虽然随机对照试验(randomized control trials,RCTs)是评价未上市新药疗效的"金标准",但在解决中药上市后安全性和有效性再评价问题上存在不足。在广大人群中开展真实世界研究(real world study,RWS),试验时间较长,观察指标全...虽然随机对照试验(randomized control trials,RCTs)是评价未上市新药疗效的"金标准",但在解决中药上市后安全性和有效性再评价问题上存在不足。在广大人群中开展真实世界研究(real world study,RWS),试验时间较长,观察指标全面,可以较真实地收集药品安全性和有效性相关信息,从而为评价药品的受益-风险及采取相应措施提供重要依据。在保证人民群众用药安全、有效的前提下,基于RWS的中药上市后临床再评价研究可能延长药品的市场生命,也有利于药品生产企业的健康发展。RWS是开展上市后中药临床再评价研究的一种新理念,必将在中药上市后再评价实践工作中得到充分的应用和检验。展开更多
This paper reviewed the situation of regulations and guidelines on post-marketing medicines in the developed countries and in China. The developed countries have accumulated a lot of empirical principles and technique...This paper reviewed the situation of regulations and guidelines on post-marketing medicines in the developed countries and in China. The developed countries have accumulated a lot of empirical principles and techniques on post- marketing surveillance （also named pharmacovigilance）, therefore, their regulation systems are nearly perfect. In China, the regulations on post-marketing re-evaluation and relative technical guidelines do not cover the whole aspects, even lack in some important aspects, and long-term risk management mechanisms have not been established. So it is urgent to establish new regulations and improve the regulatory system in China based on the existing regulations and guidelines, by learning from the ideas of foreign advanced regulations, then fully integrating them with China＇s actual conditions, and cooperating with multidisciplinary researchers.展开更多
背景与目的血清癌胚抗原(carcinoembryonic antigen,CEA)和细胞角蛋白19的可溶性片段(soluble fragment of cytokeratin-19,CYFRA21-1)系非小细胞肺癌(non-small cell lung cancer,NSCLC)患者术前检查重要的肿瘤标志物(tumor markers,TM...背景与目的血清癌胚抗原(carcinoembryonic antigen,CEA)和细胞角蛋白19的可溶性片段(soluble fragment of cytokeratin-19,CYFRA21-1)系非小细胞肺癌(non-small cell lung cancer,NSCLC)患者术前检查重要的肿瘤标志物(tumor markers,TMs),但其对NSCLC患者术后的预后作用尚存争议。本研究旨在探讨血清CEA和CYFRA21-1在手术治疗后的NSCLC患者预后中的临床价值。方法回顾性总结175例经手术并辅以化疗的NSCLC患者的临床资料及随访情况,依据CEA、CYFRA21-1水平进行分组,用Kaplan-Meier法对各组进行生存分析。用Cox比例风险回归模型分析影响NSCLC患者术后预后的因素。结果术前CEA、CYFRA21-1升高组的患者总生存时间(overall survival,OS)少于术前正常组的患者,术前CYFRA21-1升高组差异有统计学意义(P=0.001)。与术前术后CEA、CYFRA21-1均正常等组的患者OS比较,术前术后CEA、CYFRA21-1均升高组的患者OS最短,两组差异均有统计学意义(P<0.05)。与CEA联合CYFRA21-1术前术后均正常等组的患者OS比较,CEA联合CYFRA21-1术前术后均升高组的患者OS最短,差异有统计学意义(P<0.001)。CEACYFRA21-1(HHHH)、CEACYFRA21-1(NNHH)、CYFRA21-1(HH)、CEA(HH)、男性是判断预后的独立危险因素(P<0.05)。结论血清CEA或CYFRA21-1在手术前及术后均高于正常,尤其是两者联合在手术前及术后均升高的NSCLC患者预后不良。手术前后血清CEA、CYFRA21-1的检测有助于NSCLC患者术后预后的判断。展开更多
文摘虽然随机对照试验(randomized control trials,RCTs)是评价未上市新药疗效的"金标准",但在解决中药上市后安全性和有效性再评价问题上存在不足。在广大人群中开展真实世界研究(real world study,RWS),试验时间较长,观察指标全面,可以较真实地收集药品安全性和有效性相关信息,从而为评价药品的受益-风险及采取相应措施提供重要依据。在保证人民群众用药安全、有效的前提下,基于RWS的中药上市后临床再评价研究可能延长药品的市场生命,也有利于药品生产企业的健康发展。RWS是开展上市后中药临床再评价研究的一种新理念,必将在中药上市后再评价实践工作中得到充分的应用和检验。
基金Supported by the Research on Key Techniques of Reevaluation of Post-marketing Chinese Medicines,the Ministry of Science and Technology(No.2009ZX09502-030)the Sixth-Science Foundation of Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences(No. Z0215)
文摘This paper reviewed the situation of regulations and guidelines on post-marketing medicines in the developed countries and in China. The developed countries have accumulated a lot of empirical principles and techniques on post- marketing surveillance （also named pharmacovigilance）, therefore, their regulation systems are nearly perfect. In China, the regulations on post-marketing re-evaluation and relative technical guidelines do not cover the whole aspects, even lack in some important aspects, and long-term risk management mechanisms have not been established. So it is urgent to establish new regulations and improve the regulatory system in China based on the existing regulations and guidelines, by learning from the ideas of foreign advanced regulations, then fully integrating them with China＇s actual conditions, and cooperating with multidisciplinary researchers.
文摘背景与目的血清癌胚抗原(carcinoembryonic antigen,CEA)和细胞角蛋白19的可溶性片段(soluble fragment of cytokeratin-19,CYFRA21-1)系非小细胞肺癌(non-small cell lung cancer,NSCLC)患者术前检查重要的肿瘤标志物(tumor markers,TMs),但其对NSCLC患者术后的预后作用尚存争议。本研究旨在探讨血清CEA和CYFRA21-1在手术治疗后的NSCLC患者预后中的临床价值。方法回顾性总结175例经手术并辅以化疗的NSCLC患者的临床资料及随访情况,依据CEA、CYFRA21-1水平进行分组,用Kaplan-Meier法对各组进行生存分析。用Cox比例风险回归模型分析影响NSCLC患者术后预后的因素。结果术前CEA、CYFRA21-1升高组的患者总生存时间(overall survival,OS)少于术前正常组的患者,术前CYFRA21-1升高组差异有统计学意义(P=0.001)。与术前术后CEA、CYFRA21-1均正常等组的患者OS比较,术前术后CEA、CYFRA21-1均升高组的患者OS最短,两组差异均有统计学意义(P<0.05)。与CEA联合CYFRA21-1术前术后均正常等组的患者OS比较,CEA联合CYFRA21-1术前术后均升高组的患者OS最短,差异有统计学意义(P<0.001)。CEACYFRA21-1(HHHH)、CEACYFRA21-1(NNHH)、CYFRA21-1(HH)、CEA(HH)、男性是判断预后的独立危险因素(P<0.05)。结论血清CEA或CYFRA21-1在手术前及术后均高于正常,尤其是两者联合在手术前及术后均升高的NSCLC患者预后不良。手术前后血清CEA、CYFRA21-1的检测有助于NSCLC患者术后预后的判断。
