1.Phenotypic distribution and population genetic frequency analysis of ABO and Rh blood group antigens among voluntary blood donors in Yantai
Hewei SONG ; Xiaojun ZHANG ; Qun XU ; Xiangzhong LIU ; Nan GUO ; Di SUN
Chinese Journal of Blood Transfusion 2026;39(1):69-75
Objective: To investigate the distribution characteristics of ABO and Rh blood group antigen phenotypes among blood donors in the Yantai, Shandong. Methods: Blood samples from 310 180 voluntary blood donors in Yantai collected from January 2019 to December 2023 were tested for ABO and Rh blood group antigens using standard serological methods. RhD-negative samples were further typed for C, c, E, and e antigens. Population genetic analysis of blood groups was performed: allele frequencies were inferred from ABO phenotypes, and Rh allele/haplotype frequencies were estimated based on the proportion of RhD-negative donors and CcEe antigen typing, followed by Hardy-Weinberg equilibrium testing. Results: The phenotypic distribution frequency of ABO blood groups was B(32.72%)>O(28.93%)>A(27.65%)>AB(10.70%). The inferred allele frequencies were r(53.74%)>q(24.78%)>p(21.48%), consistent with Hardy-Weinberg equilibrium (P>0.05). A total of 1 872 Rh-negative donors (0.603%) were identified. The most common Rh phenotypes were ccdee (59.56%) and Ccdee (30.18%). The distribution of Rh antigen phenotypes deviated significantly from Hardy-Weinberg equilibrium (χ
=37.15, P<0.001), with the cde haplotype showing the highest frequency. There was no statistically significant difference in ABO blood group distribution between RhD-positive and RhD-negative donors (P>0.05). Conclusion: The ABO blood group distribution among voluntary blood donors in Yantai is generally stable and consistent with population genetic equilibrium, whereas the Rh antigen phenotype distribution deviates from equilibrium, indicating potential underlying genetic structural differences.
2.Physical fitness status and its association with lifestyle behaviors among secondary vocational school students
LIU Zhihao, ZOU Xiaojun, XUE Jianhua, YANG Xiaofang, XU Huaping, KONG Junfeng, LU Jinkui, CHEN Yajun
Chinese Journal of School Health 2026;47(6):784-788
Objective:
To analyze the compliance status of physical fitness indicator and lifestyle characteristics among secondary vocational school students, as well as their associations, so as to provide a reference for physical fitness promotion among secondary vocational school students.
Methods:
Using a convenience sampling method, a questionnaire survey and physical fitness tests were conducted from September to December 2024 among 5 141 secondary vocational school students recruited from 16 secondary vocational schools across 8 provinces/municipalities in China, including Fujian, Chongqing, Guangdong, Guangxi, Hubei, Jiangxi, Shanghai and Zhejiang. Data on lifestyle factors were collected using a self designed questionnaire combined with standardized scales, including dietary habits, unhealthy behaviors, and 24 hour behaviors (physical activity, screen time, and sleep behavior). Multivariable Logistic regression model was used to analyze the associations of individual lifestyle behaviors and clustering of unhealthy lifestyle behaviors with non-compliance in physical fitness indicators among secondary vocational school students.
Results:
The compliance rates for waist circumference, vital capacity, grip strength, standing long jump, 30 second sit ups, 20 meter shuttle run, 50 meter dash, sit and reach, 20 second side steps among secondary vocational school students were 55.9%, 89.6%, 81.8%, 79.4%, 77.8%, 61.4%, 87.0%, 12.6%, and 63.5%, respectively, with a non-overweight/obesity rate of 78.9%. The reporting rates of daily breakfast consumption, milk consumption, and vegetable consumption were 58.9%, 18.3%, and 37.5%, respectively. The reporting rates of frequent takeout consumption, frequent sugar sweetened beverage consumption, smoking, alcohol drinking, insufficient moderate to vigorous physical activity (MVPA), excessive screen time, and insufficient sleep were 30.0%, 43.8%, 8.4%, 15.8%, 42.9%, 90.8%, and 42.6%, respectively. Multivariable Logistic regression analysis showed that secondary vocational school students with insufficient MVPA had higher risks of non-compliance in vital capacity, grip strength, standing long jump, 30 second sit ups, 20 meter shuttle run, 50 meter dash, and 20 second side steps ( OR =1.22- 1.60 ); secondary vocational school students who consumed breakfast daily had lower risks of non-compliance in vital capacity and overweight/obesity ( OR =0.81, 0.85); daily vegetable consumption was associated with a lower risk of vital capacity non-compliance ( OR =0.72); frequent takeout consumption was associated with an increased risk of non-compliance in the sit and reach test ( OR =1.28); smoking was associated with increased risks of non-compliance in the 20 meter shuttle run and 20 second side steps ( OR =1.38, 1.58) (all P <0.05). Regarding the clustering of unhealthy behaviors, secondary vocational school students with 4- 5 clustered unhealthy behaviors had higher risks of non-compliance in waist circumference and standing long jump; those with≥6 clustered behaviors had higher risks of non-compliance in standing long jump, 20 meter shuttle run, and 20 second side step ( OR = 1.17-1.36, all P <0.05).
Conclusions
The clustering of unhealthy behaviors is negatively associated with physical fitness status among secondary vocational school students. Secondary vocational schools should prioritize the promotion of comprehensive lifestyle management to improve the physical fitness levels of secondary vocational school students.
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.Impact of uric acid on female fertility and the pregnancy outcomes of assisted reproductive technology
Jun ZHANG ; Shuo HUANG ; Jing SHI ; Qiong LIU ; Donglin HAN ; Xiaojun YU ; Jie ZHAO
Chinese Journal of Reproduction and Contraception 2025;45(3):305-309
Uric acid is the end product of purine metabolism in the human body. In recent years, the role of uric acid in female fertility and assisted reproductive technology (ART) has gained increasing attention. Dysregulation of uric acid metabolism can lead to hyperuricemia (HUA). HUA is not only closely related to metabolic syndrome and cardiovascular diseases but may also adversely affect female fertility by influencing ovarian function and embryos development. In this review, we explored the role of uric acid in female fertility, including its association with female subfertility, infertility, adverse pregnancy outcomes and metabolic syndrome, as well as its potential impact on ART like in vitro fertilization-embryo transfer and intracytoplasmic sperm injection. Further studies are needed to clarify the threshold and clinical intervention value of uric acid levels in women of childbearing age, providing a basis for reproductive health counseling and personalized pregnancy assistance for HUA patients of childbearing age.
5.Meta-integration of the experience of postpartum lifestyle changes in women with hypertensive disorders of pregnancy
Xiaojun LIU ; Lina WANG ; Jiaqi TIAN ; Ling ZHANG ; Yuanyuan LI ; Lijuan YANG
Chinese Journal of Practical Nursing 2025;41(23):1817-1825
Objective:To systematically assess qualitative studies exploring the experiences of postpartum lifestyle changes among women with hypertensive disorders of pregnancy, comprehensively integrate these experiences, and provide a foundational reference for the subsequent development of targeted healthy lifestyle interventions.Methods:A comprehensive computerized search was conducted across PubMed, Embase, Web of Science, Cochrane Library, Pro quest, CINAHL, China National Knowledge Infrastructure, Wanfang Database, VIP, and China Biomedical Database, encompassing all qualitative studies that met the inclusion criteria from the inception of the databases to June 21st 2024. The quality of the retrieved literature was evaluated using the Centre for Evidence-Based Health Care Quality Assessment Criteria for Qualitative Research at the Joanna Briggs Institute, Australia. The results were integrated using the pooled integration method, and the quality of the integrated findings was rated using the ConQual method.Results:A total of 10 papers were included, and 23 findings were distilled and grouped into 9 new categories, resulting in 4 integrative findings: multiple dilemmas and challenges to postpartum lifestyle change, postpartum lifestyle change with the change of mother′s role, facilitators of postpartum lifestyle change, and impediments to postpartum lifestyle change.Conclusions:Postnatal lifestyle change in women with hypertensive disorders of pregnancy is crucial for improving prognosis. In the future, healthcare professionals should improve the social support system, promote postnatal role change to adapt to the new life, improve women′s awareness of risk and disease, maintain the continuity of postnatal follow-up, and incorporate a variety of behavioural change strategies to stimulate the motivation for lifestyle change, so as to promote the effective change of postnatal lifestyles.
6.Application of scoring FOCUS-PDCA cycle management in improving the accuracy of nutritional risk screening 2002 scoring among inpatients
Jiajia CHEN ; Wenshi WU ; Haiyan LI ; Ziran TANG ; Huili WEN ; Cuiping WU ; Xiaojun LIU
Chinese Journal of Clinical Nutrition 2025;33(1):48-53
Objective:To explore the effectiveness of find-organize-clarify-understand- select-plan-do-check-act (FOCUS-PDCA) cycle management in improving the accuracy of Nutritional Risk Screening 2002 (NRS 2002) scoring in inpatients.Methods:This study was a retrospective study. Data from a continuous quality improvement project, namely Improving the Accuracy of Nutritional Risk Screening for Inpatients from People's Hospital of Longhua in 2021 were selected. The NRS 2002 scores of newly admitted patients from 8 departments with relatively high nutritional risk (departments of gstroenterology, neurology, nephrology, respiratory medicine, oncology and hematology, neurosurgery, gastrointestinal surgery, and critical care medicine) from April 10, 2021 to April 29, 2021 (before intervention) were collected. The NRS 2002 scores were evaluated by a multidisciplinary nutrition support team in terms of accuracy and error types. Possible issues in the process of nutritional screening were analyzed and mitigated using the FOCUS-PDCA cycle management method. The NRS 2002 scores from July 18, 2021 to August 8, 2021 (after intervention) were collected in real time to summary the data on accuracy and error types and to evaluate the effect of FOCUS-PDCA.Results:The accuracy of NRS 2002 score in the 8 departments was increased from 52.97% (294/555) to 81.13% (473/583) after intervention, and the difference was statistically significant ( χ2=102.606, P<0.001). The accuracy of nutritional status impairment score was 64.14% before intervention, compared with 90.57% after intervention ( χ2=114.484, P<0.001). The accuracy of disease severity score was 78.56%, compared with 89.54% after intervention( χ2=25.736, P<0.001). The false-negative rate was 68.02% before intervention and 31.87% after intervention, and the difference was statistically significant ( χ2=31.501, P<0.001). Conclusion:FOCUS-PDCA can improve the accuracy of NRS 2002 scoring in inpatients, reduce the risk of failing to identify patients at nutritional risk, and contribute to further nutritional diagnosis and treatment.
7.Robot-assisted laparoscopic inferior vena cava segmental resection for renal tumor with tumor thrombus invading the vascular wall
Shuai LIU ; Zhuo LIU ; Yunhe GUAN ; Guoliang WANG ; Xiaojun TIAN ; Hongxian ZHANG ; Lei LIU ; Lulin MA ; Shudong ZHANG
Journal of Peking University(Health Sciences) 2025;57(4):796-802
Objective:To evaluate the safety and oncological outcomes of robot-assisted laparoscopic inferior vena cava(IVC)segmental resection in renal tumor with IVC tumor thrombus(IVCTT).Methods:Clinical data from renal tumor patients undergoing robot-assisted laparoscopic IVC segmental resection at Peking University Third Hospital from Jan.2021 to Feb.2025 were retrospectively analyzed.Data collection included baseline demographics,tumor characteristics,perioperative parameters,and follow-up outcomes.Surgical records and pathological reports were retrieved from the electronic medical record system.Continuous variables were presented as median(P25,P75),and categorical variables as frequency(percentage).Results:Forty-four patients were enrolled.The cohort comprised 31 malesand 13 females,with a median age of 62(55,68)years.Right-sided tumors were observed in 39 cases and left-sided in 5 cases.Median tumor diameter was 8.1(6.1,10.1)cm.Mayo classifications included grade Ⅱ(n=37),Ⅲ(n=6),and Ⅳ(n=1).Neoadjuvant therapy was administered to 23 patients.Seventeen patients were complicated by IVC bland thrombus.Median operative time was 224.0(167.3,303.8)min,with intraoperative blood loss of 500.0(300.0,850.0)mL.Transfusion was administered to 19 patients,with a median blood transfusion of 800.0(400.0,1 200.0)mL.Postoperative complica-tions occurred in 25 cases(56.8%),classified as Clavien-Dindo grade Ⅰ(n=8)and grade Ⅱ(n=17).Procedure-specific complications included deep vein thrombosis(n=6),transfusion-requiring ane-mia(n=5),lower extremity edema(n=2),and pulmonary embolism(n=2),with no procedure-related mortality.Median postoperative serum creatinine was 116.0(86.5,157.5)μmnol/L.Pathological examination identified clear cell renal cell carcinoma as the predominant subtype,observed in 34 cases(77.3%).Pathological staging revealed T3b(n=12),T3c(n=29),and T4(n=3)disease,with nodal involvement(N1)in 8 cases and distant metastasis(M1)in 17.At a median follow-up of 10 months(range:1-49 months),cancer-specific mortality occurred in 3 patients,while 1 succumbed to other causes.Disease progression included pulmonary metastasis(n=5),hepatic metastasis(n=4),and local recurrence(n=4).Adjuvant therapy regimens comprised targeted-immunotherapy combina-tions(n=9)and targeted monotherapy(n=18).Conclusion:Robot-assisted laparoscopic I VC seg-mental resection achieves precise thrombus removal with confirmed short-term efficacy in renal tumor with IVCTT,though vigilance against vascular complications remains critical.
8.Oriented electrostatically spun polycaprolactone/silk fibroin scaffold loaded with calcium titanate promotes peripheral nerve regeneration
Xiaojun LIU ; Yuqing SHANG ; Wenchao GUAN ; Linlin XU ; Guicai LI
Chinese Journal of Tissue Engineering Research 2025;29(28):6070-6082
BACKGROUND:Oriented polycaprolactone/silk fibroin blend electrospinning scaffolds can repair peripheral nerve damage and promote nerve regeneration,but the repair effect is limited,and it is necessary to further combine bioactive materials,growth factors,and other factors to prepare bionic neural scaffolds.Calcium titanate nanoparticles have the ability to promote adhesion between Schwann cells and have been widely used in the field of biomedical materials.OBJECTIVE:To prepare polycaprolactone/silk fibroin-calcium titanate functionalized scaffolds by electrospinning technology,and to further explore the effect of the scaffold on Schwann cell viability and adhesion.METHODS:Polycaprolactone/silk fibroin scaffolds were prepared by electrospinning technology.The optimal parameters were selected by adjusting the syringe flow rate,receiving device speed and spinning time during the preparation process for subsequent experiments.Under the optimal parameters,randomly oriented polycaprolactone/silk fibroin scaffolds(denoted as PCL/SF-R),oriented polycaprolactone/silk fibroin scaffolds(denoted as CTO-0),and oriented polycaprolactone/silk fibroin scaffolds containing 0.1,0.5,and 1.0 mg/mL polydopamine modified calcium titanate(denoted as CTO-1,CTO-5,and CTO-10,respectively)were prepared by electrospinning technology.The physical properties of the five groups of scaffolds were characterized.The extracts of the five groups of scaffolds were co-cultured with rat fibroblast cell line(L929).Cell proliferation was detected by MTT assay.Rat Schwann cell line(RSC96)was inoculated on the five groups of scaffolds.Cell viability,cytoskeleton staining,and cytoskeleton and cell adhesion related genes were detected.RESULTS AND CONCLUSION:(1)The optimal parameters for preparing electrospinning scaffolds were as follows:syringe flow rate 15 μL/min,receiving device speed 1 800 r/min,and spinning time 1 hour.(2)The PCL/SF-R group had the largest water contact angle and the smallest elastic modulus,while the CTO-0 group had the smallest water contact angle and the largest elastic modulus.The degradation rate of the scaffolds in the CTO-0 group was lower than that in the CTO-1 group,and the degradation rate of the scaffolds decreased with the increase of the mass concentration of calcium titanate in the oriented scaffolds.(3)The scaffolds in the five groups had no toxic effects on L929 cells and had good biocompatibility.CCK-8 assay results showed that CTO-10 could improve the viability of RSC96 cells.Cytoskeleton staining results showed that the aspect ratio and cell protrusion length of cells on the oriented scaffolds were higher than those on the randomly oriented scaffolds.qPCR test results showed that the mRNA expressions of YAP and Cntn2 in the CTO-5 and CTO-0 groups were higher than those in the PCL/SF-R group(P<0.05).(4)The results indicate that the oriented polycaprolactone/silk fibroin-calcium titanate scaffold has good biocompatibility,mechanical properties,and hydrophilicity,which can enhance the viability and migration ability of Schwann cells and promote peripheral nerve regeneration.
9.Preparation, preclinical evaluation and preliminary clinical application of 64Cu-DOTATATE
Huanhuan LIU ; Xiaojun ZHANG ; Guangyu MA ; Yue PAN ; Jingfeng ZHANG ; Hui WEN ; Xiaodan XU ; Ruimin WANG ; Jinming ZHANG
Chinese Journal of Nuclear Medicine and Molecular Imaging 2025;45(6):358-363
Objective:To prepare domestic 64Cu-1, 4, 7, 10-tetraazacyclododecane-1, 4, 7, 10-tetraacetic acid- D-Phe1-Tyr3-Thr8-octreotide (DOTATATE), and to verify its distribution and preliminary diagnostic value in neuroendocrine tumors (NETs). Methods:DOTATATE was labeled with the domestic 64Cu to obtain 64Cu-DOTATATE. The lipophilicity, in vitro stability, and pharmacokinetics were studied. Biodistribution experiments and microPET imaging were performed on NCI-H727 (somatostatin receptor (SSTR)2 positive expression) tumor-bearing nude mice. The preliminary clinical applications were conducted on 10 NETs patients (5 males, 5 females; age (58.5±13.0) years) from Chinese PLA General Hospital between May 2023 and April 2024. Data were analyzed by using independent-sample t test. Results:64Cu-DOTATATE was successfully prepared with the radiochemical purity greater than 98%, log P of -2.609±0.051 and good stability. Pharmacokinetic experiments in BALB/c mice suggested rapid blood clearance of the drug (elimination half-time of 22.78min). Biodistribution results in tumor-bearing mice showed that 64Cu-DOTATATE was mainly metabolized through the liver and kidneys, with significant tumor uptake at 1h ((2.519±0.273) percentage activity of injection dose per gram of tissue (%ID/g)) and sustained high uptake at 24h ((4.331±0.549)%ID/g). MicroPET imaging of tumor-bearing mice showed a slight increase in uptake and good retention at 24h, with a significant statistical difference compared to the blocked group ((2.197±0.250) vs (0.985±0.064) % ID/g; t=6.40, P=0.008). The tumor/liver ratios were 0.075±0.007, 0.083±0.011, 0.118±0.005, 0.263±0.031 at 1, 2, 6 and 24h, respectively. Preliminary clinical application indicated that 64Cu-DOTATATE exhibited good targeting in patients, and the liver radioactivity distribution was moderate (SUV max=10.62±3.46), providing good image quality. Conclusion:Domestic 64Cu-DOTATATE PET/CT imaging is a promising imaging evaluation method in NETs with the value for further clinical research.
10.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.


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