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OBJECTIVE@#To introduce the test methods of embryo toxicity applied to medical devices for human assisted reproductive technology (ARTMD), and provide the evaluation reference.@*METHODS@#The embryo toxicity test methods of ARTMD were summarized, and the key procedures and challenges in their safety evaluation were also discussed.@*RESULTS@#Establishing sensitive and stable test system is important to guarantee the safety and efficacy of ARTMD.@*CONCLUSIONS@#It remains development opportunities in improving sample preparation, extending test technology and expending evaluation method.
Subject(s)
Humans , Reproductive Techniques, Assisted , Toxicity TestsABSTRACT
The purpose of this study was to investigate the NOAEL of the nickel ion and provide with basic data for the biological evaluation of those medical devices containing nickel. Five groups SD rats were repeatedly exposed during 14 d respectively to nickel at first stage doses of 4.9, 3.7, 2.5 mg/(kg.d), and the second stage doses of 1.2, 0.25 mg/(kg.d) by the intravenous route. The results showed that the NOAEL of nickel ion is 0.25 mg/(kg.d) for SD rats, and the result was verified by subchronic systemic toxicity test of nickel alloy. The threshold of toxicological concern (TTC) of nickel is 150 μg/d (based on application of 100-fold uncertainty factor and a body weight of 60 kg)deduced by these data.
Subject(s)
Animals , Rats , Equipment and Supplies/adverse effects , Nickel/toxicity , No-Observed-Adverse-Effect Level , Rats, Sprague-Dawley , Risk AssessmentABSTRACT
Skin-substitute has developed rapidly and it is essential to evaluate its effectiveness before clinical use.This paper reviews the development of skin-substitute,methods to evaluate the effectiveness of skin-substitute and relevant standards.This paper highlights the and means of preclinical effectiveness evaluation and provides theoretical basis for preclinical safety evaluation of skin-substitute.
Subject(s)
Skin, ArtificialABSTRACT
Various types of medical devices used in assisted reproductive technologies (ART) should be detected for their safety by strict biological assays. Mouse embryo assay(MEA)has been recognized as one of the most important and standardized methods with the threshold more than 80% of blastocyst formation rate (BR) after 96 h culture of fertilized eggs. The disadvantage using BR for embryonic quality control has been concerned as it is ubiquitously dependent of embryonic morphology and the detailed data including molecular and genetic information is obviously missing and incomplete. This leads to the urgent requirement for more sensitive and efficient assessments for the quality control of ART. This study evaluated the reliability of an immunofluorescent MEA by counting total cell and differential number of the cells in the inner cell mass (ICM) and trophectoderm (TE) in the blastocyst. This method improved the traditional MEA, provided a sensitive and powerful platform to assess embryonic developmental viability and should be suggested as a standard assay to be globally used for the quality control of medical devices and pre-clinical procedures in ART.
Subject(s)
Animals , Mice , Blastocyst , Embryonic Development , Equipment Safety , Reproducibility of Results , Reproductive Techniques, AssistedABSTRACT
Objective To investigate the interference effects of vitamin C on three different detection methods of blood glucose.Methods According to CLSI EP7-A2 document,5% volume of vitamin C(series concentrations) solution was added to fresh mixed serum,then hexokinase method(A),glucose oxidase method(B) and glucose reductase electrode method(C) were used to detect the level of fresh mixed serum glucose.The interference level of vitamin C on three different detection methods of blood glucose was evaluated.Results In 1 250 mg/L vitamin C,there was no interference on the method A for detecting blood glucose.In 156 mg/L vitamin C,it caused unacceptable negative interference on the method B and unacceptable positive interference on the method C.Moreover the interference degree of these two methods was increased with vitamin C concentration increase,but the same concentration of vitamin C had no significant difference on detecting different blood glucose levels by the same detection method.Conclusion High concentration of vitamin C can cause significant interference on glucose detection by glucose oxidase method and glucose reductase electrode method.
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Infertility has become a global problem affecting human reproductive health.As an important treatment for infertility, assisted reproductive technology has made great progress over the past few decades.Rapid development has also taken place in medical devices for human assisted reproductive technology.It is imperative to establish the risk management and safety evaluation system of these products.In 2016, the industry standard YY/T 1434-2016 Human in vitro Assisted Reproductive Technology With Medical Equipment in vitro Mouse Embryo Test was officially released.In this paper, the key notes and elements of this in vitro mouse embryo test are briefly reviewed.
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Objective:To observe the impact of compound glycyrrhizin combined with triamcinolone acetonide on clinical effects and immune function in the patients with oral lichen planus ( OLP) . Methods:Totally 100 patients with OLP were randomly divided into the control group (50 cases) and the study group (50 cases). The control group was locally injected with triamcinolone acetonide, and the study group was treated with compound glycyrrhizin tablets additionally. The treatment course was 4 weeks. Visual analogue scale ( VAS) and REU scoring system were used to assess pain and symptoms of OLP, the clinical effects and cellular immune function were compared, and the adverse reactions were recorded as well. Results:After the treatment, the VAS score and REU score respec-tively lower than those for the control group, and there were differents between the two groups (P<0. 05). The total effective rate was 84. 0% in the study group, which was higher than that in the control group (66. 0%) (P<0. 05). The percentage of CD3+ and CD4+ cells was increased, that of CD19+ cells and the ratio of CD4+/CD8+ were decreased, and there were significant differences be-tween the two groups (P<0. 05). The adverse reactions in both groups were mild. Conclusion:Compound glycyrrhizin combined with triamcinolone acetonide is effective for OLP and can improve the immune function in the patients.
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Objective To evaluate the effects of transforming growth factor β1 (TGF-β1 )on migration, adhesion and proliferation of periodontal ligament stem cells (PDLSCs)and explore the mechanisms of PDLSCs-induced periodontal remodeling.Methods PDLSCs were isolated and identified from human teeth.The effect of TGF-β1 on migration of PDLSCs was evaluated using transwell migration assay.Cells attachment assay was used to test the effect of TGF-β1 on the adhesion of PDLSCs.In addition,the effect of TGF-β1 on the proliferation of PDLSCs was evaluated by MTT and cell growth rate assay.Results The results showed that TGF-β1 induced the migration of PDLSCs in a dose-dependent manner,improved the adhesion and proliferation of PDLSCs.So we propose that TGF-β1 may promote periodium remodeling by inducing PDLSCs migration,following adhesion and proliferation in these areas.Conclusion This study demonstrated for the first time that TGF-β1 increases the adhesion and migration of PDLSCs in vitro .The signal pathway is involved in the TGF-β1-induced migration of PDLSCs and the mechanical-chemical interaction during the orthodontic periodontal remodeling will be researched in our further studies.
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Objective To explore the predictive values of the levels of procalcitonin (PCT) and thyroid hormone on the prognosis in patients with systemic inflammatory response syndrome (SIRS) complicated with euthyroid sick syndrome (ESS) and their values on differential diagnosis of ESS. Methods A total of 238 patients with SIRS hospitalized in the Emergency Department, Jiangsu Provincial Hospital of Integration of Chinese and Western Medicine, Jiangsu Branch of China Academy of Chinese Medical Sciences from July 2012 to December 2014 were divided into two groups: death group (31 cases) and survival group (207 cases), 182 patients being complicated with ESS and 56 patients without ESS. The differences in the levels of PCT, free triiodothyronine (FT3) and acute physiology and chronic health evaluation (APACHE Ⅱ) score in patients with different clinical outcomes were analyzed. The effects of the inflammatory mediators including levels of PCT, interleukin-6 (IL-6), C-reactive protein (CRP), and thyroid function such as free thyroxine (FT4) and thyroid stimulating hormone (TSH) on clinical outcomes and their predictive values on death of emergency patients with SIRS were also studied. Furthermore, the correlations between APACHEⅡscore and PCT, IL-6, CRP, thyroid hormone were analyzed. Results The level of PCT and APACHE Ⅱ score in death group were significantly higher than those in survival group [PCT (ng/L): 8.38 (13.88) vs. 1.04 (3.57), APACHEⅡscore:27.42±6.88 vs. 16.35±6.72, both P0.05). The mortality was increased markedly in patients with higher PTC level and lower FT3 level compared with normal PCT level and normal FT3 level [18.8% (30/160) vs. 1.3% (1/78), 17.1%(31/181) vs. 0 (0/57), both P0.05). PCT was positively correlated with APACHEⅡscore (r>0.33, P<0.001), while FT3 was negatively correlated with APACHEⅡscore (r<-0.33, P<0.001). There were no correlations between IL-6 (r = 0.319, P < 0.001), CRP (r = 0.161, P < 0.05), FT4 (r = -0.170, P < 0.01), TSH (r = -0.057, P = 0.385), and APACHEⅡscore. The levels of PCT, IL-6 and CRP and APACHEⅡscore in patients with ESS were significantly higher than those in patients without ESS [PCT (ng/L):2.54 (5.90) vs. 0.20 (0.43), IL-6 (ng/L):98.62 (351.20) vs. 16.85 (33.60), CRP (mg/L):88.00 (110.50) vs. 25.50 (48.00), APACHEⅡscore:17.62±8.17 vs. 10.98±4.97, all P<0.01]. The cut-off values for predicting patient's death of these indexes showed by receiver operating characteristic curve (ROC curve) analysis were as follows: PCT: cut-off value ≥ 1.755 ng/L, sensitivity: 87.1%, specificity: 58.0%, area under the ROC curve (AUC): 0.802; FT3: cut-off value ≤ 2.92 pmol/L, sensitivity: 93.5%, specificity: 54.1%, AUC: 0.785;APACHE Ⅱ score: cut-off value ≥ 21.5, sensitivity: 83.9%, specificity: 88.4%, AUC: 0.920. Conclusions The levels of serum PCT, FT3 and APACHEⅡscore are prognostic factors in patients with SIRS. Meanwhile, the levels of serum PCT, IL-6, CRP and APACHE Ⅱ score should be taken into consideration in differential diagnosis of ESS in patients with SIRS.
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Objective To evaluate the influence of blood transfusion or pregnancy on blood cross-matching results.Methods 1 000 specimens with blood transfusion or pregnancy history were collected and performed the blood group typing,blood cross matching,irregular antibody screening and identification by the micro-gel method with the specimens of first time transfuse blood and without pregnancy history as the control.The inconsistency rate of positive negative blood grouping,unqualified rate of blood cross matching and the positive rate of irregular antibody were compared between the two groups by the t-test.The causes influen-cing the blood cross-matching results were analyzed.Results The inconsistency rate of blood cross-matching in the blood transfu-sion or pregnancy group was significantly higher than that in the control group(P 0.05);the positive rate of irregular antibody screening in the blood transfu-sion or pregnancy group was also significantly higher than that in the control group(P <0.05),indicating that the main causes in-fluencing blood cross matching was the existence of irregular antibodies in the patients in vivo.Conclusion Blood transfusion or pregnancy may stimulate the body to produce the irregular antibodies.Therefore the irregular antibody screening should be per-formed before blood transfusion and blood without corresponding antigen will be selected for transfusion according to the antibody identification results for ensuring safe and effective blood transfusion.
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@# Malignant gliomas represent the largest group of brain tumors in humans. Recent studies have explored the molecular changes and apoptosis on gliomas, which involved the molecular etiology malignant progression, molecular subtyping, gene therapy, and prognostic evaluation of gliomas. This paper reviewed the relevant advances in the field of gliomas molecular biology.