体外诊断试剂临床试验的质量控制

随着体外诊断技术的发展和体外诊断试剂生产企业研发水平的不断提高,体外诊断试剂临床试验日益增多。部分体外诊断试剂在获得食品药品监督管理部门注册许可进入临床使用前,必须要经过临床试验,但体外诊断试剂临床试验在实施过程中存在较多质量问题。本文从体外诊断试剂临床试验项目预试验实施、知情同意、方案入排标准设计及执行、生物样本管理、伴随诊断试剂盒肿瘤疗效评价数据收集、临床试验记录和报告等临床试验项目实施关键点,分析了体外诊断试剂临床试验质量控制中存在的问题,为体外诊断试剂临床试验的规范化实施提供参考。     

乳腺癌放疗病人癌因性疲乏与社会支持及心理弹性的相关性研究

目的:探讨乳腺癌放疗病人癌因性疲乏与社会支持及心理弹性的关系。方法:采用方便抽样法选取2018年10月—2019年10月92例乳腺癌放疗病人,在病人放疗期间应用癌因性疲乏量表、社会支持量表、心理弹性量表对其进行调查,乳腺癌放疗病人癌因性疲乏与心理弹性、社会支持三者的关系应用Pearson相关分析,应用多元回归分析影响乳腺癌放疗病人癌因性疲乏的独立因素。结果:乳腺癌放疗病人癌因性疲乏总分为(26.25±4.78)分、社会支持总分为(45.23±3.98)分、心理弹性总分为(60.12±5.11)分。Pearson相关分析显示,乳腺癌放疗病人癌因性疲乏总分、情感疲乏及认知疲乏评分与社会支持总分、社会支持利用度评分和心理弹性总分及其各维度评分呈负相关(P<0.05)。多元回归分析显示,病人文化程度、临床分期、放疗效果、社会支持及心理弹性是乳腺癌放疗病人癌因性疲乏发生的独立影响因素(P<0.05)。结论:影响乳腺癌放疗病人癌因性疲乏的因素较多,护理人员可通过加强病人放疗期间心理疏导,强化病人外部社会支持,从而减轻病人放疗期间癌因性疲乏,促进病人身心健康。     

A study of Helicobacter pylori infection,dietary pattern and habits in patients with gastric cancer in South India

ObjectiveTo determine the association of Helicobacter pylori (H. pylori) infection, dietary pattern and habits with gastric cancer in populations where consumption of smoked and salted meat is not high.MethodsA total of 54 patients were included in the study with 27 each in case and control groups. H. pylori status was determined in both the groups. The dietary pattern was assessed for intake of carbohydrates, non-vegetarian diet, salt, spices, fruits and vegetables, using a food frequency questionnaire. Habits such as smoking, tobacco chewing and alcohol consumption, H. pylori status and dietary pattern were compared between the two groups.ResultsForty four percent of the patients with gastric cancer were positive for H. pylori infection compared to 63% of the controls, which is not statistically significant. 44% of the patients with gastric cancer had a frequent carbohydrate intake compared to 30% of the controls. Patients with gastric cancer had a lower intake of fruits (P >0.05) and vegetables (P >0.05) than controls. Habits like smoking, tobacco chewing and alcohol use were more prevalent among the cases when compared to the controls. However, these differences were not statistically significant. Intake of non-vegetarian diet, salt and spices was found to be similar in both the groups.ConclusionsThe H. pylori status was similar between patients with gastric cancer and controls. High intake of carbohydrates, low intake of fruits and vegetables, habits like smoking, tobacco chewing and alcohol intake were more frequent in patients with gastric cancer compared to the controls, although the difference did not reach significance.     

Controversies in autism: is a broader model of social disorders needed?

Depression is a common and disabling condition with a high relapse frequency. Maternal mental health problems and experience of traumatic life events are known to increase the risk of behavior problems in children. Recently, genetic factors, in particular gene-by-environment interaction models, have been implicated to explain depressive etiology. However, results are inconclusive. Study participants were members of the SESBiC-study. A total of 889 mothers and their children were followed during the child’s age of 3 months to 12 years. Information on maternal depressive symptoms was gathered postpartum and at a 12 year follow-up. Mothers reported on child behavior and traumatic life events experienced by the child at age 12. Saliva samples were obtained from children for analysis of 5- HTTLPR and BDNF Val66Met polymorphisms. Multivariate analysis showed a significant association between maternal symptoms of depression and anxiety, and internalizing problems in 12-year-old children (OR 5.72, 95% CI 3.30-9.91). Furthermore, carriers of two short alleles (s/s) of the 5-HTTLPR showed a more than 4-fold increased risk of internalizing problems at age 12 compared to l/l carriers (OR 4.73, 95% CI 2.14-10.48). No gene-by-environment interaction was found and neither depressive symptoms postpartum or traumatic experiences during childhood stayed significant in the final model. Concurrent maternal symptoms of depression and anxiety are significant risk factors for behavior problems in children, which need to be taken into account in clinical practice. Furthermore, we found a main effect of 5- HTTLPR on internalizing symptoms in 12-year-old children, a finding that needs to be confirmed in future studies.     

Primary signet ring cell carcinoma of the breast: A rare entity with unique biological behavior—A clinical study based on pure signet ring cell carcinoma cohort

BackgroundPrimary signet ring cell carcinoma (SRCC) of the breast is a rare entity, and only a few case reports of the pure SRCC cases could be found in English literatures. We summarized the clinicopathological characteristics of a relatively large cohort of pure breast SRCCs for the first time.MethodsWe reviewed the medical records of 23 cases of pure breast SRCC with a median follow-up time of 70 months.ResultsThree patients had bilateral primary breast cancer (BC) and two of them had bilateral pure SRCCs. 30 % of patients had the malignant tumor family history including two bilateral BC patients. Malignant calcification was observed in 35.3 % of mammography images. Multifocal lesions were microscopically found in 26.1 % of cases. 63.6 % of the cases had lymph node metastasis, 45.5 % were classified as Stage III, 69.6 % had high value of Ki-67 index, and 34.8 % were triple negative subtype. 19.0 % of patients had local recurrence, and 52.6 % had distant metastasis. Four in five patients with positive tumor family history and follow-up data had relapse of SRCC. The 5-year overall survival rate was 73.7 %, the 5-year relapse-free survival rate was 54.3 %, and the 5-year breast cancer specific survival rate was 78.3 %.ConclusionPure SRCC of the breast showed an aggressive behavior. Neoadjuvant chemotherapy could be considered, breast-conserving surgery should be prudently chosen, and axillary lymph node dissection may be necessary. The high rate of positive tumor family histories and high bilateral incidence, which showed an adverse effect on prognosis, indicate the unique genetic burden of SRCC.     

探讨look-locker序列和B1-corrected VFA序列在上腹部组织T1值定量分析中的价值

目的评估两种平扫T1mapping的成像方法(自由呼吸Look-locker序列和屏气B1-correctedVFAvariable-flipangle(VFA)序列)在上腹部组织(脾脏、胰腺、双肾皮质及髓质、腹直肌及竖脊肌)所得T1值的定量特征,并评价其变异度。方法对66名患者行Look-locker序列和B1-correctedVFA序列;测量两种序列在上腹部组织所得T1值,并比较所得T1值的差异,以P<0.05为差异有统计学意义,应用变异系数(coefficientof variation,CV)来评价两种成像方法的变异度,采用Bland-Altman法对两名医师间的测量结果进行对比。结果 2名阅片者采用两种序列所得T1值得相关系数分别为0.973、0.924,P值<0.001。两种序列在双肾皮质、髓质所得T1值比较,差异无统计学意义(P>0.05)。同侧肾皮、髓质之间所得T1值存在差异(t=10.27、13.45、12.44、17.24;P<0.05)。脾脏、胰腺、双肾皮髓质、腹直肌及竖脊肌所得T1值之间差异有统计学意义(P<0.05)。Looklocker序列在腹部组织所得T1值的变异系数低于B1-correctedVFA序列。BlandAltman散点图显示Look-locker序列测定的f值分布相对更集中。结论对腹部各组织采用Look-locker序列和B1-corrected VFA序列所得T1值是不同的,采用Looklocker序列测量的T1值一致性评估变异度小,稳定性高,临床实用价值更高。     

综合护理干预在手术室护理中的应用分析

目的:探讨综合护理干预在手术室中的临床效果。方法:选择郑州大学附属肿瘤医院120例行手术治疗的患者作为观察对象,随机分为观察组和对照组。其中对照组60例,使用传统常规的护理方法,观察组60例,在对照组常规护理的基础上实施综合护理干预,然后观察并比较两组效果。结果:经过分析显示,观察组患者的术后下床活动时间,住院时间,拆线时间明显少于对照组,两组相比具有明显的统计学差异(P<0.05);在护理满意度上也具有明显的统计学差异(P<0.05)。结论:通过实施综合护理干预,患者的满意度和患者的生活质量得到了提高。     

手术室综合护理对腹腔镜结直肠肿瘤切除术的临床分析

目的:探讨手术综合护理对腹腔镜结直肠肿瘤切除术的临床效果。方法:选择60例腹腔镜结直肠肿瘤切除患者,随机分为观察组和对照组。其中对照组30例,使用传统常规的护理方法,观察组30例,在对照组护理的基础上实施综合护理,然后观察两组患者的手术时间,术中出血量,下床活动时间及焦虑评分。结果:经过分析显示,观察组的手术时间,术中出血量和焦虑评分均明显少于对照组,下床活动时间也明显早于对照组,两组相比具有显著统计差异(P<0.05)。结论:通过实施综合护理干预,提高患者生活质量有积极意义,值得临床予以推广。     

人骨髓间充质干细胞表达外源性IL-24基因对肺癌细胞A549增殖的影响

目的探讨以人骨髓间充质干细胞(hBMSCs)为基因治疗载体表达外源性IL-24对肺癌细胞A549增殖和凋亡的影响。方法分离培养hBMSCs,并通过流式细胞术鉴定。慢病毒介导IL-24基因转染hBMSCs,构建表达外源性基因IL-24的hBMSCs(hBMSCs-IL-24),qPCR及ELISA法检测hBMSCs-IL-24中IL-24基因mRNA及蛋白表达。CCK-8法检测hBMSCs-IL-24分泌的外源性IL-24对肺癌细胞A549增殖活性的影响。AnnexinV-PI检测hBMSCs-IL-24对A549细胞凋亡的影响。结果慢病毒介导的外源基因IL-24成功转染hBMSCs(hBMSCs-IL-24),其IL-24基因在mRNA及蛋白水平均有明显表达。hBMSCs-IL-24分泌的外源性IL-24蛋白显著抑制肺癌细胞A549的增殖并促进其凋亡。结论 hBMSCs-IL-24能够在mRNA及蛋白水平表达外源性IL-24基因,IL-24蛋白能显著抑制肺癌细胞A549的增殖,促进凋亡。