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.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.
3.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.
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.Mechanisms and perspectives of B vitamins associated one carbon metabolism on colorectal cancer risk
Yanhui MA ; Lisong SHEN ; Yingxia ZHENG
Chinese Journal of Preventive Medicine 2024;58(11):1739-1751
Colorectal cancer (CRC) represents a significant global health challenge as a common malignancy of the digestive tract. The involvement of B vitamins—specifically folic acid (B9), riboflavin (B2), pyridoxine (B6), and cobalamin (B12)—is crucial in metabolic processes by mediating the transfer of one-carbon (1C) units, which plays a fundamental role in cellular functions and tumor growth. 1C metabolism is involved in synthesis of proteins, lipids, nucleic acids, and other cofactors. 1C metabolism, intertwined with the metabolism of other nutrients, forms complex pathways where B vitamins act as precursors or coenzymes, influencing the production of various intermediates. These vitamins, as essential nutrients, are implicated to varying the pathogenesis and progression of colorectal cancer such as epigenetics. Furthermore, 1C metabolism affects tumor cell fate through multiple aspects including nucleotide synthesis, redox homeostasis, and the interaction with gut microbiota. Given these roles, understanding and monitoring B vitamin levels and their metabolic pathways are essential for colorectal cancer prevention and management. This approach not only helps in reducing tumor-related mortality but also opens new avenues for research into CRC mechanisms and potential therapeutic strategies.
6.Analysis of two consanguineous Chinese pedigrees affected with Hereditary prokallikrein deficiency and High molecular weight kininogen deficiency
Bile CHEN ; Zuoting XIE ; Zhou ZHENG ; Yuan CHEN ; Huilin CHEN ; Mingshan WANG ; Yanhui JIN
Chinese Journal of Medical Genetics 2024;41(9):1066-1071
Objective:To analyze the genetic variants of two consanguineous Chinese pedigrees affected with Hereditary prokallikrein (PK) and High molecular weight kininogen (HMWK) deficiency and explore their molecular pathogenesis.Methods:A PK deficiency pedigree (10 individuals from 4 generations) and a HMWK deficiency pedigree (6 individuals from 3 generations) which were admitted to the First Affiliated Hospital of Wenzhou Medical University on December 3, 2021 and June 16, 2022, respectively were selected as the study subjects. Clinical data of the two pedigrees were collected, and the related coagulation indexes of the probands and their family members were determined. Genomic DNA of the two pedigrees was extracted from peripheral blood samples. This study was approved by the First Affiliated Hospital of Wenzhou Medical University (Ethics No. KY2022-R193).Results:The plasma PK activity of proband A, a 29-year-old female, and her brother were extremely low (< 1.0%). Proband B was a 66-year-old male with extremely low plasma HMWK activity (< 1.0%). Genetic sequencing revealed that the proband A and her brother had both harbored a homozygous c. 417_418insCATTCTTA (p.Arg140Hisfs*3) insertional variant in exon 5 of the KLKB1 gene, with her grandmother, maternal grandmother, father, mother, sister and son all carrying heterozygous insertion variant, and her ancestor father and husband are both wild-type. Proband B had harbored a homozygous c. 460C>A (p.Pro154Thr) missense variant in exon 4 of the KNG1 gene, and his son carries a heterozygous missense variant. All other members of the pedigree are wild type. Based on the guidelines from the American College of Medical Genetics and Genomics (ACMG), the variants were respectively rated as pathogenic (PVS1+ PM2_Supporting+ PM4) and likely pathogenic (PS4+ PM2_Supporting+ PP3+ PP4). Conclusion:The c. 417_418insCATTCTTA (p.Arg140Hisfs*3) variant of the KLKB1 gene and the c. 460C>A (p.Pro154Thr) variant of the KNG1 gene probably underlay the decreased PK and HMWK activities in the two pedigrees, respectively.
7.Mechanisms and perspectives of B vitamins associated one carbon metabolism on colorectal cancer risk
Yanhui MA ; Lisong SHEN ; Yingxia ZHENG
Chinese Journal of Preventive Medicine 2024;58(11):1739-1751
Colorectal cancer (CRC) represents a significant global health challenge as a common malignancy of the digestive tract. The involvement of B vitamins—specifically folic acid (B9), riboflavin (B2), pyridoxine (B6), and cobalamin (B12)—is crucial in metabolic processes by mediating the transfer of one-carbon (1C) units, which plays a fundamental role in cellular functions and tumor growth. 1C metabolism is involved in synthesis of proteins, lipids, nucleic acids, and other cofactors. 1C metabolism, intertwined with the metabolism of other nutrients, forms complex pathways where B vitamins act as precursors or coenzymes, influencing the production of various intermediates. These vitamins, as essential nutrients, are implicated to varying the pathogenesis and progression of colorectal cancer such as epigenetics. Furthermore, 1C metabolism affects tumor cell fate through multiple aspects including nucleotide synthesis, redox homeostasis, and the interaction with gut microbiota. Given these roles, understanding and monitoring B vitamin levels and their metabolic pathways are essential for colorectal cancer prevention and management. This approach not only helps in reducing tumor-related mortality but also opens new avenues for research into CRC mechanisms and potential therapeutic strategies.
8.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" .
9.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.
10.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.


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