1.Research Strategies for Quality Evaluation of Medical Wound Dressings.
Yanhui XU ; Xiang LI ; Jinsheng XIE ; Fang LIN ; Jingfeng ZHENG
Chinese Journal of Medical Instrumentation 2025;49(4):453-459
Due to the wide variety and varying quality of medical wound dressings, as well as the current lack of unified national or industry standards for regulation, this paper proposes a research strategy for establishing a quality evaluation system for medical wound dressings. By developing a technical roadmap, this strategy clarifies the process flow and key points in the quality evaluation process, establishes evaluation methods for various types of medical wound dressings, and addresses important issues such as how to determine key performance indicators based on product characteristics and how to research and validate test methods for key items. This provides a detailed and feasible research strategy and evaluation method for medical wound dressing manufacturers, testing institutions, and regulatory authorities. It reduces the difficulty and cost of quality evaluation for medical wound dressings and has certain significance in standardizing and improving their quality level, ensuring their safety and effectiveness, and serving the quality and safety regulation of medical devices..
Bandages/standards*
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Quality Control
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Humans
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Wounds and Injuries/therapy*
2.Discussion on the decoction and dosing methods of rhubarb root and rhizome in classical prescriptions
Zilin REN ; Changxiang LI ; Yuxiao ZHENG ; Xin LAN ; Ying LIU ; Yanhui HE ; Fafeng CHENG ; Qingguo WANG ; Xueqian WANG
Journal of Beijing University of Traditional Chinese Medicine 2025;48(1):48-54
The purpose of this paper is to explore the decoction and dosing methods of rhubarb root and rhizome in classical prescriptions and to provide a reference basis for the clinical use of rhubarb root and rhizome. By collating the relevant classical prescriptions of rhubarb root and rhizome in Shanghan Lun and Jingui Yaolüe, the relationship between its decoction and dosing methods and the syndrome was analyzed. The decoction of rhubarb root and rhizome in classical prescriptions can be divided into three categories: simultaneous decoction, decoction later, and other methods (impregnation in Mafei decoction, decoction with water from the well spring first taken in the morning, and pills). If it enters the blood level or wants to slow down, rhubarb root and rhizome should be decocted at the same time with other drugs. If it enters the qi level and wants to speed up, rhubarb root and rhizome should be decocted later. If it wants to upwardly move, rhubarb root and rhizome should be immersed in Mafei decoction. If it wants to suppress liver yang, rhubarb root and rhizome should be decocted with water from the well spring first taken in the morning. If the disease is prolonged, rhubarb root and rhizome should be taken in pill form. The dosing methods of rhubarb root and rhizome can be divided into five categories: draught, twice, three times, before meals, and unspecified. For acute and serious illnesses with excess of pathogenic qi and adequate vital qi, we choose draught. For gastrointestinal diseases, we choose to take the medicine twice. For achieving a moderate and long-lasting effect, we choose to take the medicine three times. If the disease is located in the lower part of the heart and abdomen, we choose to take it before meals. The use of rhubarb root and rhizome in clinical practice requires the selection of the appropriate decoction and dosing methods according to the location of the disease, the severity of the disease, the patient′s constitution, and the condition after taking the medicine.
3.Correlation Analysis between Gestational Weight Gain and Adverse Pregnancy Outcomes among Pregnant Women with a History of Macrosomia in Subse-quent Pregnancies
Jia WANG ; Yanan ZHENG ; Xuesong LI ; Jingying XIA ; Ying SUI ; Yanhui ZHAO
Journal of Practical Obstetrics and Gynecology 2025;41(11):935-939
Objective:To explore the association between macrosomia delivery history and adverse pregnancy outcomes in subsequent pregnancies under different stratification of gestational weight gain(GWG).Methods:A retrospective study was conducted on 500 multiparous women with a history of macrosomia delivery who gave birth at The Second Hospital of Jilin University from January 2020 to November 2023.Meanwhile,1500 multiparous women without a history of delivering macrosomic infants were selected as the control group through 1∶3 matc-hing based on age(±1 year).The differences in general characteristics,GWG,and pregnancy outcomes be-tween the two groups were compared.According to the appropriate GWG values recommended by Chinese health industry standards,pregnant women in both groups were classified into insufficient GWG,appropriate GWG,and excessive GWG.Multivariate Logistic regression analysis was used to compare the relationship be-tween a history of macrosomia delivery and adverse pregnancy outcomes under different GWG stratifications.Re-sults:The History of macrosomia group had significantly higher rates of excessive GWG(50.60%vs.48.13%),incidence of gestational diabetes mellitus(GDM)(23.40%vs.17.07%),rate of cesarean section(60.20%vs.45.33%),and rate of macrosomia(26.60%vs.7.87%)compared to the control group(P<0.05).Multivariate Logistic regression analysis showed that a history of macrosomia delivery was an independent risk factor for GDM,cesarean section,and macrosomia in subsequent pregnancies(aOR>1,P<0.05).Stratified analysis based on GWG revealed that,compared with the control group,regardless of the GWG status,the risk of cesare-an section and macrosomia was higher in women with a history of macrosomia delivery(aOR>1,P<0.05).Mo-reover,for those with a history of macrosomia delivery and excessive weight gain during pregnancy,the risk of preeclampsia(aOR 3.167,P<0.05)and GDM(aOR 1.661,P<0.05)was significantly increased.When the GWG was appropriate for pregnant women with a history of macrosomia delivery,there was no significant correla-tion between a history of macrosomia delivery and preeclampsia or GDM(P>0.05).Conclusions:A history of macrosomia delivery increased the risk of multiple adverse pregnancy outcomes,such as GDM,cesarean section,and macrosomia.For multiparous women at different GWG levels,the risk of cesarean section and macrosomia was significantly increased in those with a history of macrosomia delivery.When GWG was appropriate,a history of macrosomia delivery was not found to be an independent risk factor for preeclampsia and GDM.
4.Correlation Analysis between Gestational Weight Gain and Adverse Pregnancy Outcomes among Pregnant Women with a History of Macrosomia in Subse-quent Pregnancies
Jia WANG ; Yanan ZHENG ; Xuesong LI ; Jingying XIA ; Ying SUI ; Yanhui ZHAO
Journal of Practical Obstetrics and Gynecology 2025;41(11):935-939
Objective:To explore the association between macrosomia delivery history and adverse pregnancy outcomes in subsequent pregnancies under different stratification of gestational weight gain(GWG).Methods:A retrospective study was conducted on 500 multiparous women with a history of macrosomia delivery who gave birth at The Second Hospital of Jilin University from January 2020 to November 2023.Meanwhile,1500 multiparous women without a history of delivering macrosomic infants were selected as the control group through 1∶3 matc-hing based on age(±1 year).The differences in general characteristics,GWG,and pregnancy outcomes be-tween the two groups were compared.According to the appropriate GWG values recommended by Chinese health industry standards,pregnant women in both groups were classified into insufficient GWG,appropriate GWG,and excessive GWG.Multivariate Logistic regression analysis was used to compare the relationship be-tween a history of macrosomia delivery and adverse pregnancy outcomes under different GWG stratifications.Re-sults:The History of macrosomia group had significantly higher rates of excessive GWG(50.60%vs.48.13%),incidence of gestational diabetes mellitus(GDM)(23.40%vs.17.07%),rate of cesarean section(60.20%vs.45.33%),and rate of macrosomia(26.60%vs.7.87%)compared to the control group(P<0.05).Multivariate Logistic regression analysis showed that a history of macrosomia delivery was an independent risk factor for GDM,cesarean section,and macrosomia in subsequent pregnancies(aOR>1,P<0.05).Stratified analysis based on GWG revealed that,compared with the control group,regardless of the GWG status,the risk of cesare-an section and macrosomia was higher in women with a history of macrosomia delivery(aOR>1,P<0.05).Mo-reover,for those with a history of macrosomia delivery and excessive weight gain during pregnancy,the risk of preeclampsia(aOR 3.167,P<0.05)and GDM(aOR 1.661,P<0.05)was significantly increased.When the GWG was appropriate for pregnant women with a history of macrosomia delivery,there was no significant correla-tion between a history of macrosomia delivery and preeclampsia or GDM(P>0.05).Conclusions:A history of macrosomia delivery increased the risk of multiple adverse pregnancy outcomes,such as GDM,cesarean section,and macrosomia.For multiparous women at different GWG levels,the risk of cesarean section and macrosomia was significantly increased in those with a history of macrosomia delivery.When GWG was appropriate,a history of macrosomia delivery was not found to be an independent risk factor for preeclampsia and GDM.
5.Research progress in mechanisms of gut microbiota in diabetic cognitive impairment and its targeted intervention
Yage DU ; Yanhui LU ; Yu AN ; Ying SONG ; Jie ZHENG
Journal of Shanghai Jiaotong University(Medical Science) 2024;44(4):494-500
Diabetes mellitus type 2 might cause mild cognitive impairment in its advanced stages,potentially progressing to dementia.Diabetic cognitive impairment(DCI)stands as a chronic complication of diabetes mellitus,with its underlying pathogenesis still remaining elusive.Research has revealed that gut microbiota dysbiosis influenced the central nervous system through the"microbiota-gut-brain axis",thereby contributing to the progression of cognitive impairment.Therefore,the regulation of gut microbiota emerges as a promising approach to the prevention and treatment of DCI.This article comprehensively reviews the mechanisms through which gut microbiota influences DCI.Furthermore,it delves into experimental studies exploring targeted therapies for gut microbiota,including probiotics,fecal microbiota transplantation,dietary and nutrient interventions,as well as traditional Chinese medicine.These studies not only address diabetes-related cognitive impairment but also consider aspects such as glycolipid metabolism and inflammation.The insights gleaned from these studies provide valuable guidance for the clinical application of gut microbiota-targeted intervention in DCI.
6.Short-chain fatty acids and diabetic cognitive impairment
Jie ZHENG ; Yu AN ; Yage DU ; Ying SONG ; Yanhui LU
Chinese Journal of Behavioral Medicine and Brain Science 2024;33(10):949-954
Diabetes mellitus and its consequences have gained increased attention with the incidence rate rising.Diabetic cognitive impairment (DCI), a neurological consequence of diabetes mellitus, has shown a significant increase in recent years, and its related mechanisms need to be elucidated. Short-chain fatty acids (SCFAs), which are metabolites of dietary fiber fermented by gut microbiota and play a significant role in the "microbial-gut-brain axis", have become a popular research topic in recent years for their link to diabetes mellitus and brain function. Therefore, it is important to explore the relationship between SCFAs and DCI. This review summarized the changing characteristics of SCFAs in diabetes mellitus, cognitive impairment and DCI populations, as well as the mechanisms of SCFAs in DCI, which include glucose-lipid metabolism, pathological protein aggregation, inflammation, and mitochondrial autophagy.Future studies should address the common pathophysiological mechanisms of diabetes mellitus and cognitive impairment, in order to explore the effects of different types and doses of SCFAs in DCI and the underlying mechanisms, so as to provide a theoretical basis for the prevention and treatment of the disease in the context of the "co-morbidity model" .
7.Investigation on improving standard of polypropylene infusion bottles
Xiang LI ; Jinfeng ZHENG ; Fang LIN ; Yanhui XU ; Xia ZHAO
Drug Standards of China 2024;25(2):176-180
Objective:To explore the use of differential scanning calorimetry(DSC)method to identify polypropyl-ene infusion bottles material.Methods:The thermal analysis curve under nitrogen was determined at temperatures between 40 ℃ and 200 ℃ with a heating rate of 20 ℃·min-1,then cooled to 40 ℃ at a rate of 20 ℃·min-1.The sample was heated from 40 ℃ to 200 ℃ at a heating rate of 10 ℃·min-1,held the specimen at 200 ℃ for 10 min,then cooled to 40 ℃ at a rate of 10 ℃·min-1.Results:The melting peak temperature(Tm)of polypropyl-ene infusion bottles was between 145-150 ℃.Conclusion:The proposed method is accurate,sensitive,and sim-ple,and can be used for determination of polypropylene infusion bottles material,which can also provide reference for the standard improvement of polypropylene infusion bottles.
8.Investigation on dissolved substances of polypropylene port for plastic infusion containers
Fang LIN ; Yanhui XU ; Xiang LI ; Jinfeng ZHENG ; Xia ZHAO
Drug Standards of China 2024;25(4):416-422
Objective:To establish a preparation method for dissolved matter test solution of polypropylene port for plastic infusion containers,and to provide a reference for a standard system for pharmaceutical packaging materials of this product.Methods:Determination for results of dissolved matter test solution by specific surface area method and mass method were compared and analyzed in pair.Results:There were differences in sample amount and con-tact area between the two methods,but the results of dissolved matter test solution were generally consistent.Paired sample Wilcoxon signed rank test and paired sample T-test were used in pH,readily oxidizable substances,and non-volatile substance which indicators are quantifiable.Results show that there were no significant differences between the test solution,with Cohen's d values of 0.153,0.218,and 0.296,respectively,which were small in magnitude.Conclusion:In the case of insignificant differences between the two sampling methods,for polypropyl-ene port for plastic infusion containers and other irregular products,it is recommended that the test solution is prepared by leaching by mass,that is,a leaching ratio of 0.2 g·mL-1 by mass or volume,with more reproducible results.This study provides a reference for the establishment of standard for polypropylene port for plastic infusion containers.
9.Comparison of 131I therapeutic responses and clinical outcomes in patients with familial and sporadic differentiated thyroid cancer
Yanhui JI ; Xuan WANG ; Xue LI ; Danyang SUN ; Qian XIAO ; Yajing HE ; Zhaowei MENG ; Qiang JIA ; Jian TAN ; Wei ZHENG
Chinese Journal of Radiological Medicine and Protection 2024;44(6):531-536
Objective:To analyze the clinical outcomes of initial radioactive iodine 131I therapy (RIT) for patients with familial differentiated thyroid cancer (FDTC) and sporadic differentiated thyroid cancer (SDTC), along with their influencing factors. Methods:The clinical data of 120 FDTC and 480 SDTC patients who received RIT at the Department of Nuclear Medicine, Tianjin Medical University General Hospital from January 2016 to January 2022 were retrospectively analyzed. These patients, categorized into the FDTC and SDTC groups, were further divided into three subgroups based on their response to initial RIT: no evidence of disease (NED), biochemical persistence of disease (BPD), or structural/functional persistence of disease (S/FPD). For the NED subgroup, the disease-free survival (DFS) was analyzed. For the BPD and S/FPD subgroups, the progression-free survival (PFS) was investigated. Furthermore, risk factors for failure to reach the NED status were identified.Results:After initial RIT, 56 (46.7%), 50 (41.7%), 14 (11.6%) patients in the FDTC group reached the NED, BPD, and S/FPD statuses, respectively, while 284 (59.1%), 160 (33.3%), 36 (7.5%) and SDTC patients in the SDTC group were in the NED, BPD, and S/FPD statuses, respectively ( χ2 = 10.10, P = 0.013). The last follow-up revealed that 71 (59.1%), 36 (30.1%), 13 (10.8%) patients in the FDTC group were in the NED, BPD and S/FPD statuses, respectively, while 337 (70.2%), 114 (23.7%), 29 (6.1%) patients in the SDTC group reached the NED, BPD and S/FPD statuses, respectively ( χ2 = 8.99, P = 0.026). The F-NED and S-NED subgroups exhibited 5-year DFS rates of 92.4% and 97.4%, respectively, the F-BPD and S-BPD subgroups displayed 5-year PFS rates of 88.3% and 90.8%, respectively, while the F-S/FPD and S-S/FPD subgroups yielded in 5-year PFS rates of 78.2% and 79.6%, respectively. Univariate binary logistic regression analysis indicated that the maximum diameter of tumors, T stage, M stage, recurrence risk stratification, and postoperative stimulated thyroglobulin (p-sTg) were correlated with the achievement of the NED status ( χ2=6.37-13.10, P < 0.05). Multivariable binary logistic regression analysis showed that T stage and p-sTg were independent risk factors in the achievement of the NED status ( χ2=0.11-11.33, P < 0.05). Conclusions:The response to initial RIT assists in guiding the development of subsequent treatment and follow-up strategies for DTC patients. Given that the SDTC patients exhibited better outcomes than the FDTC patients, more alertness should be paid to the RIT for FDTC patients. For patients with higher p-sTg and T stage, the initial RIT dose and follow-up interval should be increased and reduced respectively as appropriate.
10.Comparison on efficacy of MRI-transrectal ultrasound software fusion-guided biopsy and cognitive fusion-guided biopsy for detecting prostate cancer
Jing YANG ; Hao FENG ; Han XIA ; Yanhui MA ; Xiao XIAO ; Zhiyuan WANG ; Wenjuan XU ; Zheng WANG ; Qibing FAN ; Yuyong SHEN ; Jing DING ; Tingyue QI
Chinese Journal of Interventional Imaging and Therapy 2024;21(7):403-407
Objective To compare the efficacy of MRI-transrectal ultrasound(TRUS)software fusion-guided biopsy and cognitive fusion-guided biopsy for detecting prostate cancer(PC).Methods Data of 120 patients with suspected PC(127 lesions)who underwent transperineal prostate biopsy with 2-3 times of target biopsy(TB)and 10 times of system biopsy were retrospectively analyzed.According to TB guidance methods,73 cases(78 lesions)received MRI-TRUS software fusion-guided biopsy were classified into group A,and 47 cases(49 lesions)received cognitive fusion-guided biopsy were classified into group B.The positive rate of PC,clinic significant PC(csPC)and PC in different sized lesions by TB were compared between groups,and the positive rate of PC between 2 or 3 times TB was also compared within each group.Results The positive rate of PC and csPC detected by TB was 55.13%(43/78)and 39.74%(31/78)in group A,53.06%(26/49)and 34.69%(17/49)in group B,respectively,no significant difference was found(all P>0.05).The positive rate of PC in lesions with the maximum diameter≤10 mm detected by TB in group A was higher than that in group B(P<0.05),but no significant difference of lesions with the maximum diameter>10 mm and<15 mm nor≥15 mm was found between groups(all P>0.05).No significant difference of positive rate of PC was found between 2 and 3 times TB in group A(P>0.05),while positive rate of PC of 3 times TB was significantly higher than that of 2 times TB in group B(P<0.05).Conclusion MRI-TRUS software fusion-guided biopsy had positive rate of PC and csPC similar to that of cognitive fusion-guided biopsy,but was helpful for reducing times of TB and increasing detecting rate for lesions with the maximum diameter≤10 mm.


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