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Food and medicinal substances(FAMS) with both edible and medicinal uses have a long history in China, being an important part of China's excellent traditional culture and traditional Chinese medicine(TCM). The legal management of FAMS is in the form of catalogue, which has a history of nearly 40 years. More than 100 substances have been included in the China's FAMS catalogue. According to the Regulation of Food and Medicinal Substances Catalogue, safety assessment is a basis for substances to be included in the catalogue. The safety assessment of FAMS should follow the principles and requirements of food safety risk assessment. However, FAMS is a complex mixture, and the nature and data adequacy of the assessed substance should be comprehensively considered. Different eva-luation models and methods should be selected according to the principle of case analysis. With the development of next-generation technologies such as big data, artificial intelligence, high-throughput and high-content in vitro testing, and computational toxicology and the trend of increasing edible substances with medicinal effects applying for the inclusion in the China's FAMS catalogue, the methods of risk assessment are applied in the management of FAMS, novel food products, and local characteristic food products, playing a scientific role. This paper systematically reviews the methods, challenges, and prospects of safety assessment of FAMS.

Objective: To explore the effect of lncRNA ADPGK-AS1 on the proliferation and apoptosis of retinoblastoma cells and its possible mechanism. Methods: The tumor tissues of 31 patients with retinoblastoma admitted to Henan Provincial Eye Hospital from February to June 2020 and their corresponding normal tissues adjacent to the cancer were collected. The expression levels of lncRNA ADPGK-AS1 and miR-200b-5p in retinoblastoma tissues and normal adjacent tissues were detected by real-time fluorescence quantitative polymerase chain reaction (qRT-PCR). Human retinal epithelial cell ARPE-19, human retinoblastoma cell Y-79 and WERI-Rb-1 were cultured in vitro . The expression levels of lncRNA ADPGK-AS1 and miR-200b-5p were detected by qRT-PCR. Y-79 cells were randomly divided into si-con group, si-lncRNA ADPGK-AS1 group, miR con group, miR-200b-5p group, si-lncRNA ADPGK-AS1+ anti-miR con group, and si-lncRNA ADPGK-AS1+ anti-miR-200b-5p group. The proliferation, cloning and apoptosis of cells in each group were detected by tetramethylazol blue method, plate cloning test and flow cytometry, respectively. The targeting relationship between lncRNA ADPGK-AS1 and miR-200b-5p was detected by double luciferase report test, and the expression level of cleaved-caspase-3 protein was detected by western blot. Results: Compared with the adjacent tissues, the expression of lncRNA ADPGK-AS1 in retinoblastoma tissues was increased ( P <0.05), while the expression of miR-200b-5p was decreased ( P <0.05). Compared with ARPE-19 cells, the expression of lncRNA ADPGK-AS1 in Y-79 and WERI-Rb-1 cells was increased ( P <0.05), while the expression of miR-200b-5p was decreased ( P <0.05). Compared with the si-con group, the cell viability of the si-lncRNA ADPGK-AS1 group was reduced (1.06±0.09 vs 0.53±0.05, P <0.05), the number of cell clone formation was reduced (114.00±8.03 vs 57.00±4.13, P <0.05), while the apoptosis rate [(7.93±0.68)% vs (25.43±1.94)%] and the protein level of cleaved-caspase-3 were increased ( P <0.05). Compared with the miR-con group, the cell viability of the miR-200b-5p group was decreased (1.05±0.08 vs 0.57±0.05, P <0.05), the number of cell clone formation was decreased (118.00±10.02 vs 64.00±5.13, P <0.05), while the apoptosis rate [(7.89±0.71)% vs (23.15±1.62)%] and the protein level of cleaved-caspase-3 were increased ( P <0.05). lncRNA ADPGK-AS1 could target the expression of miR-200b-5p. Compared with the si-lncRNA ADPGK-AS1+ anti-miR-con group, cell viability of the si-lncRNA ADPGK-AS1+ anti-miR-200b-5p group was increased (0.53±0.04 vs 1.25±0.10, P <0.05), and the number of cell clones was increased (54.00±4.39 vs 125.00±10.03, P <0.05), while the rate of apoptosis [(25.38±1.53)% vs (9.76±0.71)%] and the protein level of cleaved-caspase-3 were decreased ( P <0.05). Conclusion: Interfering with the expression of lncRNA ADPGK-AS1 could inhibit the proliferation and clone formation and induce apoptosis of retinoblastoma cells by targeting the expression of miR-200b-5p.

Xanthii Fructus is a traditional Chinese medicine for the treatment of sinusitis and headache,rich in medicinal materials and is widely used for more than 1 800 years. Modern pharmacological studies have showed that Xanthii Fructus has anti-inflammatory,analgesic,anti-tumor,anti-bacterial,hypoglycemic,anti-allergic,immunomodulatory and other pharmacological effects,which can be commonly used in the treatment of diseases relating to immune abnormalities,such as rheumatoid arthritis,acute and chronic rhinitis,allergic rhinitis,and skin diseases,with a high medicinal value. Toxicological studies have shown that Xanthii Fructus poisoning can cause substantial damage to organs,such as the liver,kidney,and gastrointestinal tract,especially to liver. Because of the coexisting of its efficacy and toxicity,Xanthii Fructus often leads to a series of safety problems in the clinical application process. This study attempts to summarize its characteristics of adverse reactions,analyze the root cause of the toxicity of Xanthii Fructus from such aspects as processing,dose,course of treatment and eating by mistake,discuss the substance of its efficacy/toxicity from chemical compositions,and put forward exploratory thinking about how to promote its clinical rational application from the aspects such as strict processing,reasonable compatibility,medication information,contraindication,strict control of the dose,and course of treatment,so as to promote the safe and reasonable application of Xanthii Fructus.

Technique of homologous recombination based gene targeting developed in the late 1980s and won the Nobel Prize in Physiology or Medicine in 2007. However, this technique could only performed in mice which embryonic stem (ES) cells could keep in the potential of multifunction in vitro. Therefore gene knockout technology was difficult to be applied in other species of animals for a long time. Since 2008, with the development of the new technologies, such as the new ES cell gene targeting, zinc finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs) and clusters of regularly interspaced short palindromic repeats/Cas9 (CRISPR/Cas9), building gene knockout in large and medium animals models which are similar to human in disease research becomes possible. This review describes some new gene knockout technologies in large and medium animal models for recent years.

Objective: To study the differential microRNAs expression between patients with essential hypertension and healthy controls., Methods: Whole blood from 15 hypertensive patients and 5 controls healthies were separated into plasma at 3000 rpm for 10 minutes. MicroRNAs were harvested using kit, and stored at -80°C. MicroRNAs profiling were performed using Exiqon microRCURY(TM) LNA microRNAs array, and were quantitative RT-PCR for the differential microRNAs expression. In addition, we used a set of plasma samples from 24 hypertensive patients and 22 healthy donors to independently validate the expression of these signature microRNAs., Results: MicroRNAs expression profile was found to be differentially in the essential hypertensive patients compared with the healthy donors. Of 1700 microRNAs detected on the microarray, 46 microRNAs were found to be differentially expressed in the essential hypertensive patient, 27 microRNAs were collected in Sanger microRNAs data-bank, the function of remaining 19 microRNAs were unknown. In the 27 microRNAs, 9 microRNAs were up-regulated in the hypertension patient samples, while 18 known microRNAs were down-regulated. MiR-296-5p (Fold change 0.47, P = 0.013) and miR-133b (Fold change 0.57, P = 0.033) were consistently down-regulated in the patient plasma, whereas let-7e (Fold change 1.62, P = 0.009) and hcmv-miR-UL112 (Fold change 2.72, P = 0.004), one human cytomegalovirus encoded microRNAs, were up-regulated in the patient samples. The microRNAs expression was independently validated using another sample. We showed that MHC class I polypeptide-related chain B (MHC class I polypeptide-related chain B, MICB) and Interferon regulatory factor 1 (Interferon regulatory factor 1, IRF1) were functional targets of hcmv-miR-UL112 by fluorescent reporter assays., Conclusions: The hypertensive patients have distinct microRNAs expression Profile. Hcmv-miR-UL112 may have important implications toward pathogenesis of essential hypertension.

Objective: To evaluate the efficacy and tolerability of the fixed combination of amlodipine 5 mg/benazepril 10 mg once-daily therapy, compared with benazepril, 10 mg, monotherapy in patients with mild and moderate hypertension, and to evaluate the 24 h antihypertensive efficacy and the duration of action by ambulatory blood pressure monitoring., Methods: In a multicenter, randomized, double-blind, parallel controlled trial, 356 cases of hypertensive patients after 2 weeks wash-out, and then given 4 weeks of benazepril 10 mg monotherapy, 220 patients with mean seated diastolic blood pressure (SeDBP) remained ≥ 90 mm Hg (1 mm Hg = 0.133 kPa) were randomly divided into benazepril 10 mg/amlodipine 5 mg (BZ10/AML5) fixed-dose combination therapy group (once a day, n = 113), and benazepril monotherapy group (daily 20 mg, n = 107). In the two groups the patients with SeDBP ≥ 90 mm Hg were doubled the dosage of the initial regimen at the end of 4-week treatment for additional 4 weeks, and the patients with SeDBP < 90 mm Hg remained the initial regimen for additional 4 weeks. The primary endpoint was to evaluate the improvement of SeDBP at the end of 8-week treatment. There were 74 patients (the combination therapy group n = 38, monotherapy therapy group n = 36) completed the 24 h ambulatory blood pressure monitoring which was included in the final efficacy analysis., Results: The randomized, double-blind treatment for 8 weeks, the mean value of SeDBP reduction, the reaching target blood pressure rate and total successful response rate to the treatment (a SeDBP < 90 mm Hg or a decrease of 10 mm Hg or more from baseline) were (11.7 ± 6.8) mm Hg, 65.7% and 88.5% in the combination therapy group, respectively, and were (7.7 ± 6.9) mm Hg, 35.5% and 65.5% in the monotherapy group, respectively. There were statistically significant difference between the combination therapy and the monotherapy groups in all the 3 indexs (P < 0.001). The fixed combination significantly reduced systolic blood pressure (SBP) and diastolic blood pressure (DBP) values throughout the 24 h. The trough to peak ratios of DBP/SBP in the fixed compound of benazepril/amlodipine (10 mg/5 mg) and benazepril (20 mg) alone were 83.1%/76.0% and 85.8%/79.5%, respectively. Adverse events rates were 16.8% in the combination therapy group and 35.5% in the monotherapy group (P < 0.001)., Conclusions: The combination therapy with benazepril/amlodipine was superior to benazepril monotherapy and was well tolerated in patients with essential hypertension and allowing a satisfactory BP control for 24 hours.

Objective: This study was designed to evaluate reperfusion therapy, co-administered with high dose glucose-insulin-potassium (GIK) treatment on serum soluble Fas/APO-1 (sFas) and Fas ligand (sFasL) concentration in Acute Myocardial Infarction (AMI) patients., Methods: Seventy-four patients with AMI underwent reperfusion therapy were randomized into GIK group (n = 35) receiving high-dose GIK for 24 hours or a vehicle group (n = 39). Thirty-four control subjects (NC) were also enrolled in the present study. Strepavidin-biotin ELISA was used to determine the serum sFas and sFasL concentration at baseline and different time point (24 h, 3 d, 7 d and 14 d) after reperfusion., Results: (1) The serum concentration of sFas and sFas-L ([sFas] and [sFas-L]) of AMI patients were significantly elevated at baseline as compared with NC (P < 0.01). (2) The [sFas] in GIK and non-GIK group decreased 24 h after reperfusion (P < 0.01 vs. baseline) and then increased during 3-7 d period (P < 0.01 vs. 24 h). (3) The GIK group demonstrated reduced [sFas] at 14 d (P < 0.01 vs. 7 d), with no concomitant changes in the non-GIK group. (4) The [sFasL] in the GIK and non-GIK group were no significant difference during 3-14 d period. CONCLUSION Owing to cardioprotective effects reported here and by others, a high-dose GIK infusion co-administered with the timely establishment of perfusion should be strongly considered as a treatment of choice for AMI.