1.Key Issues and Research Ideas of Traditional Chinese Medicine Anti-aging Guided by Essence-Qi-spirit Theory of Qiluo Doctrine
Peipei JIN ; Liping CHANG ; Cong WEI ; Mengnan LI ; Hui QI ; Hongrong LI ; Yunlong HOU ; Zhenhua JIA
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(9):240-246
Aging has emerged as a cutting edge and hotspot in global life science field, with anti-aging and geriatric disease prevention and treatment becoming critical issues urgently demanding solutions in international medical communities. In the face of the challenge of accelerating global population aging, in-depth exploration of aging mechanisms and the development of effective intervention strategies hold significant scientific and clinical value. This study supported by the national key research and development program of China, employed the essence-Qi-spirit theory of Qiluo doctrine as its guiding framework, focusing on the key scientific issue of the core traditional Chinese pathogenesis of aging, namely "depletion of kidney essence, deficiency of primordial Qi, and impairment of body and spirit". The treatment principle of "tonifying the kidney to replenish essence, harmonizing Yin and Yang, warming and invigorating primordial Qi, and nourishing the body and spirit" was established. Centered on holistic aging, systemic aging, and aging-related diseases, the research integrated multidisciplinary research approaches to construct multi-modal aging models and a multi-dimensional evaluation system, and it utilized multi-omics technologies to deeply analyze aging mechanisms. By systematically reviewing historical kidney-tonifying and anti-aging formulas and combining big data with artificial intelligence technologies, an information database of anti-aging traditional Chinese medicine substance was developed to reveal the differences and synergistic effects of various treatment methods and formulas on anti-aging. Based on this treatment method, the research integrated two millennia of kidney-tonifying medicinal experience to develop the innovative anti-aging traditional Chinese medicine, namely Bazhi Bushen capsules. It was validated that this capsule can delay holistic and systemic aging through multiple targets and mechanisms, thereby elucidating the scientific connotation of the essence-Qi-spirit theory of Qiluo doctrine in guiding anti-aging research from multiple dimensions and providing robust support for leveraging the advantages of traditional Chinese medicine to occupy the commanding heights of international anti-aging research.
2.Spousal correlations of blood lipid based on a family design
Yixin LI ; Huangda GUO ; Hexiang PENG ; Tianjiao HOU ; Hanyu ZHANG ; Yinxi TAN ; Yi ZHENG ; Mengying WANG ; Yiqun WU ; Xueying QIN ; Jin LI ; Ying YE ; Tao WU ; Dafang CHEN ; Yonghua HU ; Liming LI
Journal of Peking University(Health Sciences) 2025;57(3):423-429
Objective:To explore the spousal correlations of total cholesterol(TC),total triglyceride(TG),low-density lipoprotein cholesterol(LDL-C),and high-density lipoprotein cholesterol(HDL-C),and to investigate the reasons behind these spousal correlations.Methods:Participants and data were from the baseline survey of family-based cohort studies in Fangshan,Beijing and Tulou,Fujian.The ori-gin of spousal correlations were explored from perspectives of convergence,assortative mating,social ho-mogamy.Pearson's correlation and generalized linear models(GLM)were used to estimate the spousal correlation.Convergence was assessed by Pearson's correlation between the phenotypic differences be-tween couples and the duration of marriage,with GLM used for further validation.Pearson's correlation of genetic risk scores(GRS)and couple-specific Mendelian randomization(MR)were calculated to assess the genetic correlation and possible causal relationships between spouses.Two-independent-sample t-tests were used to compare GRS consistency across subgroups divided by education attainment,couple-specific MR and Q statistics used to test assortative mating in subgroups and intergroup differences.Results:In the study,342 couples(287 couples from Fangshan and 55 couples from Fujian)were included,with the average age of(64.91±8.76)years.Spousal correlations of TC,TG,HDL-C,and LDL-C showed statistically significant associations both before and after adjusting for covariates,with effect sizes of 0.229(95%CI:0.125-0.327),0.257(95%CI:0.155-0.354),0.179(95%CI:0.074-0.280),and 0.181(95%CI:0.076-0.282).For convergence,for each additional year of marriage,ΔTC increased by 0.016 mmol/L(95%CI:0.001-0.033 mmol/L),and ΔLDL-C increased by 0.017 mmol/L(95%CI:0.002-0.031 mmol/L).For assortative mating,GRS correlations and results of couple specific MR didn't show any statistical significance.For social homogamy,no differences in GRS or assortative mating were found between subgroups stratified by education attainment.Conclusion:The blood lipid in participants exhibit spousal phenotypic correlations,however,no effects of convergence,assortative mating or social homogamy were observed.More independent studies with larger sample sizes are warranted to further validate these findings in the future.
3.Distribution characteristics of 14 chemical elements in the external environment of different water iodine areas in Xi'an
Xuehua SHI ; Ping LI ; Tiejun HOU ; Shanshan HE ; Lu DONG ; Ling JIN ; Peijie YAO
Chinese Journal of Endemiology 2025;44(9):726-731
Objective:To investigate the distribution of iodine and other chemical elements in soil, grain and vegetables in different water iodine areas of Xi'an City, and to provide theoretical basis for prevention and treatment of iodine related diseases and water improvement measures.Methods:From September to November 2021, a stratified cluster sampling method was used to select three survey villages in Xi'an, namely Yehu Village, Xingbei Village, and Quanzhong Village, where the iodine level of residents' drinking water < 10, 10 - 100, and > 100 μg/L. Drinking water samples were collected from seven survey sites based on the source of domestic drinking water to determine the iodine level of the water. At the same time, soil samples of cultivated land, residents' grains (wheat, corn), and vegetables were collected from survey villages to determine the content of 14 elements including calcium, iron, magnesium, chromium, nickel, copper, zinc, cadmium, lead, arsenic, mercury, selenium, iodine, and fluoride.Results:The iodine level in the water of 7 survey sites in three survey villages was 5.80, 6.40, 25.51, 42.20, 53.90, 111.65, and 177.63 μg/L, respectively. A total of 70 samples of soil, 65 samples of wheat, 76 samples of corn, and 141 samples of vegetables were collected. Among them, the levels of various elements in vegetables and grains were lower than those in the soil. Only calcium and fluoride were higher in vegetables than in grains, while iron, chromium, copper, zinc, selenium, and iodine were lower in vegetables than in grains. According to the range of water iodine level, there were statistically significant differences in the content of calcium, iron, chromium, nickel, copper, zinc, mercury, iodine, and fluoride in soils from different water iodine regions ( Fcalcium, iron, chromium, nickel = 42.04, 13.55, 12.22, 11.20, Hcopper, zinc, mercury, iodine, fluoride = 14.27, 9.19, 14.72, 25.14, 16.50, P < 0.05). The comparison of magnesium, zinc, cadmium, arsenic, and selenium content in wheat showed statistically significant differences ( Fadmium, selenium = 6.34, 3.31, Hmagnesium, zinc, arsenic = 6.12, 11.55, 6.23, P < 0.05). The comparison of calcium, iron, magnesium, chromium, nickel, copper, zinc, cadmium, lead, arsenic, mercury, iodine, and fluoride content in corn showed statistically significant differences ( Fmagnesium, chromium, nickel, copper, zinc, iodine = 18.89, 13.76, 17.86, 24.17, 28.46, 15.96, Hcalcium, iron, cadmium, lead, arsenic, mercury, fluoride = 11.57, 40.53, 26.50, 33.05, 33.73, 36.01, 29.21, P < 0.05). The comparison of calcium, iron, magnesium, chromium, zinc, cadmium, lead, arsenic, mercury, and selenium content in vegetables showed statistically significant differences ( H = 23.93, 8.12, 10.03, 7.01, 16.09, 18.36, 23.07, 6.51, 27.67, 7.86, P < 0.05). Conclusions:There are significant differences in the distribution of 14 elements in soil, grain, and vegetables in different water iodine regions. In addition to drinking water, precise guidance should also be provided based on the iodine content in soil, grain, and vegetables in different water iodine areas.
4.Nomogram model of recurrence after RFCA for patients with atrial fibrillation complicated with heart failure
Yanru LI ; Weidong JIN ; Hao GUO ; Minglei HAN ; Zhen LIU ; Yonglan HOU
The Journal of Practical Medicine 2025;41(17):2637-2645
Objective To develop and validate a nomogram model for predicting recurrence after radiofre-quency catheter ablation(RFCA)in patients with atrial fibrillation and heart failure using body surface electrocar-diogram indicators and clinical indicators.Methods We retrospectively analyzed 305 patients with atrial fibrilla-tion complicated with heart failure who underwent RFCA from January 2019 to January 2024.Patients were random-ized into training set(213 cases)and validation set(92 cases)at a ratio of 7:3 and followed up for at least 1 year.Based on the recurrence status,the patients were divided into recurrence group and non-recurrence group,with body surface electrocardiogram indicators and clinical indicators collected.Multivariate logistic regression analysis identified for risk factors for post RFCA recurrence,which were used to construct a nomogram.Model performance was assessed using the area under the receiver operating characteristic curve(AUC),Hosmer-Lemeshow test,calibration curves,and decision curve analysis(DCA).Results Among the 305 patients,84(27.54%)experi-enced recurrence after treatment.In the training set,61 patients had recurrence and 152 did not.No statistical differences were observed between the training set and the validation set(all P>0.05).In the training set,the recurrence group exhibited a higher proportion of persistent atrial fibrillation and significantly higher CHA2DS2-VASc scores,larger left atrial diameter,longer PR interval,and higher levels of NLR and NT-proBNP compared to the non-recurrence group(all P<0.05).Multivariate stepwise regression analysis revealed that high CHA2DS2-VASc score,long left atrial diameter,prolonged PR interval,and high NLR were independent risk factors of recurrence after RFCA(P<0.05)A four-factor prediction model was established as:Ln(P/1-P)=-12.87+0.84*CHA2DS2-VASc score+0.11* left atrial diameter+0.03*PR interval+0.31*NLR.The training and validation models showed AUCs of 0.85(95%CI:0.80~0.91)and 0.85(95%CI:0.76~0.94),respectively,suggesting that the model had good predictive efficiency.Hosmer-Lemeshow test results(χ2=2.43,P=0.965 for the training set;χ2=5.30,P=0.725 for the validation set)confirmed model fit,indicating that the fitted probability value was consistent with the actual probability value.Calibration curves after 1 000 times of Bootstrap repeated sampling showed the bias calibration curves of the training set and the validation set had good consistency with the actual curves,both close to the ideal curve.DCA revealed clinical utility across a wide threshold probability range(0.02~1.0 for the training set;0.04~1.0 for the validation set).Conclusion This nomogram,based on body surface electrocardiogram indicators and clinical indicators,effectively predicts post-RFCA recurrence in atrial fibrillation and heart failure patients,offering a useful tool for early assessment of recurrence risk.
5.Nomogram model of recurrence after RFCA for patients with atrial fibrillation complicated with heart failure
Yanru LI ; Weidong JIN ; Hao GUO ; Minglei HAN ; Zhen LIU ; Yonglan HOU
The Journal of Practical Medicine 2025;41(17):2637-2645
Objective To develop and validate a nomogram model for predicting recurrence after radiofre-quency catheter ablation(RFCA)in patients with atrial fibrillation and heart failure using body surface electrocar-diogram indicators and clinical indicators.Methods We retrospectively analyzed 305 patients with atrial fibrilla-tion complicated with heart failure who underwent RFCA from January 2019 to January 2024.Patients were random-ized into training set(213 cases)and validation set(92 cases)at a ratio of 7:3 and followed up for at least 1 year.Based on the recurrence status,the patients were divided into recurrence group and non-recurrence group,with body surface electrocardiogram indicators and clinical indicators collected.Multivariate logistic regression analysis identified for risk factors for post RFCA recurrence,which were used to construct a nomogram.Model performance was assessed using the area under the receiver operating characteristic curve(AUC),Hosmer-Lemeshow test,calibration curves,and decision curve analysis(DCA).Results Among the 305 patients,84(27.54%)experi-enced recurrence after treatment.In the training set,61 patients had recurrence and 152 did not.No statistical differences were observed between the training set and the validation set(all P>0.05).In the training set,the recurrence group exhibited a higher proportion of persistent atrial fibrillation and significantly higher CHA2DS2-VASc scores,larger left atrial diameter,longer PR interval,and higher levels of NLR and NT-proBNP compared to the non-recurrence group(all P<0.05).Multivariate stepwise regression analysis revealed that high CHA2DS2-VASc score,long left atrial diameter,prolonged PR interval,and high NLR were independent risk factors of recurrence after RFCA(P<0.05)A four-factor prediction model was established as:Ln(P/1-P)=-12.87+0.84*CHA2DS2-VASc score+0.11* left atrial diameter+0.03*PR interval+0.31*NLR.The training and validation models showed AUCs of 0.85(95%CI:0.80~0.91)and 0.85(95%CI:0.76~0.94),respectively,suggesting that the model had good predictive efficiency.Hosmer-Lemeshow test results(χ2=2.43,P=0.965 for the training set;χ2=5.30,P=0.725 for the validation set)confirmed model fit,indicating that the fitted probability value was consistent with the actual probability value.Calibration curves after 1 000 times of Bootstrap repeated sampling showed the bias calibration curves of the training set and the validation set had good consistency with the actual curves,both close to the ideal curve.DCA revealed clinical utility across a wide threshold probability range(0.02~1.0 for the training set;0.04~1.0 for the validation set).Conclusion This nomogram,based on body surface electrocardiogram indicators and clinical indicators,effectively predicts post-RFCA recurrence in atrial fibrillation and heart failure patients,offering a useful tool for early assessment of recurrence risk.
6.Assessment of the clinical value of AI in pulmonary embolism diagnosis and pulmonary artery obstruction index(PAOI)calculation on CTPA
Shutong YANG ; Zhujun LI ; Chao JIN ; Wei HOU ; Wenzhe ZHAO ; Baoping ZHANG ; Qian TIAN ; Yao XIAO ; Zhijie JIAN ; Zhe LIU
Journal of Xi'an Jiaotong University(Medical Sciences) 2025;46(1):157-161
Objective To validate the diagnostic performance and risk stratification ability of an AI-based recognition system(PE-AI)for pulmonary embolism(PE)using computed tomography pulmonary angiography(CTPA)so as to analyze its diagnostic value in clinical practice.Methods A total of 416 patients with suspected PE who underwent CTPA from January 1,2023 to December 10,2023 at our hospital were included in this study.Two junior radiologists and PE-AI separately detected and diagnosed emboli in the collected cases by double-blind method,and recorded the diagnosis time respectively.Three senior radiologists reviewing with clinical follow-up results were used as the gold standard in this study.Diagnostic performance was evaluated by using the receiver operating characteristic(ROC)curve analysis and Delong-t test.For positive cases,the pulmonary artery obstruction index(PAOI)calculated by AI and manually were collected respectively and consistency analysis was performed.Results The area under the curve(AUC)of PE-AI,manual and combined diagnosis was 85.6%,90.8%and 95.1%,respectively,which differed significantly(P<0.05).The reading time of PE-AI[(0.16±0.07)min]was significantly lower than the time of manual[(4.42±1.85)min,P<0.001]and combined diagnosis[(4.58±1.84)min,P<0.001].The PAOI measured by PE-AI and manually had high consistency(intraclass correlation efficient,ICC=0.80)in the subgroup analysis of confirmed cases.Conclusion AI can quickly identify pulmonary artery emboli in a short time and assist radiologists to improve diagnostic efficiency.At the same time,through the intelligent detection of PAOI,it is helpful for the risk stratification of patients with PE and optimizing the diagnosis and treatment pathway for pulmonary embolism.
7.Study on the distribution of FMR1 CGG repeat numbers among 16 610 women of childbearing age in China
Yahui SHEN ; Wei HOU ; Xiaolin FU ; Manli ZHANG ; Xiaoxiao XIE ; Chunyan ZHANG ; Jiaxin BIAN ; Xiao MAO ; Juan WEN ; Chunyu LUO ; Hua JIN ; Qian ZHU ; Qingwei QI ; Yeqing QIAN ; Jing YUAN ; Yanyan ZHAO ; Ailan YIN ; Shutie LI ; Yulin JIANG ; Rui XIAO ; Yanping LU
Chinese Journal of Reproduction and Contraception 2025;45(4):398-402
Objective:To investigate the distribution of CGG repeat numbers in the FMR1 gene among reproductive-age women in China, providing data reference for carrier screening and genetic counseling of Fragile X syndrome. Methods:This cross-sectional study recruited 16 610 reproductive-age women from 12 medical institutions between July 2022 and October 2023. Peripheral venous blood samples (3 mL) were collected, and genomic DNA was extracted. The number of CGG repeats in the FMR1 gene was determined using the triplet-primed polymerase chain reaction (TP-PCR) combined with capillary electrophoresis technology. Statistical analyses were performed to assess the prevalence and distribution of CGG repeat expansions. Results:Among 16 610 women of childbearing age, 5 684 (34.220%) women had the same number of CGG repeats in the two alleles of FMR1 gene, and 10 926 (65.780%) women had different numbers of repeats in the two alleles. Among the 33 220 FMR1 alleles in 16 610 women of reproductive age, the most common CGG repeat numbers were 29 [48.645% (16 160/33 220)] and 30 [26.276% (8 729/33 220)], while the most frequent CGG genotype was CGG 29/29 [24.726% (4 107/16 610)]. The CGG repeat numbers of FMR1 gene were normal in 16 498 women (99.326%). Among the 112 women (0.674%) with CGG repeat abnormities, 96 (0.578%) women were classified as intermediate carriers, 15 (0.090%) as premutation carriers, and 1 (0.006%) as a full mutation carrier, whose CGG genotype was (36, >200). Conclusion:In the general reproductive-age female population in China, the normal CGG repeat numbers of the FMR1 gene account for 99.326%, while the intermediate carrier rate is 0.578%, and the combined carrier rate of the premutation and full mutation types is 0.096%.
8.Assessment of Genotoxicity of Tissue Engineered Materials Based on Improved in vivo Hepatocyte Unscheduled DNA Synthesis(UDS)Assay
Luan-luan WANG ; Li HOU ; Xiang-yu CHU ; Zi-yi YANG ; Ling-xiao SUN ; Xiao-fei WANG ; Qiu-jin QU ; Jing XU ; Zeng-xiang LIU ; Xiao-xia SUN
Progress in Modern Biomedicine 2025;25(17):2740-2748
Objective:An in vivo mammalian hepatocyte Unscheduled DNA Synthesis(UDS)test was used to evaluate the genotoxicity of Cross-linked Sodium Hyaluronate Gel and Bone Repair Materials,providing experimental evidence for establishing a UDS testing method for medical devices and materials.Methods:0.9%sodium chloride injection and cottonseed oil were used as the solvent for test materials and negative control,respectively.N-dimethylnitrosamine(NDMA)was used as the positive control for the early sampling times,and 2-acetylaminofluorene(2-AAF)was used as the positive control for the late sampling times.SD rats were administered a single dose for toxic exposure,and liver tissues were collected at 4 h and 16 h,respectively.Hepatocytes were isolated using collagenase perfusion.After labeling with 5-ethynyl-2'-deoxyuridine(EdU),and the net average fluorescence intensity(NAFI)of cell nuclei and nucleoplasm was measured by fluorescence microscope.Data from 50 cells were used to analyze the DNA repair level.Results:Compared with the negative control groups,the positive control groups(NDMA and 2-AAF)showed highly statistically significant differences in NAFI(P<0.01),indicating successful induction of DNA damage.There was no statistically significant differences between the cross-linked sodium hyaluronate gel groups,bone repair material groups and the negative control group(P>0.05),suggesting that these materials did not significantly induce DNA damage under the experimental conditions.Conclusion:This study first applied EdU labeling technology to the in vivo hepatic UDS assay,achieving non-radioactive labeling through click chemistry reactions.Under the conditions of this study,cross-linked sodium hyaluronate gel and bone repair materials did not exhibit genotoxicity.In the follow-up,the sample range can be expanded and the observation period can be prolonged to further improve the genotoxicity evaluation system of medical devices.
9.Meta-Analysis of Animal Experiments on Astragali Radix or Its Ingredients for Acute Pancreatitis
Xingxin CAO ; Aiyi LI ; Jinghan HOU ; Mingxue LI ; Yanyan LI ; Weihua JIN ; Fengmei YANG ; Suqin DUAN ; Zhanlong HE
Laboratory Animal and Comparative Medicine 2025;45(5):561-573
Objective Based on the Preferred Reporting Items for Systematic reviews and Meta-Analyses(PRISMA)guidelines,to obtain precise and reliable comprehensive effect conclusions by quantitatively combining pharmacodynamic results from animal experiments investigating Astragali Radix(single-entity Astragali Radix preparation)or its ingredients for treatment of acute pancreatitis(AP)in literature reports through meta-analysis.Methods Databases including China National Knowledge Infrastructure(CNKI),VIP Database for Chinese Technical Periodicals(VIP),Wanfang Data Knowledge Service Platform,China Biomedical Literature Database(CBMdisc),PubMed,and Web of Science(WOS)were searched from inception to March 2025 for animal studies related to Astragali Radix(single-entity Astragali Radix preparation)or its ingredients for AP treatment.Risk of bias for included studies was assessed with SYRCLE tool.Heterogeneity among studies was evaluated according to Cochrane Handbook using Cochrane's Qtest and/2statistic.Sensitivity analysis was performed using the leave-one-out method,and publication bias risk was detected using Egger's test.Results A total of 297 articles were retrieved,and after screening and evaluation,19 animal studies were finally included for meta-analysis.These 19 publications cover SD rats,as well as three breeds of mice:C57BL/6 mice,BALB/c mice,and Kunming mice.SYRCLE scores ranged from 3 to 4.The results of the sensitivity analysis showed that no study significantly affected the heterogeneity index.The results of Egger's test showed a significant publication bias with P<0.05.Cochrane's Qtest and I2statistic indicated substantial heterogeneity among studies.Meta-analysis results of 19 animal studies showed that single-entity Astragali Radix preparation(Astragali Radix injection)could reduce serum amylase(AMY)levels,an AP-specific indicator.The Astragali Radix ingredients could decrease both AMY and lipase(LPS)levels.Astragali Radix injection or its ingredients could reduce serum levels of tumor necrosis factor-α(TNF-α),interleukin(IL)-6,and IL-1 β,while increasing IL-10 levels;could increase serum levels of superoxide dismutase(SOD)and glutathione peroxidase(GSH-Px),and decrease malondialdehyde(MDA)levels.High-dose groups of Astragali Radix injection or Astragali Radix ingredients were more effective than low-dose groups in reducing AMY,TNF-α,and IL-6 levels and increasing SOD levels,but dosage effect on MDA levels was not demonstrated.Conclusion Evidence-based analysis of animal experiment results shows that in various animal models including SD rats,C57BL/6 mice,BALB/c mice,and Kunming mice,Astragali Radix injection or its ingredients can effectively reduce expression or secretion levels of AP-specific indicators(AMY and LPS).The mechanisms may be related to some inflammatory mediators,including reducing TNF-α,IL-6,and IL-1 β levels and increasing IL-10 levels;They may also intervene in oxidative/antioxidative equilibrium,such as increasing SOD and GSH-Px levels and reducing MDA levels.Except for MDA,dose-response relationships are shown for reducing AMY,TNF-α,and IL-6 levels and increasing SOD levels with Astragali Radix injection or its ingredients.However,due to high heterogeneity,potential publication bias risk,and species differences between animal models and human diseases in existing studies,further high-quality clinical trials or animal experiments are still needed in the future.
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.

Result Analysis
Print
Save
E-mail