OBJECTIVE To clarify the roles and functions of full-time pharmacists in the management of early-phase clinical trials of antineoplastic drugs， and to provide theoretical and practical support for their transformation from traditional drug managers to multi-dimensional roles in clinical research. METHODS Combined with relevant regulations such as the Good Clinical Practice （GCP） （2020 Edition）， and based on the clinical practice experience of the Phase Ⅰ Clinical Ward in our hospital， this study systematically sorted out full-time pharmacists’ roles and functions in early-phase clinical trials of antineoplastic drugs， and explored the core challenges and optimization pathways for role transformation and capacity-building of domestic full-time clinical trial pharmacists. RESULTS & CONCLUSIONS Full-time pharmacists assumed multiple roles in early-phase clinical trials of antineoplastic drugs， including providing pharmaceutical support for protocol design， implementing whole-process standardized management of clinical trial drugs， ensuring medication safety for clinical trial subjects/participants， conducting quality control throughout the clinical trial process， and serving as a bridge for interdisciplinary collaboration and communication. Currently， there are challenges in this field in China， such as unclear roles， an imperfect capacity building system， and insufficient regulatory support. This paper proposes that by establishing a standardized role framework， clarifying the core responsibilities and authorities of full-time pharmacists， and leveraging cutting-edge technologies to provide comprehensive support for their roles， so as to fully harness their pharmaceutical expertise and contribute to the standardization and efficiency of the antineoplastic new drug development process.

Objective To prepare Zanthoxylum alkaloid thermosensitive hydrogel, optimize the preparation process and conduct related performance studies. Methods Zanthoxylum alkaloids were obtained by reflux extraction, followed by enrichment and purification using macroporous adsorption resin. Poloxamer 407 and Poloxamer 188 were used as substrates to prepare the thermosensitive hydrogel of Zanthoxylum alkaloids, and the preparation process was optimized by orthogonal design. The quality of the hydrogel was systematically evaluated based on its gelation temperature, gelation time, Fourier transform infrared （FTIR） spectroscopy, scanning electron microscopy （SEM） images, mechanical properties, and in vitro release profile. Results The optimal preparation conditions for the Zanthoxylum alkaloid thermosensitive hydrogel were: 20% （g/ml） poloxamer 407, 2% （g/ml） poloxamer 188 and 100 μg/ml Zanthoxylum alkaloid. The gelation temperature was 32.6℃, and the average gelling time was 143.3 s. The hydrogel appeared as a transparent liquid at room temperature and was transformed into a semi-solid gel state when the temperature exceeded 33℃. Experimental results confirmed the successful preparation of poloxamer 407 and poloxamer 188 thermosensitive hydrogel loaded with Zanthoxylum alkaloids, which exhibited good bio adhesion, self-healing properties, and tensile strength. Conclusion The Zanthoxylum alkaloid thermosensitive hydrogel demonstrated favorable mechanical properties and a sustained-release effect, showing promising potential for further development and application.

Objective To evaluate the efficacy and safety of a combination therapy regimen comprising stereotactic body radiation therapy (SBRT) combined with liposomal irinotecan, camrelizumab, and anti-angiogenic therapy (CAP) in patients with advanced bone and soft tissue sarcomas. Methods This study is a prospective subgroup analysis of the multicenter, open-label, single-arm phase Ⅱ CAP trial (NCT04569916), which enrolled 60 patients with advanced solid tumors who had progressed after standard therapy between November 2020 and February 2023, including 11 patients with advanced bone and soft tissue sarcomas. All patients received sequential liposomal irinotecan within 48 hours after stereotactic body radiotherapy (SBRT), followed by maintenance therapy with camrelizumab and an anti-angiogenic agent until disease progression or intolerable toxicity. The primary efficacy endpoint was objective response rate (ORR). Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Results In the bone and soft tissue sarcoma subgroup (n=11), three patients achieved partial response (PR), five had stable disease (SD), and three experienced disease progression (PD). ORR was 27.3%, and DCR was 72.7%. mPFS was 5.8 months (95%CI: 2.2-10.3), and mOS not reached. Regarding safety, adverse reactions primarily included bone marrow suppression, fatigue, and gastrointestinal reactions, indicating overall manageable toxicity. Conclusion As a subgroup analysis of the CAP study, this research suggests that radiotherapy combined with liposomal irinotecan, camrelizumab, and anti-angiogenic therapy demonstrates certain efficacy in advanced bone and soft tissue sarcomas that have failed multiple lines of treatment, with overall manageable adverse reactions. Future studies should expand the sample size.

It is proposed that although allergic rhinitis manifests primarily in the nasal orifices， its root lies in deficiency of the lung and spleen and insecurity of the lung defensive qi， while deficiency of healthy qi with latent pathogen， triggering by external stimuli， and constraint of defensive yang constitute the key pathogenesis. The onset of disease is not caused solely by newly contracted external pathogens. Rather， on the basis of insecurity of the lung-defense qi， external stimuli such as wind-cold and abnormal qi， dust mites， pollen， and sudden climatic changes， activate the latent pathogen， resulting in constraint of defensive yang， disharmony between nutritive and defensive qi， impaired diffusion of lung qi， failure to contain body fluids， and dysfunction of the nasal orifices. The disease progression can be summarized as following steps， deficiency of healthy qi with latent pathogen， activation by external stimuli， constraint of defensive yang， dysfunction of the nasal orifices， incomplete elimination of the pathogen and incomplete recovery of healthy qi. The general therapeutic principle is to consolidate the defensive qi and vent the latent pathogen while regulating the lung and nasal orifices simultaneously. The empirical prescription Xingui Fangzhi Decoction （辛桂防芷汤） is used as the basic formula and modified dynamically according to the attack and remission stages. During the attack stage， treatment focuses on dispelling wind and cold， regulating defensive qi， and venting the latent pathogen； during the remission stage， it emphasizes supplementing qi， consolidating the defensive exterior， and reinforcing the spleen to resolve the latent pathogen.

Objective To optimize the process conditions and analyze the components of alkaloids from Zanthoxylum bungeanum Maxim（Z. bungeanum）using macroporous resin. Methods Combining single factor tests and orthogonal tests, the content of hydroxy-α-sanshool（HAS）and hydroxy-β-sanshool（HBS）were considered as indexes to determine the best process parameters. Ultra-performance liquid chromatography-quadrupole tandem time-of-flight mass spectrometry（UPLC-Q-TOF-MS^E）was used to identify the structures of alkaloids. Results The optimal conditions were Mitsubishi HP-20 macroporous resin, the loading solution concentration was 0.2 g crude drug/ml, the ratio of crude drug to resin volume was 1 g∶2.5 ml, the diameter/height ratio of resin column was 1∶7, the dynamic adsorption flow rate was 4 times of bed volume（BV）per hour, and the adsorption time was 1 h. Impurities were removed by using 2 BV of 20% ethanol, 5 BV of 80% ethanol was used to elution, and the content of HAS and HBS was 4.71% and 1.02%, respectively. A total of 20 alkaloids were identified from Z. bungeanum. Conclusion This method was stable and feasible, obtaining high purity and various kinds of alkaloids, which could be used for the enrichment and purification of alkaloids from Z. bungeanum.

Objective : To explore the role and mechanism of 25-hydroxycholesterol (25-HC) in inflammatory bow- el disease (IBD) in mice． Methods : All mice were divided into three groups : the control group was fed normally ; the DSS model group was fed with 2. 5% dextran sulfate sodium (DSS) solution ; the DSS + 25-HC experimental group was fed with 2. 5% DSS solution and he mice in the experimental group were intraperitoneally injected with 25-HC．The symptom changes of the mice were evaluated by assessing the disease activity index(DAI) ，and the tis- sue changes were judged by histological scoring．The expression of interleukin-17 and its signaling pathways in the mice were detected by Western blot，qRT-PCR, immunohistochemistry /fluorescence，and flow cytometry．Combined with the detection of tight junction proteins in the intestinal epithelium of the mice，the mechanism by which 25-HC affects IBD in mice was explored． Results : In comparison to the DSS control group，The DSS + 25-HC experimen- tal group mice exhibited a reduction in body weight ( F = 30. 1，P ＜0. 000 1) ，a shortened colon ( F = 63. 8，P < 0. 05) ，and elevated DAI(F = 774. 5，P＜0. 000 1) and histopathological scores(F = 141. 5，P＜0. 05) ．Addition- ally，the expression of tight junction-associated proteins(ZO-2，Occludin，JAM and Claudin-4) was found to be sig- nificantly reduced．The level of IL-17 significantly decreased，and its expression level was positively correlated with tight junction proteins． Conclusion 25-HC inhibited IL-17 production by colonic γδ T cells through the RORγt pathway，aggravated mucosal injury，and promoted the development of DSS-induced acute colitis in mice．

Objective To observe the ultrasonic manifestations of abdominal pregnancy.Methods Ultrasonic and clinical data of 18 pregnant woman with abdominal pregnancy diagnosed by operation and pathology were retrospectively analyzed.Results Among 15 cases in first trimester,no preoperative ultrasonic diagnosis of abdominal pregnancy was obtained.Ultrasound showed no gestational sac in uterine cavity but mass in pelvic cavity,which located in the adnexal region in 8 cases,in the front and the post of uterus each in 2 cases,while in the adnexal region and the front of uterus in 1 case,in the post of the cervix in 1 case,and closed to uterine wall in 1 case,without obvious tubal echo around mass in all 15 cases.There were 2 cases of abdominal pregnancy in the second trimester,which were first diagnosed with ultrasound at 13+6 weeks and 21 weeks,with gestational sac located on the left side of uterus and behind the uterus,respectively.One case of abdominal pregnancy in the third trimester was first diagnosed with ultrasound at 35 4 weeks,with gestational sac located on the right side of uterus.Ultrasonic manifestations of the above three cases all showed gestational sac located outside the uterus without myometrium wrapping around the gestational sac nor placenta implanted in uterus,while echoes of fluid accumulation were detected around fetus.The ultrasonic diagnosis rate of abdominal pregnancy was 16.67％(3/18).Conclusion In the first trimester,if the ectopic pregnancy mass was large or the gestational sac located adjacent to the cervix,anterior or posterior to uterus and on the uterine wall,also no fallopian tube-like echo around the mass,the possibility of abdominal pregnancy should be considered.Ultrasonic manifestations of abdominal pregnancy in the second and third trimester present as gestational sac outside uterine cavity without wrapping uterine muscle layer around,no placenta implantation in uterine cavity,as well as echoes of fluid accumulation around fetus.Transabdominal combined with transvaginal ultrasound could improve diagnostic rate of abdominal pregnancy.

Objective:To explore the effect of CO2 fractional laser combined with glucocorticoid(GC)on T follicular helper cell(Tfh)and B cell subsets in patients with advanced vitiligo(VL).Methods:Patients with advanced VL(128 cases)who were treated in Affiliated Hospital of Hebei University of Engineering from August 2019 to March 2022 were selected as research objects,and divided into group A(64 cases,CO2 fractional laser combined with GC)and group B(64 cases,CO2 fractional laser)according to different treatment methods,clinical efficacy and safety of the two groups were compared.Another healthy subjects(64 cases)were selected as control group.Collected clinical data of the three groups of subjects for comparative analysis.Randomized walking model was used to evaluate the effect of CO2 fractional laser combined with GC on immune function and inflammatory response in patients with advanced VL.Results:Compared with group B,group A had a higher clinical total effective rate(P<0.05)and a lower probability of adverse reactions(P<0.05).After treatment,compared with control group,proportion of Tfh2 and Tfh17 in group A had no significant difference(P>0.05),while proportion of Tfh2 and Tfh17 in group B still had significant difference(P<0.05);compared with group B,proportion of Tfh2 in group A after treatment was higher(P<0.05),while proportion of Tfh17 type was lower(P<0.05).After treat-ment,compared with control group,proportion of memory transformed B cell in group B was still significantly different(P<0.05).After treatment,compared with control group,levels of IgA,IgE and IgM in group B were still significantly different(P<0.05);compared with group B,level of IgM in group A was higher after treatment(P<0.05).After treatment,compared with control group,levels of IL-21 and IL-1β in group B were still significantly different(P<0.05);compared with group B,level of IL-10 in group A after treatment was higher(P<0.05),while levels of IL-21 and IL-1β were lower(P<0.05).Evaluation results of random walking model showed that the improvement of immune function and inflammatory reaction in group A was better than that in group B.Conclusion:CO2 fractional laser combined with GC can improve the immune function and inflammatory reaction of patients with advanced VL better after treatment,and the probability of adverse reactions is lower.

Objective:To explore the combined predictive value of serum stromal cell-derived factor-1 (SDF-1), chitinase 3-like protein 1 (YKL-40), carbohydrate antigen 724 (CA724) and pepsinogen (PG) on recurrence after endoscopic submucosal dissection (ESD) in patients with early gastric cancer.Methods:96 patients with early gastric cancer admitted to Yan 'an Hospital of Traditional Chinese Medicine from August 2021 to August 2023 were retrospectively selected and enrolled into the study. According to the recurrence after ESD, they were divided into recurrence group (31 cases) and non-recurrence group (65 cases). The differences in baseline data, serum SDF-1, YKL-40, CA724 and PG levels were compared between groups. The correlation between serum SDF-1, YKL-40, CA724 and PG levels and clinical indicators of patients was analyzed. Normally distributed quantitative data were expressed as xˉ± s, and independent sample t test was used for inter-group comparison. Counting data were calculated as percentages, and χ2 test was used for inter-group comparison. Spearman method was used for correlation analysis. Multivariate logistics regression analysis was used to analyze the factors affecting postoperative recurrence. ROC curve was used to analyze the single and combined diagnostic value of each serum indicator on recurrence after ESD. Results:The number of well-differentiated cases in recurrence group (32.26%, 10/31) was lower than that in non-recurrence group (70.77%, 46/65), the difference was statistically significant ( χ2=12.81, P<0.001). The levels of SDF-1 [(160.57±16.49) μg/L], YKL-40 [(208.49±22.69) μg/L] and CA724 [(10.49±1.91) kU/L] of recurrence group were higher than non-recurrence group[(136.57±14.56) μg/L, (157.53±20.46) μg/L, (5.11±0.83) kU/L)], and the differences were statistically significant ( t=7.23, 11.01 and 19.29, respectively, all P<0.05), while the PGⅠ/PGⅡ [(2.87±0.57) μg/L] was lower than that in non-recurrence group [(4.18±0.76) μg/L], the difference was statistically significant( t=8.514, P<0.05). Correlation analysis showed that SDF-1, YKL-40 and CA724 were negatively correlated with the degree of differentiation ( r=-0.545, -0.415, -0.718, respectively, all P<0.05), and the PGⅠ/PGⅡ was positively correlated with the degree of differentiation ( r=0.687, P<0.05). Multivariate logistics regression analysis suggested that SDF-1 ( OR=8.191, 95% CI=1.483-45.246, P=0.016), YKL-40 ( OR=9.843, 95% CI=1.782-54.387, P=0.009), CA724 ( OR=10.386, 95% CI=2.053-52.506, P=0.005), PGⅠ/PGⅡ ( OR=0.108, 95% CI=0.028-0.417, P=0.001) and differentiation degree ( OR=0.421, 95% CI=0.219-0.810, P=0.010) were influencing factors of postoperative recurrence. ROC analysis results showed that the AUCs of SDF-1, YKL-40, CA724 and PGⅠ/PGⅡ in predicting postoperative recurrence of early gastric cancer patients were 0.857, 0.956, 0.945 and 0.910, sensitivities were 80.65%, 90.32%, 83.87% and 83.87%, specificities were 78.46%, 76.92%, 81.54% and 80.00%, respectively. The AUC, sensitivity and specificity of combined prediction were 0.986, 96.77% and 73.85%. Conclusion:The levels of serum SDF-1, YKL-40 and CA724 in patients with early gastric cancer recurrence after ESD are higher while the PGI/PGII is lower, and the above levels are relevant factors for postoperative recurrence and can be used as clinical reference indicators to predict recurrence after ESD.

Objective:To analyze the relationship between the social network characteristics and mental health of elderly people in rural areas.Methods:A total of 274 elderly individuals aged 60 and above from rural communi-ties were selected.A self-designed structured interview questionnaire on social network structure was used to collect social network data,and Brief Version of the Mental Health Inventory for the Elderly(MHIE)was used to assess mental health levels.Based on the social escort model,the elderly people's social relationships were represented u-sing a three-tier concentric circle structure,indicating different levels of social relationship closeness.The structure of the social network included the size,frequency of contact,and intimacy of the relationships.The network size was represented by the number of nominators,and heterogeneity refers to the different types of relationships.Results:The concentric circle structure of the social network of rural elderly people consists of core family relationships,ex-tended family relationships,and friendships,from inner to outer circles.Regression analysis results showed that the heterogeneity of the social network was positively correlated with the MHIE scores(β=2.58).The intimacy of ex-tended family members and friends was positively correlated with the MHIE scores(β=1.07,0.87).The size of the extended family members was negatively correlated with the MHIE scores(β=-5.52).Conclusion:The het-erogeneity of the social network and intimacy play a positive role in the mental health of rural elderly people,while a large extended family network may impose psychological burdens.