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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.
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Objective To investigate the present situation of radiation environment in Beijing and provide data support for monitoring and management of radiation environment in Beijing. Methods The γ radiation dose rate of environmental surface as well as the radioactive levels of aerosol, sediment, surface water, and soil samples were monitored in Beijing from 2015 to 2022. The radioactive levels of various environmental elements in this area were presented using statistical charts and statistical tables, and the related issues were discussed. Results The automatic monitoring and cumulative monitoring results of γ radiation dose rate were in the range of local natural background fluctuation. The radioactive levels of beryllium-7, lead-210, and polonium-210 in aerosols were low in summer and high in winter. The radioactive levels of total α, total β, and beryllium-7 in sediments were low in winter and high in summer. The activity concentration of radionuclide potassium-40 in aerosols and sediments did not change significantly with seasons. The total α and total β radioactivity levels of surface water fluctuated within the range of background. These values of reservoir water were within the limits specified in the Hygienic Standard for Drinking Water (GB 5749—2006). Natural radionuclides in soil were within the range of natural background fluctuation, and artificial radionuclides in soil were within the range of normal fluctuation over the years. Conclusion From 2015 to 2022, the environmental surface γ radiation dose rate as well as aerosol, sediment, surface water, and soil radioactivity levels in Beijing were generally low, all of which fluctuated within the environmental background.
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Purpose@#This study aims to evaluate the efficacy and safety of trastuzumab biosimilar (HLX02) in combination with pertuzumab and chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)–positive metastatic breast cancer (MBC) after progression of trastuzumab. @*Materials and Methods@#In this prospective, single-arm, phase II study, patients with HER2-positive MBC after progression of trastuzumab received pertuzuamb, HLX02, and chemotherapy in Beijing Cancer Hospital from March 2020 to December 2022. The primary endpoint was progression-free survival (PFS), and secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety. The study was registered with ClinicalTrials.gov (NCT05188495). @*Results@#A total of 45 patients were included in this study. Twelve patients (26.7%) were treated in second-line and 33 patients (73.3%) were in third-line and later setting. Eighty percent and 15.5% patients had previously received pyrotinib/lapatinib and T-DM1, respectively. With a median follow-up of 24.4 months (range, 1.2 to 43.9 months), the median PFS was 7.6 months (95% confidence interval, 4.3 to 10.9), OS was not reached, the ORR was 31.1%, and DCR was 91.1%. The treatment was well tolerated. @*Conclusion@#The combination of trastuzumab biosimilar HLX02, pertuzumab, and chemotherapy exhibited promising efficacy and a favorable safety profile as second- and beyond-line treatment in HER2-positive MBC.
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Entinostat plus exemestane in hormone receptor-positive (HR+) advanced breast cancer (ABC) previously showed encouraging outcomes. This multicenter phase 3 trial evaluated the efficacy and safety of entinostat plus exemestane in Chinese patients with HR + ABC that relapsed/progressed after ≥1 endocrine therapy. Patients were randomized (2:1) to oral exemestane 25 mg/day plus entinostat (n = 235) or placebo (n = 119) 5 mg/week in 28-day cycles. The primary endpoint was the independent radiographic committee (IRC)-assessed progression-free survival (PFS). The median age was 52 (range, 28-75) years and 222 (62.7%) patients were postmenopausal. CDK4/6 inhibitors and fulvestrant were previously used in 23 (6.5%) and 92 (26.0%) patients, respectively. The baseline characteristics were comparable between the entinostat and placebo groups. The median PFS was 6.32 (95% CI, 5.30-9.11) and 3.72 (95% CI, 1.91-5.49) months in the entinostat and placebo groups (HR, 0.76; 95% CI, 0.58-0.98; P = 0.046), respectively. Grade ≥3 adverse events (AEs) occurred in 154 (65.5%) patients in the entinostat group versus 23 (19.3%) in the placebo group, and the most common grade ≥3 treatment-related AEs were neutropenia [103 (43.8%)], thrombocytopenia [20 (8.5%)], and leucopenia [15 (6.4%)]. Entinostat plus exemestane significantly improved PFS compared with exemestane, with generally manageable toxicities in HR + ABC (ClinicalTrials.gov #NCT03538171).
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Objective:To explore independent predictors for poor outcome at 3 months in elderly patients with acute cerebral infarction(ACI)treated with intravenous thrombolysis(IVT), and to develop a nomogram-based predictive model.Methods:This was a retrospective cohort study.Clinical, laboratory and imaging data of 346 elderly patients with ACI treated with IVT from January 2016 to April 2021 in our hospital were collected.Poor outcome was defined as a modified Rankin Scale(mRS)score >2 at 3 months after the stroke.Logistic regression analysis was used to screen for independent factors predicting poor outcome in elderly ACI patients treated with IVT, and a corresponding nomogram model was developed using the R software.The ROC curve, calibration plots and decision curve analysis were used to evaluate discrimination, calibration and clinical application value of the nomogram model.Results:Among 346 candidates, 109 developed a poor outcome, representing a rate of 31.5%.Logistic regression analysis showed that symptomatic hemorrhagic transformation( OR=15.647, 95% CI: 8.913-27.454), stroke severity(moderate stroke, OR=3.322, 95% CI: 1.414-7.811; moderate-severe stroke, OR=8.169, 95% CI: 4.102-16.258; severe stroke, OR=9.653, 95% CI: 5.440-17.121), stroke-associated pneumonia( OR=2.239, 95% CI: 1.134-4.420), and heart failure( OR=2.758, 95% CI: 1.424-5.336)were independent predictors for poor outcome at 3 months in elderly ACI patients treated with intravenous thrombolysis(all P<0.05). With the area under curve(AUC-ROC)value at 0.85(95% CI: 0.80-0.89), the nomogram model, which was composed of the above four predictors, demonstrated good discrimination.On the calibration plot, the mean absolute error was 0.020, indicating that the model had good calibration.Decision curve analysis revealed that the model had good clinical application value. Conclusions:The nomogram model composed of symptomatic hemorrhagic transformation, stroke severity, stroke-associated pneumonia and heart failure may predict poor outcome at 3 months in elderly ACI patients treated with IVT, with high prediction accuracy and high clinical application value.
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Objective:To construct a set of sensitive quality indexes for specialized nursing in dental clinics. These indicators are used to monitor and evaluate the quality of dental outpatient nursing care.Methods:Based on "structure-process-outcome" three-dimensional theory, through literature research, semi-structured interviews with 14 medical and nursing staff in Hefei Stomatological Hospital and two rounds of Delphi expert consultation with 19 stomatological management experts in stomatology departments of 19 first-class hospitals or third-class stomatological specialized hospitals in 11 provinces and cities in China, the three-level index system was determined, the calculation formula and data collection method of each index were clarified, and the weight of each index was determined by analytic hierarchy process.Results:The effective recovery rate of the two rounds of expert consultation was 100% and 89.47%. The expert authority coefficient were 0.905 and 0.906. Kendall′s W coefficients of the first, second and third level indicators in the second round of consultation were 0.206, 0.122 and 0.114. The differences were statistically significant ( χ2=7.00, 18.61, 149.23, all P<0.05). These indicators were assigned importance values ranged from 4.12 to 4.88 (>3.50), and coefficient of variations ranged from 0.07 to 0.23(<0.25). The final indicators included 3 first-level indicators, 10 second-level indicators and 26 third-level indicators. Conclusions:The research method of the constructed index is scientific, the content is reliable and the pertinence is strong. These indicators are conducive to the objective evaluation of the quality of dental outpatient care.
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Objective To investigate and evaluate the changes in total α and total β radioactivity levels in drinking water in Beijing, China, 2012—2021. Methods The test results of total α and total β radioactivity levels at 14 monitoring sites from 9 groundwater sources and 5 surface water sources in Beijing, 2012—2021 were collected. The radioactivity levels in the two types of water sources were compared. Statistical charts were used to show the monitoring situation at sampling sites in different regions during different periods, and related issues were explored. Results The total α and total β activity concentrations measured at monitoring sites from some water sources in Beijing, 2012—2021, were less than the total α and total β guideline values specified in the Standards for Drinking Water Quality (GB 5749—2006) (total α: 0.5 Bq/L, total β: 1.0 Bq/L). The mean total α activity concentration in the groundwater was significantly higher than that in the surface water. The total α and total β radioactivity levels in the reservoir D in the surface water were slightly higher than those in the other surface water. Conclusion In the past decade from 2012 to 2021, the total α and total β radioactivity levels in some water sources in Beijing were generally in a good condition and fluctuated within the range of environmental background values, without significant changes on the whole.
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Objective:To explore the effect of holding a spiny massaging ball intervention in intraoperative management of patients′ pain and anxiety during Percutaneous Transforaminal Endoscopic Discectomy under local anesthesia.Methods:90 cases of patients undergoing PTED with local anesthesia in our hospital were recruited and randomly divided into the experimental group and the control group. The experimental group squeezed a spiny massaging ball during the surgery, and the control group only received routine care. The patients′ pain degree, anxiety degree, satisfaction and Heart rate, blood pressure were measured.Results:The scores of intraoperative pain, anxiety in the experimental group were significantly lower than those in the control group( t=7.858 and 2.260, P<0.05). There were no obvious change in satisfaction( P>0.05). The changes of heart rate and blood pressure in the experimental group were small, compared with the control group ( P<0.05). Conclusion:The intervention of holding a spiny massaging ball can effectively alleviate patients′ pain and anxiety during PTED under local anesthesia, stable patients′ heart rate, blood pressure changes, improve surgical comfort and safety.
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Objective:To understand the clinical diagnosis and treatment ability of Chinese and French medical students, so as to improve the education of clinical medicine in China, improve the diagnosis and treatment ability of medical students, and provide reference for improving training quality of medical personnel.Methods:Retrospective analysis was made on the clinical skills competition of Chinese and French medical students, and the percentages of three categories of students' scores were compared (1 team of general practice residents, 3 teams of Chinese undergraduates, and 3 teams of French undergraduates).Results:In clinical basic skills such as electrocardiogram and imaging interpretation site, the scores of general practice residents were higher than those of Chinese and French undergraduates, and there was no significant difference between Chinese and French undergraduates. In clinical virtual case sites, except for few items in surgery site, general practice residents and Chinese undergraduates were better than French undergraduates in many evaluation items. In the internal medicine site, 6 out of 8 scoring items of French undergraduates were higher than those of Chinese undergraduates. In the medical team comprehensive first-aid site, 8 out of 10 scoring items of Chinese undergraduates were higher than those of French undergraduates.Conclusion:Clinical thinking and decision-making of undergraduates in our university need to be improved compared with that of French students. The general practice residents in our school need to be strengthened in the aspects of clinical thinking, decision-making and the cooperation with emergency team.
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Objective:To investigate the protective effect of external diaphragm pacing on the prevention of ventilator-induced diaphragm dysfunction (VIDD) in rabbits and its mechanism.Methods:Eighty-five New Zealand white rabbits were randomly (random number) divided into the blank control group (BC, n=5), spontaneous breathing group (SB, n=20), volume control ventilation group (VC, n=20), external diaphragm pacing group (EDP, n=20), external diaphragm pacing and volume control ventilation group (EDP+ VC, n=20). After successful modeling, the rabbits in each group were treated accordingly except for the BC group. Rabbitss in the BC group were not mechanically ventilated, and the diaphragm was removed immediately after anesthetizing. Whole diaphragms of 5 rabbits per time point per other group were also collected after anesthesia at post treatment hour (PTH) 6 and on post treatment day (PTD) 1, 3, and 7. Diaphragm weight/body weight and diaphragm isometric contractile force of each group were measured. The pathological changes of diaphragmatic tissues were observed by HE staining. The protein expressions of Cyt c, RyR1, caspase-3, and p-mTORC1 were measured by Western blot. Repeated measures analysis of variance was used for the comparison between multiple groups of variables at different time points, and LSD- t test was used for the further comparison between two groups at the same time point, a P<0.05 was considered statistically significant. Results:Compared with the BC group, the VC group showed diaphragmatic pathological changes conformed to VIDD: DW/BW was decreased obviously; HE staining revealed obvious changes in diaphragmatic tissue; Diaphragmatic contractility was also significantly decreased; The expression of Cyt c and caspase-3 were increased while the expression of RyR1 and p-mTORC1 were decreased gradually with the extension of treatment time ( P<0.05). Compared the EDP+VC group with the VC group, with the extension of treatment time, DW, DW/BW, pathological damages and diaphragmatic contractility were improved [PTD 1: (0.80±0.05)kg vs (0.56±0.04) kg, PTD 3: (1.06±0.05) kg vs (0.47±0.03) kg, PTD 7: (1.24±0.10) kg vs (0.39±0.07) kg, all P<0.05; PTD 1: (2.05±0.54) vs (1.86±0.72), PTD 3: (2.19±0.61) vs (1.74±0.40), PTD 7: (2.46±0.62) vs (1.53±0.85), all P<0.05; PTD 1: (2.39±0.42) N/cm 2vs (1.91±0.25) N/cm 2, PTD 3: (2.57±0.62) N/cm 2vs (1.72±0.50) N/cm 2, PTD 7: (2.77±0.55) N/cm 2vs (1.54±0.33) N/cm 2, all P<0.05]. The expression of Cyt c and caspase-3 were decreased while the expression of RyR1 and p-mTORC1 were increased gradually in the EDP+VC group ( P<0.05). Conclusions:External diaphragm pacer plays a protective role in ventilator-induced diaphragm dysfunction, which can inhibit mitochondrial damage, reduce oxidative damage, and mitigate diaphragmatic atrophy and injury.
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Background@#Maedi/Visna virus (MVV) is a contagious viral pathogen that causes considerable economic losses to the sheep industry worldwide. @*Objectives@#In China, MVV has been detected in several regions, but its molecular characteristics and genetic variations were not thoroughly investigated. @*Methods@#Therefore, in this study, we conducted next-generation sequencing on an MVV strain obtained from northwest China to reveal its genetic evolution via phylogenetic analysis. @*Results@#A MVV strain obtained from Inner Mongolia (NM) of China was identified. Sequence analysis indicated that its whole-genome length is 9193 bp. Homology comparison of nucleotides between the NM strain and reference strains showed that the sequence homology of gag and env were 77.1%–86.8% and 67.7%–75.5%, respectively. Phylogenetic analysis revealed that the NM strain was closely related to the reference strains isolated from America, which belong to the A2 type. Notably, there were 5 amino acid insertions in variable region 4 and a highly variable motif at the C-terminal of the surface glycoprotein (SU5). @*Conclusions@#The present study is the first to show the whole-genome sequence of an MVV obtained from China. The detailed analyses provide essential information for understanding the genetic characteristics of MVV, and the results enrich the MVV library.
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Objective:To analyze the association of sleep apnea hypopnea syndrome (SAHS) and diabetic kidney disease (DKD) in elderly type 2 diabetes (T2DM) patients and to explore possible mechanism.Methods:84 elderly hospitalized patients with T2DM and had underwent sleep breathing monitoring in Guangzhou First People's Hospital during March 2018 to January 2019 were collected.Those patients were divided into three groups according to their apnea-hypopnea indices (AHI): no or mild SAHS group, moderate group and severe group. The general clinical data, blood biochemical indexes, urinary albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) were collected and compared among the three groups. Multiple regression analysis was used to analyze the influencing factors of eGFR and lnUACR in elderly patients with type 2 diabetes.Results:The lowest SpO 2 and eGFR in moderate and severe SAHS group were lower than those in no or mild SAHS group, while the UACR, homocysteine (Hcy), serum amyloid (SAA), AHI, oxygen desaturation index (ODI), serum creatinine, Cystatin C and high sensitivity C-reactive protein (hsCRP) were higher in moderate and severe SAHS group than those in no or mild SAHS group ( P<0.05). The severity of SAHS was positively correlated with the stage of chronic kidney disease (CKD) and albuminuria level ( r=0.504, 0.382, P<0.05). Multiple linear regression model showed that lnAHI, hemoglobin A1c (HbA1c) and systolic blood pressure (SBP) were independently correlated with eGFR; lnAHI and SBP were independently correlated with lnUACR; ODI, gender and age were independently correlated with EGFR; ODI and SBP were independently correlated with lnUACR. Conclusions:SAHS is an independent risk factor for renal complications in elderly diabetic patients, and its mechanism may be related to oxidative stress and inflammatory reaction.
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Objective: To evaluate the efficacy and safety of PEG-rhG-CSF therapy in the primary and secondary prevention of chemo-therapy-induced neutropenia . Methods: This single-center, one-arm, and open-label clinical study involved 217 patients with non-my-eloid malignant tumors. These patients included 18 gynecologic oncology (3 endometrial and 15 ovarian cancer), 50 breast cancer, 30 bone tumor, and 119 lymphoma patients who underwent a total of 774 cycles of chemotherapy, comprising 146 primary and 71 sec-ondary prevention patients. The patients ≥45 kg and those <45 kg received a single subcutaneous injection of 6 mg and 3 mg PEG-rhG-CSF, respectively, 24-48 h after the chemotherapy was completed. All patients received only one dose of PEG-rhG-CSF admin-istration per chemotherapy cycle. Results: The overall incidence of febrile neutropenia (FN) was found to be 5.7%, with rates of 4.9% and 7.2% in the primary and secondary prevention groups, respectively. Univariate and multivariate Logistic regression analyses re-vealed that the longer PEG-rhG-CSF was sustained in the treatment cycle, the lower the incidence of FN was. The incidence of FN was significantly lower in the second cycle of the treatment than in the first in both the primary and secondary prevention groups (cycle 1 vs. cycle 2: 11.6% vs. 4.4%, respectively, P=0.039, in the primary group; 16.9% vs. 5.6%, respectively, P=0.034, in the secondary group). The overall incidence of gradeⅣneutropenia was 10.3% (80/774), with rates of 6.7% (34/510) and 17.4% (46/264) in the primary and secondary prevention groups, respectively (P<0.001). The incidence of gradeⅣneutropenia was significantly lower in the second cy-cle of the treatment than in the first (cycle 1 vs. cycle 2: 17.1% vs. 5.3%, respectively, P=0.004, in the primary group; 46.5% vs. 11.3%, respectively, P<0.001, in the secondary group). The treatment-induced toxicity mainly involved bone pain, with 3.7% (8/217) and 1.8% (4/217) incidence rates for grade 1-2 and 3-4 bone pain, respectively. Conclusions: PEG-rhG-CSF administration can effectively reduce the incidence of FN (5.7%) when prophylactically applied to patients with non-myeloid malignant tumors. Primary prevention can sig- nificantly reduce the risk of grade IV neutropenia in all chemotherapy cycles relative to the secondary prevention.
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A laboratory animal expert consultation system provides an interactive platform for industry experts and users. Based on intelligent mobile terminal used as the application supporter, the platform combines the internet with laboratory animal to share the experts' knowledge, breaks through temporal and spatial restrictions, and resolves other problems such as poor timeliness of inquire service, knowledge data staticization, and irrational exploitation of internet to gain prompt inquire service. The platform would meet the needs of industry users for real-time aids and bridge the gap between industry experts and users. Thus, the transfer of expert' knowledge is realized in pace with the increasing knowledge resource of this platform to accelerate the transformation of theoretical knowledge into the industry. Our study focuses on the system characteristics, the main frame structure, the design of function module and the system implementation.
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Objective:To systematically review the resilience intervention in patients with cancer, so as to evaluate its effectiveness. Methods: Studies published until March 2017 were searched in CNKI, VIP, WanFang Data, CBM, PubMed, Cochrane library, Wiley Online Library, Elsevier ScienceDirect, Springer Link and EBSCO. The randomized controlled trials(RCTs) about resilience intervention in patients with cancer were included. Two reviewers independently performed screening, quality assessment and data extraction Qualitative synthesis was adopted to review the resilience intervention and to evaluate its effectiveness of included studies. Results: Totally 14 studies were included for the analysis. Eight studies evaluated the effectiveness of individuation intervention, and 6 studies evaluated the effectiveness of group intervention. Thirteen studies suggested that individuation intervention and group intervention might significantly improve the resilience in cancer patients. Conclusion: The results suggest individuation or group intervention may improve the resilience in patients with cancer. Current studies on resilience intervention are limited, and the measure has been taken seems lacks of high-quality research design.
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Objective To explore the chain mediating effect of mastery and self-efficacy between optimism and resilience of breast cancer patients.Methods Totally 262 breast cancer patients were investigated with general information questionnaire,resilience scale (RS-14),mastery scale for Chinese version (MSC),general self-efficacy scale (GSES) and revised life orientation test (LOT-R).Causual steps and Bootstrap method were used to test the chain mediating effect of mastery and self-efficacy between optimism and resilience.Results The media score of the participants was 18 for optimism,and the average score of the participants was 27.1±4.6 for mastery,26.0±5.9 for self-efficacy,76.6± 13.9 for resilience.There existed a significant difference in RS-14 scores among the patients with different family relationships,family income,and form of payment (all P<0.05).Correlation analysis showed that optimism,mastery,self-efficacy,and resilience were positively correlated with each other(r=0.57-0.74,all P< 0.01).Mediation modeling analysis showed that optimism had a direct effect on resilience.The effect value was 0.361,and the effect was 49.7%.Mastery and self-efficacy mediation effect value were 0.123 and 0.162,and the mediation effect were 16.9% and 22.3%.While chain mediating effect of mastery-self-effcacy was also significant,and the mediation effect value was 0.081 and the mediation effect was 11.1%.Conclusion Optimism influences breast cancer patients' resilience,not only through the direct path,but also through the indirect path of mastery and self-efficacy,as well as the chain mediating path between these two variables.
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<p><b>OBJECTIVE</b>To investigate the efficacy of short-term full-dose prophylaxis in adult Chinese patients with severe hemophilia A.</p><p><b>METHODS</b>Thirteen adult Chinese patients with severe hemophilia A receiving on-demand or low-dose prophylaxis underwent ultrasound examination of the target joints and evaluation of Hemophilia Joint Health Score (HJHS). The data of annual bleeding episodes in the period of on-demand or low-dose prophylaxis were collected retrospectively from the patients, and the changes in bleeding and joint condition (ultrasound findings of the target joints and HJHS) were observed during short-term full-dose prophylaxis. The activity intensity of the patients was assessed using the IPAQ questionnaire, and the 72 h FⅧ trough activity was measured during full-dose prophylaxis.</p><p><b>RESULTS</b>The median age of the 13 patients was 26.0 (20.5-29.0) years. For full-dose prophylaxis, the patients received a median therapeutic dose of 31.0 (29.1-33.0) IU/kg, administered for 3 times per week; the median 72 h FⅧ trough activity of patients was 1.7% (1.3-3.4%). During the follow-up period for 3 months, the annual bleeding rates (ABR) and annual joint bleeding rates (AJBR) decreased significantly in all the patients (=0.001 and 0.001, respectively), but zero bleeding was achieved in only 4 patients (30.8%) and zero joint bleeding in 7 patients (53.8%); 9 patients (69.2%) still experienced breakthrough bleeding. The damage severity of target joints assessed by ultrasound and HJHS in 6 patients (46.2%)was worse than before and no obvious progression of target joints damage was found in 7 patients (53.8%). Compared with the patients without progression, the patients with worsened joint damage had poorer baseline joint condition, higher bleeding frequencies before and during the follow-up, a higher intensity of physical activity, and a lower baseline FⅧ activity.</p><p><b>CONCLUSIONS</b>At present, although short-term full-dose prophylaxis can significantly reduce the bleeding and partially prevent the progression of joint damage, it is not yet possible to achieve the goal of zero bleeding for all adult patients with severe hemophilia A in China, nor can it completely prevent further joint damage. For adult patients with different clinical bleeding phenotypes, joint conditions and physical activity intensity, individualized therapy involving additional evaluation methods should be implemented, and physiotherapy and surgical intervention can be considered when necessary.</p>
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Objective To investigate the correlation between serum laminin (LN),type collagen (ⅣC),type procollagen N-terminal peptide (PⅢNP),hyaluronic acid (HA) and the severity as well as the prognosis of idiopathic pulmonary fibrosis (IPF).Methods From February 2015 to July 2016,160 IPF patients and 160 healthy subjects as controls were enrolled in this retrospective study.Serum LN,ⅣC,PⅢNP,and HA were analyzed in IPF patients and healthy controls.Pulmonary function test and chest high resolution computed tomography (HRCT) were carried out in IPF patients.Demographics and clinical characteristics,the percentage of forced vital capacity in the prediction value (FVC%pred),the percentage of diffusing capacity of the lung for carbon monoxide in the prediction value (DLCO%pred),and HRCTscore were collected.IPF patients were followed up.Results (1)There were no significant difference between two groups in age and sex ratio.The proportion of smoker in IPF patients was significantly higher than that in healthy controls(P < 0.01).(2)Serum LN(P < 0.01),ⅣC(P < 0.01),PⅢNP(P < 0.01),and HA(P < 0.01) were significantly increased in the patients with IPF compared with the healthy controls.(3)Serum LN,ⅣC,PⅢNP,and HA of IPF patients positively correlated with HRCT score,all P < 0.01,and negatively correlated with FVC%pred and DLCO%pred (all P < 0.05).(4)Serum LN(P < 0.01),ⅣC(P < 0.05),PⅢNP(P < 0.01),and HA(P < 0.01) in acute exacerbation IPF patients were significantly higher than those in the stable IPF patients.(5)Serum LN(P < 0.01),ⅣC(P <0.01),PⅢNP(P < 0.01),and HA(P < 0.01) in the survived patients were significantly lower than those inthe dead patients.Conclusions Serum LN,ⅣC,PⅢNP,and HA may reflect IPF prognosis and the severity of IPF.
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Objective To investigate the role of nine respiratory pathogens (hereinafter referred to as United Nine Detection(UND)) in acute exacerbation of interstitial lung disease. to provide an evidence of the pathogenesis and effective diagnosis and treatment of AE-ILD. Methods We detected the expression of of IgM antibody of UND in respiratory infection pathogens in serum in the AE-ILD group,the ILD stable group and the normal control group,and observed their dynamic changes. Results The test results of UND showed that the Pathogen-positive rate were 52.1%,27.8%,22%,in 73 cases of the AE-ILD group,72 cases of the ILD stable group and 50 cases of the normal controls,respectively. Statistical analysis showed that pathogen infection rate has statistics difference between the AE-ILD group and the ILD stable group,between the AE-ILD group and the normal control group respectively(P=0.003;P=0.001),while the ILD stable group and the normal control group hadd no significant difference (P = 0.417). The virus positive rates of the three groups were 31.5%,16.7%,10%respectively. Statistical analysis showed that the virus infection rate had statistics difference between the AE-ILD groups and the ILD stable group,between the AE-ILD group and the normal control group(P=0.037;P=0.005). Mycoplasma,influenza B virus,respiratory syncytial virus had high positive rate in these three groups. Dynamic changes of the IgM antibody showed that the positive number of pathogens decreased gradually in long admission of patients with AE-ILD. Conclusions The infection rate of UND in patients with AE-ILD is higher than patients with ILD in the stable stage and the normal controls. It suggests that AE-ILD may be associated with infection.
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OBJECTIVE To investigate the protective effect of total saponins from stems and leaves of Panax ginseng (GSLS) on cisplatin (CDDP)-induced kidney damage in mice and its possible mechanism. METHODS Thirty-two male ICR mice were randomly divided into normal control group, CDDP group, and GSLS(150 and 300)+CDDP groups. GSLS was administered to mice by oral gavage once a day for 7 d. On the 7th day, a single injection of CDDP 20 mg·kg-1 was given 1 h after GSLS 150 and 300 mg·kg-1 before GSLS 150 and 300 mg·kg-1 continued to be given for 3 d. Blood urea nitrogen (BUN) and creatinine (CRE) , catalase (CAT) in renal tissue, reduced glutathione (GSH), tumor necrosis factorα(TNF-α) and interleukin 1β(IL-1β) of cisplatin induced mice were detected after 72 h. HE and PAS staining were used to observe the renal histopathological changes;While TUNEL and Hoechst33258 staining were employed to observe apoptosis in kidney tissues. RESULTS Compared with normal control group, CDDP group had a significant reduction in relative body mass (P<0.05), and the level of GSH and CAT in kidney tissues (P<0.05). The level of CRE, BUN, TNF-α, and IL-1βin serum and renal indexes significantly increased (P<0.05, P<0.01), especially BUN and CRE that respectively doubled and quadrupled. CDDP group developed glomerulus swelling, renal tubular expansion and epithelial cell necrosis. Trans?parent tube type of tube cavity appeared, the nucleus pycnosis disappeared, but renal interstitial edema and inflammatory cell infiltration appeared. There was a large amount of glycogen deposition and high expressions of TUNEL positive cells and Hoechst33258 positive cells. Compared with CDDP group, the levels of BUN and CRE in GSLS treatment group significantly decreased (P<0.05, P<0.01) in serum, glycogen deposition was reducted and apoptosis of renal tubular epithelial cells decreased in kidney tissues (P<0.05). The level of TNF-α, IL-1β(P<0.05) and the degree of renal tissue necrosis were significantly reduced (P<0.05) in CDDP+GSLS 300 group, but there was a significant increase in the level of CAT and GSH (P<0.05). CONCLUSION GSLS can protect against mouse kidney injury induced by cisplatin. The mechanism may be related to oxidation, reduced inflammation reaction and resistance to apoptosis.