1.Protocol for patient version of the cancer symptom management guideline
Jing CHI ; Lanfang ZHANG ; Tingting YANG ; Shihui XIE ; Chaixiu LI ; Shisi DENG ; Jianyao TANG ; Chuhan ZHONG ; Bingqian GUO ; Qiuyan REN ; Yuman LI ; Zhengya QIN ; Ping ZHAO ; Yanni WU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(06):900-907
Effective symptom management can alleviate the physical and psychological distress experienced by patients with cancer, improve quality of life, and contribute to treatment adherence and improve clinical outcomes. However, most existing guidelines are developed for healthcare professionals, and patients and the public have limited access to standardized and comprehensible guidance on symptom management. To address this gap and to facilitate effective communication and shared decision-making, this study proposes the development of a patient version of the cancer symptom management guideline. The development process will adhere to the methodological framework recommended by the Guidelines International Network and the World Health Organization. The GRADE approach will be employed to assess the certainty of evidence and to formulate recommendations. In addition, the process will be informed by the Appraisal of Guidelines for Research and Evaluation Ⅱ (AGREE Ⅱ) instrument and the Reporting Items for Practice Guidelines in Healthcare-Public or Patient Versions of Guidelines (RIGHT-PVG). This protocol outlines the establishment of the guideline working group, the identification and prioritization of key questions, evidence retrieval and appraisal, and the formulation of recommendations, with the aim of ensuring methodological rigor and transparency in the development of the patient guideline and providing methodological reference for similar guideline initiatives.
2.Effect of pegylated interferon-α-2b therapy on cytotoxicity of virus-specific CD8+ T cells in HBeAg-negative patients with chronic hepatitis B virus infection
Lei QIN ; Guangpeng LI ; Peijun SHEN ; Lanfang ZHANG ; Xiaofei YANG ; Meijuan PENG ; Ye ZHANG
Journal of Clinical Hepatology 2025;41(4):628-636
ObjectiveTo investigate the change in the activity of hepatitis B virus (HBV)-specific CD8+ T cells after pegylated interferon-α-2b (PEG-IFN-α-2b) therapy in HBeAg-negative patients with chronic HBV infection. MethodsA total of 53 HBeAg-negative patients with chronic HBV infection who attended The First Affiliated Hospital of Xinxiang Medical University and Tangdu Hospital of Air Force Mdical University from April 2020 to June 2022 were enrolled and treated with PEG-IFN-α-2b (180 μg/week, subcutaneous injection) antiviral therapy. The study endpoint was HBsAg clearance (course of treatment<48 weeks) or 48 weeks (course of treatment≥48 weeks). Peripheral blood mononuclear cells were isolated at baseline and study endpoint, and peripheral blood T cell counts were measured. Enzyme-linked immunospot assay was used to measure the frequency of HBV-specific CD8+ T cells secreting perforin, granzyme B, and interferon-γ. A total of 17 HLA-A*02-restricted patients were selected, and CD8+ T cells were purified to establish direct- and indirect-contact co-culture systems for HBV-specific CD8+ T cells and HepG2.2.15 cells. The level of lactate dehydrogenase in supernatant was measured to calculate the mortality rate of HepG2.2.15 cells, and the levels of HBV DNA, cytotoxic molecules, and cytokines in supernatant were also measured. Flow cytometry was used to measure the expression of apoptosis ligands, and the cytotoxicity of HBV-specific CD8+ T cells was evaluated. The independent samples t-test or the paired t-test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U test or the Wilcoxon rank-sum test was used for comparison of non-normally distributed continuous data between two groups. ResultsThe HBsAg clearance rate at study endpoint was 30.19% (16/53). There were no significant differences in peripheral blood T cell counts (CD3+, CD4+, and CD8+ T cells) between baseline and study endpoint (P>0.05). At study endpoint, there was a significant increase in the frequency of HBV-specific CD8+ T cells secreting perforin, granzyme B, and interferon-γ (U=177.50, t=11.90, U=186.50, all P<0.001), and the patients with HBsAg clearance had a significantly higher frequency of such HBV-specific CD8+ T cells than those without HBsAg clearance (U=120.50, t=2.73, U=121.50, all P<0.01). In the direct- and indirect-contact co-culture systems at study endpoint, HBV-specific CD8+ T cells induced a significant reduction in HBV DNA in the supernatant of HepG2.2.15 cells (all P<0.001) and significant increases in the secretion of interferon-γ and tumor necrosis factor-α (all P<0.05); in the direct-contact co-culture system, HBV-specific CD8+ T cells induced significant increases in the mortality rate of HepG2.2.15 cells (13.62%±3.27% vs 11.39%±2.40%, t=2.27, P=0.030) and the secretion of perforin and granzyme B (t=72.50, U=52.50, both P<0.05). In the direct- and indirect-contact co-culture systems, compared with HBV-specific CD8+ T cells from the patients without HBsAg clearance, the HBV-specific CD8+ T cells from patients with HBsAg clearance had a significantly greater reduction in HBV DNA (P<0.05) and significant increases in the secretion of interferon-γ and tumor necrosis factor-α (P<0.05). ConclusionPEG-IFN-α-2b therapy can help to achieve a relatively high HBsAg clearance rate in HBeAg-negative patients with chronic HBV infection, and the activity of HBV-specific CD8+ T cells is significantly enhanced, which is closely associated with HBsAg clearance.
3.Outcome Indicators in Randomized Controlled Trials of Traditional Chinese Medicine Intervention in Ulcerative Colitis
Yasheng DENG ; Lanfang MAO ; Jiang LIN ; Yanping FAN ; Wenyue LI ; Yonghui LIU ; Zhaobing NI ; Jinzhong YU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):245-251
To systematically review randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) intervention in ulcerative colitis (UC), and analyze the characteristics of these studies and their outcome indicators, thereby providing references for the design of future RCTs of TCM intervention in UC and offering evidence supporting the clinical application of TCM in UC. A computerized search was conducted in the China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science databases for RCTs of TCM intervention in UC published from January 2021 to August 2024. The risk of bias was assessed, and outcome indicators were qualitatively analyzed. A total of 555 RCTs were included, with a sample size of 44 853 participants. The largest sample size was 218 cases, and the smallest was 28 cases, with most studies focusing on 60-100 participants. Of the 386 RCTs that explicitly reported TCM syndrome types, the top three were large intestine dampness-heat syndrome (31.05%), spleen and kidney yang deficiency syndrome (12.47%), and spleen deficiency with dampness syndrome (9.17%). The interventions, ranked by frequency of use, included internal Chinese medicine compounds/preparations (64.5%), Chinese medicine compounds/preparations with retained enema (18.2%), internal Chinese medicine compounds/preparations + external TCM treatment (5.95%), and external TCM treatment alone (4.86%). The treatment duration was mainly 4-8 weeks (64.86%), with 61 studies (10.99%) reporting follow-up time. A total of 157 outcome indicators were used, with a frequency of 3 460 occurrences, classified into six domains: TCM syndromes and symptoms (346 occurrences, 10%), symptoms/signs (541 occurrences, 15.64%), physical and chemical examinations (2 119 occurrences, 61.24%), quality of life (107 occurrences, 3.09%), long-term prognosis (61 occurrences, 1.76%), and safety events (284 occurrences, 8.21%). The analysis reveals several limitations in the outcome indicators of TCM intervention in UC, including the lack of a basis for sample size calculation, non-standardized TCM syndrome classification, absence of trial design and registration, inadequate blinding and allocation concealment, adherence issues with interventions, imbalanced selection of surrogate and endpoint indicators, inconsistency in the timing of outcome measurements, design issues that require standardization, and ethical and safety concerns. It is recommended that future studies actively construct a set of core indicators for UC that include standardized TCM syndrome classification, clear efficacy evaluation indicators, key endpoint indicators, and reasonable measurement time points. Long-term prognostic impacts, comprehensive assessments of patients' quality of life, and consideration of economic benefits should be emphasized, providing a basis for the clinical practice of TCM in the treatment of UC.
4.Outcome Indicators in Randomized Controlled Trials of Traditional Chinese Medicine Intervention in Ulcerative Colitis
Yasheng DENG ; Lanfang MAO ; Jiang LIN ; Yanping FAN ; Wenyue LI ; Yonghui LIU ; Zhaobing NI ; Jinzhong YU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):245-251
To systematically review randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) intervention in ulcerative colitis (UC), and analyze the characteristics of these studies and their outcome indicators, thereby providing references for the design of future RCTs of TCM intervention in UC and offering evidence supporting the clinical application of TCM in UC. A computerized search was conducted in the China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science databases for RCTs of TCM intervention in UC published from January 2021 to August 2024. The risk of bias was assessed, and outcome indicators were qualitatively analyzed. A total of 555 RCTs were included, with a sample size of 44 853 participants. The largest sample size was 218 cases, and the smallest was 28 cases, with most studies focusing on 60-100 participants. Of the 386 RCTs that explicitly reported TCM syndrome types, the top three were large intestine dampness-heat syndrome (31.05%), spleen and kidney yang deficiency syndrome (12.47%), and spleen deficiency with dampness syndrome (9.17%). The interventions, ranked by frequency of use, included internal Chinese medicine compounds/preparations (64.5%), Chinese medicine compounds/preparations with retained enema (18.2%), internal Chinese medicine compounds/preparations + external TCM treatment (5.95%), and external TCM treatment alone (4.86%). The treatment duration was mainly 4-8 weeks (64.86%), with 61 studies (10.99%) reporting follow-up time. A total of 157 outcome indicators were used, with a frequency of 3 460 occurrences, classified into six domains: TCM syndromes and symptoms (346 occurrences, 10%), symptoms/signs (541 occurrences, 15.64%), physical and chemical examinations (2 119 occurrences, 61.24%), quality of life (107 occurrences, 3.09%), long-term prognosis (61 occurrences, 1.76%), and safety events (284 occurrences, 8.21%). The analysis reveals several limitations in the outcome indicators of TCM intervention in UC, including the lack of a basis for sample size calculation, non-standardized TCM syndrome classification, absence of trial design and registration, inadequate blinding and allocation concealment, adherence issues with interventions, imbalanced selection of surrogate and endpoint indicators, inconsistency in the timing of outcome measurements, design issues that require standardization, and ethical and safety concerns. It is recommended that future studies actively construct a set of core indicators for UC that include standardized TCM syndrome classification, clear efficacy evaluation indicators, key endpoint indicators, and reasonable measurement time points. Long-term prognostic impacts, comprehensive assessments of patients' quality of life, and consideration of economic benefits should be emphasized, providing a basis for the clinical practice of TCM in the treatment of UC.
5.Unveiling the renoprotective mechanisms of self-assembled herbal nanoparticles from Scutellaria barbata and Scleromitrion diffusum in acute kidney injury: A nano-TCM approach.
Lunyue XIA ; Qunfang YANG ; Kangzhe FU ; Yutong YANG ; Kaiyue DING ; Yuexue HUO ; Lanfang ZHANG ; Yunong LI ; Borong ZHU ; Peiyu LI ; Yijie HUO ; Liang SUN ; Ya LIU ; Haigang ZHANG ; Tao LIU ; Wenjun SHAN ; Lin ZHANG
Acta Pharmaceutica Sinica B 2025;15(8):4265-4284
Acute kidney injury (AKI) is a critical clinical condition characterized by rapid renal function decline, with high morbidity, mortality, and healthcare costs. Traditional Chinese medicine (TCM) has shown potential effects on mitigating oxidative stress and programmed cell death in AKI models. Scutellaria barbata D. Don (SB) and Scleromitrion diffusum (Willd.) R. J. Wang (SD), a classic TCM herbal pair exhibited anti-inflammatory and antioxidant activities. Using advanced chromatographic separation technology, we enriched the effective fractions of water extracts from SB-SD, obtaining self-assembled herbal nanoparticles (SB and SD nanoparticles, SSNPs) rich in flavonoids and terpenoids. These SSNPs demonstrated robust antioxidant properties in vitro and mitigated AKI progression in vivo by activating the nuclear factor erythroid 2-related factor 2 (Nrf2) signaling pathway. Oral administration of SSNPs in mice resulted in absorption into the bloodstream, formation of a protein corona, reduced macrophage phagocytosis, and enhanced bioavailability and renal targeting. Furthermore, we investigated the self-assembly principle of SSNPs using representative flavonoids and terpenoids. Kinetic studies and in situ transmission electron microscopy (in situ TEM) revealed that these compounds self-assemble via supramolecular forces like hydrogen bonding and π-π interactions, forming stable nanostructures. This study elucidates the renoprotective effects and mechanisms of SB and SD, and provides a novel approach for the development of TCM-based nanomedicines, highlighting the potential of nano-TCM in AKI treatment.
7.The correlation of serum ferritin and 25(OH)D with early renal damagein children with new-onset type 1 diabetes mellitus
Lanfang CAO ; Li YANG ; Qingbo XU
Chinese Journal of Diabetes 2025;33(6):444-448
Objective To investigate the correlation and predictive value of serum ferritin(SF),25(OH)D and early renal damage in children with new type 1 diabetes mellitus(T1DM).Methods A total of 102 newly diagnosed T1DM children admitted to the Department of Endocrinology,Genetics and Metabolism of our hospital from January 2020 to June 2023 were collected as the study objects.According to UACR,the study subjects were divided into T1DM group<30 mg/g(n=50),microalbuminuria group 30~300 mg/g(MUAlb)group(n=32),and macroalbuminuria group>300 mg/g(CUAlb)group(n=20).Another 65 healthy children who underwent physical examination during the same period were selected as normal control(NC)group.General data and biochemical indexes of all groups were compared to analyze the correlation and predictive value of changes in SF and 25(OH)D levels with early renal damage.Results The levels of SF and TG in NC,T1DM,MUAlb and CUAlb groups increased in turn(P<0.05),while 25(OH)D decreased in turn(P<0.05).The levels of TC,FC-P,FPG and HbA1c in the T1DM,MUAlb and CUAlb groups were higher than those in the NC group(P<0.05),and the levels of FIns was lower than that in the NC group(P<0.05).The level of LDL-C in MUAlb and CUAlb groups were higher than in NC group(P<0.05),the levels of TC,FPG and HbA1c in MUAlb and CUAlb groups were higher than those in T1DM group(P<0.05),and UACR was higher than that in NC and T1DM groups(P<0.05).LDL-C in MUAlb group was higher than that in T1DM group(P<0.05).Blood urea in the CUAlb group were higher than those in the NC group(P<0.05),Scr and UACR was higher than that in the MUA1b group(P<0.05),and eGFR was higher than that in the T1DM,MUAlb,and CUAlb groups(P<0.05).Spearman correlation analysis showed that SF were positively correlated with TC,LDL-C,TG,UACR and HbA1c(P<0.05)and negatively correlated with 25(OH)D(P<0.05).25(OH)D was negatively correlated with TC,LDL-C,TG,UACR,HbA1c(P<0.05).Logistic regression analysis showed that SF and 25(OH)D were the influencing factors of early renal injury in children with T1DM.ROC curve analysis showed that the area under the curve of SF and 25(OH)D was 0.813 and 0.808,with the sensitivity 67.3%and 78.8%,the specificity 80.0%and 72.0%,and the cut-off values were 113.6 ng/ml and 54.17 nmol/L,respectively.Conclusions The changes in serum SF and 25(OH)D levels are associated with different stages of early renal damage and may be involved in the occurrence and development of early renal damage in children with T1DM.
8.The Methodological Quality of TCM Clinical Practice Guidelines for Coronary Heart Disease was Evaluated Based on Multiple Tools
Yudong YU ; Jingjing YAN ; Bin LI ; Jia LI ; Pengzhen YU ; Beibei LIANG ; Lanfang ZHONG
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(1):110-120
Objective Based on the three tools of the AGREE Next Steps Consortium(AGREE Ⅱ),China Clinical Guidelines Evaluation System(AGREE-China)and Scientificity Transparency Applicability Rankings(STAR),the methodological quality of Chinese medicine clinical treatment guidelines for coronary heart disease published by domestic institutions was systematically evaluated.Methods Computer system retrieval of China National Knowledge Infrastructure(CNKI),WanFang Data,Chinese Science and Technology Journal Database(VIP),China Biology Medicine(CBM)and Yimai Tong,and collect clinical practice guidelines of traditional Chinese medicine for coronary heart disease issued by domestic institutions(including expert consensus).The search period was from the establishment of the database to December 31,2023.Results A total of 21 guidelines were included.AGREE Ⅱ recommended 13 for grade A and 8 for grade B.The approval-China review strongly recommends 12,weakly recommends 8,and does not recommend 1.The highest STAR rating is a 4.0 star recommendation and the lowest is a 1.5 star recommendation.Conclusions There are a large number of TCM diagnosis and treatment guidelines and expert consensus on coronary heart disease in China,but the quality is uneven.It is suggested that the future guideline formulation should pay attention to the evidence-based principle,promote the standardization and standardization of the guideline formulation,and improve the scientific and applicability of the guideline.
9.Exercise-based pre-rehabilitation before surgery for patients with lung cancer:a scoping review
Xinyi ZHENG ; Xianwu LUO ; Lanfang ZUO ; Yuwei LI ; Ying LIANG
Modern Clinical Nursing 2025;24(3):69-75
Objective To review literature on exercise-based pre-rehabilitation before surgery in patients with lung cancer,hence to provide a guidance for development of standardised programs for pre-rehabilitative exercise.Methods Following the Australian JBI Evidence-based Health Care Centre Scope Review guidelines,a comprehensive search was conducted across the databases of PubMed,Embase,Web of Science,CINAHL,CNKI,WanFang Data and SinoMed.The search covered the inception of databases to 29th February,2024.The retrieved literature was then screened and relevant information was extracted.Results A total of 20 articles were included in this review.Exercise-based pre-rehabilitation for lung cancer patients was mainly divided into single-modality pre-rehabilitation and multimodal pre-rehabilitation(exercise combined with interventions in nutrition,psychology and health behaviour).The period of intervention for exercise-based pre-rehabilitation was typically 2-3 weeks before surgery,with 3-5 sessions per week.The outcome indicators mainly included respiratory function,capacity of physical activity,quality of life,psychological status and postoperative complications.Conclusion The preoperative exercise-based pre-rehabilitation before surgery for the patients with lung cancer is feasible and effective in enhancing physical function of the patients.Further studies can focus on the development of patient-centred standardised exercise pre-rehabilitation programs.
10.Analysis of the development trajectory and influencing factors of subjective cognitive decline in elderly patients with depression
Lanfang SHEN ; Jiangqin LYU ; Songtao LI
Chinese Journal of Practical Nursing 2025;41(21):1662-1668
Objective:To investigate the development trajectory of subjective cognitive decline (SCD) in elderly patients with depression and analyze the influencing factors of its categorical differences.Methods:The elderly patients with depression who received treatment in Shaoxing Seventh People′s Hospital from May 2021 to May 2024, were selected as the research subjects through convenience sampling. A cross-sectional survey was conducted using 21-Item Subjective Cognitive Decline Questionnaire on the second day of admission, one week after treatment, one month after treatment, and three months after treatment. The optimal number of categories was analyzed and classified using a growth mixed model. Potential independent influencing factors between categories were analyzed through multivariate logistic regression.Results:This study included 200 elderly patients with depression, including 79 males and 121 females, aged (70.00 ± 3.15) years.The development trajectory of SCD can be divided into three potential categories. Among them, the low SCD persistent type accounts for 49% (98/200), the high SCD remission type accounts for 22% (44/200), and the high SCD persistent type accounts for 29% (58/200).The results of multivariate logistic regression analysis showed that age, gender, place of residence, occupation, history of hypertension, Hamilton Depression Scale-17(HAMD-17) score, presence of visual impairment, slow gait, nutritional risk, and fall status within the past year were independent influencing factors for the development of SCD in elderly patients with depression ( χ2 values were 4.51-11.24, all P<0.05). Conclusions:The development of SCD in elderly patients with depression is consistent to some extent, influenced by factors such as HAMD-17 score, visual impairment, and nutritional risk. This suggests that personalized plans can be developed for different types of development in the care of elderly patients with depression, and timely interventions can be made for the development of SCD in patients.

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