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ObjectiveThis article aims to investigate the clinical features of portal biliopathy （PB） patients， in order to improve the understanding of PB. MethodsClinical data were collected from 22 patients who were diagnosed with PB in recent years in The First Hospital of Jilin University， and an analysis was performed for their clinical manifestations， liver function， abdominal color Doppler ultrasound， abdominal CT， and hepatobiliary magnetic resonance imaging. The imaging manifestations of biliary tract abnormalities were described， as well as the type of collateral circulation and the location of thrombosis. ResultsAs for the initial symptom in these 22 patients， three were 11 patients with gastrointestinal bleeding， 5 with abdominal distension， 3 with abdominal pain， 1 with fever， 1 with abdominal discomfort， and 1 with gingival bleeding. There were 3 patients with an increase in aspartate aminotransferase， 4 with an increase in alanine aminotransferase， 4 with an increase in gamma-glutamyl transpeptidase， 7 with an increase in alkaline phosphatase， 8 with a reduction in cholinesterase， 9 with a reduction in albumin， 2 with an increase in globulin， and 5 with an increase in total bilirubin. Among the 22 patients， 20 had cavernous transformation of the portal vein， and 2 had portal vein thrombosis without cavernous transformation. All 22 patients had bile duct abnormalities， among whom 2 had extrahepatic bile duct abnormalities alone， 12 had intrahepatic bile duct dilatation alone， and 8 had dilatation of both intrahepatic and extrahepatic bile ducts. Varices at different sites were observed in 20 patients， among whom 19 had esophageal and gastric varices and 1 had peri-gallbladder varices， and no varices was observed in the superior mesenteric vein or the splenic vein. ConclusionThere are no typical clinical symptoms and changes in liver function parameters in patients with PB， but radiological examination may show dilatation， stenosis， or malformation of the bile ducts at different parts. Therefore， it is necessary to expand the sample size to further explore the diagnosis and treatment of PB.
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Clinical research of artificial intelligence (AI) medical devices is one of the most important links in the process of AI medical devices product development. This paper discusses the key elements of the ethical review of clinical research of artificial intelligence medical devices and the four aspects including strengthening the legislative construction and supervision, strengthening the capacity building of the ethics committee, improving the ethical review system and system construction, expanding platform construction and strengthening regional linkage that can improve the quality of ethical review in the future, protect the safety of subjects, and ensure the efficiency and quality of clinical research.
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Dbait is a small double-stranded DNA molecule that has been utilized as a radiosensitizer to enhance the sensitivity of glioma to radiotherapy (RT). However, there is no effective drug delivery system to effectively overcome the blood-brain barrier (BBB). The aim of this study was to develop a gene delivery system by using the BBB and glioma dual-targeting and microenvironment-responsive micelles (ch-K(s-s)R8-An) to deliver Dbait into glioma for RT. Angiopep-2 can target the low-density lipoprotein receptor-related protein-1 (LRP1) that is overexpressed on brain capillary endothelial cells (BCECs) and glioma cells. In particular, due to upregulated matrix metalloproteinase 2 (MMP-2) in the tumor microenvironment, we utilized MMP-2-responsive peptides as the enzymatically degradable linkers to conjugate angiopep-2. The results showed that ch-K(s-s)R8-An micelles maintained a reasonable size (80-160 nm) with a moderate distribution and a decreased mean diameter from the cross-linking as well as exhibited low critical micelle concentration (CMC) with positive surface charge, ranging from 15 to 40 mV. The ch-K5(s-s)R8-An/pEGFP showed high gene transfection efficiency , improved uptake in glioma cells and good biocompatibility and . In addition, the combination of ch-K5(s-s)R8-An/Dbait with RT significantly inhibited the growth of U251 cells . Thus, ch-K5(s-s)R8-An/Dbait may prove to be a promising gene delivery system to target glioma and enhance the efficacy of RT on U251 cells.
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Recruitment advertising for clinical trials is a communication carrier of research information prior to participants' participation in the trial, and an important part of the form to recruit and inform subjects. Recruitment advertising should include the necessary information about the clinical trial, but cannot contain the inappropriate content such as those misleading and inducting information, and the content and the modality of advertising must be approved by ethics committee before being used. At present, there are laws and regulations, ethical review, re-searchers' understanding, non-standard operation and other issues in the advertising for recruitment. Therefore, it ' s need to continuously strengthen the ethical review and management of advertising to protect the rights and inter-ests of subjects from the angles of improving relevant laws and regulations, enhancing ethical review ability, raising researchers' awareness and strengthening fighting force on the illegal activities and so on.
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The nanotechnology has been successfully applied in the diagnosis and treatment of diseases and develops rapidly.As a cutting-edge technique,there exist a series of ethical issues when applying nanotechnology in human body,such as risk management,benefit assessment,privacy protection and informed consent.Clinical trials initiated by researchers also face ethical challenges.Therefore,it should study on the ethical issues when using nanotechnology in medicine.To insure the healthy development of nanotechnology in medical application,the regulations and rules should be improved,the assessment of risks and benefits should be strengthened,the ethical review should be reinforced,and the awareness level of the researchers should be enhanced.
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Objective To construct an active targeting drug delivery system‐polymer vesicles(PVs), and examined the cellular uptake. Methods Maleimide‐ polyethylene glycol‐poly(lactic‐co‐glycolic acid)(MAL‐PEG‐PLGA)was used as carrier materials to prepare PVs by self‐assembling. And then PVs was modified by Tf and Tet‐1(Tf/Tet‐1‐PVs). To evaluate its ac‐tive targeting, coumarin‐6 was used as a fluorescent probe to analyze cellular uptake of PVs for both BCEC and Neuro‐2a cells. Results PVs was about 80 nm with rounded shape and had obvious film structure. Tf/Tet‐1‐PVs exhibited a significant role in promoting cellular uptake for both BCEC and Neuro‐2a cells compared with control and single ligand‐modified group. Conclusion PVs modified with dual ligands could promote the cell uptake for both brain capillary cells and nerve cells.