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.Efficacy and Mechanism of Action in Jishengshenqi Pill Combined with Dapagliflozin in the Treatment of Diabetes Nephropathy Based on NLRP3 Inflammatory Corpuscles
Ji-qin ZHONG ; Lin LI ; Zheng-feng LI
Progress in Modern Biomedicine 2025;25(15):2438-2444
Objective:To explore the efficacy and mechanism of action in Jishengshenqi pill combined with dapagliflozin in the treatment of diabetes nephropathy(DN)based on NOD like receptor protein 3(NLRP3)inflamma tory corpuscles.Methods:140 DN patients were divided into control group(n=70,treated with dapagliflozin)and study group(n=70,treated with Jishengshenqi pill combine with dapagliflozin)used random number table.The TCM syndrome scores,blood glucose index,renal function index,peripheral blood NLRP3 levels,and related factor levels between two groups of patients were compared.Results:The scores of dysuria,fatigue and cold intolerance,edema,soreness and coldness in the waist and knees,abdominal distension,pale complexion and lower five shift diarrhea in the study group after treatment were lower than those in the control group(P<0.05).Fasting blood glucose(FBG),serum creatinine(SCr),2-hour postprandial blood glucose(2hPG),blood urea nitrogen(BUN),hemoglobin A1c(HbA1c),NLRP3 messenger RNA(mRNA),and cysteine protease 1(Caspase-1)levels in the study group after treatment were lower than those in the control group(P<0.05).Conclusion:After the treatment of Jishengshenqi pill combined with dapagliflozin in DN patients,the clinical symptoms and blood glucose can be effectively controlled,and renal function can also be improved,it is speculated that this is related to the inhibition of NLRP3 mRNA expression in peripheral blood mononuclear cells and the activation and amplification of downstream inflammatory pathways.
3.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.
4.Diagnostic value of fetal cardiac ultrasound screening views in the first trimester for congenital heart disease
Chengcheng WU ; Chunya JI ; Liqun FENG ; Wei SHAO ; Naimin SUN ; Jun ZHANG ; Zhong YANG ; Chen LING ; Lingling SUN ; Qi PAN ; Xuedong DENG ; Linliang YIN
Chinese Journal of Ultrasonography 2025;34(9):799-804
Objective:To investigate the diagnostic value of fetal cardiac ultrasound view visualization in the first trimester for congenital heart disease(CHD).Methods:A retrospective analysis was performed on 13 323 singleton fetuses who underwent first-trimester(11-13 +6 weeks)ultrasound screening at the Ultrasound Medicine Center,the Affiliated Suzhou Hospital of Nanjing Medical University from January 2018 to June 2024. Cardiac views including the four-chamber view(4CV),left ventricular outflow tract view(LVOT),and Results:The study group showed significantly higher rates of "poorly visualized" 4CV,LVOT,and 3VT than the control group(2.70% vs. 0.14%, P=0.005;36.49% vs. 4.76%, P<0.001;36.49% vs.2.46%, P<0.001). The efficacies of combination 1(any view abnormal)and combination 2(any view "poorly visualized" or "abnormal")were comparable,with AUCs of 0.86 and 0.85( P=0.424). The AUCs of combination 3(3VT "poorly visualized" or any view "abnormal")and combination 4(4CV "poorly visualized" or any view "abnormal")were 0.88 and 0.86( P=0.424),all significantly higher than combination 5(LVOT "poorly visualized" or any view "abnormal",AUC=0.84,all P<0.05). Conclusions:"Poorly visualized" cardiac views in the first trimester demonstrate good diagnostic efficacy for CHD,particularly when 3VT or 4CV are affected,warranting heightened clinical vigilance for fetal cardiac anomalies.
5.CURRENT DISTRIBUTION OF AEDES AEGYPTI IN LEIZHOU PENINSULA,ZHANJIANG CITY,GUANGDONG PROVINCE
Rui-Peng LU ; Jin-Hua DUAN ; Yu-Wen ZHONG ; Hui DENG ; Jun WU ; Li-Ping LIU ; Wei-Xiong YIN ; Feng XING ; Hui HUANG ; Chang-Jie FU ; Zong-Jing CHEN ; Ming-Ji CHENG ; Sheng-Jun HU ; Ya-Ting CHEN ; Wen-Ting GUO ; Li-Feng LIN
Acta Parasitologica et Medica Entomologica Sinica 2025;32(1):16-21
Objective To investigate the status of population dynamics and distribution changes of Aedes aegypti in Guangdong Province.Methods Continuous monitoring was conducted from May 2018 to July 2024 in Wushi Town and Qishui Town,Leizhou City,Zhanjiang City,Guangdong Province.Additionally,a survey of the distribution of Ae.aegypti along the Leizhou Peninsula coast was carried out.Results The density of Ae.aegypti in Zhanjiang showed a gradual decline from 2018 to 2024.The last detection of adult Ae.aegypti in Wushi Town was in September 2021,and the last larva was found in October 2023.No Ae.aegypti was detected in Qishui Town during surveys from 2021 to 2024.A survey of 18 coastal villages in the Leizhou Peninsula revealed no detections of Ae.aegypti.Conclusions This study provides a basis for understanding the distribution and population density fluctuations of Ae.aegypti,assessing its invasion risk,and scientifically conducting relevant prevention and control efforts.
6.Simultaneous content determination of sixteen constituents in Jiawei Huoxiang Zhengqi Soft Capsules by UPLC-MS/MS
Qian WANG ; Xia GAO ; Jian FENG ; Bin JIN ; Xia-lin CHEN ; Liang CAO ; Ji-feng LI ; Yong-wen ZHANG ; Zhen-zhong WANG
Chinese Traditional Patent Medicine 2025;47(5):1431-1436
AIM To establish a UPLC-MS/MS method for the simultaneous content determination of liquiritin,liquiritin apioside,verbascoside,narirutin,isoacteoside,apigetrin,hesperidin,isoliquiritin,ononin,liquiritigenin,glycyrrhizic acid,isoliquiritigenin,honokiol,obovatol,pogostone and magnolol in Jiawei Huoxiang Zhengqi Soft Capsules.METHODS The analysis was performed on a 40 ℃ thermostatic ZORBAX Eclipse Plus C18 column(2.1 mm×100 mm,1.8 μm),with the mobile phase comprising of 0.1%formic acid-acetonitrile flowing at 0.4 mL/min in a gradient elution manner,and electron spray ionization source was adopted in positive and negative ion scanning with multiple reaction monitoring mode.RESULTS Sixteen constituents showed good linear relationships within their own ranges(r>0.990 0),whose average recoveries were 83.74%-105.12%with the RSDs of 1.10%-4.8%.CONCLUSION This accurate,sensitive,stable and reproducible method can provide a reference for the overall quality control of Jiawei Huoxiang Zhengqi Soft Capsules.
7.Efficacy and Mechanism of Action in Jishengshenqi Pill Combined with Dapagliflozin in the Treatment of Diabetes Nephropathy Based on NLRP3 Inflammatory Corpuscles
Ji-qin ZHONG ; Lin LI ; Zheng-feng LI
Progress in Modern Biomedicine 2025;25(15):2438-2444
Objective:To explore the efficacy and mechanism of action in Jishengshenqi pill combined with dapagliflozin in the treatment of diabetes nephropathy(DN)based on NOD like receptor protein 3(NLRP3)inflamma tory corpuscles.Methods:140 DN patients were divided into control group(n=70,treated with dapagliflozin)and study group(n=70,treated with Jishengshenqi pill combine with dapagliflozin)used random number table.The TCM syndrome scores,blood glucose index,renal function index,peripheral blood NLRP3 levels,and related factor levels between two groups of patients were compared.Results:The scores of dysuria,fatigue and cold intolerance,edema,soreness and coldness in the waist and knees,abdominal distension,pale complexion and lower five shift diarrhea in the study group after treatment were lower than those in the control group(P<0.05).Fasting blood glucose(FBG),serum creatinine(SCr),2-hour postprandial blood glucose(2hPG),blood urea nitrogen(BUN),hemoglobin A1c(HbA1c),NLRP3 messenger RNA(mRNA),and cysteine protease 1(Caspase-1)levels in the study group after treatment were lower than those in the control group(P<0.05).Conclusion:After the treatment of Jishengshenqi pill combined with dapagliflozin in DN patients,the clinical symptoms and blood glucose can be effectively controlled,and renal function can also be improved,it is speculated that this is related to the inhibition of NLRP3 mRNA expression in peripheral blood mononuclear cells and the activation and amplification of downstream inflammatory pathways.
8.Simultaneous content determination of sixteen constituents in Jiawei Huoxiang Zhengqi Soft Capsules by UPLC-MS/MS
Qian WANG ; Xia GAO ; Jian FENG ; Bin JIN ; Xia-lin CHEN ; Liang CAO ; Ji-feng LI ; Yong-wen ZHANG ; Zhen-zhong WANG
Chinese Traditional Patent Medicine 2025;47(5):1431-1436
AIM To establish a UPLC-MS/MS method for the simultaneous content determination of liquiritin,liquiritin apioside,verbascoside,narirutin,isoacteoside,apigetrin,hesperidin,isoliquiritin,ononin,liquiritigenin,glycyrrhizic acid,isoliquiritigenin,honokiol,obovatol,pogostone and magnolol in Jiawei Huoxiang Zhengqi Soft Capsules.METHODS The analysis was performed on a 40 ℃ thermostatic ZORBAX Eclipse Plus C18 column(2.1 mm×100 mm,1.8 μm),with the mobile phase comprising of 0.1%formic acid-acetonitrile flowing at 0.4 mL/min in a gradient elution manner,and electron spray ionization source was adopted in positive and negative ion scanning with multiple reaction monitoring mode.RESULTS Sixteen constituents showed good linear relationships within their own ranges(r>0.990 0),whose average recoveries were 83.74%-105.12%with the RSDs of 1.10%-4.8%.CONCLUSION This accurate,sensitive,stable and reproducible method can provide a reference for the overall quality control of Jiawei Huoxiang Zhengqi Soft Capsules.
9.Diagnostic value of fetal cardiac ultrasound screening views in the first trimester for congenital heart disease
Chengcheng WU ; Chunya JI ; Liqun FENG ; Wei SHAO ; Naimin SUN ; Jun ZHANG ; Zhong YANG ; Chen LING ; Lingling SUN ; Qi PAN ; Xuedong DENG ; Linliang YIN
Chinese Journal of Ultrasonography 2025;34(9):799-804
Objective:To investigate the diagnostic value of fetal cardiac ultrasound view visualization in the first trimester for congenital heart disease(CHD).Methods:A retrospective analysis was performed on 13 323 singleton fetuses who underwent first-trimester(11-13 +6 weeks)ultrasound screening at the Ultrasound Medicine Center,the Affiliated Suzhou Hospital of Nanjing Medical University from January 2018 to June 2024. Cardiac views including the four-chamber view(4CV),left ventricular outflow tract view(LVOT),and Results:The study group showed significantly higher rates of "poorly visualized" 4CV,LVOT,and 3VT than the control group(2.70% vs. 0.14%, P=0.005;36.49% vs. 4.76%, P<0.001;36.49% vs.2.46%, P<0.001). The efficacies of combination 1(any view abnormal)and combination 2(any view "poorly visualized" or "abnormal")were comparable,with AUCs of 0.86 and 0.85( P=0.424). The AUCs of combination 3(3VT "poorly visualized" or any view "abnormal")and combination 4(4CV "poorly visualized" or any view "abnormal")were 0.88 and 0.86( P=0.424),all significantly higher than combination 5(LVOT "poorly visualized" or any view "abnormal",AUC=0.84,all P<0.05). Conclusions:"Poorly visualized" cardiac views in the first trimester demonstrate good diagnostic efficacy for CHD,particularly when 3VT or 4CV are affected,warranting heightened clinical vigilance for fetal cardiac anomalies.
10.Clinical Observation of Modified Banxia Houpu Decoction Plus Deanxit for the Treatment of Cancer-Related Depression of Phlegm Blended with Qi Type
Zhong-Deng HUANG ; Ji-Ling XIONG ; Gao-Feng CHEN ; Shou-Jie LI
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(1):77-83
Objective To investigate the clinical efficacy of modified Banxia Houpu Decoction plus Deanxit for the treatment of cancer-related depression(CRD)of phlegm blended with qi type.Methods Sixty-four CRD patients with phlegm blended with qi type were randomly divided into the treatment group and the control group,with 32 patients in each group.The control group was given oral use of Deanxit,and the treatment group was treated with modified Banxia Houpu Decoction plus Deanxit orally.The course of treatment covered 4 weeks.The changes of Karnofsky Performance Status(KPS)scores,self-rating depression scale(SDS)scores,and traditional Chinese medicine(TCM)syndrome scores in the two groups were observed before and after the treatment.Moreover,the efficacy for improving KPS scores and TCM syndrome efficacy in the two groups were also evaluated.Results(1)After 4 weeks of treatment,the total effective rate for improving KPS scores in the treatment group was 90.63%(29/32),and that in the control group was 78.13%(25/32).The intergroup comparison showed that the efficacy for improving KPS scores in the treatment group was significantly superior to that in the control group(P<0.01).(2)In terms of the efficacy of TCM syndromes,after 4 weeks of treatment,the total effective rate for improving TCM syndrome scores in the treatment group was 87.50%(28/32),and that in the control group was 40.63%(13/32),and the efficacy of TCM syndromes in the treatment group was significantly superior to that in the control group(P<0.05).(3)After treatment,the KPS scores in the treatment group were significantly increased compared with those before treatment(P<0.05),and the KPS scores in the control group tended to increase compared with those before treatment,but the difference was not statistically significant(P>0.05).The intergroup comparison showed that the effect on increasing KPS scores in the treatment group was significantly superior to that in the control group(P<0.05).(4)After treatment,the SDS scores in the two groups were lower than those before treatment(P<0.05),and the effect on lowering SDS scores in the treatment group was significantly superior to that in the control group(P<0.05).(5)After treatment,the TCM syndrome scores of the two groups were lower than those before treatment(P<0.05),and the effect on lowering TCM syndrome scores in the treatment group was significantly superior to that in the control group(P<0.05).Conclusion Modified Banxia Houpu Decoction plus Deanxit exerts certain effect for the treatment of CRD of phlegm blended with qi type.The combined therapy can effectively improve the depression mood and quality of life of the patients,and its efficacy is superior to that of Deanxit alone.

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