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.

Objective:To explore the feasiblility and impact in developing school-based nutritional education through child-to-child approach. Method : Using controlled-comparison quasi-experiment approach, the intervention of nutrition education was implemented based on the Child-to-Child model among more than 3000 primary school students in Shanxi and Zhejiang Province. Results:The knowledge, attitude and practice of students from pilot schools were improved significantly after intervention (P

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.

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.

Objective lo analyze the difference of peri-coronary tat attenuation index(pr Al)on different grades of hypertension(HT),and to explore the value of pFAI in evaluating the risk of HT patients.Methods Retrospective data on hospitalized patients who underwent coronary computed tomography angiography(CCTA)examination for chest pain were collected.A total of 415 clini-cally confirmed HT patients were selected as observation group(including 132 patients in grade 1 HT group,137 patients in grade 2 HT group,146 patients in grade 3 HT group),and 187 non-hypertension patients during the same period as control group.The differ-ence of fat attenuation index(FAI)in three main coronary arteries[left anterior descending artery(LAD),left circumflex artery(LCX),right coronary artery(RCA)]was compared,and the correlation between pF AI and HT patients was analyzed.Results RCA-FAI(-78.86 HU±7.66 HU)and LAD-FAI(-80.62 HU±7.50 HU)were higher in HT group than those in control group(-84.46 HU± 8.00 HU,-83.43 HU±7.51 HU,P＜0.05).pFAI value was higher in grade 3 HT group than that in grade 1 HT group and grade 2 HT group(P＜0.05),while there were no differences between grade 1 HT group and grade 2 HT group(P＞0.05).After adjusting the influence of traditional risk factors and coronaryartery disease,RCA-FAI had relatively closer relationship with HT grades(r=0.47,P＜0.001).Conclusion LAD-FAI,RCA-FAI in the HT group are higher than those in control group and RCA-FAI has relatively closer relationship with HT grades,suggesting that RCA-FAI may be an imaging indicator to evaluate the pro-gression of HT and predict the risk of HT.

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.

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.
China ; Equipment Reuse ; Equipment Safety ; Equipment and Supplies ; Risk Assessment ; United States

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.
Absorbable Implants ; Animals ; Coronary Artery Disease ; Drug-Eluting Stents ; Percutaneous Coronary Intervention ; Prosthesis Design ; Stents ; Tissue Scaffolds ; Treatment Outcome

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.
Collagen Type I ; chemistry ; Hydrogels ; chemistry ; Materials Testing ; Permeability

Foodborne Campylobacter is recognized as the leading causes of the bacterial diarrheal illness in both developing and developed countries. C. jejuni and C. coli caused 95% of the human campylobacterisosis. Bacteria culture has been recognized as the "Gold standard" for the diagnosis of the Campylobacter infection. The National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention coordinated the experienced researchers from China National Center for Food Safety Risk Assessment and other local Centers for Disease Control and Prevention to write up the standards for entitled Isolation and Identification of Campylobacter jejuni and Campylobacter coli (T/CPMA 006-2019). The standard is drafted with principles of emphasizing the scientific, normative, applicability and feasible nature. This group standard recommended the procedures and steps for the isolation and identification of C. jejuni and C.coli from variant samples. The standard aims to improve the capacity for Campylobacter identification in China.