Objective To analyze the reasons for the failure of subject screening in clinical trials of antineoplastic drugs and the impact of natriuretic criteria on the entry of subjects into clinical trials,to explore the strategies to improve the suc-cessful enrolment of screened subjects,and to provide reference bases for research institutes and sponsors in the formulation of na-triuretic criteria.Methods This study selected data from 40 drug clinical trials conducted at the Drug Clinical Trial Research Center of the Cancer Hospital of the Chinese Academy of Medical Sciences from January 1,2016,to June 30,2022.It statistically described the collected data on the frequency and percentage composition of screening failures among participants and the inclu-sion and exclusion criteria in the protocols.Results A total of 425 subjects were screened out of 40 clinical trial programmers covering 8 tumor types,with the majority being＜65 years of age(333,78.4％),of which the most important reasons included vol-untary withdrawal(71,16.7％),tumor metastasis(52,12.2％),failure to recover from treatment of pre-existing disease(38,8.9％),failure of bone marrow function(19,4.5％),and non-compliant liver function(15,3.5％).Among the nadir indicators,the age of the subjects(100％),ECOG score(97.5％),bone marrow function(ANC:95.0％,PLT:97.5％,HB:97.5％),liver function(T-BiL:95.0％,ALT:87.5％,AST:95.0％),renal function(CR:80.0％),and viral screening(HIV:80.0％,HBV:70.0％,HCV:62.5％)were relatively stringent.Conclusion The main reasons for subject screening failure in clinical trials in oncology in our hospital are voluntary withdrawal,brain metastasis,and failure of their biochemical test standards,which are close-ly related to the setting of clinical trial nadir criteria.Therefore,an in-depth understanding of subjects'characteristics,accurate set-ting of appropriate nadir criteria,continuous improvement of trial design,and strengthening of communication with subjects to pro-vide more relevant information will help to improve the screening success rate of clinical trials.

Objective To analyze the reasons for the failure of subject screening in clinical trials of antineoplastic drugs and the impact of natriuretic criteria on the entry of subjects into clinical trials,to explore the strategies to improve the suc-cessful enrolment of screened subjects,and to provide reference bases for research institutes and sponsors in the formulation of na-triuretic criteria.Methods This study selected data from 40 drug clinical trials conducted at the Drug Clinical Trial Research Center of the Cancer Hospital of the Chinese Academy of Medical Sciences from January 1,2016,to June 30,2022.It statistically described the collected data on the frequency and percentage composition of screening failures among participants and the inclu-sion and exclusion criteria in the protocols.Results A total of 425 subjects were screened out of 40 clinical trial programmers covering 8 tumor types,with the majority being＜65 years of age(333,78.4％),of which the most important reasons included vol-untary withdrawal(71,16.7％),tumor metastasis(52,12.2％),failure to recover from treatment of pre-existing disease(38,8.9％),failure of bone marrow function(19,4.5％),and non-compliant liver function(15,3.5％).Among the nadir indicators,the age of the subjects(100％),ECOG score(97.5％),bone marrow function(ANC:95.0％,PLT:97.5％,HB:97.5％),liver function(T-BiL:95.0％,ALT:87.5％,AST:95.0％),renal function(CR:80.0％),and viral screening(HIV:80.0％,HBV:70.0％,HCV:62.5％)were relatively stringent.Conclusion The main reasons for subject screening failure in clinical trials in oncology in our hospital are voluntary withdrawal,brain metastasis,and failure of their biochemical test standards,which are close-ly related to the setting of clinical trial nadir criteria.Therefore,an in-depth understanding of subjects'characteristics,accurate set-ting of appropriate nadir criteria,continuous improvement of trial design,and strengthening of communication with subjects to pro-vide more relevant information will help to improve the screening success rate of clinical trials.

In recent years, the potential hepatotoxicity of green tea extract (GTE) has attracted more and more attention. With reference to the current studies on liver injury caused by GTE and the latest drug hepatotoxicity classification, this article systematically elaborates on the objectivity and causal mechanisms of liver injury caused by GTE. Based on the main risk factors for liver injury caused by GTE, this article also proposes recommendations for safe and rational use of such products, so as to provide valuable insights for in-depth research on the mechanism of liver injury caused by GTE and risk prevention and control, and meanwhile, it also provides an important reference for the therapeutic use of GTE to improve health conditions.

Objective:To re-evaluate the systematic reviews of the effectiveness of virtual reality technology in pain management in children.Methods:Using computers to search for systematic reviews of the effectiveness of virtual reality technology in pain management for pediatric patients in China National Knowledge Infrastructure (CNKI), Wanfang Database, VIP, China Biology Medicine disc, Cochrane Library, PubMed, Embase, CINAHL and Web of Science. The retrieval period was from the establishment of the databases to November 4, 2022. Literature screening and data extraction were conducted independently by two researchers, methodological quality evaluation was performed for the included studies using the A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR 2) checklist, and the evidence quality rating was evaluated using Grades of Recommendations Assessment, Development and Evaluation (GRADE) system.Results:A total of 14 systematic reviews were included. AMSTAR 2 evaluation results showed that the methodological quality of 2 systematic reviews was low, and 12 were extremely low. GRADE was used to evaluate the quality of evidence of the outcome indicators, and the results showed that among the 26 outcome indicators included, 23.08% (6/26) were medium evidence, 76.92% (20/26) were low evidence, and the quality of no evidence was high.Conclusions:There is a lack of high-quality evidence to support the conclusion that virtual reality technology can relieve pain in children. The methodological quality and evidence quality of systematic reviews are low, and more standardized and rigorous studies need to be carried out in the future to further verify the application effect of virtual reality technology in pain management of children.

Objective To assess the efficacy of different internal fixations of palatal fracture.Methods Seventy-four patients with palatal fracture admitted between October 2007 and October 2013 were reviewed retrospectively.Through out-patient follow-up,postoperative occlusion and palatal complications were examined and fracture healing was evaluated using CT scan.Results Palatal type Ⅰ-Vfractures involved in 8 patients (11％),14 patients (19％),26 (35％),12 patients (16％),6 patients (8％),and 8 patients (11％) respectively.Forty-three patients were available to follow-up,including 31 patients with good or acceptable occlusion.All wounds healed without palate associated infections,plate exposure or oronasal fistula.Of the 27 patients classified as type Ⅱ,Ⅲ and V sagittal palatal fractures,both nasomaxillary and zygomatico-maxillary struts fixation (n =17) and isolated zygomatico-maxillary struts fixation (n =10) had insignificant differences in success rate as to occlusion assessment (82％ vs 80％,P ＞0.05).Whereas compared with isolated vertical buttress fixation (n =15),additional immobilization of horizontal alveolar buttresses (n =12) had significantly higher success rate (100％ vs 67％,P ＜ 0.05).Conclusion Complete rigid fixation at early stage,including vertical buttress fixation,in particular the zygomatico-maxillary struts,and horizontal alveolar buttress fixation can achieve satisfactory outcome.