1.Construction and validation of a predictive model for kinetophobia in patients after percutaneous coronary intervention
Haizhen WANG ; Lili ZHOU ; Pengfei CHENG ; Sheng KE ; Yuan SONG ; Rui WU ; Xiuqin FENG ; Jingfen JIN
Chinese Journal of Nursing 2024;59(17):2108-2115
Objective This study aims to develop and validate a dynamic web-based nomogram for predicting kinetophobia in patients following percutaneous coronary intervention(PCI).Methods A prospective design was employed to selectively enroll 330 PCI patients admitted to a hospital in Hangzhou from December 2022 to July 2023.Single-factor analysis and Lasso regression were utilized to identify independent risk factors for kinesophobia post-PCI.Logistic regression was performed using R software,and a nomogram was constructed.The model was assessed through the area under the receiver operating characteristic curve(AUC)and Hosmer-Lemeshow tests.Results There were 206 cases of kinesiophobia in 330 patients after PCI,and the incidence was 62.4%.Logistic regression analysis identified combined heart failure,emergency surgery,NYHA cardiac function grade,ADL level,sedentary behavior,Chinese version of PROMIS Physical Function Summary Table score,and Chinese version of Perceptive Social Support Scale score as independent influencing factors for kinesophobia after PCI(P<0.05).The AUC value of the model was 0.821,with a sensitivity of 70.4%and specificity of 82.0%.The Hosmer-Lemeshow fit test yielded a non-significant result(x2=9.350,P=0.314).Calibration and decision curves demonstrated the model's favorable calibration and clinical practicability.The C-index of the nomogram prediction model was 0.778,0.774,and 0.800,respectively,by 5-fold cross-validation,10-fold cross-validation,and the Bootstrap method.Conclusion The dynamic nomogram model developed in this study effectively predicts kinesophobia in patients after PCI.It provides valuable references and support for clinical staff in early identification of high-risk patients,enabling the formulation of individualized health education strategies and exercise rehabilitation plans.
2.Efficacy,metabolic characteristics,safety and immunogenicity of AK-HER2 compared with reference trastuzumab in patients with metastatic HER2-positive breast cancer:a multicenter,randomized,double-blind phase Ⅲ equivalence trial
Yang LUO ; Tao SUN ; Zhimin SHAO ; Jiuwei CUI ; Yueyin PAN ; Qingyuan ZHANG ; Ying CHENG ; Huiping LI ; Yan YANG ; Changsheng YE ; Guohua YU ; Jingfen WANG ; Yunjiang LIU ; Xinlan LIU ; Yuhong ZHOU ; Yuju BAI ; Yuanting GU ; Xiaojia WANG ; Binghe XU ; Lihua SONG
China Oncology 2024;34(2):161-175
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.
3.Effects of transitional care led by special disease nurses in patients with venous thromboembolism after intervention
Guiling ZHANG ; Ying XIAO ; Jie ZHANG ; Jingfen SONG ; Guohua WANG
Chinese Journal of Modern Nursing 2023;29(6):821-826
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.
4.Practice and exploration of nursing efficiency management in a large general public hospital
Meijuan LAN ; Jianping SONG ; Jingfen JIN ; Shenmei YU ; Caijuan XU ; Yan YANG ; Yuping ZHANG ; Fei ZENG
Chinese Journal of Hospital Administration 2021;37(4):332-335
Under the background of efficiency medical reform, the authors introduced the nursing efficiency management system of a large public hospital, which was divided into two dimensions: nursing resource allocation efficiency and nursing service efficiency. The specific four measures included the establishment of multi-campus unified management organization structure based on nursing management committee, nursing performance reform based on structured big data information platform, the construction of nurse-led patient whole process management model and the accelerated rehabilitation nursing practice from surgery to the whole hospital, so as to provide reference for the nursing efficiency management of large general public hospitals under the medical reform.
5.Correlation between the distribution of intracranial and extracranial aterial lesions and risk factors in Chinese patients with ischemic stroke :a multicenter registry study
Yu TANG ; Lingyun JIA ; Yingqi XING ; Pinjing HUI ; Xuan MENG ; Delin YU ; Xiaofang PAN ; Yalan FANG ; Binbin SONG ; Chunxia WU ; Chunmei ZHANG ; Xiufang SUI ; Youhe JIN ; Jingfen ZHANG ; Jianwei LI ; Ling WANG ; Yuming MU ; Jingxin ZHONG ; Yuhong ZHU ; Heng ZHANG ; Xiaoyu CAI ; Yang HUA
Chinese Journal of Ultrasonography 2019;28(5):369-374
Objective To investigate the distribution characteristics and risk factors of intracranial and extracranial aterial lesions in Chinese patients with ischemic stroke . Methods In this multi‐center study ,2 310 continuously inpatients with ischemic stroke diagnosed in 20 stroke screening and prevention project base hospitals from June 2015 to M ay 2016 were enrolled . Carotid ultrasonography and transcranial color‐coded sonography or transcranial Doppler were performed in all patients to confirm the presence of cerebral artery stenosis or occlusion . According to the distribution of lesions ,the subjects were divided into 2 groups :the simple intracranial artery stenosis group and the simple extracranial artery stenosis group . T he difference of risk factors between the two groups was compared . Results Of the 2 310 patients with ischemic stroke ,1 516 ( 65 .6% ) had simple intracranial artery stenosis and 794 ( 34 .4% ) had simple extracranial artery stenosis . T he incidence of anterior circulation artery stenosis was higher in the group of intracranial artery stenosis than that in the extracranial artery stenosis group ( 68 .1% vs 48 .7% , P <0 .001) . Posterior circulation artery stenosis and combined anterior with posterior circulation artery stenosis were more common in patients with extracranial artery stenosis group than those in intracranial artery stenosis group ( 36 .4% vs 22 .1% ,14 .9% vs 9 .8% ;all P <0 .001) . Univariate analysis of risk factors for stroke showed that patients with intracranial arterial stenosis had a higher prevelence of hypertension , diabetes ,obesity ,and family history of stroke ,and their systolic blood pressure ,diastolic blood pressure , body mass index ( BM I) ,fasting blood‐glucose ,glycosylated hemoglobin ,triacylglycerol ,total cholesterol , and low‐density lipoprotein cholesterol were significantly higher than those in the extracranial arterial stenosis group ( all P < 0 .05 ) . T he proportion of elderly ( ≥ 65 years old ) ,male and smokers in the extracranial arterial stenosis group was significantly higher than that in the intracranial arterial stenosis group ( all P <0 .05) . Multivariate logistic regression analysis showed that elderly ( ≥65 years old) ,male , and smoking history were independent risk factors for extracranial arterial stenosis ( OR= 2 .012 ,1 .637 , 1 .325 ,respectively ;all P <0 .05) . While hypertension ,diabetes ,less physical activity ,and high BM I levels were independent risk factors for simple intracranial arterial disease ( OR = 1 .301 ,1 .252 ,1 .248 ,1 .030 , respectively ;all P <0 .05) . Conclusions There are significant differences in the distribution characteristics and risk factors of intracranial and extracranial aterial lesions in patients with ischemic stroke in China .
6.Correlation between smoking and occurrence of intracranial artery stenosis by ultrasonography:an analysis of multi-center research results
Ran LIU ; Yang HUA ; Lingyun JIA ; Yingqi XING ; Pinjing HUI ; Xuan MENG ; Delin YU ; Xiaofang PAN ; Yalan FANG ; Binbin SONG ; Chunxia WU ; Chunmei ZHANG ; Xiufang SUI ; Youhe JIN ; Jingfen ZHANG ; Jianwei LI ; Ling WANG ; Yuming MU ; Jingxin ZHONG ; Yuhong ZHU ; Heng ZHANG ; Xiaoyu CAI
Chinese Journal of Cerebrovascular Diseases 2017;14(6):297-301,312
Objective To analyze the correlation between smoking and occurrence of intracranial artery stenosis.Methods From June 2015 to May 2016,a total of 10 711 inpatients with transient ischemic attack (TIA) or ischemic stroke from 20 basel hospitals of nationwide were enrolled using a cross-sectional study,76 patients with unknown smoking and smoking cessation years were excluded.Finally,a total of 10 635 patients were enrolled.Transcranial color coded sonography and/or transcranial Doppler were used evaluate the intracranial artery stenosis lesions.The basic risk factors for cerebrovascular disease (age,sex,smoking and smoking years,whether smoking cessation and years,hypertension,diabetes,hyperlipidemia,atrial fibrillation,and family history of stroke) were recorded.According to the different smoking years,the smoking years were divided into five groups:non-smoking,smoking time ≤10-year,11 to 20-year,21 to 30-year,and >30-year groups for trend chi square test.According to the different smoking cessation years in the smokers,the smoking cessation years were divided into four groups:non-cessation,cessation time 1 to 10-year,11 to 20-year,and >20-year groups for trend chi square test.The effects of different smoking years and different smoking cessation years on the occurrence of intracranial arterial stenosis were analyzed.Results The incidence of intracranial artery stenosis in the smokers (40.4%[1 433/3 547]) was significantly higher than that in the non-smoking patients (29.4%[2 085/7 088]).There was significant difference (χ2=128.850,P<0.01),and the incidence of cerebral infarction in the smokers (91.6%[3 250/3 547]) was significantly higher than the non-smokers (85.0%[6 027/7 088]).There was significant difference (χ2=92.328,P<0.01).Smoking was an independent risk factor for intracranial artery stenosis (OR,1.603;95%CI 1.456-1.765;P<0.01).With the increase of smoking years,the detection rate of intracranial arterial stenosis increased gradually (trend χ2=115.437,P<0.01).Whether giving up smoking had no significant effect on the incidence of intracranial artery stenosis in patients with ≥20 years of smoking (trend χ2=1.043,P=0.307).Conclusions Smoking is an independent risk factor for affecting intracranial artery stenosis;the risk of disease increases with the number of smoking years.Long-term smokers (≥20 years) cannot reduce the effect on intracranial artery stenosis,even if they give up smoking.
7.Correlation between serum lipid level and carotid artery stenosis in patients with ischemic cerebrovascular disease:a multi-center registry study
Yunlu TAO ; Yang HUA ; Lingyun JIA ; Yingqi XING ; Pinjing HUI ; Xuan MENG ; Delin YU ; Xiaofang PAN ; Yalan FANG ; Binbin SONG ; Chunxia WU ; Chunmei ZHANG ; Xiufang SUI ; Youhe JIN ; Jingfen ZHANG ; Jianwei LI ; Ling WANG ; Yuming MU ; Jingxin ZHONG ; Yuhong ZHU ; Heng ZHANG ; Xiaoyu CAI
Chinese Journal of Cerebrovascular Diseases 2017;14(6):292-296
Objective To investigate the effect of serum lipid level on carotid artery stenosis in patients with ischemic cerebrovascular disease.Methods Using a multi-center cross-sectional study,10 711 consecutive inpatients with transient ischemic attack (TIA) or ischemic stroke diagnosed clearly in 20 stroke screening and prevention project base hospitals from June 2015 to May 2016 were enrolled.According to the results of carotid ultrasonography,1 560 patients with extracranial carotid artery stenosis rate≥50% screened were enrolled in the study.They were divided into a severe stenosis group (70%-99%) and a mild-moderate stenosis group (<70%).The distribution of total cholesterol (TC),triacylglycerol (TG),low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) levels in both groups of carotid stenosis patients were analyzed,and the quantitative classification was based on the normal range of serum lipids.The distributions of serum lipid levels in different grades in patients of both groups were compared with the non-parameter test.Results The incidence of dyslipidemia in the severe stenosis group was higher than that in the mild and moderate stenosis group.There was no significant difference between the two groups (54.4%[319/586]vs.48.3%[470/974],P<0.05).Dyslipidemia was an independent risk factor for severe carotid artery stenosis (OR,1.27,95% CI 1.24-1.30,P<0.01).The TC and LDL-C levels in patients of the severe stenosis group were significantly higher than those in the mild-moderate stenosis group (TC:3.98[3.31,4.82]mmol/L vs.3.91[3.31,4.53]mmol/L,LDL-C:2.48[1.86,3.14]vs.2.30[1.79,2.80];all P<0.01).With the increase of TC and LDL-C levels,there was significant differences between the severe stenosis group and the mild-moderate stenosis group (all P<0.05),and the proportions of TC >5.80 mmol/L (7.3%[43/586]vs.0.4%[4/974]) and LDL-C>3.12 mmol/L (26.3%[154/586]vs.10.0%[97/974]) in patients of the severe stenosis group were higher than those in the mild-moderate stenosis group (26.3%[154/586]vs.10.0%[97/974]).Conclusion The high LDL-C and TC levels may increase the incidence of severe carotid artery stenosis or occlusion.
8.Age characteristics and distribution of cerivocerebral large artery lesions in inpatients with cerebral ischemia:an analysis of multi-center research results
Na LI ; Yang HUA ; Lingyun JIA ; Yingqi XING ; Pinjing HUI ; Xuan MENG ; Delin YU ; Xiaofang PAN ; Yalan FANG ; Binbin SONG ; Chunxia WU ; Chunmei ZHANG ; Xiufang SUI ; Youhe JIN ; Jingfen ZHANG ; Jianwei LI ; Ling WANG ; Yuming MU ; Jingxin ZHONG ; Yuhong ZHU ; Heng ZHANG ; Xiaoyu. CAI
Chinese Journal of Cerebrovascular Diseases 2017;14(6):285-291
Objective To investigate the differences of distribution characteristics and risk factors of large artery lesions in patients with ischemic cerebrovascular disease in different age groups in order to provide the basis for the prevention and treatment of stroke in different age groups.Methods From June 2015 to May 2016,a total of 10 711 consecutive inpatients with transient ischemic attack (TIA) and ischemic stroke from 20 centers nationwide were enrolled.Each 10 years was used as an age group from 40 years.All the patients were divided into 5 age groups.The differences of the different risk factors for cerebrovascular disease among the 5 groups were compared.All patients were separated by gender.The chi square test was used to compare the incidences of large artery stenosis of the intracranial and external and anterior and posterior circulation,and the number of vascular lesions in the same sex in different age groups.Results (1) The risk factors of elderly patients were mainly hypertension,diabetes mellitus,and atrial fibrillation (χ2=61.938,χ2=13.349,and χ2=55.940;all P<0.01).The smoking history,family history of cerebrovascular disease,and obesity were more frequent among the young and middle-aged people (χ2=131.505,χ2=7.298,and χ2=100.911,all P<0.01).(2) The linear trend chi square test results showed that the proportion of multivessel diseases in female and male extracranial arterial lesions increased gradually with the increase of age.(χ2=54.799,χ2=161.370,all P<0.01).The proportion of multivessel diseases in the intracranial artery in female decreased gradually (χ2=5.328,P=0.021),and that in male did not have obvious trend of change (χ2=0.289,P=0.591).(3) The linear trend chi square test results showed that the incidence of simple intracranial arterial stenosis in female and male intracranial arterial stenosis decreased gradually with the increase of age (χ2=20.090,χ2=42.351,all P<0.01),and the incidence of simple extracranial arterial stenosis increased gradually (χ2=40.311,χ2=90.698,all P<0.01).The incidence of both intracranial and extracranial artery stenoses increased gradually (χ2=12.077,χ2=45.887,all P<0.01).The incidence of simple posterior circulation vascular stenosis increased gradually in female (χ2=16.434,P<0.01),but that did not have obvious trend of change in male (χ2=1.701,P=0.192).The incidence of stenosis of both anterior and posterior arteries in female and male increased gradually (χ2=4.587,P=0.032;χ2=35.156,P<0.01).Conclusions The distribution of atherosclerotic lesions in ischemic cerebrovascular disease of the different age groups was different.No matter female or male patients,the majority of the young and middle-aged patients were intracranial artery lesions,and the elderly patients were mainly extracranial artery lesions.The majority of elderly women had posterior circulation artery lesions.Understanding the characteristics in patients with intracranial arterial lesion in different age groups will help to develop individualized stroke prevention and treatment strategies for the population of different age groups.
9.The application of Six-Step standardized communication procedure in improving the communication ability of nurses
Jianping SONG ; Jingfen JIN ; Shenmei YU ; Huafen WANG ; Xiuqin FENG ; Meiqi YAO ; Yuping ZHANG
Chinese Journal of Nursing 2017;52(1):63-66
Objective To explore the effects of Six-Step standardized communication procedure in improving the communication ability of nurses.Methods C-I-CARE communication procedure was converted into Chinese.The Chinese version of Six-Step standardized communication procedure was Yi Kan,Er Yin,San Gaozhi,Si Wen,Wu Da,Liu Zaijian.The procedure was propagandized by making posters,setting up computer desktop,training nurses by lectures,video and role play.The effects were evaluated by pre and post self-control test among 100 nurses.Results The average score of communication behavior of 100 nurses after applying standardized communication procedure increased from 2.55±0.67 to 4.44±0.59 (t=-23.174,P<0.001).In 2015,the nursing department received 622 silk banners and commendatory letters for appreciating nursing work,increased by 18.9% compared to 2014.The discharged patient satisfaction increased from 94.2% to 96.93%.The satisfaction of doctors to nurses' collaboration was 99.86%.There was no nursing complaint or dispute caused by bad communication.Conclusion The application of procedure and standardized communication method can improve the communication ability of nurses,optimize the relationship between nurses and patients and increase patient satisfaction.

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