Phase Ⅰ clinical trials play a crucial role in the research and development of new drugs, serving as the initial studies to assess their safety, tolerability, effectiveness, and pharmacokinetic properties in humans. These trials involve uncertainties regarding safety and efficacy. Comprehensive management of all aspects of phase Ⅰ clinical trials for anti-tumor drugs is crucial to protect the rights and safety of participants. This article provides an in-depth analysis of the key points and precautions necessary for effective quality control throughout the process. The analysis is informed by guidelines such as the “Good Clinical Practice for Drugs” “Key Points and Judgment Principles for Drug Registration Verification” “Key Points and Judgment Principles for Supervision and Inspection of Drug Clinical Trial Institutions” and the standard operating procedures for quality control of the center. Topics discussed include informed consent, inclusion criteria, experimental drugs, biological samples, adverse events, and serious adverse events. The goal is to standardize quality control in phase Ⅰ clinical trials of anti-tumor drugs, ensure the authenticity and reliability of clinical trial data, and protect the rights and safety of participants.

Objective To investigate the safety, economic benefits and psychological effects of day breast conserving surgery for breast cancer. Methods The demographic data and clinical data of breast cancer patients undergoing day (day surgery group) and ward (ward surgery group) breast conserving surgeries in West China Hospital of Sichuan University from March 2020 to June 2021 were retrospectively collected; the demographic data, clinical data, medical and related transportation costs, and preoperative and postoperative BREAST-Q scores of breast cancer patients undergoing day (day surgery group) and ward (ward surgery group) breast conserving surgery in West China Hospital of Sichuan University from June 2021 to June 2022 were prospectively collected. The safety, economic benefit, and psychological satisfaction of day surgery was analyzed. Results A total of 42 women with breast cancer were included in the retrospective study and 39 women with breast cancer were included in the prospective study. In both prospective and retrospective studies, the mean age of patients in both groups were <50 years. There were only statistical differences between the two groups in the aspects of hypertension (P=0.022), neoadjuvant chemotherapy (P=0.037) and postoperative pathological estrogen receptor (P=0.033) in the prospective study. In postoperative complications, there were no statistical differences in the surgical-related complications or anesthesia-related complications between the two groups in either the prospective study or the retrospective study (P>0.05). In terms of the overall cost, we found that the day surgery group was more economical than the ward surgery group in the prospective study (P=0.002). There were no statistical differences in postoperative psychosocical well-being, sexual well-being, satisfaction with breasts or chest condition between the two groups (P>0.05). Conclusion It is safe and reliable to carry out breast conserving surgery in day surgery center under strict management standards, which can save medical costs and will not cause great psychological burden to patients.

OBJECTIVE To enhance the training quality of anticoagulation specialty clinical pharmacists， address the resource limitations of a single training base， and promote homogenization of training quality. METHODS A multi-base joint training system for anticoagulation specialty clinical pharmacists in the Beijing area was established. A mixed research method was employed， collecting data through performance comparisons， questionnaires， and qualitative interviews to compare the differences between the joint training model （experimental group， n＝16） and traditional teaching model （the control group， n＝17）. RESULTS The established joint training system encompassed a unified joint training teaching plan， the formation of a joint training teaching team， the establishment of joint theoretical teaching courses， the implementation of joint case discussions and literature presentations， as well as strengthening the assessment throughout the joint training process. Compared to the control group [theoretical assessment of （76.44±3.66） points， case assessment of （84.31±3.27） points]， the experimental group students achieved higher scores in theoretical assessment （[ 79.85±4.64） points] and case assessment （[ 88.70±5.51） points] （P＜0.05）. Through questionnaires and qualitative interviews， the trainees in experimental group were highly satisfied with the joint training model in terms of theoretical learning， communication skills， and teaching interaction. CONCLUSIONS The multi-base collaborative training system for anticoagulation specialty clinical pharmacists can integrate advantageous resources and significantly enhance the training effectiveness of anticoagulation specialty clinical pharmacists， offering value for wider promotion.

Objective:To investigate the effect of oral immunotherapy with donor human milk on feeding tolerance in premature infants with very low birth weight.Methods:A total of 94 extremely low birth weight preterm infants admitted to the neonatal Intensive Care Unit of Cangzhou People's Hospital from August 2022 to February 2024 were selected, These infants were randomized at 1:1 into 2 groups (47 cases each) using random number method. The control group were given oral 0.9% sodium chloride (oral drip), while the experimental group were given donor human milk (oral drip). General information were collected, including gender, delivery method, twins or not, small for gestational age or not, birth weight, gestational age, intestinal feeding of dairy products, and so on. Total intestinal feeding time, length of hospital stay and feeding intolerance were compared between groups.Results:The total intestinal feeding time and length of hospital stay were significantly shorter in the experimental group compared with the control group ( P<0.05). The incidence of feeding intolerance in the experimental group was also lower than that in the control group ( P<0.05). Conclusion:Oral immunotherapy with donor human milk can improve the feeding tolerance in premature infants with very low birth weight and shorten the hospital stay.

Objective:To gain a deep understanding of the supportive care needs of families of children with retinoblastoma (RB) through qualitative research.Methods:From March to May 2022, a semi-structured interview was conducted using purposive sampling to select the family members of 15 RB children in the Department of Eye Tumor of Beijing Tongren Hospital affiliated to Capital Medical University. Colaizzi 7-step analysis method was used to refine, extract, and analyze interview data.Results:The supportive care needs of the families of RB children were summarized into three themes and six sub-themes, namely, psychological needs (emotional listening and psychological support), knowledge needs (disease knowledge needs, children's post discharge guidance, internet resource needs), and economic needs (social resource integration) .Conclusions:RB, as a malignant eye tumor, often brings a heavy burden to families. Family members of children generally experience negative emotions such as anxiety and depression, as well as a lack of knowledge. The economic burden on families is heavy, and there is a high demand for supportive care. The supportive care program for families of RB children is not yet perfect, and nurses should provide emotional support and professional assistance to the families, providing help and guidance in psychological counseling, knowledge needs, economic assistance, and other aspects.

Objective To explore the interactive effect of vitamin D and triglyceride(TG)/high-density lipoprotein cholesterol(HDL-C)on the time to achieve glycemic control in hospitalized patients with type 2 diabetes mellitus(T2DM).Methods A retrospective cohort study was conducted on 82 T2DM patients admitted to Henan Hongli Hospital from March 2021 to December 2023.Patients were categorized into two groups based on the time it took for their blood glucose to reach target levels during their hospitalization:the≤7 d group and the>7 d group.The baseline data,vitamin D levels,and TG/HDL-C ratios of both groups were compared.The relationship between vitamin D,TG/HDL-C levels,and the time it took for blood glucose to reach target levels was analyzed.Further-more,the TG/HDL-C levels of patients with varying vitamin D levels were compared,and the relative risk(RR)and receiver operating characteristic(ROC)curve were used to analyze the interactive effect and predictive value of vitamin D and TG/HDL-C levels on the time it took for hospitalized T2DM patients to achieve target blood glucose levels.Results The hospitalization duration of the group with a duration of>7 days was longer than that of the group with a duration of≤7 days.The fasting blood glucose,glycosylated hemoglobin,and TG/HDL-c levels were higher in the former group,while the vitamin D level was lower.The proportion of patients with vitamin D deficiency and severe deficiency was higher in the former group compared to the latter group(P<0.05).Pearson correlation analysis revealed that vitamin D level was negatively correlated with the time to achieve glycemic control(r=-0.733,P<0.001),while TG/HDL-C level was positively correlated with the time to achieve glycemic control(r=0.830,P<0.001).After adjustment,logistic regression analysis indicated that vitamin D(95%CI:0.482～0.694)and TG/HDL-C level(95%CI:1.053～1.392)remained independent factors influencing the time to achieve glycemic control in hospitalized T2DM patients(P<0.05).Patients with insufficient,deficient,and severely defi-cient vitamin D had higher TG/HDL-C levels compared to those with sufficient vitamin D(P<0.05).The relative risk(RR)of patients with vitamin D deficiency and elevated TG/HDL-C coexisting resulting in a hospitalization duration of>7 days for T2DM patients was 15.867,indicating a synergistic effect.The area under the receiver operating characteristic(AUC)curve for predicting the time to achieve glycemic control in hospitalized T2DM patients using a combination of vitamin D and TG/HDL-C was 0.929,which was greater than that of vitamin D and TG/HDL-C alone(Z=3.849,3.526,P<0.05).Conclusion The vitamin D and TG/HDL-C levels in hospitalized T2DM patients are closely related to the time of reaching glycemic targets.The simultaneous exposure of both factors can affect the time of achieving glycemic targets,and the combined prediction of vitamin D and TG/HDL-C has good reference value for predicting the time of achieving glycemic targets in hospitalized T2DM patients.

Objective To investigate the predictive value of preoperative blood inflammatory markers for the recurrence risk in patients with basal cell carcinoma(BCC).Methods A total of 225 patients with BCC were divided into the high-risk recurrence group(155 cases)and the low-risk recurrence group(70 cases).General information and preoperative hematological indicators were collected in the two groups of patients.The neutrophil-to-lymphocyte ratio(NLR),lymphocyte-to-monocyte ratio(LMR),systemic inflammation marker(SIM)and platelet-to-lymphocyte ratio(PLR)were calculated.Receiver operating characteristic(ROC)curves were used to determine the predictive value of hematological markers with statistically significant differences between the two groups for BCC recurrence and to establish optimal cutoff values.Univariate and multivariate Logistic regression analyses were conducted to identify factors influencing BCC recurrence.A multivariate Logistic regression model was established to predict the recurrence risk of BCC.Area under the curve(AUC)and the Hosmer-Lemeshow test were used to evaluate the prediction efficiency and goodness-of-fit of the model.Results ROC analysis identified that optimal cutoff values for LMR and SIM were 5.12 and 0.86,respectively.Univariate Logistic regression analysis showed that LMR,SIM,ulceration at the primary tumor site,UV exposure and tumor maximum diameter were factors influencing BCC recurrence.Multivariate Logistic regression revealed that SIM≥0.86,tumor maximum diameter≥2.0 cm and UV exposure were risk factors for BCC recurrence,while LMR≥5.12 had a protective effect.The Logistic prediction model for BCC recurrence risk was Logit(P)=-1.598-1.517×LMR+1.323×SIM+2.406×UV exposure+3.465×tumor maximum diameter,with good model fit(P=0.725)and an AUC of 0.869(95%CI:0.822-0.917)for predicting BCC recurrence risk.Conclusion Monitoring preoperative LMR and SIM levels can assist in assessing the risk of recurrence in BCC patients and provide important guidance for clinical decision-making.

Purpose/Significance To analyze the multidimensional interaction between the characteristics of traditional Chinese and western medicine in patients with type 2 diabetes mellitus and its influence on traditional Chinese medicine(TCM)syndrome differentia-tion.Method/Process Based on the real-world electronic medical record(EMR)data,the traditional association rule algorithm is im-proved,and the important TCM syndromes are screened out as dependent variables by increasing the respect index,and the logistic regres-sion algorithm is used to explore the influence of traditional Chinese and western medicine indexes on TCM syndromes.Result/Conclusion Based on 688 patients,112 association rules are obtained,of which 12 includes TCM syndromes.The respect of association rules between middle-earth stagnation syndrome and overweight/obesity is the highest,moreover,overweight/obesity patients have a higher prevalence rate of middle-earth stagnation syndrome.There is a strong correlation between middle-earth stagnation syndrome,peripheral neuropathy or hypertension and overweight/obesity.Patients with diabetic nephropathy are more likely to have qi and yin deficiency syndrome.

Fibromyalgia syndrome （FMS） is a refractory， chronic non-articular rheumatic disease characterized by widespread pain throughout the body， for which there are no satisfactory therapeutic drugs or options. There are rich Chinese medical therapies， and some non-drug therapies， such as acupuncture， Tai Chi， and Ba-Duan-Jin， have shown satisfactory efficacy and safety and definite advantages of simultaneously adjusting mind and body. FMS is taken as a disease responding specifically to traditional Chinese medicine （TCM） by the National Administration of Traditional Chinese Medicine in 2018. In order to clarify the research progress in FMS and the clinical advantages of TCM/integrated Chinese and Western medicine， the China Academy of Chinese Medicine organized a seminar for nearly 20 experts in Chinese and Western medicine， including rheumatology， psychology， acupuncture and moxibustion， and encephalopathy， with the topic of difficulties in clinical diagnosis and treatment of FMS and advantages of TCM and Western medicine. The recommendations were reached on the difficulties in early diagnosis and solutions of FMS， mitigation of common non-specific symptoms， preferential analgesic therapy， TCM pathogenesis and treatment advantages， and direction of treatment with integrated Chinese and Western medicine. FMS is currently facing the triple dilemma of low early correct diagnosis， poor patient participation， and unsatisfactory benefit from pure Western medicine treatment. To solve the above problems， this paper suggests that rheumatologists should serve as the main diagnostic force of this disease， and they should improve patient participation in treatment decision-making， implement exercise therapy， and fully utilize the holistic and multidimensional features of TCM， which is effective in alleviating pain， improving mood， and decreasing adverse events. In addition， it is suggested that FMS treatment should rely on both TCM and Western medicine and adopt multidisciplinary joint treatment， which is expected to improve the standard of diagnosis and treatment of FMS in China.

The traditional Chinese medicine （TCM） in pediatric care has a long history，proven efficacy，and distinctive characteristics.The China Association of Chinese Medicine has organized a series of youth salons to discuss the clinical advantages of treating diseases.Experts at this seminar proposed that the superior disease categories in pediatric TCM are significant for showcasing the unique strengths and advantages of TCM in the treatment of pediatric diseases，enhancing diagnostic and treatment levels，inheriting TCM knowledge，promoting the integration of TCM and Western medicine，and meeting patients' needs.The strengths of pediatric TCM are summed up as "having what others do not，excelling at what others have，being special in what others excel at，and ensuring safety in what others specialize in." The scope of superiority in pediatric TCM covers multiple systems，including respiratory，digestive，endocrine，psychological，and dermatological systems.This article summarized the advantages of TCM in treating 13 diseases discussed in the salon，such as upper respiratory tract infections，coughs，pneumonia，allergic rhinitis，bronchial asthma，atopic dermatitis，functional dyspepsia，functional constipation，enuresis，marginal short stature，simple obesity，attention deficit hyperactivity disorder，and tic disorders.The overall advantages were reflected in three aspects：First，the holistic concept and treatment based on syndrome differentiation in TCM highlight the advantage of treating the root causes of diseases，making the treatment methodical and precise.Second，most traditional Chinese herbs are natural and have strong safety profiles.Third，TCM treatment methods are abundant，especially the external treatment methods，which are widely used in pediatrics，highly accepted by parents，and have definite efficacy，as well as good safety and compliance.