Objective:To compare behavior problems of children in town and countryside in east China Method:1983 children of 6 years old were collected from towns and countryside of Cangnan county of Zhejiang province They were assessed with Rutter's Children Behavioral Scale The rate of return was 94 3% Result:The prevalence of behavior problems in children of countryside was 12 8%, that of children of town was 7 7% In both children from town and countryside, negative rearing attitudes (i e scold and hit, indulgent), pressure of school exam were all risk factors for behavior problems In children from countryside, risk factors included mother's disadvantage factors In children from town, the risk factors included father's personal problems Conclusion:There were some difference in behavior problems and related factors of children of countryside and town

Objective To evaluate the efficacy and safety of low-dose dexamethasone pretreatment regimen in prevention of hypersensitive reaction (HR) related to docetaxel in elderly tumor patients. Methods According to the order for admission and the ratio of 3:2, 91 elderly patients with docetaxel weekly therapy were randomly divided into two groups: experimental group and control group. All patients aged from 65 to 82 years with a median age of 68 years old. There were 54 patients in the experimental group and 37 patients in the control group. In the experimental group, patients received oral dexamethasone 4. 5 mg once daily on 1 day before treatment, the day of treatment and continuing for 3 days after treatment, while patients received 8 mg twice daily in the control group. All patients were scored according to MCIRS by the physician. The side effects were evaluated by NCI-CTCAE3.0. Results Four cases in the experimental group (7.4 %) and three cases in the control group (8. 1%) occurred HR, and there was no significant statistical difference (P=1. 000). Conclusions The low dose dexamethasone is efficient and safe compared with the conventional dose dexamethasone, and there is no significant difference in HR incidence between two groups.

OBJECTIVE To analyze 28 cases in an outbreak of neonatal enterovirus nosocomial infection during summer of 2006.METHODS Demographic characteristics,clinical manifestations,laboratory data and outcome were analyzed to reveal the clinical severity.RESULTS The outbreak lasted more than one month and the nosocomial infection rate increased to 6.4%.There were 22 cases(78.6%) first presented with fever.Half of the patients were detected enterovirus from blood or cerebrospinal fluid by PCR.All of the 28 cases were diagnosed enterovirus infection based on the contact history,clinical signs and laboratory results.Among them,ten cases had viral meningitis.All patients discharged home after hospitalization with no sequelae.CONCLUSIONS Although this group of neonatal enterovirus infection developed viral meningitis,they had relatively mild illness with benign clinical course.Extreme vigilance is required in interrupting the spread of nosocomial enterovirus infections in neonatal units.This includes respect of strict hygiene measures and meticulous hand-washing.

According to the ISO 9001 quality management standardization,we build a new model by eight principles. Through implement the standardizations,we are benefited of the specification of the management and enhance the research reputation in the institute. We are also obtained the trust of the customers and optimize the research process and enhance the achievement quality.This system is rigorous and abundant.It is specific and manipulate easily.Through implement quality management standardization systems,it can also promote the achievement to transform the productivity in a forward step.

Objective The radioactivity level in historical waste from a plant is high, and decommissioning operators may be exposed to high radiation doses. The objective of the study is to carry out a radiation safety analysis of the retrieval and conditioning of naturally occurring radioactive material (NORM) waste, put forward appropriate radiation protection measures, and minimize the exposure doses of operators. Methods The source terms of NORM waste in the temporary storehouse were analyzed; MicroShield, a point kernel integration program, was used for modeling and calculation; and radiation protection measures under decommissioning conditions were put forward based on on-site monitoring data. Results The maximum gamma dose rate calculated near the waste pile in the temporary storehouse was 313.9 μGy/h, equivalent to the monitoring level; distance decay and appropriate shielding measures significantly reduced gamma dose rates for operators. Conclusion Decommissioning sites of temporary storehouses are of great harm to operators. Measures such as shielding, isolation, remote operations, and personal protection can effectively reduce the exposure doses of operators.

Objective:This study collected a real-world data on survival and efficacy of gemcitabine-containing therapy in advanced breast cancer. Aimed to find the main reasons of affecting the duration of gemcitabine-base therapy in advanced breast cancer patients.Methods:Advanced breast cancer patients who received gemcitabine-base therapy from January 2017 to January 2019 were enrolled(10 hospitals). The clinicopathological data, the number of chemotherapy cycles and the reasons for treatment termination were collected and analyzed. To identify the reasons related with continuous treatment for advanced breast cancer and the factors which affect the survival and efficacy.Results:A total of 224 patients with advanced breast cancer were enrolled in this study, with a median age of 52 years (26-77 years), 55.4%(124/224) was postmenopausal. Luminal type were 83 cases, TNBC were 97 cases, and human epidermal growth factor receptor 2 (HER's-2) overexpression were 44. At the analysis, 224 patients who received the gemcitabine-based regimens were evaluated, included 5 complete reponse (CR), 77 partial response (PR), 112 stable disease (SD) and 27 progressive disease (PD). The objective response rate (ORR) was 36.6%(82/224). Seventy patients had serious adverse diseases, including leukopenia (9), neutrophilia (49), thrombocytopenia (15), and elevated transaminase (2). The median follow-up time was 41 months (26~61 months), and the median PFS was 5.6 months. The reasons of termination treatment were listed: disease progression were 90 patients; personal reasons were 51 patients; adverse drug reactions were 18 patients; completed treatment were 65 patients. It was found that progression-free survival (PFS) was significantly longer in patients receiving >6 cycles than that in patients with ≤6 cycles (8.2 months vs 5.4 months, HR=2.474, 95% CI: 1.730-3.538, P＜0.001). Conclusions:Gemcitabine-based regimen is generally well tolerated in the Chinese population and has relatively ideal clinical efficacy in the real world. The median PFS is significantly prolonged when the number of treatment cycles are appropriately increased.

Background and purpose:For patients with human epidermal growth factor receptor 2(HER2)-positive metastatic breast cancer,trastuzumab treatment can prolong the overall survival and significantly improve the prognosis of patients.However,the reference original research trastuzumab(Herceptin?)is more expensive.Biosimilars have comparable efficacy and safety profiles while increasing patient access to treatment.This clinical trial aimed to evaluate the efficacy,pharmacokinetics,safety and immunogenicity of the trastuzumab biosimilar AK-HER2 compared to trastuzumab(Herceptin?)in patients with HER2-positive metastatic breast cancer.Methods:This multi-center,randomised,double-blind phase Ⅲ clinical trial was conducted in 43 subcenters in China.This study complied with the research protocol,the ethical principles stated in the Declaration of Helsinki and the quality management standards for drug clinical trials.It was approved by the hospital's medical ethics committee.The clinical trial registration agency is the State Food and Drug Administration(clinical trial approval number:2015L04224;clinical trial registration number:CTR20170516).Written informed consent was obtained from subjects before enrollment.Enrolled patients were randomly assigned to the AK-HER2 group and the control group,respectively receiving AK-HER2 or trastuzumab(initial loading dose 8 mg/kg,maintenance dose 6 mg/kg,every 3 weeks as a treatment cycle,total treatment time is 16 cycles)in combination with docetaxel(75 mg/m2,treatment duration is at least 9 cycles).The primary endpoint of this clinical trial was the objective response rate(ORR9)between the AK-HER2 group and the control group in the 9th cycle.Secondary efficacy endpoints included ORR16,disease control rate(DCR),clinical benefit rate(CBR),progression-free survival(PFS)and 1-year survival rate.In this study,100 subjects(AK-HER2 group to control group=1:1)were randomly selected for blood sample collection after the 6th cycle of medication,The collection time points were 45 minutes after infusion(the end of administration),4,8,24,72,120,168,336,and 504 hours after the end of administration.After collection,blood samples were analyzed by PK parameter set(PKPS).Other evaluation parameters included safety and immunogenicity assessment.Results:A total of 550 patients with HER2-positive metastatic breast cancer were enrolled in this clinical trial between Sep.2017 and Mar.2021.In the AK-HER2 group(n=237),129 subjects in the experimental group achieved complete response(CR)or partial response(PR),and the ORR9 was 54.4%.There were 134 subjects in the control group(n=241)who achieved CR or PR,and the ORR9 was 55.6%.The ORR9 ratio between the AK-HER2 group and the control group was 97.9%[90%confidence interval(CI):85.4%-112.2%,P=0.784],which was not statistically significant.In all secondary efficacy endpoints,no statistically significant differences were observed between the two groups.We conducted a mean ratio analysis of pharmacokinetics(PK)parameters between the AK-HER2 group and the control group,and the results suggested that the pharmacokinetic characteristics of the two drugs are similar.The incidence of treatment emergent adverse event(TEAE)leading to drug reduction or suspension during trastuzumab treatment was 3.6%(10 cases)in the AK-HER2 group and 8.1%(22 cases)in the control group.There was statistically significant difference between the two groups(P=0.027).The incidence rate was significantly lower in the AK-HER2 group than in the control group,and there was no statistically significant difference among the other groups.The differences in the positive rates of anti-drug antibodies(ADA)and neutralizing antibodies(NAB)between groups were of no statistical significance(P=0.385 and P=0.752).Conclusion:In patients with HER2-positive metastatic breast cancer,AK-HER2 was comparable to the trastuzumab(Herceptin?)in terms of drug efficacy,pharmacokinetics,safety and immunogenicity.

Objective:This study collected a real-world data on survival and efficacy of gemcitabine-containing therapy in advanced breast cancer. Aimed to find the main reasons of affecting the duration of gemcitabine-base therapy in advanced breast cancer patients.Methods:Advanced breast cancer patients who received gemcitabine-base therapy from January 2017 to January 2019 were enrolled(10 hospitals). The clinicopathological data, the number of chemotherapy cycles and the reasons for treatment termination were collected and analyzed. To identify the reasons related with continuous treatment for advanced breast cancer and the factors which affect the survival and efficacy.Results:A total of 224 patients with advanced breast cancer were enrolled in this study, with a median age of 52 years (26-77 years), 55.4%(124/224) was postmenopausal. Luminal type were 83 cases, TNBC were 97 cases, and human epidermal growth factor receptor 2 (HER's-2) overexpression were 44. At the analysis, 224 patients who received the gemcitabine-based regimens were evaluated, included 5 complete reponse (CR), 77 partial response (PR), 112 stable disease (SD) and 27 progressive disease (PD). The objective response rate (ORR) was 36.6%(82/224). Seventy patients had serious adverse diseases, including leukopenia (9), neutrophilia (49), thrombocytopenia (15), and elevated transaminase (2). The median follow-up time was 41 months (26~61 months), and the median PFS was 5.6 months. The reasons of termination treatment were listed: disease progression were 90 patients; personal reasons were 51 patients; adverse drug reactions were 18 patients; completed treatment were 65 patients. It was found that progression-free survival (PFS) was significantly longer in patients receiving >6 cycles than that in patients with ≤6 cycles (8.2 months vs 5.4 months, HR=2.474, 95% CI: 1.730-3.538, P＜0.001). Conclusions:Gemcitabine-based regimen is generally well tolerated in the Chinese population and has relatively ideal clinical efficacy in the real world. The median PFS is significantly prolonged when the number of treatment cycles are appropriately increased.

Objective : To analyze the overall survival( OS) of sequential osimertinib treatment in patients with epidermal growth factor receptor(EGFR) exon 20 T790M mutant advanced non⁃small cell lung cancer(NSCLC) and risk factors of the efficacy of sequential osimertinib treatment. Methods : The data of 138 advanced NSCLC patients with acquired EGFR exon 20 T790M mutation who took sequential osimertinib as second⁃line treatment. KaplanMeier variable was used for survival analysis. The Log⁃rank method was used for univariate analysis. The COX risk regression model was used for multivariate analysis. The survival status and influencing factors of patients treated with sequential osimertinib were analyzed. Results : At the last follow⁃up , 99 of the 138 patients died. Median progression free survival (PFS1)of first⁃line of first⁃ or second⁃generation epidermal growth factor receptor tyrosine kinase inhibitors(EGFR⁃TKIs) was 11 months (95% CI: 10. 1 - 11. 9) ; median PFS2 of osimertinib was 10 months (95% CI: 8. 5 - 11. 5) ; The median PFS with sequential osimertinib treatment was 24 months(95% CI: 21. 7 -26. 3) , the median OS was 32 months(95% CI: 28. 9 - 35. 1) . In univariate and multivariate analysis , PFS1 was an independent prognostic factor for PFS and OS(P < 0. 001) . Conclusion Sequential osimertinib treatment for advanced NSCLC patients with acquired EGFR exon 20 T790M mutation achieved good PFS(24 months) and OS (32 months) .