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.

Background:Circular RNAs(circRNAs)are covalently closed single-stranded RNAs with multiple biological functions.CircRNA.0007127 is derived from the carbon catabolite repression 4-negative on TATA-less(CCR4-NOT)complex subunit 2(CNOT2),which was found to regulate tumor cell apoptosis through caspase pathway.Methods:Potential circRNA.0007127 target microRNAs(miRNAs)were analyzed by miRanda,TargetScan,and RNAhybrid software,and the miRNAs with binding sites for apoptosis-related genes were screened.The roles of circRNA.0007127 and its downstream target,microRNA(miR)-513a-5p,were validated by quantitative real-time polymerase chain reaction(qPCR),flow cytometry,mitochondrial membrane potential,immunofluorescence,western blot,and caspase-8(CASP8)protein activity in vitro in H2O2-induced K-562 cells.The circRNA.0007127-miR-513a-5p and CASP8-miR-513a-5p interactions were verified by luciferase reporter assays.Results:Silencing circRNA.0007127 decreased cell apoptosis by inhibiting CASP8 pathway activation in K-562 cells.Compared with the control group,the expression of CASP8 was reduced by 50％and the 43-kD fragment of CASP8 protein was significantly reduced(P≤0.05).The luciferase reporting assay showed that circRNA.0007127 combined with miR-513a-5p or CASP8,with extremely significant differences(P≤0.001).The overexpression of miR-513a-5p inhibited the gene expression level of CASP8 in a human myeloid leukemia cell model(75％change)and the level of a 43-kD fragment of CASP8 protein(P≤0.01).The rescue experiment showed that cotransfection with circRNA.0007127 small-interfering RNA(siRNA)and the miR-513a-5p inhibitor increased CASP8 gene expression and the apoptosis rate,suggesting that the miR-513a-5p inhibitor is a circRNA.0007127 siRNA antagonist.Conclusions:CircRNA.0007127 regulates K-562 cell apoptosis through the miR-513a-5p/CASP8 axis,which can serve as a novel powerful molecular target for K-562 cells.

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

Objective:To analyze the detection strategy and basic detection situation of markers of infectious diseases transmitted by transfusion in blood testing laboratories of blood stations in China.Methods:Based on the data of practice comparison working party of Blood Stations in Mainland of China from 2017 to 2021, the data on the testing strategies and the basic detection information of the markers for the transmission of infectious diseases through transfusion in the member laboratories of the practice comparison working party of Blood Stations in Mainland of China from 2017 to 2021 were collected, and the situation of the selection for testing markers, testing strategy and the testing method and other relevant aspects were sorted out and analyzed by charts.Results:The selection of the testing markers was consistent, but HTLV testing item was added in some member laboratories. The detection strategy of using two ELISA reagents and one nucleic acid testing (NAT) reagent simultaneously was adopted in 47 member blood stations; 3) NAT method was dominated by mini pool-NAT in member laboratories. The number of members adopting mini-pools of 8 (MP8)-NAT decreased from 17 in 2017 to 14 in 2021, while the number of members adopting mini-pools of 6 (MP6)-NAT increased from 13 in 2017 to 22 in 2021; Roche NAT system accounted for the largest proportion.Conclusions:In order to ensure blood safety and avoid missing detection, the blood stations still adopt the detection strategy of using two ELISA reagents and one nucleic acid testing (NAT) reagent simultaneously; Meanwhile, in order to increase the NAT positive rate, the proportion of mini pool-NAT mainly decreased year by year despite its dominating role, while the proportion of individual donation-NAT increased year by year; NAT method is transiting from mini-pools of 8 (MP8) to mini-pools of 6 (MP6); The proportion of imported NAT system used in NAT laboratory is relatively large.