ObjectiveTo investigate the risk factors for post-acute pancreatitis diabetes mellitus （PPDM-A） in patients with acute pancreatitis （AP）， to construct a nomogram prediction model， and to provide a reference for the development of individualized treatment regimens. MethodsA total of 351 patients with AP who were admitted to Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University from June 2021 to January 2025 were prospectively enrolled， and they were randomly divided into modeling group with 246 patients and validation group with 105 patients at a ratio of 7∶3. According to the presence or absence of PPDM-A in the patients with AP， the modeling group was further divided into PPDM-A group with 86 patients and non-PPDM-A group with 160 patients. Clinical data were collected from all patients. The least absolute shrinkage and selection operator （LASSO） regression analysis was used to determine independent variables， and a Logistic regression analysis was used to investigate the influencing factors for PPDM-A. R software was used to construct a nomogram model. The receiver operating characteristic curve was used to assess the discriminatory ability of the model， and the Hosmer-Lemeshow test was used to test the model fitting degree， and the calibration curve was used to evaluate the model consistency； and decision curve analysis （DCA） was used to assess its clinical application value. The independent-samples t test was used for comparison of continuous data between two groups， and the chi-square test was used for comparison of categorical data between two groups. ResultsAmong the 246 patients， 86 developed PPDM-A， resulting in an incidence rate of 34.96%. There were significant differences between the PPDM-A group and the non-PPDM-A group in the proportion of patients with an age of ≥60 years （65.12% vs 40.62%， P<0.05）， male sex （75.58% vs 55.63%， P<0.05）， a body mass index （BMI） of ≥24 kg/m² （63.95% vs 37.50%， P<0.05）， alcoholic AP （56.98% vs 36.87%， P<0.05）， moderate-to-severe AP （54.65% vs 35.00%， P<0.05）， or a computed tomography severity index （CTSI） score of ≥4 points （48.84% vs 28.75%， P<0.05）， as well as significant differences in the levels of blood calcium （1.46±0.35 mmol/L vs 1.89±0.37 mmol/L， P<0.05） and random blood glucose （Glu） （17.68±4.12 mmol/L vs 11.68±4.27 mmol/L， P<0.05）. The LASSO regression analysis obtained 8 independent variables. The Logistic regression analysis showed that age， sex， BMI， alcoholic AP， moderate-to-severe AP， CTSI score， and Glu were risk factors for PPDM-A （all P<0.05）， while blood calcium was a protective factor （P<0.05）. The model had an area under the ROC curve （AUC） of 0.932 （95% confidence interval ［CI］： 0.903 — 0.962） in the modeling group， and the Hosmer-Lemeshow goodness-of-fit test yielded χ²=7.346 （P=0.728）， the accuracy of model fitting was good； the calibration curve showed that the predicted probability was consistent with the actual probability， indicating that the consistency was good. The model had an AUC of 0.835 （95%CI： 0.753 — 0.917） in the validation group， and the Hosmer-Lemeshow goodness-of-fit test yielded χ²=7.014 （P=0.711）， the accuracy of model fitting was good； the calibration curve showed that the predicted probability was consistent with the actual probability， indicating that the consistency was good. The DCA results of the modeling group showed that the model exhibited a high clinical value in evaluating PPDM-A when the threshold probability was 0.13 — 0.94. ConclusionAge， sex， BMI， alcoholic AP， moderate-to-severe AP， blood calcium， CTSI score， and Glu are influencing factors for PPDM-A. The nomogram model constructed based on the above influencing factors shows good performance in predicting the risk of PPDM-A and can thus provide a reference for developing prevention strategies for PPDM-A in clinical practice.

6-Thioguanine(6-TG)is an antineoplastic agent used in treatment of acute leukemia.However,significant interindividual variability in dosing regimens and frequent clinical manifestations of hepatotoxicity and myelosuppression as adverse effects have affected its therapeutic efficacy.Consequently,the development of rapid analytical methods for 6-TG in clinical samples,enabling continuous therapeutic drug monitoring of plasma concentrations,holds substantial significance in optimizing dosage regimens,mitigating adverse reactions,and investigating drug metabolism mechanisms.In this study,multi-tipped gold nanostars(AuNSs)were prepared.With bis-(p-sulfonylphenyl)phenylphosphine molecule as the protecting agent and internal standard molecule,the AuNSs were assembled onto a highly sensitive surface-enhanced Raman(SERS)substrate for developing a ratio-based SERS quantitative analysis method for 6-TG in serum.The AuNSs containing multiple tips and gaps exhibited strong local surface plasmon resonance effect and SERS activity,ensuring the sensitivity of the analytical method.Furthermore,the introduction of internal standard molecules could improve the reproducibility,which guaranteed this method suitable for rapid analysis of drug molecules in complex samples.Quantitative analysis of 6-TG was achieved with linear detetion range of 1.0×10?4-1.0 mmol/L.In the spiked recovery experiments of serum,the RSD was less than 5.32%,and the recoveries were 94%-104%,which proved that this method could be used for rapid quantitative determination of 6-TG in serum.This method provided a powerful tool for studying drug pharmacokinetics,which could promote the optimization of the usage methods of anti-cancer drugs,and it was expected to further enhance the clinical efficacy and safety of 6-TG,enabling it to achieve the best therapeutic effect.

This study was aimed at investigating the effects of demethylase fat mass and obesity-associated protein(FTO)and methyltransferase methyltransferase like protein 3(METTL3),key molecules in N6-methyladenosine(m6A)modification,on the replication and proliferation of Japanese encephalitis virus(JEV).Recombinant lentiviruses were generated by packaging the FTO and green fluorescent protein into lentiviral vectors.Neuro2a cells,a mouse neuroblastoma cell line,were infected with the lentivirus,and stable FTO-expressing cell lines were obtained through puromycin selection.Successful overexpression of FTO was confirmed through fluorescence microscopy,real-time quantitative PCR,and western blot analysis.When Neuro2a cells overexpressing FTO were infected with JEV,the overexpression of FTO decreased JEV replication in the cells,and increased the expression of interferon(IFN)and related molecules.Additionally,treatment of JEV-infected Neuro2a cells with the METTL3-specific inhibitor STM2457 resulted in a dose-dependent decrease in JEV replication and viral protein expression.These findings suggested that lowering m6A methylation levels inhibits JEV replication,thus shedding light on the regulatory role of methylation modification in JEV replication.

Yinyang Gongji Pills have the effects of strengthening the body resistance to eliminate pathogenic factors, removing stasis, and reducing swelling, which is a commonly used traditional Chinese medicine(TCM) formula for treating intestinal accumulation. A real-world, registered, and single-arm clinical trial was conducted to observe the clinical efficacy and safety of Yinyang Gongji Pills combined with capecitabine in the treatment of advanced colorectal cancer and analyze the clinical characteristics of the patients. A total of 60 patients with advanced colorectal cancer who refused or could not tolerate standard treatment of western medicine were included in the study. They were treated with Yinyang Gongji Pills combined with capecitabine until disease progression or intolerable adverse events occurred. The main observation indicators were progression-free survival(PFS) and safety. The treatment effects of the patients under different baseline characteristics were analyzed. The clinical trial has found that the median PFS of all enrolled patients was 7.3 months, with 30.1% of patients having a PFS exceeding 12.0 months. Layered analysis showed that the median PFS of patients with the onset site being the colon and rectum were respectively 8.4 and 4.7 months. The median PFS of patients with high, medium, and low tumor burden were respectively 7.0, 4.7, and 10.8 months. The median PFS of patients with wild-type and mutant-type RAS/BRAF were respectively 7.9 and 6.9 months. The median PFS of patients with KPS scores ≥80 and ≤70 were respectively 7.9 and 6.5 months. The median PFS of patients treated with Yinyang Gongji Pills for ≥6, 3-6, and ≤3 months were respectively 8.0, 5.2, and 4.2 months. The median PFS of patients with spleen, kidney, liver, and lung syndrome differentiation in TCM were respectively 8.3, 6.7, 7.3, and 5.6 months. The median PFS of patients with TCM pathological factors including phlegm, dampness, and blood stasis were respectively 7.0, 7.3, and 6.5 months. Common adverse reactions include anemia, decreased white blood cells, decreased appetite, fatigue, and hand foot syndrome, with incidence rates being respectively 44.2%, 34.6%, 42.3%, 32.7%, and 17.3%. The results showed that the combination of Yinyang Gongji Pills and capecitabine demonstrated potential clinical efficacy and good safety in this study. The patients have clinical characteristics such as low tumor burden, onset site at the colon, KPS scores ≥ 80, long duration of oral TCM, and TCM syndrome differentiation including spleen or liver.
Humans ; Capecitabine/adverse effects* ; Colorectal Neoplasms/mortality* ; Drugs, Chinese Herbal/adverse effects* ; Male ; Middle Aged ; Female ; Aged ; Adult ; Treatment Outcome

Objective:To analyze the quality stability of Ruduxiao preparations from both process stability and for-mulation stability.Methods:HPLC fingerprints of different formulations of Rutuxiaoqi were established.According to the fingerprint screening results,the abnormal content of tansanone in some batches of manufacturer A and the pollution components of manufacturer B for non-medicinal purposes were tracked.Accelerated stability tests were performed on cross-manufacturer samples,and evaluated via multifaceted indicators including description,moisture content and fingerprint profiling.Results:A total of 35 common peaks were identified in the fingerprint,and the reference fingerprints of tablet and granule were close to each other,but the difference was obvious from that of cap-sule.The main difference lies in that some peaks attributed to Salvia Miltiorrhiza in the reference fingerprint of the capsules produced by manufacturer C were partially missing and their contents were relatively low.There were devi-ations in the extraction process of Salvia Miltiorrhiza from tablets of manufacturer A,and the contaminated compo-nent of manufacturer B was confirmed to be scutellaria extract powder by comparison of reference substances and UPLC Q-TOF MS/MS,which may come from collinear pollution.In the accelerated stability test,the granules packaged in the composite film of manufacturer D showed stable performance.The tablets packaged with aluminum-plastic blister were significantly affected by water vapor,and appeared splits,contents overflow,softening,etc.The weight of the tablets increases significantly,and the common peak 1 of fingerprint was significantly degraded,while the tablets and capsules packaged with HDPE plastic bottles were degraded obviously.Conclusion:The established fingerprint method can effectively characterize the overall situation of Ruduxiao preparations,not only can detect the abnormal process changes and non-medicinal component residues,but also can reveal the sensitive conditions that affect the stability of the samples,providing a reference for process verification and upgrading of packaging materials for manufacturers.The peak of common peak 1 can be used as an indicator of the stability of Ruduxiao preparations.

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.

ObjectiveBased on multi-index and multi-method detection， the quality of Rukuaixiao preparations was systematically evaluated from the perspective of characteristic components， and the existing problems were analyzed. MethodsLiquid chromatography-mass spectrometry（LC-MS） for the determination of 16 characteristic components was established to evaluate the quality of 129 batches of Rukuaixiao preparations. High performance liquid chromatography（HPLC） was established to determine the contents of salvianolic acids and tanshinones， investigate the rationality of quality control index of Salviae Miltiorrhizae Radix et Rhizoma in the standard for Rukuaixiao preparations in the 2020 edition of Pharmacopoeia of the People's Republic of China（hereinafter referred to as Chinese Pharmacopoeia） （volume Ⅰ）， and trace the causes of significant difference among different batches. The processing and different extraction methods of Vaccariae Semen were tested， analyzing the impact of formulation changes across different editions of Chinese Pharmacopoeia. The LC-MS was established for determining the changes in the ratio of toosendanin and isotoosendanin after water extraction of Toosendan Fructus. The contents of active components in different parts of Gleditsiae Spina were determined to identify the reason of the low contents of characteristic components in some enterprises. ResultsBased on the comprehensive analysis of the samples from different dosage forms， the contents of characteristic components of Vaccariae Semen and Gleditsiae Spina in tablets from manufacturer B and granules from manufacturer D were significantly higher than those in tablets from manufacturer A， and tablets and capsules from manufacturer C. The contents of tanshinones in some batches of products from manufacturer A were abnormally high， potentially linked to the use of 70% ethanol reflux during extraction of Salviae Miltiorrhizae Radix et Rhizoma. All samples from manufacturer C exhibited abnormally high proportions of salvianic acid A and 3，4-dihydroxybenzaldehyde（salvianolic acid degradation products） to the total seven phenolic acids， indicating a risk of blindly pursuing tanshinol content and neglecting more effective components. The extraction rate of the characteristic components from Vaccariae Semen by decocting with water was obviously higher than that by reflux extraction with 70% ethanol. However， using the stir-fried Vaccariae Semen could reduce the loss of ingredients. The content ratio of toosendanin and isotoosendanin decreased from the crude herb to the prepared medicine when Toosendan Fructus was prepared by water decoction. The reason for the low component content of Gleditsiae Spina may be attributed to manufacturers using excessive non-medicinal parts in their formulations. ConclusionIt is suggested that enterprises should ensure the quality of raw material inputs， especially those without quality-control items in the standard， reduce the use of non-medicinal parts， and prohibit arbitrary alterations to manufacturing methods or processes. It is also recommended that Vaccariae Semen in Rukuaixiao capsules and granules should be changed to the stir-fried processed products. Isotoosendanin should be taken into consideration in the drug supervision when Toosendan Fructus is prepared into medicine by water decoction. Salvianolic acid B should be set as a quality control index for Salviae Miltiorrhizae Radix et Rhizoma when revising the pharmacopoeia standard of Rukuaixiao preparations.

ObjectiveBased on multi-index and multi-method detection， the quality of Rukuaixiao preparations was systematically evaluated from the perspective of characteristic components， and the existing problems were analyzed. MethodsLiquid chromatography-mass spectrometry（LC-MS） for the determination of 16 characteristic components was established to evaluate the quality of 129 batches of Rukuaixiao preparations. High performance liquid chromatography（HPLC） was established to determine the contents of salvianolic acids and tanshinones， investigate the rationality of quality control index of Salviae Miltiorrhizae Radix et Rhizoma in the standard for Rukuaixiao preparations in the 2020 edition of Pharmacopoeia of the People's Republic of China（hereinafter referred to as Chinese Pharmacopoeia） （volume Ⅰ）， and trace the causes of significant difference among different batches. The processing and different extraction methods of Vaccariae Semen were tested， analyzing the impact of formulation changes across different editions of Chinese Pharmacopoeia. The LC-MS was established for determining the changes in the ratio of toosendanin and isotoosendanin after water extraction of Toosendan Fructus. The contents of active components in different parts of Gleditsiae Spina were determined to identify the reason of the low contents of characteristic components in some enterprises. ResultsBased on the comprehensive analysis of the samples from different dosage forms， the contents of characteristic components of Vaccariae Semen and Gleditsiae Spina in tablets from manufacturer B and granules from manufacturer D were significantly higher than those in tablets from manufacturer A， and tablets and capsules from manufacturer C. The contents of tanshinones in some batches of products from manufacturer A were abnormally high， potentially linked to the use of 70% ethanol reflux during extraction of Salviae Miltiorrhizae Radix et Rhizoma. All samples from manufacturer C exhibited abnormally high proportions of salvianic acid A and 3，4-dihydroxybenzaldehyde（salvianolic acid degradation products） to the total seven phenolic acids， indicating a risk of blindly pursuing tanshinol content and neglecting more effective components. The extraction rate of the characteristic components from Vaccariae Semen by decocting with water was obviously higher than that by reflux extraction with 70% ethanol. However， using the stir-fried Vaccariae Semen could reduce the loss of ingredients. The content ratio of toosendanin and isotoosendanin decreased from the crude herb to the prepared medicine when Toosendan Fructus was prepared by water decoction. The reason for the low component content of Gleditsiae Spina may be attributed to manufacturers using excessive non-medicinal parts in their formulations. ConclusionIt is suggested that enterprises should ensure the quality of raw material inputs， especially those without quality-control items in the standard， reduce the use of non-medicinal parts， and prohibit arbitrary alterations to manufacturing methods or processes. It is also recommended that Vaccariae Semen in Rukuaixiao capsules and granules should be changed to the stir-fried processed products. Isotoosendanin should be taken into consideration in the drug supervision when Toosendan Fructus is prepared into medicine by water decoction. Salvianolic acid B should be set as a quality control index for Salviae Miltiorrhizae Radix et Rhizoma when revising the pharmacopoeia standard of Rukuaixiao preparations.

INTRODUCTION: Lecanemab has shown promise in treating early Alzheimer's disease (AD), but its safety and efficacy in Chinese populations remain unexplored. This study aimed to evaluate the safety and 6-month clinical outcomes of lecanemab in Chinese patients with mild cognitive impairment (MCI) or mild AD. METHODS: In this single-arm, real-world study, participants with MCI due to AD or mild AD received biweekly intravenous lecanemab (10 mg/kg). The study was conducted at Hainan Branch, Ruijin Hospital Shanghai Jiao Tong University School of Medicine. Patient enrollment and baseline assessments commenced in November 2023. Safety assessments included monitoring for amyloid-related imaging abnormalities (ARIA) and other adverse events. Clinical and biomarker changes from baseline to 6 months were evaluated using cognitive scales (mini-mental state examination [MMSE], montreal cognitive assessment [MoCA], clinical dementia rating-sum of boxes [CDR-SB]), plasma biomarker analysis, and advanced neuroimaging. RESULTS: A total of 64 patients were enrolled in this ongoing real-world study. Safety analysis revealed predominantly mild adverse events, with infusion-related reactions (20.3%, 13/64) being the most common. Of these, 69.2% (9/13) occurred during the initial infusion and 84.6% (11/13) did not recur. ARIA-H (microhemorrhages/superficial siderosis) and ARIA-E (edema/effusion) were observed in 9.4% (6/64) and 3.1% (2/64) of participants, respectively, with only two symptomatic cases (one ARIA-E presenting with headache and one ARIA-H with visual disturbances). After 6 months of treatment, cognitive scores remained stable compared to baseline (MMSE: 22.33 ± 5.58 vs . 21.27 ± 4.30, P = 0.733; MoCA: 16.38 ± 6.67 vs . 15.90 ± 4.78, P = 0.785; CDR-SB: 2.30 ± 1.65 vs . 3.16 ± 1.72, P = 0.357), while significantly increasing plasma amyloid-β 42 (Aβ42) (+21.42%) and Aβ40 (+23.53%) levels compared to baseline. CONCLUSIONS: Lecanemab demonstrated a favorable safety profile in Chinese patients with early AD. Cognitive stability and biomarker changes over 6 months suggest potential efficacy, though high dropout rates and absence of a control group warrant cautious interpretation. These findings provide preliminary real-world evidence for lecanemab's use in China, supporting further investigation in larger controlled studies. REGISTRATION ClinicalTrials.gov , NCT07034222.
Humans ; Alzheimer Disease/drug therapy* ; Male ; Female ; Aged ; Middle Aged ; Cognitive Dysfunction/drug therapy* ; Aged, 80 and over ; Amyloid beta-Peptides/metabolism* ; Biomarkers ; East Asian People