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.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.
4.Development and validation of a Knowledge-Attitude-Practice Scale for Dietary Management During Hemodialysis
Taofeng WU ; Yingying JIANG ; Hongyun YAN ; Jingfang CHEN ; Lanfang HU ; Yan BAI ; Lili ZHANG ; Xianrong XU ; Xingxing SHEN ; Jianzhen FAN ; Cuiling SUN ; Xiaolan FANG
Chinese Journal of Modern Nursing 2025;31(7):846-852
Objective:To develop a Knowledge-Attitude-Practice (KAP) Scale for Dietary Management During Hemodialysis and to test its reliability and validity.Methods:Based on the KAP theoretical framework, an initial version of the scale was developed through a literature review and expert consultations. A convenience sampling method was used to recruit hemodialysis patients from four hospitals in Suzhou in March 2024. Questionnaire item analysis and reliability and validity tests were conducted.Results:A total of 460 questionnaires were distributed and 438 valid responses were collected, with an effective response rate of 95.22%. The final scale included three dimensions (knowledge, attitude, and practice) with 34 items. Content validity at the scale level was 0.910, and the item level ranged from 0.800 to 1.000. Exploratory factor analysis extracted three common factors, with a cumulative variance contribution rate of 74.520%. Confirmatory factor analysis showed a good model fit. The total Cronbach's α coefficient of the scale was 0.971, and the Cronbach's αcoefficients for the three dimensions were 0.963, 0.933, and 0.934, respectively. The test-retest reliability coefficient was 0.839.Conclusions:The Knowledge-Attitude-Practice Scale for Dietary Management During Hemodialysis demonstrates good reliability and validity, making it a valuable tool for assessing the KAP level of dietary management in hemodialysis patients.
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.Development and validation of a Knowledge-Attitude-Practice Scale for Dietary Management During Hemodialysis
Taofeng WU ; Yingying JIANG ; Hongyun YAN ; Jingfang CHEN ; Lanfang HU ; Yan BAI ; Lili ZHANG ; Xianrong XU ; Xingxing SHEN ; Jianzhen FAN ; Cuiling SUN ; Xiaolan FANG
Chinese Journal of Modern Nursing 2025;31(7):846-852
Objective:To develop a Knowledge-Attitude-Practice (KAP) Scale for Dietary Management During Hemodialysis and to test its reliability and validity.Methods:Based on the KAP theoretical framework, an initial version of the scale was developed through a literature review and expert consultations. A convenience sampling method was used to recruit hemodialysis patients from four hospitals in Suzhou in March 2024. Questionnaire item analysis and reliability and validity tests were conducted.Results:A total of 460 questionnaires were distributed and 438 valid responses were collected, with an effective response rate of 95.22%. The final scale included three dimensions (knowledge, attitude, and practice) with 34 items. Content validity at the scale level was 0.910, and the item level ranged from 0.800 to 1.000. Exploratory factor analysis extracted three common factors, with a cumulative variance contribution rate of 74.520%. Confirmatory factor analysis showed a good model fit. The total Cronbach's α coefficient of the scale was 0.971, and the Cronbach's αcoefficients for the three dimensions were 0.963, 0.933, and 0.934, respectively. The test-retest reliability coefficient was 0.839.Conclusions:The Knowledge-Attitude-Practice Scale for Dietary Management During Hemodialysis demonstrates good reliability and validity, making it a valuable tool for assessing the KAP level of dietary management in hemodialysis patients.
7.Analysis of drug resistance and virulence genes of clinical isolates of Staphylococcus aureus in Northwest Hubei Province
Yating ZHANG ; Wuhui JIANG ; Kang YANG ; Lanfang LIU ; Yan YANG
International Journal of Laboratory Medicine 2024;45(19):2311-2315,2322
Objective To investigate the drug resistance and virulence genes of Staphylococcus aureus iso-lated from clinical specimens of hospitals in northwest Hubei province.Methods A total of 142 clinical iso-lates of Staphylococcus aureus were collected from 5 hospitals in Shiyan City from 2019 to 2021.Broth mi-crodilution method was used to detect drug resistance,and PCR method was used to detect 9 enterotoxin genes such as sea,mecA and Panton-Valentine leukocidein(PVL)virulence genes.Results A total of 44 methicillin-resistant Staphylococcus aureus(MRSA)strains were detected in 142 strains of Staphylococcus aureus,and the detection rate was 30.99%(44/142).The resistance rates of MRSA to erythromycin,clindamycin,levo-floxacin,tetracycline and gentamicin were higher than those of methicillin-sensitive Staphylococcus aureus(MSSA),and the differences were statistically significant(P<0.05).The detection rate of enterotoxin genes was 70.42%(100/142),among which the detection rates of classic enterotoxin genes(sea-see)and new ente-rotoxin genes(seg-sej)were 47.18%(67/142)and 42.25%(60/142),respectively.The detection rate of PVL virulence genes was 13.38%(19/142),among which the detection rates of MSSA and MRSA were 9.18%(9/98)and 22.73%(10/44),respectively,and the difference was statistically significant(P<0.05).Conclusion The detection rate of enterotoxin and PVL gene of Staphylococcus aureus isolated from clinical isolates is high.In clinical di-agnosis and treatment,it is necessary to control hospital infection,take effective isolation measures in time and strengthen the monitoring of PVL gene.
8.Mechanism of propofol inhibiting carotid sinus baroreflex in rats with type 2 diabetes mellitus: GluR2 subunit-containing AMPA receptors in nucleus ambiguus
Chunxin HAN ; Lanfang JIANG ; Aozhang JI ; Zhao ZHUANG ; Qianqian CAO ; Shoushi WANG
Chinese Journal of Anesthesiology 2023;43(9):1067-1071
Objective:To evaluate the relationship between the mechanism of propofol inhibiting carotid sinus baroreflex (CSR) and GluR2 subunit-containing AMPA receptors in the nucleus ambiguus of rats with type 2 diabetes mellitus (T2DM).Methods:SPF healthy male Sprague-Dawley rats, aged 3 weeks, were selected and fed a high glucose and high fat diet for 6 weeks, and then streptozotocin 30 mg/kg was intraperitoneally injected to prepare a T2DM model of rats. Twenty-four T2DM rats were divided into 4 groups ( n=6 each) using a random number table method: diabetes mellitus-normal saline group (DN group), diabetes mellitus-propofol group (DP group), AMPA receptor agonist-normal saline group (AN group), and AMPA receptor agonist-propofol group (AP group). Another 12 normal rats were selected and divided into 2 groups ( n=6 each) using a random number table method: normal-normal saline group (NN group) and normal-propofol group (NP group). AMPA receptor agonist mibamitor 1 nmol/L (50 nl) was injected into the nucleus ambiguus using a micropipette at 30 min before perfusion of isolated carotid sinus in AN and AP groups. Propofol 45 mg·kg -11·h -1 was infused for 2 h via the femoral vein in NP group, DP group and AP group, and the equal volume of normal saline was given instead in the other groups. A model for perfusing isolated carotid sinus was developed at 20 min after infusion of propofol or normal saline, the intracarotid sinus pressure (ISP)-mean arterial blood pressure (MAP) curve was drawn, and CSR parameters such as maximum slope (PS), threshold pressure (TP), saturation pressure (SP), equilibrium pressure (EP), maximum decrease in MAP reflexivity (RD), and carotid sinus baroreceptor operating range (OR) were recorded. Brain tissues were taken at the end of perfusion, and the expression of GluR2 subunit in the nucleus ambiguus was detected by Western blot and immunofluorescence. Results:Compared with the corresponding normal saline groups (NN group, DN group, AN group), PS and RD were significantly decreased, TP, SP and OR were increased ( P<0.05), and the ISP-MAP curve was shifted upward in propofol groups (NP group, DP group, AP group), the expression of GluR2 subunit in the nucleus ambiguus was down-regulated in NP and DP groups ( P<0.05), and no significant change was found in the expression of GluR2 subunit in the nucleus ambiguus in AP group ( P>0.05). Compared with NP group, PS and RD were significantly decreased, TP, SP and OR were increased ( P<0.05), the ISP-MAP curve was shifted upward, and the expression of GluR2 subunit in the nucleus ambiguus was down-regulated in DP group ( P<0.05). Compared with DP group, PS and RD were significantly increased, TP, SP and OR were decreased ( P<0.05), the ISP-MAP curve was shifted downward, and the expression of GluR2 subunit in the nucleus ambiguus was up-regulated in AP group ( P<0.05). Conclusions:The mechanism by which propofol inhibits CSR may be related to down-regulation of the expression of GluR2 subunits-containing AMPA receptors in the nucleus ambiguus of rats with T2DM.
9.Landing practices of national medical insurance negotiated drugs in tertiary medical institutions of Zhejiang province
Jin PENG ; Junnan JIANG ; Zenghui QIU ; Lanfang LIU ; Lan YAO
China Pharmacy 2023;34(10):1159-1164
OBJECTIVE To provide reference for the subsequent landing of national medical insurance negotiated drugs (referred to as “national negotiated drugs”) at the provincial level. METHODS By reviewing the data publicly released by the official websites of National Healthcare Security Administration and the Healthcare Security Administration of Zhejiang Province, combined with policy documents, the descriptive analysis was conducted on the number of tertiary medical institutions, the actual allocation of national negotiated drugs, the availability rate of national negotiated drugs, the allocation rate of national negotiated drug varieties, and the allocation rate of medical institutions of various cities in Zhejiang province. The Spearman rank correlation test was used to analyze the correlation between the number of types of national negotiated drugs equipped in tertiary medical institutions in Zhejiang province and the per capita disposable income, the number of tertiary medical institutions equipped with national negotiated drugs, and the implementation time of disease diagnosis-related grouping (DRG) of various cities in Zhejiang province. RESULTS As of the first quarter of 2022, 135 tertiary medical institutions in Zhejiang province were equipped with a total of 261 types of national negotiated drugs, accounting for 94.91% of the 2021 edition of the National Negotiated Drugs Catalogue (275 types). The allocation rates of Goserelin acetate sustained-release implant, Sacubitril valsartan sodium tablets, Alteplase for injection and other varieties were at high level, and the types of national negotiated drugs equipped were highly coincident with the top 10 causes of death with disease of urban and rural residents in Zhejiang province. The tertiary medical institutions in Hangzhou had the most types of national negotiated drugs, with 230 types, while Quzhou had the lowest, with only 34 types; allocation rate of national negotiated drugs in medical institutions of Zhoushan was the highest (100%), while that of Lishui was the lowest (57.14%). The types of national negotiated drugs equipped were positively correlated with per capita disposable income in various cities and the number of tertiary medical institutions equipped with national negotiated drugs (P<0.01), and there was no significant correlation with the length of implementation of DRG (P>0.05). CONCLUSIONS mail:lanyao@mails.tjmu.edu.cn The landing of national negotiated drugs in Zhejiang province is generally good, with a high rate of equipping tertiary medical institutions with national negotiated drugs and a high rate of equipping drug varieties. Therefore, it is recommended that the provincial implementation of national negotiated drugs should be multi-faceted, and policy-making departments should adopt a dual-channel of “unbundling” and “driving” to smooth the drug chain into hospitals. The health insurance sector should improve the “dual channel” management mechanism to share the pressure on hospitals to use drugs. At the same time, it should also improve the multi-level medical security system and raise the level of reimbursement of medical insurance for national negotiated drugs.
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

Result Analysis
Print
Save
E-mail