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.Effect of CIP2 A over-expression on proliferation and apoptosis of gastric epithelial cells
Haiyun ZHANG ; Xiangrong CHANG
Chinese Journal of Pathophysiology 2016;32(10):1881-1886
AIM:To investigate the effects of cancerous inhibitor of protein phosphatase 2A (CIP2A) over-ex-pression on the proliferation and apoptosis of gastric epithelial cells .METHODS:The mRNA expression of CIP2A and cy-clin D1 in the tissues of normal gastric mucosa and gastric polyps was detected by RT -qPCR.The GES-1 cells were divided into control group, Ad-emp group and Ad-CIP2A group.The cell proliferation ability was detected by MTT assay and BrdU assay , and the cell apoptosis was analyzed by flow cytometry .The expression of apoptosis-related molecules was determined by Western blot and RT-qPCR.The levels of inflammatory cytokines were measured by ELISA after GES-1 cells were infec-ted with Ad-emp and Ad-CIP2A.Furthermore, the protein levels of p-Rb, E2F1 and cyclin D1 in the GES-1 cells was de-termined by Western blot after transfected with E2F1 siRNA.RESULTS:The expression of CIP2A and cyclin D1 in ade-nomatous gastric polyps tissues was significantly higher than that in normal gastric mucosa tissues , and no significant change of that between hyperplastic gastric polyps tissues and normal gastric mucosa was observed .After transfected with CIP2A, the proliferation ability of GES-1 cells was increased , the cell apoptosis was inhibited , the concentrations of IL-1βand IL-10 was up-regulated and the protein levels of p-Rb, E2F1 and cyclin D1 were increased, while the protein levels of p-Rb, E2F1 and cyclin D1 were significantly decreased after transfected with E2F1 siRNA.CONCLUSION: CIP2A promotes the proliferation and inhibits the apoptosis of GES-1 cells by activating Rb/E2F1.
4.Effects ofHuanshuai Oral Liquid in the Process of Hypoxia-Microvascular Waste-Renal Interstitial Fibrosis in Mice with Atherosclerosis Renal Artery Stenosis
Lvgui FANG ; Xiangrong RAO ; Shen LI ; Li WANG ; Jianxin LU ; Lingyan WU ; Chang LIU
Chinese Journal of Information on Traditional Chinese Medicine 2015;(1):53-57
Objective To explore the mechanism ofHuanshuai Oral Liquid in the process of hypoxia-microvascular waste-renal interstitial fibrosis in mice with atherosclerosis renal artery stenosis.Methods The atherosclerosis renal artery stenosis model was established on Apoe-/- mice by high fat feed and uninephrectomy. After 2 weeks of renal ablation, model mice were randomly divided into TCM group (Huanshuai Oral Liquid) and model group. C57BL/6J mice were taken as the blank group. The mice of TCM group receivedHuanshuai Oral Liquid 0.01 mL/(g?d) for gavage, while the blank group and the model group received normal saline 0.01 mL/(g?d) for gavage. Renal function, atherosclerosis and renal interstitial fibrosis were assessed in the 12th week after taking medicine via immunohistochemical method to detect the expressions of the collagen typeⅣ, alpha smooth muscle actin (α-SMA) andⅧ factor related antigen (vWF), and via RT-PCR to detect the expressions of HIF-1α and TGF-β.ResultsCompared with the blank group, the model group suffered severe renal artery stenosis and renal fibrosis, and the expressions of HIF-1α, TGF-β, collagen typeⅣ andα-SMA significantly increased (P<0.05), while the expression of vWF decreased (P<0.05). Compared with the model group, the expressions of HIF-1α, TGF-β, collagen typeⅣ andα-SMA group, the expressions of HIF-1α, TGF-β, collagen typeⅣ andα-SMA significantly decreased in the TCM group (P<0.05), while the expression of vWF significantly increased (P<0.05).ConclusionHuanshuai Oral Liquid could significantly improve the renal function and the renal tubular-interstitial fibrosis. The mechanism might be associated with regulating the expressions of HIF-1α and TGF-β.
5.Recommendations for mitral regurgtitation with Doppler echocardiography.
Xiangrong CHANG ; Deyu LI ; Jiangli LIN ; Changqiong ZHENG ; Li RAO ; Hong TANG ; Tianfu WANG
Journal of Biomedical Engineering 2005;22(6):1279-1282
Mitral regurgitation is one of the most serious heart diseases. With the development of up-to-date medical techniques, the ratio of successful operations in valvular repair and valvular replacement has been largely improved. Examinations before operation become extremely crucial. Accurate method is required in assessing the degree of mitral regurgitation to set down the corresponding treatment method. This paper reviews the evaluation methods of mitral valvular regurgitation provided in these years and presents comments on the application areas as well as the merits and disadvantages of those methods. Finally, the prospect of the method based on three-dimensional Doppler ultrasonographic imaging on mitral regurgitation is discussed.
Echocardiography, Doppler, Color
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Echocardiography, Three-Dimensional
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Humans
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Image Processing, Computer-Assisted
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Mitral Valve Insufficiency
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diagnostic imaging

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