OBJECTIVE To investigate the effect of pharmaceutical services guided by root cause analysis （RCA） in a problem-oriented manner combined with knowledge-attitude-practice （KAP） theory on reducing the incidence of protocol violations of investigational medicinal products in pediatric clinical trials. METHODS A total of 617 participants from 69 drug clinical trial projects conducted in our hospital from January 2016 to December 2020 were selected as the control group， and 868 participants from 72 drug clinical trial projects from January 2022 to December 2025 as the observation group. RCA was performed on the protocol violations of investigational medicinal product in the control group to identify the types and underlying causes. The control group received routine pharmaceutical services for drug clinical trials， while the observation group was provided with precision pharmaceutical services from the three dimensions of knowledge， attitude and practice on the basis of routine pharmaceutical services， according to the root causes identified by RCA. The occurrence of investigational medicinal products protocol violations was compared between the two groups. RESULTS The total incidence of protocol violations of investigational medicinal products， as well as the incidences of minor and major protocol violations， were all significantly lower in the observation group than in the control group （ P ＜0.001）. The main types of protocol violations in both groups included missed/under-/over-dosing of medications， non-adherence to administration time， failure to adjust dosage as required， and combined medication/vaccination in violation of the protocol. Regarding the responsible subjects of protocol violations， the incidences of protocol violations attributed to participants and their guardians as well as investigators and accidental factors were significantly lower in the observation group than in the control group （ P ＜0.001， P ＜0.001， P ＝0.025）. However， there were no statistically significant differences in the incidences of protocol violations caused by sponsor-related reasons between the two groups （ P ＞0.05）. CONCLUSIONS Pharmaceutical services led by pharmacists， based on problem-oriented RCA and combined with KAP theory， can effectively reduce the protocol violations of investigational medicinal products rate in pediatric clinical trials， thereby safeguarding the safety and rights of study participants.

Objective: To conduct screening for rare blood types within important blood group systems for the Chinese population, such as Rh, Duffy, Kidd, P1Pk, Diego, and MNS, in the Guangzhou region, and to establish a corresponding rare blood type database and physical repository. Methods: The saline medium microplate method was used to screen blood donors with the ccDEE phenotype combined with either Jk(a-) or Jk(b-). The polybrene microplate method was employed to screen for donors with Fy(a-), s(-), Lu(b-), Di(b-), k(-), and p phenotypes. The urea lysis microplate method was applied to screen for the Jk(a-b-) phenotype. A high-resolution melting (HRM) curve method was established for screening some donors with the Di(b-) phenotype. Subsequently, expanded phenotyping of antigens in the Rh, Kidd, MNS, Duffy, P1Pk, Lewis, Kell, and Lutheran blood group systems was performed on identified rare blood type donors using monoclonal antibodies. The test results are entered into the Rare Blood Type Bank Management System of the Guangzhou Blood Center, enabling functions such as confirmation reminders and cryopreservation storage when the donor donates again. Red blood cells of rare blood types are processed into frozen red blood cells for long-term storage. Results: Among voluntary blood donors, 16 cases of the ccDEE combined with Jk(a-) phenotype were identified (0.221 7%, 16/7 216); 10 cases of the ccDEE combined with Jk(b-) phenotype (0.138 6%, 10/7 216); 78 cases of the Fy(a-) phenotype (0.169 5%, 78/46 012); 39 cases of the Lu(b-) phenotype (0.138 2%, 39/28 214); 31 cases of the s(-) phenotype (0.081 8%, 31/37 913); 22 cases of the Di(b-) phenotype (0.029 9%, 22/73 691); 30 cases of the Jk(a-b-) phenotype (0.010 1%, 30/298 250); and 1 case of the k(-) phenotype (0.001 3%, 1/77 382), which was further identified as KELnull phenotype (K0). No p phenotype donors were identified (0/88 528). A total of 228 units of frozen red blood cells were prepared. The screening results were compared and analyzed with rare blood type data from other regions. Conclusion: This study, through a combination of different screening methods, significantly improved the efficiency of rare blood type screening while remaining cost-effective. By conducting large-scale screening and performing data informatization processing, a database and physical repository of rare blood types in the Guangzhou region were successfully established. This provides a strong guarantee for the timely supply of blood to patients with difficult-to-match and rare blood types in the region, effectively enhances the level of transfusion safety in the region, and offers a practical paradigm for constructing a comprehensive blood transfusion support system.

Objective:To investigate the effect and safety of etonogestrel implant and levonorgestrel-releasing intrauterine system (LNG-IUS) in the treatment of adenomyosis.Methods:Eighty patients with adenomyosis in Northwest Women's and Children's Hospital were selected from September 2021 to September 2023. According to the random number table method, they were divided into observation group and control group, with 45 cases in each group. The patients in observation group were treated with etonogestrel implant, while the patients in control group were given LNG-IUS. The uterine conditions, visual analogue scale (VAS) score, menstrual pattern, sex hormones [estradiol, luteinizing hormone (LH) and follicle stimulating hormone (FSH)] and laboratory indicators [hemoglobin, serum ferritin (SF) and carbohydrate antigen 125] before treatment and after 12 months of treatment and incidence of adverse reactions were compared between the two groups of patients. Measurement data were expressed as xˉ±s. Repeated measures analysis of variance was used for comparison between the two groups at multiple time points. LSD-t test was used for pairwise comparison. Two independent sample t test was used for comparison between the two groups. Paired t test was used for comparison before and after treatment. Enumeration data were expressed as n (%), and χ2 test was used for comparison between groups. Results:After 12 months of treatment, the uterine volume and endometrial thickness in observation group and control group were reduced compared to before treatment [observation group: (122.72±13.52) cm 3 vs. (202.72±20.75) cm 3, (6.83±1.35) mm vs. (9.84±1.76) mm, t=21.67,9.10, respectively, both P<0.001; control group: (134.82±17.64) cm 3 vs. (203.46±20.03) cm 3, (7.52±1.52) mm vs. (9.79±1.82) mm, t=17.25,6.42, respectively, both P<0.001], and the indicators in observation group were lower than those in control group ( t=3.65, 2.28, P<0.001, P=0.025, respectively). The levels of estradiol, LH and FSH were lower than those before treatment[observation group: (1.40±0.30) nmol/L vs. (2.42±0.41) nmol/L, (10.12±1.14) U/L vs. (12.84±2.63) U/L, (5.32±0.87) U/L vs. (9.34±1.35) U/L, t=13.47,6.36,10.03, respectively, all P<0.001; control group: (1.68±0.33) nmol/L vs. (2.40±0.48) nmol/L, (11.41±1.53) U/L vs. (12.96±2.25) U/L, (7.03±1.04) U/L vs. (9.53±1.31) U/L, t=8.29,3.82,16.79, respectively, all P<0.001], and the observation group had lower levels than the control group( t=4.21,4.54,8.46, respectively, all P<0.001). Hemoglobin and SF levels were higher than those before treatment, and the levels in observation group were higher than those in control group [observation group: (116.46±3.07) mg/L vs. (109.46±3.64) mg/L, (117.33±16.46) μg/L vs. (53.82±7.52) μg/L, t=9.86,18.95, respectively, both P<0.001; control group: (114.63±3.48) mg/L vs. (110.63±3.48) mg/L, (95.34±12.63) μg/L vs. (52.58±8.21) μg/L, t=5.45,23.61, respectively, both P<0.001], and the levels in observation group were higher than those in control group( t=2.64,7.11, P=0.010, P<0.001, respectively). The level of carbohydrate antigen 125 was lower than that before treatment, [observation group:(40.31±3.10) kU/L vs.(68.31±4.75) kU/L, t=33.12, P<0.001;control group:(57.45±4.27) kU/L vs.(67.64±4.83) kU/L, t=10.60, P<0.001], and the level in observation group was lower than that in control group ( t=21.79, P<0.001). At 3, 6 and 12 months after treatment, the VAS score in both group decreased gradually, and the scores in observation group were lower than those in control group [(4.35±0.88) points vs. (4.71±0.75) points, (3.21±0.73) points vs. (3.63±0.82) points, (2.64±0.51) points vs. (3.16±0.64) points, all P<0.05]. Before treatment, there was no statistically significant difference in menstrual patterns between the two groups of patients ( P>0.05). After 12 months of treatment, the proportion of normal menstrual patterns in the implant group was higher than that in the sustained-release group [68.9% (31/45) vs. 46.7% (21/45), χ2=4.56, P=0.033], while the proportion of frequent bleeding was lower than that in the sustained-release group [6.7% (3/45) vs. 22.2% (10/45), χ2=4.41, P=0.036]. There was no statistical significant difference in the incidence of adverse reactions between the two groups during treatment [8.9% (4/45) vs. 11.1% (5/45), χ2=0.00, P=1.000]. Conclusion:Compared with LNG-IUS, etonogestrel can more effectively improve the uterine conditions, relieve the dysmenorrhea symptoms, and improve the blood related indicators, and with high safety.

Objective:To investigate the relationship between lean lipid accumulation product (LAP) and metabolic associated fatty liver disease (MAFLD).Methods:This cross-sectional study consecutively enrolled 1 990 adult subjects who underwent health examinations at the Second Affiliated Hospital of Xi′an Jiaotong University between June 2021 and May 2023. All recruited participants had a body mass index (BMI)<23 kg/m2. Data collection included general information, physical examination, serum biochemical parameter measurements, and liver ultrasonography. Participants were divided into four groups (Q1-Q4) according to quartiles value of LAP from low to high. The differences of biochemical parameters and the prevalence of lean MAFLD were compared among the groups. Logistic regression, restricted cubic spline (RCS) and receiver operating characteristic (ROC) curve analysis were used to explore the relationship between LAP and lean MAFLD and assess the diagnostic predictive value of LAP for lean MAFLD.Results:A total of 1990 participants were selected, and the detection rate of lean MAFLD was 4.97% (99 cases). The detection rate of lean MAFLD showed a significant increasing trend from Q1 to Q4 groups ( P<0.001) and respectively was 0.40%, 0.81%, 4.01% and 14.70%. The average age, male proportion, BMI and waist circumference significantly increased in a dose-response manner from Q1 to Q4 (all P<0.001). Indirect bilirubin, alanine aminotransferase, aspartate aminotransferase, γ-glutamyltranspeptidase, alkaline phosphatase, total cholesterol, triglycerides, low-density lipoprotein, serum uric acid, fasting blood glucose, fatty liver index, fibrosis-4 index and every metabolic syndrome component in groups Q2 to Q4 were significantly higher than in the Q1 group, while high-density lipoprotein levels gradually decreased (all P<0.05). RCS showed that the risk of lean MAFLD rose significantly with the increase of LAP ( P<0.005), presenting a nonlinear relationship between them ( P for nonlinear<0.001). Logistic regression analysis revealed that after adjusting other confounding factors, the risk of lean MAFLD in the Q4 group remained 4.75 times higher than that in the Q1 group (95% CI: 11.22-31.69, P<0.05). ROC curve demonstrated that LAP had a better predictive value for lean MAFLD than BMI and waist circumference, with area under the curve of 0.839, critical value of 19.59, diagnostic sensitivity of 82.8% and specificity of 75.1%. Conclusions:Elevated LAP is independently and positively correlated with the risk of lean MAFLD, and its predictive efficacy is significant superior to traditional obesity indicators.

ObjectiveTo understand the infection characteristics and drug resistance of carbapenem-resistant Serratia marcescens (CRSM) in a general hospital in Shanghai, and to provide a theoretical basis for clinical anti-infective treatment and prevention of drug-resistant bacteria. MethodsClinical data on cases with CRSM infections detected in clinical specimens at a gradeⅢ level A general hospital in Shanghai from June 2022 to June 2024 were retrospectively collected, and their clinical distributions, factors of hospital-acquired infections, prognosis, and drug-resistant situation were analyzed simultaneously. ResultsA total of 38 cases with CRSM were detected from June 2022 to June 2024, and the number of CRSM strains accounted for 25.00% (38/152) of the number of SM strains. The 38 CRSM infection samples were all derived from sputum. CRSM were distributed in 9 clinical departments, and the top 3 departments having the highest percentages of CRSM among SM strains, were intensive care unit (ICU) (78.79%, 26/33), gastrointestinal surgery department (57.14%, 4/7), and thyroid hernia surgery department (50.00%, 1/2). Among the 38 patients with CRSM infections, 8 cases were identified as hospital-acquired infection, resulting in a hospital-acquired infection rate of 21.05. The mortality rate of the 38 cases of CRSM infected patients within 30 days after detection of CRSM was 23.68% (9/38). The results of multivariate logistic regression analysis showed that sequential organ failure assessment (SOFA) score ≥6.5 points (OR=15.33, P<0.001), septic shock (OR=4.85, P=0.032), and suffering from neoplastic diseases (OR=0.12, P=0.018) were the related factors for death within 30 days after the detection of CRSM in patients with CRSM infection. The results of drug sensitivity test showed that the 38 cases of CRSM exhibited 100.00% (38/38) sensitivity to trimethoprim/sulfamethoxazole, tigecycline, or ceftazidime/avibactam; demonstrated high resistance toβ-lactams except for ceftazidime (18.42%, 7/38), the latter of which was one of the third-generation of cephalosporins; showed elevated resistance to fluoroquinolones [levofloxacin (89.47%, 35/38), ciprofloxacin (94.74%, 36/38)]; maintained good tetracycline sensitivity [doxycycline (97.37%, 37/38), minocycline (76.32%, 29/38)]; and displayed high susceptibility to the aminoglycoside gentamicin (94.74%, 36/38) and elevated resistance to tobramycin (86.84%, 34/38). The detection rate of serine carbapenemase in the 38 strains of CRSM was 100.00%, while all strains tested negative for metallo-β-lactamases. ConclusionFrom June 2022 to June 2024, the detection rate of CRSM in a gradeⅢ level A general hospital in Shanghai was relatively high, especially in the ICU. CRSM has a high resistance rate to commonly used antibacterial drugs such as the first and second-generation cephalosporins, quinolones, and polypeptide antibacterial drugs. Therefore the dynamics of drug-resistant bacteria should be tracked in a timely manner to guide the rational clinical application of antibacterial drugs.

Objective To develop and evaluate dietary and exercise intervention program for over-weight/obese patients with polycystic ovary syndrome(PCOS).Methods Seventy patients with over-weight/obese PCOS were prospectively selected as research subjects and divided into intervention group(n=35)and control group(n=35)according to random number table method.According to the completion of the intervention plan,29 cases were finally included in the intervention group and 28 cases in the control group.The control group was given conventional nursing intervention,while the intervention group was applied with the diet and exercise intervention program for overweight/obese patients with PCOS.Both groups were intervened for 3 months.The physical indicators,PCOS sign scores,natural pregnancy rate,degree of self-body image distress(Multidimensional Self-body Im-age Relationship Questionnaire-Appearance Subscale)and self-efficacy level(Self-efficacy Scale)before and after the intervention were compared between the two groups.The occurrence of adverse reactions during the intervention period between the two groups were compared.Results After 1 month and 3 months of intervention,the body mass index(BMI)and PC OS sign score of the pa-tients in the intervention group were significantly lower than those in the control group(P＜0.05).The natural conception rate of the intervention group was 34.48％(10/29),which was significantly higher than 10.71％(3/28)of the control group(P＜0.05).After 1 month and 3 months of inter-vention,the scores of the self-body image relationship-appearance subscale of the patients in the inter-vention group were significantly higher than those in the control group(P＜0.001).After 3 months of intervention,the score of the Self-efficacy Scale of patients in the intervention group was significantly higher than that in the control group(P＜0.001).During the intervention period,no adverse reac-tions caused by diet and exercise intervention occurred in either group.Conclusion Implementing a diet and exercise intervention program for overweight/obese patients with PCOS is beneficial for re-ducing patients' BMI,increasing the natural pregnancy rate,improving self-body image disorders,and enhancing self-efficacy.

Objective: To investigate the survival rate of female breast cancer patients in Panyu District, Guangzhou City, so as to provide the basis for improving the prognosis of breast cancer patients. Methods: Basic information including age, clinical stage and surgical treatment of female breast cancer patients registered in Panyu District and diagnosed in 2017 were collected through the Guangzhou Municipal Cancer Registration and Reporting Management System, and were followed up until December 31, 2022. The survival rate was calculated using the life table. Factors affecting survival time among female breast cancer patients were analyzed using a multivariable Cox proportional hazard regression model. Results: A total of 227 female breast cancer patients were reported in Panyu District in 2017, and had a median age of 51 (interquartile range, 17) years. There were 43 cases (18.94%) in stage Ⅰ, 55 cases (24.23%) in stage Ⅱ, 63 cases (27.75%) in stage Ⅲ, 27 cases (11.89%) in stage Ⅳ, and 39 cases (17.18%) with unknown staging. Surgical treatment was performed in 204 cases (89.87%), and chemotherapy was administered in 73 cases (32.16%). By December 31, 2022, there were 40 deaths and 14 patients lost to follow-up. The one-year, three-year and five-year survival rates were 96.44%, 87.45% and 82.87%, respectively. Multivariable Cox proportional hazard regression analysis showed that older age (HR=1.023, 95%CI: 1.002-1.046), clinical stage Ⅲ (HR=10.050, 95%CI: 1.324-76.270) or IV (HR=42.663, 95%CI: 5.588-325.742) were associated with a higher risk of mortality in female breast cancer patients, while surgical treatment (HR=0.278, 95%CI: 0.130-0.598) was associated with a lower risk of mortality. Conclusions The five-year survival rate of female breast cancer patients in Panyu District was 82.87%. Age, clinical stage and surgical treatment were the main influencing factors for the survival time of female breast cancer patients.

OBJECTIVE To carry out regular monitoring of carbapenem-resistant Klebsiella pneumoniae(CRKP)contamination status in the environment of intensive care unit(ICU)and take targeted prevention and control measures so as to reduce the incidence of hospital-associated infections with multidrug-resistant organisms(MDROs).METHODS The surfaces of surroundings of the patients who were colonized and infected with CRKP in the ICU of grade A tertiary hospital of Shanghai and the hands of relevant staff were sampled by stages from Jan 1,2021 to Jun 30,2024.The distribution of the CRKP strains in the surroundings were analyzed according to the locations positive for CRKP,and the disinfection measures were accordingly and continuously modified.The trend of isolation rate of CRKP strains from the ICU patients was analyzed during the time period when the measures were implemented.RESULTS Totally 266 environmental samples were collected during the baseline period(from Jan.1 2021 to Dec.31 2021),265 during intervention period(from Jan.1 2022 to Dec.31 2023),274 during con-solidation period(from Jan.1 to Jun.30 2024);the isolation rates of the CRKP strains were 4.51％,4.91％and 3.65％,respectively.The isolation rate of the strains was highest from the bed unit(10.40％),followed by the article for public use(6.74％),articles used by health care workers(2.98％)and diagnosis and treatment arti-cles(1.91％).The isolation rate of CRKP of the patients was 24.75％during the baseline period,15.48％during the intervention period,5.69％during the consolidation period,showing a continuously downward trend(x2=30.330,P＜0.001).CONCLUSION It is necessary to regularly carry out the environmental monitoring of CRKP strains,seek for the weak links of environmental disinfection and implement the intensified prevention and control measures so as to reduce the incidence of CRKP infection,which may provide theoretical bases for effective control of the CRKP strains.

Objective To investigate the differences of language abilities between children with developmental delay(DD)and those with autism spectrum disorder(ASD)aged 3-6 years,and to provide references for clinical differential diagnosis and subsequent rehabilitation therapy.Methods In this study,61 cases of DD children and 61 cases of ASD chil-dren were selected.The language ability of children was assessed using the"Children's Language Ability Assessment Stand-ards and Methods",which evaluated grammar,comprehension,expression and communication abilities.Results Children with DD showed better comprehension and social skills but weaker grammar and expressive abilities.Children with ASD generally had lower levels in all language areas.There was no significant difference in the average language ability or expres-sive ability the two groups(P＞0.05),but the language comprehension ability and communication ability of the ASD group were significantly lower than those of the DD group(P＜0.05).The grammar ability of the ASD group was higher than that of the DD group(P＜0.05).Conclusion The levels of different language areas of children with DD and ASD children are significantly different.Language ability tests can assist in the differential diagnosis of DD and ASD children,and provide reference for language rehabilitation training.

Objective:To explore the serum miRNA-144-5p (miR-144-5p) level in liver cancer patients and its relationship with clinical characteristics, as well as the target genes of miR-144-5p and the possible pathogenic mechanisms.Methods:The morning fasting serum samples were retrospectively collected from 100 newly diagnosed liver cancer patients (liver cancer group) before any treatment in Shanxi Province Cancer Hospital from June 2019 to June 2020, as well as 100 healthy individuals (healthy control group) during physical examinations in the same period. The real-time fluorescence quantitative polymerase chain reaction method was used to measure the transcription level expression of miR-144-5p in serum. The high and low expressions of miR-144-5p in patients were determined based on the median relative expression level of miR-144-5p; the distribution differences between patients with high and low expressions of miR-144-5p among different clinical pathological features were compared. The online tools miRDB, TargetScan 8.0 and miRWalk were used to predict potential target genes for miR-144-5p, and Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analyses were performed through a bioinformatics platform, and complementary sequences between miR-144-5p and target genes were analyzed using RNA22 software.Results:The median age of the liver cancer group was 54 years old, ranging from 38 to 74 years old, including 80 males (80.0%) and 20 females (20.0%); the median age of the healthy control group was 46 years old, ranging from 34 to 66 years old, including 69 males (69.0%) and 31 females (31.0%); there was no statistically significant difference in age and gender composition between the two groups (both P > 0.05). The median transcription level relative expression of miR-144-5p in liver cancer patients was lower than that in the healthy control group [ M ( Q1, Q3)] [0.311 (0.066, 2.270) vs. 1.067 (0.263, 3.620)], and the difference was statistically significant ( Z = -4.16, P < 0.001). The proportion of patients with low expression of miR-144-5p was higher in the group with maximum diameter of tumor > 5 cm compared to the group with maximum diameter of tumor ≤5 cm [59.3% (35/59) vs. 36.6% (15/41)] and in the group with metastasis compared to the group without metastasis [60.4% (29/48) vs. 40.4% (21/52)], and the differences were statistically significant (both P < 0.05). There was no statistically significant difference in the distribution of patients with high and low expressions of miR-144-5p among different subgroups based on gender, age >55 years, presence of hepatitis, cirrhosis, alpha fetoprotein >400 μ g/L, and differentiation degree (all P > 0.05). According to predictions, there were 34 miR-144-5p target genes shared by the three bioinformatics online tools. GO and KEGG enrichment analyses showed that these target genes were associated with ubiquitination, primarily enriched in the ubiquitin-mediated proteolysis pathway (hsa04120) and the mTOR signaling pathway (hsa04150). RNA22 software analysis showed that miR-144-5p mainly had complementary sequences with 3' untranslated regions of UBR5 and UBE4A genes. Conclusions:The serum miR-144-5p level in liver cancer patients is relatively low, and its expression level may be related to tumor size and metastasis. miR-144-5p may affect the occurrence and development of liver cancer by regulating ubiquitination level through target genes such as UBR5 and UBE4A.