1.Analysis of the status of clinical trial registration for contraceptives based on WHO International Clinical Trials Registry Platform
Mingjun YANG ; Fang TIAN ; Xin ZHANG ; Minjie XIA ; Jingying HU ; Weihua LI ; Daxu FU
Chinese Journal of Reproduction and Contraception 2025;45(7):720-724
Objective:To analyze the registration status of clinical trials related to contraceptives based on the data of World Health Organization International Clinical Trials Registry Platform (ICTRP), so as to understand the situation of contraceptives development, and provide reference for improving the quality of clinical trials.Methods:All records in the database of ICTRP before January 1, 2025 was researched to screen out contraceptives clinical trials, and the registration time, registration platform, regional distribution, trial design and research content were analyzed.Results:A total of 206 clinical trials related to contraceptives were included. The projects were mainly carried out in the United States, Germany, and India. About 95.63% (197/206) of the study subjects were women of reproductive age. The main type of study was intervention [89.32% (184/206)], among which random trials accounted for 53.26% (98/184), and parallel group trials were the most common [82.65% (81/98)]. Over 64.56% (133/206) of the trials were indicated with open-label. Most of the clinical trials were in phase Ⅲ [47.57% (98/206)] and phase Ⅳ [16.50% (34/206)]. The interventions in female studies were mainly in three aspects: oral contraceptive [42.64% (84/197)], intrauterine delivery [15.23% (30/197)], and vaginal delivery [15.23% (30/197)], and the primary outcome included pregnancy rate [54.82% (108/197)], adverse drug reactions [13.20% (26/197)], ovulation inhibition [8.63% (17/197)], and vaginal infection [4.06% (8/197)].Conclusion:The clinical trials of contraceptives were unevenly distributed, the research types were mainly randomized interventional trials, the included participants were mainly women of reproductive age, the intervention measures were mostly oral contraceptive, intrauterine delivery and vaginal delivery.
2.Analysis of the status of clinical trial registration for contraceptives based on WHO International Clinical Trials Registry Platform
Mingjun YANG ; Fang TIAN ; Xin ZHANG ; Minjie XIA ; Jingying HU ; Weihua LI ; Daxu FU
Chinese Journal of Reproduction and Contraception 2025;45(7):720-724
Objective:To analyze the registration status of clinical trials related to contraceptives based on the data of World Health Organization International Clinical Trials Registry Platform (ICTRP), so as to understand the situation of contraceptives development, and provide reference for improving the quality of clinical trials.Methods:All records in the database of ICTRP before January 1, 2025 was researched to screen out contraceptives clinical trials, and the registration time, registration platform, regional distribution, trial design and research content were analyzed.Results:A total of 206 clinical trials related to contraceptives were included. The projects were mainly carried out in the United States, Germany, and India. About 95.63% (197/206) of the study subjects were women of reproductive age. The main type of study was intervention [89.32% (184/206)], among which random trials accounted for 53.26% (98/184), and parallel group trials were the most common [82.65% (81/98)]. Over 64.56% (133/206) of the trials were indicated with open-label. Most of the clinical trials were in phase Ⅲ [47.57% (98/206)] and phase Ⅳ [16.50% (34/206)]. The interventions in female studies were mainly in three aspects: oral contraceptive [42.64% (84/197)], intrauterine delivery [15.23% (30/197)], and vaginal delivery [15.23% (30/197)], and the primary outcome included pregnancy rate [54.82% (108/197)], adverse drug reactions [13.20% (26/197)], ovulation inhibition [8.63% (17/197)], and vaginal infection [4.06% (8/197)].Conclusion:The clinical trials of contraceptives were unevenly distributed, the research types were mainly randomized interventional trials, the included participants were mainly women of reproductive age, the intervention measures were mostly oral contraceptive, intrauterine delivery and vaginal delivery.
3.Preparation and characterization of 3D plant-based scaffold based on decellularization method in liver tissue engineering
Jingjing HU ; Songlin HE ; Daxu ZHANG ; Shuo ZHAO ; Xiaonan SHI ; Weilong LI ; Shujun YE ; Jingyi WANG ; Quanyi GUO ; Li YAN
Chinese Journal of Tissue Engineering Research 2024;28(29):4645-4651
BACKGROUND:Tissue engineering has brought new hope to the clinical challenge of liver failure,and the preparation of plant-derived decellularized fiber scaffolds holds significant importance in liver tissue engineering. OBJECTIVE:To prepare apple tissue decellularized scaffold material by using fresh apple slices and a solution of sodium dodecyl sulfate,and assess its biocompatibility. METHODS:Fresh apples were subjected to decellularization using phosphate buffer saline and sodium dodecyl sulfate solution,separately.Afterwards,the decellularized apple tissues and apple decellularized scaffold materials were decontaminated with phosphate buffer saline.Subsequently,scanning electron microscopy was used to assess the effectiveness of decellularization of the apple materials.Adipose-derived mesenchymal stem cells were extracted from the inguinal fat BALB/C of mice,and their expression of stem cell-related markers(CD45,CD34,CD73,CD90,and CD105)was identified through flow cytometry.The cells were then divided into a scaffold-free control group and a scaffold group.Equal amounts of adipose-derived mesenchymal stem cells were seeded onto both groups.The biocompatibility of the decellularized scaffold with adipose-derived mesenchymal stem cells was evaluated using CCK-8 assay,hematoxylin-eosin staining,and phalloidine staining.Cell adhesion and growth on the scaffold were observed under light microscopy and scanning electron microscopy.Furthermore,the scaffold was subdivided into the non-induced group and the hepatogenic-induced group.Adipose-derived mesenchymal stem cells were cultured on the decellularized apple scaffold,and they were cultured for 14 days in regular culture medium or hepatogenic induction medium for comparison.Immunofluorescent staining using liver cell markers,including albumin,cytokeratin 18,and CYP1A1,was performed.Enzyme-linked immunosorbent assay was used to detect the secretion of alpha fetoprotein and albumin.Additionally,scanning electron microscopy was employed to observe the morphology of the induced cells on the scaffold,verifying the expression of liver cell-related genes on the decellularized scaffold material.Finally,the cobalt-60 irradiated and sterilized decellularized apple scaffolds were transplanted onto the surface of mouse liver and the degradation of the scaffold was observed by gross observation and hematoxylin-eosin staining after 28 days. RESULTS AND CONCLUSION:(1)The scanning electron microscopy results revealed that the decellularized apple scaffold material retained a porous structure of approximately 100 μm in size,with no residual cells observed.(2)Through flow cytometry analysis,the cultured cells were identified as adipose-derived mesenchymal stem cells.(3)CCK-8 assay results demonstrated that the prepared decellularized apple tissue scaffold material exhibited no cytotoxicity.Hematoxylin-eosin staining and phalloidine staining showed that adipose-derived mesenchymal stem cells were capable of adhering and proliferating on the decellularized apple tissue scaffold.(4)The results obtained from immunofluorescence staining and enzyme-linked immunosorbent assay revealed that adipose-derived mesenchymal stem cells cultured on the decellularized apple scaffolds exhibited elevated expression of liver-specific proteins,including albumin,alpha-fetoprotein,cytokeratin 18,and CYP1A1.These results suggested that they were induced differentiation into hepatocyte-like cells possessing functional characteristics of liver cells.(5)The decellularized apple scaffold implanted at 7 days has integrated with the liver,with partial degradation of the scaffold observed.By 28 days,the decellularized apple scaffold has completely degraded and has been replaced by newly-formed tissue.(6)The results indicate that the decellularized scaffold material derived from apple tissue demonstrates favorable biocompatibility,promoting the proliferation,adhesion,and hepatic differentiation of adipose-derived mesenchymal stem cells.
4.Development and challenges of reproductive pharmacology
Chinese Journal of Reproduction and Contraception 2024;44(6):557-561
Currently, the major task of reproductive pharmacology is fertility preservation. Aside from studying the efficacy of contraceptives, the research area of reproductive pharmacology has been expanded to probe into the pharmacodynamics and the mechanism of action of medications for treatment of reproductive system disease and assisted fertility as well. The development of analysis techniques, including genomics, transcriptomics, metabolomics, proteomics, organoid culture, stem cell technology and single cell sequencing, provide multiple ways to explore therapeutic targets and new mechanisms of the treatment approaches. With the changes of age structure diagram in China population accompanied with coexisting lower fertility, higher abortion rate and increased number of seniors, more attention in the area of reproductive pharmacology should be paid on the research and development of contraceptives suitable for the young and the unmarried girls to avoid unnecessary abortion and preserve their fertility and provide more opportunities for those who willing to have children, extending their the reproductive span. Furthermore, pharmacological effects, especially the impact and outcomes of assisted reproductive technology and pertaining products on the health of the offspring should be paid more investigation and concerned, which belong to a part of the basic national policy of eugenics and are crucial to enhance the population quality of all the nationalities. This is a major challenge for the reproductive pharmacology researchers faced.
5.Development and challenges of reproductive pharmacology
Chinese Journal of Reproduction and Contraception 2024;44(6):557-561
Currently, the major task of reproductive pharmacology is fertility preservation. Aside from studying the efficacy of contraceptives, the research area of reproductive pharmacology has been expanded to probe into the pharmacodynamics and the mechanism of action of medications for treatment of reproductive system disease and assisted fertility as well. The development of analysis techniques, including genomics, transcriptomics, metabolomics, proteomics, organoid culture, stem cell technology and single cell sequencing, provide multiple ways to explore therapeutic targets and new mechanisms of the treatment approaches. With the changes of age structure diagram in China population accompanied with coexisting lower fertility, higher abortion rate and increased number of seniors, more attention in the area of reproductive pharmacology should be paid on the research and development of contraceptives suitable for the young and the unmarried girls to avoid unnecessary abortion and preserve their fertility and provide more opportunities for those who willing to have children, extending their the reproductive span. Furthermore, pharmacological effects, especially the impact and outcomes of assisted reproductive technology and pertaining products on the health of the offspring should be paid more investigation and concerned, which belong to a part of the basic national policy of eugenics and are crucial to enhance the population quality of all the nationalities. This is a major challenge for the reproductive pharmacology researchers faced.
6.Analysis of 17 cases of Vaterian system adenomyomatous hyperplasia
Weizheng LIU ; Jie LI ; Mingyi CHEN ; Jianan JIANG ; Yang LIU ; Daxu ZHANG ; Wenping LYU
Chinese Journal of Hepatobiliary Surgery 2023;29(5):354-356
Objective:To study the features of adenomyomatous hyperplasia (AH) of the Vaterian system (common bile duct and ampulla of Vater) to help in the diagnosis and management of this disease.Methods:A retrospective analysis on the data of 17 patients who had a postoperative pathological diagnosis of AH of the Vaterian system treated from January 2005 to December 2021 at the First Medical Center of the PLA General Hospital was carried out with 12 males and 5 females, aged (58.4±11.3) years. The clinical presentations, treatment and postoperative pathology of these patients were analyzed. Patients with dysplasia of the tubular mucosal epithelium in the non-cancerous area around the AH under microscopy were included in the AH with dysplasia group ( n=8), and those without dysplasia were included in the control group ( n=9). The clinical characteristics of the two groups were compared. Results:The main clinical symptoms were abdominal pain in 8 patients, jaundice in 7 patients and fever in 2 patients. Preoperative imaging showed 10 cases of occupying lesions and 6 cases of abnormally dilated intrahepatic and extrahepatic bile ducts without obvious lesions or stones or biliary tract injury stenosis. Sixteen patients underwent radical pancreaticoduodenectomy, and 1 patient underwent extrahepatic biliary resection combined with choledochojejunostomy for bile duct obstruction due to biliary stones, 3 patients had combined malignant tumors, 1 patient had a carcinoma of AH origin at the ampulla of Vater, and the other 2 patients had neoplastic lesions in the mucosal epithelium adjacent to the AH (cholangiocarcinoma and ampullary carcinoma, respectively). There were no significant differences in age, gender, bile duct stones, cholangitis, combined carcinoma and liver function indexes between the two groups of patients with AH of the Vaterian system (all P>0.05). Conclusion:Adenomyomatous hyperplasia of the Vaterian system was difficult to distinguish preoperatively from malignant tumors basing on its clinical presentations or imaging findings. Such patients are recommended to be treated surgically.
7.RAPD analysis of nine populations of medicinal mulberry cultivated in Xinjiang
Daxu FU ; Hui ZHANG ; Wen CHEN ; Xue SU ; Kun SUN ; Jiakuan CHEN ;
Chinese Traditional and Herbal Drugs 1994;0(09):-
Object To study the inherited relationships among nine medicinal mulberry populations cultivated in different regions of Xinjiang at DNA level Methods DNA of all populations was amplified by ten random primers from 100 ramdom primers, the polymorphic bands of RAPD were counted And the results of populations were analyzed by clustering analysis NTSYS PC software Results A total of 108 bands was obtained, 91 of total bands (84 26%) was polymorphic The results indicated that there were apparent and abundant genetic variations in Morus L of Xinjiang Besides, eight specific bands of M nigra were obtained Conclusion The genetic relationship among medicinal resources plants of mulberry in Xinjiang indicats by the RAPD analysis to be consistent with their traditional classifications in the main
8.Nutritional components and aging-delaying action of some wild berries in Changbai Mountainous Area
Zhenwei GAN ; Daxu ZHANG ; Yajie ZHANG ; Qiuli CHEN ; Huafeng LIU ; Xuanyue MA
Journal of Xi'an Jiaotong University(Medical Sciences) 1982;0(04):-
Objective To investigate the nutritional components and aging-delaying action of some wild berries such as vaccimum vitia-idaea, vitis amurensis, and actinidia arguta in Changbai Mountainous area. Methods Contents of vitamin B 1, B 2, C, niacin, ?-carotene, and minerals such as Fe, Ca and Zn were analyzed. Wild berry juice was administered to aged mice for 30 days respectively at the doses of 3 g?kg -1 and 6 g?kg -1. Then activities of SOD and GSH-Px, and contents of MDA and lipofuscin were measured. Results Contents of vitamin B 1, B 2, C, ?-carotene, and Fe, Ca, Zn in the berries were significantly higher than those in common cultivated fruits. In the meantime, activities of SOD and GSH-Px in red blood cells and the liver were enhanced remarkably (P

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