1.Current Status and Optimization Strategies for Setting Objective Performance Criteria in Clinical Trials of Traditional Chinese Medicine
Jiaqi LAI ; Qian HUANG ; Xueyin CHEN ; Shaonan LIU ; Lihong YANG ; MIMAZHUOGA ; DAWA ; Zhijian LI ; Tuerxun WUFUER ; Xinfeng GUO
Journal of Traditional Chinese Medicine 2026;67(13):1461-1464
Current formulation of objective performance criteria (OPC) in traditional Chinese medicine (TCM) faces methodological challenges, including poor reporting quality, insufficient standardization of methods, limited comparability of study populations, and inadequate consideration of the genetic and environment particularities of ethnic minority populations. In response to these issues, this paper proposes optimization strategies for setting OPC in TCM, with particular attention to ethnic minority medicine. These include improving methodological techniques and statistical descriptions, ensuring transparency in meta-analyses and data sources; standardizing the estimation of point estimates and confidence intervals, and incorporating multidisciplinary expert consensus for value determination; introducing local real-world data from the same period, especially cohort study evidence, to compensate for the lack of high-quality randomized controlled trial data. Through process transparency and dynamic updating mechanisms, the credibility of OPC method can be enhanced, thereby providing methodological support for strengthening evidence-based research capacity in this field.
2.Proximal effect of anxiety on non-suicidal self-injury behaviors in adolescent patients with depression and the intervention efficacy of modified cognitive behavioral therapy: an ecological momentary assessment study
Shaonan HUANG ; Jun KONG ; Zheng LIU ; Yi ZHANG ; Weijuan ZHANG ; Xiao WANG ; Xiucheng TANG ; Jiansong ZHOU
Sichuan Mental Health 2025;38(5):414-420
BackgroundIn recent years, the prevalence of depression among adolescents has risen steadily, alongside an increasing prominence of non-suicidal self-injury (NSSI) behaviors in this population, which may elevate suicide risk and constitute a serious public health problem. Negative emotions such as anxiety and depression are closely related to NSSI behaviors. Previous studies have predominantly relied on retrospective reports, limiting the ability to dynamically capture temporal relationships between emotional fluctuations and NSSI behaviors. Moreover, cognitive behavioral therapy (CBT) often lacks targeted design to address proximal triggers in interventions for NSSI behaviors. ObjectiveTo verify that anxiety as a proximal trigger factor for NSSI behaviors in adolescent patients with depression, and to evaluate the efficacy of modified CBT integrated with ecological momentary assessment (EMA) data in alleviating their anxiety and self-injury urges. MethodsA prospective cohort study design was adopted. A total of 132 adolescent patients with a history of NSSI behaviors who were treated at Jiujiang Fifth People's Hospital from January to December 2024 and met the diagnostic criteria for depression in the Diagnosed and Statistical Manual of Mental Disorders, fifth edition (DSM-5). A smartphone-based EMA application to conduct natural situation emotions on participants for 14 consecutive days. The monitoring period spanned from 10∶00 to 22∶00 daily, with randomized assessments pushed every 2 hours. The assessment tools included the Self-rating Anxiety Scale (SAS) and the negative affect subscale of the Positive and Negative Affect Schedule (PANAS), with real-time recording of NSSI behaviors and emotional states before and after their occurrence. Repeated measures analysis of variance was used to compare the dynamic changes in the scores of each scale before and after the episodes of NSSI behaviors. A modified CBT was administered to 83 participants who completed EMA data collection, with sessions conducted once weekly for 12 weeks. Anxiety levels were accessed using the SAS, and the self-injury urges was evaluated using the Ottawa Self-injury Inventory (OSI) before and after the intervention. ResultsEMA data revealed that SAS scores were significantly higher during the 1-2 hours before NSSI episodes compared to baseline periods [(56.19±11.06)vs.(52.83±10.25),P<0.01]. SAS scores were positively correlated with the NSSI behavioral scores (r=0.460,P<0.01,95% CI:0.310-0.580). After receiving modified CBT intervention, adolescent patients with depression demonstrated statistically significant decreases in both SAS scores [(52.30±8.10) vs.(48.70±7.30),t(82)=4.820,P<0.01,Cohen's d=0.420] and the OSI self-injury impulse subcale scores [(12.80±2.70) vs.(9.60±2.50),t(82)=5.170,P<0.01,Cohen's d=0.510] compared to their pre-intervention levels. ConclusionAnxiety may serve as a proximal trigger for NSSI behaviors in adolescent patients with depression. Modified CBT integrating EMA data could potentially alleviate their anxiety level and self-injury urges. [Funded by Science and Technology Plan Project of Jiangxi Provincial Health Commission (number, SKJP220227629)]
3.Construction of Core Outcome Set for Clinical Research on Uyghur Medicine in Treating Psoriasis
Ruifang YU ; Abuduwaiti JULAITI ; Shaonan LIU ; Genghang CHEN ; Qian HUANG ; Wufuer ZAITUGULI ; Upur TURSON ; Zhijian LI ; Xinfeng GUO
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(6):1334-1339
Objective To construct the core outcome set(COS)for clinical research on Uyghur medicine in treating psoriasis by using internationally-recognized research methods,thus to aid the researchers in choosing the standardized outcomes and to enhance the quality of evidence from research findings.Methods A systematic retrieval of Chinese and English databases was conducted to collect outcomes from clinical studies,systematic reviews,and registered protocols of Uyghur medicine for treating psoriasis.An outcome pool was constructed based on the results of literature review.The outcomes were supplemented after qualitative surveys of patients and physicians,and then an initial list of outcomes was formed.Two rounds of Delphi surveys on the initial list were conducted for obtaining Likert scale ratings from different stakeholder groups to evaluate the importance of outcomes.After that,a consensus meeting was held to finalize the COS for clinical research on Uyghur medicine in treating psoriasis.Results The COS for clinical research on Uyghur medicine in treating psoriasis comprises six domains,totaling 14 outcomes.The 14 outcomes were psoriasis symptoms(psoriasis area and area severity index),skin manifestations(erythema,scaling,infiltration,etc.),investigator global assessment,patient global assessment,treatment satisfaction,health-related quality of life,recurrence rate,adverse events,drug adverse reactions,blood routine,urine routine,liver and kidney function,Uyghur medicine symptom assessment,and fluid changes.Conclusion The COS for clinical research on Uyghur medicine in treating psoriasis has been constructed,and will provide a reference for the selection of efficacy-evaluation outcomes and for the reporting of outcomes in related studies.
4.Development of Core Outcome Set for Clinical Research on Vitiligo Treated with Uyghur Medicine
Qian HUANG ; Xinfeng GUO ; Lihong YANG ; Genghang CHEN ; Wufuer TUERSON ; Yiming Maimaiti TURSUNTAI ; Abuduwayiti JULAITI ; Zhijian LI ; Shaonan LIU
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(10):2595-2602
Objective To develop a core outcome set(COS)for treatment of progressive vitiligo in Uyghur medicine,and to standardize the selection and reporting of outcome measures in relevant studies.Methods Based on the existing core outcome domain set of randomized controlled trials for vitiligo,additional outcome indicators reflecting the advantages and characteristics of Uyghur medical treatment were developed.Specific indicators for Uyghur medical treatment of progressive vitiligo were collected through literature review and semi-structured questionnaire surveys,and then a list of indicators were formed.The Delphi survey and consensus meetings were used to select core indicators.Results A total of 54 studies were included,and 86 questionnaires were collected.Through literature review and questionnaire surveys,a list of 28 indicators were obtained.After two rounds of Delphi survey and one consensus meeting,12 outcome indicators in 7 domains were finally determined,including vitiligo lesion area,repigmentation,disease control time,maintenance of repigmentation,recurrence rate,immune indicators,psychological health,patients' quality of life,adverse events,adverse reaction incidence,liver and kidney function monitoring,and Uyghur medicine syndrome differentiation of mucus.Additionally,some measurement tools for certain indicators were recommended.Conclusion The development of the COS for vitiligo treatment in Uyghur medicine helps to comprehensively evaluate the efficacy of Uyghur medicine,and will provide a model for establishing efficacy evaluation methods that conform to the characteristics of ethnic minority medicine.
5.Survey on Status and Development Needs of Evidence-Based Medicine Capability in Ethnic Minority Medicine
Ruifang YU ; Genghang CHEN ; Xueyin CHEN ; Jiaqi LAI ; Qian HUANG ; Lihong YANG ; Yuwei LIU ; Xinfeng GUO ; Shaonan LIU
Journal of Traditional Chinese Medicine 2024;65(15):1559-1564
ObjectiveTo investigate the current status and development needs of evidence-based medicine (EBM) capability in ethnic minority medicine, and explore effective strategies to enhance EBM capability in this field. MethodsThe questionnaire survey was conducted in various ethnic minority medical institutions and research organisations. The questionnaire covered three dimensions, firstly, perceptions and attitudes towards evidence-based medicine; secondly, advantages and challenges in the development of ethnic minority medicine; thirdly, demands and recommendations for enhancing evidence-based medicine capability in ethnic minority medicine. ResultsA total of 501 valid questionnaires were collected, of which 103 questionnaires were collected by re-sending to minority medicine regions with insufficient participation. The questionnaires included 354 responses (70.66%) from practitioners of minority medicine, including Tibetan medicine, Mongolian medicine, Uyghur medicine, Zhuang medicine, and Korean medicine. Among the 501 questionnaires, 146 respondents (29.14%) indicated that they knew about EBM, 355 respondents (70.86%) had either a "general understanding" or had "not heard about" EBM before, and 469 respondents (93.61%) believed that introducing ECM could promote the development of ethnic minority medicine. The primary challenge in promoting EBM in the field of ethnic minority medicine is the lack of professionals in EBM and a lack of understanding of how to apply it into clinical practice (442 respondents, 88.22%). In the 9-point importance rating for enhancing evidence-based abilities, high scores were achieved in standardization of clinical practice guidelines (7.50±1.90) and methods for sample sizes in clinical research (7.45±1.90). Regarding the demand for improving clinical research literacy, expert academic lectures, and experience sharing (404 respondents, 80.64%) and evidence-based methodology monographs on ethnic minority medicine (401 respondents, 80.04%) were emphasized. ConclusionsPractitioners in ethnic minority medicine hold a positive attitude towards integrating EBM. However, there remains substantial room for the education and dissemination of EBM. Enhancing evidence-based capabilities can be achieved through specific measures such as cultivating or recruiting talents in EBM, establishing evidence-based support platforms for clinical research, organizing regular academic lectures and exchanges, and strengthening the construction of theoretical frameworks and evaluation systems tailored to ethnic minority medicine, thereby following a path of evidence-based practices aligned with the unique characteristics of ethnic minority medicine.
6. The application of positron emission tomography in the research and development of central nervous system drugs
Size LI ; Xiaojie WU ; Jing ZHANG ; Qi HUANG ; Yihui GUAN ; Fang XIE ; Qi HUANG ; Yihui GUAN ; Fang XIE ; Shaonan WANG ; Jing ZHANG
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(3):316-327
Positron emission tomography (PET) now plays an important role in the research and development (R&D) of central nervous system (CNS) drugs. PET could characterize the biodistribution, pharmacokinetics, and receptor binding of CNS drugs quantitatively. The present review summarized the quantitative methods of PET used in the pharmacokinetics and receptor occupancy analysis of CNS drugs. Moreover, the present review listed various applications of PET supporting R&D of CNS drugs, which could provide a new direction for the R&D of CNS drugs.
7.Research progress of polymyxin B-associated skin hyperpigmentation
Shaonan ZHANG ; Xiaohui HUANG ; Huijie YUE
Adverse Drug Reactions Journal 2020;22(1):38-41
Polymyxin B is mainly used in the treatment of severe drug-resistant gram-negative bacterial infection. In recent years, more and more cases of skin pigmentation caused by polymyxin B have been reported. The incidence of polymyxin B-related skin pigmentation in infants was higher than that in adults. The mechanism of polymyxin B-induced hyperpigmentation is not clear, which may be related to histamine release, skin inflammation, and the stimulation of melanin synthesis induced by polymyxin B. Although skin pigmentation has no significant effect on the treatment and prognosis in patients, it may cause psychological burden and affect the life quality, which should be paid more attention to and further studied.
8.Research progress of polymyxin B-associated skin hyperpigmentation
Shaonan ZHANG ; Xiaohui HUANG ; Huijie YUE
Adverse Drug Reactions Journal 2020;22(1):38-41
Polymyxin B is mainly used in the treatment of severe drug-resistant gram-negative bacterial infection. In recent years, more and more cases of skin pigmentation caused by polymyxin B have been reported. The incidence of polymyxin B-related skin pigmentation in infants was higher than that in adults. The mechanism of polymyxin B-induced hyperpigmentation is not clear, which may be related to histamine release, skin inflammation, and the stimulation of melanin synthesis induced by polymyxin B. Although skin pigmentation has no significant effect on the treatment and prognosis in patients, it may cause psychological burden and affect the life quality, which should be paid more attention to and further studied.
9.Effects of high dose atorvastatin administration on platelet activities and ventricular remodeling of patients with acute myocardial infarction
Shaonan LI ; Zhen LIU ; Huifang HUANG ; Pingan CHEN ; Xiaoming LEI
Journal of Chinese Physician 2015;17(4):519-523
Objective To investigate the effects of high dose atovastatin administration on platelet activity and ventricular remodeling of patients with ST-Segment elevation myocardial infarction (STEMI) underwent primary percutaneous coronary intervention (PCI).Methods A total of 260 STEMI patients who hospitalized in our Department of Cardiology from June 2012 to December 2013 was enrolled and randomly divided into two groups:controlled group (n =140) and high dose atorvastatin group (n =120).Indicators of platelet activities including mean platelet volume (MPV),platelet large cell ratio (P-LCR),blood CD62p,and glucose protein Ⅱ b/Ⅲa (PAC-1) were measured before and 48 hours after PCI.TIMI myocardial perfusion grade (TMPG) after PCI was recorded and patients accepted ultrasound cardiogram (UCG) examinations 5 ~7 days after PCI and 6 months after discharge.After PCI,Patients were followed up for 6 months,statin-associated liver impairment,myopath and major adverse cardiac events (MACE) happened during follow-up periods were recorded.Results MPV,P-LCR,CD62p,and PAC-1 in patients of high dose atorvastatin group were less than controlled group and TMPG were better than controlled group [(12.96±1.73)fl vs (14.18 ± 1.86)fl,P <0.05;(29.12 ±5.83)% vs (30.66 ±6.12)%,P < 0.05;(45.36±5.24)% vs (48.44±4.75)%,P <0.01;(74.61 ±5.57)% vs (78.55±5.78)%,P <0.01].Six months after PCI,UCG examination showed that Left ventricular end-diastolic volume (LV-EDV),left ventricular end-systolic volume (LVESV) and left ventricular mass index (LVMI) in high dose group were less than controlled group while the left ventricular ejection fraction (LVEF) was higher than controlled group [(110.46 ±8.86)ml vs (112.61 ±8.5)ml,P <0.01;(60.16 ±6.13)ml vs (63.52 ± 5.54)ml,P <0.01;(1O1.69±4.35)g/m2 vs (103.96 ±4.17)g/m2,P <0.05;(50.08 ±3.78)% vs (48.47 ± 4.12) %,P < 0.05].After 6 months of follow-up,the incidence rate of statin-associated liver impairment and myopathe had no significant difference between two groups and Kaplan-Meier survival analysis showed patients of two groups had significantly different cumulative non-events survival rates (91.7% vs 82.4%,Log rank =4.409,P =O.036).Conclusions Loading dose atorvastatin before PCI combined high maintenance dose after PCI can inhibit platelet activation and improve myocardial perfusion levels of patients with STEMI underwent primary PCI.It also can reduce Left ventricular remodeling and improve patient's prognosis without increasing side effects.
10.The association of insulin resistance, blood pressure variability and severity of acute coronary syndrome
Shaonan LI ; Yi LUO ; Guanglian LI ; Huifang HUANG ; Pingan CHEN ; Zhen LIU
Chinese Journal of Internal Medicine 2012;51(8):609-612
Objective To investigate the association of insulin resistance (IR),blood pressure variability (BPV) and the severity of acute coronary syndrome (ACS),and assess the effect of percutaneous coronary intervention (PCI) on recent prognosis.Methods A total of 260 patients diagnosed as ACS and hospitalized in our department of cardiology from December 2009 to December 2010 were enrolled in the study.There were 93 cases of unstable angina pectoris ( UAP),84 of non ST segment elevation myocardial infarction and 83 of unstable angina pectoris.The subjects were divided into two groups according to 24 hour systolic blood pressure coefficient of variability (24 h SBP-CV) levels:high-CV group (24 h SBP-CV >11.5,n =130) and low-CV group(24 h SBP-CV < 11.5,n =130).The differences in HOMA-IR and the severity of coronary artery diseases between the two groups were compared.The association of major adverse cardiac events within 6 months after PCI treatment,and IR as well as BPV was analyzed.Results Compared with the low-CV group,ACS patients in the high-CV group had obviously higher HOMA-IR levels (5.7 ± 1.2 vs 4.0 ± 1.4,P <0.01 ),more multivessel diseases (49.2% vs 33.3%,P <0.05) and B2/C type coronary diseases (48.5% vs 27.7%,P <0.01 ),and higher coronary Gensini scores (59.7 ± 17.5vs 43.8 ± 18.6,P < 0.01 ).Multi-factors logistic regression analysis indicated that both 24 h BPV-CV and IR were independent predictors for MACE incidence within 6 months after undergone PCI ( P < 0.05 or P <0.01 ).Conclusions IR and BPV were obviously associated with the severity of coronary artery diseases in ACS patients.IR and 24 h BPV-CV were valuable in predicting recent prognosis of ACS patients.

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