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.Application of"six combinations"principles for designation of ideological and political cases of Medical Immunology
Xiaotao JIANG ; Yanjun LIU ; Wei ZHU ; Xiaorui HOU ; Xiao YU ; Yuhui QIU ; Yumei HE ; Sha WU
Chinese Journal of Immunology 2025;41(11):2741-2743
Designation of ideological and political teaching of Medical Immunology courses focuses on"cultivate talent for Party and the State",and adheres to goal of"build morality and cultivate people".From perspective of big ideology and politics,with basic foundation of"major guiding,disciplines supporting and curriculum shaping",principle of"six combinations"is applied to con-struct ideological and political cases of Medical Immunology courses,to create an infiltrating teaching pattern,which simultaneously cultivate talent for the Party and the State,and forms a synergistic effect of professional course learning and ideological and political learning.
4.Impact of of deep core muscle training on improving the motor control of load transfer activities in post-partum women with pelvic girdle pain
Yanping LIU ; Ziling LIN ; Yanjun HOU
Chinese Journal of Rehabilitation Medicine 2025;40(12):1796-1802
Objective:To investigate the effects of deep core muscle training on pain and motor control during load trans-fer activities in patients with postpartum pelvic girdle pain(PPGP),and to explore the potential mechanisms by which deep core stability training alleviates PPGP pain.Method:From July 2024 to April 2025,56 PPGP women at the Affiliated Rehabilitation Hospital of Fujian University of Traditional Chinese Medicine were randomly divided into a control group(n=28)and an experi-mental group(n=28).Both groups received conventional treatment,while the experimental group underwent deep core stability muscle training in addition to the conventional treatment,three times a week for eight con-secutive weeks.Before and after the treatment,real-time ultrasound was used to assess the thickness of the transversus abdominis muscle(TrA)during maximal expiratory contraction,the thickness during ASLR activity,priority activation rate,the elastic modulus,and the elastic velocity,which reflect the changes in the move-ment control ability of the TrA muscle.The pelvic girdle questionnaire(PGQ)was used to assess the changes in pain and functional impairment in patients,with pain intensity assessed using the visual analogue scale(VAS),and the ASLR score used to assess the changes in load transfer activity ability between the trunk and lower limbs.Result:After eight weeks of treatment,the thickness of the TrA contraction during maximal expiratory and ASLR activity in the experimental group was significantly greater than that in the control group(P<0.05),and the contraction rate during breathing and the pre-activation rate during activation were both significantly higher than those in the control group(P<0.05).The percentage of internal oblique muscle activation in the experimental group during maximal expiration was significantly lower than that in the control group(P<0.05).The elastic modulus of TrA in the experimental group at rest,during maximal expiration,and during ASLR testing were all significantly greater than those in the control group(P<0.05).In addition,the results of pain scores and functional scales showed that the VAS score,PGQ score,and the ASLR score in the experimental group were all significantly lower than those in the control group after intervention(P<0.05).Conclusion:The deep core muscle training program can effectively alleviate pain and improve function in pa-tients with PPGP,and its mechanism may be related to enhancing TrA function and the motor control during load-transfer activities in PPGP.
5.Impact of of deep core muscle training on improving the motor control of load transfer activities in post-partum women with pelvic girdle pain
Yanping LIU ; Ziling LIN ; Yanjun HOU
Chinese Journal of Rehabilitation Medicine 2025;40(12):1796-1802
Objective:To investigate the effects of deep core muscle training on pain and motor control during load trans-fer activities in patients with postpartum pelvic girdle pain(PPGP),and to explore the potential mechanisms by which deep core stability training alleviates PPGP pain.Method:From July 2024 to April 2025,56 PPGP women at the Affiliated Rehabilitation Hospital of Fujian University of Traditional Chinese Medicine were randomly divided into a control group(n=28)and an experi-mental group(n=28).Both groups received conventional treatment,while the experimental group underwent deep core stability muscle training in addition to the conventional treatment,three times a week for eight con-secutive weeks.Before and after the treatment,real-time ultrasound was used to assess the thickness of the transversus abdominis muscle(TrA)during maximal expiratory contraction,the thickness during ASLR activity,priority activation rate,the elastic modulus,and the elastic velocity,which reflect the changes in the move-ment control ability of the TrA muscle.The pelvic girdle questionnaire(PGQ)was used to assess the changes in pain and functional impairment in patients,with pain intensity assessed using the visual analogue scale(VAS),and the ASLR score used to assess the changes in load transfer activity ability between the trunk and lower limbs.Result:After eight weeks of treatment,the thickness of the TrA contraction during maximal expiratory and ASLR activity in the experimental group was significantly greater than that in the control group(P<0.05),and the contraction rate during breathing and the pre-activation rate during activation were both significantly higher than those in the control group(P<0.05).The percentage of internal oblique muscle activation in the experimental group during maximal expiration was significantly lower than that in the control group(P<0.05).The elastic modulus of TrA in the experimental group at rest,during maximal expiration,and during ASLR testing were all significantly greater than those in the control group(P<0.05).In addition,the results of pain scores and functional scales showed that the VAS score,PGQ score,and the ASLR score in the experimental group were all significantly lower than those in the control group after intervention(P<0.05).Conclusion:The deep core muscle training program can effectively alleviate pain and improve function in pa-tients with PPGP,and its mechanism may be related to enhancing TrA function and the motor control during load-transfer activities in PPGP.
6.Application of"six combinations"principles for designation of ideological and political cases of Medical Immunology
Xiaotao JIANG ; Yanjun LIU ; Wei ZHU ; Xiaorui HOU ; Xiao YU ; Yuhui QIU ; Yumei HE ; Sha WU
Chinese Journal of Immunology 2025;41(11):2741-2743
Designation of ideological and political teaching of Medical Immunology courses focuses on"cultivate talent for Party and the State",and adheres to goal of"build morality and cultivate people".From perspective of big ideology and politics,with basic foundation of"major guiding,disciplines supporting and curriculum shaping",principle of"six combinations"is applied to con-struct ideological and political cases of Medical Immunology courses,to create an infiltrating teaching pattern,which simultaneously cultivate talent for the Party and the State,and forms a synergistic effect of professional course learning and ideological and political learning.
7.miR-185-5p alleviates the inflammatory response of acute gouty arthritis by inhibiting of IL-1β.
Nan HOU ; Xianghui MA ; Wei ZHOU ; Min YUAN ; Liming XU ; Huanxia SUN ; Yifan LIU ; Lining LIU ; Yanjun SHI ; Chunxian LI ; Yanfa FU
Chinese Journal of Cellular and Molecular Immunology 2024;40(1):51-57
Objective To investigate the relationship between interleukin-1β (IL-1β) and miR-185-5p in the process of joint injury in acute gouty arthritis (AGA). Methods The serum miR-185-5p levels of 89 AGA patients and 91 healthy volunteers were detected by real-time quantitative PCR. The correlation between miR-185-5p expression level and VAS score or IL-1β expression level was evaluated by Pearson correlation coefficient method. Receiver operating characteristic (ROC) curve was used to evaluate the diagnostic value of miR-185-5p in AGA. THP-1 cells were induced by sodium urate (MSU) to construct an in vitro acute gouty inflammatory cell model. After the expression level of miR-185-5p in THP-1 cells was upregulated or downregulated by transfection of miR-185-5p mimics or inhibitors in vitro, inflammatory cytokines of THP-1 cells, such as IL-1β, IL-8 and tumor necrosis factor α (TNF-α), were detected by ELISA. The luciferase reporter gene assay was used to determine the interaction between miR-185-5p and the 3'-UTR of IL-1β. Results Compared with the healthy control group, the expression level of serum miR-185-5p in AGA patients was significantly reduced. The level of serum miR-185-5p was negatively correlated with VAS score and IL-1β expression level. The area under the curve (AUC) was 0.905, the sensitivity was 80.17% and the specificity was 83.52%. Down-regulation of miR-185-5p significantly promoted the expression of IL-1β, IL-8 and tumor necrosis factor (TNF-α), while overexpression of miR-185-5p showed the opposite results. Luciferase reporter gene assay showed that IL-1β was the target gene of miR-185-5p, and miR-185-5p negatively regulated the expression of IL-1β. Conclusion miR-185-5p alleviates the inflammatory response in AGA by inhibiting IL-1β.
Humans
;
3' Untranslated Regions
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Arthritis, Gouty/genetics*
;
Interleukin-1beta/genetics*
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Interleukin-8
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Luciferases
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MicroRNAs/genetics*
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Tumor Necrosis Factor-alpha
8.Application of immunophenotype analysis in distinguishing APL from HLA-DR negative AML
Weifeng GAO ; Zhijuan SHAN ; Yiping ZHOU ; Xinrui PEI ; Yu YANG ; Yanjun HOU ; Hebing ZHOU
Chinese Journal of Clinical Laboratory Science 2024;42(4):272-276
Objective To investigate the diagnostic value of immunophenotype in distinguishing acute promyelocytic leukemia(APL)from HLA-DR negative acute myeloid leukemia(AML)using flow cytometry.Methods A retrospective observational study was con-ducted including 42 APL patients and 28 newly diagnosed or relapsed HLA-DR negative AML patients admitted to our hospital from 2014 to 2024.Immunophenotype analysis was performed on bone marrow aspirate samples using flow cytometry.The positive expression rates of CD64,MPO,CD7,CD11c,CD9,CD123 and other antigens were compared between the two groups using the Chi-square test.The diagnostic efficiency of the CD9/123 and CD64+MPO+CD7 CD11c-models for APL was evaluated using receiver operating charac-teristic(ROC)curves.Results The HLA-DR negative AML group exhibited significantly lower positive rates of CD64,CD9 and MPO(P<0.05),and higher positive rates of CD11c and CD7(P<0.05)compared to APL group.The CD64+MPO+CD7-CD11c-model had an area under the curve(AUCROC)of 0.859,sensitivity of 93.8%and specificity of 75.0%for distinguishing APL.The CD9/CD123 expression pattern had AUCROC of 0.919,sensitivity of 83.3%and specificity of 84.0%for APL diagnosis.The combined CD9/123 and CD64+MPO+CD7-CD11c-model had AUCROC of 0.955,sensitivity of 83.3%and specificity of 100%.Conclusion The combined CD9/123 and CD64+MPO+CD7-CD11c-expression pattern may serve as a helpful tool for differentiating APL from HLA-DR negative AML.
9.Functional gastrointestinal disorders, mental health, genetic susceptibility, and incident chronic kidney disease
Mengyi LIU ; Panpan HE ; Ziliang YE ; Sisi YANG ; Yanjun ZHANG ; Qimeng WU ; Chun ZHOU ; Yuanyuan ZHANG ; Fan Fan HOU ; Xianhui QIN
Chinese Medical Journal 2024;137(9):1088-1094
Background::Whether functional gastrointestinal disorders (FGIDs) are associated with the long-term risk of chronic kidney disease (CKD) remains unclear. We aimed to investigate the prospective association of FGIDs with CKD and examine whether mental health mediated the association.Methods::About 416,258 participants without a prior CKD diagnosis enrolled in the UK Biobank between 2006 and 2010 were included. Participants with FGIDs (including irritable bowel syndrome [IBS], dyspepsia, and other functional intestinal disorders [FIDs; mainly composed of constipation]) were the exposure group, and non-FGID participants were the non-exposure group. The primary outcome was incident CKD, ascertained from hospital admission and death registry records. A Cox proportional hazard regression model was used to investigate the association between FGIDs and CKD, and the mediation analysis was performed to investigate the mediation proportions of mental health.Results::At baseline, 33,156 (8.0%) participants were diagnosed with FGIDs, including 21,060 (5.1%), 8262 (2.0%), and 6437 (1.6%) cases of IBS, dyspepsia, and other FIDs, respectively. During a mean follow-up period of 12.1 years, 11,001 (2.6%) participants developed CKD. FGIDs were significantly associated with a higher risk of incident CKD compared to the absence of FGIDs (hazard ratio [HR], 1.36; 95% confidence interval [CI], 1.28–1.44). Similar results were observed for IBS (HR, 1.27; 95% CI, 1.17–1.38), dyspepsia (HR, 1.30; 95% CI, 1.17–1.44), and other FIDs (HR, 1.60; 95% CI, 1.43–1.79). Mediation analyses suggested that the mental health score significantly mediated 9.05% of the association of FGIDs with incident CKD and 5.63–13.97% of the associations of FGID subtypes with CKD. Specifically, the positive associations of FGIDs and FGID subtypes with CKD were more pronounced in participants with a high genetic risk of CKD.Conclusion::Participants with FGIDs had a higher risk of incident CKD, which was partly explained by mental health scores and was more pronounced in those with high genetic susceptibility to CKD.
10.Intestinal epithelial cell NCoR deficiency ameliorates obesity and metabolic syndrome.
Shaocong HOU ; Hengcai YU ; Caihong LIU ; Andrew M F JOHNSON ; Xingfeng LIU ; Qian JIANG ; Qijin ZHAO ; Lijuan KONG ; Yanjun WAN ; Xiaowei XING ; Yibing CHEN ; Jingwen CHEN ; Qing WU ; Peng ZHANG ; Changtao JIANG ; Bing CUI ; Pingping LI
Acta Pharmaceutica Sinica B 2024;14(12):5267-5285
Nuclear receptor corepressor (NCoR1) interacts with various nuclear receptors and regulates the anabolism and catabolism of lipids. An imbalance in lipid/energy homeostasis is also an important factor in obesity and metabolic syndrome development. In this study, we found that the deletion of NCoR1 in intestinal epithelial cells (IECs) mainly activated the nuclear receptor PPARα and attenuated metabolic syndrome by stimulating thermogenesis. The increase in brown adipose tissue thermogenesis was mediated by gut-derived tricarboxylic acid cycle intermediate succinate, whose production was significantly enhanced by PPARα activation in the fed state. Additionally, NCoR1 deletion derepressed intestinal LXR, increased cholesterol excretion, and impaired duodenal lipid absorption by decreasing bile acid hydrophobicity, thereby reversing the possible negative effects of intestinal PPARα activation. Therefore, the simultaneous regulatory effect of intestinal NCoR1 on both lipid intake and energy expenditure strongly suggests that it is a promising target for developing metabolic syndrome treatment.

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