1.Efficacy and safety of deep hyperthermia combined with sintilimab and nab-PC regimen in the treatment of advanced squamous non-small cell lung cancer with driver gene negative and PD-L1 expression positive
Jing XIAO ; Chao LI ; Shuping ZHANG ; Xiaoyun CHENG ; Wenfeng HAN ; Hongmei ZHOU
Cancer Research and Clinic 2024;36(1):24-31
Objective:To investigate the clinical efficacy and safety of deep hyperthermia combined with sintilimab and nab-PC (albumin-bound paclitaxel + carboplatin) regimen in the treatment of advanced squamous non-small cell lung cancer (NSCLC) with driver gene negative and programmed death-1 receptor ligand 1 (PD-L1) expression positive.Methods:A prospective case-control study was performed. A total of 84 advanced squamous NSCLC patients with driver gene negative and PD-L1 expression positive in Hebei Seventh People's Hospital from January 2020 to December 2022 were collected, and all patients were divided into the observation group and the control group according to the random number table method, with 42 cases in each group. The control group was given the treatment of sintilimab combined with nab-PC regimen, and the observation group was given deep hyperthermia on the basis of the control group. After 4 consecutive cycles of treatment, the short-term efficacy of the two groups was compared. The levels of serum tumor markers [carcinoembryonic antigen (CEA), squamous cell carcinoma antigen (SCCA), cytokeratin fragment 19 (CYFR21-1)], and the positive expression rates of immunohistochemistry markers [p40, p63, and cytokeratin 5/6 (CK5/6)] before and after treatment were compared between two groups. Functional Assessment of Cancer Therapy-Lung cancer module (FACT-L) scores, the adverse reactions and the long-term survival of the two groups were compared.Results:There were 26 males and 16 females in the observation group, and the age was (59±11) years; there were 22 males and 15 females in the control group, and the age was (58±11) years. The objective remission rate and the disease control rate were 71.43% (30/42), 90.48% (38/42), respectively in the observation group, and 50.00% (21/42), 80.95% (34/42), respectively in the control group; the objective remission rate in the observation group was higher than that in the control group, and the difference was statistically significant ( χ2 = 4.04, P = 0.044); and there was no statistically significant difference in the disease control rate of both groups ( χ2 = 1.56, P = 0.212). The levels of serum CEA, SCCA and CYFRA21-1, and the positive expression rates of p40, p63, and CK5/6 in the two groups after treatment were lower than those before treatment (all P < 0.05); and the scores of physiological status, functional status, additional concern in FACT-L scores and the total score of the scale after treatment were higher than those before treatment (all P < 0.05). There were no statistically significant differences in the incidence of adverse reactions including thrombocytopenia, neutropenia, leukopenia, anemia, fever of the two groups (all P > 0.05). The median progression-free survival (PFS) time was 6.5 months (95% CI: 3.82-12.75), 5.1 months (95% CI: 3.14-12.26),respectively in the observation group and the control group, and the difference in the median PFS time was statistically significantly of both groups ( χ2 = 4.21, P = 0.040). The median overall survival (OS) time was 12.9 months (95% CI: 6.25-15.46), 9.7 months (95% CI: 4.74-13.02), respectively in the observation group and the control group, and the difference in the median OS time was statistically significantly of both groups ( χ2 = 4.43, P = 0.035). Conclusions:Deep hyperthermia combined with sintilimab and nab-PC regimen in the treatment of advanced squamous NSCLC with driver gene negative and PD-L1 expression positive can effectively reduce the serum tumor markers levels and positive expression rate of immunohistochemical markers, improve the quality of life of patients, and increase the short-term and long-term efficacy.
2.Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial.
Chengyuan GU ; Zengjun WANG ; Tianxin LIN ; Zhiyu LIU ; Weiqing HAN ; Xuhui ZHANG ; Chao LIANG ; Hao LIU ; Yang YU ; Zhenzhou XU ; Shuang LIU ; Jingen WANG ; Linghua JIA ; Xin YAO ; Wenfeng LIAO ; Cheng FU ; Zhaohui TAN ; Guohua HE ; Guoxi ZHU ; Rui FAN ; Wenzeng YANG ; Xin CHEN ; Zhizhong LIU ; Liqiang ZHONG ; Benkang SHI ; Degang DING ; Shubo CHEN ; Junli WEI ; Xudong YAO ; Ming CHEN ; Zhanpeng LU ; Qun XIE ; Zhiquan HU ; Yinhuai WANG ; Hongqian GUO ; Tiwu FAN ; Zhaozhao LIANG ; Peng CHEN ; Wei WANG ; Tao XU ; Chunsheng LI ; Jinchun XING ; Hong LIAO ; Dalin HE ; Zhibin WU ; Jiandi YU ; Zhongwen FENG ; Mengxiang YANG ; Qifeng DOU ; Quan ZENG ; Yuanwei LI ; Xin GOU ; Guangchen ZHOU ; Xiaofeng WANG ; Rujian ZHU ; Zhonghua ZHANG ; Bo ZHANG ; Wanlong TAN ; Xueling QU ; Hongliang SUN ; Tianyi GAN ; Dingwei YE
Chinese Medical Journal 2023;136(10):1207-1215
BACKGROUND:
LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer.
METHODS:
We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels.
RESULTS:
On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]).
CONCLUSION:
LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04563936.
Humans
;
Male
;
Antineoplastic Agents, Hormonal/therapeutic use*
;
East Asian People
;
Gonadotropin-Releasing Hormone/agonists*
;
Goserelin/therapeutic use*
;
Prostate-Specific Antigen
;
Prostatic Neoplasms/drug therapy*
;
Testosterone
3.Summary of best evidence for emergency target blood pressure management of acute aortic dissection
Wei XU ; Xiaoli CHEN ; Congying NIU ; Wenfeng LIN ; Baozhen CHENG ; Liqin SUN
Chinese Journal of Practical Nursing 2022;38(34):2703-2710
Objective:To evaluate and summary the relevant evidence of emergency target blood pressure management in acute aortic dissection, so as to provide guidance for the evidence-based practice of emergency target blood pressure management.Methods:According to the "6S" evidence pyramid model, the evidence about emergency target blood pressure management of acute aortic dissection in various databases and professional association websites at home and abroad was retrieved, including clinical decision, guidelines, expert consensus, systematic evaluation, randomized controlled trial, cohort study, case series, etc. Two researchers used corresponding literature quality evaluation tools to evaluate the quality of the included literature, extracted and summarized the evidence of the literature above grade B.Results:A total of 22 articles were included in this study, including 6 clinical decisions, 5 guidelines, 7 expert consensus, 1 systematic evaluation, 1 randomized controlled trial, 1 cohort study and 1 case series, forming 37 best evidences, including 9 topics such as target value setting, management strategies, disease observation, medical history collection, monitoring methods, vasoactive drugs, non vasoactive drugs, auxiliary examination, health education.Conclusions:The summarized best evidence provides a reference for emergency medical staff to manage the emergency target blood pressure of acute aortic dissection. It is recommended that emergency medical staff follow the summarized best evidence to formulate an individualized target blood pressure management scheme for patients.
4.Predictive value of soluble urokinase-type plasminogen activator receptor combined with alpha-fetoprotein and model for end-stage liver disease score in short-term prognosis assessment of patients with chronic hepatitis B related acute-on-chronic liver failure
Hongmei YANG ; Yu LI ; Jing AI ; Wenfeng SUN ; Cheng QIU ; Lunli ZHANG
Chinese Journal of Infectious Diseases 2021;39(5):271-275
Objective:To investigate the predictive value of serum soluble urokinase-type plasminogen activator receptor (suPAR) combined with alpha-fetoprotein (AFP) and model for end-stage liver disease (MELD) score in short-term prognosis assessment of patients with chronic hepatitis B (CHB) related acute-on-chronic liver failure (ACLF).Methods:From January 2018 to May 2020, 66 patients with CHB related ACLF from Fuzhou First People′s Hospital were enrolled. After 90 days of follow-up, the patients with CHB related ACLF were divided into death group and survival group according to the outcome. Meanwhile, 30 patients with CHB were enrolled by simple random sampling method. The differences of serum suPAR in patients with CHB related ACLF and patients with CHB were analyzed. The values of suPAR, AFP and MELD score were compared between death group and survival group in patients with CHB related ACLF. The predictive value of suPAR, AFP, MELD score, Child-Turcotte Pugh score (CTP score) and suPAR combined with AFP and MELD score in the short-term prognosis of patients with CHB related ACLF were analyzed by area under the receiver operator characteristic curve (AUROC). Data were analyzed by two independent sample t test or non-parametric test. Results:The serum suPAR level of patients with CHB related ACLF was (9.6±0.8) ln ng/L, which was higher than that of patients with CHB ((8.0±0.3) ln ng/L). The difference was statistically significant ( t=14.533, P<0.01). The suPAR and MELD score of patients with CHB related ACLF in the death group were (9.9±0.7) ln ng/L and 29.6 (7.1) points, respectively, which were higher than those in the survival group ((9.4±0.7) ln ng/L and 21.0 (5.0) points, respectively). The AFP level in the death group was 45.9 (108.1) μg/L, which was lower than that in the survival group (209.3 (187.1) μg/L). There were significant differences in suPAR ( t=2.895, P=0.005), MELD score ( Z=4.708, P<0.01) and AFP ( Z=3.051, P<0.01) between the death group and the survival group. AUROC of suPAR (0.741, P=0.001), AFP (0.724, P=0.002) and MELD score (0.885, P<0.01) had predictive value for death in patients with CHB related ACLF. The sensitivities of suPAR, AFP, MELD score, CTP score and suPAR combined with AFP and MELD score were 84.6%, 73.1%, 88.5%, 96.2% and 84.6%, respectively, and the specificities were 75.0%, 72.5%, 70.0%, 52.5% and 92.5%, respectively. The AUROC of suPAR combined with AFP and MELD score was 0.871 ( P<0.01), which was higher than that of CTP score (0.793, P<0.01). Conclusions:Serum suPAR is increased in patients with CHB related ACLF. SuPAR combined with AFP and MELD score could apply in the prognostic value for patients with CHB related ACLF.
5.Effect of school health promotion intervention on overweight and obesity of middle school students
CHENG Qiaoyun, ZHENG Wenfeng, WU Hong, ZHAO Jianming, GUO Zhenping
Chinese Journal of School Health 2021;42(3):381-384
Objective:
To evaluate the effects of overweight and obesity intervention in the health-promoting school model and to provide reference for effective prevention and control of overweight and obesityin middle Schools.
Methods:
Using stratified cluster random sampling, 10 middle schools in Sanmenxia City were randomly divided into intervention group and control group. In the intervention group and the control group, one middle school and one high school were randomly selected. The students from the two classes randomly selected in the first and second grades in the four schools that were selected, the questionnaire survey and medical examination was conducted before and after the intervention to evaluate the intervention effect.
Results:
After intervention, the ratio of overweight and obesity of the intervention group decreased from 22.70% before intervention to 17.45%, statistical significance(χ 2=4.11, P<0.05), and the ratio of overweight and obesity of the control group increased from 22.39% before intervention to 22.91%, no significant difference(P>0.05). After the intervention, the response rates of limiting red meat, fried food and sugarsweetened beverages were all higher than those before the intervention, the differences were statistically significant (χ 2=125.73, 10.69, 208.55, 170.66, 50.01, P<0.01).
Conclusion
The comprehensive intervention measures of overweight and obesity in the model of health promotion school can encourage students to develop healthy behaviors and effectively prevent and control middle school students from overweight and obesity, and it is easy to form a long-term intervention mechanism.
6. Bibliometric analysis of scientific articles on epidemiological study of burns in China
Wenfeng CHENG ; Chuan′an SHEN ; Dongxu ZHAO ; Dawei LI ; Yuru SHANG
Chinese Journal of Burns 2017;33(4):233-237
Objective:
To analyze the current status of epidemiological study of burns in China, and to explore the related strategies.
Methods:
Retrospective or cross-sectional scientific articles in Chinese or English on epidemiological study of burns in China published from January 2005 to December 2015 were systemically retrieved from 4 databases. The databases include
7.Effects of bundle care on preventing cannula dislocation for tracheotomy in patients with inhalation injury
Hongyan LU ; Shujun WANG ; Congcong GUO ; Yuanyuan LI ; Hongjuan ZHU ; Wenfeng CHENG ; Liyun LIU ; Bingli LI
Chinese Journal of Modern Nursing 2017;23(34):4322-4325
Objective To explore the effects of bundle care on preventing cannula dislocation for tracheotomy in patients with inhalation injury. Methods Totally 51 patients who received tracheotomy in the First Affiliated Hospital of PLA General Hospital between January 2010 and December 2014 were selected as a control group, while another 36 patients with inhalation injury who were admitted and received tracheotomy from January 2015 to May 2017 were selected as an observation group. Patients in the control group received conventional nursing after tracheotomy, while patients in the observation group received safely managed bundle care on the basis of conventional nursing. The incidence of unanticipated cannula dislocation after tracheotomy and before extubation were then observed between the patients in the two groups. Results The incidence of unanticipated cannula dislocation of the patients in the observation group and the control group was 2.8% (1/36) and 19.6% (10/51), respectively (χ2=5.412,P< 0.05). Conclusions Bundle care, when applied in the management of cannula for tracheotomy in patients with inhalation injury, can reduce the incidence of unanticipated cannula dislocation.
8.Effects of transfection of human epidermal growth factor gene with adenovirus vector on biological characteristics of human epidermal cells.
Kai YIN ; Li MA ; Chuan'an SHEN ; Yuru SHANG ; Dawei LI ; Longzhu LI ; Dongxu ZHAO ; Wenfeng CHENG
Chinese Journal of Burns 2016;32(5):305-311
OBJECTIVETo investigate the suitable transfection condition of human epidermal cells (hECs) with human epidermal growth factor (EGF) gene by adenovirus vector (Ad-hEGF) and its effects on the biological characteristics of hECs.
METHODShECs were isolated from deprecated human fresh prepuce tissue of circumcision by enzyme digestion method and then sub-cultured. hECs of the third passage were used in the following experiments. (1) Cells were divided into non-transfection group and 5, 20, 50, 100, 150, and 200 fold transfection groups according to the random number table (the same grouping method below), with 3 wells in each group. Cells in non-transfection group were not transfected with Ad-hEGF gene, while cells in the latter six groups were transfected with Ad-hEGF gene in multiplicities of infection (MOI) of 5, 20, 50, 100, 150, and 200 respectively. The morphology of the cells was observed with inverted phase contrast microscope, and expression of green fluorescent protein of the cells was observed with inverted fluorescence microscope at transfection hour (TH) 24, 48, and 72. (2) Another three batches of cells were collected, grouped, and treated as above, respectively. Then the transfection rate of Ad-hEGF gene was detected by flow cytometer (n=3), the mass concentration of EGF in culture supernatant of cells was detected by enzyme-linked immunosorbent assay (n=6), and the proliferation activity of cells was detected by cell counting kit 8 (CCK8) and microplate reader (n=6) at TH 24, 48, and 72, respectively. (3) Cells were collected and divided into non-transfection group and transfection group, with 6 wells in each group. Cells in non-transfection group were cultured with culture supernatant of cells without transfection, while cells in transfection group were cultured with culture supernatant of cells which were transfected with Ad-hEGF gene in the optimum MOI (50). CCK8 and microplate reader were used to measure the biological activity of EGF secreted by cells on culture day 1, 3, and 5. (4) Cells were collected and divided into non-transfection group and transfection group, with 12 wells in each group. Cells in non-transfection group were not transfected with Ad-hEGF gene, while cells in transfection group were transfected with Ad-hEGF gene in the optimum MOI (50). The expression levels of cytokeratin 14 (CK14) and CK19 of cells were measured by immunofluorescence staining at TH 24. (5) Cells were collected, grouped, and treated as in (4), with 6 wells in each group. At post scratch hour (PSH) 0 (immediately after scratch), 12, 24, and 48, the migration distance of cells was observed and measured with inverted phase contrast microscope. Data were processed with analysis of variance of factorial design, analysis of variance for repeated measurement, and LSD test.
RESULTS(1) At TH 24 and 48, morphology of cells in each transfection group and non-transfection group were similar. Compared with that in non-transfection group, the cell debris increased significantly in 200 fold transfection group at TH 72. At TH 24, 48, and 72, the expression of green fluorescent protein was not seen in cells of non-transfection group, whereas it increased in cells of transfection group over transfection time. (2) The transfection rate of Ad-hEGF gene of cells in each transfection group increased gradually over transfection time. At TH 72, the transfection rates of Ad-hEGF gene of cells in 50-200 fold transfection groups were all above 90%, while the transfection rates of Ad-hEGF gene of cells in non-transfection group, 5, and 20 fold transfection groups were (0.51±0.20)%, (62.44±6.23)%, and (75.00±5.43)% respectively, which were obviously lower than the rate in 50 fold transfection group [(93.12±2.55)%, with P values below 0.01]. The mass concentration of EGF in culture supernatant of cells in each transfection group increased gradually over transfection time. At TH 72, the mass concentration of EGF in culture supernatant of cells in 50 fold transfection group was obviously higher than that in each of the other groups (with P values below 0.01). The proliferation activity of cells in each group at TH 24 and 48 was similar (with P values above 0.05). At TH 72, the proliferation activity of cells in 200 fold transfection group was obviously lower than that in other groups (with P values below 0.05). (3) On culture day 1, the biological activity of EGF secreted by cells in two groups was similar (P>0.05). On culture day 3 and 5, the biological activity of EGF secreted by cells in transfection group were obviously higher than that in non-transfection group (with P values below 0.01). (4) At TH 24, the expression levels of CK14 and CK19 of cells in transfection group were higher than those in non-transfection group. (5) The width of scratch in two groups was nearly the same at PSH 0. At PSH 12-48, the migration distance of cells in transfection group was obviously longer than that in non-transfection group (with P values below 0.01).
CONCLUSIONSThe suitable range of MOI of hECs transfected with Ad-hEGF gene is 50-150, and 50 is the optimum. hECs transfected with Ad-hEGF gene with MOI 50 can effectively express the EGF gene and keep its good abilities of proliferation, differentiation, and migration, as well.
Adenoviridae ; Cell Differentiation ; Cell Proliferation ; Cells, Cultured ; EGF Family of Proteins ; genetics ; metabolism ; Epidermis ; cytology ; Genetic Vectors ; Humans ; Keratins ; metabolism ; Male ; Transfection
9.In vitro antifungal activity of closantel against Candida albicans
Wenfeng CHEN ; Ziping ZHANG ; Bo CHENG
Chinese Journal of Dermatology 2012;45(8):549-552
Objective To determine the in vitro antifungal effects of closantel against Candida albicans.Methods A microdilution method was used to determine the minimum inhibitory concentration (MIC)of fluconazole alone and in combination with closantel against Candida albicans standard strain CAF-2.Ten strains of Candida albicans were cultured in RPMI-1640 liquid culture containing 10% calf serum with or without the presence of closantel at 16 mg/L,followed by the observation of hypha formation.Transmission electron microscopy (TEM) and scanning electron microscopy (SEM) were performed to observe the ultrastructure of Candida albicans CAF-2 strain after exposure to closantel at 16 mg/L for 24 hours.Results Closantel could inhibit the growth of Candida albicans,and enhance the antifungal effect of fluconazole against Candida albicans in vitro.The percentage of Candida albicans forming hypha was 91.2% ± 3.9% in untreated Candida albicans,significantly higher than that in closantel-treated Candida albicans (29.8% ± 5.1%,t =30.24,P < 0.05).As TEM showed,closantel-treated Candida albicans gave a round,oval or pleomorphic appearance,with an irregular budding from the cell surface.Further more,the electron dense layer in the outer layer of cell wall was absent or unevenly distributed,the transparent layer was irregularly thickened,some cell membrane was locally disrupted or collapsed,and intracellular vacuoles increased after closantel treatment.Scanning microscopy revealed a rough surface,sparse and irregular budding of Candida albicans after treatment with closantel.Conclusion Closantel exhibits a promising anti-Candida albicans property in vitro.
10.Mental Health Literacy in Three Cities of China:A Survey Study
Fei LI ; Shuiyuan XIAO ; Zhiping HUANG ; Jianguo SHI ; Zaohuo CHENG ; Wenfeng LUO ; Fangru YANG ; Liang ZHOU
Chinese Mental Health Journal 2009;23(12):883-887
Objective:To assess mental health literacy of urban porpulation and its related factors.Method:Subjects were sampled from 3 cities in the east(Wuxi),central(Changsha)and west(Xi'an)part of China.Subjects were asked to answer a questionnaire which included 5 vignettes of mental disorders and related questions.Results:54.1% of 7309 participants correctly recognized the cases of mania,but only 11.2% correctly recognized the cases of schizophrenia with negative symptoms.The average rate of correct recognition for all 5 vignettes was 41.7%.Participants with higher education level recognized the vignettes more correctly.Ill-character,stress and the pressure from work were reported to be the 3 main reasons of mental disorders.There were strong negative attitudes toward psychiatric patients,especially those with schizophrenia and mania.Conclusion:While the rate of correct recognition of mental disorders is acceptable when compared with similar studies in other parts of the world,negative attitude toward patients with mental disorder is still prevalent in China.


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