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Objective:To investigate the relationship between metabolic syndrome (MetS) and clinicopathological characteristics of patients with gastric cancer.Methods:The clinicopathological data of 245 patients with gastric cancer diagnosed by pathology in Xinzhou People's Hospital of Shanxi Province from January 2015 to December 2018 were retrospectively analyzed, and 462 non-tumor patients who underwent routine physical examination at Xinzhou People's Hospital of Shanxi Province during the same period were selected as control group. The occurrence of MetS and the correlation of MetS with clinicopathological characteristics and overall survival of patients with gastric cancer were analyzed.Results:The incidence rate of MetS in 245 patients with gastric cancer was 21.6% (53/245) and 13.6% (63/462) in the control group, and the difference between the two was statistically significant ( χ2 = 7.464, P = 0.008). Among patients with gastric cancer, the incidence of postoperative lung infection in the MetS group and non-MetS group was 17.0% (9/245) and 3.1% (6/462), respectively, and the difference was statistically significant ( χ2 = 13.874, P = 0.001); there was no significant difference in the tumor site and the incidence of incision infection, abdominal cavity infection, anastomotic leakage, gastric emptying disorder, and overall survival between the two groups (all P > 0.05). In patients with gastric cancer, MetS was associated with poor histological differentiation and late TNM stage ( χ2 = 4.242, P = 0.040; χ2 = 5.547, P = 0.027). Conclusions:The incidence of MetS in patients with gastric cancer is higher than that in the general population, and MetS-related abnormalities are more common in patients with low differentiated, undifferentiated and advanced gastric cancer. MetS may play a role in the occurrence and development of gastric cancer.
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Bioresorbable vascular scaffolds(BVS) are new treatment strategies of percutaneous coronary intervention. They have been introduced to overcome limitations of bare metal stents (BMS) and drug-eluting stents(DES), since they provide temporary scaffolding and then disappear, liberate the treated vessel from cage. In this article, we review the current status and problems of BVS, various tests required before gaining regulatory approval for clinical use.
Subject(s)
Animals , Absorbable Implants , Coronary Artery Disease , Drug-Eluting Stents , Percutaneous Coronary Intervention , Prosthesis Design , Stents , Tissue Scaffolds , Treatment OutcomeABSTRACT
OBJECTIVES@#To establish an experimental method for evaluating material permeability of type I collagen hydrogels.@*METHODS@#Using BSA-FITC as an indicator, by combining BSA-FITC with PBS they were used as permeability media, and using transwell load hydrogen sample to detect BSA-FITC transparent rate.@*RESULTS@#In the concentration range of 100 μg·mL~0.781 μg·mL, the standard curve ≥ 0.99, Lower Limit of Quantity (LLOQ) is 3.125 μg·mL, RSD <5%, detection recovery rate is in the range of 80%~120%.@*CONCLUSIONS@#In this study, we established an experimental method for evaluating material permeability of hydrogel. The BSA-FITC transparent rate of type I collagen hydrogel was 100% at 28 h.
Subject(s)
Collagen Type I , Chemistry , Hydrogels , Chemistry , Materials Testing , PermeabilityABSTRACT
Some single-use medical devices are reprocessed and reused in some countries in the world, but the regulatory approach is different, and in some countries it isn't regulated yet. In this article, the regulatory status quo of single-use medical devices is reviewed. The regulatory development, important regulatory documents and regulatory approaches of single-use medical device reprocessing in the United States, Germany and the UK are introduced. And how to perform scientific risk assessment and effective risk control is discussed. The information is useful to establish China-specific regulations, and to develop relevant standards, guidelines or specifications and the risk control strategies.
Subject(s)
China , Equipment Reuse , Equipment Safety , Equipment and Supplies , Risk Assessment , United StatesABSTRACT
The reuse of high-cost single-use medical devices (SUD) is permitted in many countries, such as the United States, Germany and the United Kingdom, but strict regulatory requirements must be met. In addition to regulatory policies and regulations, such as market access mode and special requirements on Good Manufacture Practice (GMP), there are strict technical requirements on the potential risk control and quality assurance system. Therefore, effective risk assessment and risk control technology are the keys to ensure effective quality control and safe use of SUDs. In this article, based on analyzing the technological requirements of the national regulatory on SUDs in the United States, Germany and Britain, and combined with the review from latest relevant literature, to discuss the strategies of how to carry out scientific risk assessment. Some risk control technologies on the reuse of SUDs are introduced, which will provide support for the further study on risk control strategies and regulatory decisions for the reuse of SUDs in China.
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Objective:To investigate and compare the effects of water extracts of Whitmania pigra Whitman and Hirudinaria ma-nillensis Lesson on the angiogenesis of Tg (kdrl:mCherry) zebrafish. Methods:The zebrafish embryos 6-8 hours after fertilization (6-8hpf) were transferred to the culture medium containing Whitmania pigra Whitman or Hirudinaria manillensis Lesson extract at different concentrations, and the culture medium containing the drugs was replaced every 24 h. And then, at 72 hpf, the larvalmorphology and intersegmental vessels were observed under a microscope. The hatchability of 48-and 72-hpf embryos, and the number of intersegmen-tal vessels and the heart rate of 72-hpf juveniles were measured. Results:Compared with the control group, when the concentration of Whitmania pigra Whitmanis was higher than 30μg· ml-1 , and the concentration of Hirudinaria manillensis Lesson was higher than 20μg· ml-1, the number of intersegmental vessels was significantly reduced (P<0. 01). Compared with the control group, at 48 hpf, when the concentration of the drug groups was higher than 40 μg· ml-1 , the hatchability of the two groups significantly decreased ( P<0. 01);at 72 hpf, the hatchability of Whitmania pigra Whitman decreased significantly at the concentration of 100 μg·ml-1 (P<0.01), while the hatchability of Hirudinaria manillensis Lesson decreased significantly at the concentration of 80 μg· ml-1(P <0. 01). There was no obvious yolk sac edema, pericardial edema and spine curvature in the two groups. The heart rate decreased sig-nificantly (P<0. 01), while was still within the normal range. Conclusion:Both Whitmania pigra Whitman and Hirudinaria manillen-sis Lesson have notable anti-angiogenic activity, and the anti-angiogenesis activity of Hirudinaria manillensis Lesson is stronger. They both have effects on the development of zebrafish embryos, while the toxicity is not obvious.
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BACKGROUND:Hydrophobic acrylic foldable intraocular lens should be evaluated biologicaly with New Zealand rabbits as implant objects prior to clinical trial. OBJECTIVE:To observe the biological safety of hydrophobic acrylic foldable intraocular lens. METHODS: Twelve New Zealand rabbits were enroled. The right eyes were implanted with self-developed hydrophobic acrylic foldable intraocular lens (Shenyang Baiao Medical Device Co., Ltd., China) as experimental group, and the left eyes were implanted with Acrysof IQ SN60WF (Alcon, USA) as control group. RESULTS AND CONCLUSION: After implantation, there were no significant differences in the cornea, anterior chamber, implant position, posterior segment of eyebal between two groups. Tissue proliferation had no obviously difference between the two groups, and there were cornea and lens pouch inflammations. No macrophages and other inflammatory cels were visualized on the surface of intraocular lens, and fibrous tissues were found on the intraocular lens surface and in the haptics root. These findings suggest that the self-developed hydrophobic acrylic foldable intraocular lens has no difference from Acrysof IQ SN60WF widely used in clinic, and it has the biological safety.