1.Current Status and Prospective of Research on Disease-Syndrome Integrated Animal Models of Spleen and Stomach Diseases in Traditional Chinese Medicine
Jiaqi ZHANG ; Lihui FANG ; Yongtian WEN ; Shan LIU ; Zhuo SHI ; Xintong WANG ; Xinyi DAI ; Meiling SHE ; Lanshuo HU ; Yangxi FU ; Zheng WANG ; Fengyun WANG ; Xudong TANG
Journal of Traditional Chinese Medicine 2026;67(5):510-516
Animal model research on spleen and stomach diseases in traditional Chinese medicine (TCM) is of great significance for elucidating the nature of diseases and syndromes and for revealing the mechanisms of action of Chinese herbal medicinals. At present, studies on classical TCM syndrome models of spleen and stomach diseases mainly focus on spleen deficiency syndrome, liver constraint syndrome, and damp-heat syndrome. Model construction is mostly based on the etiological and pathophysiological characteristics of syndrome, and model evaluation primarily involves macroscopic manifestations and physicochemical indicators. This paper summarizes the current research status of animal models integrating disease and syndrome for seven common spleen and stomach diseases, including chronic gastritis and gastric precancerous lesions, gastroesophageal reflux disease, functional dyspepsia, inflammatory bowel disease, irritable bowel syndrome, functional constipation, and functional diarrhea. The modeling methods and characteristics of disease-syndrome combined animal models for each disease are analyzed. It is proposed that future research on disease-syndrome integration in spleen and stomach diseases should move toward syste-matic, precise, and integrative development, and that interdisciplinary and cross-disciplinary research approaches should be adopted to enhance the predictive value and application efficiency of disease-syndrome combined animal models.
2.Timing selection for the treatment of vitreous hemorrhage after panretinal photocoagulation in proliferative diabetic retinopathy
Hongru MA ; Xinyi HOU ; Chenglin FU ; Chunhua DAI ; Jing ZHANG ; Meng XIN ; Shu LIU
International Eye Science 2026;26(9):1578-1584
Panretinal photocoagulation(PRP)is the first-line treatment for severe non-proliferative diabetic retinopathy and proliferative diabetic retinopathy(PDR).Its therapeutic efficacy varies due to multiple patient-specific systemic and ocular factors. Despite standardized PRP, some patients fail to show adequate regression of neovascularization and subsequently develop vitreous hemorrhage(VH). In such cases, pars plana vitrectomy(PPV)effectively clears the hemorrhage, restores transparency of the ocular media, supplement PRP, and delays the progression of PDR, thus becoming a critical intervention. With recent advances in surgical techniques, concepts, and equipment, early PPV intervention for VH following PRP has emerged as a growing research focus. Nevertheless, consensus remains lacking regarding its indications, optimal timing, and surgical protocols. This article systematically reviews relevant domestic and international studies, summarizing the surgical timing, approaches, and prognoses of PPV for VH in PDR patients after PRP, aiming to provide evidence-based reference for clinical decision-making and reduce the risk of PDR-related blindness.
3.Study on the mechanism of electroacupuncture in alleviating the inflammato-ry injury of sensory nerves in type 2 diabetes rats with dry eye
Mimi WAN ; Luping HE ; Zhangyitian FU ; Xinyi SUN ; Weiping GAO
Recent Advances in Ophthalmology 2025;45(7):510-517
Objective This study reveals the potential mechanism of electroacupuncture in alleviating the inflamma-tory injury of sensory nerves and alleviating the abnormal sensation on the ocular surface in type 2 diabetes rats with dry eye.Methods Healthy male SD rats were induced to establish type 2 diabetes dry eye rat model.Model rats were ran-domly divided into model group,electroacupuncture group,sham-acupuncture group,and fluorometholone group in the 12th week of the experiment.The blank group was established as well,and each group was intervened for 2 weeks.The corneal fluorescein sodium staining(FL),break-up time(BUT),phenol red thread test(PRT),corneal mechanical per-ception threshold(CTT)and blink frequency were measured in each group of rats.After sampling,the expression of neu-ronal injury markers,neuron specific enolase(NSE),neurofilament light chain protein Nf Light(NF-L),phosphorylated microtubule associated protein(Phospho-TAU),as well as inflammatory factors of cysteine protease-1(Caspase-1),inter-leukin-18(IL-18),and interleukin-1β(IL-1β),were observed in the trigeminal ganglion(TG)and spinal cord caudate nu-cleus(SpVc)of each group of rats.Results At the end of the 14th week,compared with the blank group,the FL of the model group,electroacupuncture group,sham-acupuncture group,and fluorometholone group significantly increased,while PRT and BUT significantly decreased.Moreover,the CTT and blink frequency of the model group,sham-acupuncture group,and fluorometholone group significantly decreased(all P<0.01).Compared with the model group,the electroacu-puncture group and the fluorometholone group showed a decrease in FL,as well as an increase in BUT,PRT,CTT,and blink frequency,with statistically significant differences(all P<0.05).Compared with the electroacupuncture group,the sham-acupuncture group showed significantly higher FL along with significantly lower values in BUT,PRT,CTT,and blink frequency(all P<0.05),while the fluorometholone group exhibited decreased FL,PRT,CTT,and blink frequency but in-creased BUT(all P<0.05).Compared to the sham-acupuncture group,the fluorometholone group exhibited significantly lower FL,but higher BUT and PRT(all P<0.01).In TG and Sp Vc,compared with the blank group,the expression of NSE,NF-L and Phospho-TAU increased in the model group and the sham-acupuncture group(all P<0.05);compared with the model group,the expression of NSE,NF-L and Phospho-TAU significantly reduced in the electroacupuncture group(P<0.01);compared with the electroacupuncture group,the expression of NSE,NF-L and Phospho-TAU increased in the electroacupuncture group and the expression of Phospho-TAU in the sham-acupuncture group also increased(P<0.05);compared with the sham-acupuncture group,the expression of Phospho-TAU or NF-L significantly reduced in the fluoro-metholone group(all P<0.05).The Western Blot results indicate that compared with the blank group,the protein expres-sion of Caspase-1,IL-1β,and IL-18 in TG and SpVc of the model group increased;moreover,the expression of Caspase-1 and IL-18 proteins in the sham-acupuncture group also increased(all P<0.05).Compared with the model group,the ex-pression of Caspase-1,IL-1β,and IL-18 proteins in TG and SpVc reduced in the electroacupuncture group and the fluoro-metholone group,and the expression of IL-1 β proteins in TG and SpVc also reduced in the sham-acupuncture group(all P<0.05).Compared with the electroacupuncture group,the expression of Caspase-1,IL-1 β,and IL-18 proteins in TG and SpVc increased in the sham-acupuncture group(all P<0.05).Compared with the sham-acupuncture group,the expression of Caspase-1,IL-1 β,and IL-18 proteins in TG and SpVc reduced in the fluorometholone group(all P<0.05).Conclusion Electroacupuncture can effectively alleviate the abnormal ocular surface sensation of type 2 diabetes dry eye rats by alleviating the neuroinflammatory injury in TG and SpVc.
4.Study on the mechanism of electroacupuncture in alleviating the inflammato-ry injury of sensory nerves in type 2 diabetes rats with dry eye
Mimi WAN ; Luping HE ; Zhangyitian FU ; Xinyi SUN ; Weiping GAO
Recent Advances in Ophthalmology 2025;45(7):510-517
Objective This study reveals the potential mechanism of electroacupuncture in alleviating the inflamma-tory injury of sensory nerves and alleviating the abnormal sensation on the ocular surface in type 2 diabetes rats with dry eye.Methods Healthy male SD rats were induced to establish type 2 diabetes dry eye rat model.Model rats were ran-domly divided into model group,electroacupuncture group,sham-acupuncture group,and fluorometholone group in the 12th week of the experiment.The blank group was established as well,and each group was intervened for 2 weeks.The corneal fluorescein sodium staining(FL),break-up time(BUT),phenol red thread test(PRT),corneal mechanical per-ception threshold(CTT)and blink frequency were measured in each group of rats.After sampling,the expression of neu-ronal injury markers,neuron specific enolase(NSE),neurofilament light chain protein Nf Light(NF-L),phosphorylated microtubule associated protein(Phospho-TAU),as well as inflammatory factors of cysteine protease-1(Caspase-1),inter-leukin-18(IL-18),and interleukin-1β(IL-1β),were observed in the trigeminal ganglion(TG)and spinal cord caudate nu-cleus(SpVc)of each group of rats.Results At the end of the 14th week,compared with the blank group,the FL of the model group,electroacupuncture group,sham-acupuncture group,and fluorometholone group significantly increased,while PRT and BUT significantly decreased.Moreover,the CTT and blink frequency of the model group,sham-acupuncture group,and fluorometholone group significantly decreased(all P<0.01).Compared with the model group,the electroacu-puncture group and the fluorometholone group showed a decrease in FL,as well as an increase in BUT,PRT,CTT,and blink frequency,with statistically significant differences(all P<0.05).Compared with the electroacupuncture group,the sham-acupuncture group showed significantly higher FL along with significantly lower values in BUT,PRT,CTT,and blink frequency(all P<0.05),while the fluorometholone group exhibited decreased FL,PRT,CTT,and blink frequency but in-creased BUT(all P<0.05).Compared to the sham-acupuncture group,the fluorometholone group exhibited significantly lower FL,but higher BUT and PRT(all P<0.01).In TG and Sp Vc,compared with the blank group,the expression of NSE,NF-L and Phospho-TAU increased in the model group and the sham-acupuncture group(all P<0.05);compared with the model group,the expression of NSE,NF-L and Phospho-TAU significantly reduced in the electroacupuncture group(P<0.01);compared with the electroacupuncture group,the expression of NSE,NF-L and Phospho-TAU increased in the electroacupuncture group and the expression of Phospho-TAU in the sham-acupuncture group also increased(P<0.05);compared with the sham-acupuncture group,the expression of Phospho-TAU or NF-L significantly reduced in the fluoro-metholone group(all P<0.05).The Western Blot results indicate that compared with the blank group,the protein expres-sion of Caspase-1,IL-1β,and IL-18 in TG and SpVc of the model group increased;moreover,the expression of Caspase-1 and IL-18 proteins in the sham-acupuncture group also increased(all P<0.05).Compared with the model group,the ex-pression of Caspase-1,IL-1β,and IL-18 proteins in TG and SpVc reduced in the electroacupuncture group and the fluoro-metholone group,and the expression of IL-1 β proteins in TG and SpVc also reduced in the sham-acupuncture group(all P<0.05).Compared with the electroacupuncture group,the expression of Caspase-1,IL-1 β,and IL-18 proteins in TG and SpVc increased in the sham-acupuncture group(all P<0.05).Compared with the sham-acupuncture group,the expression of Caspase-1,IL-1 β,and IL-18 proteins in TG and SpVc reduced in the fluorometholone group(all P<0.05).Conclusion Electroacupuncture can effectively alleviate the abnormal ocular surface sensation of type 2 diabetes dry eye rats by alleviating the neuroinflammatory injury in TG and SpVc.
5.Clinical characteristics and contributors to diagnostic delay in autoimmune gastritis
Haofeng LI ; He MA ; Tao FU ; Xinyi HUANG ; Qing SHI ; Yan ZHENG ; Hanning LIU ; Hengqi LIU ; Yan GUO ; Chunhui LAN
Journal of Army Medical University 2025;47(19):2396-2404
Objective To analyze the diagnostic process and clinical characteristics of autoimmune gastritis(AIG)in order to improve the awareness and diagnostic proficiency of this disease.Methods A retrospective cohort study was conducted on 114 patients diagnosed with AIG in Army Medical Center of PLA between January 2021 and June 2024.Comprehensive statistical analysis was performed on clinical data,including demographic characteristics(age,sex),clinical symptoms,comorbidities,diagnostic process,Helicobacter pylori(H.pylori)infection and treatment history,laboratory indicators[results of routine blood test,anemia-related indices,thyroid function,anti-parietal cell antibody(APCA),intrinsic factor antibody(IFA)],and gastrointestinal endoscopic findings(frequency and endoscopic features).Results Among the 114 patients,males accounted for 28.1%(32/114)and females for 71.9%(82/114),and they were at a mean age of 56.3±8.4 years.Predominant symptoms included epigastric/upper abdominal pain(47.4%,54/114)and postprandial fullness(43.0%,49/114),while 24.6%(28/114)reported acid reflux or heartburn.Diagnostic delay occurred in 76.4%(87/114)of patients,with a median delay duration of 11.5 months.Primary diagnostic clues were endoscopic reverse gradient atrophy(significantly more severe mucosal atrophy in the gastric corpus/fundus versus antrum;53.5%,61/114)and repeated H.pylori eradication failure(≥2 attempts;22.8%,26/114).Positivity rate of thyroid peroxidase antibody(TPOAb)and thyroglobulin antibody(TgAb)was 56.9%(33/58)and 36.2%(21/58),respectively.APCA positive rate was 98.8%(81/82),IFA positive rate was 34.1%(28/82),and dual-antibody rate was 32.9%(27/82).Anemia was present in 25.7%(26/101)of the patients.Gastric neuroendocrine tumors(NET)were found in 12.2%(14/114),intraepithelial neoplasia in 5.3%(6/114),and gastric adenocarcinoma in 0.9%(1/114).Among colonoscopy-examined patients,tubular adenomas occurred in 25.0%(13/52)and colorectal malignancies in 3.4%(2/58).There were 18.4%(21/114)patients having gallbladder-related diseases,7.9%(9/114)having diabetes mellitus,and 1.8%(2/114)of subacute combined degeneration of the spinal cord.Conclusion AIG is frequently associated with diagnostic delay.The reverse pattern of atrophy on endoscopy serves as a critical diagnostic clue,necessitating enhanced recognition in endoscopists.Patients with recurrent H.pylori eradication failure(≥2 attempts)should be evaluated for AIG.
6.Association of thoracic aortic calcification with autonomic nervous system function in patients undergoing peritoneal dialysis
Jing WANG ; Xinyi FU ; Yaoyu HUANG ; Yujun QIAN ; Hongqing CUI ; Li ZHANG ; Ningning WANG ; Haibin REN ; Hongwu CHEN ; Huijuan MAO
Chinese Journal of Nephrology 2025;41(5):332-340
Objective:To investigate the relationship between thoracic aortic calcification (TAC) and autonomic nervous system (ANS) function in patients receiving continuous ambulatory peritoneal dialysis (CAPD).Methods:It was a cross-sectional study. The CAPD patients with dialysis duration >6 months between January and December 2022 were retrospectively enrolled. The baseline clinical data, heart rate variability (HRV) data such as standard deviation of all normal to normal intervals (SDNN), root mean square of successive differences between adjacent normal-to-normal intervals (RMSSD), high frequency (HF), very low frequency (VLF), low frequency (LF), LF/HF, acceleration capacity (AC) and deceleration capacity (DC), and skin sympathetic nerve activity (SKNA) were collected. TAC was defined as TAC score (TACS) >100 AU. The patients were divided into TACS >100 AU group and TACS≤100 AU group based on whether the thoracic aorta was calcified. The differences of those data between the two groups were compared. Logistic regression model was used to analyze the related factors of TAC. Spearman correlation analysis method was used to analyze the correlation between peripheral blood neuropeptide Y, ANS parameters, average amplitude SKNA (aSKNA) and TACS. Cox regression model was used to analyze the risk factors of all-cause mortality in patients with CAPD.Results:The study included 106 CAPD patients with 50 males (47.2%), age of (46.04±11.10) years and dialysis duration of (41.55±30.52) months. TACS>100 AU group exhibited significantly lower heart rate ( t=2.015, P=0.046), DC ( t=2.131, P=0.035), LF/HF ( Z=3.332, P<0.001) and ln(LF/HF) ( t=3.326, P=0.001), and higher AC ( t=-2.392, P=0.019) than TACS≤100 AU group. Multivariate logistic regression analysis results showed that after adjusting for age and eosinophil count, lnVLF ( OR=0.66, 95% CI 0.45-0.98, P=0.038), lnLF ( OR=0.69, 95% CI 0.49-0.97, P=0.032), DC ( OR=0.79, 95% CI 0.64-0.99, P=0.039) and AC ( OR=1.32, 95% CI 1.04-1.68, P=0.021) were independently correlated with the risk of TAC. Spearman correlation analysis showed that neuropeptide Y level in peripheral blood was correlated with aSKNA ( r=0.23, P=0.017), lnSDNN ( r=-0.20, P=0.036) and TACS ( r=0.19, P=0.048). During the follow-up period of (25.8±4.2) months, 5 patients (4.72%) died, including 1 patient in the TACS≤100 AU group and 4 patients in the TACS>100 AU group. Compared with the survival group, the death group had higher TACS ( Z=-2.262, P=0.024) and lower LF/HF ( Z=-2.750, P=0.006). Cox regression analysis results showed that increased ln(LF/HF) was an independent influencing factor for all-cause mortality in CAPD patients ( HR=0.22, 95% CI 0.05-0.83, P=0.026). Conclusions:HRV parameters (lnVLF, lnLF, AC and DC) of CAPD patients are independently associated with TAC. The dysfunction of ANS in CAPD patients (especially the decreased vagus nerve activity) may promote TAC.
7.A case of intracranial venous hypertension caused by coated stent grafts for right innominate vein occlusion
Xuedong BAO ; Chang WU ; Yaxue SHI ; Lanhua MI ; Sijie LIU ; Xinyi FU
Chinese Journal of Nephrology 2025;41(11):864-866
Central venous lesions are challenging in the maintenance of hemodialysis vascular access, with endovascular therapy as the preferred treatment. Coated stent grafts, with superior primary patency rates and the ability to mitigate the risk of vascular rupture and bleeding, have become one of the clinical options. However, they pose a risk of occluding important tributary veins. This report describes a case of right innominate vein occlusion treated with a small-caliber coated stent graft, resulting in postoperative symptoms of intracranial venous hypertension. This case highlights the need to pay attention to neurological symptoms caused by central venous lesions and conduct a more meticulous assessment of contralateral venous return before placing coated stent grafts, to avoid irreversible neurological symptoms.
8.Research on the prevalence of overweight and obesity among children
Xinyi LIANG ; Jingnan CHEN ; Xuelian ZHOU ; Ruimin CHEN ; Jingsi LUO ; Rongxiu ZHENG ; Chunxiu GONG ; Chunlin WANG ; Zhe SU ; Mireguli MAIMAITI ; Yan LIANG ; Hui YAO ; Haiyan WEI ; Hongwei DU ; Shaoke CHEN ; Yu YANG ; Feihong LUO ; Pin LI ; Min ZHU ; Wei WU ; Ke HUANG ; Guanping DONG ; Junfen FU
Chinese Journal of Pediatrics 2025;63(6):612-619
Objective:To investigate the prevalence and risk factors of overweight and obesity among Chinese children aged 3-18 years from 11 provinces, antonomous regions, or municipalities.Methods:This national cross-sectional community health survey utilized a multistage stratified cluster-random sampling method to recruit 193 997 nationally representative participants from 11 provinces, autonomous regions, or municipalities between January 2017 and December 2019. All participants underwent physical examinations, and their caregivers completed questionnaires assessing participants′ dietary, lifestyle, familial, and perinatal information. Multilevel multinomial logistic regression models were employed to identify the potential risk factors.Results:The cohort comprised 193 997 children (102 178 boys, 91 819 girls),aged (10±4) years. Overall prevalence rates were 30 574(15.8%)overweight children and 17 217(8.9%) obesity children. Boys exhibited higher overweight and obesity rates than girls (17.0% (17 368/102 178) vs. 14.4% (13 206/102 178), 11.3% (11 553/91 819) vs. 6.2% (5 664/91 819), χ2=249.12,1 578.69,both P<0.001). The detection rates of obesity in Tanner stage 2 and 3 were the highest in boys and girls, with 13.4%(2 231/16 665) and 8.6%(880/10 221) respectively. Risk factors for obesity included parental overweight (paternal OR=2.34 and maternal OR=2.29), annual household income of 100 000-200 000 yuan (compared with<100 000 yuan, OR=1.04), higher paternal education (compared with below high school,high school and a college education OR=1.09,1.14), birth weight >4.0 kg (≤5 and>5 years old OR=1.74, 1.44,respectively), and western food consumption≥1 time/month (compared with<1, 1-2, 3-4,>4 times/month OR=1.36, 1.30, 1.67(≤5 years), 1.19, 1.16, 1.15 (>5 years), respectively) (all P<0.05). Conversely, coarse grain intake≥1 times/week (compared with<1 times/week, every day, 3-4, 1-2 times/week OR=0.74, 0.80, 0.71 (≤5 years), 0.75, 0.87, 0.90(>5 years), respectively, all P<0.05) was associated with reduced obesity risk. Conclusions:Obesity epidemiology in children demonstrates significant heterogeneity across age, gender, geographic regions, and pubertal stages. It is necessary to establish a personalized prevention and control strategy.
9.Genetic diversity analysis of oxacillinase in 241 clinical isolates of Pseudomonas aeruginosa
Yuelong LI ; Jingyi ZHANG ; Yubing FU ; Meiqing SUN ; Beibei MIAO ; Xinyi GONG ; Xiao HAN ; Huan XING ; Pengfang GAO ; Jiachen LI ; Yating TANG ; Xinya FAN ; Yanlei GE ; Haijian ZHOU ; Juan LI ; Aiying DONG
Chinese Journal of Preventive Medicine 2025;59(7):1004-1012
Objective:To analyze the carriage status, subtype distribution and flanking gene sequence characteristics of oxacillinases (OXA enzyme) in 241 clinical strains of Pseudomonas aeruginosa, and assess their roles in the drug resistance of Pseudomonas aeruginosa and ability to horizontally transfer across species. Methods:Clinical P. aeruginosa isolates were collected from four hospitals in Sanya, Tangshan, Zhangjiakou, and Beijing. The prevalence of oxacillinases and their flanking gene sequences was analyzed by whole-genome sequencing (NGS) and bioinformatic approaches. Results:A total of 241 isolates of P. aeruginosa were gathered, and 35 blaOXA subtypes were identified through screening of 252 blaOXA genes. These genes were classified into three subfamilies: blaOXA-50-like (241, 95.6%), blaOXA-1-like (9, 3.6%) and blaOXA-10-like (2, 0.8%). Among these, 11 subtypes (11, 31.4%) were novel blaOXA subtypes. Nine of these belonged to the blaOXA-50-like subfamily and were designated as blaOXA-1244, blaOXA-1245, blaOXA-1246, blaOXA-1250, blaOXA-1252, blaOXA-1253, blaOXA-1254, blaOXA-1255, and blaOXA-1256. The remaining two belonged to the blaOXA-10-like subfamily and were named blaOXA-1247 and blaOXA-1248. Compared to the amino acid sequence of OXA-10, the newly identified subtype OXA-1247 exhibited a mutation at position 117, where a valine was replaced by a leucine. This change was thought to improve the enzyme′s ability to hydrolyze carbapenems. In the analysis of the flanking sequences of the blaOXA genes, Class I integrons were identified in four bacterial strains. The variable regions of these integrons carried three distinct patterns of resistance gene cassettes: aac( 6′) -Ib-blaOXA-1247-ant( 3′′) -Ia, aac( 6′) -Ib-blaOXA-1248 and aac( 6′) -Ib- blaIMP-45-blaOXA-1-catB3. Among these, the strain BJ2326 carried a class I integron that was connected to the downstream IS CR1 element to form a composite class I integron structure, additionally carrying the resistance gene blaPER-1. Out of the 223 non-wild-type P. aeruginosa strains, 127 strains exhibited non-wild-type profiles to the four beta-lactam antibiotics MEM, CAZ, FEP, and TZP, with the combination of MEM+CAZ+FEP being the most prevalent, representing 57.0% of the total. Conclusions:The blaOXA genes in 241 clinical P. aeruginosa strains showed diversity. Some blaOXA genes had a co-transfer risk with the metallo-β-lactamase resistance gene blaIMP-45. Among the 11 newly discovered blaOXA subtypes, the new subtype OXA-1247 may have carbapenemase activity and potential for horizontal transfer.
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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