Objective To summarize experience of anti-cancer drug management for clinical trials,and to explore a more efficient and standardized management model of anti-cancer drugs used in clinical trials.Methods Based on our current work in central pharmacy,the particularity and complexity of anti-cancer drug management for clinical trials were analyzed.In the meantime,we identified high-risk parts in the drug management process.Based on those risks,feasible measures were taken and presented in detail.Results Management of anti-cancer drugs used in clinical trials has its characteristics,such as long cycle,low error-tolerant rate,closed-loop model,etc.Recognizing these representative high-risk parts during the trials and making responses,including standardization of drug management records and disposition of drugs and packaging returned by subjects,should be achieved as soon as possible.Conclusion Establishing and observing strict rules and regulations,improving the hardware and software performance of the central pharmacy as well as implementing risk-based drug management is beneficial to conduct clinical trials normatively.

Background and Purpose:The early prediction of local tumor progression-free survival(LTPFS)after radiofrequency ablation(RFA)for colorectal cancer(CRC)lung metastases has significant clinical importance.The application of radiomics in the prediction of tumor prognosis has been explored.This study aimed to construct a radiomics-based nomogram for predicting LTPFS after RFA in CRC patients with lung metastases.Methods:This study retrospectively analyzed 172 CRC patients with 401 lung metastases admitted to Department of Interventional Radiology,Fudan University Shanghai Cancer Center from August 2016 to January 2019.This study was reviewed by the medical ethics committee of Fudan University Shanghai Cancer Center(ethics number:2402291-24).After augmentation of pre-ablation and immediate post-ablation computed tomography(CT)images,the target metastases and ablation regions were segmented manually to extract the radiomic features.Maximum relevance and minimum redundancy algorithm(MRMRA)and least absolute shrinkage and selection operator(LASSO)regression models were applied for feature selection.The clinical model,the radiomics model,and the fusion model were constructed based on the selected radiomic features and clinical variables screened by the multivariate analysis.The Harrell concordance index(C-index)and area under receiver operating characteristic(ROC)curves(AUC)were calculated to evaluate the prediction performance.Finally,the corresponding nomogram of the best model was drawn.Results:Among all the lung metastases,102(25.4%)had final recurrence,and 299(74.6%)had complete response(CR).The median follow-up time was 21 months(95%CI:19.466-22.534),and the LTPFS rates at 1,2,and 3 years after RFA were 76.5%(95%CI:72.0-80.4),72.1%(95%CI:66.6-76.9)and 69.9%(95%CI:64.0-75.1).In both the training and test dataset,the fusion model based on the final 12 radiomic features through the LASSO regression and 4 clinical variables screened by multivariate analysis achieved the highest AUC values for LTPFS,with C-index values of 0.890(95%CI:0.854-0.927)and 0.843(95%CI:0.768-0.916),respectively.Conclusion:The fusion model based on radiomic features and clinical variables is feasible for predicting LTPFS after RFA of CRC patients with lung metastases,whose performance is superior to the single radiomic and clinical model.At the same time,the nomogram of the fusion model can intuitively predict the prognosis of CRC patients with lung metastases after RFA,thus assisting clinicians in developing individualized follow-up review plans for patients and adjusting treatment strategies flexibly.

Objective:To analyze and compare the X-ray procedures and radiation dose composition of ophthalmic inpatients, and to explore the changes of the X-ray examination mode in recent years and the effect of optimization in imaging technology on the radiation dose level of the patients.Methods:The simple random sampling method was used to retrospectively select the imaging data of the ophthalmic inpatients in the Second Affiliated Hospital of Zhejiang University School of Medicine from July 1st to November 31st in 2019 and from July 1st to November 31st in 2020. A total of 516 cases were selected according to the imaging time, including 258 cases in 2019 and 258 cases in 2020. Based on our previous research and the related documents of low-dose CT screening, a series of optimizations on CT scanning parameters and process were carried out in 2020, including the frequency of DR and CT scanning, the number of examinations per capita, the composition ratio of CT and DR, and X-ray dose per capita.Results:In 2020, the average effective doses of chest CT and orbital CT for ophthalmic inpatients were (2.587±1.586) mSv and (0.877±0.733) mSv, significantly lower than those in 2019 ( F=0.52, 0.72, P<0.05), and decreased by 34.82% and 37.13%, respectively. There was no significant difference in the average effective dose of chest DR and head CT between 2020 and 2019 ( F=6.01, 1.81, P>0.05). The number of X-ray examination per capita increased by 0.15 times, and the effective dose increased by 1.44 times (1.589 mSv). Chest DR was the main type of X-ray examination, accounting for 68.79% of all examinations in 2019, while chest CT was the main type, accounting for 71.05% in 2020. The composition of chest CT in 2020 increased by 63.17% compared with 2019, and the compositions of chest DR, orbital CT and cranial CT were decreased by 53.88%, 5.79% and 2.89%, respectively. Conclusions:With dose optimization measures, the single CT dose of ophthalmic inpatients in 2020 was lower than that in 2019. Chest CT increased significantly in frequency, and became main X-ray examination instead of chest DR which made the effective dose of ophthalmic inpatients increasing significantly.

Objective:To optimize the scheme and process of chest CT scanning and control the dose level to the examined individuals by establishing the diagnostic reference level (DRL) and warning dose value from chest CT examinations in our hospital.Methods:The medical records for 205 511 examined individuals, who had undergone chest CT scans in the Second Affiliated Hospital of Zhejiang University Medical College from January 1, 2018 to December 31, 2019, were reviewed consecutively. For the two-year examination periods, these examined individuals were divided into two groups, one for 2018 totalling 90 507 and another for 2019 with a total of 115 004. The mean value of doses from chest CT scans in 2018 was set as the DRL for the hospital, with the 75th and 25th percentiles as the upper and lower limits of diagnostic reference range (DRR) and the 97.5th percentiles as the warning dose values. The doses above the upper limit of DRR were considered to be relatively-high whearas the ones exceeding the warning dose value to be over-high. Based on the analysis of the over high dose in 2018, the scanning scheme and inspection process of the chest CT scans were improved in 2019. The number of examinations were estimated for the 2018 period for chest plain CT scans, chest enhancement CT scans, lung cancer screening low-dose CT scans, and relatively-high and over-high dose CT scans, as well as the single scanning doses to the examined in the two groups. The number of examinations resulting in high dose to the examined due to different reasons before and after the improvement were studied. The various parameters on the examined in the two groups were compared statistically.Results:After the improvement, the average dose from chest plain CT scans decreased by 8.67 %, with the statistically significant difference as compared with before improvement ( t=55.71, P<0.05). The average dose from low-dose chest CT scans fell by 20.13% with statistically significant difference ( t=81.99, P<0.05). The fraction of the examinations with slightly-high doses arising from chest plain CT scans and low dose chest CT scans dropped by 3.66% and 17.15%, respectively. The fraction of the examinations with slightly-high dose from chest enhanced CT increased by 1.7%. The fraction of the examinations with over-high dose from chest plain CT scans, enhanced CT scans and low-dose CT scans decreased by 0.55%, 1.06% and 1.74%, respectively. After improvement, the optimized fraction of the examinations with over-high dose, dropped by 4.72%, 31.49% and 19.18% respectively. Conclusions:The establishment of the DRL and the warming dose value of for chest CT examinations in our hospital is helpful to find out the cause of high dose scanning, promote the optimization of dose, reduce the average dose to the examinedes, and avoid using excessive dose during scanning.

Objective: To investigate the relationship between after-school schedule and bone mineral density in middle-school students in Shanghai, to provide a reference for taking targeted measures. Methods: From November 2017 to April 2018，eighteen classes of six middle schools in Shanghai (from urban districts, urban-suburb combined districts and suburban districts, respectively) were selected based on cluster random sampling. In each school, 2-4 classes were further randomly chosen in the 6th grade. Questionnaires were completed by 518 students and their parents, as well as physical examination and bone mineral density assessment. Results: The average time spent on after-school academic learning during weekends was 4.0 (IQR: 2.0, 6.0) h. The Z-score of bone density was 0.3 (IQR: -0.7, 1.0). The smooth curve fit model showed a non-linear relationship between after-school academic learning time during weekends and the Z-scores of bone mineral densities. A two-stage multiple linear regression analysis was further applied according to the fit results, and the results showed that when total afterschool academic learning time <4.5 hours during weekends, the learning time was inversely correlated with the bone density Z-scores (β=-0.11,P=0.01), and when the learning time ≥4.5 hours, there was no significant correlation between the learning time and bone density Z-scores (β=0.02, P=0.65). Parent and student questionnaires showed that there was a non-linear relationship between students’ daily time spent on outdoor sports-related activities and bone density Z-scores. When time spent on the outdoor activities ≥45 minutes per day, outdoor activities were positively correlated with bone density Z-scores (P<0.05). However, when the time spent on outdoor activities <45 minutes per day, there was no significant relationship between outdoor activities and bone density Z-scores (P>0.05). Conclusion Too much time on after-school academic learning during weekends or limited time on outdoor activities are both related to impaired bone mineral densities. Therefore, a reasonable after-school schedule for middle-school students is important for physical development, especially during weekends.

Objective To investigate the effect of calcium acetate in treatment of elderly patients with CAPD in peritoneal dialysis patients with hyperphosphatemia and efficacy.MethodsFrom March 2013 to January 2016,46 elderly patients with CAPD were randomly divided into experimental group and control group.The control group were used calcium 1.5mmol/L Liquor Dialysisintraperitoneus CAPD treatment,and control diet.Besides these treatments,the experimental group were given calcium acetate tablets 668mg/3 times every day after a meal, 2 tablets each time.All patients were detected before treatment and 4,6 and 10 weeks after the serum calcium, phosphorus and calcium and phosphorus in blood iPTH index, calculate the product of calcium and phosphorus,record and statistical analysis.ResultsTwo groups after 4 week of treatment, all outcome measures were decreased;the experimental group blood phosphorus decreased significantly after 6 weeks treatment;it after 10 weeks of treatment, serum calcium(t=5.202),phosphorus(t=7.767),blood iPTH(t=-10.324) and the calcium phosphorus product (t=-4.106) compared with that before treatment,there were statistically significant differences(P<0.01);the control group after 10 weeks of treatment, with all outcome measures there were no significant differences.The experimental group after 10 weeks of treatment,serum calcium(t=-4.055),phosphorus (t=-9.037),blood iPTH(t=9.940) and the calcium phosphorus product(t=-4.211)compared with the control group,the differences were statistically significant(P<0.01).ConclusionCalcium acetate treatment can significantly reduce the blood serum of aged CAPD in peritoneal dialysis patients with high phosphorus,effectively prolong the survival time and improve the quality of life during treatment.

Background and purpose: Current colorectal cancer patient-derived xenografts (PDXs) models were established by samples taken during surgery. However, metastatic colorectal cancer (mCRC) patients have less surgical opportunities, and it was difcult to obtain enough tumor fragment. The aim of the present study was to es-tablish mCRC PDXs by image-guided biopsy. Methods: A total of 12 patients with colorectal cancer who underwent surgery were included. All patients had recurrent lesions or metastatic lesions needed to be histologically confirmed, and none of them had contraindication to biopsy. Tumor tissues not required for clinical diagnosis were used to establish mCRC PDXs. Results: Seven PDXs grew sufficiently for transfer into mice. The success rate was 77.8%. Conclusion:The PDXs established by image-guided biopsy had the advantage of convenient operation, good reproducibility, high achievement ratio, short experimental periodicity and reliably retain specific genetic and morphological features of the primary patient tumors.

Objective: To investigate the efficacy and safety of IA regimen which contains idarubicin (IDA) 8 mg/m², 10 mg/m² or 12 mg/m² as induction chemotherapy for adult patients with de-novo acute myeloid leukemia (AML) . Methods: A total of 1 215 newly diagnosed adult AML patients, ranging from May 2011 to March 2015 in the First Affiliated Hospital of Soochow University and other 36 clinical blood centers in China were enrolled in the multicenter, single-blind, non-randomized, clinical controlled study. To compare the response rate of complete remission (CR) , adverse events between different dose idarubicin combined with cytarabine (100 mg/m²) as induction chemotherapy in newly diagnosed patients of adult AML. Results: Of 1 207 evaluable AML patients were assigned to this analysis of CR rate. The CR rates of IDA 8 mg/m² group, IDA 10 mg/m² group and IDA 12 mg/m² group were 73.6% (215/292) , 84.1% (662/787) and 86.7% (111/128) , respectively (P<0.001) . After adjusted for age, blast ratio of bone marrow, FAB classification and risk stratification, the odds ratios (95% CI) of IDA 10 mg/m² group and IDA 12 mg/m² group were 0.49 (0.34-0.70) and 0.36 (0.18-0.71) , as compared with the IDA 8 mg/m² group (P<0.001, P=0.003) . In the intermediate and favorable groups, CR rates was 76.5% (163/213) , 86.9% (506/582) and 86.1% (68/79) in different doses of IDA (P=0.007) . Interestingly, IA regimen with IDA 10 mg/m² was the only beneficial factor affecting CR in this group after adjusted for age, blast ratio of bone marrow and FAB classification[OR=0.47 (95% CI 0.31-0.71) , P<0.001]. CR rates in adverse group was 50.0% (18/36) , 60.6% (43/71) and 81.8% (18/22) respectively (P=0.089) . However, the odds ratios (95% CI) of IDA 12 mg/m² when compared with the IDA 8 mg/m² was 0.22 (0.06-0.80) , after adjusted for age, blast ratio of bone marrow and FAB classification. The median time (days) of neutrophil count less than 0.5×10⁹/L in IDA 8 mg/m² group, IDA 10 mg/m² group and IDA 12 mg/m² group were 14 (11-18) , 15 (11-20) and 18 (14-22) , respectively (P=0.012) and of platelet count lower than 20×10⁹/L were 14 (7-17) , 15 (11-20) and 17 (15-21) , respectively (P=0.001) . The incidences of lung infection in the three groups were 9.8%, 13.5% and 25.2%, respectively (P<0.001) . Conclusions For young adult patients (aged 18-60 years) with AML in China, intensifying induction therapy with idarubicin 10 mg/m² is clinically superior to IDA 8 mg/m² and IDA 12 mg/m² in favorable intermediate AML subgroup. However, idarubicin 12 mg/m² is more suitable to adverse AML subgroup.

Objective To investigate the current situation of clinical nurses′ rights & interests maintenance and occupational stress in Hengyang, and explore the relationship between nurses′rights&interests maintenance and occupational stress.Methods Totally 690 nurses from ten secondary and tertiary hospitals in Hengyang were surveyed during August and September 2015 by general information questionnaires, nurses′rights & interests maintenance questionnaire and nurses occupational stress scale.Results The scores of nurses′rights & interests maintenance and nurses′occupational stress were (3.47±0.67), (3.21±0.95). The score and dimension scores of nurses′rights&interests maintenance were negative correlated with the total score and factor scores of nurses′occupational stress (r=-0.263- -0.425,P< 0.01). Job stress, one child or not, age, role adaptation, monthly income were indicated as predictive factors of rights & interests maintenance of nurses. Conclusions Rights & interests maintenance and occupational stress of nurses has a significant correlation, therefore, the medical and health institutions should further implement relevant laws and regulations; protect rights and interests of nurses from different aspects to reduce occupational stress;and stabilize the nursing team and promote development of nursing career.

Objective To analyze the results of screening for tuberculosis (TB) in health examination participants and study the spontaneous occurrence of TB in the subjects with strong positive reaction to tuberculin skin test (TST) in ten years. Method Totally 12 598 health examination participants without past TB history were selected, of whom 8 896 were college students, 2 496 migrant workers and 1 206 had close contacts with active TB patients. They were screened by TST with strong positive reaction. All of subjects with TST strong positive results received chest X-ray examination and sputum acid-fast bacteria detection. The subjects diagnosed to have TB were given regularly anti-tuberculosis drugs treatment and followed up for ten years. The 429 subjects without TB and no isoniazid preventive treatment were chosen to be followed up for ten years and spontaneous occurrence of TB in first three years and the fourth to tenth years respectively, as well as the recurrence of TB for the patients who received anti-tuberculosis regimen were recorded. Result Thirty-seven cases were diagnosed as TB by TST screening, and the total detection rate was 0.29% (37/12 598). Among them 11 were college students (0.12%, 11/8 896), 12 were migrant workers (0.48%, 12/2 496) and 14 were close contacts (1.16%, 14/1 206) respectively. The detection rates were different among the three groups (χ2=31.40, P=0.000). Among 897 strong positive subjects, the strong positive rate was 7.12%(897/12 598), 316 were college students (3.55%, 316/8 896), 388 migrants workers (15.54%, 388/2 496), and 193 close contacts (16.00%, 193/1 206) respectively. There was significant difference in strong positive rate among the three groups (χ2=583.04, P=0.000), and the strong positive rate of college students was lower compared with that of the migrant workers and the close contacts (χ2=483.51 and 344.11, P<0.01). In ten years, 54 subjects were diagnosed as TB in 429 subjects with strong positive reaction to TST, the spontaneous cumulative incidence rate was 12.58% (54/429). Among them, the cumulative morbidity rate was 9.21%(14/152) in college students, 9.58%(18/188) in migrant workers and 24.72%(22/89) in close contacts respectively. The spontaneous morbidity rate of close contacts was higher than that of college students and migrant workers(χ2=10.63 and 11.21, P<0.001); 75 were lost in 398 participants, the dropout rate was 18.84%(75/398). In first three years of follow-up, 31 were diagnosed TB in 429 participants, the cumulative incidence rate was 7.23% (31/429). Of them 9 were college students (5.92%, 9/152), 10 migrant workers (5.32%, 10/188) and 12 close contacts (13.48%, 12/89) respectively (χ2=6.60, P=0.037). In the fourth to tenth years of follow-up, 23 were diagnosed TB in 398 participants, the cumulative incidence rate was 5.78% (23/398), which was not significantly different compared with the cumulative incidence rate of the first three years (χ2=2.50, P=0.37). Tirty-seven patients received standard anti-tuberculosis drug therapy for one year, no one of them had recurrence at ten-year follow-up. Conclusion The migrant workers and close contacts are the high-risk populations for TB. All of them with strong positive response to TST results are susceptible to TB. So regular physical examination is recommended for them and health management should be strengthened.