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。     

道县2004～2005年餐饮具卫生监测分析

目的了解道县餐饮具卫生状况及餐饮具消毒效果,为整治饮食卫生提供可靠依据。方法于2004~2005年对全县餐饮具进行抽样检验,按GB14934-94《食(饮)具消毒卫生标准》检测大肠菌群项目并评价。结果2005年餐饮具合格率较2004年明显提高;大中型饮食单位餐饮具合格率高于小型;小餐具合格率明显高于其他餐饮具;蒸汽消毒方法消毒效果最好。结论继续推行食品卫生监督化分级管理,完善卫生设施,加强卫生管理,是改善餐饮具卫生状况的有效措施。     

Does monthly native arteriovenous fistula blood-flow surveillance detect significant stenosis--a randomized controlled trial.

BACKGROUND: Clinical practice guidelines recommend that the preferred method of surveillance for arteriovenous fistula (AVF) is the measurement of AVF blood flow (Qa). As these recommendations are based on observational studies, we conducted a randomized, prospective, double-blind, controlled trial to assess whether Qa surveillance results in an increased detection of AVF stenosis. METHODS: A total of 137 patients were randomly assigned to receive either continuing AVF surveillance using current clinical criteria (control, usual treatment) or usual treatment plus AVF blood-flow surveillance by ultrasound dilution (Qa surveillance group). The primary outcome measure was the detection of a significant (>50%) AVF stenosis. RESULTS: There were 67 and 68 patients assigned to the control and Qa surveillance groups, respectively. Patients in the Qa surveillance group were twice as likely to have a stenosis detected compared with the control hazard ratio (HR) confidence interval (CI) group (2.27, 95% 0.85-5.98, P = 0.09), with a trend for a significant stenosis to be detected earlier in the Qa surveillance group (P = 0.09, log rank test). However, using the Qa results alone prior to angiography, the area under the receiver operating characteristic curve demonstrated, at best, a moderate prediction of (>50%) AVF stenosis (0.78, 95% CI 0.63-0.94, P = 0.006). CONCLUSION: This study demonstrates that the addition of AVF Qa monitoring to clinical screening for AVF stenosis resulted in a non-significant doubling in the detection of angiographically significant AVF stenosis. Further, large multi-centre randomized trials are feasible and will be necessary to confirm whether Qa surveillance and the correction of detected AVF stenosis will lead to a reduction in AVF thrombosis and increased AVF survival.     

职业性萘暴露工人的健康监护结果评价

目的：讨论萘对人体的慢性毒效应和亚临床客观检测指标。方法：对河南省萘暴露工人（环境接触萘浓度平均为８．２５～２６．４３ｍｇ／ｍ３）进行了健康监护和医学动态观察。结果：发现长期萘暴露工人的白细胞、血小板减少及眼晶体混浊检出率显著高于对照组（Ｐ＜０．００１）；血清ＳＯＤ同功酶、ＧＳＨ－ＰＸ活性显著低于对照组，而ＬＰＯ水平、神经元特异性烯醇化酶（ＮＳＥ）活性水平以及外周血染色体畸变和微核阳性检出率均显著高于对照组（Ｐ＜０．００１）。神经行为功能检查结果，主要为消极情绪增加，记忆力下降等。事件相关电位Ｐ３００峰潜伏期比对照组显著延长，与对照组差异显著（Ｐ＜０．０５）。结论：慢性低浓度萘暴露对工人主要损害部位（靶器官）有皮肤，眼、血液和神经组织等。ＮＣＴＢ、ＮＳＥ、Ｐ３００三项可作为早期神经受损的客观指标。     

Guillain-Barré syndrome in South-West Stockholm, 1973–1991, 3. Clinicoepidemiological subgroups

Using hierarchical cluster analysis, applied to 47 cases of Guillain-Barre Syndrome (GBS) incident in South-West Stockholm (SWS) during the period from January 1973 to June 1992, we identified three major clinicoepidemiological subgroups. The first subgroup, 25.5% of the cases (26.7 ± 6.7 years), recorded a peak incidence at ages 20–29 years and presented significant differences from other subgroups, a high proportion of cases with onset at low age preceded by respiratory infection (83.3%) and with normal motor conduction velocity (50.0%). Also found, were less affected biological parameters, a rapidly progressive course and independence in gait at one month after onset. A second subgroup, 27.7% of cases, was severely affected, clinically and functionally. It consisted predominantly of young individuals (22.7 ± 11.1 years), with a high incidence (69.2% of cases) in autumn. A third subgroup, comprising 40.47; of cases, was older (61.1 ± 11.0 years) and, in general, also severely affected. The incidence of this form appeared to be invariant with time.     

Glafenine-associated anaphylaxis as a cause of hospital admission in the Netherlands

Summary In 1981 generalized anaphylaxis was registered on 166 occasions in Dutch general and academic hospitals. Clinical details of 120 of those patients revealed that in 107 anaphylaxis was either probable (n=90) or possible (n=17), whereas in 13 cases some other reaction than anaphylaxis had occurred. The series of confirmed cases contained 46 men and 61 women, with mean ages of 47 y and 48 y, respectively.There was a complete recovery in 102 patients and two patients died. Hypotension was present in 79 cases (74%), dyspnoea in 34 cases (32%) and a skin reaction, mainly urticaria, erythema or angioedema, was mentioned in 62 cases (58%). Most cases of anaphylaxis were drug-induced (76%), the main causes being the analgesic glafenine and contrast media. Glafenine was mentioned as the cause in 36% of all admissions for drug-induced anaphylaxis. Only 3.7% of cases had been reported to the voluntary reporting scheme of the Netherlands Centre for Monitoring of Adverse Reactions to Drugs.On the basis of reimbursement data, the risk of developing severe anaphylaxis to glafenine was estimated at 11.7–19.3-fold relative to indomethacin, and 13.4–20.2-fold relative to oral penicillins.     

Natural killer cell activity and autologous mixed lymphocyte response of splenic,mesenteric lymph node,and colonic lymphocytes during DMH-induced colon carcinogenesis in the rat

Twoin vitro models of immune surveillance were used to examine the immune status of the gut-associated lymphoid tissue, mesenteric lymph nodes, and spleen during the early stages of 1,2-dimethylhydrazine (DMN)-induced colon tumorigenesis. DMH-and vehicletreated Fischer rats were sacrificed at one of three time points; one week, two months, or five months after cessation of treatment. Colonic, lymph node, and splenic natural killer cell cytolytic activity toward YAC-1 tumor targets and T-cell response to autologous la-induced balstogenesis were measured at each time point. We found little change in natural killer cell activity or T-cell proliferation induced by autologous Ia gene products at these time periods.This investigation was supported in part by grant CA26917 from the National Cancer Institute, Department of Health and Human Services.