1.Structure, content and psychometric properties of assessment tools for interoceptive function: a scoping review based on COSMIN and ICF
Xiaoxiao WANG ; Lu QU ; Jiaxin WANG ; Meiping ZHAO ; Muzi LI ; Qiaoyun LIU
Chinese Journal of Rehabilitation Theory and Practice 2025;31(2):172-183
ObjectiveTo review the interoceptive assessment tools in terms of structure, content and psychometric properties, based on the framework of the International Classification of Functioning, Disability and Health (ICF). MethodsThe literature on interoceptive evaluation tools was retrieved from databases of CNKI, PubMed, Medline and EBSCO. The principal structures and contents of the assessment tools were analyzed based on the ICF framework, and the quality of the psychometric properties were appraised using COSMIN. ResultsA total of 13 interoceptive assessment tools were ultimately included, involving 16 literature references. There were five interoceptive sensitivity tools, four accuracy tools and four awareness tools. In terms of content, interoceptive sensitivity tools involved 33 categories of body functions, six categories of activities and participation, and one of environmental factors; while interoceptive accuracy tools only involved seven categories of body function, and two of activities and participation items; interoceptive awareness tools involved 30 categories of body function, four categories of activities and participation, and three of environmental factors. In terms of psychometric properties, Body Perception Questionnaire-Short Form (BPQ-SF) was the sensitivity tool with the best reliability and validity (qualified rate of 7/8), followed by Interoceptive Sensitivity Questionnaire (ISQ) (qualified rate of 6/8). Most of the accuracy tools adopted standardized measurement methods, but lacked sufficient reliability and validity verification. The awareness tools were good in reliability and validity (qualified rate above 5/8), especially Multidimensional Assessment of Interoceptive Awareness (MAIA-1) and Body Awareness Questionnaire (BAQ) (qualified rate of 8/8). ConclusionBPQ-SF and ISQ are recommended for interoceptive sensitivity assessment, Water-loading Test and Heart-beat Tracking Task for interoceptive accuracy assessment, and MAIA-1 and BAQ for interoceptive awareness assessment.
2.Analysis of Differential Compounds of Poria cocos Medicinal Materials by Integrated Qualitative Strategy Based on UPLC-Q-Orbitrap-MS
Jiayuan WANG ; Xiaohan FAN ; Xiaoxiao WEI ; Rong CAO ; Jin WANG ; Lei WANG ; Fengqing XU ; Shunwang HUANG ; Deling WU ; Hongsu ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):148-156
ObjectiveTo establish a rapid analytical method for identifying the differential components in Poria cocos medicinal materials based on ultra performance liquid chromatography-quadrupole-electrostatic field orbital trap high-resolution mass spectrometry(UPLC-Q-Orbitrap-MS), combined with mass defect filtering(MDF) and molecular network integration techniques. MethodsUPLC-Q-Orbitrap-MS was used for MS data acquisition and identification of P. cocos medicinal materials, with the help of MDF for the study of cleavage behavior and structural identification of triterpenoids. According to the similarity of MS/MS fragmentation patterns of each component, global natural product social molecular network(GNPS) was established, and Cytoscape 3.6.1 was used to screen molecular clusters with similar structures and the the structure of main compound classes were identified and confirmed. Multivariate statistical analyses such as principal component analysis(PCA) and orthogonal partial least squares-discriminant analysis(OPLS-DA) were used to screen the differential components of the five P. cocos medicinal materials with the variable importance in the projection(VIP) value>1 and P<0.05 as the criteria. ResultsA total of 66 compounds were identified by database comparison, 8 compounds were newly identified by MDF, 28 compounds were newly identified by GNPS, and a total of 102 chemical compounds were identified, including 43 triterpenoids, 16 saccharides, 26 amino acids and peptides, 3 nucleosides, and 14 other compounds. Triterpenoids were predominant in Poriae Cutis and wild Fushen, amino acids and peptides were the most abundant in Poria and cultivated Fushen, carbohydrates were the most abundant in Poriae Cutis. Type Ⅰ and Ⅱ triterpenoids had higher amounts in Poria and cultivated Fushen, type Ⅲ triterpenoids were more abundant in Poriae Cutis, all four types of triterpenoids were higher in Fushenmu, and type Ⅰ, Ⅱ, and Ⅳ triterpenoids were higher in wild Fushen. A total of 12 common differential chemical constituents were screened, including serine, guanosine, gallic acid, 2-octenal, maltotriose, trametenolic acid, dehydroeburicoic acid, dehydrotrametenolic acid, poricoic acid A, poricoic acid B, poricoic acid E and G, but the relative contents of them varied significantly among different medicinal materials. ConclusionAmong the five P. cocos medicinal materials, the types of constituents are generally similar, but their relative contents differed significantly among these medicinal materials, especially in the distribution of triterpenoids. The integration of UPLC-Q-Orbitrap-MS, MDF and GNPS can provide a reference for the rapid qualitative analysis of other Chinese medicines.
3.Analysis of Differential Compounds of Poria cocos Medicinal Materials by Integrated Qualitative Strategy Based on UPLC-Q-Orbitrap-MS
Jiayuan WANG ; Xiaohan FAN ; Xiaoxiao WEI ; Rong CAO ; Jin WANG ; Lei WANG ; Fengqing XU ; Shunwang HUANG ; Deling WU ; Hongsu ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):148-156
ObjectiveTo establish a rapid analytical method for identifying the differential components in Poria cocos medicinal materials based on ultra performance liquid chromatography-quadrupole-electrostatic field orbital trap high-resolution mass spectrometry(UPLC-Q-Orbitrap-MS), combined with mass defect filtering(MDF) and molecular network integration techniques. MethodsUPLC-Q-Orbitrap-MS was used for MS data acquisition and identification of P. cocos medicinal materials, with the help of MDF for the study of cleavage behavior and structural identification of triterpenoids. According to the similarity of MS/MS fragmentation patterns of each component, global natural product social molecular network(GNPS) was established, and Cytoscape 3.6.1 was used to screen molecular clusters with similar structures and the the structure of main compound classes were identified and confirmed. Multivariate statistical analyses such as principal component analysis(PCA) and orthogonal partial least squares-discriminant analysis(OPLS-DA) were used to screen the differential components of the five P. cocos medicinal materials with the variable importance in the projection(VIP) value>1 and P<0.05 as the criteria. ResultsA total of 66 compounds were identified by database comparison, 8 compounds were newly identified by MDF, 28 compounds were newly identified by GNPS, and a total of 102 chemical compounds were identified, including 43 triterpenoids, 16 saccharides, 26 amino acids and peptides, 3 nucleosides, and 14 other compounds. Triterpenoids were predominant in Poriae Cutis and wild Fushen, amino acids and peptides were the most abundant in Poria and cultivated Fushen, carbohydrates were the most abundant in Poriae Cutis. Type Ⅰ and Ⅱ triterpenoids had higher amounts in Poria and cultivated Fushen, type Ⅲ triterpenoids were more abundant in Poriae Cutis, all four types of triterpenoids were higher in Fushenmu, and type Ⅰ, Ⅱ, and Ⅳ triterpenoids were higher in wild Fushen. A total of 12 common differential chemical constituents were screened, including serine, guanosine, gallic acid, 2-octenal, maltotriose, trametenolic acid, dehydroeburicoic acid, dehydrotrametenolic acid, poricoic acid A, poricoic acid B, poricoic acid E and G, but the relative contents of them varied significantly among different medicinal materials. ConclusionAmong the five P. cocos medicinal materials, the types of constituents are generally similar, but their relative contents differed significantly among these medicinal materials, especially in the distribution of triterpenoids. The integration of UPLC-Q-Orbitrap-MS, MDF and GNPS can provide a reference for the rapid qualitative analysis of other Chinese medicines.
4.Key Points for Quality Management in Phase Ⅰ Clinical Trials of Anti-Tumor Drugs
Li GONG ; Bin LIAO ; Jie SHEN ; Juan ZHAO ; Yi GONG ; Xiaoxiao LU ; Huiyao YANG ; Sha LI ; Yongsheng LI
Cancer Research on Prevention and Treatment 2025;52(5):347-354
Phase Ⅰ clinical trials play a crucial role in the research and development of new drugs, serving as the initial studies to assess their safety, tolerability, effectiveness, and pharmacokinetic properties in humans. These trials involve uncertainties regarding safety and efficacy. Comprehensive management of all aspects of phase Ⅰ clinical trials for anti-tumor drugs is crucial to protect the rights and safety of participants. This article provides an in-depth analysis of the key points and precautions necessary for effective quality control throughout the process. The analysis is informed by guidelines such as the “Good Clinical Practice for Drugs” “Key Points and Judgment Principles for Drug Registration Verification” “Key Points and Judgment Principles for Supervision and Inspection of Drug Clinical Trial Institutions” and the standard operating procedures for quality control of the center. Topics discussed include informed consent, inclusion criteria, experimental drugs, biological samples, adverse events, and serious adverse events. The goal is to standardize quality control in phase Ⅰ clinical trials of anti-tumor drugs, ensure the authenticity and reliability of clinical trial data, and protect the rights and safety of participants.
5.Investigation and Trend Prediction of Disease Burden of Hypertensionin the Elderly Population Globally and in China from 1990 to 2021
Xiaoxiao ZHAO ; Xiaohui LU ; Lixin KE ; Wulin GAO ; Xiangran MENG ; Lili REN ; Yunhan DING ; Qiang ZHANG ; Yangqin XUN ; Jibiao WU ; Cuncun LU
Medical Journal of Peking Union Medical College Hospital 2025;16(3):647-658
To analyze the disease burden of hypertension in the elderly population from 1990 to 2021 and to predict future trends in China and globally, thereby providing insights for public health decision-making regarding older adults with hypertension in China. Data on hypertension-related deaths and disability adjusted life years (DALYs) for individuals aged ≥60 years was extracted from the Global Burden of Disease (GBD)2021 database for the world, China, and five sociodemographic index (SDI) regions. Age-standardized mortality and DALYs rates for hypertension in the elderly population were calculated, and Joinpoint regression was used to assess trend changes of disease burden, with results reported as average annual percentage change (AAPC). Additionally, subgroup analyses were conducted based on age and sex. The relative impact of aging, population growth, and epidemiological changes on disease burden was analyzed using a three-factor decomposition method. Future projections for the disease burden from 2022 to 2040 were performed using a Bayesian model. From 1990 to 2021, both age-standardized mortality and DALYs rates for hypertension in the elderly population demonstrated a significant downward trend globally and in China (both AAPC values were negative, all Although age-standardized mortality and DALYs rates for hypertension among the elderly in China have shown a downward trend over the past three decades, the absolute burden remains substantial. There is an urgent need for the formulation and implementation of more effective public health policies and clinical interventions to address this critical public health challenge.
6.Analysis of influencing factors for early neurological deterioration in isolated basal ganglia lacunar infarction
Journal of Apoplexy and Nervous Diseases 2025;42(1):42-46
摘要
目的 探讨孤立性基底节区腔隙性脑梗死早期神经功能恶化(END)的相关影响因素。方法 连续性收集2020年1月—2023年12月就诊于郑州大学人民医院的孤立性基底节区腔隙性脑梗死患者236例,临床资料完整,根据是否出现END将患者分为END组59例及非END组177例,比较患者一般资料,使用多因素二元Logistic回归分析基底节区腔隙性脑梗死患者发生END的影响因素。结果 急性孤立性基底节区腔隙性脑梗死END发生率为25%(59/236),END组病灶累及内囊后肢患者比例、入院NIHSS评分、HbA1c水平、收缩压、女性均高于非END组,两组比较差异有统计学意义(P<0.05)。多因素二元Logistic回归模型分析显示病灶累及内囊后肢(OR=3.167,95%CI 1.305~7.690,P=0.011)是END发生的独立危险因素,HbA1c水平(OR=6.368,95%CI 1.555~26.075,P=0.010)、入院NIHSS评分(OR=2.019,95%CI 1.236~3.299,P=0.005)、收缩压(OR=1.626,95%CI 1.373~1.926,P<0.001)是END发生的相关危险因素。结论 孤立性基底节区腔隙性脑梗死END发生率较高,与病灶累及内囊后肢、入院NIHSS评分高、HbA1c水平升高、收缩压高相关。
Abstract
Objective To identify influencing factors for early neurological deterioration (END) in isolated basal ganglia lacunar infarction (iBGLI). Methods Clinical data were continuously collected from 236 patients with iBGLI confirmed by magnetic resonance imaging between January 2020 and December 2023. The patients were divided into END group (n=59) and non-ED group (n=177) according to the presence or absence of END. General patient information was compared between the two groups, and factors influencing the occurrence of END in patients with iBGLI were identified by multivariate binary logistic regression. Results The incidence of END in acute iBGLI was 25% (59/236). The percentage of patients with lesions affecting the posterior limb of the internal capsule, admission NIHSS score, HbA1c level, systolic blood pressure, and number of females were significantly higher in the END group than in the non-END group (all P<0.05). Multivariate binary logistic regression showed that lesions affecting the posterior limb of the internal capsule (odds ratio (OR=3.167,95%CI 1.305~7.690,P=0.011) was an independent risk factor for the development of END,whereas HbA1c level(OR=6.368,95%CI 1.555~26.075,P=0.010), admission NIHSS score(OR=2.019,95%CI 1.236~3.299, P=0.005), and systolic blood pressure(OR=1.626,95%CI 1.373~1.926,P<0.001) were associated risk factors for END. Conclusion The higher incidence of END in iBGLI is associated with lesions affecting the posterior limb of the internal capsule, admission NIHSS score, HbA1c level, and systolic blood pressure.
Prognosis
7.Construction and evaluation of a multi-base collaborative training system for anticoagulation specialty clinical pharmacists
Shujie DONG ; Liping DU ; Yatong ZHANG ; Zheng DING ; Wenxing PENG ; Zinan ZHAO ; Xiaoxiao LI ; Li YANG
China Pharmacy 2025;36(15):1837-1840
OBJECTIVE To enhance the training quality of anticoagulation specialty clinical pharmacists, address the resource limitations of a single training base, and promote homogenization of training quality. METHODS A multi-base joint training system for anticoagulation specialty clinical pharmacists in the Beijing area was established. A mixed research method was employed, collecting data through performance comparisons, questionnaires, and qualitative interviews to compare the differences between the joint training model (experimental group, n=16) and traditional teaching model (the control group, n=17). RESULTS The established joint training system encompassed a unified joint training teaching plan, the formation of a joint training teaching team, the establishment of joint theoretical teaching courses, the implementation of joint case discussions and literature presentations, as well as strengthening the assessment throughout the joint training process. Compared to the control group [theoretical assessment of (76.44±3.66) points, case assessment of (84.31±3.27) points], the experimental group students achieved higher scores in theoretical assessment ([ 79.85±4.64) points] and case assessment ([ 88.70±5.51) points] (P<0.05). Through questionnaires and qualitative interviews, the trainees in experimental group were highly satisfied with the joint training model in terms of theoretical learning, communication skills, and teaching interaction. CONCLUSIONS The multi-base collaborative training system for anticoagulation specialty clinical pharmacists can integrate advantageous resources and significantly enhance the training effectiveness of anticoagulation specialty clinical pharmacists, offering value for wider promotion.
8.Expert Consensus on Clinical Diseases Responding Specifically to Traditional Chinese Medicine: Threatened Abortion
Xinchun YANG ; Shuyu WANG ; Huilan DU ; Songping LUO ; Zhe JIN ; Rong LI ; Xiangyan RUAN ; Qin ZHANG ; Xiaoling FENG ; Shicai CHEN ; Fengjie HE ; Shaobin WEI ; Qun LU ; Yanqin WANG ; Yang LIU ; Qingwei MENG ; Zengping HAO ; Ying LI ; Mei MO ; Xiaoxiao ZHANG ; Ruihua ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(7):241-246
Threatened abortion is a common disease of obstetrics and gynecology and one of the diseases responding specifically to traditional Chinese medicine (TCM). The China Association of Chinese Medicine organized experts in TCM obstetrics and gynecology, Western medicine obstetrics and gynecology, and pharmacology to deeply discuss the advantages of TCM and integrated Chinese and Western medicine treatment as well as the medication plans for threatened abortion. After discussion, the experts concluded that chromosome, endocrine, and immune abnormalities were the key factors for the occurrence of threatened abortion, and the Qi and blood disorders in thoroughfare and conception vessels were the core pathogenesis. In the treatment of threatened abortion, TCM has advantages in preventing miscarriages, alleviating clinical symptoms and TCM syndromes, relieving anxiety, regulating reproductive endocrine and immune abnormalities, personalized and diversified treatment, enhancing efficiency and reducing toxicity, and preventing the disease before occurrence. The difficulty in diagnosis and treatment of threatened abortion with traditional Chinese and Western medicine lies in identifying the predictors of abortion caused by maternal factors and the treatment of thrombophilia. Recurrent abortion is the breakthrough point of treatment with integrated traditional Chinese and Western medicine. It is urgent to carry out high-quality evidence-based medicine research in the future to improve the modern diagnosis and treatment of threatened abortion with TCM.
9.Isolation of Endophytic Fungi from Angelica sinensis and Evaluation of Their Secondary Metabolite Activities
Yujie ZHAO ; Nan WANG ; Ming HUANG ; Zongyuan WANG ; Yajuan DU ; Xiaoxiao ZHAO ; Yang LI ; Jiamei PEI ; Kailin CHEN ; Bei WANG ; Xinguo ZHANG
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(4):139-145
Objective To isolate endophytic fungi from Angelica sinensis and evaluate the bioactivity of their secondary metabolites.Methods Angelica sinensis and rhizosphere soil were utilized as materials.The tissue homogenization method was employed with six diverse culture media to isolate endophytic fungi.The antibacterial activity of secondary metabolites was gauged using a 96-well plate assay,while UV spectrophotometry was used to evaluate the inhibitory activity of four enzymes.Results A total of 153 fungal strains were isolated and purified from Angelica sinensis roots,stems,leaves,and soil.The samples exhibited specific inhibitory activities against adenosine deaminase(ADA),β-lactamase,xanthine oxidase(XO),and tyrosinase(TYR),with rates of 45.83%,52.78%,51.39%and 55.56%,respectively.Furthermore,1.39%of the samples displayed wide-ranging inhibitory effects against four indicator bacteria.Strain 6B also showcased the lowest inhibitory concentration values of 62.5 and 7.81 μg/mL against Escherichia coli ATCC25922 and ATCC35218,respectively,signifying its potential research significance.Conclusion Angelica sinensis has abundant endophytic fungal resources and is a good source for discovering active compounds,demonstrating certain research value.
10.Comprehensive Clinical Evaluation of Duliang Soft Capsules in Treatment of Migraine with Wind-cold Blood Stasis Syndrome
Xiaoxiao ZHAO ; Xuming ZHANG ; Junyu XI ; Zhenkai LU ; Fumei LIU ; Lianxin WANG ; Yuanyuan LI ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(8):223-232
ObjectiveTo comprehensively assess the clinical value of Duliang soft capsules in the treatment of migraine with wind-cold blood stasis syndrome, and to provide guidance for national medical decision-making, clinical drug promotion, and pharmaceutical services. MethodThe evaluation of Duliang soft capsules' clinical value was conducted in accordance with the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs (Trial Version, 2021) using a combination of qualitative and quantitative methods. Utilizing the CSC v2.0 software, this study conducted a comprehensive clinical evaluation of Duliang soft capsules across the "6+1" dimensions, including safety pre- and post-market launch, effectiveness in treating migraine, economy (cost-effectiveness), and innovation, suitability, accessibility, and traditional Chinese medicine (TCM) characteristics in both its technology and clinical applications. ResultSafety: Duliang soft capsules were found to have good safety based on evidence from known adverse reactions (spontaneous reporting system (SRS) data, literature data, etc.), pre-marketing toxicological research, and post-marketing drug monitoring. Effectiveness: A meta-analysis indicated that the combination of Duliang soft capsules and western medicine was more effective than Western medicine alone in the treatment of migraine. The product's effectiveness was rated as "Best" based on the quality and value of the evidence. Economy: Duliang soft capsules are moderately priced and categorized as a Type B medical insurance product. Economic research indicated that the combination of Western medicine and Duliang soft capsules was more cost-effective than Western medicine alone. The product's economy was rated as "Better". Innovation: Duliang soft capsules, with Angelicae Dahuricae Radix and Chuanxiong Rhizoma as the main components, hold one invention patent and have been awarded the China Patent Excellence Award. The pharmaceutical company has introduced innovative extraction (CO2 supercritical extraction technology) and formulation (soft capsule) processes. The product's innovation was rated as "Better". Suitability: A questionnaire survey on Duliang soft capsules showed that it was well-suited for both patients and healthcare professionals. The product received a comprehensive assessment of suitability through the "Evaluation of Chinese Patent Medicine Information Services". The product's suitability was rated as "Best". Accessibility: Duliang soft capsules are moderately priced, making them accessible and affordable. The product's accessibility was rated as "Good" based on evidence from these three aspects. TCM characteristics: The formulation of Duliang soft capsules can be traced back to WANG Qiu's Selected Formulas from the Praiseworthy Studio (Shi Zhai Bai Yi Xuan Fang) from the Song Dynasty, and it was documented in ZHANG Jiebin's The Complete Works of Zhang Jing-yue (Jing Yue Quan Shu) as "Duliangwan". The product has been extensively studied with over 2000 clinical cases since its market launch, and its TCM characteristics were rated as outstanding with sufficient evidence. ConclusionThe comprehensive clinical value evaluation of Duliang soft capsules demonstrated its high effectiveness, suitability, and accessibility, and outstanding TCM characteristics. The product's safety, economy, and innovation received good ratings. In summary, Duliang soft capsules exhibited significant clinical value and outstanding TCM characteristics, the evidence was sufficient, and the result was confirmed, providing crucial references for clinical decision-making and pharmaceutical management.

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