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.Urinary continence and short-term oncologic efficacy of total prostatic urethral preservation(TPUP)technique in laparoscopic radical prostatectomy
Xiangrong YING ; Ke GAO ; Zibin XU ; Haojie ZHANG ; Chong SHEN ; Yu REN ; Zhengang LUO ; Gangfeng WU
Chinese Journal of Urology 2025;46(10):764-768
Objective:To explore the short-term oncological efficacy of the total prostatic urethra preservation(TPUP)technique in laparoscopic radical prostatectomy and its impact on postoperative urinary continence rate.Methods:The clinical data of 17 prostate cancer patients admitted to Shaoxing People’s Hospital from July 2023 to July 2024 were retrospectively analyzed. The age was(70.5 ± 6.5)years,the body mass index was(23.6 ± 2.5)kg/m 2,and the prostate-specific antigen(PSA)level was(7.845 ± 3.929)ng/ml. The preoperative biopsy pathological Gleason score were 6 in 8 cases,and 7 in 9 cases. All patients underwent laparoscopic radical prostatectomy,and the TPUP technique was used during the operation. The integrity of the preserved urethra was improved by preserving the prostatic surgical capsule closely attached to the corpus spongiosum of the urethra. During the operation,the urethra was completely preserved in 2 cases,nearly completely preserved in 14 cases,and partially preserved in 1 case. The recovery of urinary continence on the day of catheter removal and at 1 and 3 months after the operation was recorded. Recovery of urinary continence was defined as pad within 24 hours. PSA was re - examined at 6 weeks and 3 months after the operation. Results:All 17 operations in this study were successfully completed. The operation time was(143.6 ± 31.6)minutes,and the intraoperative blood loss was 50.0(20.0,50.0)ml. None of the cases was converted to open surgery,and no Clavien - Dindo grade ≥ 2 complications such as blood transfusion or intestinal injury occurred during the peri-operative period. The PSA levels at 6 weeks and 3 months after the operation were 0.054(0.008,0.215)ng/ml and 0.008(0.005,0.037)ng/ml,respectively. The indwelling catheter time after the operation was(13.4 ± 2.1)days. The number of cases with recovered urinary continence on the day of catheter removal and at 1 and 3 months after the operation was 10,15,and 17,respectively.Conclusions:The TPUP technique in laparoscopic radical prostatectomy leads to good recovery of postoperative urinary continence,and there is a slowly PSA decrease in the short term.
4.Urinary continence and short-term oncologic efficacy of total prostatic urethral preservation(TPUP)technique in laparoscopic radical prostatectomy
Xiangrong YING ; Ke GAO ; Zibin XU ; Haojie ZHANG ; Chong SHEN ; Yu REN ; Zhengang LUO ; Gangfeng WU
Chinese Journal of Urology 2025;46(10):764-768
Objective:To explore the short-term oncological efficacy of the total prostatic urethra preservation(TPUP)technique in laparoscopic radical prostatectomy and its impact on postoperative urinary continence rate.Methods:The clinical data of 17 prostate cancer patients admitted to Shaoxing People’s Hospital from July 2023 to July 2024 were retrospectively analyzed. The age was(70.5 ± 6.5)years,the body mass index was(23.6 ± 2.5)kg/m 2,and the prostate-specific antigen(PSA)level was(7.845 ± 3.929)ng/ml. The preoperative biopsy pathological Gleason score were 6 in 8 cases,and 7 in 9 cases. All patients underwent laparoscopic radical prostatectomy,and the TPUP technique was used during the operation. The integrity of the preserved urethra was improved by preserving the prostatic surgical capsule closely attached to the corpus spongiosum of the urethra. During the operation,the urethra was completely preserved in 2 cases,nearly completely preserved in 14 cases,and partially preserved in 1 case. The recovery of urinary continence on the day of catheter removal and at 1 and 3 months after the operation was recorded. Recovery of urinary continence was defined as pad within 24 hours. PSA was re - examined at 6 weeks and 3 months after the operation. Results:All 17 operations in this study were successfully completed. The operation time was(143.6 ± 31.6)minutes,and the intraoperative blood loss was 50.0(20.0,50.0)ml. None of the cases was converted to open surgery,and no Clavien - Dindo grade ≥ 2 complications such as blood transfusion or intestinal injury occurred during the peri-operative period. The PSA levels at 6 weeks and 3 months after the operation were 0.054(0.008,0.215)ng/ml and 0.008(0.005,0.037)ng/ml,respectively. The indwelling catheter time after the operation was(13.4 ± 2.1)days. The number of cases with recovered urinary continence on the day of catheter removal and at 1 and 3 months after the operation was 10,15,and 17,respectively.Conclusions:The TPUP technique in laparoscopic radical prostatectomy leads to good recovery of postoperative urinary continence,and there is a slowly PSA decrease in the short term.
5.Associations of negative life events and coping styles with sleep quality among Chinese adolescents: a cross-sectional study.
Zheng REN ; Xiumin ZHANG ; Yue SHEN ; Xiangrong LI ; Minfu HE ; Hong SHI ; Hanfang ZHAO ; Shuang ZHA ; Shuyin QIAO ; Yuyu LI ; Yajiao PU ; Xinwen FAN ; Xia GUO ; Hongjian LIU
Environmental Health and Preventive Medicine 2021;26(1):85-85
BACKGROUND:
Limited published research has examined the relationships of negative life events and coping styles with sleep quality in Chinese junior high school students. We aimed to investigate the prevalence of poor sleep quality and to clarify the role of coping styles between negative life events and sleep quality.
METHODS:
A cross-sectional study of 3081 students was conducted in Ganzhou City, Jiangxi Province, Southeastern China. Adolescent Self-Rating Life Events Checklist, Simplified Coping Style Questionnaire, and Pittsburg Sleep Quality Index were applied to assess negative life events, coping styles, and sleep quality, respectively. Descriptive analyses, independent-samples t tests, one-way analyses of variance, Pearson correlation analyses, and structural equation modeling (SEM) were applied to analyze the data.
RESULTS:
The prevalence of poor sleep quality was 26.7%. Negative life events (B = 0.038, P < 0.001) and negative coping style (B = 0.049, P < 0.001) demonstrated a positive association with poor sleep quality, while positive coping style indicated a negative association with poor sleep quality (B = -0.029, P < 0.001). Interactions of negative life events and coping styles with sleep quality were not found (all P > 0.05). The association between negative life events and sleep quality was mediated by negative coping styles.
CONCLUSIONS
Our results indicated that poor sleep quality was common in these Chinese adolescents. Negative life events and negative coping style were associated with an increased prevalence of poor sleep quality, while the positive coping style was related to a decreased prevalence of poor sleep quality. A negative coping style mediated the association between negative life events and sleep quality.
Adaptation, Psychological
;
Adolescent
;
Child
;
China
;
Cross-Sectional Studies
;
Humans
;
Life Change Events
;
Psychology, Adolescent
;
Psychology, Child
;
Sleep
6.Establishment and associated factors of health records among young Chinese migrants.
Hong SHI ; Xiumin ZHANG ; Xiangrong LI ; Zheng REN ; Hanfang ZHAO ; Minfu HE ; Xinwen FAN ; Xia GUO ; Shuang ZHA ; Shuyin QIAO ; Yuyu LI ; Yajiao PU ; Hongjian LIU
Environmental Health and Preventive Medicine 2021;26(1):39-39
BACKGROUND:
Most Chinese migrants have been faced with obstacles to getting access to local public health services. Young migrants among internal migrants make a major contribution to the economy. However, the establishment of their health records has been ignored. This research was aimed at exploring the status and associated factors of the establishment of health records among young Chinese migrants.
METHODS:
Data were obtained from the 2017 China Migrants Dynamic Survey (CMDS). Chi-square test and binary logistic regression were performed to investigate the associated factors of the establishment of health records among young Chinese migrants.
RESULTS:
Approximately 30.2% of young migrants had their health records established in inflow communities. Urban residence, medical insurance (insured), and lower average monthly household income were attributed to the establishment of more health records. Young migrants who were in northeast China and across provinces and immigrated for working or engaging in trade were less likely to have health records established. Young migrants who participated in social activities and public affairs activities and took type of people in touch as natives in the inflow area showed a higher possibility of establishing health records. Meanwhile, receiving health education and hearing about national basic public health services (BPHSs) were beneficial for establishing the health records of more young migrants.
CONCLUSION
This study showed that the health records of young migrants had a relatively low establishment rate. Sociodemographic and migration characteristics, health status, public health services, and social integration factors were all related to the health record establishment of young Chinese migrants.
Adolescent
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Adult
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China
;
Female
;
Health Records, Personal
;
Humans
;
Male
;
Transients and Migrants/statistics & numerical data*
;
Young Adult
7.The Associations of Family Functioning, General Well-Being,and Exercise with Mental Health among End-Stage RenalDisease Patients
Qi WANG ; Hongjian LIU ; Zheng REN ; Wenjing XIONG ; Minfu HE ; Nan LI ; Xinwen FAN ; Xia GUO ; Xiangrong LI ; Hong SHI ; Shuang ZHA ; Xiumin ZHANG
Psychiatry Investigation 2020;17(4):356-365
Objective:
This study aims to explore the relationships of family functioning, general well-being, and exercise with psychological distress.Furthermore, we investigated the special roles of general well-being and exercise on the association between family functioningand psychological distress.
Methods:
Of 769 end-stage renal disease (ESRD) patients participated in the cross-sectional study which consisted of the 12-item GeneralHealth Questionnaire (GHQ-12), the Family APGAR Scales, and the General Well-Being Schedule. The collected data were analyzedusing multiple linear regression analysis and path analysis.
Results:
The prevalence of psychological distress was 72.3%. Family functioning, general well-being and exercise were associated factorsof psychological distress (p<0.05). The indirect effect of family functioning on psychological distress was partially mediated by generalwell-being (Effect=-0.08, 95% CI=-0.11, -0.04). In addition, the effect of family functioning on general well-being was moderated byexercise (Index=-0.092, SE=0.033, 95% CI=-0.159, -0.029).
Conclusion
The prevalence of psychological distress among ESRD patients was high. Family functioning, general well-being and exercisewere associated with psychological distress. Family functioning could affect psychological distress partially by affecting general wellbeing.Furthermore, exercise had a significant moderating effect on the relationship between family functioning and general well-being.Psychiatry Investig 2020;17(4):356-365
8.Advanced applications of membrane technology in biological detection.
Jinxuan ZHANG ; Jianquan LUO ; Zhongyuan REN ; Hao ZHANG ; Xiangrong CHEN ; Yinhua WAN
Chinese Journal of Biotechnology 2019;35(12):2257-2268
Membrane creates the functions of protection, supporting, dispersion and separation. More functions can be designed by modifying membrane surface and grafting/loading selective ligands or catalysts on the membrane, thus membrane technology has been widely applied in biological detection, and its application approaches becomes diverse. Rational design of functional membranes can meet the demands in different steps of biological detection process, including sample pretreatment, preparation, response and sensing. This review summarized the functionalization methods of filtration membranes, applications of membrane technology in sample preparation and detection process, as well as the research on the integration of functional membranes. By revisiting the research progress on functional membrane design, preparation and applications for biological detection, it is expected to take better advantage of membrane materials structure and performance for constructing efficient and stable detection platform, which is more "adapted" to the detection environment.
Membranes, Artificial
9. Midterm outcomes of surgical treatment of traumatic severe tricuspid insufficiency
Fuen ZHANG ; Jiyong LI ; Ping BO ; Jianqun ZHANG ; Tong REN ; Xiangrong CAO
Chinese Journal of Surgery 2019;57(2):134-138
Objective:
To investigate the indication and midterm outcomes of surgical treatment of traumatic tricuspid insufficiency.
Methods:
Totally 19 patients with traumatic tricuspid insufficiency who underwent surgical treatment at Department of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University from January 2002 to January 2018 were included in this retrospective study. There were 12 male and 7 female patients, aged (43.1±12.9) years (range: 17-68 years). The main causes of traumatic tricuspid insufficiency included blunt chest trauma following high-speed vehicle accidents (17 patients) and high-fall trauma (2 patients). The preoperative New York Heart Association functional class was class Ⅱ in 5 patients, class Ⅲ in 12 patients, and class Ⅳ in 2 patients. The mechanism of tricuspid insufficiency included anterior chordal rupture in 9 patients, anterior papillary muscle rupture in 3 patients, anterior and posterior chordal or papillary muscle rupture in 4 patients, laceration of leaflet combined with chordal rupture in 2 patients and infection combined with anterior papillary muscle rupture in 1 patient. Anular dilation and enlargement of the right ventricle were observed in all the patients. Paired
10. Preparation and characteristic analysis of six influenza A (H7N9) pseudovirus derived from different districts of China
Baoying HUANG ; Shanqin LI ; Xiangrong QI ; Jiao REN ; Jingdong SONG ; Wenjie TAN ; Houwen TIAN ; Li RUAN
Chinese Journal of Experimental and Clinical Virology 2017;31(4):281-286
Objective:
To prepare strains of influenza A (H7N9) pseudovirus derived from different districts of China for vaccine efficacy evaluation.
Methods:
Phylogenetic tree was built based on hemagglutinin (HA) amino acid sequence analyses from 29 influenza A (H7N9) virus strains and 6 influenza A (H7N9) virus strains with HA determinants variation were selected. 293FT cells were co-transfected with plasmid pNL4-3-Luc.R-E-, pVRC-HA and pVRC-NA with codon-optimized hemagglutinin (HA) and neuraminidase (NA) derived from the six influenza A (H7N9) virus strains, respectively. Transmission electron microscopy assay and Western blot analysis were performed to demonstrate morphology and specificity of these particles, luciferase activity assay and hemagglutinin titers detection were used to determine their infectivity and hemagglutinin activity. And finally, pseudovirus-based neutralization assays were evaluated with HA immunized mice serum.
Results:
Six influenza A (H7N9) peseudovirus particles derived from different districts of China were selected and prepared. All of the particles bearing HA and NA were characterized with classic influenza virus morphology, with TCID50 titer ranged from 104TCID50/50 μl to 105TCID50/50 μl and with hemagglutinin activity ranged from 64 to 512. Neutralization efficacies on influenza A/Shanghai/1/2013(H7N9) HA vaccine serum against 100TCID50 dose of these pseudovirus particles indicated their potential application in the vaccine cross-protective evaluation in future.
Conclusions
Six influenza A (H7N9) pseudovirus derived from different districts of China with potential antigenic variation on HA were constructed successfully, established foundation for their further application in vaccine cross-reactive efficacy evaluation.

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