Objective To quantify the expressions of tumor necrosis factor-α (TNF-α),caspase-8 and caspase-3 in lichen planus (LP) lesions,and to investigate their significance.Methods Skin samples were collected from the lesions of 20 patients with LP and normal skin of 20 healthy human controls.Immunohistochemistry was used to determine the expressions of TNF-αt,caspase-8 and caspase-3,and terminal deoxynucleotidyl transferase-mediated dUTP-biotin nick end-labeling (TUNEL) technique to evaluate the apoptosis in keratinocytes,in these samples.Results The expression levels (expressed in integrated optical density,IOD)of TNF-α,caspase-8 and caspase-3 were (12.58 ± 2.33) × 103,(11.69 ± 3.52) × 103 and (11.45 ± 2.82) × 103 respectively in LP lesions,significantly higher than those in the normal skin ((5.12 ± 1.78) × 103,(3.87 ± 3.36)× 103,(4.76 ± 1.93) × 103,t =11.38,7.19,8.76,respectively,all P ＜ 0.01).Elevated apoptosis index was noted in keratinocytes from LP lesions compared with those from normal skin (71.35 ± 7.93 vs.33.62 ± 8.75,t =14.29,P ＜ 0.01).In LP lesions,the expressions of both TNF-α and caspase-8 were positively correlated with the apoptosis index of keratinocytes (r =0.72,0.75,respectively,both P ＜ 0.01) and the expression of caspase-3 (r =0.68,0.73,respectively,both P ＜ 0.01).Conclusion The up-regulated expressions of TNF-α,caspase-8 and caspase-3 may participate in the apoptosis in keratinocytes in LP.

【Objective:】 To sort out the influencing factors of drug clinical trial risks and improve the risk management level of drug clinical trials in China. 【Methods:】 The literature analysis method was used to sort out the literature related to the risk management of drug clinical trials in China, and the text analysis method was used to summarize and refine the influencing factors of drug clinical trial risks. 【Results:】 The risk categories of drug clinical trials were divided into 5 parts, namely drug clinical trial institution management, ethics committee management, clinical trial designs, researchers, and subjects, involving 13 main risk influencing factors and 21 specific risk points. 【Conclusion:】 By strengthening the construction of drug clinical trial institutions and ethical management capabilities, optimizing research protocol design, enhancing researchers’ awareness and ability, and establishing a subject management system to improve the quality of drug clinical trials.

Risk assessment of clinical trials is of great significance to improve the quality of clinical trials. Through systematic comparative analysis of risk assessment tools for clinical trials in Britain, Germany and France, this paper found that the three countries’ risk assessment tools were consistent in terms of legal system guarantee and assessment process, but there were obvious differences in the basic risk classification and risk grading standards of clinical trials. Based on the experience of Britain, France and Germany, this paper proposed to improve the relevant regulations and documents of clinical trial risk management in China from the perspective of Chinese national conditions, further explore the factors affecting clinical trial risk, and develop and design clinical trial risk assessment tools with different discipline characteristics according to the specialties of the discipline to improve the quality and level of clinical trials.

Objective    To explore the predictive value of a simplified signs scoring system for the severity and prognosis of patients with coronavirus disease 2019 (COVID-19). Methods     Clinical data of 1 605 confirmed patients with COVID-19 from January to May 2020 in 45 hospitals of Sichuan and Hubei Provinces were retrospectively analyzed. The patients were divided into a mild group (n=1 150, 508 males, average age of 51.32±16.26 years) and a severe group (n=455, 248 males, average age of 57.63±16.16 years). Results    Age, male proportion, respiratory rate, systolic blood pressure and mean arterial pressure in the severe group were higher than those in the mild group (P<0.05). Peripheral oxygen saturation (SpO2) and Glasgow coma scale (GCS) were lower than those in the mild group (P<0.05). Multivariate logistic regression analysis showed that age, respiratory rate, SpO2, and GCS were independent risk factors for severe patients with COVID-19. Based on the above indicators, the receiver operating characteristic (ROC) curve analysis showed that the area under the curve of the simplified signs scoring system for predicting severe patients was 0.822, which was higher than that of the quick sequential organ failure assessment (qSOFA) score and modified early warning score (MEWS, 0.629 and 0.631, P<0.001). The ROC analysis showed that the area under the curve of the simplified signs scoring system for predicting death was 0.796, higher than that of qSOFA score and MEWS score (0.710 and 0.706, P<0.001). Conclusion    Age, respiratory rate, SpO2 and GCS are independent risk factors for severe patients with COVID-19. The simplified signs scoring system based on these four indicators may be used to predict patient's risk of severe illness or early death.