1.Forty Cases of Mid-Stage Diabetes Kidney Disease Patients of Blood Stasis Syndrome Treated with Huayu Tongluo Formula (化瘀通络方) as an Adjunct Therapy: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial
Yun MA ; Kaishuang WANG ; Shuang CAO ; Bingwu ZHAO ; Lu BAI ; Su WU ; Yuwei GAO ; Xinghua WANG ; Dong BIAN ; Zhiqiang CHEN
Journal of Traditional Chinese Medicine 2025;66(6):588-595
ObjectiveTo evaluate the clinical efficacy of Huayu Tongluo Formula (化瘀通络方, HTF) in patients with mid-stage diabetic kidney disease of blood stasis syndrome and explore its potential mechanisms. MethodsA multi-center, randomized, double-blind, placebo-controlled clinical trial was conducted. Ninety patients of mid-stage diabetic kidney disease of blood stasis syndrome were divided into a control group of 46 cases and a treatment group of 44 cases. Both groups received conventional western medicine treatment, the treatment group additionally taking HTF, while the control group taking a placebo of the formula. The treatment was administered once daily for 24 weeks. The primary outcomes included 24-hour urine total protein (24 h-UTP), serum albumin (Alb), glycated hemoglobin (HbA1c), and serum creatinine (Scr).The secondary outcomes included changes in levels of endothelin-1 (ET-1), nitric oxide (NO), vascular endothelial growth factor (VEGF), and traditional Chinese medicine (TCM) syndrome scores before and after treatment. Clinical efficacy was evaluated based on TCM syndrome scores and overall disease outcomes. Adverse reactions and endpoint events were recorded. ResultsIn the treatment group after treatment, 24 h-UTP, ET-1, and VEGF levels significantly decreased (P<0.05), Alb and NO levels significantly increased (P<0.05); while the TCM syndrome scores for edema, lumbar pain, numbness of limbs, dark purple lips, dark purple tongue or purpura, and thin, rough pulse all significantly decreased (P<0.05). In the control group, no significant changes were observed in any of the indicators after treatment (P>0.05).Compared with the control group, the treatment group showed significant reductions in 24 h-UTP, ET-1, and VEGF levels, and increases in Alb and NO levels (P<0.05). The TCM syndrome scores for edema, lumbar pain, dark purple tongue or purpura, and thin, rough pulse were all lower in the treatment group than in the control group (P<0.05). The total effective rate of TCM syndrome in the treatment group was 59.09% (26/44), and the overall clinical effective rate was 45.45% (20/44). In the control group, these rates were 15.22% (7/46) and 8.7% (4/46), respectively, with the treatment group showing significantly better outcomes (P<0.05). A total of 7 adverse events occurred across both groups, with no significant difference (P>0.05). No endpoint events occurred during the study. ConclusionOn the basis of conventional treatment of Western medicine, HTF can further reduce urinary protein levels and improve clinical symptoms in patients with mid-stage diabetic kidney disease of blood stasis syndrome. The mechanism may be related to its effects on endothelial function.
2.Impact on analgesic efficacy and safety of esketamine as an adductor canal block adjuvant in knee arthroplasty
Yan ZHANG ; Yichao CAI ; Na CAO ; Huiru YANG ; Xinghua BIAN ; Kan LI
Adverse Drug Reactions Journal 2024;26(11):672-676
Objective:To explore the impact on analgesic efficacy and safety of esketamine as an adductor canal block adjuvant in knee arthroplasty.Methods:The study was a prospective, single center, randomized controlled trial. The subjects were patients who received knee arthroplasty in Zhangjiakou First hospital from October 2021 to October 2023. The patients were randomly divided into trial group and control group using a random number table method. The patients in the both groups received general anesthesia and postoperative patient-controlled intravenous analgesia (PCIA). The patients in the trial group were injected with 0.375% ropivacaine combined with esmketamine, while those in the control group were only injected with 0.375% ropivacaine. The postoperative vital signs, quadriceps femoris muscle strength, resting and dynamic visual analogue scale (VAS) pain score, use of PCIA, and incidence of postoperative adverse reactions in patients between the 2 groups were compared.Results:A total of 120 patients were included in this study, with 60 cases in each group. There were no significant differences in heart rate, mean arterial pressure, respiratory rate, and body temperature in patients between the trial group and the control group at 24 and 48 hours after operation (all P>0.05). There were no significant differences in quadriceps femoris muscle strength at 12, 24 and 48 hours after operation (all P>0.05). At rest, the VAS pain score at 12 hours after operation in the trial group was lower than that in the control group [(2.89±0.49) points vs. (3.36±0.23) points], the difference was statistically significant ( P<0.05). In the active state, the VAS scores at 12 and 24 hours after operation in the trial group were lower than those in the control group [(3.78±0.41) points vs. (4.11±0.45) points, (3.79±0.56) points vs. (4.19±0.69) points], the differences were statistically significant (all P<0.05). The number of times of PCIA compression 24 hours after operation in the experimental group was less than that in the control group [(5.35±1.03) times vs. (7.89±1.34) times], and the difference was statistically significant ( P<0.05), the sensory block time in the experimental group was longer than that in the control group [(488.26±57.75) min vs. (92.26±65.15) min], and the difference was statistically significant ( P<0.05). There were no significant differences in total incidence of adverse reactions including nausea, vomiting, urinary retention, dizziness, drowsiness, delirium and hallucination in patients between the 2 groups within 1 week after operation (all P>0.05). Conclusion:Esketamine as an adjuvant of ropivacaine for adductor block can alleviate the pain level of patients undergoing knee arthroplasty, and it has good safety.
3.Impact on analgesic efficacy and safety of esketamine as an adductor canal block adjuvant in knee arthroplasty
Yan ZHANG ; Yichao CAI ; Na CAO ; Huiru YANG ; Xinghua BIAN ; Kan LI
Adverse Drug Reactions Journal 2024;26(11):672-676
Objective:To explore the impact on analgesic efficacy and safety of esketamine as an adductor canal block adjuvant in knee arthroplasty.Methods:The study was a prospective, single center, randomized controlled trial. The subjects were patients who received knee arthroplasty in Zhangjiakou First hospital from October 2021 to October 2023. The patients were randomly divided into trial group and control group using a random number table method. The patients in the both groups received general anesthesia and postoperative patient-controlled intravenous analgesia (PCIA). The patients in the trial group were injected with 0.375% ropivacaine combined with esmketamine, while those in the control group were only injected with 0.375% ropivacaine. The postoperative vital signs, quadriceps femoris muscle strength, resting and dynamic visual analogue scale (VAS) pain score, use of PCIA, and incidence of postoperative adverse reactions in patients between the 2 groups were compared.Results:A total of 120 patients were included in this study, with 60 cases in each group. There were no significant differences in heart rate, mean arterial pressure, respiratory rate, and body temperature in patients between the trial group and the control group at 24 and 48 hours after operation (all P>0.05). There were no significant differences in quadriceps femoris muscle strength at 12, 24 and 48 hours after operation (all P>0.05). At rest, the VAS pain score at 12 hours after operation in the trial group was lower than that in the control group [(2.89±0.49) points vs. (3.36±0.23) points], the difference was statistically significant ( P<0.05). In the active state, the VAS scores at 12 and 24 hours after operation in the trial group were lower than those in the control group [(3.78±0.41) points vs. (4.11±0.45) points, (3.79±0.56) points vs. (4.19±0.69) points], the differences were statistically significant (all P<0.05). The number of times of PCIA compression 24 hours after operation in the experimental group was less than that in the control group [(5.35±1.03) times vs. (7.89±1.34) times], and the difference was statistically significant ( P<0.05), the sensory block time in the experimental group was longer than that in the control group [(488.26±57.75) min vs. (92.26±65.15) min], and the difference was statistically significant ( P<0.05). There were no significant differences in total incidence of adverse reactions including nausea, vomiting, urinary retention, dizziness, drowsiness, delirium and hallucination in patients between the 2 groups within 1 week after operation (all P>0.05). Conclusion:Esketamine as an adjuvant of ropivacaine for adductor block can alleviate the pain level of patients undergoing knee arthroplasty, and it has good safety.
4.Measurement model of life stress structure of submariners:based on exploratory and confirmatory factor analysis
Houyu ZHAO ; Qinglin CHENG ; Cunwen BIAN ; Peng YI ; Xinghua SHEN
Chinese journal of nautical medicine and hyperbaric medicine 2022;29(1):37-42
Objective:To preliminarily establish a measurement model of life stress scale for submariners.Methods:The research hypothesis that the structure of life stress scale for submariners includes four dimensions and 92 items was put forward by literature review,referencing existing stress scales,personal interviews,and expert evaluation. On the basis of the questionnaire survey among 562 submariners,exploratory factor analysis and confirmatory factor analysis were used to test the hypothesis.Results:Exploratory factor analysis showed that the structure of life stress scale for submariners includes six dimensions,i.e.,noise and vibration stress,daily life stress,management stress,family stress,social isolation stress,and self-management stress,and 32 items in total. The results of confirmatory factor analysis showed that the fitness index of the model reached the standard of good after modification( χ2/df=1.435,GFI=0.849,CFI=0.959,RMSEA=0.045,IFI=0.960,TLI=0.954,NFI=0.878),indicating that the measurement model has a good external quality. Moreover,each latent variable had good component reliability and mean variance extraction(CR:0.854-0.929,AVE:0.500-0.688),indicating that the internal quality of the measurement model and the latent trait of latent variables were good. Conclusion:The structure of life stress scale for submariners includes six dimensions. The correlation among latent variables in the measurement model shows that these six dimensions are a whole of mutual interaction and the structure of the scale is reasonable.
5.Measurement model of life stress structure of submariners:based on exploratory and confirmatory factor analysis
Houyu ZHAO ; Qinglin CHENG ; Cunwen BIAN ; Peng YI ; Xinghua SHEN
Chinese journal of nautical medicine and hyperbaric medicine 2022;29(1):37-42
Objective:To preliminarily establish a measurement model of life stress scale for submariners.Methods:The research hypothesis that the structure of life stress scale for submariners includes four dimensions and 92 items was put forward by literature review,referencing existing stress scales,personal interviews,and expert evaluation. On the basis of the questionnaire survey among 562 submariners,exploratory factor analysis and confirmatory factor analysis were used to test the hypothesis.Results:Exploratory factor analysis showed that the structure of life stress scale for submariners includes six dimensions,i.e.,noise and vibration stress,daily life stress,management stress,family stress,social isolation stress,and self-management stress,and 32 items in total. The results of confirmatory factor analysis showed that the fitness index of the model reached the standard of good after modification( χ2/df=1.435,GFI=0.849,CFI=0.959,RMSEA=0.045,IFI=0.960,TLI=0.954,NFI=0.878),indicating that the measurement model has a good external quality. Moreover,each latent variable had good component reliability and mean variance extraction(CR:0.854-0.929,AVE:0.500-0.688),indicating that the internal quality of the measurement model and the latent trait of latent variables were good. Conclusion:The structure of life stress scale for submariners includes six dimensions. The correlation among latent variables in the measurement model shows that these six dimensions are a whole of mutual interaction and the structure of the scale is reasonable.

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