1.The Solomon Four-Group Design:Key Considerations in Design and Statistical Analysis and Their Significance in Clinical Trials of Traditional Chinese Medicine
Wenqian ZHANG ; Yufei LI ; Tong LIN ; Xintong WEI ; Yingjie WANG ; Jianping LIU ; Ying ZHANG
Journal of Traditional Chinese Medicine 2025;66(16):1649-1655
The Solomon four-group design, a critical method for improving internal validity in clinical research, can reduce bias and control the interference of Hawthorne effects and pretest sensitization on research results, which offers unique advantages in evaluating complex intervention outcomes. This paper systematically outlined the core framework and key points of statistical analysis of the Solomon four-group design, summarized its applications in clinical research at home and abroad, explored its advantages and limitations, and discussed the potential value in traditional Chinese medicine (TCM) clinical trials. It is believed that the Solomon four-group design can help distinguish between testing effects and intervention effects in TCM clinical studies, and reduce the bias in the evaluation of subjective indicators. Meanwhile, given the complexity of the Solomon four-group design and the particularity of TCM clinical research, it is proposed that future TCM clinical studies should focus on using psychological scales, know-ledge, attitude, and behavior measurements, and other similat evaluations as endpoints. It also advocates strengthening interdisciplinary collaboration to provide new methodological paths for TCM clinical research.
2.Health risk assessment of heavy metals and metalloids in atmospheric PM2.5 from Inner Mongolia Autonomous Region in 2023
Jiake ZHU ; Shengmei YANG ; Yuhan QIN ; Nana WEI ; Wenqian ZHANG ; Xinrui JIA ; Wenyu ZHANG ; Xuanhao BAI ; Minghui YIN ; Li ZHANG ; Huan LI ; Duoduo WU ; Xuanzhi YUE ; Yaochun FAN
Journal of Environmental and Occupational Medicine 2025;42(10):1201-1208
Background The Inner Mongolia Autonomous Region is a vast area with a wide array of ecological environments, resulting in considerable regional variations in air pollution characteristics. Current research is limited by a scarcity of systematic, region-wide studies and risk assessments. Objective To assess the health risks associated with inhalation exposure to nine heavy metal and metalloid elements in atmospheric fine particulate matter (PM2.5) for the population of the Inner Mongolia Autonomous Region. Methods From the 10th to the 16th of each month throughout 2023, atmospheric PM2.5 samples were collected at designated monitoring sites in 12 leagues (cities) across the Inner Mongolia Autonomous Region to analyze the characteristics and trends in concentration. The health risk assessment model developed by the United States Environmental Protection Agency was employed to evaluate both the non-carcinogenic and carcinogenic risks associated with the heavy metal elements beryllium (Be), cadmium (Cd), chromium (Cr), hydrargyrum (Hg), plumbum (Pb), manganese (Mn), and nickel (Ni) and the metalloid elements stibium (Sb) and arsenic (As). Results In 2023, a total of
3.Application of index finger proximal dorsal island flap supplied by nutrient vessels of superficial branch of radial nerve for thumb skin and soft tissue defect.
Huanyou YANG ; Huiwen ZHANG ; Wenqian BU ; Wei WANG ; Jian ZHANG ; Bin WANG
Chinese Journal of Reparative and Reconstructive Surgery 2025;39(7):869-872
OBJECTIVE:
To explore the method and effectiveness of index finger proximal dorsal island flap supplied by the nutrient vessels of superficial branch of radial nerve for treatment of thumb skin and soft tissue defect.
METHODS:
Between August 2019 and December 2024, 12 patients with thumb skin and soft tissue defects caused by trauma accompanied by variation of the first dorsal metacarpal artery were treated. There were 8 males and 4 females, aged 19-55 years, with an average age of 32 years. The wound area ranged from 2.2 cm×2.0 cm to 5.5 cm×3.5 cm. The time from injury to operation ranged from 1.5 to 6.0 hours, with an average of 4.5 hours. After thorough debridement, the wound was repaired with a index finger proximal dorsal island flap supplied by the nutrient vessels of the superficial branch of the radial nerve. The flap area ranged from 2.4 cm×2.2 cm to 6.0 cm×4.0 cm. The donor site was repaired with free skin grafting. Regular follow-up was conducted postoperatively to observe the appearance, texture, sensory recovery of the flap, and the condition of the donor site.
RESULTS:
The operation time ranged from 30 to 72 minutes, with an average of 47 minutes; intraoperative blood loss ranged from 30 to 70 mL, with an average of 46 mL. After operation, partial necrosis occurred at the skin edge of the radial incision on the dorsum of the hand in 1 case, which healed after dressing changes; all other flaps survived uneventfully, with primary wound healing. The skin grafts at the donor sites all survived. All 12 patients were followed up 5-36 months, with an average of 14 months. The appearance and texture of the flaps were good. At last follow-up, the two-point discrimination of the flaps ranged from 4 to 9 mm, with an average of 5.2 mm. According to the functional evaluation criteria for upper limb issued by the Hand Surgery Society of Chinese Medical Association, the results were excellent in 11 cases and good in 1 case. No scar contracture, pain, or joint movement limitation was observed at the donor sites.
CONCLUSION
For patients with skin and soft tissue defects of the thumb accompanied by variation of the first dorsal metacarpal artery, the index finger proximal dorsal island flap supplied by the nutrient vessels of the superficial branch of the radial nerve can be selected. This method has advantages such as shorter operation time, less intraoperative bleeding, and good postoperative appearance and sensation of the flap.
Humans
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Male
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Adult
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Female
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Thumb/surgery*
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Soft Tissue Injuries/surgery*
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Radial Nerve/surgery*
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Middle Aged
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Surgical Flaps/innervation*
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Plastic Surgery Procedures/methods*
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Skin Transplantation/methods*
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Young Adult
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Treatment Outcome
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Fingers/surgery*
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Skin/injuries*
4.Progress in research on health literate schools
Chinese Journal of School Health 2024;45(3):448-451
Abstract
Health literate schools (HeLit-Schools) play a significant role in fostering students health literacy. The paper elucidates the background and conceptual connotations of HeLit-Schools, and analyzes how HeLit-Schools effectively integrate and enhance the health literacy of schools in three aspects: philosophy and core drivers, strategy and method implementation, as well as evaluation mechanisms and standard setting. Furthermore, the paper explores the implications of foreign HeLit-Schools research and practice for China under the context of "Healthy China" construction, as well as the key strategies for Chinese schools in the implementation of HeLit-Schools, aiming to provide a new perspective and theoretical support for Chinese schools to practice the "Healthy China initiative" and strengthen school construction from the perspective of health literacy.
5.Inhibitory effect of exosome-loaded KV11 on corneal neovascularization via VDAC1 and autophagy
Wenqian CHEN ; Wei DU ; Wenzhen YU
Chinese Journal of Experimental Ophthalmology 2024;42(2):108-116
Objective:To investigate the effects and mechanism of exosome (EXO)-loaded kringle V11 (KV11) delivery on corneal neovascularization (CNV).Methods:KV11 was bound to the surface of endothelial cell-derived exosomes by using CP05, an EXO-targeting anchoring peptide, to produce EXO-KV11.The binding efficiency and optimal concentration ratio were determined using the Apogee flow system.A total of 100 8-week-old healthy male SPF grade SD rats were selected, 10 of which were randomly selected as a normal control group without any treatment.The CNV model was established by alkali burn in the other 90 rats, which were randomly divided into three groups, EXO-KV11 group, KV11 group, and normal saline group by the random number table method, with 30 rats in each group.Each group was injected subconjunctivally with 100 μl of EXO-KV11 (25 μg), KV11 (25 μg), or normal saline every other day from the first day after the alkali burn, respectively.The CNV of rats was observed on days 1, 4, 7, and 14 after alkali burn.The CNV area was calculated by ventricular perfusion with fluorescein isothiocyanate-dextran (FITC-dextran) and corneal angiography.The amount of CNV lumen was observed by hematoxylin and eosin staining.The distribution of CD31 in rat corneas was determined by immunohistochemical method.The expression levels of voltage-dependent anion channel 1(VDAC1), endoplasmic reticulum stress, autophagy and apoptosis-associated proteins were detected by Western blot.This study was approved by the Animal Ethics Committee of Peking University People's Hospital (No.20210019). All animal procedures complied with the regulations of the Vision and Ophthalmology Association and the Animal Protection and Use Committee of Peking University.Results:The optimal concentration ratio of KV11 to EXO was 4∶1 and the binding affinity reached up to 87.5% by Apogee flow cytometers.On days 7 and 14 after alkali burn, there were significant differences in CNV area among the four groups ( F=4.613, 15.590; both at P<0.05). On day 7 after alkali burn, the CNV area was smaller in EXO-KV11 group than in KV11 and normal saline groups, with statistically significant differences (both at P<0.05). On day 14 after alkali burn, the CNV area was smaller in EXO-KV11 and KV11 groups than in normal saline group, and smaller in EXO-KV11 group than in KV11 group, showing statistically significant differences (all at P<0.05). The results of quantitative analysis of corneal fluorescence mounts showed that the relative CNV fluorescence area of the normal saline group, KV11 group and EXO-KV11 group were (8.3±1.7)%, (5.2±1.6)%and (3.4±0.7)%, respectively, showing a statistically significant overall comparison difference ( F=11.735, P<0.01). The relative CNV fluorescence area was larger in KV11 and normal saline groups than in EXO-KV11 group, and larger in normal saline group than in KV11 group, showing statistically significant differences (all at P<0.05). On day 14 after alkali burn, massive neovascular lumens were observed in the matrix of the normal saline group.The number of neovascular lumens in KV11 group was smaller than that in normal saline group.The corneal structure appeared normal in EXO-KV11 group, and neovascular lumens were rare.Numerous CD31-positive cells were observed in the corneal stroma of the normal saline group, which formed into lumen structures.The number of lumens surrounded by CD31-positive cells in the corneal stroma was smaller in KV11 group than in normal saline group, and smaller in EXO-KV11 group than in KV11 group.There were significant differences in the relative expression levels of VDAC1, protein kinase R-like endoplasmic reticulum kinase (PERK), p62, cleaved caspase 3 among the four groups ( F=35.960, 8.947, 17.791, 101.168; all at P<0.01). The relative expression levels of VDAC1, PERK, p62, cleaved caspase 3 were higher in EXO-KV11 group than in KV11 and normal saline groups, showing statistically significant differences (all at P<0.001). There was no significant difference in the relative expression of microtubule-associated proteins 1A/1B light chain 3B (LC3B)Ⅱ/LC3BⅠ protein among all four groups ( F=0.445, P=0.727). Conclusions:EXO-KV11 can inhibit CNV more remarkably than KV11.EXO-KV11 inhibits CNV by promoting the expression of VDAC1 and PERK and suppressing the autophagic flux.
6.Correlation between serum calcium level and prognosis of acute kidney injury patients with hypercalcemia
Dan PENG ; Wenqian WEI ; Dongfang ZHAO ; Zhouxia XIANG ; Kasimumali AYIJIAKEN ; Meng HE ; Shu RONG
Clinical Medicine of China 2024;40(2):81-87
Objective:To analyze the correlation between serum calcium levels and the prognosis of survival and renal recovery in patients with acute kidney injury (AKI) accompanied by hypercalcemia.Methods:This retrospective study analyzed the clinical data of patients with AKI accompanied by hypercalcemia admitted to Shanghai General Hospital from December 2015 to August 2022. There were 157 patients included in the study. The observation endpoint was set at discharge, focusing on the patients' survival and renal recovery during this period. Based on their status at discharge, patients were divided into a survival group (116 cases) and a death group (41 cases); and among the survivors, into a renal recovery group (63 cases) and a non-recovery group (53 cases). Continuous variables conforming to normal distribution were expressed as xˉ± s, and the mean comparison between the two groups was performed using an independent sample t-test. Continuous variables not conforming to normal distribution were represented by median (interquartile range) and compared between groups using the Mann-Whitney U test. Categorical variables were expressed as frequency (percentage), and comparisons were made using the chi-squared (χ 2) test or Fisher's exact test, as applicable. The correlation between serum calcium levels and patient outcomes was analyzed using univariate and multivariate Logistic regression. Results:The average age of the study subjects was (68.37±16.28) years, with 97 males (61.78%). The ages in the survival and death groups were (65.39±16.13) years and (76.80±13.67) years, respectively, with 66 males in the survival group and 31 in the death group. The history of malignancy (excluding multiple myeloma) was 37 cases and 23 cases, respectively, and serum albumin levels were (35.41±6.84) g/L and (30.82±5.75) g/L, respectively. Significant Statistical differences were observed in age, gender, history of malignancy (excluding multiple myeloma), and serum albumin were found between the survival and death groups (statistical values: t=4.04, χ 2=4.49, χ 2=7.51, t=3.85; all P<0.05). AIK 1 stage were 33.33%(21/63) and 64.15%(34/53), 2 stage were 36.51%(23/63) and 24.53%(13/34), 3 stage were 30.16%(23/63) and 11.32%(6/34) in the renal recovery and non-recovery groupsrespectively. Serum calcium at discharge in the renal recovery and non-recovery groups were (2.50±0.38) mmol/L and (2.70±0.58) mmol/L, respectively, with mean serum calcium levels of (2.60±0.29) mmol/L and (2.78±0.39) mmol/L, and lowest serum calcium levels of (2.28±0.36) mmol/L and (2.50±0.51) mmol/L, respectively. BNP levels were 118 (64, 283) ng/L and 248 (69, 1 383) ng/L, respectively. Significant differences in AKI stage, serum calcium at discharge, mean serum calcium, lowest serum calcium, and BNP were observed between the two groups (statistical values: χ 2=11.84, t=2.26, t=2.75, t=2.73, U=2.62, all P<0.05). Multivariate logistic regression analysis showed that age ( OR=1.062, 95% CI 1.027-1.098, P<0.001), history of malignancy (excluding multiple myeloma) ( OR=3.811, 95% CI 1.623-8.951, P=0.002), and serum albumin ( OR=0.889, 95% CI 0.829-0.953, P=0.001) were independent risk factors for in-hospital mortality of patients; severity of AKI(AKI2 OR=2.984, 95% CI 1.281-6.954, P=0.011, AKI3 OR=5.280, 95% CI 1.863-14.963, P=0.002) and serum calcium level at discharge ( OR=0.813, 95% CI 0.666-0.992, P=0.041) were independent risk factors affecting early renal recovery of patients. Conclusion:Serum calcium level is not associated with the risk of in-hospital mortality in patients with AKI accompanied by hypercalcemia but is related to the prognosis of early renal recovery. Proactively managing serum calcium, along with treatment of the primary malignancy and correction of hypoalbuminemia can help improve the prognosis of these patients.
7.Combined with systematic pharmacology and metabonomics to explore the mechanism of Baicalein in the treatment of hyperuricemia
Jingzhen LIANG ; Yingjie GAO ; Wenqian YE ; Bingyan WEI ; Zhaoyang CHEN ; Fan YANG
Chinese Journal of Comparative Medicine 2024;34(9):1-11
Objective To explore the effect and mechanism of Baicalein in the treatment of hyperuricemia.Methods The mouse model of hyperuricemia was established by yeast extract combined with potassium oxazinate.The effect and potential mechanism of Baicalein in the treatment of hyperuricemia were studied by biochemical indexes,pathological changes,non-target metabonomics and network pharmacology.Results Baicalein could reduce the contents of serum uric acid,creatinine and blood urea nitrogen,reduce the inflammatory injury of renal tissue,up-regulate the expression level of uric acid excretion protein and down-regulate the expression level of uric acid reabsorption protein.Nine disease-related targets such as BCL2,SIRT1 and XDH were screened by network pharmacology.Six key metabolic pathways including nicotinic acid and nicotinamide metabolism,caffeine metabolism and purine metabolism were screened by metabonomics analysis.Conclusions Baicalein can treat hyperuricemia and reduce renal injury,and its mechanism may be related to the metabolic pathways of nicotinic acid and nicotinamide regulated by SIRT1 and quinolinate.
8.Worsening renal function and the plasma B-type natriuretic peptide in prognosis of patients with acute heart failure
Dongfang ZHAO ; Wenqian WEI ; Dan PENG ; Zhouxia XIANG ; Shu RONG
Clinical Medicine of China 2023;39(4):266-272
Objective:To analyze the effects of different plasma B-type natriuretic peptide (BNP) changes on worsening renal function (WRF) on 1-year all-cause mortality in patients with acute heart failure (AHF).Methods:The clinical data of 399 patients with AHF admitted to our hospital from January 2015 to December 2019 were retrospectively analyzed. According to the severity of WRF, the patients were divided into non-severe worsening renal function (nsWRF) group, severe worsening renal function (sWRF) group and non-WRF group. Plasma BNP decrease was defined as a reduction of B-type natriuretic peptide (BNP) at the time of discharge by ≥30% compared with the time of admission.Demographic characteristics and medical history, clinical data at admission, during hospitalization and at discharge, and survival status 1 year after discharge were collected. The measurement data presented in the form of normal distribution are as follows: single factor analysis of variance is used for comparison between groups, and LSD- t test is used for comparison between pairs; The Kruskal Wallis rank sum test was used for the multi group comparison of non normal distribution measurement data, and Wilcoxon rank sum test was used for the pairwise comparison. The comparison of counting data between groups was conducted using χ 2 test. Survival analysis was conducted using the Kaplan Meier method and Log rank test, and the Cox proportional risk regression model was used to analyze the influencing factors of 1-year all-cause mortality in patients. Results:399 cases of AHF were divided into nsWRF group with 68 cases, sWRF group with 82 cases, and nWRF group with 249 cases. 86 cases (21.5%) died within 1 year after discharge. The one-year mortality rate of the sWRF group was higher than that of the nWRF group and nsWRF group [42.7% (35/82) vs 16.1% (40/249), 16.2% (11/68)], and the differences were statistically significant (The χ 2 values were 24.94 and 12.28 respectively, both P<0.001), while there was no statistically significant difference between the nWRF group and the nsWRF group (χ 2=0.00、 P=0.982). The 1-year mortality rate of the nWRF group and sWRF group with decreased BNP during hospitalization was lower than that of the non decreased BNP group [29.1% (6/55) vs 70.4% (19/27), 10.5% (17/162) vs 26.4% (23/87), The χ 2 values are 12.61 and 10.67 respectively, and the P values are <0.001 and 0.001, respectively. The occurrence of nsWRF during hospitalization did not increase the one-year all-cause mortality risk of AHF patients ( P=0.754), but the occurrence of sWRF increased the all-cause mortality risk of AHF patients (odds ratio=2.33, 95% confidence interval: 1.31-4.13, P=0.004). The decrease in BNP during hospitalization reduced the one-year all-cause mortality risk of AHF patients (odds ratio=0.36, 95% confidence interval: 0.23-0.55, P<0.001). Conclusions:NsWRF does not increase the one-year all-cause mortality risk of AHF patients, while sWRF increases the one-year all-cause mortality risk, and a decrease in BNP during hospitalization reduces the one-year all-cause mortality risk.
9.Prospective study on the effects of resistance training with elastic band at home on muscle function and walking ability of severely burned children
Ting HUO ; Jingjing RUAN ; Meijun JIANG ; Fang LEI ; Wei HUANG ; Wenqian TANG ; Weiguo XIE ; Xiangyang XU ; Song WANG ; Shuhua LIU
Chinese Journal of Burns 2023;39(12):1131-1139
Objective:To explore the effects of resistance training with elastic band at home on muscle function and walking ability of severely burned children.Methods:A prospective non-randomized controlled study was conducted. From January 2022 to April 2023, 40 children with severe burns who met the inclusion criteria were admitted to Tongren Hospital of Wuhan University & Wuhan Third Hospital. According to the willingness of the children or their families, the children were assigned to conventional rehabilitation group and combined rehabilitation group. During the study, 8 children dropped out of the study, 17 children were finally included in the conventional rehabilitation group with 6 males and 11 females, aged (8.5±2.4) years, and 15 children were included in the combined rehabilitation group with 5 males and 10 females, aged (9.6±2.5) years. The children in the 2 groups received conventional burn rehabilitation treatment in the hospital, including active and passive activity training, scar massage, and pressure therapy. The children in combined rehabilitation group received resistance training with elastic band of 3 to 5 times per week after discharge, and the children in conventional rehabilitation group received daily activity ability training after discharge. Before home rehabilitation training (1 week before discharge) and 12 weeks after home rehabilitation training, the grip strength was measured using a handheld grip dynamometer, the muscle strengths of the upper and lower limbs were measured using a portable dynamometer for muscle strength, lean body mass was measured by bioelectrical impedance measuring instrument, and the 6-min walking distance was measured. Data were statistically analyzed with independent sample t test, paired sample t test, Mann-Whitney U test, or Fisher's exact probability test. Results:After 12 weeks of home rehabilitation training, the grip strengths of children in combined rehabilitation group and conventional rehabilitation group were (15±4) and (11±4) kg, respectively, which were significantly higher than (10±4) and (9±4) kg before home rehabilitation training (with t values of -9.99 and -11.89, respectively, P values all <0.05); the grip strength of children in combined rehabilitation group was significantly higher than that in conventional rehabilitation group ( t=3.24, P<0.05). After 12 weeks of home rehabilitation training, the muscle strengths of upper and lower limbs of children in combined rehabilitation group (with t values of -11.39 and -3.40, respectively, P<0.05) and the muscle strengths of upper and lower limbs of children in conventional rehabilitation group (with t values of -7.59 and -6.69, respectively, P<0.05) were significantly higher than those before home rehabilitation training, and the muscle strengths of upper and lower limbs of children in combined rehabilitation group were significantly higher than those in conventional rehabilitation group (with t values of 3.80 and 7.87, respectively, P<0.05). After 12 weeks of home rehabilitation training, the lean body mass of children in combined rehabilitation group was significantly higher than that before home rehabilitation training ( t=0.21, P<0.05). After 12 weeks of home rehabilitation training, the 6-min walking distances of children in conventional rehabilitation group and combined rehabilitation group were significantly longer than those before home rehabilitation training (with t values of -5.33 and -3.40, respectively, P<0.05), and the 6-min walking distance of children in combined rehabilitation group was significantly longer than that in conventional rehabilitation group ( t=3.81, P<0.05). Conclusions:Conventional burn rehabilitation treatment in hospital and home resistance training with elastic band for 12 weeks after discharge can significantly improve the muscle function and walking ability of severely burned children.
10.Preliminary study on improved "pull technique" for peritoneal dialysis extubation
Wenqian WEI ; Shu RONG ; Man YANG ; Lijie GU ; Weijie YUAN
Clinical Medicine of China 2021;37(4):323-326
Objective:To introduce the improved "pull technique" and its preliminary application in Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.Methods:Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine has started to implement the "pull technique" since March 2018.After one patient suffered from postoperative tunnel infection, we′ve improved the operation method: after successful extubation, small incision was made at the tunnel entrance, and the skin was properly trimmed and sutured to close the tunnel entrance.Results:Until May 2020, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine has implemented the modified tube removal for 15 patients.During the follow-up period (0-25 months), there was no secondary infection or peritoneal effusion.Conclusion:For patients who meet the indications of "pull technique" , the improved "pull technique" is a trial method, which can reduce the risk of secondary infection and peritoneal effusion.


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