医学研究机构与医药公司在控制临床试验的标准方面持不同观点
摘要:
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小试牛刀:克唑替尼在ALK阳性局部晚期非小细胞肺癌新辅助治疗的应用
1 文献来源Zhang C,Li SL,Nie Q,et al.Neoadjuvant Crizotinib in resectable locally advanced non-small-cell lung cancer with ALK-rearrangement [J].J Thorac Oncol,2018,Nov 5.doi:10.1016/j.jtho.2018.10.161.[Epub ahead of print]2证据水平4.3背景·局部晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)存在异质性,预后令人不满意.现有的两种主要治疗模式为根治性同步放化疗或手术加化/放疗.
关键词: 局部晚期非小细胞肺癌 新辅助治疗 克唑替尼 间变性淋巴瘤激酶 -
厄洛替尼对比长春瑞滨联合顺铂辅助治疗ⅢA期EGFR突变阳性非小细胞肺癌患者的疗效
1 文献来源Yue DS,Xu SD,Wang Q,et al.Erlotinib versus Vinorelbine plus Cisplatin as adjuvant therapy in Chinese patients with stage Ⅲ A EGFR mutationpositive non-small-cell lung cancer (EVAN):A randomised,open-label,phase 2 trial [J].Lancet Respir Med,2018,6(11):863-873.
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新辅助治疗PD-1免疫检查点抑制剂在可切除肺癌患者中的应用
1 文献来源Forde PM,Chaft JE,Smith KN,et al.Neoadjuvant PD-1 blockade in resectable lung cancer [J].N Engl J Med,2018,378(21):1976-1986.2证据水平1b.3背景·在晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)患者中,程序性死亡受体1(programmed death 1,PD-1)免疫检查点抑制剂可以启动抗肿瘤免疫,从而杀死肿瘤细胞并改善生存.
关键词: 非小细胞肺癌 新辅助治疗 PD-1免疫检查点抑制剂 -
厄洛替尼与标准一线化疗作为新辅助治疗ⅢA-N2期EGFR突变阳性非小细胞肺癌患者的疗效比较
1 文献来源Zhong WZ,Wu YL,Chen KN,et al.CTONG 1103:Erlotinib versus Gemcitabine plus Cisplatin as neoadjuvant treatment for stage ⅢA-N2 EGFR-mutation positive non-small-cell lung cancer (EMERGING):A randomised study [J].Ann Oncol,2018,29(8S):LBA48_PR.2证据水平1b.3背景·ⅢA-N2期非小细胞肺癌(non-small-cell lung cancer,NSCLC)具有相当大的异质性,根据同侧纵隔淋巴结受累程度不同分为ⅢA1~ⅢA4(Robinson分类),而目前治疗方案各异,包括放化疗、手术切除后化疗、新辅助治疗后手术切除.
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厄洛替尼辅助治疗可切除EGFR突变非小细胞肺癌的疗效
1 文献来源Pennell NA,Neal JW,Chaft JE,et al.SELECT:A phase Ⅱ trial of adjuvant Erlotinib in patients with resected epidermal growth factor receptormutant non-small-cell lung cancer [J].J Clin Oncol,2019,37(2):97-104.2证据水平1b.3背景早期非小细胞肺癌(non-small cell lung cancer,NSCLC)患者手术完全切除后仍可能会复发,这使得应用辅助治疗方法清除癌细胞成为迫切的临床需求.
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严重妊娠期高血压增加母婴围产期不良结局的风险
1 文献来源Magee LA,von Dadelszen P,Singer J,et al. The CHIPS randomized controlled trial (control of hypertension in pregnancy study) :Is severe hypertension just an elevated blood pressure?[J]. Hypertension,2016,68(5):1153-1159.
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二甲双胍在伴多囊卵巢综合征妊娠中的 应用增加子代4岁时超重的风险
1 文献来源Hanem LGE,Stridsklev S,Júlíusson PB,et al. Metformin use in PCOS pregnancies increases the risk of offspring overweight at 4 years of age:Follow?up of two RCTs[J]. J Clin Endocrinol Metab,2018,103 (4):1612-1621.
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基于美国女性大型前瞻性队列研究探讨妊娠期糖尿病与远期心血管疾病的关系
1 文献来源Tobias DK,Stuart JJ,Li S,et al. Association of a history of gestational diabetes and long ? term cardiovascular disease risk in a large prospective cohort of US women. The Nurses ' Health Study Ⅱ(NHS Ⅱ)[J]. JAMA Intern Med,2017,177(12):1735-1742.
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预测妊娠期糖尿病风险模型的外部验证:基于荷兰人群的前瞻性多中心队列研究
1 文献来源Lamain?de RM,Kwee A,Naaktgeboren CA,et al. External validation of prognostic models to predict risk of gestational diabetes mellitus in one Dutch cohort:Prospective multicentre cohort study [J]. BMJ,2016,354:i4338.
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延长新辅助放化疗与直肠癌手术间隔时间的评价
1 文献来源Petrelli F,Sgroi G,Sarti E,et al. Increasing the interval between neoadjuvant chemoradiotherapy and surgery in rectal cancer:A meta-analysis of published studies[J]. Ann Surg,2016,263(3):458-464.