Humans ; Aged ; Lung Diseases ; Pneumonia/drug therapy* ; Adrenal Cortex Hormones/therapeutic use* ; Pulmonary Disease, Chronic Obstructive/drug therapy* ; Administration, Inhalation ; Community-Acquired Infections/drug therapy*

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 To explore the effects of drug therapy combined with multi-dimensional psychological intervention on the insomnia of shift medical staff in"sunshine hospital"mode,and to provide a reference for improving the physical and mental health of shift medical staff.Methods A total of 140 cases of medical staff with insomnia in shifts in Wuhan were included and divided into study group and control group by random number table method,70 cases in each group.The control group was given drug treatment,and the study group was treated combined with multi-dimensional psychological intervention.based on"sunshine hospital"model.The scale and questionnaire of PSQI,ISI,ESS and FAS were used to evaluate sleep status and HAMD,HAMA,PHQ-9 and SAS were used to evaluate psychological status,at baseline,visit 1(baseline+intervention for 1 month)and visit 2(baseline+intervention for 3 months),respectively.Results(1)Sleep status:There were differences in 7 dimensions of PSQI score,ISI,ESS,and FAS score between the study group and the control group at different periods(P<0.05);Among them,the PSQI scores of the two groups showed significant difference between the two groups at interview 2(P<0.05);There were significant differences in sleep quality,sleep efficiency scores,ESS and FAS between the two groups at visit 1 and visit 2(P<0.05).(2)Psychological status:HAMD,HAMA,PHQ-9 and SAS scores of the study group and the control group were different in different periods(P<0.05).At interview 2,there were significant differences in HAMA and SAS scores between the two groups(P<0.05).Conclusion Based on the"sunshine hospital"model of drug therapy combined with multi-dimensional psychological intervention,it can significantly improve sleepiness,fatigue symptoms,sleep quality,sleep efficiency,and anxiety and depression of first-line shift medical staff in the short term,and significantly alleviate overall insomnia and anxiety in the long term.

Objective:To explore the effect of transitional care led by special disease nurses in patients with venous thromboembolism (VTE) after intervention.Methods:From February 2020 to April 2021, 124 patients undergoing VTE intervention in Vascular Surgery of Xinxiang Central Hospital were selected by convenient sampling. According to the propensity matching score of 1∶1, the patients were divided into the control group and the observation group, with 62 cases each. The control group was given routine nursing, and the observation group received transitional care led by special disease nurses on the basis of the control group. The follow-up lasted for 12 months. The severity of post-venous thrombosis syndrome (Villalta Scale score), medication compliance, follow-up compliance and quality of life score were compared between the two groups.Results:The completion rates of follow-up at the end of 3, 6 and 12 months in the control group were 95.16% (59/62), 82.26% (51/62) and 70.97% (44/62), respectively. The completion rates of follow-up at the end of 3, 6 and 12 months in the observation group were 100.00% (62/62), 96.77% (60/62) and 91.94% (57/62), respectively. The completion rate of follow-up at each time point in the observation group was higher than that in the control group, and the differences were statistically significant at the end of 6 and 12 months ( P<0.05). The Villalta score of the control group and the observation group increased gradually. The Villalta scores of the observation group at the end of 3, 6 and 12 months were lower than that of the control group, with statistically significant differences ( P<0.05). The score of medication compliance in the control group decreased gradually, while the score of medication compliance in the observation group increased gradually. The scores of medication compliance in the observation group at the end of 3, 6 and 12 months were higher than that in the control group, with statistically significant differences ( P<0.05). The quality of life score of the observation group gradually increased, and the quality of life scores of the observation group at the end of 6 and 12 months were higher than those of the control group, the differences were statistically significant ( P<0.05) . Conclusions:The transitional care led by special disease nurses can effectively increase the postoperative follow-up and medication compliance of VTE patients, reduce the severity of post-venous thrombosis syndrome and improve the quality of life.

Objective : To evaluate the effects of low temperature plasma modification on the surface morphology and bonding durability of zirconia ceramics. Methods: 180 pieces of zirconia ceramic(Y-TZP) were randomly divided into 5 groups(n= 36). Group A:blank group; Group B:sandblast group; Group C:nitrogen( N2) plasma group; Group D:oxygen(O2) plasma group; Group E:argon(Ar) plasma group. The surface hydrophilicity and microstructure of zirconia ceramics were observed,and the changes of surface elements and functional groups were detected. Each group of bonded specimens was randomly divided into two subgroups(n= 15). After receiving 0 and10 000 cycles of heat and cold,the shear strength was measured. The measured results were statistically analyzed and the fracture mode was analyzed. Results: The surface contact angles of groups B,C,D and E were significantly lower than those of group A,with statistically significant differences(P<0. 001). Compared with group A,the surface morphology of group C,D and E did not significantly change,while that of group B significantly changed. XPS showed that the surface carbon decreased,oxygen increased and carbon/oxygen ratio decreased after plasma treatment. SBS results showed that the immediate shear bonding strength of group A was lower than that of the other four groups(P<0. 001),and there was no significant difference in the immediate shear bonding strength of groups B,C,D and E(P>0. 05);After artificial aging,the shear bonding strength of group A was significantly lower than that of the other four groups,and the difference of shear bonding strength between groups A and B before and after artificial aging was statistically significant(P<0. 001). Conclusion The zirconia ceramics achieves better bonding strength and durability with resin cement through three kinds of low temperature plasmas,without changing the surface morphology.

Objective:To study the radiation dose rate and effective dose in ambient environment due to 125I seed implantation in the treatment of the patients suffering abdominal and pelvic tumors, so as to provide reference for occupational protection of different groups. Methods:Within 24 hours after operation, the radiation dose rate to 42 patients with abdominal and pelvic tumor with 125I seed implantation was monitored by using pocket dosimeter. The relationships between the total activity in the implanted particles and the measured dose rate, as well as between the implanted depth and the dose rate under the standard activity, were obtained by curve fitting. According to the formula, the relationship between the dose rate and the warning time was calculated. Results:The dose rates at 30 cm, 50 cm and 100 cm of vertical particle implantation site were (6.92±2.87), (4.10±1.62) and (1.30±0.48) μSv/h, respectively ( χ2=73.71, P<0.05). The dose rates on the left and right sides were (0.378±0.156) and (0.384±0.153) μSv/h at 30 cm, (0.170±0.089) and (0.17±0.086) μSv/h at 50 cm, (0.039 ±0.014) and (0.043±0.017) μSv/h at 100 cm, respectively ( χ2=76.19, 76.33, P<0.05). There was a linear relationship between the dose rate at the vertical particle implantation site and the total activity in the implanted particles, and between the dose rate and the implantation depth under the standard activity. The relationship between the warning time and the dose rate to adults in the same bed, co-workers, minors in the same bed and pregnant women were as follows: t ( d)=-106.616+ 83.779ln D( t), t ( d)=26.556+ 85.933ln D ( t), t( d)=3.088+ 85.017ln D( t). Conclusions:After 125I seed implantation, the radiation dose in the ambient environment is low, ensuring the radiation safety; and the measured dose rate decreases with the decrease in the total activity in the implanted particle and the increase in the implantation depth; at the same time, the warning time for different groups is calculated according to the measured dose rate or the total activity in the implanted particle and the depth of the implanted particle, so as to carry out individualized protection.

Objective:To investigate the significance and regulatory mechanism of miR-142-3p and ER1 in serum and placenta of pregnant women with gestational diabetes mellitus (GDM) complicated with preeclampsia (PE) in the occurrence and development of disease.Methods:A total of 198 pregnant women admitted from Jun. 2019 to Jun. 2020 were selected as the study subjects, including 66 pregnant women with GDM (GDM group) , 60 pregnant women with GDM complicated with PE (GDM+PE group) and 72 normal pregnant women (control group) . Clinical indicators were detected and pregnancy outcome data were collected. The relative expression levels of miR-142 -3p and ER1 mRNA in serum and placental tissues of study subjects were determined by quantitative real-time polymerase link assay. The expression of ER1 protein in the placenta was detected by Western blot. Human choriotrophoblast cells HTR-8/SVneo were treated with miR-142-3p.Results:The expression levels of miR-142-3p in serum and placenta tissues in GDM+PE group were significantly lower than those in GDM+PE group and control group ( P<0.05) . The mRNA expression of ER1 in serum and placenta in GDM+PE group was significantly higher than that in GDM+PE group and control group ( P<0.05) . There was a significant negative correlation between the relative expression levels of miR-142-3p and ER1 mRNA in serum and placental tissues of pregnant women in the GDM+PE group ( r=-0.589 and -0.643, P=0.006 and < 0.001) .After transfection of HTR-8/SVneo cells with miR-142-3p, ER1 mRNA expression in the mimic group was 1.09±0.14,significantly lower than that of NC group (2.14±0.52) , inhibitor group (3.69±0.88) and inhibitor NC group (2.26±0.43) ( P<0.001) . The expression of DNMT1 in inhibitor group was significantly higher than that in the other three groups ( P<0.001) . Conclusion:In patients with GDM complicated with PE, miR-142-3p levels are reduced and ER1 levels are increased, which may be involved in the occurrence and progression of the disease.

Objective: To understand indoor air quality in middle and primary schools of Hangzhou in autumn and winter seasons, and to provide references of promoting indoor air quality of schools. Methods: Totally 33 classrooms of 11 schools in urban area were selected into study during Sept.2018 to Jan.2019. Daily measurements of PM2.5 and CO2 were performed in selected classes during school working time by air quality monitors. Totally, monitoring data of 35 964 hours were analyzed using univariate and multiplicity analysis for PM2.5 and CO2 level, variability and possible influence factors. Results: In autumn and winter, hourly average values of classroom PM2.5 and CO2 concentration level in Hangzhou were between 35.30 to 74.65 μg/m3 and between 949.17 to 2 029.98 mg/m3, respectively. The concentration levels of PM2.5 and CO2 were higher with the temperature(F=1 412.84, 775.66, P<0.01). No statistical significance was be found for the difference of PM2.5 concentration among monitoring times. Wave changes in CO2 were observed with time variation PM2.5 and CO2 concentration level of 68.42% monitoring times was complied with standards. School type and temperature correlated with PM2.5 concentration level. The PM2.5 concentration level in senior high school was higher than that in junior high school, while the value in primary school was the minimum(β=0.44, P<0.01). And the PM2.5 concentration increased with the temperature decreased(β=8.31, P<0.01). School type, temperature and monitoring time correlated with CO2 concentration level. CO2 concentration increased with the increase of grade, decrease in temperature and later time during the day(β=213.64, 162.38, P<0.01). The CO2 concentration level in later monitoring time was lower than that in earlier monitoring time(β=-16.28, P<0.01). Conclusion Classroom CO2 concentration level in Hangzhou was closed to that in European schools, while PM2.5 concentration level was much higher. Comparing with other cities in China, classroom PM2.5 and CO2 concentration level in Hangzhou is better. The results highlighted that school location, design and routine management should be advanced consideration for good air quality in classroom.

This study aimed to evaluate the efficacy of Chinese herbal medicine (CHM) in patients with severe/critical coronavirus disease 2019 (COVID-19). In this retrospective study, data were collected from 662 patients with severe/critical COVID-19 who were admitted to a designated hospital to treat patients with severe COVID-19 in Wuhan before March 20, 2020. All patients were divided into an exposed group (CHM users) and a control group (non-users). After propensity score matching in a 1:1 ratio, 156 CHM users were matched by propensity score to 156 non-users. No significant differences in seven baseline clinical variables were found between the two groups of patients. All-cause mortality was reported in 13 CHM users who died and 36 non-users who died. After multivariate adjustment, the mortality risk of CHM users was reduced by 82.2% (odds ratio 0.178, 95% CI 0.076-0.418; P < 0.001) compared with the non-users. Secondly, age (odds ratio 1.053, 95% CI 1.023-1.084; P < 0.001) and the proportion of severe/critical patients (odds ratio 0.063, 95% CI 0.028-0.143; P < 0.001) were the risk factors of mortality. These results show that the use of CHM may reduce the mortality of patients with severe/critical COVID-19.
Age Factors ; Aged ; COVID-19/therapy* ; China ; Drugs, Chinese Herbal/therapeutic use* ; Female ; Humans ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Odds Ratio ; Propensity Score ; Retrospective Studies ; Survival Rate

Objective To explore the effect of conbercept combined with operation on treatment of patients with neovascular glaucoma.Methods A total of 10 patients with neovascular glaucoma (10 eyes) were selected and randomly divided into experimental group and control group.The experimental group was treated with intravitreal injection of conbercept plus trabeculectomy and panretinal photocoagulation (PRP),while the control group was treated with atropine,glucocorticoid and panretinal photocoatulation.The pre-treatment and post-treatment visual acuity,intraocular pressure and vascular endothelial growth factor (VEGF) expression in serum and humor aqueous were compared.Results After treatment,the visual acuity improved significantly (P ＜ 0.05).The intraocular pressure of the experimental group and control group before treatment and after treatment decreased significantly (P ＜ 0.05).The expression level of the post-treatment VEGF in serum and humor aqueous in the experimental group and control group decreased significantly,and the level of VEGF experimental group was much more lower (P ＜ 0.05).Conclusion Application of conbercept combined with surgery can effectively improve the clinical symptoms and reduce intraocular pressure in patients with neovascular glaucoma.