1.Application Characteristics and Patterns of Marketed Traditional Chinese Patent Medicines for Treating Abortion
Changyue SONG ; Shuangfei DENG ; Siyu LI ; Daiyue DING ; Jinghong XIE ; Xiaohui SU ; Xiangying KONG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(11):244-251
ObjectiveThis paper aims to analyze the variety characteristics and prescription patterns of marketed traditional Chinese patent medicines for treating abortion and provide references for new medicine development and clinical application. MethodsRelevant information of traditional Chinese patent medicines for treating abortion was systematically retrieved and collected. Microsoft Excel 2021 software was used to sort and statistically analyze the medicine syndrome types, quantity, market situation, and status of package inserts. Based on the Ancient and Modern Medical Case Cloud Platform (V2.3.9), the medicine properties, flavors, meridian tropism, and medication characteristics of standardized prescriptions were analyzed. ResultsA total of 39 marketed traditional Chinese patent medicines for treating abortion in China were included. According to disease type, these medicines were categorized as therapeutic medicines for threatened abortion and recurrent spontaneous abortion. According to clinical function, they were categorized into three groups: fetus stabilization, blood nourishment, and adjunctive conditioning. They were also categorized into pre-pregnancy conditioning and post-pregnancy fetal maintenance by clinical intervention stage. Post-marketing research showed that only three products had undergone safety evaluations and one involved pharmacoeconomic research, indicating a general lack of standardized evidence-based data. Dosage forms were mainly pills and granules. Package insert analysis revealed that 15 products listed "contraindications", while 28 included "precautions". Based on prescription inclusion and exclusion criteria, 25 products were selected for further analysis. Their therapeutic effects were mainly concentrated on "tonifying the kidney and spleen, replenishing Qi, and nourishing blood", with core medicines including Paeoniae Radix Alba, Angelicae Sinensis Radix, and Atractylodis Macrocephalae Rhizoma. Most medicines were warm or neutral in nature, predominantly sweet and pungent in flavor, and mainly entered the spleen, liver, and kidney meridians. ConclusionTraditional Chinese patent medicines for treating abortion demonstrate clear clinical value. However, shortcomings remain, including insufficient post-marketing research, prescription homogeneity, and incomplete package inserts. Future efforts should establish a clinically value-oriented modern development pathway, strengthen safety surveillance and evidence evaluation, improve package inserts, and promote precision use to further enhance clinical value.
2.Analysis of Variety Characteristics and Patterns of Marketed Traditional Chinese Patent Medicines for Treating Chronic Gastritis
Daiyue DING ; Changyue SONG ; Shuangfei DENG ; Siyu LI ; Xiangying KONG ; Xiaohui SU ; Na LIN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(11):252-260
ObjectiveThis study aims to systematically review the marketed traditional Chinese patent medicines for treating chronic gastritis (CG) in China. By analyzing their variety characteristics and prescription patterns, it seeks to provide references for clinical syndrome differentiation-based drug selection, treatment method optimization, and the design of high-quality clinical research. MethodsInformation on marketed traditional Chinese patent medicines for treating CG was collected. Microsoft Excel software was used to collate and statistically analyze representative drugs for each pathological stage, market status, syndrome types, and other contents. The Ancient and Modern Medical Case Cloud Platform (V2.3.9) was employed to analyze the formula composition patterns of standardized prescriptions. ResultsA total of 141 marketed traditional Chinese patent medicines for treating CG in China were included. Based on the disease's pathological progression, they can be classified into drugs for non-atrophic gastritis, atrophic gastritis, and precancerous lesions. Post-marketing research reveals that relevant evaluation is only conducted on 17 drugs, of which 2 involve pharmacoeconomic studies and 14 possess standardized evidence-based evidence. The primary dosage forms were capsules, granules, and tablets. From the 100 prescriptions screened according to inclusion/exclusion criteria, the varieties indicated for the stomach collateral stasis syndrome in atrophic gastritis accounted for the highest proportion. The main efficacy distributions were clearing heat, detoxifying, and relieving pain by promoting Qi circulation. Core drugs included Glycyrrhizae Radix et Rhizome, Paeoniae Radix Alba, and Aucklandiae Radix. Medicinal properties were predominantly warm and neutral. Flavors were mainly bitter, pungent, and sweet. The drugs primarily entered the spleen and stomach meridians. Analysis of the package inserts reveals that 67 products list "contraindications", 110 include "precautions", and 23 explicitly state "adverse reactions". ConclusionTraditional Chinese patent medicines for treating CG hold unique value in clinical practice. However, currently there are challenges such as insufficient clarity in syndrome type descriptions within package inserts and a relative lack of high-level evidence-based medical evidence, as well as pharmacoeconomic evaluations. Future efforts should focus on addressing these shortcomings by advancing research on syndrome characteristics and medication patterns based on syndrome differentiation, systematically conducting pharmacoeconomic evaluations, strengthening the accumulation of high-level evidence-based evidence, and, on this basis, improving patient medication adherence. This will comprehensively enhance the clinical application value and scientific connotation of this category of drugs.
3.Analysis on Characteristics and Prescriptions of Chinese Patent Medicines for Functional Diarrhea on Market
Shuangfei DENG ; Siyu LI ; Changyue SONG ; Caiyu LIU ; Daiyue DING ; Xiaohui SU ; Xiaoqin LUO ; Haiyu ZHAO ; Xiangying KONG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(11):261-268
ObjectiveThis study focused on the marketed Chinese patent medicines for the treatment of Functional Diarrhea (FDr) in China and their prescription characteristics, in order to provide support for the clinical application and research and development of anti-FDr Chinese patent medicines. MethodsCollect the information of Chinese patent medicines that have been marketed to treat FDr, use Microsoft Excel 2021 software to conduct preliminary data collation and statistical analysis, and use the ancient and modern medical record cloud platform (V2.3.9) to analyze the standardized Chinese patent medicine prescriptions from the aspects of drug nature and taste, medication characteristics and prescription rules. Results147 kinds of FDr Chinese patent medicines were included in this study. There are a total of 40 varieties of FDr Chinese patent medicines suitable for children; The distribution of dosage forms is mainly pills, tablets, and capsules. 110 prescriptions were screened, among which the proportion of Chinese patent medicines for the treatment of spleen deficiency syndrome was the highest; The top three drug use frequency were licorice, Atractylodes macrocephala, and Poria cocos; The medicinal properties are mainly warm and flat, and the medicinal taste is mostly pungent, sweet and bitter, and most of them belong to the two meridians of the spleen and stomach; The association rules analysis obtains 20 strong association pairing sets; Three drug combinations were obtained by cluster analysis. ConclusionFDr Chinese patent medicine shows unique value in clinical application, especially in the field of children. However, there are still problems such as strong professionalism in the indication expression of drug instructions, limited coverage of the medical insurance catalog, and lack of high-level evidence-based medicine and pharmacoeconomic evidence. To this end, in the future, efforts should be made to build a multi-level evidence-based evidence system, improve medication compliance, and deepen research on syndrome-based medication laws, so as to enhance the clinical application value and scientific connotation of FDr Chinese patent medicines.
4.Characteristics and Prescription Analysis of Marketed Chinese Patent Medicines for Rheumatoid Arthritis
Siyu LI ; Shuangfei DENG ; Daiyue DING ; Changyue SONG ; Xiaohui SU ; Xiangying KONG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(11):269-276
ObjectiveTo study the marketed products and prescription characteristics of Chinese patent medicines for rheumatoid arthritis (RA) in China, thus providing support for clinical application and innovative research and development of Chinese patent medicines for RA. MethodsInformation on marketed Chinese patent medicines for RA treatment was collected. Preliminary data organization and statistical analysis were performed in Microsoft Excel 2021. Subsequently, the standardized prescriptions were analyzed via the Ancient and Modern Medical Case Cloud Platform (V2.3.9) across dimensions including medicinal properties, flavors, channel tropisms, usage characteristics, and formulation patterns. ResultsThis study ultimately included 311 marketed Chinese patent medicines for RA in China. Their initial market launch dates were mostly concentrated from the 1990s to the early 21st century. The National Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance Drug Directory included 89 Chinese patent medicines for RA. The primary dosage forms were tablets, capsules, medicated wines, and pills. After screening, 237 prescriptions were obtained, and the research on their origins was lagging. Among them, the Chinese patent medicines for treating wind-cold-dampness obstruction syndrome accounted for the highest proportion. The top three most frequently used medicinals were Angelicae Sinensis Radix, Notopterygii Rhizoma et Radix, and Saposhnikoviae Radix. Medicinal properties were primarily warm and plain, and flavors were mostly pungent, sweet, and bitter. The medicinals predominantly exhibited the liver and spleen channel tropism. Association rule analysis revealed that the herb pairs with the highest confidence were Chuanxiong-Angelicae Sinensis Radix and Myrrha-Olibanum. Cluster analysis yielded three medicinal combinations. ConclusionAlthough Chinese patent medicines for RA have application advantages, issues such as narrow syndrome coverage and insufficient innovation in dosage forms exist. Future development should focus on constructing an evidence-based system, strengthening the textual research on prescription origins and the exploration of classical famous formulas, and promoting dosage form innovation and precise medication to enhance their clinical value.
5.Association of mixed exposure to lithium, vanadium, uranium, and bismuth in early pregnancy with gestational weight gain
Jiao LI ; Qi LI ; Shuang CHENG ; Jiayi SONG ; Xiaohui GUO ; Xiang WANG ; Di CHENG ; Kefeng FAN ; Ju WANG
Journal of Environmental and Occupational Medicine 2026;43(4):475-484
Background Gestational weight gain is closely related to maternal and infant health outcomes. Pregnant women are simultaneously exposed to four metals—lithium (Li), vanadium (V), uranium (U), and bismuth (Bi)—through inhalation of fine particulate matter and consumption of contaminated food and water. Existing studies suggest that exposure to these metals may be associated with gestational weight gain. However, no study has yet explored the complex relationships between exposure to mixtures of these four metals and weight gain at different stages of pregnancy. Objective To investigate the associations between mixed exposure to Li, V, U, and Bi in early pregnancy and the average weekly gestational weight gain during both early pregnancy and mid-to-late pregnancy. Methods This prospective study recruited eligible women in early pregnancy from an obstetrics clinic of a tertiary hospital in Jinan, China, between September 2021 and July 2023. Pre-pregnancy weight, current weight (at 11+0 to 13+6 weeks of gestation), and spot urine samples (≥5.0 mL) were collected at enrollment. Urinary concentrations of Li, V, Bi, and U were determined using inductively coupled plasma mass spectrometry. Participants were followed up in late pregnancy (≥28 weeks of gestation) to collect information on physical activity via questionnaire; weight measurements at the last antenatal visit (35+0 to 37+6 weeks of gestation) were obtained from the hospital information system. After adjusting for covariates, multiple linear regression and generalized additive models were used to assess the associations of individual metals with weekly weight gain in early pregnancy and in mid-to-late pregnancy. Bayesian kernel machine regression (BKMR) and quantile-based g-computation (Qgcomp) were applied to evaluate the joint effects of the metal mixture exposure on weekly weight gain at the two gestational stages. Results A total of 313 pregnant women were included. The geometric means of urinary Li, V, U, and Bi concentrations were 37.07, 0.20, 0.06, and 0.04 μg·L−1, respectively; after creatinine adjustment, the corresponding values were 46.82, 0.25, 0.07, and 0.05 μg·g−1 (Cr). The mean weekly gestational weight gain was (0.19±0.25) kg in early pregnancy and (0.53 ± 0.18) kg in mid-to-late pregnancy. Both multiple linear regression and generalized additive models showed that urinary V concentration was positively associated with average weekly gestational weight gain in early pregnancy, while no significant associations were found for other metals or for gestational weight gain in mid-to-late pregnancy. In the BKMR model with early-pregnancy weight gain as the outcome, V had the strongest association [posterior inclusion probability (PIP)=0.773]. When other metals were fixed at their medians, V showed a positive non-linear association with the outcome. A significant single-metal effect of V and its interaction with Li were observed. Compared with the 50th percentile of the metal mixture, the average weekly weight gain in early pregnancy increased by 0.016 (95%CI: 0.003, 0.029) and 0.018 (95%CI: 0.001, 0.036) at the 60th and 65th percentiles, respectively; conversely, at the 25th percentile, it decreased by 0.026 (95%CI: 0.002, 0.050). Overall, the joint effect of the metal mixture on early- pregnancy weight gain showed an upward trend. In the BKMR model for mid-to-late pregnancy gestational weight gain, all PIPs were<0.5, and no significant single-metal effects, interactions, or joint effects were identified. Qgcomp results confirmed a positive association between the metal mixture and early-pregnancy weight gain (b=0.031, 95%CI: 0.010, 0.051; P<0.01), with V contributing the highest positive weight (0.71). No significant association was found for weight gain in mid-to-late pregnancy (b=0.007, P=0.339). Conclusion Higher levels of co-exposure to the Li, V, Bi, and U metal mixture during early pregnancy may be associated with increased average weekly weight gain in early pregnancy. Among these metals, V exhibits a predominant role and appears to interact with Li. No association is observed between early-pregnancy metal mixture exposure and average weekly gestational weight gain in mid-to-late pregnancy. These findings suggest that monitoring and managing metal exposure during early pregnancy may be crucial for the rational regulation of gestational weight gain.
6.Expert consensus on neoadjuvant PD-1 inhibitors for locally advanced oral squamous cell carcinoma (2026)
LI Jinsong ; LIAO Guiqing ; LI Longjiang ; ZHANG Chenping ; SHANG Chenping ; ZHANG Jie ; ZHONG Laiping ; LIU Bing ; CHEN Gang ; WEI Jianhua ; JI Tong ; LI Chunjie ; LIN Lisong ; REN Guoxin ; LI Yi ; SHANG Wei ; HAN Bing ; JIANG Canhua ; ZHANG Sheng ; SONG Ming ; LIU Xuekui ; WANG Anxun ; LIU Shuguang ; CHEN Zhanhong ; WANG Youyuan ; LIN Zhaoyu ; LI Haigang ; DUAN Xiaohui ; YE Ling ; ZHENG Jun ; WANG Jun ; LV Xiaozhi ; ZHU Lijun ; CAO Haotian
Journal of Prevention and Treatment for Stomatological Diseases 2026;34(2):105-118
Oral squamous cell carcinoma (OSCC) is a common head and neck malignancy. Approximately 50% to 60% of patients with OSCC are diagnosed at a locally advanced stage (clinical staging III-IVa). Even with comprehensive and sequential treatment primarily based on surgery, the 5-year overall survival rate remains below 50%, and patients often suffer from postoperative functional impairments such as difficulties with speaking and swallowing. Programmed death receptor-1 (PD-1) inhibitors are increasingly used in the neoadjuvant treatment of locally advanced OSCC and have shown encouraging efficacy. However, clinical practice still faces key challenges, including the definition of indications, optimization of combination regimens, and standards for efficacy evaluation. Based on the latest research advances worldwide and the clinical experience of the expert group, this expert consensus systematically evaluates the application of PD-1 inhibitors in the neoadjuvant treatment of locally advanced OSCC, covering combination strategies, treatment cycles and surgical timing, efficacy assessment, use of biomarkers, management of special populations and immune related adverse events, principles for immunotherapy rechallenge, and function preservation strategies. After multiple rounds of panel discussion and through anonymous voting using the Delphi method, the following consensus statements have been formulated: 1) Neoadjuvant therapy with PD-1 inhibitors can be used preoperatively in patients with locally advanced OSCC. The preferred regimen is a PD-1 inhibitor combined with platinum based chemotherapy, administered for 2-3 cycles. 2) During the efficacy evaluation of neoadjuvant therapy, radiographic assessment should follow the dual criteria of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune RECIST (iRECIST). After surgery, systematic pathological evaluation of both the primary lesion and regional lymph nodes is required. For combination chemotherapy regimens, PD-L1 expression and combined positive score need not be used as mandatory inclusion or exclusion criteria. 3) For special populations such as the elderly (≥ 70 years), individuals with stable HIV viral load, and carriers of chronic HBV/HCV, PD-1 inhibitors may be used cautiously under the guidance of a multidisciplinary team (MDT), with close monitoring for adverse events. 4) For patients with a poor response to neoadjuvant therapy, continuation of the original treatment regimen is not recommended; the subsequent treatment plan should be adjusted promptly after MDT assessment. Organ transplant recipients and patients with active autoimmune diseases are not recommended to receive neoadjuvant PD-1 inhibitor therapy due to the high risk of immune related activation. Rechallenge is generally not advised for patients who have experienced high risk immune related adverse events such as immune mediated myocarditis, neurotoxicity, or pneumonitis. 5) For patients with a good pathological response, individualized de escalation surgery and function preservation strategies can be explored. This consensus aims to promote the standardized, safe, and precise application of neoadjuvant PD-1 inhibitor strategies in the management of locally advanced OSCC patients.
7.Protective Effect of Bushen Zhuyun Prescription on Abortion Rats with Kidney Deficiency-Corpus Luteum Inhibition Syndrome via ERα/PI3K/Akt Signaling Pathwa
Changyue SONG ; Siyu LI ; Fengyu HUANG ; Mingzhu QI ; Daiyue DING ; Shuangfei DENG ; Heqiao LI ; Jinghong XIE ; Guohua WANG ; Chen ZANG ; Hong XU ; Xiaohui SU ; Xiangying KONG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(24):107-116
ObjectiveTo investigate the protective effects and mechanisms of Bushen Zhuyun prescription (BSZY) on abortion rats with kidney deficiency-corpus luteum inhibition syndrome. MethodsAn abortion rat model with kidney deficiency-corpus luteum inhibition syndrome was constructed. Pregnant mice aged 8-10 weeks were randomly divided into a control group (Control), a model group (Model), low-dose BSZY (BSZY-L), medium-dose BSZY (BSZY-M), and high-dose BSZY (BSZY-H) groups (2.57, 5.14, 10.28 g·kg-¹), and a Zishen Yutai Pill (ZSYT) group (1.575 g·kg-¹). Hematoxylin-eosin (HE) staining was used to evaluate histopathological changes in ovarian and decidual tissue of rats in each group. Enzyme-linked immunosorbent assay (ELISA) was employed to measure levels of estrogen (E₂), progesterone (P), luteinizing hormone (LH), prolactin (PRL), and follicle-stimulating hormone (FSH) in serum. The candidate targets of BSZY were obtained from the Traditional Chinese Medicine System Pharmacology Platform (TCMSP) and Integrative Pharmacology-based Research Platform of Traditional Chinese Medicine (TCMIP) v2.0 databases, while disease targets for recurrent spontaneous abortion (RSA) were retrieved from GeneCards, DrugBank, Online Mendelian Inheritance in Man (OMIM), and Therapeutic Target Database (TTD). The intersection targets were identified by the Venny 2.1.0 platform. Pathway enrichment analysis was conducted based on the Metascape database to predict the potential mechanisms of BSZY. Additionally. Western blot was used to verify the effects of BSZY on the expression of estrogen receptor (ERα), phosphatidylinositol 3-kinase (PI3K), and protein kinase B (Akt) and explore its protective mechanism on RSA rats. ResultsCompared with the control group, the model group exhibited significantly decreased uterine, ovarian, and embryonic wet weights (P<0.05, P<0.01), with an abortion rate of 57.18%. The ovarian tissue showed varying degrees of reduction in primordial follicles, primary follicles, mature follicles, and corpora lutea, along with a large number of atretic follicles. The endometrium was thinner, and decidual tissue exhibited cellular edema and disorganized arrangement. In contrast, compared with the model group, the BSZY groups at all doses and the ZSYT group demonstrated increased uterine, ovarian, and embryonic wet weights, along with a reduced abortion rate. The number of primordial follicles, primary follicles, mature follicles, and corpora lutea increased, while atretic follicles decreased. The endometrium thickened, and decidual tissue displayed normal cellular structure with tight arrangement. Additionally, the model group showed significantly decreased levels of E₂, P, PRL, and FSH in serum (P<0.05, P<0.01), along with a decreasing trend in LH level. In contrast, the BSZY groups at all doses exhibited significantly elevated levels of E₂, P, LH, PRL, and FSH in serum (P<0.05, P<0.01). Network pharmacology predictions suggested that BSZY may exert protective effects against abortion in rats by activating the ERα/PI3K/Akt signaling pathway. Western blot results confirmed that BSZY significantly upregulated the expression of ERα, PI3K, and p-Akt proteins (P<0.05, P<0.01). ConclusionBSZY has a protective effect on the abortion rats with kidney deficiency-corpus luteum inhibition syndrome, possibly by activating the ERα/PI3K/Akt signaling pathway to reduce ovarian apoptosis and regulate endocrine function, thereby lowering the abortion rate.
8.Genome-wide identification, characterization, and expression analysis of MAPK genes in response to Plasmodiophora brassicae infection in Brassica juncea.
Chu XU ; Haiping WANG ; Jiangping SONG ; Xiaohui ZHANG ; Huixia JIA ; Jiaqi HAN ; Zhijie LI ; Sen LI ; Wenlong YANG
Chinese Journal of Biotechnology 2025;41(2):736-752
In recent years, the spread of clubroot disease caused by Plasmodiophora brassicae infection has seriously affected the yield and quality of Brassica juncea (L.) Czern.. The cascade of mitogen-activated protein kinases (MAPKs), a highly conserved signaling pathway, plays an important role in plant responses to both biotic and abiotic stress conditions. To mine the MAPK genes related to clubroot disease resistance in B. juncea, we conducted a genome-wide analysis on this vegetable, and we analyzed the phylogenetic evolution and gene structure of the MAPK gene family in mustard. The 66 BjuMAPK genes identified by screening the whole genome sequence of B. juncea were unevenly distributed on 17 chromosomes. At the genomic scale, tandem repeats led to an increase in the number of MAPK genes in B. juncea. It was found that members of the same subfamily had similar gene structures, and there were great differences among different subfamilies. These predicted cis-acting elements were related to plant hormones, stress resistance, and plant growth and development. The expression of BjuMAPK02, BjuMAPK15, BjuMAPK17, and BjuMAPK19 were down-regulated or up-regulated in response to P. brassicae infection. The above results lay a theoretical foundation for further studying the functions of BjuMAPK genes in B. juncea in response to the biotic stress caused by clubroot disease.
Mustard Plant/parasitology*
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Plasmodiophorida/pathogenicity*
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Plant Diseases/genetics*
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Mitogen-Activated Protein Kinases/metabolism*
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Phylogeny
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Disease Resistance/genetics*
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Gene Expression Regulation, Plant
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Genome, Plant
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Plant Proteins/genetics*
9.Enhanced radiotheranostic targeting of integrin α5β1 with PEGylation-enabled peptide multidisplay platform (PEGibody): A strategy for prolonged tumor retention with fast blood clearance.
Siqi ZHANG ; Xiaohui MA ; Jiang WU ; Jieting SHEN ; Yuntao SHI ; Xingkai WANG ; Lin XIE ; Xiaona SUN ; Yuxuan WU ; Hao TIAN ; Xin GAO ; Xueyao CHEN ; Hongyi HUANG ; Lu CHEN ; Xuekai SONG ; Qichen HU ; Hailong ZHANG ; Feng WANG ; Zhao-Hui JIN ; Ming-Rong ZHANG ; Rui WANG ; Kuan HU
Acta Pharmaceutica Sinica B 2025;15(2):692-706
Peptide-based radiopharmaceuticals targeting integrin α5β1 show promise for precise tumor diagnosis and treatment. However, current peptide-based radioligands that target α5β1 demonstrate inadequate in vivo performance owing to limited tumor retention. The use of PEGylation to enhance the tumor retention of radiopharmaceuticals by prolonging blood circulation time poses a risk of increased blood toxicity. Therefore, a PEGylation strategy that boosts tumor retention while minimizing blood circulation time is urgently needed. Here, we developed a PEGylation-enabled peptide multidisplay platform (PEGibody) for PR_b, an α5β1 targeting peptide. PEGibody generation involved PEGylation and self-assembly. [64Cu]QM-2303 PEGibodies displayed spherical nanoparticles ranging from 100 to 200 nm in diameter. Compared with non-PEGylated radioligands, [64Cu]QM-2303 demonstrated enhanced tumor retention time due to increased binding affinity and stability. Importantly, the biodistribution analysis confirmed rapid clearance of [64Cu]QM-2303 from the bloodstream. Administration of a single dose of [177Lu]QM-2303 led to robust antitumor efficacy. Furthermore, [64Cu]/[177Lu]QM-2303 exhibited low hematological and organ toxicity in both healthy and tumor-bearing mice. Therefore, this study presents a PEGibody-based radiotheranostic approach that enhances tumor retention time and provides long-lasting antitumor effects without prolonging blood circulation lifetime. The PEGibody-based radiopharmaceutical [64Cu]/[177Lu]QM-2303 shows great potential for positron emission tomography imaging-guided targeted radionuclide therapy for α5β1-overexpressing tumors.
10.Research status of prediction models for post-stroke neurological deterioration:a scoping review
Xiaohui SUN ; Zhuoma PENGMAO ; Xiaowei SONG ; Ceshu GAO ; Jian WU
Chinese Journal of Cerebrovascular Diseases 2025;22(4):235-251
Objective To evaluate the modeling characteristics and predictive performance of models for predicting post-stroke neurological deterioration(ND)published in existing literatures.Methods Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses(PRISMA)guidance for scoping reviews,a comprehensive search was conducted in PubMed,CINAHL,Cochrane Library,Embase,Web of Science,Scopus,CNKI,Wanfang Data,and VIP databases from inception to December 15,2024.The search strategy combined Medical Subject Headings(MeSH)and free-text terms,with key words including"Stroke""Ischemic Stroke""Neurological Deterioration""Nomograms""Risk Prediction""Predictive Models""卒中""脑梗死""脑出血""神经功能恶化"and"预测模型".Base on the data extraction checklist and critical appraisal,data extraction covered three domains:(1)basic characteristics,including author,publication year,country,study design(retrospective,prospective,registry-based),sample source(single-center,multicenter),stroke subtypes(acute ischemic stroke[AIS]-conservative therapy,AIS-intravenous thrombolysis[IVT],AIS-endovascular therapy[EVT],intracerebral hemorrhage[ICH]),ND time windows(acute[≤72 h],subacute[≤ 7 d],long-term[≤90 d]),and outcome types(single/composite endpoints);(2)model evaluation metrics,including missing data handling(complete-case analysis,multiple imputation),model development methodologies(multivariate Logistic regression,least absolute shrinkage and selection operator regression,machine learning),presentation formats(nomograms,web calculators,risk prediction tool),discrimination(area under the curve,C-index),calibration(Hosmer-Lemeshow test,calibration curve and slope),clinical utility(decision curve analysis[DCA],global metrics Brier score,R2,AIC),sample size(training set,internal validation set,external validation set),sample size requirements(events per variable[EPV]≥10 to mitigate overfitting),and validation(internal/external);(3)predictor features,including selection strategies(prior knowledge-driven,univariate analysis),quantity,and attributes(demographics,medical history,physical examination,treatment intervention information,imaging/laboratory indicators).Predictive models that meet exclusion criteria from prior literature were analyzed by their discrimination,calibration,clinical utility and global metrics.Forest plots were utilized to visualize discrimination(evaluated via difference in area under the curve)of the extracted models.The prediction model risk of bias assessment tool(PROBAST)was applied to assess bias risk and clinical applicability.Occurrence frequencies of the post-stroke neurological deterioration predictors were ranked and the top 6 high-frequency predictors were extracted.Results(1)Among 3 728 screened studies,25 were included based on the inclusion and exclusion criteria.(2)Basic characteristics:retrospective(72%[18/25])and single-center(64%[16/25])designs dominated.With most models targeted on AIS(92%[23/25]),and the rest(8%[2/25])on ICH.ND was primarily defined by neurological scale changes(60%[15/25];e.g.,National Institutes of Health stroke scale[NIHSS]score increase or Glasgow coma scale[GCS]score decrease),with time windows categorized as acute(36%[9/25]),subacute(48%[12/25]),or long-term(16%[4/25]).(3)Model evaluation:multivariate Logistic regression(96%[24/25])and nomograms(88%[22/25])were predominant.Only 24%(6/25)explicitly addressed missing data handling methods,and 52%(13/25)with EPV≥10.The median area under the curve was 0.865(range:0.650-0.981).44%(11/25)of the studies reported calibration curves,and 4%(1/25)reported calibration slopes.All studies utilized DCA to validate their clinical applicability,84%(21/25)of the studies conducted internal validation,while only 32%(8/25)conducted external validation.PROBAST evaluation revealed low overall bias risk in 8%(2/25;no error across participant,predictor,outcome,or analysis domains)and low clinical applicability risk in 44%(11/25;alignment with target populations,accessible predictors,and clinically relevant outcomes)of the studies.(4)Predictors:64%(16/25)of the predictor were screened predominantly through the prior knowledge-driven based strategy.The top 6 high-frequency predictors are NIHSS score(64%[16/25]),age(36%[9/25]),blood glucose/diabetes(36%[9/25]),blood pressure/hypertension(32%[8/25]),the Alberta stroke program early CT score(20%[5/25]),and neutrophil-to-lymphocyte ratio(20%[5/25]).AIS-ND predictors emphasized readily available metrics,such as NIHSS(65%[15/23]),age(35%[8/23]),while ICH-ND primarily relied on imaging markers(e.g.,baseline hematoma volume[2/2],location[1/2]).Conclusion Current post-stroke ND predictive models demonstrate satisfactory performance on discrimination and multimodal integration,but their practical application are hindered by insufficient calibration quantification,high bias risk,and limited clinical translatability.


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