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.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.
3.Discovery of a potential hematologic malignancies therapy: Selective and potent HDAC7 PROTAC degrader targeting non-enzymatic function.
Yuheng JIN ; Xuxin QI ; Xiaoli YU ; Xirui CHENG ; Boya CHEN ; Mingfei WU ; Jingyu ZHANG ; Hao YIN ; Yang LU ; Yihui ZHOU ; Ao PANG ; Yushen LIN ; Li JIANG ; Qiuqiu SHI ; Shuangshuang GENG ; Yubo ZHOU ; Xiaojun YAO ; Linjie LI ; Haiting DUAN ; Jinxin CHE ; Ji CAO ; Qiaojun HE ; Xiaowu DONG
Acta Pharmaceutica Sinica B 2025;15(3):1659-1679
HDAC7, a member of class IIa HDACs, plays a pivotal regulatory role in tumor, immune, fibrosis, and angiogenesis, rendering it a potential therapeutic target. Nevertheless, due to the high similarity in the enzyme active sites of class IIa HDACs, inhibitors encounter challenges in discerning differences among them. Furthermore, the substitution of key residue in the active pocket of class IIa HDACs renders them pseudo-enzymes, leading to a limited impact of enzymatic inhibitors on their function. In this study, proteolysis targeting chimera (PROTAC) technology was employed to develop HDAC7 drugs. We developed an exceedingly selective HDAC7 PROTAC degrader B14 which showcased superior inhibitory effects on cell proliferation compared to TMP269 in various diffuse large B cell lymphoma (DLBCL) and acute myeloid leukemia (AML) cells. Subsequent investigations unveiled that B14 disrupts BCL6 forming a transcriptional inhibition complex by degrading HDAC7, thereby exerting proliferative inhibition in DLBCL. Our study broadened the understanding of the non-enzymatic functions of HDAC7 and underscored the importance of HDAC7 in the treatment of hematologic malignancies, particularly in DLBCL and AML.
4.Development and validation of a prediction score for subtype diagnosis of primary aldosteronism.
Ping LIU ; Wei ZHANG ; Jiao WANG ; Hongfei JI ; Haibin WANG ; Lin ZHAO ; Jinbo HU ; Hang SHEN ; Yi LI ; Chunhua SONG ; Feng GUO ; Xiaojun MA ; Qingzhu WANG ; Zhankui JIA ; Xuepei ZHANG ; Mingwei SHAO ; Yi SONG ; Xunjie FAN ; Yuanyuan LUO ; Fangyi WEI ; Xiaotong WANG ; Yanyan ZHAO ; Guijun QIN
Chinese Medical Journal 2025;138(23):3206-3208
5.Efficacy of rigid ureteroscopic laser lithotripsy combined with N-trap in the treatment of ureteral stones with a maximum diameter equal to or greater than 1.5 cm
Jinghui JI ; Xiushi LIN ; Dameng PAN ; Zhiying WU ; Zixuan XUE ; Xiaojun TIAN ; Shudong ZHANG ; Binshuai WANG ; Min QIU
Journal of Peking University(Health Sciences) 2025;57(4):676-683
Objective:To investigate the efficacy of rigid ureteroscopic laser lithotripsy combined with N-trap(RULL+N-trap),which is scoop-shaped,in the treatment of ureteral stones with a maximum diameter ≥1.5 cm.Methods:This retrospective cohort study included patients diagnosed with ureteral calculi who underwent rigid ureteroscopic lithotripsy(RULL)combined with N-Trap stone entrapment system at the Department of Urology,Peking University Third Hospital,by the same surgical team between June 2021 and September 2024.A total of 364 patients were initially enrolled.After excluding 21 patients due to missing critical outcome variables,two distinct cohorts were established:38 patients with ureteral stones measuring ≥1.5 cm in maximum diameter,and 305 patients with stones<1.5 cm in maximum diameter.To minimize selection bias and control for confounding variables,propensity score matching(PSM)was employed.This resulted in two well-balanced groups:31 patients with stones 1.5 cm in maximum diameter and 31 patients with stones<1.5 cm in maximum diameter,matched on baseline demographic and clinical characteristics.The primary outcomes assessed between the two groups included stone clearance.Secondary outcomes included changes in renal function indicators,specifically serum creatinine(SCr)and estimated glomerular filtration rate(GFR),and other factors like postopera-tive hospital stay and operative time.Results:In the matched cohort,the patients with stones ≥1.5 cm in maximum diameter had significantly longer operative time compared with those with smaller stones:(85.8±28.8)min vs.(62.4±24.6)min(P<0.05).Postoperative length of hospital stay showed no significant difference:(2.26±1.79)d vs.(2.03±0.80)d(P>0.05).The stone clearance on postoperative day one was 90.3%in the study group vs.100.0%in the control group(P>0.05).One month postoperatively,the stone clearance was 93.5%vs.100.0%,respectively(P>0.05).Changes in SCr were(-6.58±16.10)μmol/L vs.(-13.70±12.50)μmol/L,and changes in GFR were(5.92±14.90)mL/(min·1.73 m2)vs.(7.47±11.20)m L/(min·1.73 m2),with no statistically significant differences observed between the two groups for either renal function marker(P>0.05).Conclusion:Ureteroscopic lithotripsy combined with N-trap is an optional method for treating ureteral stones with a maximum diameter ≥1.5 cm.The overall therapeutic efficacy is comparable,with the added benefit of significantly reducing the economic burden on patients.
6.Advances and controversies in partial nephrectomy for T 3a renal cell carcinoma
Jinghui JI ; Xiushi LIN ; Xiaojun TIAN ; Min QIU
Chinese Journal of Urology 2025;46(8):632-635
Renal cell carcinoma(RCC)has a relatively high incidence among genitourinary malignancies and therefore occupies a pivotal position in the diagnosis and treatment of urological tumors. Its staging,grading,and corresponding therapeutic strategies have been relatively well established. However,in clinical practice,we have observed that a subset of patients with RCC,preoperatively diagnosed as stage T1 based on imaging,are found on postoperative pathology after partial nephrectomy to have tumor extension into the renal sinus,resulting in pathological upstaging(cT 1/pT 3a). Multiple studies have demonstrated that the overall prognosis of cT 1/pT 3a patients undergoing partial nephrectomy is inferior to that of cT 1/pT 1 patients,but shows no significant difference compared with cT 1/pT 3a patients treated with radical nephrectomy. Moreover,partial nephrectomy offers clear advantages over radical nephrectomy in terms of intraoperative blood loss and preservation of renal function parameters such as estimated glomerular filtration rate(eGFR)and serum creatinine,which translate into improved quality of life. In addition,this paper introduces predictive methods for pathological upstaging in partial RCC,including novel imaging-based approaches such as the contour irregular degree(CID)on computed tomography(CT),histopathological predictors such as Fuhrman grading,and the preliminary application of machine learning in enhancing diagnostic accuracy.
7.Brain computer interface nursing bed control system based on deep learning and dual visual feedback.
Pai WANG ; Xingxing JI ; Jiali WANG ; Xiaojun YU
Journal of Biomedical Engineering 2025;42(5):1021-1028
In order to meet the need of autonomous control of patients with severe limb disorders, this paper designs a nursing bed control system based on motor imagery-brain computer interface (MI-BCI). In view of the low decoding performance of cross-subjects and the dynamic fluctuation of cognitive state in the existing MI-BCI technology, the neural network structure optimization and user interaction feedback enhancement are improved. Firstly, the optimized dual-branch graph convolution multi-scale neural network integrates dynamic graph convolution and multi-scale convolution. The average classification accuracy is higher than that of multi-scale attention temporal convolution network, Gram angle field combined with convolution long short term memory hybrid network, Transformer-based graph convolution network and other existing methods. Secondly, a dual visual feedback mechanism is constructed, in which electroencephalogram (EEG) topographic map feedback can improve the discrimination of spatial patterns, and attention state feedback can enhance the temporal stability of signals. Compared with the single EEG topographic map feedback and non-feedback system, the average classification accuracy of the proposed method is also greatly improved. Finally, in the four classification control task of nursing bed, the average control accuracy of the system is 90.84%, and the information transmission rate is 84.78 bits/min. In summary, this paper provides a reliable technical solution for improving the autonomous interaction ability of patients with severe limb disorders, which has important theoretical significance and application value.
Humans
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Brain-Computer Interfaces
;
Deep Learning
;
Electroencephalography
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Feedback, Sensory
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Neural Networks, Computer
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Beds
8.Efficacy of rigid ureteroscopic laser lithotripsy combined with N-trap in the treatment of ureteral stones with a maximum diameter equal to or greater than 1.5 cm
Jinghui JI ; Xiushi LIN ; Dameng PAN ; Zhiying WU ; Zixuan XUE ; Xiaojun TIAN ; Shudong ZHANG ; Binshuai WANG ; Min QIU
Journal of Peking University(Health Sciences) 2025;57(4):676-683
Objective:To investigate the efficacy of rigid ureteroscopic laser lithotripsy combined with N-trap(RULL+N-trap),which is scoop-shaped,in the treatment of ureteral stones with a maximum diameter ≥1.5 cm.Methods:This retrospective cohort study included patients diagnosed with ureteral calculi who underwent rigid ureteroscopic lithotripsy(RULL)combined with N-Trap stone entrapment system at the Department of Urology,Peking University Third Hospital,by the same surgical team between June 2021 and September 2024.A total of 364 patients were initially enrolled.After excluding 21 patients due to missing critical outcome variables,two distinct cohorts were established:38 patients with ureteral stones measuring ≥1.5 cm in maximum diameter,and 305 patients with stones<1.5 cm in maximum diameter.To minimize selection bias and control for confounding variables,propensity score matching(PSM)was employed.This resulted in two well-balanced groups:31 patients with stones 1.5 cm in maximum diameter and 31 patients with stones<1.5 cm in maximum diameter,matched on baseline demographic and clinical characteristics.The primary outcomes assessed between the two groups included stone clearance.Secondary outcomes included changes in renal function indicators,specifically serum creatinine(SCr)and estimated glomerular filtration rate(GFR),and other factors like postopera-tive hospital stay and operative time.Results:In the matched cohort,the patients with stones ≥1.5 cm in maximum diameter had significantly longer operative time compared with those with smaller stones:(85.8±28.8)min vs.(62.4±24.6)min(P<0.05).Postoperative length of hospital stay showed no significant difference:(2.26±1.79)d vs.(2.03±0.80)d(P>0.05).The stone clearance on postoperative day one was 90.3%in the study group vs.100.0%in the control group(P>0.05).One month postoperatively,the stone clearance was 93.5%vs.100.0%,respectively(P>0.05).Changes in SCr were(-6.58±16.10)μmol/L vs.(-13.70±12.50)μmol/L,and changes in GFR were(5.92±14.90)mL/(min·1.73 m2)vs.(7.47±11.20)m L/(min·1.73 m2),with no statistically significant differences observed between the two groups for either renal function marker(P>0.05).Conclusion:Ureteroscopic lithotripsy combined with N-trap is an optional method for treating ureteral stones with a maximum diameter ≥1.5 cm.The overall therapeutic efficacy is comparable,with the added benefit of significantly reducing the economic burden on patients.
9.Advances and controversies in partial nephrectomy for T 3a renal cell carcinoma
Jinghui JI ; Xiushi LIN ; Xiaojun TIAN ; Min QIU
Chinese Journal of Urology 2025;46(8):632-635
Renal cell carcinoma(RCC)has a relatively high incidence among genitourinary malignancies and therefore occupies a pivotal position in the diagnosis and treatment of urological tumors. Its staging,grading,and corresponding therapeutic strategies have been relatively well established. However,in clinical practice,we have observed that a subset of patients with RCC,preoperatively diagnosed as stage T1 based on imaging,are found on postoperative pathology after partial nephrectomy to have tumor extension into the renal sinus,resulting in pathological upstaging(cT 1/pT 3a). Multiple studies have demonstrated that the overall prognosis of cT 1/pT 3a patients undergoing partial nephrectomy is inferior to that of cT 1/pT 1 patients,but shows no significant difference compared with cT 1/pT 3a patients treated with radical nephrectomy. Moreover,partial nephrectomy offers clear advantages over radical nephrectomy in terms of intraoperative blood loss and preservation of renal function parameters such as estimated glomerular filtration rate(eGFR)and serum creatinine,which translate into improved quality of life. In addition,this paper introduces predictive methods for pathological upstaging in partial RCC,including novel imaging-based approaches such as the contour irregular degree(CID)on computed tomography(CT),histopathological predictors such as Fuhrman grading,and the preliminary application of machine learning in enhancing diagnostic accuracy.
10.Gegen Qinliantang and Its Modified Prescriptions Ameliorate Insulin Resistance in Type 2 Diabetes Mellitus: A Review
Yimin LIU ; Yanhua JI ; Mengjie CHEN ; Xiaojun YAN ; Hongning LIU ; Zhijun ZENG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(15):256-263
Gegen Qinliantang is a representative prescription for dual releasing of exterior and interior and treating diarrhea with fever in the Treatise on Cold Damage and Miscellaneous Diseases (《伤寒杂病论》). This prescription consists of Puerariae Lobatae Radix, Scutellariae Radix, Coptidis Rhizoma, and Glycyrrhizae Radix et Rhizoma Praeparata cum Melle. The combination of the four herbal medicines has the ability to clear both the exterior and the interior, thereby halting diarrhea and clearing heat. According to the idea of treating different diseases with the same method, Gegen Qinliantang is used in clinical practice to treat type 2 diabetes mellitus (T2DM), which demonstrates positive outcomes. T2DM is a chronic metabolic disease characterized by elevated blood glucose levels. The etiology and pathogenesis of T2DM are complex, mainly related to heredity, lifestyle, environment, diet and other factors. Clinical observations and experimental studies have shown that Gegen Qinliantang and its effective ingredients have significant effects of preventing and treating T2DM. Clinically, Gegen Qinliantang is often applied with modification, or in combination with Western drugs, demonstrating better therapeutic effects than Western drugs alone. Clinical practice has confirmed that Gegen Qinliantang can effectively alleviate the clinical symptoms, reduce the occurrence of complications, and alleviate gastrointestinal adverse reactions in T2DM patients. Experimental studies have demonstrated that Gegen Qinliantang can ameliorate insulin resistance and boost pancreatic function by regulating the insulin and inflammation signaling pathways, alleviating oxidative stress, and modulating gut microbiota to treat T2DM. Nevertheless, more thorough studies remain to be carried out to decipher the mechanism of Gegen Qinliantang in ameliorating insulin resistance in T2DM. To provide theoretical and data references for the subsequent in-depth research on the mechanism of Gegen Qinliantang in treating T2DM and the prevention and treatment of this disease, this article systematically reviews the clinical and experimental research progress of Gegen Qinliantang in ameliorating insulin resistance in T2DM.

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