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Objective:To analyze whether involved-field irradiation (IFI) was associated with improved survival and reduced treatment-related adverse events compared with elective nodal irradiation (ENI) in Chinese patients with esophageal squamous cell carcinoma receiving radiotherapy.Methods:Literature review was conducted from CNKI, Wanfang Data, PubMed, Embase, Web of Science and Cochrane Central databases (until July 31, 2022). Relevant data were collected according to the inclusion and exclusion criteria. Primary outcomes included overall survival (OS) rate and treatment-related adverse events. Secondary outcomes included progression-free survival (PFS) rate and local control rate (LCR). Risk of bias was assessed using the Cochrane Risk of Bias tool. The quality of the results was assessed by using the meta analysis of Evidence Evaluation and Grading of Recommendations, Assessment, Development and Evaluations (GRADE) methods.Results:A total of 7 articles with 918 patients were included of which 465 received IFI and 453 received ENI. The 1-, 2-, 3-and 5-year OS rates in the IFI group were not significantly different from those in the ENI group (1-year OS rate: RR=1.00, 95% CI=0.94-1.07, P=0.97, high certainty; 2-year OS rate: RR=1.01, 95% CI=0.90-1.13, P=0.90, high certainty; 3-year OS rate: RR=0.86, 95% CI=0.71-1.05, P=0.14, high certainty; 5-year OS rate: RR=0.76, 95% CI=0.42-1.37, P=0.36, low certainty). In the IFI group, patients with ≥grade 2 acute radiation esophagitis ( RR=0.71, 95% CI=0.58-0.87, P=0.001, high certainty), ≥grade 3 acute radiation esophagitis ( RR=0.39, 95% CI=0.24-0.64, P<0.001, high certainty) and ≥grade 2 acute radiation pneumonitis ( RR=0.72, 95% CI=0.52-0.99, P=0.04, high certainty) were significantly lower compared with those in the ENI group. However, no significant differences were observed in the incidence of ≥grade 3 late radiation esophagitis, ≥grade 3 acute radiation pneumonitis and ≥grade 3 late radiation pneumonitis between two groups. No significant differences were noted in the 1-, 2-, 3-PFS rates and LCR between two groups. Conclusions:For Chinese patients with esophageal squamous cell carcinoma, IFI and ENI yield similar efficacy in terms of OS, PFS and LCR. However, IFI has a lower incidence of ≥grade 2 acute radiation esophagitis, ≥grade 3 acute radiation esophagitis and ≥grade 2 acute radiation pneumonitis than ENI.
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RESUMO Objetivo Verificar a efetividade, eficiência e satisfação no teste de usabilidade para o aplicativo de avaliação do zumbido. Método Trata-se de um estudo descritivo de teste de usabilidade, no qual será avaliado satisfação, eficácia e eficiência do aplicativo. O teste foi realizado virtualmente por meio de um formulário do Google Forms. Primeiramente, os participantes receberam as instruções de acesso e uso do avazum através de textos e imagens ilustrativas. Logo após, os usuários fizeram o uso do aplicativo, observando suas funções e usabilidade. Em seguida, os participantes responderam o questionário de usabilidade. A análise estatística foi realizada no software Statistics Package for the Social Sciences (SPSS) versão 21.0 para realizar a análise descritiva como frequência, percentagens dos dados do System Usability Questionnaire (SUS), além de análise do score do Net Promoter Score (NPS). Resultados Sendo assim, a média geral do score do SUS foi condizente com score de usabilidade satisfatório, o que implica dizer que o aplicativo não apresenta graves problemas de usabilidade, além da porcentagem geral NPS indicar uma satisfação muito boa dos usuários, com bom percentual de usuários promotores. No que diz respeito sobre a efetividade, foi possível observar que o Avazum atinge os objetivos propostos, além de ser eficiente, pois apresenta uma linguagem clara e confortabilidade durante o uso. Conclusão O Avazum obteve satisfação muito boa dos usuários, além de atingir os objetivos propostos, tornando-o efetivo, apresentou uma linguagem clara e confortabilidade durante o uso, aduzindo eficiência na avaliação multidisciplinar do zumbido.
ABSTRACT Purpose To verify the effectiveness, efficiency, and satisfaction in the usability test of the tinnitus assessment application. Methods This is a descriptive usability test study that assessed the satisfaction, effectiveness, and efficiency of the application. The test was carried out virtually via Google Forms. First, the participants received instructions on how to access and use Avazum, through texts and illustrative images. Afterward, the users used the application, observing its functions and usability. Next, the participants answered the usability questionnaire. Statistical analysis was performed using the Statistical Package for the Social Sciences, version 21.0, to perform descriptive analysis such as frequency, percentages of data in the System Usability Questionnaire (SUS), and analysis in the Net Promoter Score (NPS). Results Thus, the overall mean SUS score was consistent with satisfactory usability, which implies that the application does not present serious usability problems. Also, the overall NPS percentage indicated very good user satisfaction, with a good percentage of promoting users. As far as effectiveness is concerned, it was found that Avazum reached its goals, besides being efficient, as it uses clear language and is comfortably used. Conclusion Avazum obtained very good satisfaction from users, in addition to achieving its goals. It proved to be effective, has clear language, and is comfortably used, adducing efficiency in the multidisciplinary evaluation of tinnitus.
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Objective:To compare the efficacy and prognosis of elective nodal irradiation (ENI) combined with nedaplatin chemotherapy and involved field irradiation (IFI) combined with nedaplatin chemotherapy in the radical radiotherapy treatment of patients with cervical or upper thoracic esophageal cancer.Methods:Seventy-eight patients with cervical or upper thoracic esophageal cancer in Hai'an Traditional Chinese Medicine Hospital from February 2017 to February 2020 were selected and divided into ENI group and IFI group according to random number table method, with 39 cases in each group. The ENI group was treated with ENI combined with nedaplatin chemotherapy, while the IFI group was treated with IFI combined with nedaplatin chemotherapy. After 2 months of treatment, the therapeutic effect and the dose of lung irradiation were compared between the two groups, and the occurrence of adverse reactions and prognosis were compared.Results:The total effective rate and disease control rate were 69.23% (27/39) and 82.05% (32/39) in IFI group, and 64.10% (25/39) and 74.36% (29/39) in ENI group, there was no significant difference between the two groups ( χ2 = 0.23, P = 0.631; χ2 = 0.68, P = 0.411). The lung irradiation doses of V 5 Gy and V 20 Gy in IFI group were lower than those in ENI group (both P < 0.05). The incidence rates of bone marrow suppression and radiation lung injury in IFI group were lower than those in ENI group (all P < 0.05). By the end of follow-up, the survival rates of IFI group and ENI group were 76.92% (30/39) and 66.67% (26/39), respectively. There was no significant difference in overall survival between the two groups ( χ2 = 1.06, P = 0.300). Conclusions:ENI and IFI combined with nedaplatin chemotherapy in the radical radiotherapy treatment of cervical and upper thoracic esophageal cancer have similar efficacy and prognosis, but IFI can reduce the lung radiation dose and the incidence of adverse reactions.
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Objective To study the irradiation dose of organs at risk (OAR) in involved field radiation and extended field radiation in patients with thoracic esophageal cancer who received intensity modulated radiotherapy (IMRT). Methods A total of 40 patients with thoracic esophageal cancer were treated with IMRT. The involved field, extended field, and OAR were outlined to generate IMRT plans. The conformity index (CI) and homogeneity index (HI) of planning target volume (PTV) and the irradiation parameters of OAR were evaluated for the two plans. Paired t-test was used for comparison of irradiation parameters. Results The PTV of both plans received the prescribed dose. There were no significant differences in CI and HI of PTV between the two groups (P = 0.317, 0.130). There were significant differences in average lung dose, lung V5, lung V20, lung V30, spinal cord Dmean, heart Dmean, heart Dmax, heart V30, heart V40, and heart V60 between the two groups (P < 0.01). Conclusion Compared with the extended field, the involved field can reduce the irradiation dose of ORA in patients with thoracic esophageal cancer, thus reducing the risk of radiation.
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Objective:To explore the efficacy of elective nodal irradiation (ENI) and involved field irradiation (IFI) combined with chemotherapy in treatment of esophageal cancer.Methods:A total of 104 patients with esophageal cancer in Affiliated Hospital of Jiangnan University from May 2018 to May 2020 were selected as subjects for prospective study. All patients were randomly divided into observation group and control group by lottery method with 52 cases in each group. The target volume of observation group was delineated with IFI, and the control group was delineated with ENI. The curative effects, the levels of serum tumor markers [carbohydrate antigen 50 (CA50), squamous cell carcinoma (SCC) and carcinoembryonic antigen (CEA)] before and after treatment, the 1-year overall survival (OS) rate, the incidence of adverse reactions and the scores of various dimensions of health survey summary (SF-36) after treatment were compared between the two groups.Results:The total effective rate in the observation group was 90.38% (47/52), the total effective rate in the control group was 84.62% (44/52), and the difference was not statistically significant ( χ2 = 0.79, P =0.374). There was no statistical difference in CA50, CEA, SCC levels between the two groups before and after treatment (all P > 0.05). After treatment, the CA50, CEA and SCC levels in the two groups were lower than those before treatment, and the differences were statistically significant (all P < 0.05). The 1-year OS rate of the observation group was 94.23%, the control group was 90.38%, and the difference in OS between the two groups was not statistically significant ( χ2 = 0.54, P = 0.462). The incidence of acute radiation esophagitis in the observation group was lower than that in the control group, and the difference was statistically significant ( P < 0.001). There was no statistical difference between the two groups in SF-36 scale scores of physical functioning, role-physical, bodily pain, mental health, vitality, social functioning, role-emotional, and general health after treatment (all P > 0.05). Conclusions:Both ENI and IFI are effective treatments for patients with esophageal cancer. There is no significant difference in the quality of life of patients between the two delineation methods, but the incidence of acute radiation esophagitis is lower in patients with IFI regimen.
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Objective:To explore the benefit groups of patients with locoregional recurrence of esophageal thoracic squamous cell carcinoma who received radiotherapy or chemoradiotherapy with different patterns of irradiation.Methods:Clinical data of 344 esophageal thoracic squamous cell carcinoma patients with postoperative recurrence who received intensity conformal radiotherapy or concurrent chemoradiotherapy in the Fourth Hospital of Hebei Medical University from 2009 to 2014 were retrospectively analyzed. The distribution of recurrence sites and prognostic factors were analyzed. A stratified analysis was carried out on the benefit groups of patients receiving the elective nodal irradiation (ENI) and involved field irradiation (IFI).Results:276 cases (80.2%) recurred at a single site and 68 cases (19.8%) recurred at more than two sites. The follow-up rate was 96.2%. The 1-, 3-and 5-year overall survival rates were 53.6%, 22.6% and 16.4%, respectively, with a median of 12.8 months (95% CI: 11.3-14.3 months). The 1-, 3-and 5-year local recurrence-free survival rates were 46.5%, 16.9% and 12.0%, respectively, with a median of 11.0 months (95% CI: 9.6-12.4 months). The 1-, 3-and 5-year progression-free survival rates were 39.8%, 11.3% and 6.7%, respectively, with a median of 7.9 months (95% CI: 5.8-10.0 months). Multivariate analysis showed that gender, the log odds of metastatic lymph nodes (LODDS) and the number of chemotherapy cycles were the independent prognostic factors ( P=0.003, <0.001, <0.001). Subgroup univariate analysis demonstrated that patients with an esophageal lesion length<5.0 cm, N 0 stage, the number of surgically-dissected lymph nodes of ≤9, the number of postoperative positive lymph node metastasis site of 0, and LODDS≤0.030 obtained benefits from ENI ( P=0.032, 0.012, 0.001, 0.012 and 0.014). Patients with the number of surgically-dissected lymph nodes of ≥16 achieved benefits from IFI ( P=0.035). Conclusions:Radiotherapy is an effective treatment mode for patients with local recurrence after esophageal cancer surgery. For patients with preoperative esophagography showing shorter esophageal lesions, earlier postoperative pathological N stage, lower LODDS score, and fewer surgically-dissected lymph nodes probably obtain more benefits from ENI than IFI. However, patients with more surgically-dissected lymph nodes may obtain more benefit from IFI compared with ENI.
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Objective@#To evaluate the effect of different irradiation methods on the long-term prognosis of patients with clinical T2-3N0M0 esophageal squamous cell carcinoma, aiming to select the optimal treatment for these patients.@*Methods@#A total of 268 eligible patients admitted to our hospital from January 2007 to December 2012 were enrolled in this study. All patients were divided into the involved-field irradiation (IFI) and elective node irradiation (ENI) groups. The composition ratio, prognostic factors and adverse events were analyzed between two groups.@*Results@#The median overall survival (OS) time was 35.5 months (95%CI : 30.12-40.88) and the median disease-free survival (DFS) time was 23.5 months (95%CI: 19.00-28.00). According to the multivariate analysis results, all patients were assigned into two groups at a ratio of 1 vs.1(n=86 in each group). Multivariate analysis after propensity score matching (PSM) demonstrated that irradiation method was the independent factor of OS (P=0.038), and T stage and radiotherapy were the independent factors affecting DFS (P=0.002, 0.032). The incidence of ≥grade Ⅱ adverse events did not significantly differ between two groups (P=0.819, 0.756). However, patients with combined chemotherapy experienced more adverse events.@*Conclusion@#ENI can prolong the OS and DFS of patients with clinical T2-3N0M0 esophageal squamous cell carcinoma, and does not increase the incidence of severe adverse events.
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Objective To evaluate the effect of different irradiation methods on the long-term prognosis of patients with clinical T2-3N0M0 esophageal squamous cell carcinoma,aiming to select the optimal treatment for these patients.Methods A total of 268 eligible patients admitted to our hospital from January 2007 to December 2012 were enrolled in this study.All patients were divided into the involved-field irradiation (IFI) and elective node irradiation (ENI) groups.The composition ratio,prognostic factors and adverse events were analyzed between two groups.Results The median overall survival (OS) time was 35.5 months (95％CI:30.12-40.88) and the median disease-free survival (DFS) time was 23.5 months (95％CI:19.00-28.00).According to the multivariate analysis results,all patients were assigned into two groups at a ratio of 1 vs.1(n=86 in each group).Multivariate analysis after propensity score matching (PSM) demonstrated that irradiation method was the independent factor of OS (P=0.038),and T stage and radiotherapy were the independent factors affecting DFS (P=0.002,0.032).The incidence of ≥ grade Ⅱ adverse events did not significantly differ between two groups (P=0.819,0.756).However,patients with combined chemotherapy experienced more adverse events.Conclusion ENI can prolong the OS and DFS of patients with clinical T2-3NoMo esophageal squamous cell carcinoma,and does not increase the incidence of severe adverse events.
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Abstract The street life is part of a larger process of vulnerability. Many youths use the streets as an escape from poverty, abuse and violence. However, a focus on risks may neglect positive factors that have the potential to promote healthy development. Accordingly, we examined trajectories of street-involved youth with different subjective well-being (SWB) profiles. Interviews conducted at three time points with six-months intervals included a semi-structured life experience interview (e.g., leaving home, street life, and school experience) and well-being measures. Cluster analysis identified three groups namely average SWB, positive SWB, and negative SWB. Within each SWB profile, two participants were selected to a multiple case study. The results revealed that positive SWB group had connections with other environments (family and institutions) beyond the street, while youth with negative SWB reported low social support and strong involvement with the street. Negative SWB group were formed by girls who reported family conflict, emotional, physical and sexual violence and adjustment difficulties. Finally, this study suggests that well-being research can contribute to protective practices, also indicating to the need to strengthen family and institutional ties as a strategy for the youth development. The longitudinal approach points that early interventions can anticipated positive developmental outcomes.
Resumo A vida nas ruas trata-se de um processo de vulnerabilidade. Jovens usam as ruas como fuga da pobreza, abuso e violência. Contudo, o foco nos riscos pode negligenciar fatores positivos com potencial para promover o desenvolvimento saudável. Destarte, investigou-se trajetórias de jovens em situação de rua com diferentes perfis de bem-estar subjetivo (BES). Entrevistas realizadas em três momentos, com intervalos de seis meses, incluíram um roteiro semiestruturado de experiência de vida (e.g., saída de casa, vida na rua e experiência escolar) e medidas de bem-estar. A análise de cluster identificou três grupos: BES médio, BES positivo e BES negativo. Selecionou-se dois participantes de cada grupo para um estudo de casos múltiplos. Identificou-se que o grupo BES positivo manteve vínculos com a família e instituições além da rua, enquanto o BES negativo relatou baixo apoio social e forte envolvimento com a rua. O BES negativo compôs-se de meninas com conflitos familiares, violência emocional, física e sexual e dificuldades de adaptação. Sugere-se que a pesquisa sobre o bem-estar pode contribuir para práticas de proteção, indicando a necessidade de fortalecer os laços familiares e institucionais como estratégia para o desenvolvimento. A abordagem longitudinal evidencia que intervenções precoces podem antecipar resultados positivos no desenvolvimento.
Resumen La vida en calle es un proceso de vulnerabilidad. Jóvenes usan las calles como escape de la pobreza, abuso y violencia. Pero, centrarse en riesgos puede descuidar de factores positivos con potencial de promover un desarrollo saludable. Para tanto, se investigó trayectorias de jóvenes en situación de calle con diferentes perfiles de bienestar subjetivo (BS). Entrevistas realizadas en tres ocasiones, a intervalos de seis meses, incluyeron un guion semiestructurado de experiencia de vida (e.g., salida de casa, vida en calle y experiencia escolar) y medidas de bienestar. Análisis de cluster identificó tres grupos: BS medio, BS positivo y BS negativo. Dos participantes de cada grupo fueron seleccionados para un estudio de caso múltiple. BS positivo mantenía lazos con la familia y instituciones más allá de calle, mientras que BS negativo informaba bajo apoyo social y fuerte participación en calle. BS negativo consistió en niñas con conflictos familiares, violencia emocional, física y sexual y dificultades de adaptación. Se sugiere que la investigación del bienestar puede contribuir a las prácticas de protección, lo que indica la necesidad de fortalecer lazos familiares e institucionales como estrategia para el desarrollo. El enfoque longitudinal muestra que intervenciones tempranas pueden anticipar resultados de desarrollo positivos.
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Objective To explore the clinical efficacy of lymph node involved-field irradiation (IFI) and elective nodal irradiation (ENI) for treatment of esophageal cancer among Asian populations. Methods The randomized controlled trials and retrospective analyses of Asian esophageal cancer patients treated by IFI and ENI were retrieved by computer in Cochrane Library, PubMed, Embase, CNKI, and Wanfang database. The last retrieval time was May 2018. According to the inclusion and exclusion criteria, the clinical efficacy, adverse reactions and failure modes were selected in each study. A Meta-analysis was performed by using Review Manager 5.3 software to compare the advantages and disadvantages of IFI group and ENI group in treatment of Asian esophageal cancer patients. Results Eventually, a total of 18 domestic and foreign literature that meet the standards (6 randomized controlled trials, 12 retrospective analyses) were included, with a total of 2220 patients. There were no significant differences in the overall survival rate, the local control rate, the local/regional failure rate, the distant metastasis rate, the intra-field recurrence rate, and the field recurrence rate between the IFI group and the ENI group (all P>0.05). The overall failure rate of ENI group was slightly lower than that of IFI group (P= 0.05). The incidence of radiation pneumonitis in ENI group was higher than that in IFI group (P= 0.004), and the incidence of radiation esophagitis was higher than that in IFI group (P< 0.01). Conclusion For Asian patients with esophageal cancer, ENI has no obvious advantage compared with IFI, including the increase of adverse reactions.
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Objective To investigate the prognostic effects and failure patterns of different clinical target volumes of IMRT in definitive chemoradiotherapy for cervical and upper-thoracic esophageal cancer,in order to provide a reference for radiotherapy target area delineation.Methods A retrospective analysis was performed on the clinical data of 132 patients with cervical and upper-thoracic esophageal cancer who received definitive IMRT and concurrent chemotherapy in our hospital from 2010 to 2014.Seventy-one patients received elective nodal irradiation (ENI) and the other 61 patients received involvedfield irradiation (IFI).The Kaplan-Meier method was used to calculate local control (LC),progressionfree survival (PFS) and overall survival (OS) rates.The significant difference was evaluated by the logrank test.The prognostic factors were determined by Cox univariate and multivariate analyses.Results The last follow-up time was December 2017,the median follow-up time was 59.5 (14.2-95.8) months.Follow-up rate was 99.2％.For the ENI and IFI groups,the 1-,3-,5-year LC were 77.5％,58.8％,48.8％ vs.64.3％,29.1％,26.2％ (x2=9.68,P=0.002),PFS were 68.6％,37.7％,25.9％ vs.47.5％,17.2％,3.6％ (x2=11.39,P=0.001),OS were 81.7％,53.9％,31.3％ vs.70.5％,31.9％,16.3％ (x2=7.70,P =0.006),respectively.In multivariate analysis,T stage,N stage,and RT field were independent factors for LC,PFS and OS(P＜0.05).The total failure rates,local-regional recurrent rate in ENI group were lower than those in IFI group (x2 =13.23,5.24,P＜0.05).No significant differences were found in acute radiation esophagitis,pneumonitis and myelosuppression (Grades ≥ 3) between the two groups(P＞0.05).Conclusions Compared with IFI,ENI can significantly reduce local-regional recurrence and distant metastasis and improve the long-term survival for cervical and upper-thoracic esophageal cancer patients who received definitive chemoradiotherapy.
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Objective Ethical review is an important safeguard for the development of human subject research.The post approval review during the research process is particularly vital because it is the core method in the ethical review to protect participants' safety and right.In this article,current problems about post approval review were analyzed deeply to explore how to improve the mechanism of post approval review from the combination of management and technical aspect,particularly for the plan of not-for-cause visit.Methods According to the work experiences,literature review,identifying problems,to explore the collaboration to strengthen post approval review with experts,pharmacological institutions and scientific research management department.Results There are more and more frequent ethical issues during the implementation process,besides continuing strengthen the passive continuing review,continuing review guidelines and more detailed active continuing review screening and implementation mechanism should be developed.Conclusions It will prevent the occurrence of injury through establishing more optimal post approval review mechanism and a forehand active prevention strategy,which play an important role in the ethical review of human subject research.
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Objective To study the surgical treatment strategy of acute type A aortic dissection involving coronary artery on the basis of Fuwai type and evaluate the clinical efficacy. Methods 50 patients with coronary involvement were retrospec-tively analyzed from April 2014 to August 2016. The treatment mothod was based on Fuwai type,mainly including coronary ar-tery repair(CAR)and coronary artery bypass grafting(CABG). The clinical effect of this surgical strategy in the perioperative and follow-up period was analysed. Results A total of 50 patients were included. Of which,38 patients were treated with CAR, 12 patients CABG,including 3 remedial bypass and 2 prophylactic bypass. All patients were followed up from 4 to 32 months,with an average time of 18. 6 months. In group CABG, 1 patient died of multiple organ failure after surgery,and the other patients had no major adverse cardiovascular events and deaths during perioperative period and follow-up period. Conclu-sion This strategy for the treatment of involved coronary arteries based on the Fuwai type has some guiding significance on the surgical treatment of acute type A aortic dissection.
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Objective@#To investigate clinic-pathological characteristics, diagnosis, treatment and prognosis of intravascular large B cell lymphoma (IVLBCL) in China.@*Methods@#Clinical and pathological records were analyzed from 12 IVLBCL patients diagnosed between Jan 2010 to Jun 2016. Kaplan-Meier method was used to estimate overall survival (OS), and univariate analysis was performed to identify prognostic factors.@*Results@#A series of 12 patients with IVLBCL (median age, 53.8 years; range, 32-76 years; 6 males and 6 females) was reviewed. Fever was the most common symptom (10/12), respiratory symptoms (cough, pleural effusion, dyspnea, 50%) and hemophagocytic lymphohistiocytosis (50%) were frequently observed, and only 12 patients had neurological symptom. All patients had elevated lactic dehydrogenase and serum ferritin. International Prognostic Index score was high in 75% of total patients. All patients had extra-nodal involved, pulmonary (6/12) and bone marrow (4/12) were frequently involved. Large lymphoid cells within vessel lumina or sinuses were observed in all patients. These cells were large, with scant cytoplasm, vesicular nuclei, and one or more nucleoli, and the structures of vessels and sinus were reserved. CD20 and CD79a were positive in all cases. 11patients received rituximab combined CHOP regimen chemotherapies, overall response rate (ORR) was 90.1%, and complete response rate was 66.7%. Median survival time and median progression time were not reached after a median follow-up of 20 months. Univariate analysis revealed that no clinical characters were associated with OS.@*Conclusion@#As a rare variant of DLBCL, IVLBCL presented with pulmonary involved frequently, and trans-bronchial lung biopsy had good positive rates. Rituximab contained chemotherapy was the backbone for IVLBCL.
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Objective To observe the curative effect,failure pattern and treatment-related toxicities of elective nodal irradiation (ENI) and involved field irradiation (IFI) in patients with thoracic esophageal squamous cell carcinoma treated with radical radiotherapy, and determine the reasonable target delineation of radiotherapy. Methods Using prospective randomized controlled design, a total of 86 patients with thoracic esophageal squamous cell carcinoma were randomly allocated to two groups:ENI group(n=39)and IFI group(n=47).Both groups received concurrent chemoradiotherapy.In ENI group,the high-risk lymphatic drainage area received prophylactic irradiation on the basis of IFI group.After the treatment, all patients were followed up for 3~33 months.The median follow-up period was 15 months.The short-term effective rate, one year survival rate, progression free survival rate and the local control rate of two groups were calculated. The survival curve was drawn by the Kaplan-Meier method,and the survival rate was compared using the Log-rank method.Meanwhile, the treatment failure pattern and incidence of adverse reactions were analyzed in the two groups. Results There was no significant difference in effective rate between ENI group and IFI group (92.3% vs. 95.7%,χ 2=0.460, P>0.05). The one-year survival rates were 66.7% and 68.1% for the two groups,respectively.The progression-free survival rates were 56.4% and 53.2% respectively.The local control rates were 92.3% and 87.5% respectively,with no statistical difference(P>0.05). The median survival time was 15 months at the end of the follow-up for group ENI and group IFI, and there was no significant difference in survival rate between two groups(Log-rank χ2=1.520,P=0.218).There were 35 cases with treatment failure in all 86 patients, of which 17 cases were in group ENI and 18 cases in group IFI. The regional failure rates were 35.9% and 27.7% in ENI and IFI groups respectively,distant metastasis rates were 20.5% and 14.9% respectively,in-field failure rates were 30.8% and 23.4% respectively, and out-of-field failure rates were 4.3% and 5.1% respectively, which showed no significant differences (P>0.05). There were no significant differences in side effects, the incidence of bone marrow suppression,gastrointestinal reactions,radiation esophagitis and radiation-induced lung injury between two groups (P>0.05). Conclusion ENI shows similar recent efficacy, failure patterns, adverse reactions and prognosis with IFI for thoracic esophageal squamous cell carcinoma patients receiving radical radiotherapy. So IFI treatment is recommended to minimize the exposure dosage of normal tissue.
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Objective In recent years,technology and ideology of big data has played an important role in promoting clinical science research and medical management,which has been paid more attention.And relative researches and findings were reported constantly.However,there still exists some problems on how to apply patient-related big data to clinical researches based on ethical principles.Moreover,for ethical management,it is challenging that technology and ideology of big data is introduced to human-involved clinical researches,especially for the management and protection of biological samples,clinical data,identity information and gene data.Therefore,in the present study,the ethical management methods of human-involved clinical researches in the age of big data are explored.Methods Combining work experience and think from researches,we want to make some targeted suggestions on ethical review.Results In the age of big data,following suggestions should be taken into consideration in human-involved clinical researches,which include standardizing management system of biological sample bank,establishing compulsory isolation system for identity information,improving accountability mechanism for data leakage,and defining participating qualification of gene-involved project.Conclusions The suggestions are expected to exert an enlightening and promoting role in the reformation of ethical review system in the age of big data.
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Objective This study was conducted to evaluate treatment-related toxicities,the patterns of failure,overall survival(OS)and progression-free survival(PFS)by comparing IFI with ENI in combination with chemotherapy. Methods Eligible patients were treated with concurrent chemoradiotherapy and randomized into either an IFI or ENI arm. The primary end points wereacute treatment-related toxicities. The secondary end points were patterns of failure,OS and PFS. Kaplan?Meier survival rate of the method for calculating the Logrank test difference method. Results Between April 2012 and October 2016,a total of 228 patients were enrolled from nine centers in china. Grade≥3,Grade≥2 radiation esophagitis and pneumonitis in the IFI arm were significantly lower than that of the ENI arm(P=0.018,0.027).No significant differences were observed in overall failure rates,loco-regional failure,distant failure rates,in-field and out-field lymph node failure between the two arms(P=0.401,0.561,0.510,0.561,0.681).The 1-,2-, 3-,4-yearand median OS in the ENI arm and IFI arm were 84.1%,57.3%,39.4%,31.6%,28 months and 83.6%,62.1%,44.5%,31.5%,32 months(P=0.654),respectively. The 1-,2-,3-yearand median PFS in the ENI arm and IFI arm were 71.9%,42.3%,32.7%,20 months and 70.1%,45.0%,35.9%,22 months (P=0.885),respectively. Conclusions Compared to ENI,IFI resulted in decreased radiation pneumonitis and esophagitis without sacrificing loco-regional lymph nodal control,PFS and OS in thoracic ESCC. Clinical Trial Registry Chinese Clinical trail registry,registration number:NCT01551589.
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Objective: To investigate clinic-pathological characteristics, diagnosis, treatment and prognosis of intravascular large B cell lymphoma (IVLBCL) in China. Methods: Clinical and pathological records were analyzed from 12 IVLBCL patients diagnosed between Jan 2010 to Jun 2016. Kaplan-Meier method was used to estimate overall survival (OS), and univariate analysis was performed to identify prognostic factors. Results: A series of 12 patients with IVLBCL (median age, 53.8 years; range, 32-76 years; 6 males and 6 females) was reviewed. Fever was the most common symptom (10/12), respiratory symptoms (cough, pleural effusion, dyspnea, 50%) and hemophagocytic lymphohistiocytosis (50%) were frequently observed, and only 12 patients had neurological symptom. All patients had elevated lactic dehydrogenase and serum ferritin. International Prognostic Index score was high in 75% of total patients. All patients had extra-nodal involved, pulmonary (6/12) and bone marrow (4/12) were frequently involved. Large lymphoid cells within vessel lumina or sinuses were observed in all patients. These cells were large, with scant cytoplasm, vesicular nuclei, and one or more nucleoli, and the structures of vessels and sinus were reserved. CD20 and CD79a were positive in all cases. 11patients received rituximab combined CHOP regimen chemotherapies, overall response rate (ORR) was 90.1%, and complete response rate was 66.7%. Median survival time and median progression time were not reached after a median follow-up of 20 months. Univariate analysis revealed that no clinical characters were associated with OS. Conclusion: As a rare variant of DLBCL, IVLBCL presented with pulmonary involved frequently, and trans-bronchial lung biopsy had good positive rates. Rituximab contained chemotherapy was the backbone for IVLBCL.
Subject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , Antineoplastic Combined Chemotherapy Protocols , China , Lymphoma, Large B-Cell, Diffuse , Prognosis , Retrospective Studies , RituximabABSTRACT
PURPOSE: Perioperative chemotherapy improves survival outcomes in locally advanced (LA) gastric cancer. MATERIALS AND METHODS: We retrospectively analyzed patients with LA gastric cancer who were offered perioperative chemotherapy consisting of epirubicin, oxaliplatin, and capecitabine (EOX) from May 2013 to December 2015 at Tata Memorial Hospital in Mumbai. RESULTS: Among the 268 consecutive patients in our study, 260 patients (97.0%) completed neoadjuvant chemotherapy, 200 patients (74.6%) underwent D2 lymphadenectomy, and 178 patients (66.4%) completed adjuvant chemotherapy. The median follow-up period was 17 months. For the entire cohort, the median overall survival (OS), 3-year OS rate, median progression-free survival (PFS), and 3-year PFS rate were 37 months, 64.4%, 31 months, and 40%, respectively. PFS and OS were significantly inferior in patients who presented with features of obstruction than in those who did not (P=0.0001). There was no difference in survival with respect to tumor histology (well to moderately differentiated vs. poorly differentiated, signet ring vs. non-signet ring histology) or location (proximal vs. distal). Survival was prolonged in patients with an early pathological T stage and a pathological node-negative status. In a multivariate analysis, postoperative pathological nodal status and gastric outlet obstruction on presentation significantly correlated with survival. CONCLUSIONS: EOX chemotherapy with curative resection and D2 lymphadenectomy is a suggested alternative to the existing perioperative regimens. The acceptable postoperative complication rate and relatively high resection, chemotherapy completion, and survival rates obtained in this study require further evaluation and validation in a clinical trial.
Subject(s)
Humans , Capecitabine , Chemotherapy, Adjuvant , Cohort Studies , Disease-Free Survival , Drug Therapy , Epirubicin , Follow-Up Studies , Gastrectomy , Gastric Outlet Obstruction , Lymph Node Excision , Lymph Nodes , Multivariate Analysis , Postoperative Complications , Retrospective Studies , Stomach Neoplasms , Survival Analysis , Survival RateABSTRACT
Chemoradiotherapy is a major treatment for inoperable esophageal carcinoma (EC).However, there is still controversy over the target volume for radiation, particularly nodal target volume.EC is characterized by a high rate of lymph node metastasis, and its metastatic pattern is not always predictable.Elective nodal irradiation (ENI) will increase the radiation field, which may increase the incidence of adverse events.Some investigators used involved-field irradiation (IFI) to reduce treatment-related toxicities without compromising survival.Studies have demonstrated that regional and distant micrometastases can be controlled, to some extent, by chemotherapy, incidental irradiation, and the abscopal effects of radiation.With either ENI or IFI, EC recurrence is usually found in the primary tumor and at distant sites, without survival difference.These data suggest that IFI is feasible in EC patients.