日本蓝皮书的介绍及启示

目的：介绍日本仿制药上市后质量动态信息的最新查询途径,为建立我国相关橙皮书提供借鉴。方法：介绍日本蓝皮书的背景、结构和内容,并以熊去氧胆酸片为例,详细介绍日本蓝皮书的使用方法。结果与结论：仿制药质量再评价工作在日本开展了近20年,淘汰了约10%的不合格药品。对于仿制药质量再评价的跟踪和实施、市场抽验及药品质量研讨会有效保证了口服固体仿制药药品质量的一致性和有效性,日本蓝皮书是对该项工作成果的集中系统整理,对我国开展仿制药一致性评价工作具有积极的启示。     

Scores of plaque, bleeding, suppuration and probing depth to predict probing attachment loss 5 years of observation following nonsurgical periodontal therapy

The purpose of the present study was to determine the diagnostic value of clinical scores of supragingival plaque, bleeding, suppuration and probing depth to predict probing attachment loss in patients on maintenance following nonsurgical periodontal therapy. Non-molar teeth in 39 subjects were monitored and the above scores were repeatedly obtained throughout 5 years of observation following initial treatment. Probing attachment loss between 0-60 months was determined by a combination of linear regression analysis and end-point analysis. The results revealed that all the investigated scores were associated with probing attachment loss. This association was demonstrated by improved diagnostic predictability along with increased frequency or magnitude of the various scores. Also, the diagnostic predictability improved with increase in length of time for recording of the scores. The diagnostic predictability of either accumulated plaque scores and accumulated bleeding scores reached a maximum of about 30%. Residual probing depth greater than or equal to 7 mm reached a predictability of around 50% and increase in probing depth greater than or equal to 1.0 mm reached about 80% after 60 months. Thus, of the clinical scores investigated, increase in probing depth was found to be most valuable in predicting probing attachment loss.     

构建苦碟子注射液再评价证据体的研究

文献中散在报道了有关该注射液有效性或安全性的各种研究,但是鲜有全面系统将其上市前和上市后的研究资料相结合进行分析的报告。该文将从安全性循证证据研究角度出发,系统收集多个源头的证据,如药品质量控制、非临床安全性、成分提取研究、注射液配伍研究、上市后临床有效性和安全性研究、以及文献评价等7个方面,系统分析该药的药理作用、疗效、以及安全性问题等,发掘有关苦碟子安全性评价的证据体,为其临床安全用药以及进一步的品种开发提供有用信息。     

The concept of leukaemic stem cells in acute myeloid leukaemia 25 years on: hitting a moving target

The concept of leukaemic stem cells (LSCs) was experimentally suggested 25 years ago through seminal data from John Dick's group, who showed that a small fraction of cells from acute myeloid leukaemia (AML) patients were able to be adoptively transferred into immunodeficient mice. The initial estimation of the frequency was 1:250 000 leukaemic cells, clearly indicating the difficulties ahead in translating knowledge on LSCs to the clinical setting. However, the field has steadily grown in interest, expanse and importance, concomitantly with the realisation of the molecular background for AML culminating in the sequencing of hundreds of AML genomes. The literature is now ripe with contributions describing how different molecular aberrations are more or less specific for LSCs, as well as reports showing selectivity in targeting LSCs in comparison to normal haematopoietic stem and progenitor cells. However, we argue here that these important data have not yet been fully realised within the clinical setting. In this clinically focused review, we outline the difficulties in identifying and defining LSCs at the individual patient level, with special emphasis on intraclonal heterogeneity. In addition, we suggest areas of future focus in order to realise the concept as real-time benefit for AML patients.     

血脂康胶囊上市后治疗血脂异常证候再评价研究的思考

血脂康胶囊是由特制红曲提炼制得的现代调节血脂中药制剂,其上市后所进行的大量研究从西医药角度证实了其可有效调节血脂异常水平,但少见有关血脂康对血脂异常患者中医证候改善报道,反映出目前对血脂康是"辨证论治"中药,还是"专病专用"西药的认知缺陷。为了解决血脂康的定性问题,合理指导临床用药,急需进行血脂康治疗血脂异常中医临床再评价研究。     

中药上市后临床再评价研究若干问题思考

中药上市后再评价是一项复杂的、内容涵盖广泛的、实施难度大的研究工作,而我国上市后再评价起步较晚,从法规制度、技术规范等方面均有待完善。需要就中药上市后临床再评价过程中需注意若干问题,如再评价的法规要求、评价依据、评价对象选择等做初步探讨。     

中药上市后安全性及有效性再评价临床试验设计要求

基于药物流行病学的中药上市后再评价是研究和收集在临床实际使用情况下的长期/广泛人群的安全性,由于中药的特殊性,有必要对某些中成药进行有效性再评价,确证上市后中药的有效性.在进行中药上市后再评价临床试验之前应首先明确研究目的,在病证结合的评价模式下选择适宜的设计类型.研究人群纳入比上市前临床试验更为宽泛,可以包含特殊人群等的药物监测,样本含量要符合统计学要求.常用的设计方法有队列研究、病例对照研究、巢式病例对照、实用性随机对照.     

中药上市后特殊人群有效性及安全性评价的若干思考

我国中药在上市后,缺乏特殊人群使用的有关疗效、安全性的相关数据.作者从多个角度对中药上市后特殊人群相关研究进行思考,发现中药说明书关于特殊人群的用药标示极少;安全性评价研究方法有文献评价、数据挖掘、临床研究、药物监测,但缺乏独立性、长期性;有效性评价相对成熟,要特别关注儿童、老年人、孕妇、哺乳期妇女、肝肾功能损害者合理使用中成药.     

正则表达式在上市中药文献信息提取中的应用

上市中药文献分析任务繁重,利用计算机自动提取目标信息之后再进行人工检查,可以简化工作、提高效率.该文分析了上市中药文献信息提取的难点,认为非术语信息的匹配和不同分组的同类信息的区分是影响常用信息提取技术在上市中药文献信息提取中应用的两大关键问题.该文分析了正则表达式的模式匹配对于解决上述两大问题的价值,并选取“病例数”(非术语信息)和“有效率”(不同分组同类信息区分)2种信息,以此为例探讨了基于正则表达式的信息提取方法,初步实践了这一思路.