医疗器械不良事件监测-现状与展望

介绍医疗器械不良事件的基本概念,论述美国、欧盟、日本和有关国际组织关于医疗器械不良事件监测的管理规定,并回顾和展望我国在该领域的相关工作.     

水飞蓟宾-磷脂酰胆碱复合物对小鼠急性肝损伤保护作用的量效关系

目的　观察不同剂量水飞蓟宾 -磷脂酰胆碱复合物 (SPC)对四氯化碳 (CCl4)所致小鼠急性肝损伤的影响。方法　雌性小鼠随机分组给药后测定血清中谷丙转氨酶 (ALT)和谷草转氨酶 (AST)活性 ,取肝组织作病理学检查。结果　不同剂量的水飞蓟宾 -磷脂酰胆碱复合物均可明显降低CCl4所致小鼠血清中ALT和AST活性升高 ,并与剂量呈正相关。SPC组肝组织变性、坏死的程度亦明显减轻 (P <0 .0 0 1,P<0 .0 1,P<0 .0 5 )。结论　SPC对CCl4所致小鼠急性肝损伤具有明显的保护作用 ,高、中、低剂量组间降酶作用呈明显的量效关系。     

Neurobehavioral effects among subjects exposed to high static and gradient magnetic fields from a 1.5 Tesla magnetic resonance imaging system--a case-crossover pilot study.

The interactive use of magnetic resonance imaging (MRI) techniques is increasing in operating theaters. A study was performed on 17 male company volunteers to assess the neurobehavioral effects of exposure to magnetic fields from a 1.5 Tesla MRI system. The subjects' neurobehavioral performances on a neurobehavioral test battery were compared in four 1-hr sessions with and without exposure to magnetic fields, and with and without additional movements. Adverse effects were found for hand coordination (-4%, P < 0.05; Pursuit Aiming II) and near visual contrast sensitivity (-16% and -15%, P < 0.10; Vistech 6000). The results from the remaining tests were inconclusive due to a strong learning effect. No additional effect from gradient fields was detected. The results indicate that working near a 1.5 Tesla MRI system may lead to neurobehavioral effects. Further research is recommended, especially in members of operating teams using interactive MRI systems.     

γ射线诱发人正常肝细胞基因组不稳定性研究

目的探讨电离辐射诱发的基因组不稳定性效应。方法采用^60Co γ射线照射人正常肝细胞，检测克隆形成率和微核发生率，利用单细胞凝胶电泳（SCGE）技术检测DNA损伤情况。照射2、4、6、8和10Gy后传代培养，在40代后各剂量组再次统一照射2Gy，进行辐射损伤的检测。结果首次照射后，克隆形成率随受照剂量的增大而降低。存活细胞经二次照射后，SCGE结果和微核发生率结果表明，首次照射剂量与子代二次照射后的损伤程度存在剂量效应关系。结论γ射线不仅在肝细胞中产生直接的生物效应，而且还可以诱发产生可遗传的基因组不稳定性，使子代细胞中的突变频率增加，表现出滞后的遗传改变。二次事件的放大作用是研究基因组不稳定性的一种较好方法。     

Cadralazine and chlorthalidone as a second-step drug with atenolol in hypertensive patients: Differences in blood pressure control during exercise

Summary The long-term efficacy of a new vasodilator, cadralazine (ISF 2469), and chlorthalidone have been compared in 20 hypertensive patients not adequately controlled by atenolol. After 4 weeks of treatment with atenolol 100 mg once daily, patients whose diastolic blood pressure was >95 mmHg were randomly divided into two groups to receive in addition to atenolol, either cadralazine 15 mg once daily or chlorthalidone 25 mg once daily. Both treatments were administered for 6 months. At the end of treatment with atenolol and after 3 and 6 months of combination therapy, blood pressure and heart rate were measured at rest and during bicycle exercise 24 h after the last dose. Compared to atenolol alone, both cadralazine and chlorthalidone caused a significant and similar reduction in resting blood pressure. Both groups showed an increase in diastolic blood pressure during exercise while receiving atenolol alone. The addition of chlorthalidone did not modify the pressor response to exercise, whereas patients taking cadralazine had a decrease in exercise diastolic blood pressure, which was fully evident after 6 months of therapy. The reduction in exercise diastolic blood pressure induced by cadralazine was proportional to the increase in exercise heart rate, suggesting a fall in peripheral vascular resistance. Chlorthalidone caused a significant increase in serum glucose and uric acid and a decrease in K⁺, whereas no change was observed during cadralazine It is concluded that cadralazine given once a day with atenolol has the same efficacy in controlling blood pressure at rest as the combination of atenolol and chlorthalidone, and in addition it improves the pressor response to dynamic exercise and does not cause unwanted metabolic effects.     

Cardiovascular regulation and lipoprotein profile during administration of co-dergocrine in essential hypertension

Summary Co-dergocrine has recently been demonstrated acutely to lower plasma norepinephrine (NE) and blood pressure (BP) in patients with essential hypertension, and similar results have been obtained during chronic administration of co-dergocrine to healthy men. The present study investigated the effect of 3 weeks of treatment with co-dergocrine 4 mg/day on BP, plasma catecholamines, certain other BP-regulating factors and serum lipoproteins in patients with essential hypertension. Compared to placebo conditions, co-dergocrine decreased supine BP and heart rate by −7% and the upright plasma NE level by −24%. Supine plasma NE also fell (−24%). Total cholesterol and the LDL + VLDL-cholesterol lipoprotein fraction were lowered by −6%. No significant change was observed in plasma renin activity, angiotensin II, aldosterone and epinephrine levels, whole blood and plasma volume, exchangeable sodium, and the cardiovascular responsiveness to NE, angiotensin II and isoproterenol. The findings suggest that in patients with essential hypertension, chronic treatment with co-dergocrine may slightly decrease sympathetic outflow and, at least in the short-term, lower the potentially atherogenic serum LDL + VLDL − cholesterol fraction.     

Disposition of a silicon-containing amide, an inhibitor of acyl-CoA: cholesterol acyltransferase, in dog and rat

The pharmacokinetics of 3-(decyldimethylsilyl)-N-[2-(4-methylphenyl)-1-phenylethyl]propanamide (DMPP), an inhibitor of acyl-CoA:cholesterol acyltransferase, have been studied in the dog and the rat using 14C and 3H dual-labelled drug. In both species, gastrointestinal absorption of DMPP was slow and incomplete, amounting to approximately 20 per cent of the oral dose given in corn oil. In the rat, use of PEG-400, Tween 80, ethanol, and aqueous CMC as vehicles resulted in similar or lower absorption than corn oil. Absorbed DMPP was rapidly and extensively distributed to body tissues. Data from the rat showed highest concentrations of radioactivity in the liver and spleen, while concentrations in the adrenals and lung also markedly exceeded circulating radioactivity levels. In both dog and rat. DMPP was completely metabolized prior to excretion. The routes of biotransformation involved hydrolysis of the amide bond, oxidation of the phenyl ring, and degradation of the decyldimethylsilyl propanoyl moiety. The metabolites of DMPP were excreted slowly, predominantly in the faeces. The elimination half-life of 14C was 105 h in the dog and 83 h in the rat, while that of 3H was approximately 32 h in both species.     

四类抗感染药物不良反应相关因素的探讨与分析

目的：使输液疗法中药物不良反应降到最低限度，使患者获得安全、有效的治疗，同时，也是对有限药物资源的维护。方法：对用四类抗感染药物出现不良反应91例患者行减慢输液速度、平卧、松解领扣、按合谷穴、心理护理、保暖、进饮食等处置。结果：91例药物不良反应，有89例顺利完成输液治疗，2例无效，更换药物。结论：有责任感，加强观察护理及时发现患者反应前驱症状，迅速采取有效措施，会取得满意效果。     

A Retrospective Review of the Use and Safety of Droperidol in a Large, High-risk, Inner-city Emergency Department Patient Population

Droperidol (DROP) is used in the emergency department (ED) for sedation, analgesia, and its antiemetic effect. Its ED safety profile has not yet been reported in patients (pts). OBJECTIVES: To document the use of DROP in high-risk pts (those with head injury, alcohol or cocaine intoxication, and/or remote or recent seizures), and to determine the number of serious and minor adverse events (AEs)-seizures, hypotension, extrapyramidal side effects (EPSEs)-after DROP. METHODS: The ED database (EmSTAT) was queried to determine who received intramuscular or intravenous DROP in the ED in 1998; further chart review was done if the patient was considered high risk for or had experienced an AE. Multiple regression analysis using a random-effects model determined the significance of each variable in the occurrence of AEs. RESULTS: 2,468 patients (aged 20 months to 98 years; 112 < or =17 years; 141 > or =66 years) received DROP for agitation (n = 1,357), pain (1,135), anxiety (99), vomiting (173), or other reasons (50). There were 945 pts considered high risk; 933 charts were reviewed (DROP mean dose 4.1 +/- 2.0 mg); of these, 50 patient visits did not meet the criteria for high risk. There were 622 pts with head trauma (401 with alcohol use), including 47 with computed tomography (CT) scans positive for brain injury, 64 with cocaine use, and 197 with recent or remote seizures (137 with alcohol use). Minor AEs such as transient hypotension occurred in 96 pts after DROP (73 with alcohol use); 20 received intravenous fluids, while an additional 28 pts (8 with alcohol use) received rescue medications for EPSEs. Six possible serious AEs occurred in pts with serious comorbidities; 2 cases of respiratory depression, 3 post-DROP seizures, and 1 cardiac arrest (resuscitated) 11 hours after DROP in a cocaine-intoxicated pt (normal QT interval). There was no significant difference among high-risk groups in the occurrence of AEs. CONCLUSIONS: The vast majority of pts who received DROP in the ED did not experience an AE. A few serious AEs were noted following DROP in patients with serious comorbidities; it is not clear that DROP was causative.