1.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.
2.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.
3.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.
4.Impact of physical functioning on supportive care needs in patients with hepatocellular carcinoma: a chain-mediated model involving perceived social support, anxiety, and depression
Lanfang ZHUO ; Yu WANG ; Quan JIANG ; Xiaolong CHEN ; Xiaolan WANG ; Yanhua SHI ; Xianmei MENG
Chinese Journal of Practical Nursing 2025;41(34):2646-2654
Objective:To examine the influence of physical function status on supportive care needs (SCNS) in patients with primary liver cancer (PLC) and to explore the mediating roles of perceived social support and anxiety-depression, with the aim of providing evidence for nursing interventions to improve patients' care experience.Methods:A convenience sampling method was used to select PLC inpatients admitted to The First Affiliated Hospital of Jinan University between December 2022 and February 2024. Data were collected using a general information questionnaire, the 34-item Supportive Care Needs Survey-Short Form, the Hospital Anxiety and Depression Scale, the Perceived Social Support Scale, and the Karnofsky Performance Status Scale to conduct a cross-sectional survey. Pearson correlation analysis was performed to examine associations among SCNS, perceived social support, anxiety-depression, and physical function status. Structural equation modeling was used to assess the mediating effects of perceived social support and anxiety-depression on the relationship between physical function status and SCNS.Results:A total of 304 patients were enrolled, including 260 males and 44 females, 31 cases aged 18-40 years old, 160 cases aged 41 to 60 years old, and 113 cases over 60 years old. The mean total SCNS score was (98.32 ± 21.75) points, the mean anxiety-depression score was (23.31 ± 9.64) points, the mean perceived social support score was (56.62 ± 13.05) points, and the mean physical function status score was (66.28 ± 12.31) points. Pearson correlation analysis showed that physical function status was negatively correlated with SCNS and anxiety-depression ( r =-0.509, -0.447; both P<0.05) and positively correlated with perceived social support ( r =0.439, P<0.05). Physical function status had a direct effect of 60.74% on SCNS, with specific mediating effects of perceived social support and anxiety-depression accounting for 23.15% and 11.85%, respectively, and a chain mediating effect of 4.26%. Conclusions:Patients with PLC exhibited a moderately high level of supportive care needs. Physical function status not only exerted a direct negative effect on SCNS but also indirectly influenced SCNS through the chain mediation of perceived social support and anxiety-depression. Clinical medical staff should focus on enhancing patients' perception of social support and effectively alleviating anxiety and depressive symptoms, thereby reducing supportive care needs to some extent.
5.Impact of physical functioning on supportive care needs in patients with hepatocellular carcinoma: a chain-mediated model involving perceived social support, anxiety, and depression
Lanfang ZHUO ; Yu WANG ; Quan JIANG ; Xiaolong CHEN ; Xiaolan WANG ; Yanhua SHI ; Xianmei MENG
Chinese Journal of Practical Nursing 2025;41(34):2646-2654
Objective:To examine the influence of physical function status on supportive care needs (SCNS) in patients with primary liver cancer (PLC) and to explore the mediating roles of perceived social support and anxiety-depression, with the aim of providing evidence for nursing interventions to improve patients' care experience.Methods:A convenience sampling method was used to select PLC inpatients admitted to The First Affiliated Hospital of Jinan University between December 2022 and February 2024. Data were collected using a general information questionnaire, the 34-item Supportive Care Needs Survey-Short Form, the Hospital Anxiety and Depression Scale, the Perceived Social Support Scale, and the Karnofsky Performance Status Scale to conduct a cross-sectional survey. Pearson correlation analysis was performed to examine associations among SCNS, perceived social support, anxiety-depression, and physical function status. Structural equation modeling was used to assess the mediating effects of perceived social support and anxiety-depression on the relationship between physical function status and SCNS.Results:A total of 304 patients were enrolled, including 260 males and 44 females, 31 cases aged 18-40 years old, 160 cases aged 41 to 60 years old, and 113 cases over 60 years old. The mean total SCNS score was (98.32 ± 21.75) points, the mean anxiety-depression score was (23.31 ± 9.64) points, the mean perceived social support score was (56.62 ± 13.05) points, and the mean physical function status score was (66.28 ± 12.31) points. Pearson correlation analysis showed that physical function status was negatively correlated with SCNS and anxiety-depression ( r =-0.509, -0.447; both P<0.05) and positively correlated with perceived social support ( r =0.439, P<0.05). Physical function status had a direct effect of 60.74% on SCNS, with specific mediating effects of perceived social support and anxiety-depression accounting for 23.15% and 11.85%, respectively, and a chain mediating effect of 4.26%. Conclusions:Patients with PLC exhibited a moderately high level of supportive care needs. Physical function status not only exerted a direct negative effect on SCNS but also indirectly influenced SCNS through the chain mediation of perceived social support and anxiety-depression. Clinical medical staff should focus on enhancing patients' perception of social support and effectively alleviating anxiety and depressive symptoms, thereby reducing supportive care needs to some extent.
6.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.
7.Differential Analysis of Erythrocyte Flexibility of PbK173 Artemisinin-sensitive Strains
Hongying ZHOU ; Wenhui XU ; Miyi YANG ; Hang SHI ; Lanfang LI ; Guihua YU ; Canghai LI ; Huajing WANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(7):95-103
ObjectiveTo detect the flexibility differences of Plasmodium berghei K173 (PbK173)-infected red blood cells with varying degrees of sensitivity to artemisinin-based drugs and to preliminarily explore the underlying mechanisms of the differences. MethodA total of 102 specific-pathogen-free (SPF) male C57BL/6 mice were randomly divided into three groups, with 30 mice each in the control group and PbK173-resistant (PbK173-R) group, and 42 mice in the PbK173-sensitive (PbK173-S) group. Except for the control group, the rest groups were vaccinated with 1×107 PbK173-S/PbK173-R infected red blood cells to establish a mouse malaria model. During the administration and recovery periods (control group, PbK173-R/PbK173-S), dihydroartemisinin (DHA, 40 mg·kg-1) and malaridine (MD, 6 mg·kg-1) were administered continuously for four days. Peripheral blood was taken from the PbK173-S/PbK173-R groups with an infection rate equal to or greater than 20%. Peripheral blood and each organ were taken on the first day at the end of administration (dosing period) and on the fifth day at the end of administration (recovery period), and blood parameters and organ indices of each group were examined. The osmotic fragility of peripheral blood red blood cells in each group was detected using the red blood cell osmotic fragility test. Western blot was applied to determine the levels of Piezo1 and Band3 proteins in the red blood cell membrane. ResultDuring the administration and recovery periods, there were no significant differences between the PbK173-S MD group and the DHA group. During the administration period, there were no significant differences in hematological parameters between PbK173-S and PbK173-R in the MD group. However, during the recovery period, the red blood cell count, hemoglobin concentration and hematocrit of the PbK173-R group were significantly higher than those of the PbK173-S group (P<0.05) in the MD group. Compared with that of the control group, the osmotic fragility of the PbK173-S/PbK173-R groups was significantly enhanced (P<0.01), and the osmotic fragility of the PbK173-S group was significantly stronger than that of the PbK173-R group (P<0.01). The osmotic fragility of red blood cells in the PbK173-S group during the administration period was significantly stronger than that in the control group and PbK173-R group during the administration period (P<0.01). The osmotic fragility of red blood cells in the PbK173-R group during the recovery period was significantly higher than that in the control group during the administration period and the PbK173-S group during the recovery period (P<0.05). Compared with those in the control group, the Piezo1 protein and Band3 protein in the red blood cell membrane of the PbK173-S group were significantly reduced (P<0.01). Compared with those in the PbK173-R group, the Piezo1 protein and Band 3 protein in the red blood cell membrane of the PbK173-S group were significantly reduced. ConclusionThe flexibility of PbK173-infected red blood cells with different sensitivities to artemisinins differed. Plasmodium-infected red blood cells significantly reduced the levels of Piezo1 and Band3 proteins in the red blood cell membrane, and the erythrocyte flexibility exhibited a decreasing trend in the following order: normal group, PbK173-R group, and PbK173-S group.
8.Feasibility study of active case findings for chronic obstructive pulmonary disease based on comorbidities-associated disease collection and questionnaire screening in county territory inpatients
Kun XIAO ; Zhenyu LIANG ; Lanfang LIANG ; Pusheng XU ; Meiyi LI ; Yanting XU ; Chunhong YU
Chinese Journal of Health Management 2024;18(5):326-332
Objective:To explore the feasibility of actively screening patients with chronic obstructive pulmonary disease (COPD) among inpatients in county territory-level hospitals based on the collection of comorbidity-related diseases and questionnaire surveys.Methods:This study was a cross-sectional study. From April 1, 2023, to November 30, 2023, a total of 1 392 inpatients who met the screening criteria in county territory-level hospitals within the Western Medical Group of Baiyun District, Guangzhou, were included in the study. General information, disease data, and COPD screening data of the patients were collected. A total of 1 392 questionnaires were distributed, all of which were returned and included in the analysis. Descriptive analysis, comparative analysis, and association rule mining were conducted, including the distribution of general information, distribution of common comorbidity-related diseases in COPD, distribution of questionnaire screening and pulmonary function test results, comparison of screening results based on comorbidity-related diseases grouping, comparison of screening results based on questionnaire screening results grouping, comparison of screening results based on smoking total score grouping, and association rules between screening results and pulmonary function test results and other research data.Results:Among the 1 392 study subjects, 334 cases (24.0%) had a positive self-screening questionnaire for COPD, 44 cases (13.2%) completed pulmonary function tests, and 17 cases (38.6%) were diagnosed with COPD. The positive rate of the screening questionnaire among inpatients was lowest in surgical patients without comorbidity-related diseases and highest in male patients with single/multiple comorbidity-related diseases and symptoms of chronic respiratory system diseases. The group with multiple comorbidity-related diseases had a significantly higher positive rate in the screening questionnaire than the group with single comorbidity-related diseases and the group without comorbidity-related diseases. Only 13.2% of inpatients with a positive screening questionnaire completed pulmonary function tests, with residents covered by medical insurance with multiple comorbidity-related diseases, including cardiovascular diseases, having the lowest rate, and patients with symptoms of chronic respiratory system diseases and single comorbidity-related diseases having the highest rate.Conclusions:Based on the collection of comorbidity-related diseases and questionnaire surveys, it is feasible to actively screen COPD patients among inpatients in county territory-level hospitals. However, efforts are needed to further increase the proportion of inpatients with positive screening questionnaires undergoing pulmonary function tests.
9.Establishment of Poly (I∶C)-induced Cytokine Storm Model in Mice and Intervention Effect of Artesunate and Qingfei Paidu Decoction
Hang SHI ; Hongying ZHOU ; Lanfang LI ; Guihua YU ; Hui CHENG ; Canghai LI ; Huajing WANG
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(12):94-103
ObjectiveTo observe the intervention effect of artesunate (ART) and Qingfei Paidu decoction (QFPD) on the mouse model of cytokine storm (CS) induced by viral mimic Poly (I∶C). MethodEighty-four SPF male BALB/c mice were randomly divided into seven groups, with 12 mice in each group. Mice, except for those in the blank group (n=12), were subjected to CS model induction by tail vein injection of Poly (I∶C) at 15 mg·kg-1, followed by drug treatments of low-dose ART (ART-l, 10 mg·kg-1), medium-dose ART (ART-m, 20 mg·kg-1), high-dose ART (ART-h, 40 mg·kg-1), Qingfei Paidu Decoction (QFPD, 2.4 g·kg-1), and dexamethasone (DXM, 10 mg·kg-1). After 6 hours, lung tissues, bronchoalveolar lavage fluid (BALF), spleen, lung, and peripheral blood were collected. The lung and spleen indexes were calculated and the number of inflammatory cells in BALF was detected. The pathological changes in lung tissues were observed by hematoxylin-eosin (HE) staining and the levels of tumor necrosis factor-α (TNF-α), interferon-γ (IFN-γ), interleukin-1β (IL-1β), and IL-6 in BALF were detected by enzyme-linked immunosorbent assay (ELISA). The expression of immune cells in BALF and peripheral blood was detected by flow cytometry. ResultThe analysis of lung and spleen indexes showed that compared with the blank group, the model group showed increased lung and spleen indexes to varying degrees (P<0.05). Compared with the model group, the ART groups showed reduced spleen index (P<0.05) and the ART-l group showed reduced lung index (P<0.05). Additionally, the QFPD group showed reduced lung and spleen indexes (P<0.05). ELISA results showed that except for TNF-α, the levels of IFN-γ, IL-1β, and IL-6 in the model group increased compared with those in the blank group (P<0.05). Compared with the model group, the ART-l group and the QFPD group showed reduced content of TNF-α (P<0.05), and all groups with drug intervention showed reduced content of IFN-γ, IL-1β, and IL-6 (P<0.05). The number of inflammatory cells in BALF showed a downward trend in the model group, and the number of cells increased in the groups with drug intervention except for the DXM group (P<0.05). Flow cytometry showed that compared with the blank group, the model group showed decreased number of CD3 in the peripheral blood (P<0.05), increased Ly-6G and F4/80 (P<0.05), decreased expression of CD45, CD3, and F4/80 in BALF (P<0.05), and increased expressions of Ly-6G (P<0.05). Compared with the model group, the ART groups and QFPD group showed increased CD45 content in peripheral blood (P<0.05), decreased Ly-6G and F4/80 content (P<0.05), increased CD45 and F4/80 content in BALF (P<0.05), and decreased expression of Ly-6G (P<0.05). ConclusionART and QFPD have a good protective effect on Poly (I∶C)-induced CS in mice, and the mechanism is related to the effective intervention in immune cell disorder.
10.Clinical Characteristics and Treatment of Blau Syndrome in Chinese Children-a National Multicenter Study
Junmei ZHANG ; Xiaozhen ZHAO ; Xuemei TANG ; Yi'nan ZHAO ; Li LI ; Fengqiao GAO ; Xinwei SHI ; Yanliang JIN ; Yu ZHANG ; Lanfang CAO ; Wei YIN ; Jihong XIAO ; Weiying KUANG ; Jianghong DENG ; Jiang WANG ; Xiaohua TAN ; Chao LI ; Shipeng LI ; Haiyan XUE ; Cuihua LIU ; Xiaohui LIU ; Dongmei ZHAO ; Yuqing CHEN ; Wenjie ZHENG ; Caifeng LI
JOURNAL OF RARE DISEASES 2022;1(3):252-258

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