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.Selecting appropriate evaluation equations for assessing declining kidney function in aging individuals with disease conditions
Lengnan XU ; Congxia CHEN ; Ying SUN ; Xin LIU ; Aiqun CHEN ; Yonghui MAO
Chinese Journal of Geriatrics 2024;43(9):1155-1161
Objective:To compare the performance of 11 glomerular filtration rate(GFR)equations in Chinese elderly hospitalized patients using dynamic renal imaging as the reference standard.Methods:The retrospective study involved patients aged 60 years and older who were admitted to Beijing Hospital between January, 2017, and January 2020.Glomerular filtration rate(GFR)was assessed through dynamic renal imaging for all participants.Estimated GFR(eGFR)was calculated using various equations based on serum creatinine and/or cystatin C levels, including All Age Spectrum(FAS), Berlin Initiative Study(BIS), Chronic Kidney Disease Epidemiology Collaboration(CKD-EPI), Modification of Diet in Renal Disease Study(MDRD), MDRD in China(MDRDc), and Xiangya..Results:A total of 691 patients, of which 383 were males, with an age range of 60 to 90 years(mean age 71.9±7.7 years), were included in the study.Among the different equations used to estimate glomerular filtration rate(GFR)in ml·min -1·1.73m -2, the smallest deviations were observed with FAScys(2.48), FAScr-cys(3.07), CKD-EPIcys(4.20), and BIScr-cys(7.42).Conversely, the most accurate estimations were found with BIScr-cys(10.38), FAScr-cys(11.94), FAScys(12.08), CKD-EPIcr-cys(13.21), and CKD-EPIcys(13.51).The highest P30 values, indicating the proportion of estimates within 30% of the true GFR, were achieved by FAScr-cys(68.97%), FAScys(68.96%), CKD-EPIcys(63.22%), and BIScr-cys(61.67%).The equations with the lowest root mean square errors were BIScr-cys(9.73), CKD-EPIcr-cys(10.98), FAScr-cys(11.27), CKD-EPIcys(11.52), and FAScys(11.53).Specifically, the FAS equation showed higher accuracy in men, while BIScr-cys and CKD-EPIcys were more accurate in women.Among patients with chronic kidney disease(CKD), the P30 values for BIScr-cys, FAScys, and FAScr-cys were 86.96%, 83.33%, and 80.95% respectively.Notably, for patients with mGFR ≥ 30 ml/min, MDRDc overestimated GFR the most, whereas for patients with mGFR<30 ml/min, Xiangya exhibited the most significant overestimation of GFR. Conclusions:Among the equations tested, BIScr-cys, FAScys, and FAScr-cys demonstrated the highest accuracy and are therefore recommended for use in Chinese elderly hospitalized patients.
4.Evaluation of anticoagulant effect and predicted dose of low molecular weight heparin in hemodialysis by anti-Ⅹa factor activity
Zhenxing WANG ; Yonghui MAO ; Yuan WANG ; Peijie FU ; Xin DANG ; Lengnan XU
Chinese Journal of Preventive Medicine 2024;58(2):254-260
The purpose of this study was to explore the reasonable dose of low molecular weight heparin (LMWH) in hemodialysis (HD) and the strategy of preventing extracorporeal circuit coagulation (ECC). A retrospective case-control study included patients who used LMWH for anticoagulation during maintenance hemodialysis (MHD) in the Hemodialysis Center of Beijing Hospital from December 2020 to January 2021. Basic data such as weight, height, basic kidney disease, dialysis age and anti-Ⅹa factor activity before, during and after dialysis were collected. A total of 46 patients were enrolled in this study, including 5 patients in coagulation group (10.9%) and 41 patients in non-coagulation group (89.1%). The anti-Ⅹa factor activity reached its peak at 0.5 h after the start of HD. The level of anti-Ⅹa factor was incorporated into the receiver operating characteristic curve (ROC curve). The results showed that the area under the ROC curve (AUC) was 0.802 (95% confidence interval: 0.651-0.54, P=0.029), and the cutoff was 0.31 IU/ml (sensitivity 1, specificity 0.683). It is suggested that the body surface area should be used as the basis to estimate the anticoagulant dose of LMWH in HD, and the activity of HD 4 h anti-Ⅹa factor ≤0.31 IU/ml, which is of diagnostic value for ECC. In addition, the results of binary logistic regression analysis showed that dialysis age was an independent risk factor for ECC ( OR value 1.319, 95% CI 1.052-1.654, P=0.017). In summary, this study reveals that dialysis age may be a risk factor for ECC and that the activity of HD 4 h anti-Ⅹa factor ≤0.31 IU/ml can be used as a potential diagnostic cut-off point for ECC in HD patients, which provides a scientific basis for monitoring strategies to prevent blood coagulation in HD filters.
5.Evaluation of anticoagulant effect and predicted dose of low molecular weight heparin in hemodialysis by anti-Ⅹa factor activity
Zhenxing WANG ; Yonghui MAO ; Yuan WANG ; Peijie FU ; Xin DANG ; Lengnan XU
Chinese Journal of Preventive Medicine 2024;58(2):254-260
The purpose of this study was to explore the reasonable dose of low molecular weight heparin (LMWH) in hemodialysis (HD) and the strategy of preventing extracorporeal circuit coagulation (ECC). A retrospective case-control study included patients who used LMWH for anticoagulation during maintenance hemodialysis (MHD) in the Hemodialysis Center of Beijing Hospital from December 2020 to January 2021. Basic data such as weight, height, basic kidney disease, dialysis age and anti-Ⅹa factor activity before, during and after dialysis were collected. A total of 46 patients were enrolled in this study, including 5 patients in coagulation group (10.9%) and 41 patients in non-coagulation group (89.1%). The anti-Ⅹa factor activity reached its peak at 0.5 h after the start of HD. The level of anti-Ⅹa factor was incorporated into the receiver operating characteristic curve (ROC curve). The results showed that the area under the ROC curve (AUC) was 0.802 (95% confidence interval: 0.651-0.54, P=0.029), and the cutoff was 0.31 IU/ml (sensitivity 1, specificity 0.683). It is suggested that the body surface area should be used as the basis to estimate the anticoagulant dose of LMWH in HD, and the activity of HD 4 h anti-Ⅹa factor ≤0.31 IU/ml, which is of diagnostic value for ECC. In addition, the results of binary logistic regression analysis showed that dialysis age was an independent risk factor for ECC ( OR value 1.319, 95% CI 1.052-1.654, P=0.017). In summary, this study reveals that dialysis age may be a risk factor for ECC and that the activity of HD 4 h anti-Ⅹa factor ≤0.31 IU/ml can be used as a potential diagnostic cut-off point for ECC in HD patients, which provides a scientific basis for monitoring strategies to prevent blood coagulation in HD filters.
6.A case of successful plasma exchange in the treatment of acute renal failure related to infective endocarditis
Ying SUN ; Haitao WANG ; Fang FANG ; Songlan WANG ; Xin LIU ; Yonghui MAO
Chinese Journal of Nephrology 2024;40(6):484-486
A 65-year-old male was admitted because of anorexia, gross hematuria, skin purpura and acute renal insufficiency. Cardiovascular interventional examination was performed in other hospital 3 months before admission. During hospitalization, multiple blood cultures suggested positive Streptococcus gordonii, decreased blood complement and increased rheumatoid factor. Echocardiography revealed mitral valve vegetations (4 mm), and renal biopsy revealed endocapillary proliferative glomerulonephritis, diagnosed as infective endocarditis-associated glomerulonephritis. The combination of effective antibiotics and plasma exchange therapy significantly improved clinical symptoms and acute renal failure. The case suggests that plasma exchange is effective and safe in the treatment of immune complex-mediated glomerulonephritis caused by infective endocarditis, providing a new option for the treatment of such diseases.
7.Urinary RNA oxidation as a potential predictive biomarker for postoperative acute kidney injury in thoracic surgery patients
Lengnan XU ; Ban ZHAO ; Qinghua WENG ; Aiqun CHEN ; Ying SUN ; Jianping CAI ; Yonghui MAO
Chinese Journal of Nephrology 2024;40(10):811-814
Oxidative stress plays a key role in acute kidney injury (AKI). 8-Oxo-7,8-dihydroguanosine (8-oxo-Gsn) can reflect the overall level of oxidative stress in the body. The levels of urinary 8-oxo-Gsn and renal function-related indicators in 62 patients who underwent video-assisted thoracic surgery (VATS) or open-chest surgery were measured during the perioperative period. The results showed that urinary 8-oxo-Gsn increased 24 hours after surgery and decreased 48 hours after surgery as the condition improved. In 10 patients with severe complications, urinary 8-oxo-Gsn continued to rise. The level of urinary 8-oxo-Gsn in the VATS group recovered faster than that in the open-chest surgery group ( P<0.05). There was a certain correlation between the level of urinary 8-oxo-Gsn and postoperative renal injury in thoracic surgery, suggesting that RNA oxidative stress may play an important role in the pathogenesis of surgery-related AKI.
8.Establishment and evaluation of a nomogram prediction model for coagulation in the extracorporeal circuit in elderly hemodialysis patients
Lengnan XU ; Yulong LI ; Zhenxing WANG ; Chuanbao LI ; Yonghui MAO
Chinese Journal of Geriatrics 2023;42(10):1191-1195
Objective:To establish a predictive model for coagulation in the extracorporeal circuit in elderly hemodialysis(HD)patients.Methods:The retrospective case-control study included 196 elderly patients with chronic renal failure receiving 4-h hemodialysis for the first time at the blood purification center of our hospital between March 1, 2019 and January 30, 2022.All enrolled patients were treated with heparin or related drugs for anticoagulation(including unfractionated heparin and low molecular weight heparin), with 14 cases(7.1%)in the coagulation group with a coagulation grade ≥1.There were 182 cases(92.9%)in the non-coagulation group.Demographic data, vital signs in a sitting position and the resting state before dialysis and laboratory tests before dialysis were collected.After the prediction model was developed, it was validated in elderly patients with chronic renal failure aged ≥60 years receiving 4-hour hemodialysis for the first time at our hospital between February 1, 2022 and February 1, 2023.Results:There were significant differences in heart rate[(82.6±12.3)times/min vs.(74.4±11.1)times/min]and total cholesterol[(4.3±1.2)mmol/L vs.(3.2±1.2)mmol/L]between the coagulation group and the non-coagulation group( t=2.231, 2.012, P<0.05).Multivariate logistic analysis showed that the heart rate( OR=0.930, 95% CI: 0.871-0.993, P<0.05)and cholesterol( OR=0.623, 95% CI: 0.391-0.992, P<0.05)had an effect on blood coagulation in cardiopulmonary bypass.The area under the curve(AUC)for predicting cardiopulmonary bypass clotting by heart rate was 0.639(the optimal cutoff value was 71 beats/min), the AUC for predicting clotting by total cholesterol was 0.708(the optimal cutoff value: 4.275 mmol/L), and the prediction using the combination of heart rate and total cholesterol was more effective(AUC=0.735).The model was verified in 98 patients with good results(AUC=0.895). Conclusions:The initial coagulation risk of the extracorporeal circuit in elderly patients undergoing initial HD can be preliminarily estimated based on the nomogram.
9.Influence of clinical features at initial hemodialysis on long-term prognosis in advance-aged patients
Songlan WANG ; Aiqun CHEN ; Ban ZHAO ; Yonghui MAO ; Tianhui LI
Chinese Journal of Geriatrics 2021;40(4):469-474
Objective:To analyze the association of clinical characteristics and laboratory indicators at initial maintenance hemodialysis(MHD)with long-term prognosis in advance-aged patients, and to find influencing factors for the prognosis in advance-aged MHD patients.Methods:This retrospective study was conducted at the Nephrology Department of Beijing Hospital between April 2007 and January 2018.A total of 61 patients receiving first-time hemodialysis at ≥ 80 years of age and undergone regular dialysis for 3 months or longer were enrolled.All patients were followed-up until death or the end of July 1, 2018.Patients were divided into the survivor and non-survivor groups, and differences in clinical characteristics and laboratory indicator values were compared between the two groups.Influencing factors for prognosis in advance-aged MHD patients were analyzed by using multivariate Cox regression.Results:For the 61 subjects, the median follow-up time was 25.8 months.During the follow-up, 32 patients died(52.5%). The main death causes were infectious diseases(40.6%, n=13)and cardiovascular and cerebrovascular diseases(37.5%, n=12). The 1-, 2-, 3-, 4-, and 5-year cumulative survival rates were 75.4%(46/61), 54.1%(33/61), 37.7%(23/61), 22.9%(14/61)and 16.4%(10/61), respectively.The median survival time was 25.8 months for all patients, 27.5 months for patients aged 80-84 years, and 14.9 months for patients aged 85 years and over.The non-survivor group had a higher male ratio(65.6% or 21/32 vs.37.9% or 11/29, χ2=4.678, P=0.031)and lower levels of hemoglobin(85.4±13.0 vs.95.0±17.6 g/L, t=2.867, P=0.019)and albumin(30.3±5.0 vs.34.6±4.8 g/L, t=3.039, P=0.001)than the survivor group.Kaplan-Meier curves indicated that the survival rate decreased with age, and subjects aged less than 85 years had a higher survival rate than subjects aged 85 years and older(the median survival time: 14.9 months vs.27.5 months, Log Rank P=0.006); patients who received continuous renal replacement therapy(CRRT)before dialysis had lower survival rates than patients who did not receive CRRT(the median survival time: 7.8 months vs.29.2 months, Log Rank P=0.002); patients with high serum levels of albumin(≥33 g/L)had higher survival rates than patients with low serum levels of albumin(<33 g/L)(the median survival time: 29.2 months vs.18.9 months, Log Rank P=0.003). Multivariate Cox regression analysis showed that age at initial dialysis( HR=1.136, 95% CI: 1.005-1.285, P=0.041), female( HR=0.409; 95% CI: 0.169-0.994, P=0.048), serum albumin level( HR=0.836, 95% CI: 0.772-0.906, P<0.001)and CRRT before dialysis( HR=6.161, 95% CI: 1.848-20.538, P=0.003)were independent predictors of all-cause mortality in advance-aged patients. Conclusions:Advance-aged patients undergoing hemodialysis have complicated clinical conditions and poor prognosis.Age, gender and serum albumin level at initial dialysis and CRRT before dialysis are independent predictors of prognosis in these patients.
10.Considerations on diagnostic criteria for acute kidney injury in elderly patients and application of novel biomarkers
Chen MENG ; Ban ZHAO ; Yonghui MAO
Chinese Journal of Geriatrics 2021;40(9):1194-1198
Acute kidney injury(AKI)refers to a clinical syndrome in which the glomerular filtration rate decreases sharply in a short period of time due to various causes.Since elderly patients often have low renal functional reserve, complex underlying diseases, frequent acute events and various types of drug combinations, the incidence of AKI in elderly patients is significantly higher than that in the general population and trends upward each year.The prevention and treatment of elderly AKI should place an emphasis on the identification of risk factors and early diagnosis.There is considerable controversy over whether the existing real-world diagnostic criteria are clinically practical and appropriate.The application of novel diagnostic biomarkers for the diagnosis of AKI in the elderly population remains to be justified.This paper reviews considerations on the diagnostic criteria for AKI in the elderly and the clinical application of new biomarkers, in order to arrive at improved diagnosis and treatment recommendations.

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