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COVID-19 pandemic has put a huge burden on public health and global economy. Vaccines play an important role in controlling virus transmission and reducing mortality. While monoclonal virus neutralizing antibodies can reduce the viral load, improve symptoms, and prevent the aggravation of the disease from hospitalization. Now hundreds of clinical trials of COVID-19 vaccine and monoclonal neutralizing antibody are in progress. The vaccine focuses on disease prevention, while the neutralizing antibody focuses on disease treatment. There are quite many differences between the two kinds of clinical trials by following different technical guidelines, research purpose, trial design, implementation and outcome assessment. Therefore, it is necessary to summarize the similarities and differences between the clinical trials for the reference of new drug research and development as well as clinical researchers.
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Objective:To investigate the type and severity of skin adverse reactions induced by afatinib in the treatment of lung cancer, and to analyze their correlation with anti-lung cancer efficacy.Methods:A case-case-control study was conducted on lung cancer patients treated with afatinib in ZhongDa Hospital, Southeast University from December 2016 to January 2018. The type and severity of skin adverse reactions were evaluated in 76 patients with lung cancer based on the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0, and these patients were divided into 3 groups according to the severity of skin lesions, including grade-0, -1, and -2/3 groups. The patients underwent chest computed tomography (CT) examination every 3 months, and the tumor response to afatinib was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) . Anti-lung cancer efficacy of afatinib was compared among the patients with different grades of skin lesions by using the Kruskal-wallis H rank sum test. Results:After treatment with afatinib, 44 of the 76 patients with lung cancer achieved stable condition or partial remission, and 32 experienced disease progression. Skin adverse reactions occurred in 69 patients, and manifested as acneiform lesions in 42 (55.3%) patients, paronychia in 35 (46.1%) , mucosal erosions in 30 (39%) , hair changes in 8 (10.5%) , and hand-foot syndrome in 6 (7.9%) . Improvement was achieved in 3, 7 and 34 cases in the grade-0, -1, and -2/3 groups ( n = 7, 19 and 50 respectively) , respectively. There was a significant difference in the response rate among the 3 groups ( χ2 = 6.117, P = 0.047) , and the response rate was significantly higher in the grade-1 and -2/3 groups than in the grade-0 group (both P < 0.001) , and higher in the grade-2/3 group than in the grade-1 group ( P < 0.001) . Conclusion:The treatment of lung cancer with afatinib can cause various types of skin lesions, such as acneiform lesions, paronychia, mucosal erosions, hair changes and hand-foot syndrome, and the higher the severity of the skin lesions, the more marked the anti-lung cancer efficacy of afatinib.
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Migraine is a common nervous system disease, which could seriously affect the quality of life. However, the medical treatment of migraine cannot meet the clinical needs at present. With the deepening of research, serotonin 1F receptor agonists and drugs targeting CGRP are more and more developed and marketed. In this paper, the mechanism of action, safety and efficacy, metabolic characteristics of these drugs were systematically evaluated to provide a more scientific basis for clinical prevention and treatment of migraine.
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To point out the importance of risk management for biological agents in phase I clinical trials, taking a healthy subject for an example who suffered from agranulocytosis after the application of Tozumab. In order to ensure the safety of the subjects and smooth progress of clinical trials, risk management should be implemented in several aspects such as: informing, screening, administration, subject training, and adverse event management and so on.
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Objective To investigate the current status and influencing factors of self-efficacy for oral self-care in patients with chronic periodontitis. Methods A total of 357 patients with chronic periodontitis were investigated with the self-designed questionnaire, Self-Efficacy Scale for Self-care (SESS), Dental Fear Scale(DFS) and Medical Coping Modes Questionnaire(MCMQ). Results The total score of SESS was(58.66±7.27)points,which was at the medium level.In the scores of each dimension, self-efficacy for dietary habits was the highest,(20.42 ± 2.88)points,and self-efficacy for brushing of the teeth was the lowest,(18.37 ± 2.94)points.Multiple linear regression analysis showed that age,dental fear and medical coping mode were influencing factors of self-efficacy for oral self-care,which explained 53.6% of the variance. Conclusions Medical staff should pay more attention to the patients who are in low level of self-efficacy for self-care.Oriented by each dimension and influencing factors,specific psychological intervention should be given to reduce dental fear,improve medical coping style,enhance the level of self-efficacy for oral self-care and promote oral self-care behaviors and somatopsychic health.
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As a novel magnetic resonance functional imaging technique,diffusion-weighted imaging (DWI) has been widely used in the diagnosis of diseases of central nervous system.Recent years,DWI application is getting more and more to evaluate the biological characteritics of human body,espercially in liver,pancreas,kidneys and pelvic cavity.While,research of DWI in intestinal disease is relatively few.This article aims to review the application advances of DWI in colorectal tumor and inflammatory bowel disease (IBD).
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The recombinant adenovirus Toll like receptor 4 (TLR4) shRNA vector (pGSadeno-TLR4) was constructed and transfected into human aortic vascular smooth muscle cells (HA-VSMC).After HA-VSMC were treated with palmitate or different signaling pathway inhibitors,the mRNA and protein levels of interleukin-6 (IL-6)and NF-κB activity were tested with real-time PCR and ELISA,respectively.The results showed that palmitate increased mRNA and protein levels of IL-6 in HA-VSMC in a dose-dependent manner.The expression of IL-6 mRNA reached peak after treatment with 400 μmol/L of palmitate for 6 h,being 10.43 fold of control (P＜0.01).Treatment with 400 pmol/L of palmitate for 24 h maximally upregulated the protein level of IL-6,which was 2.18 fold of control (P＜0.01).NF-κB inhibitor parthenolide markedly inhibited palmitate-stimulated increased in IL-6 mRNA level by 65％ and protein level by 59％ (both P＜0.01).Protein kinase C (PKC) inhibitor chlerythrine suppressed palmitateinduced IL-6 mRNA expression by 24％ and IL-6 protein level by 28％.By contrast,extracellular signal-regulated protein kinase inhibitor PD98059 and phosphatidylinositol 3-kinase inhibitor wortmannin had no effect on the induction of IL-6 by palmitate.Blockade of TLR4 with pGSadeno-TLR4 significantly suppressed palmitate-induced IL-6 mRNA expression by 72％ and IL-6 protein expression by 75％ (both P＜0.01),along with decrease of NF-κB p65 activity decreased by 62％.These results suggest that TLR4/NF-κB and PKC pathways mediate palmitate-induced IL-6 expression in HA-VSMC.
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Objective To observe the change of the balance between regulatory T (Treg) cells and T helper 17(Th17) cells in peripheral blood of the patients with serofast syphilis .Methods From January 2010 to September 2012 ,28 patients with serofast syphilis in our department were selected into the observation group and 30 normal persons were selected into control group .Flow cytometry was used to measure the expression of Treg cells ,Th17 cells ,specific transcription factors Foxp3 and ROR-γ in the pe-ripheral blood .The comparative analysis was carried out .Results The proportion of Treg cells in the peripheral blood of the obser-vation group was (34 .02% ± 12 .31% ) ,which was higher than (21 .86% ± 8 .24% ) in the control group(P<0 .05) ,and the pro-portion of Th17 cells in the peripheral blood of the observation group was (3 .08% ± 2 .17% ) ,which was lower than (9 .13% ± 1 .96% ) in the control group(P<0 .01);the expression level of Foxp3 of CD4+ T cells was (2946 .35 ± 995 .63) in the observation group ,which was higher than (2468 .74 ± 869 .63) in the control group(P< 0 .05),and the expression level of ROR-γwas (1438 .29 ± 659 .31) ,which was lower than(1831 .25 ± 426 .37) in the control group(P<0 .05) .All above differences had signifi-cantly statistical significance .Conclusion The Treg/Th17 cell balance is abnormal in peripheral blood of the patients with serofast syphilis .This cellular immunity suppression of human body may be the reason leading to serofast syphilis .