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.

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.

Abastract:Objective To validate the performance of six different lipoprotein(a)[Lp(a)]immunoassay detection systems,compare the correlation and consistency of the measurement results of different detection systems,and explore their clinical application in the e-valuation of atherosclerotic cardiovascular disease(AsCVD).Methods A total of 150 AsCVD patients attending Peking Union Medi-cal College Hospital were retrospectively selected as the subjects of study group,and 50 individuals of physical examination during the same period were selected as healthy control group.Lp(a)levels were measured in 200 serum samples using six immunoassay detection systems,including two Lp(a)particle concentration assays in nmol/L(Roche and Mindray Ⅱ),and four Lp(a)mass concentration assays in mg/L(Mindray,MedicalSystem,BSBE,and Sekisui).All assays'precisions were evaluated.The results of each assay sys-tem were compared with the mean value of all the Lp(a)assays.Passing-Bablok regression analysis and Bland-Altman bias plots were used to assess the accuracy of assays,and the consistency between different systems was analyzed using the concordance correlation co-efficient(CCC).In addition,the consistencies of different assays in assessing AsCVD in clinical setting were compared using weighted Kappa statistical method,and the positive rates of Lp(a)particle concentration and mass concentration,as well as the overestimation and underestimation of mass concentration were also assessed for both the study group and the healthy control group.Results The pre-cision of the six Lp(a)assays ranged from 0.6％to 2.1％.Passing-Bablok regression analysis showed that the Spearman correlation co-efficients of the regression equations were all greater than 0.970,and the intercepts and slopes of the regression lines were-43.311 to 39.456 and 0.547 to 5.500,respectively.The Bland-Altman bias plots showed that the percent bias of the six assays compared to the mean value of Lp(a)determination was in the range of-25.939％to 40.205％.The results of the Lp(a)mass concentration detection system showed a positive deviation in Mindray and MedicalSystem,and a negative deviation in BSBE and Sekisui.Compared with the mean value of Lp(a),the results of consistency analysis showed that Roche and Mindray Ⅱ had excellent consistency(CCC:0.992 to 0.993).Mindray,MedicalSystem and BSBE had good consistency(CCC:0.950 to 0.986),and Sekisui showed moderate consistency(CCC:0.935).In descending order,the positivity rates of Lp(a)in the study groups were:MedicalSystem＞BSBE＞Mindray＞Roche=Mindray Ⅱ＞Sekisui.The overall concordances of Mindray,MedicalSystem,BSBE and Sekisui compared to Lp(a)particle concentration assay in different groups were 97.33％,93.33％,97.33％and 98.00％with Kappa values of 0.910,0.798,0.912 and 0.927,respec-tively.Conclusion The two assays for Lp(a)particle concentration have fine correlation and consistency,but there were significant differences between the four assays for Lp(a)mass concentration.Compared to the Lp(a)particle concentration assays,the four assay for Lp(a)mass concentration resulted in overestimation or underestimation of Lp(a)levels in the assessment of AsCVD.Accurate de-termination of Lp(a)concentration should be of great importance in accurately assessing the overall risk of AsCVD in patients.

ObjectiveTo explore the clinical safety of Feilike Mixture （FLK） in the real world. MethodsThe safety of all children who received FLK from 29 institutions in 12 provinces between January 21，2021 and December 25，2021 was evaluated through prospective centralized surveillance and a nested case control study. ResultsA total of 3 035 juveniles were included. There were 29 research centers involved，which are distributed across 12 provinces，including one traditional Chinese medicine （TCM） hospital and 28 general hospitals. The average age among the juveniles was （4.77±3.56） years old，and the average weight was （21.81±12.97） kg. Among them，119 cases （3.92%） of juveniles had a history of allergies. Acute bronchitis was the main diagnosis for juveniles，with 1 656 cases （54.46%）. FLK was first used in 2 016 cases （66.43%），and 142 juvenile patients had special dosages，accounting for 4.68%. Among them，92 adverse drug reactions （ADRs） occurred，including 73 cases of gastrointestinal system disorders，10 cases of metabolic and nutritional disorders，eight cases of skin and subcutaneous tissue diseases，two cases of vascular and lymphatic disorders，and one case of systemic diseases and various reactions at the administration site. The manifestations of ADRs were mainly diarrhea，stool discoloration，and vomiting，and no serious ADRs occurred. The results of multi-factor analysis indicated that special dosages （the use of FLK）［odds ratio （OR） of 2.642， 95% confidence interval （CI） of 1.105-6.323］，combined administration： spleen aminopeptide （OR of 4.978， 95%CI of 1.200-20.655），and reason for combined administration： anti-infection （OR of 1.814， 95%CI of 1.071-3.075） were the risk factors for ADRs caused by FLK. Conclusion92 ADRs occurred among 3 035 juveniles using FLK. The incidence of ADRs caused by FLK was 3.03%，and the severity was mainly mild or moderate. Generally，the prognosis was favorable after symptomatic treatment such as drug withdrawal or dosage reduction，suggesting that FLK has good clinical safety.

Objective:To evaluate the effects and underlying mechanisms of preoperative intestinal microbiota modulation on the recovery of prolonged postoperative ileus(PPOI)in gastric cancer patients with sarcopenia Methods:Skeletal muscle mass(SMM)was assessed using bioelectrical impedance analysis(BIA),and the skeletal muscle index(SMI)was calculated.A total of 156 gastric cancer patients with sarcopenia who underwent surgery at the Department of Gastrointestinal Surgery,Liyang People's Hospital,from January 2022 to December 2024 were randomly assigned to either the control group or the experimental group.The control group received conventional prehabilitation interventions,including nutritional support,respiratory function training,and physical exercise.The experimental group received probiotic-based intestinal microbiota modulation in addition to conventional prehabilitation interventions.Postoperative recovery indicators,including time to first flatus,incidence of postoperative complications,length of hospital stay,and hospitalization costs,were compared between the two groups.Results:Among the 156 sarcopenic gastric cancer patients,121 were male,and 35 were female.Statistically significant differences were observed between the two groups in terms of time to first flatus,incidence of postoperative complications,and length of hospital stay(P<0.05).Postoperative complications occurred in 38 patients(24.3%),with 10 cases(6.4%)in the experimental group and 28 cases(17.9%)in the control group.The time to first flatus in the experimental group was significantly shorter than in the control group(48.0 hours vs 72.0 hours,P<0.001).Conclusion:Preoperative intestinal microbiota modulation significantly reduces the incidence of PPOI and postoperative complications in gastric cancer patients with low SMI,thereby promoting postoperative gastrointestinal function recovery.

Ischemic stroke (IS) is a globally life-threatening disease. Presently, few therapeutic medicines are available for treating IS, and rt-PA is the only drug approved by the US Food and Drug Administration (FDA) in the US. In fact, many agents showing excellent neuroprotection but no blood flow-improving activity in animals have not achieved ideal clinical efficacy, while thrombolytic drugs only improving blood flow without neuroprotection have limited their wider application. To address these challenges and meet the huge unmet clinical need, we have designed and identified a novel compound AAPB with dual effects of neuroprotection and cerebral blood flow improvement. AAPB significantly reduced cerebral infarction and neural function deficit in tMCAO rats, pMCAO rats, and IS rhesus monkeys, as well as displayed exceptional safety profiles and excellent pharmacokinetic properties in rats and dogs. AAPB has now entered phase I of clinical trials fighting IS in China.

Objective:To investigate the efficacy and safety of transarterial chemoembolization (TACE) combined with sintilimab and bevacizumab biosimilar in the treatment of unresectable hepatocellular careinoma (uHCC).Methods:The clinical data of 64 patients with unresectable HCC, who were admitted to the First Affiliated Hospital of Soochow University between January 2021 and December 2023, were retrospectively analyzed. The patients were divided into a combination group ( n=43, receiving TACE combined with sintilimab and bevacizumab biosimilar) and control group ( n=21, receiving only sintilimab and bevacizumab biosimilar). Survival curves were drawn by Kaplan-Meier method, and the median overall survival (mOS) and median progression-free survival (mPFS) were compared between the two groups. According to the mRECIST criterion, the objective response rate (ORR) and disease control rate (DCR) were compared between the two groups. The occurrences of adverse events in both groups were recorded. Results:The mOS and mPFS in the combination group were 22.3 months and 12.4 months, respectively, which in the control group was 11.6 months and 6.4 months, respectively. The differences between the two groups were statistically significant ( P=0.001 and P=0.002). The ORR and DCR in the combination group were 62.8% and 95.3% respectively, which were significantly higher than 19.0% and 57.1% respectively in the control group (all P<0.01). No statistically significant difference in the incidence of severe adverse events existed between the two groups ( P=0.518). Conclusion:TACE combined with sintilimab and bevacizumab biosimilar has efficacy and safety than sintilimab and bevacizumab biosimilar alone.

Vertebral refracture following percutaneous vertebral augmentation (PVA) is commonly seen in elderly patients with osteoporotic thoracolumbar compression fractures (OTLCF). It can lead to recurrent pain, loss of vertebral height, progression of kyphosis, and even neurological dysfunction, significantly impairing patients′ quality of life. Current diagnosis and treatment face multiple challenges, including high misdiagnosis rate, difficulty in choosing between surgical and non-surgical treatment options, lack of standardized surgical protocols, interference from intralesional bone cement during procedures, inadequate stability of internal fixation in osteoporotic bone, and suboptimal compliance of anti-osteoporotic therapy. Establishing a standardized diagnostic and therapeutic framework is urgently needed. To standardize the management process and improve outcomes for vertebral refractures after PVA in elderly OTLCF patients, Spinal Trauma Group of the Orthopedic Branch of Chinese Medical Doctor Association organized experts in the field to develop Guideline for the diagnosis and treatment of vertebral refracture after percutaneous vertebral augmentation in elderly patients with osteoporotic thoracolumbar compression fractures ( version 2025), based on current literature and clinical experience, and adhering to principles of scientific rigor and clinical applicability. A total of 11 recommendations were proposed, encompassing diagnosis, treatment, and rehabilitation of vertebral refracture after PVA in elderly patients with OTLCF, aiming to provide a foundation for a standardized management.

Thoracolumbar spine fracture often leads to severe pain, functional impairments, and neurological deficits, for which open reduction and internal fixation can effectively restore the spinal structural stability. Open decompression and reduction with internal fixation can help relieve spinal cord compression and improve spinal function in cases of concomitant cord injury. Although spinal stability can be restored through surgery, patients often face chronic pain and functional impairments postoperatively. A postoperative rehabilitation program is critical in optimizing therapeutic outcomes, reducing complications, and minimizing the risk of secondary injuries. However, current rehabilitation methods, such as physical therapy, functional training, and pain management, are confronted with problems in clinical practice, including significant variation in efficacy, poor patient adherence, and prolonged rehabilitation period. There is an urgent need for a unified rehabilitation strategy to address these problems. To this end, the Spinal Trauma Group of the Orthopedic Physicians Branch of the Chinese Medical Association and the Spine Health Professional Committee of the Chinese Human Health Technology Promotion Association organized experts from relevant fields to formulate Evidence-based guidelines for rehabilitation treatment after internal fixation of thoracolumbar spine fracture in adults ( version 2025) by integrating evidences from clinical researches and advanced rehabilitation concepts at home and abroad. A total number of 14 recommendations concerning the rehabilitation treatment with multimodal analgesia, psychological intervention, deep vein thrombosis prevention, core muscle and extremity exercise, appropriate use of braces, early weight-bearing, device-aided rehabilitation exercise, neuroregulatory therapy, rehabilitation team were put forward, aiming to standardize the post-operative rehabilitation process following internal fixation, promote the functional recovery, and enhance patients′ quality of life.

Acute symptomatic osteoporotic thoracolumbar compression fracture (ASOTLF) can lead to chronic low back pain, kyphosis deformity, pulmonary dysfunction, loss of mobility, and even life-threatening complications. Vertebral augmentation is currently the mainstream treatment method for this condition. In 2019, the Editorial Board of Chinese Journal of Trauma and the Spinal Trauma Group of Orthopedic Surgeons Branch of Chinese Medical Doctor Association collaboratively led the development of Clinical guideline for vertebral augmentation for acute symptomatic osteoporotic thoracolumbar compression fractures. Six years later, with advances in clinical diagnosis and treatment techniques as well as accumulating evidence in related fields, the 2019 guideline requires updating. To this end, the Spinal Trauma Group of Orthopedic Surgeons Branch of Chinese Medical Doctor Association, the Spinal Health Professional Committee of China Human Health Science and Technology Promotion Association, and the Minimally Invasive Orthopedics Professional Committee of Shaanxi Medical Doctor Association have organized experts in the field to develop the Clinical guideline for vertebral augmentation of acute symptomatic osteoporotic thoracolumbar compression fractures ( version 2025) , based on the latest evidence-based medical researches. This guideline incorporates 3 recommendations retained from the 2019 version with updated strength of evidence, along with 12 new recommendations. It provides recommendations from six aspects of diagnosis, pain management, treatment option selection, prevention of postoperative complications, anti-osteoporosis therapy, and postoperative rehabilitation, aiming to provide a reference for standard treatment of vertebral augmentation for ASOTLF in hospitals at all levels.