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。     

中国县级及以上医疗机构青光眼诊疗服务 现状分析

目的：统计分析中国县级及以上医疗机构青光眼亚专科建设、诊疗设备配备和服务提供情况，为进 一步推动我国青光眼防治工作提供理论依据。方法：调查研究。2015年对全国提供眼科服务的县级 及以上医疗机构通过网上填报的方式进行普查，采用描述性统计方法，对我国县级及以上医疗机构 青光眼亚专科建设、诊疗设备配备和服务提供情况进行系统整理和统计分析。结果：本次调查覆盖 全国6 341家县级及以上医疗机构，其中设立青光眼亚专科的医疗机构有672家（10.60%）。在青光眼 检查和治疗相关设备中，视力表配置率最高（99.30%），平均每家医疗机构配置3.28台；超声生物显 微镜配置率最低（11.50%），平均每家医疗机构配置0.13台。眼压测量、白内障手术和小梁切开术是 青光眼主要的诊疗服务类型。结论：我国县级及以上医疗机构青光眼亚专科建设亟待加强，诊疗设 备配备不全，诊疗服务能力需要全面提升。     

92例重型肝炎并发自发性细菌性腹膜炎的诊断与治疗

目的探讨重型肝炎并发自发性细菌性腹膜炎(SBP)的诊断和抗生素使用。方法回顾性分析2002年7月~2005年6月间收治的92例并发SBP的重型肝炎患者的临床资料。结果92例患者中,发热72例(78.26%),腹胀85例(92.39%),腹痛38例(41.30%),反跳痛35例(38.04%),83例(90.21%)外周血中性粒细胞(PMN)分类≥0.75,40例(45.98%)腹水PMN计数≥250个/mm3,79例(90.80%)腹水PMN比值≥0.50,11例(12.00%)腹水细菌培养阳性,共分离出细菌17株,G-杆菌占52.9%(9/17),其对头孢曲松、头孢哌酮、头孢他啶、左旋氧氟沙星及泰能敏感,对丁胺卡那、氧哌嗪青霉素敏感性较低。临床治疗显示,联合使用头孢他啶和甲硝唑效果较好,并较少出现继发真菌感染。结论重型肝炎并发SBP患者的临床表现不典型,腹水培养阳性率低,外周血和腹水PMN比值是诊断SBP比较可靠的参数。治疗SBP,可首选二联使用头孢他啶与甲硝唑,疗程约10~14日。     

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.     

天然水中三卤甲烷前体活性结构的研究

通过实验证实，可用腐植酸（ＨＡ）代表天然水中三卤甲烷（ＴＨＭｓ）的前体。单一模拟化合物（含一个活性空位碳原子的间苯二酚，三个活性空位碳原子的间苯三酚，及甲基酮类化合物的丙酮酸钠）氯化后氯信形成的规律与氯化ＨＡ的不一致。而间苯二酚与丙酮酸钠的混合物（１：４Ｗ／Ｗ）能很好地反映出ＨＡ中活性结构的特性。为今后研究ＴＨＭｓ的形成提供了一个可资定量比较的ＴＨＭｓ前体。