AIM:To analyze the reasons for screening failure and explore the influencing fac-tors in clinical trial in healthy volunteers,guidance was provided to improve the success rate of screen-ing in the future.clarify the reasons for the failure in healthy subjects(HS)screening,and to provide guidance for screening in phase Ⅰ clinical trials.METHODS:We performed a retrospective study that described the process of HS screening in phase Ⅰ clinical trials carried out in department of clinical pharmacology lab,Nanjing First Hospital be-tween 2019 and 2022.We analyzed the reasons for screening failure and their impact on the failure rate.A retrospective analysis was conducted on the data of subjects who participated in drug clinical trial screening 2019 to 2022.The reasons for screening failure were analyzed,and statistical methods were used to explore the independent factors that led to screening failure.RESULTS:A to-tal of 11 clinical trials were included in this study,and 502 out of 1 582 participants(31.7％)passed the screening.The analysis of the remaining 1 080 subjects showed that the items that did not pass the screening were laboratory examinations(631 cases,58.4％),abnormal vital signs results(228 cas-es,21.1％),intolerance to blood drawn(86 cases,8.0％),sufficient subjects(62 cases,5.7％),with-drawal at the screening(54 cases,5.0％),demogra-phy(54 cases,5.0％),urinary cotinine examination(42 cases,3.9％),imaging examination(31 cases,2.9％),electrocardiogram(24 cases,2.2％),inquiry(medical inquiry 19 cases,1.8％,smoking inquiry 2 cases,0.2％,alcohol inquiry 2 cases,0.2％)and identity verification(17 cases,1.8％).In the popula-tion with a body mass index(BMI)of 19.0 to 26.0,an increase in BMI is an independent factor signifi-cantly associated with screening failure(P＜0.000 1,OR=0.890 4,95％CI 0.841 9-0.941 3).The impact of different examination items on the screening fail-ure rate varies.CONCLUSION:In clinical trials of healthy subjects,laboratory tests,vital signs and in-tolerance to blood drawn are the main reasons for screening failure.Lowering the upper limit of BMI when recruiting subjects may increase the success rate of screening.Laboratory examinations,vital signs,intolerance to blood drawn are the most im-portant three reasons for screening failure,and im-provements can be made to reduce the screening failure rate of phase Ⅰ clinical trials in response to the main screening failure reasons.

AIM:To analyze the reasons for screening failure and explore the influencing fac-tors in clinical trial in healthy volunteers,guidance was provided to improve the success rate of screen-ing in the future.clarify the reasons for the failure in healthy subjects(HS)screening,and to provide guidance for screening in phase Ⅰ clinical trials.METHODS:We performed a retrospective study that described the process of HS screening in phase Ⅰ clinical trials carried out in department of clinical pharmacology lab,Nanjing First Hospital be-tween 2019 and 2022.We analyzed the reasons for screening failure and their impact on the failure rate.A retrospective analysis was conducted on the data of subjects who participated in drug clinical trial screening 2019 to 2022.The reasons for screening failure were analyzed,and statistical methods were used to explore the independent factors that led to screening failure.RESULTS:A to-tal of 11 clinical trials were included in this study,and 502 out of 1 582 participants(31.7％)passed the screening.The analysis of the remaining 1 080 subjects showed that the items that did not pass the screening were laboratory examinations(631 cases,58.4％),abnormal vital signs results(228 cas-es,21.1％),intolerance to blood drawn(86 cases,8.0％),sufficient subjects(62 cases,5.7％),with-drawal at the screening(54 cases,5.0％),demogra-phy(54 cases,5.0％),urinary cotinine examination(42 cases,3.9％),imaging examination(31 cases,2.9％),electrocardiogram(24 cases,2.2％),inquiry(medical inquiry 19 cases,1.8％,smoking inquiry 2 cases,0.2％,alcohol inquiry 2 cases,0.2％)and identity verification(17 cases,1.8％).In the popula-tion with a body mass index(BMI)of 19.0 to 26.0,an increase in BMI is an independent factor signifi-cantly associated with screening failure(P＜0.000 1,OR=0.890 4,95％CI 0.841 9-0.941 3).The impact of different examination items on the screening fail-ure rate varies.CONCLUSION:In clinical trials of healthy subjects,laboratory tests,vital signs and in-tolerance to blood drawn are the main reasons for screening failure.Lowering the upper limit of BMI when recruiting subjects may increase the success rate of screening.Laboratory examinations,vital signs,intolerance to blood drawn are the most im-portant three reasons for screening failure,and im-provements can be made to reduce the screening failure rate of phase Ⅰ clinical trials in response to the main screening failure reasons.

Objective:To summarize the best evidence for the management of fatigue-related symptom clusters in HIV/AIDS patients.Methods:According to the "6S" model, clinical decisions, guidelines, expert consensus, systematic reviews, Meta-analysis, evidence summary, and randomized controlled trials on the management of fatigue-related symptom clusters of HIV/AIDS patients were searched from top to bottom in BMJ Best Practice, UpToDate, Joanna Briggs Institute Evidence-Based Health Care Center Database, Agency for Healthcare Research and Quality, National Institute for Health and Clinical Excellence, Medlive, Joint United Nations Programme on HIV/AIDS, Cochrane Library, PubMed, Embase, China National Knowledge Infrastructure, WanFang data, China Biology Medicine disc and other databases and websites. The search period was from January 1, 2017, to July 30, 2023. Two researchers independently used corresponding quality evaluation tools to evaluate the methodological quality of the included literature. They extracted and summarized the best evidence for the management of fatigue-related symptom clusters in HIV/AIDS patients.Results:A total of 20 articles were included, including seven clinical decisions, three guidelines, two evidence summaries, one expert consensus, three systematic reviews, and four randomized controlled trials. Thirty-four pieces of evidence were summarized from four aspects: fatigue management, frailty management, sexual dysfunction management, and sleep disorder management.Conclusions:This study summarizes the best evidence for the management of fatigue-related symptom clusters in HIV/AIDS patients. Medical and nursing staff must select and apply the evidence in a targeted manner based on clinical situations.

Objective:To investigate knowledge, attitude and practice intention of medical students on advance care planning (ACP) and to analyze the relevant influencing factors.Methods:This study was a cross-sectional study. From April to May 2019, the convenience sampling method was used to select medical students who were interning in 3 medical schools and affiliated hospitals in Guangdong Province as the research objects. General information questionnaire and self-designed ACP Knowledge, Attitude and Practice Intention Questionnaires were uesd to investigate. Multiple linear regression analysis was used to influencing factors. A total of 276 questionnaires were recovered in this survey, of which 274 were valid, the effective response rate was 99.3%.Results:The average accuracy rate of the ACP Knowledge Questionnaire for medical students was 48.75%. The average score of items of the ACP Attitude Questionnaire was (4.00±0.53) . The average score of items of the ACP Practice Intention Questionnaire for medical students was (3.94±0.59) . The results of multiple linear regression analysis showed that the attitude toward the major they studied, whether they had the part-time social experience, whether they heard of ACP and whether they received ACP training or courses were influencing factors of ACP knowledge for medical students ( P<0.05) . Whether they had clinical practice and whether they had the treatment experience of patients' death were the influencing factors of ACP attitude of medical students ( P<0.05) . Attitudes towards the major they learned and whether they had any experience in the treatment of patients' death were the influencing factors of ACP practice intention of medical students ( P<0.05) . Conclusions:Medical students have a certain acceptance of ACP, but the awareness rate of ACP is generally low. Consideration should be given to improving the relevant education methods and content to prepare for the role adaptation of medical students in future clinical work, improving the humanistic care literacy of medical students and promotion of ACP in the clinical practice.

Objective:To test whether the constructed intervention model of advance care planning (ACP) for patients with advanced cancer can be successfully implemented and the preliminary intervention effect, which provides reference for empirical research.Methods:32 cases of advanced cancer patients and 25 cases of their families at the Fifth Affiliated Hospital of Zunyi Medical University, Zhuhai were selected. The patients were subdivided into the experimental group and the control group by random number table method. The control group received routine nursing, while the experimental group adopted the intervention model of "VIP for future care" on the basis of customary nursing. We measured the main outcome indicators: enrollment rate, consent rate, completion rate and loss of follow-up rate and secondary outcome indicators: decision-making certainty, end-of-life care preference and post-intervention satisfaction of patients and their families, within 1 week and 1 month after intervention.Results:The enrollment rate, consent rate and loss of follow-up rate were 74.6% (206/276), 36.9% (76/151)and 15.6% (5/32), respectively. After intervention, the completion rates of the experimental group and the control group were 16/16 and 15/16 within one week, and 14/16 and 13/16 within one month. All of the family members were conducted during the follow-up period. The intervention mode of "VIP for future care" had a statistically significant difference in decision-making certainty between the two groups of patients ( β=0.63, 95% CI 0.08-1.18, P<0.05), no statistically significant difference in end-of-life care preference between the two groups of patients and their families ( P>0.05), and had a statistically significant difference in "whether to recommend this project to others" between the two groups ( χ2 value was 4.167 , P<0.05). Conclusions:On the premise of sufficient preparation, the "VIP for future care" intervention mode can be successfully implemented in advanced cancer patients in mainland China, can improve the decision-making certainty of patients and the satisfaction of patients and their families, and it is recommended. And should be applied to ACP intervention for patients with advanced cancer.

Objective To study the influence of serum containing Fuzheng Toudu Qudu Recipe, a Chinese formula with the actions of supporting healthy qi to expel and remove toxicity, on serum levels of interleukin 2 (IL-2) and soluble interleukin 2 receptor (sIL-2R) at different stages of CD34+derived dendritic cells (DC) of patients with minimal residual disease of myelogenous leukemia ( MRD-L) , and to explore the biological mechanism of Fuzheng Toudu Qudu Recipe in promoting CD34+ to transform into DC in MRD-L patients. Methods Bone marrow mononuclear cells ( BMMC) were separated from the bone marrow of acute myeloid leukemia patients at complete remission stage by using Ficoll centrifugation. CD34+ cells were isolated by using immuno-magnetic mircobeads method, and then were cultured with various concentrations of Chinese medicine medicated serum and cytokines in vitro for the induction of DC. The morphologic characteristics of DC were observed with the inverted phase contrast microscope, and the expression levels of DC surface molecules such as CD83, CD80, CD86, CD1a and HLA-DR were detected by using flow cytometry. On culturing day 0, 6 and 9, serum levels of IL-2 and sIL-2R of each group were measured by enzyme-linked immunosorbent assay ( ELISA). Results ( 1) Chinese medicine medicated serum combined with cytokines was effective on promoting CD34+ to differentiate into DC with typical morphology, and inducing DC to have high expression of CD80, CD83, CD86 and HLA-DR, which differed from those in fetal calf serum (FCS) group and blank rabbit serum group (P<0.01). Middle- and low-dose combination groups increased expression of CD1a, which differed from high-dose combination group and cytokines group ( P<0.01). ( 2) Content of IL-2 in combination groups was higher than that in blank rabbit serum group on culturing day 0. In the combination groups, IL-2 was higher on culturing day 6 and 9 than that on culturing day 0. Middle and high-dose combination groups had higher IL-2 content on culturing day 9 than on culturing day 6 ( P<0.05 or P<0.01). At the same time point, combination groups had higher IL-2 content than the blank rabbit serum group (P<0.05 or P<0.01). (3) Content of sIL-2R in the combination groups was lower than that in blank rabbit serum group on culturing day 0. In the combination groups, sIL-2R was lower on culturing day 9 than that on culturing day 0 and 6 ( P<0.01) . High-dose combination group had lower sIL-2R content on culturing day 6 than that on culturing day 0 (P<0.05), and the difference of sIL-2R in other groups was insignicant between on culturing day 6 and on culturing day 0 ( P>0.05) . At the same time point, combination groups had lower IL-2 content than the blank rabbit serum group (P<0.05 or P<0.01). Conclusion Fuzheng Toudu Qudu Recipe is effective on increasing serum content of IL-2 and reducing sIL-2R content, and the changes of cytokine contents are more obvious along with the maturity of DC, which indicates that the recipe plays positive effect in the process of promoting CD34+cells to differentiate into DC.