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.Application of subject-achieving quality control circle in the popular science intervention of rational medication use for patients with newly diagnosed tuberculosis
Yanjun ZHENG ; Xiangui LIN ; Xiang LI ; Honglan ZHONG ; Zhenjian XING
Modern Hospital 2025;25(7):1045-1048
Objective To investigate the application value of the subject-achieving quality control circle theory in enhan-cing medication adherence among newly diagnosed tuberculosis patients through via popular science intervention.Methods From September 2023 to April 2024,100 patients with newly diagnosed tuberculosis treated at the outpatient department were ran-domly divided into control and intervention groups,each comprising 50 cases.The control group received only routine medication education;whereas the intervention group,in addition to this,implemented popular science intervention measures based on the quality control circle theory.The medication adherence,full course completion rate,non-disease interruption rate,and self-re-ported adverse reaction rate were compared.Results After treatment,the intervention group showed higher medication adher-ence(6.76±1.02 vs.6.15±1.36),better adherence rates(78%vs.62%),and higher cure rates(76%vs.42%)than the control group,all with statistical significance.The non-disease interruption rate was also significantly lower in the intervention group(2%vs.14%).Adverse reaction reports were 6%in control and 18%in intervention group.Conclusion The subject-achieving quality control circle effectively improves medication adherence in newly diagnosed tuberculosis patients.
3.Application of subject-achieving quality control circle in the popular science intervention of rational medication use for patients with newly diagnosed tuberculosis
Yanjun ZHENG ; Xiangui LIN ; Xiang LI ; Honglan ZHONG ; Zhenjian XING
Modern Hospital 2025;25(7):1045-1048
Objective To investigate the application value of the subject-achieving quality control circle theory in enhan-cing medication adherence among newly diagnosed tuberculosis patients through via popular science intervention.Methods From September 2023 to April 2024,100 patients with newly diagnosed tuberculosis treated at the outpatient department were ran-domly divided into control and intervention groups,each comprising 50 cases.The control group received only routine medication education;whereas the intervention group,in addition to this,implemented popular science intervention measures based on the quality control circle theory.The medication adherence,full course completion rate,non-disease interruption rate,and self-re-ported adverse reaction rate were compared.Results After treatment,the intervention group showed higher medication adher-ence(6.76±1.02 vs.6.15±1.36),better adherence rates(78%vs.62%),and higher cure rates(76%vs.42%)than the control group,all with statistical significance.The non-disease interruption rate was also significantly lower in the intervention group(2%vs.14%).Adverse reaction reports were 6%in control and 18%in intervention group.Conclusion The subject-achieving quality control circle effectively improves medication adherence in newly diagnosed tuberculosis patients.
4.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.
5.Experimental study in vitro of ziyuglycoside Ⅱ in inhibition of proliferation, migration, invasion and induction of apoptosis of colon cancer cells
Xinqiang ZHONG ; Kang CHEN ; Heng DU ; Haipeng XIAO ; Yanjun LU ; Anding WU
Journal of Clinical Medicine in Practice 2024;28(1):7-12
Objective To investigate the effect and its mechanism of ziyuglycoside Ⅱ on proliferation, migration, invasion and apoptosis of colon cancer cells HT-29. Methods The effect of ziyuglycoside Ⅱ on cell proliferation of colon cancer cells HT-29 was determined by CCK-8 method; the effect of ziyuglycoside Ⅱ on cell migrative capacity of colon cancer cells HT-29 was determined by scratch assay; the effect of ziyuglycoside Ⅱ on cell invasive capacity of colon cancer cells HT-29 was determined by transwell assay; the effects of ziyuglycoside Ⅱ on cell apoptosis of colon cancer cells HT-29 was determined by flow cytometry; the effects of ziyuglycoside Ⅱ on mRNA and protein expression of protein kinase B (AKT)/phosphatidylinositol-3-kinase (PI3K) signal pathway were determined by real-time quantitative reverse transcription polymerase chain reaction (qRT-PCR) and western-blot, respectively. Results Ziyuglycoside Ⅱ (0, 1, 5, 10, 20, 40, 60 and 80 μmol/mL) inhibited proliferation of colon cancer cells HT-29 in a dose-dependent manner. Ziyuglycoside Ⅱ (5, 10 and 20 μmol/mL) inhibited migration of colon cancer cells HT-29 in a dose-dependent manner. Ziyuglycoside Ⅱ (5, 10 and 20 μmol/mL) inhibited invasion of colon cancer cells HT-29 in a dose-dependent manner. Ziyuglycoside Ⅱ (5, 10 and 20 μmol/mL) promoted apoptosis of colon cancer cells HT-29 in a dose-dependent manner. Ziyuglycoside Ⅱ (5, 10 and 20 μmol/mL) increased mRNA expression of
6.Reliability and validity test and application of the Chinese version of the Feeling of Satisfaction with Inhaler
Weiwei MENG ; Zhiqi ZHAO ; Ruoyan XIONG ; Yanjun ZHONG ; Huihui ZENG ; Yan CHEN
Journal of Central South University(Medical Sciences) 2023;48(12):1854-1864
Objective:Inhaler satisfaction is an important factor affecting inhaler adherence and the efficacy of inhalers in chronic airway diseases.Using a scientific and effective method to assess patients'satisfaction with inhalers is of great significance for improving clinical outcomes.The Feeling of Satisfaction with Inhaler-10(FSI-10)is specifically designed to assess patients'inhaler satisfaction in chronic airway diseases,but the application research on this scale is not available in China.This study aims to evaluate the reliability and validity of the Chinese version of FSI-10,describe the current status of inhaler satisfaction and discuss the associated variables in Chinese patients with chronic airway disease. Methods:Based on the English version of FSI-10,items of the Chinese version of FSI-10 were determined after forward-backward translation and cultural adaption.Totally,322 patients with chronic obstructive pulmonary disease(COPD)and asthma were enrolled from the Second Xiangya Hospital of Central South University from June to October 2022.We collected associated clinical variables and inhaler satisfaction using the Chinese version of FSI-10.The content validity of the scale was expressed by content validity index(CVI)and the construct validity was analyzed by exploratory factor analysis(EFA).The reliability of the scale was expressed by Cronbach's α coefficient,the split-half reliability and test-retest reliability.A multivariate logistic regression was conducted to examine variables related to inhaler satisfaction. Results:The reliability and validity analysis showed that the CVI was 0.983.One factor was extracted from the Chinese version of FSI-10 and the cumulative variance contribution rate was 73.114%.The Cronbach's α of the scale was 0.913,the Guttman's half-reliability coefficient was 0.905,and the test-retest reliability was 0.727(P<0.001).In addition,the total score of the scale for patients was 38.92±4.26 points and the proportion of high satisfaction(the score of FSI-10≥40)in patients with COPD was significantly lower than that in asthma patients(71.3%vs 87.9%,P<0.01).Older age(age≥70 years)was a risk factor of lower inhaler satisfaction and asthma diagnosis was a protective factor. Conclusion:The Chinese version of FSI-10 has good reliability and validity in patients with COPD and asthma,which may be further promoted and applied in patients with chronic airway disease in China.Doctors should regularly evaluate the inhaler satisfaction of patients with chronic airway diseases,especially for those elder or with severe symptoms and a long course of illness.
7.Characteristics of whole blood donors from 26 blood stations before and after the outbreak of COVID-19:a multicenter study
Peng LI ; Youhua SHEN ; Wei GAO ; Wei ZHANG ; Jianling ZHONG ; Hao LI ; Lin BAO ; Ying WANG ; Xuefang FENG ; Tao SUN ; Xiaoqin CHEN ; Li LI ; Hongzhi JIA ; Shouguang XU ; Xiaobo CAI ; Wen ZHANG ; Qunying LAI ; Zhiqiang YU ; Zhenxing WANG ; Yanjun ZHOU ; Peng WANG ; Yanhua ZHANG ; Guoqiang ZHANG ; Haiying NIU ; Hongli JING
Chinese Journal of Blood Transfusion 2023;36(10):907-912
【Objective】 To analyze the basic characteristics of whole blood donors from blood stations before and after the outbreak of COVID-19. 【Methods】 After excluding invalid data, data related to the basic characteristics of whole blood donors collected from 26 blood stations in China during 2018 to 2021 were statistically analyzed, including the trend of total whole blood donors, the number of repeated blood donors, the frequency of blood donation, the average age of donors and the recruitment of first-time blood donors. 【Results】 Affected by the epidemic, 8 out of 14 indicators were with large variations, accounting for 57%. The overall growth rate of total whole blood donors during the epidemic was higher than before the epidemic (P<0.05).The number of repeated blood donors has shown an increased trend, with a higher number during the epidemic than before (P<0.05). The frequency of blood donation was lower during the epidemic than before(P<0.05).Average ages of blood donors and female blood donors fluctuated widely during the epidemic, both higher than those before the epidemic(P<0.05).The donation rate of first-time blood donors <25 years old and ≥25 years old varied widely and irregularly during the epidemic (both P<0.05). The percentage of first-time blood donors fluctuated irregularly during the epidemic, with overall percentage lower than that before the epidemic(P<0.05). 【Conclusion】 Whole blood donors from 26 blood stations increased after the outbreak of COVID-19, and some indicators in certain areas showed significant fluctuations during the epidemic.
8.Evaluation of the fresh air purification system in the classroom under heavy pollution weather
Hang DU ; Yanwen WANG ; Liangliang CUI ; Jianlong FANG ; Qinghua SUN ; Yanjun DU ; Yingjian ZHANG ; Yu ZHONG ; Zihao HUANG ; Wenjing ZHANG ; Xiumiao PENG ; Yang ZHANG ; Tiantian LI
Chinese Journal of Preventive Medicine 2021;55(8):995-998
Evaluate the effect of the fresh air purification system on the improvement of indoor PM 2.5 levels in a primary school classroom in Jinan City, Shandong Province. Our purpose is to explore the optimal operating time of the fresh air system and the main factors that affect the fresh air purification system to improve indoor air quality. From December 9, 2019 to December 10, 2019, two classrooms of the same area on the third floor of a primary school building in Jinan City, Shandong Province were selected as monitoring points. During the operation of the fresh air purification system, the PM 2.5 concentration in the classroom is reduced by an average of 48.1%-61.5% compared to the outdoor PM 2.5 concentration. After running for about 2 hours, the indoor PM 2.5 concentration decreased to a relatively stable concentration level. The operating time of the fresh air purification system, student activities between classes, indoor temperature, indoor relative humidity, and outdoor PM 2.5 concentration are important factors that affect the indoor particulate removal rate. In the case of a certain amount of fresh air and indoor area, closing doors and windows and appropriately extending the operation time of the fresh air purification system can improve the air quality in the classroom to a certain extent and protect the health of students.
9.Evaluation of the fresh air purification system in the classroom under heavy pollution weather
Hang DU ; Yanwen WANG ; Liangliang CUI ; Jianlong FANG ; Qinghua SUN ; Yanjun DU ; Yingjian ZHANG ; Yu ZHONG ; Zihao HUANG ; Wenjing ZHANG ; Xiumiao PENG ; Yang ZHANG ; Tiantian LI
Chinese Journal of Preventive Medicine 2021;55(8):995-998
Evaluate the effect of the fresh air purification system on the improvement of indoor PM 2.5 levels in a primary school classroom in Jinan City, Shandong Province. Our purpose is to explore the optimal operating time of the fresh air system and the main factors that affect the fresh air purification system to improve indoor air quality. From December 9, 2019 to December 10, 2019, two classrooms of the same area on the third floor of a primary school building in Jinan City, Shandong Province were selected as monitoring points. During the operation of the fresh air purification system, the PM 2.5 concentration in the classroom is reduced by an average of 48.1%-61.5% compared to the outdoor PM 2.5 concentration. After running for about 2 hours, the indoor PM 2.5 concentration decreased to a relatively stable concentration level. The operating time of the fresh air purification system, student activities between classes, indoor temperature, indoor relative humidity, and outdoor PM 2.5 concentration are important factors that affect the indoor particulate removal rate. In the case of a certain amount of fresh air and indoor area, closing doors and windows and appropriately extending the operation time of the fresh air purification system can improve the air quality in the classroom to a certain extent and protect the health of students.
10.Clinical characteristics and the risk factors for severe events of elderly coronavirus disease 2019 patients.
Guyi WANG ; Chenfang WU ; Quan ZHANG ; Bo YU ; Jianlei LÜ ; Siye ZHANG ; Guobao WU ; Ying WU ; Yanjun ZHONG
Journal of Central South University(Medical Sciences) 2020;45(5):542-548
OBJECTIVES:
To investigate the clinical characteristics and risk factors for severe events of coronavirus disease 2019 (COVID-19) in elderly patients.
METHODS:
Retrospective analysis was performed on the clinical data of all elderly COVID- 19 patients treated in Changsha Public Health Treatment Center from January 17, 2020 to March 15, 2020, which included basic diseases, symptoms, test results, and other clinical characteristics, and prognostic indicators such as severity of illness, length of hospital stay, virus shedding time and mortality rate. The differences in clinical characteristics and prognostic indicators between elderly, middle-aged, and young COVID-19 patients were also analyzed. Logistic regression model was used to conduct univariate and multivariate analysis of risk factors for developing severe events in elderly COVID-19 patients; receiver operating characteristic (ROC) curve analysis was used to evaluate the prediction efficacy.
RESULTS:
Of the 230 COVID-19 adult patients, 34 were young patients (14.8%), 136 were middle-aged patients (59.1%), and 60 were elderly (26.1%). Among the 60 elderly patients, 23 were male (38.3%) and 37 were female (61.7%), with a medium age of 66 years old. Common symptoms were fever (66.7%), cough (50.0%), and fatigue (41.7%). C reactive protein (CRP) was increased significantly. The proportion of severe cases was 31.7%, and mortality was 1.7%. The median length of hospitalization and median virus shedding time were 18.5 days and 21 days, respectively. Compared with the young and the middle-aged patients, the elderly had a higher proportion of hypertension, diabetes, and cardiovascular diseases, more common shortness of breath, higher proportions of pneumonia and severe cases (all <0.05), and the decreased lymphocyte count and lymphocyte percentage (both <0.05), as well as higher CRP and erythrocyte sedimentation rate (ESR) levels (both <0.05). Compared with non-severe cases, severe elderly patients demonstrated higher CRP and aspartate aminotransferase (AST) levels (all <0.05), the reduced lymphocyte count (<0.05), and the prolonged length of hospitalization and virus shedding duration (both <0.05). Univariate logistic regression analysis indicated that the lymphocytes proportion, CRP and AST levels were significantly correlated with the risk for developing severe events in elderly COVID-19 patients (all <0.05). Multivariate logistic regression found that severe events in elderly patients with COVID-19 were significantly correlated with CRP level (OR=1.041, =0.013). ROC curve analysis revealed that the area under the curve (AUC) for CRP to diagnose severe events in elderly COVID 19 patients was 0.851.
CONCLUSIONS
The proportion of severe cases in elderly COVID-19 patients is higher than that in young and middle-aged patients. CRP level has a good predictive value for the possibility of severe events in elderly COVID-19 patients.
Adult
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Aged
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Betacoronavirus
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C-Reactive Protein
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analysis
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China
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Comorbidity
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Coronavirus Infections
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diagnosis
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physiopathology
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Female
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Humans
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Male
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Middle Aged
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Pandemics
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Pneumonia, Viral
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diagnosis
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physiopathology
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Retrospective Studies
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Risk Factors


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