benign upper digestive tract stricture underwent self-help inflatable balloon were retrospectively analyzed.Preoperative treatment,intraoperative and postoperative complications,dysphagia score before and after surgery,wearing time of external self-help inflatable balloon,and the clinical efficacy were evaluated.Results All the 10 patients received self-help inflatable balloon treatment.No complications such as bleeding and perforation occurred in all patients during the wearing of the balloon.The placement time of the balloon was 60~180 d,and the average wearing time was 104.9 d.Before surgery,nine cases had a stricture segment length less than 2 cm,and one case had a stricture segment length of 6 cm.The dysphagia score before surgery was(3.60±0.52),and the dysphagia score after removal of the self-help inflatable balloon was(0.60±0.52),and there was statistical significance in preoperative and postoperative comparison(P<0.05).The dysphagia score 3 months after removal of the external self-help inflatable balloon was(0.70±0.48),there was no significant difference in dysphagia score between the day after surgery and 3 months after surgery(P>0.05).The diameter of the stricture before and after operation was(5.09±2.02)mm and(10.35±0.73)mm respectively,and the difference was statistically significant(P<0.05).Sore throat,wing of nose pain and balloon displacement were the most common adverse events,with 30.0%(3/10),50.0%(5/10)and 70.0%(7/10),respectively.Conclusion It is safe,effective and feasible to treat refractory benign upper digestive tract stricture with self-help inflatable balloon in vitro.It is worthy for clinical application.
3.A study on the early response to antipsychotic medication in schizophrenia based on modular brain networks
Wenming LIU ; Chen WANG ; Xiancang MA
Chinese Journal of Nervous and Mental Diseases 2025;51(10):608-614
Objective To explore the differences in the topological attributes of the baseline state functional network module between responders and non-responders to pharmacological treatment in schizophrenia patients.Methods Patients with first-episode untreated schizophrenia were included.The therapeutic effect was evaluated 4 weeks after receiving standardized clinical treatment based on the percentage change of the positive and negative syndrome scale(PANSS)score before and after treatment.The patients were divided into the response group(n=45)and the non-response group(n=32).The modular topological properties of the brain functional network were calculated using resting-state functional magnetic resonance imaging(rs-fMRI)technology.The differences in functional connectivity between the treatment response group and the non-response group were then compared.The correlation between the functional connection of the patient's network module and the PANSS score was analyzed.Results Compared to the non-responder group,the responder group exhibited increased modularity and a higher average node participation coefficient.Moreover,the default network module exhibited a decreased separation index,whereas an increase was observed in the sensorimotor module separation index.Additionally,intra-modular connectivity was reduced within the visual network,sensorimotor module and subcortical nuclei module.The connections among the gray matter nucleus-visual module,gray matter nucleus-marginal module,gray matter nucleus-default network,gray matter nucleus-sensorimotor module and sensorimotor default network modules were decreased(FDR correction,P<0.05).The interconnections between gray matter nuclei-default network(r=0.42,P<0.01)and sensorimotor-default network modules(r=0.31,P=0.04)in the response group were positively correlated with the positive symptom scores,respectively.Receiver operating characteristic(ROC)curve analysis showed that the modular connection of functional networks had good classification prediction efficacy(AUC=0.858,95%CI:0.759-0.927).Conclusion The modular connections among the gray matter nucleus network,default network and sensorimotor network may provide neuroimaging evidence for the prediction of the efficacy of drug treatment for schizophrenia.
4.Current status and biological characterization of avian paramyxovirus in wild birds in China
Lu CHEN ; Minghui ZHU ; Yufeng LIU ; Shuo LIU ; Yuteng CHEN ; Haiming WANG ; Wenming JIANG ; Jingjing WANG ; Hualei LIU ; Yang LI ; Xiaohui YU
Chinese Journal of Veterinary Science 2025;45(11):2351-2357
To understand the current epidemiological status and biological characteristics of avian paramyxoviruses(APMV)in wild birds in China,a total of 1 384 fecal samples of wild birds were collected in eight provinces(autonomous regions),including Ningxia,in 2023,to detect avian pa-ramyxovirus infections by viral isolation and RT-PCR.Positive samples were subjected to F gene sequence amplification and genetic evolutionary analyses.The results showed that 10 strains of APMV were isolated and identified from 1 384 wild bird feces samples with a positive rate of 0.72%.Out of the 10 strains,4 strains were APMV-1,which was in the same branch to the Ameri-can goose APMV-1 strain and had the homology ranging from 93%to 97.3%.Three strains of APMV-4 were in the same branch with the Russian duck APMV-4 strain and the Russian pintail APMV-4 strain,with homology ranging from 99.1%to 99.5%.Three strains were APMV-6,they were in the same branch with the Russian ruddy bladdered duck APMV-6 strain,with homology ranging from 98.7%to 99.20%.The intracerebral inoculatable pathogenicity index(ICPI)of the four strains for 1-day-old chicks ranged from 0 to 0.48,which was low in pathogenicity for chick-ens.The above results enriches the epidemiological information and the biological characteristics of avian paramyxovirus in wild birds in China,which provides a reference for the early warning,scien-tific prevention and control of this disease.
5.Geneticevolution and pathogenicity analysis of a duck-derived H4N1 subtype avian influenza virus
Qiuyan MAO ; Huitong SI ; Yaxin ZHANG ; Shuo LIU ; Cheng PENG ; Wenming JIANG ; Hualei LIU
Chinese Journal of Veterinary Science 2025;45(5):1002-1008
To comprehend the genetic evolutionary characteristics and biological properties of the H4N1 subtype avian influenza virus(AIV)in China,this study conducted whole genome sequen-cing,genetic evolutionary analysis,and pathogenicity test in BALB/c mice of a duck-derived H4N1 subtype AIV strain(DK/GX/E1424/20)isolated from the live poultry market in the southern re-gion in 2020.The results indicated that the cleavage site motif of the HA protein was PEKASR/GLF,which conformed to the characteristics of low pathogenic AIV.All the eight gene fragments were situated in the Eurasian lineage,and the homology of AIV-related genes of the H1N1,H3N8,H4N6,H6N1,and H10N8 subtypes isolated from wild waterfowl was the highest,representing a recombinant virus strain.Without prior adaptation,it replicated effectively in the lungs and turbi-nates of mice,with viral titers of 3.00 and 2.08 log10EID50/mL respectively,and induced weight loss in infected mice.This study suggested that this virus had significant genetic diversity and low pathogenicity in mice,posing a potential risk for mammalian infection.
6.Isolation,identification and pathogenicity analysis of two avain infectious bronchi-tis virus strain
Hanwen ZHANG ; Yaru GAO ; Yang WANG ; Yapeng SONG ; Wenming GAO ; Lin LIU ; Xiaoyang CAO ; Jingrui LIU ; Xinsheng LI
Chinese Journal of Veterinary Science 2025;45(10):2133-2141,2155
This study aims to investigate the isolate and identify of infectious bronchitis virus(IBV)in chickens,and study its genetic variation and pathogenicity.In 2023,two strains named CK/CH/HN/SQ202301 and CK/CH/HN/SQ202302 were obtained from suspected infectious bronchitis(IB)infected materials collected in a region of Henan Province,China.Further analysis showed that the two isolates belong to the G Ⅰ-13 and GⅥ genotypes,respectively.The cleavage sites of S protein were all RRSRR.The prediction of glycosylation sites showed that the two isolates had 18 and 12 N-glycosylation sites respectively,but no O-glycosylation site.Recombinant analysis shows that C2023-1 was a recombinant strain.Pathogenicity was assessed by infecting 1-day-old SPF chicks with the two isolates,and the results showed that C2023-1 strain infection could cause clini-cal symptoms such as depression and head shaking,as well as death in chicks,with a mortality rate of 37.5%.There were no clinical symptoms or deaths after infection with C2023-2 strain.Viral load test results showed that both isolates continued to detoxify until the 10th day,and had strong rep-lication capacity in the kidney,trachea and bursa of Fabricius.The results indicate significant differences in the genetic characteristics and pathogenicity of the two isolates due to their different genotypes.This study not only provides new epidemiological data on IB,which contributes to a bet-ter understanding of IBV's epidemiological features and control challenges,but also adds valuable bioinformatics resources for IBV by analyzing its variation mechanisms and biological information.
7.Ruminations on the influence of "Imperial Han Medicine" on Hu Xishu's academic thinking on typhoid fever
Ningqian LIU ; Qingxuan FAN ; Yiyao CHEN ; Wenming YI
International Journal of Traditional Chinese Medicine 2025;47(2):145-149
As a classic work of Japanese Chinese medicine, Huang Han Yi Xue, with its ancient prescription school theories and Western medical principles, influenced the formation of Hu Xishu's academic thinking on cold-induced disease. This article combined Huang Han Yi Xue with the recordings and manuscripts of Hu's existing lectures to show another perspective on the flow of Hu's academic thought on cold-induced disease. It is considered that the influence of Huang Han Yi Xue made Hu different from the traditional typhoid scholars. Hu abandoned the annotations of Huang Di Nei Jing, emphasized the relativity of prescriptions and syndrome, focused on the state of Mingxuan reaction, paid attention to food, water and blood stasis, explained the essence of disease with physiological and anatomical knowledge, innovated the cognition of the six meridians and the eight compendiums, and formed a new theoretical system.
8.A meta analysis of the incidence and influencing factors of stroke in patients with acute type A aortic dissection
Yu ZHANG ; Yongting WANG ; Jing PANG ; Hui NIU ; Shanshan LIU ; Wenming ZHANG
Chinese Journal of Thoracic and Cardiovascular Surgery 2025;41(7):395-403
Objective:To systematically evaluate the incidence and influencing factors of postoperative stroke in patients with acute type A aortic dissection (ATAAD).Methods:Nine Chinese and English databases, including PubMed, Embase, CINAHL, JAMA, The Cochrane Library, CNKI, Wanfang, Vip and Chinese Biomedicine, were searched by computer to include literatures evaluating the incidence of postoperative stroke and its influencing factors in ATAAD patients. The search period was from the establishment of the database to September 2024. Two researchers independently screened the literature, extracted data, and evaluated the risk of bias in the included studies. Stata 14.0 software was used to combine the prevalence rate, and descriptive analysis of influencing factors was performed.Results:A total of 22 articles were included, including 16 734 ATAAD patients, published from 2018 to 2024. Meta-analysis results showed that the incidence of postoperative stroke in ATAAD patients was 16% (14%-18%). Subgroup analyses showed a higher incidence of postoperative stroke in patients with ATAAD in Europe (19%, 95% CI: 15%-23%), with a sample size of 1 to 300 patients (18%, 95% CI: 14%-22%), and in 2024 (20%, 95% CI: 14%-28%). Descriptive analysis shows that the factors influencing the occurrence of postoperative stroke in ATAAD patients include preoperative history (preoperative hypotension, preoperative history of stroke, history of carotid artery disease, history of cardiac arrest), intraoperative measures (total arch replacement, femoral artery intubation, anterograde cerebral perfusion, intraoperative oxygen satiation), and various types of time (cryopreservation time, extracorporeal circulation time, operation time). Conclusion:The incidence of postoperative stroke is higher in ATAAD patients. Preoperative hypotension, history of stroke before surgery, history of carotid artery disease, history of cardiac arrest, total arch replacement, femoral artery intubation, anterograde cerebral perfusion, decrease of cerebral oxygen saturation during operation, and longer hypothermia stop time, cardiopulmonary bypass time and operation time may increase the risk of postoperative stroke in ATAAD patients.
9.A randomized,double-blind,placebo-controlled,multicenter clinical study of Shengxuebao Mixture in treating cancer-related anemia
Zhu LIU ; Xiangrong LI ; Xiaojun DAI ; Yanjun WANG ; Xiao LI ; Keqiong WANG ; Tao WU ; Miaowen ZHONG ; Hongjiang YU ; Ji FENG ; Zuowei HU ; Kainan LI ; Shaowei CHEN ; Chunhua LI ; Zhengchuan FU ; Rui ZHANG ; Yongfa CHEN ; Hongyu XU ; Tao REN ; Yibo YAO ; Jianxu JIN ; Pengyin WANG ; Zhijiang HE ; Jian SHEN ; Lei WANG ; Min LI ; Wenming CHANG ; Xinyi CHEN ; Li HOU
Journal of Beijing University of Traditional Chinese Medicine 2025;48(10):1447-1459
Objective We aimed to evaluate the efficacy and safety of Shengxuebao Mixture in the treatment of cancer-related anemia(CRA)presenting with syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood.Methods A randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted.Eligible patients with malignant tumors meeting the inclusion and exclusion criteria were enrolled from 26 hospitals,including Dongzhimen Hospital,Beijing University of Chinese Medicine,Xiaogan Central Hospital,and Yangzhou Hospital of Traditional Chinese Medicine,from June 1,2022,to September 30,2024.Patients were allocated 1:1 to either the experimental group receiving Shengxuebao Mixture or the control group receiving its simulator(placebo)using a block randomization method under double-blind conditions.Both groups received 15 mL orally three times daily for 28 consecutive days.The primary efficacy indicators included the hemoglobin(Hb)improvement rate(RHb)and the traditional Chinese medicine(TCM)syndrome improvement rate(RTCM)at week 4 of treatment.The secondary efficacy indicators encompassed Hb and red blood cell(RBC)count,Karnofsky Performance Status(KPS)score,TCM syndrome score,individual TCM symptom scores,and changes in each of these indicators compared to the baseline period at weeks 2,4,and 6 of treatment.Safety evaluations were conducted at week 4 of treatment.Results A total of 239 patients were enrolled,with 225 cases included in the Full Analysis Set(FAS)(109 in the experimental group vs.116 control group),163 in the Per Protocol Set(PPS)(77 vs.86),and 225 in the Safety Set(SS)(109 vs.116).Baseline characteristics between groups showed no significant differences.Significant differences were observed between the experimental and control groups in RHb at week 4(FAS:49.51%vs.35.24%,P<0.05;PPS:53.25%vs.36.05%,P<0.05)and RTCM at week 4(FAS:61.54%vs.39.62%,P<0.01;PPS:64.94%vs.40.70%,P<0.01).At weeks 2,4,and 6,the experimental group showed greater improvements in Hb and RBC counts than the control group.Additionally,the TCM syndrome scores were lower in the experimental group than in the control group at these time points.Except for week 2 in PPS,the KPS improvement was better in the experimental group than in the control group(P<0.05).The experimental group also demonstrated a greater reduction in scores for individual TCM symptoms such as spiritlessness and weakness,poor appetite and reduced food intake at weeks 4 and 6 compared to the control group(P<0.05,P<0.01).Furthermore,the reduction in vertigo score was more pronounced in the experimental group at week 6(P<0.01).For the score of pale and lusterless complexion,only in the PPS was the reduction from baseline more significant in the experimental group than in the control group at weeks 4 and 6(P<0.05).No significant differences were observed between the experimental and control groups in the incidence of all adverse events or drug-related adverse reactions.Conclusion Shengxuebao Mixture demonstrates significant efficacy in patients with CRA presenting syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood,effectively increasing Hb levels,ameliorating TCM syndromes,alleviating clinical symptoms,and enhancing functional status,with no significant difference in adverse drug reactions compared to the placebo.
10.Study on the mechanism of allogeneic renal subcapsular transplantation of CD24+renal epithelial cells in the alleviation of ischemia-reperfusion-induced acute kidney injury in mice
Yuxin ZHANG ; Dawei LI ; Mengting WANG ; Shibo WANG ; Wenming LIU ; Hongqian MA ; Qiuqiu ZHANG ; Xiaoyan JIN ; Hexin YAN
Immunological Journal 2025;41(6):377-386
Objective To investigate the therapeutic effect and potential mechanisms of allogeneic renal subcapsular transplantation of CD24+renal epithelial cells for the treatment of acute kidney injury(AKI)induced by ischemia-reperfusion(I/R).Methods CD24+renal epithelial cells were isolated from mouse kidneys using flow cytometric sorting and expanded by passaging.C57BL/6N mice were randomly divided into three groups:the normal control group(n=8,sham surgery only),the model control group(n=8,unilateral kidney I/R plus contralateral nephrectomy),and the CD24+cell treatment group(n=8,AKI model followed by renal subcapsular transplantation of CD24+cells).Mice were euthanized at 24 h after modeling and serum was collected to measure biochemical markers[serum creatinine(Scr),blood urea nitrogen(BUN),tumor necrosis factor-α(TNF-α),and interleukin-6(IL-6)].Renal tissues were subjected to pathological evaluation and macrophage staining.An M1-polarized macrophage model was established using mouse bone marrow-derived macrophages co-cultured with CD24+renal epithelial cells.The polarization state of macrophages was assessed by quantitative real-time polymerase chain reaction(qPCR)and flow cytometry.Results CD24+renal epithelial cells were successfully isolated and passaged stably.Compared with the normal control group,the model control group exhibited significantly elevated Scr and BUN levels and renal pathological damage.In contrast,the CD24+cell treatment group showed significant reduction in serum biochemical markers and pathological injury compared with the model control group,along with reduction in M1 macrophage infiltration in the kidneys(P<0.05,P<0.01).In vitro co-culture experiments demonstrated that in the CD24+co-culture group,the expression of M1 polarization-related markers in macrophages was significantly lower than that in the non-co-culture group,and the proportion of CD80+M1 macrophages in the co-culture group decreased(P<0.05,P<0.01).Conclusion Allogeneic renal subcapsular transplantation of CD24+renal epithelial cells can alleviate I/R-induced AKI by inhibiting M1 macrophage polarization through paracrine mechanisms.

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