大数据时代的药品安全主动监测:对照选择的挑战与机遇

电子医疗数据已成为大数据时代开展药品安全主动监测的重要资源。基于此确认药品与不良事件是否存在关联，要回归传统的流行病学研究设计，选取恰当的对照进行对比。本文主要阐述不同对照选取的原理、适用情形，介绍、评价并比较各种对照选取的思路与参数，引入对照选择批量化实现的进展性成果，以期为我国利用电子医疗数据开展上市后药品安全性监测提供方法学参考。     

Comparative study of long-term effects of surgical excision and excision combined with radiotherapy or chemotherapy in breast cancer: an analysis of 192 cases

Clinical data of 192 patients with breast cancer with a primary lesion of 2-5 cm (stage II according to the criteria recommended by the UICC) and with histopathologically confirmed positive axillary lymph nodes were analyzed. The patients were divided into three groups: 1) surgical excision alone; 2) surgery plus irradiation; and 3) surgery plus chemotherapy. It was shown that the 5-year survival rates for these groups were 40.5%, 61.0%, and 62.0%, respectively (P less than .05).     

腹腔镜肝右后叶囊肿开窗引流术35例报告

目的：探讨肝右后叶肝囊肿的腹腔镜处理方法。方法：1998年1月～2005年12月对35例有症状的肝右后叶囊肿（21例主要位于Ⅵ段，14例主要位于第Ⅶ段）采用四孔法行囊肿开窗引流术。囊肿位于肝右后叶上段者采用肝上入路，胆囊牵引钳或三叶钳推压肝脏使其向前向下，暴露肝后囊肿，囊肿开窗，修剪带蒂大网膜放入囊肿。囊肿位于肝右后叶下段者采用肝下入路，超声刀切开肝结肠韧带，右三角韧带及肝肾间疏松组织，胆囊牵引钳抬起肝脏，囊肿开窗，大网膜放入囊腔引流。结果：35例肝右后叶肝囊肿均在腹腔镜下完成肝囊肿开窗引流术，无中转开腹手术。15例采用肝上入路，20例采用肝下入路。手术时间30～95min，平均46min。无手术并发症。35例病理检查结果均为先天性肝囊肿。术后症状均消失。术后住院2～5d，平均3．8d。35例随访6～36个月，平均34个月，33例无复发，2例（为肝上入路病例）囊肿未完全消失，但较术前明显缩小，无明显症状，观察半年未见增大。结论：肝下及肝上入路囊肿开窗引流是腹腔镜下处理肝右叶肝囊肿的有效方法。     

In vitro reversal MDR of human carcinoma cell line by an antisense oligodeoxynucleotide-doxorubicin conjugate.

A conjugate of antisense oligodeoxynucleotide (AS ODN) covalently linked with deoxorubicin (DOX) was synthesized. Its properties and antitumour activity in human carcinoma DOX resistant cells (KB-A-1) were investigated in vitro. The results showed that the conjugate was strongly stable both in Dulbecco's Phosphate-Buffered Saline (PBS) and in culture medium. The intracellular concentration of the conjugate was higher than that of the AS DON by HPLC analysis. The conjugate showed potent dose-dependent inhibition to the growth of KB-A-1 cells. Chemosensitivity of KB-A-1 cells to DOX was also investigated in vitro. When the cells were first exposed to the conjugate (0.5 microM) and then exposed to DOX for 24 h, the IC50 value of DOX decreased from 21.5 to 2.2 microM. In contrast, when treated with the mixture of the same concentration of the AS ODN with equivalent DOX, the IC50 value of DOX was 16.8 microM. Intracellular DOX concentration was detected in KB-A-1 treatment with the conjugate in vitro by HPLC. The results showed that the intracellular DOX concentration was 6.4-fold increased in KB-A-1 cells treated with the conjugate compared to treatment with DOX alone. In contrast, 1.8-fold increasing was observed when treated with the AS ODN. Western blot analysis showed a significantly decrease in the amount of P-glycoprotein in KB-A-1 cells. These results suggest that the conjugate is effective in reversing multidrug resistance. Certainly, further studies are conducting to explore the antitumour effect of the conjugate in vivo.     

聚环氧氯丙烷／液晶复合富氧膜的研究

研究了聚环氧氯丙烷(PECHCH)/N(4-乙氧基苄叉)4-丁基苯胺(EBBA)复合膜对氧气和氮气的透过性和选择性。用示差扫描量热计(DSC)、解偏振光强仪(DLI和偏光显微镜考察了复合膜的形态结构。结果表明,当PECH/EBBA复合膜处于液晶的向列相转变温度时,有较高的气体透过性和选择性。发现只有复合膜中EBBA含量在30wt％以上,PECH和EBBA呈非均相混合时,才有较明显的富氧效果。当EBBA含量达50wt%时,氧氮分离系数α=3.78。     

珠海城区初中生家庭亲密度与适应性的调查研究

目的:了解初中学生家庭亲密度及适应性的家庭功能及其相关因素,为家庭咨询或治疗提供客观依据。方法:采用整群、分 层、随机抽样方法,抽取珠海市4间中学的初一至初三学生714名,男362名,女352名,采用家庭亲密度和适应性量表中版(FACESⅡ-CV) 分别对初中学生及其父母进行调查,对家庭各成员自评结果进行比较,对有关影响因素进行分析。结果:学生与父母三者之间的亲密度及适 应性得分呈正相关(P<0.001),父母各自对家庭实际亲密度及适应性的评价基本一致,学生家庭实际亲密度及实际适应性评分比父母的低, 而理想适应性及不满程度得分比父母的高,差异有显著性(P<0.001)。三者的家庭“拱极模式”分布没有明显差异。家庭亲密度及适应性与 父母文化程度、家庭结构、家庭人数等因素有关。结论:影响初中生家庭亲密度及适应性因素是多方面的,学生与父母对家庭的不同感受对家 庭类型分布没有影响。     

腹腔镜治疗腹腔巨大囊肿及术后下身水肿处理(附5例报告)

目的探讨腹腔镜处理腹腔巨大囊肿及术后下身水肿的方法. 方法 5例腹腔巨大囊肿先行囊肿抽液(1 500～2 000 ml,平均1 800 ml)减压,2例巨大肝囊肿采用经皮穿刺抽液,3例下腹腔囊肿在脐缘小切口直视下抽液,使腹腔空间增大后行腹腔镜下囊肿切除(3例)或开窗引流(2例).对术后出现的下身水肿口服(2例)或静脉注射(3例)利尿剂. 结果 4例术后症状完全消失,1例多囊肝症状明显改善.随访3个月～1年,症状无复发.下身水肿均在5～7 d内基本消失. 结论先行囊肿抽液减压及术后应用小剂量利尿剂可使腹腔巨大囊肿能在腹腔镜下顺利处理并恢复.     

视场角设置对虚拟环境中目标判断的影响

目的探讨不同视场角参数对虚拟环境中目标判断的影响规律 ,找出最佳视场角参数。方法利用自行研制基于PC平台的虚拟现实 (VR)实验系统 ,选定 45名年龄在 2 3～ 5 8岁被试者并完成大小与角度判断的实验设计。首先进行 30 0人次的预实验 ,确定引起虚拟环境中目标判断差错的视场角及相应观察任务的差别等级 ,然后开始单因素、4水平的完全随机正式实验。结果方差分析表明 ,不同的虚拟环境视场角对目标判断的真实性有显著性影响 ,当视场角为 60°时 ,目标判断的正确率最大。结论利用VR技术进行载人航天器工效设计、操作训练或其它任务的研究时 ,应考虑视场角的作用 ,适合目标大小判断的视场角参数值宜取 60°,以便获得最大的工效