要重视中药的安全性研究

从中药的药品质量、用药剂量、用药时间、给药途径、药物相互作用、临床前研究等方面分析了影响中药安全性的原因,并提出了提高中药安全性的相应对策.     

62例患者应用刺五加注射剂安全性分析

目的 了解刺五加注射剂在临床应用中的安全性,促进临床合理用药.方法 对该院2003年6月30日～2005年3月30日所使用刺五加注射剂的住院患者用药情况及出现的不良反应进行调查分析.结果 按照药品说明书规定的剂量,以0.9%氯化钠注射液或5%～10%葡萄糖注射液作为溶媒,单独配制且单独静脉滴注,滴注速度30～50滴/分时较为安全.结论 应严格按照药品说明书的规定合理用药,以减少药品不良反应的发生.     

一种新型重组(汉逊酵母)乙型肝炎疫苗人体安全性和免疫效果考核

为了观察一种新型重组 (汉逊酵母 )乙型肝炎 (乙肝 )疫苗的人体安全性、抗体应答和母婴传播阻断效果 ,在开封市筛选 6～ 9岁乙肝病毒 (HBV)感染指标 [乙肝病毒表面抗原 (HBsAg)与抗体 (抗 HBs)、乙肝病毒核心抗体 (抗 HBc) ]均阴性的健康儿童 2 0名 ,按 0、1、6个月程序接种 1批重组 (汉逊酵母 )乙肝疫苗 ,观察不良反应。完成 3针免疫观察未见严重不良反应后 ,选择 348名 6～ 9岁HBV感染指标阴性儿童 ,随机分为 3组 ,每组接种 1批重组 (汉逊酵母 )乙肝疫苗 ,进一步观察不良反应和抗体应答。筛选 4 5名怀孕期间HBsAg、乙肝病毒e抗原 (HBeAg)双阳性母亲所生的新生儿作为研究对象 ,并以 4 1名怀孕期间HBsAg阴性母亲所生的新生儿和 5名母亲HBsAg阳性、HBeAg阴性的新生儿作为对照 ,按 0、1、6个月免疫程序接种该乙肝疫苗。结果显示 :所有接种的儿童和新生儿 ,免疫后无 1人发现有严重不良反应。 348名接种乙肝疫苗的儿童中 ,除 5人次发热反应在 38 1℃～ 38 5℃外 ,体温升高均≤ 38℃。所有发热反应者和个别头痛者均在 1d内恢复正常。儿童接种 3批疫苗 ,第 1针免疫后 7个月时抗体阳转率分别为 98 2 5 % ( 112 / 114 )、10 0 0 0 % ( 10 7/ 10 7)、99 2 1% ( 12 6 / 12 7) ;抗体几何平均滴度 (GMT)分别为35 1     

美金刚与多奈哌齐合用对帕金森痴呆患者MoCA、ADL与血清CRP、PARK7的影响

【摘要】 目的 研究分析美金刚与多奈哌齐合用对帕金森痴呆患者MoCA、ADL与血清CRP、PARK7的影响。方法 选取本院收治的89例行帕金森痴呆患者进行研究,将所选患者按照治疗方法的不同随机分为研究组49例与对照组40例。对照组患者给予多奈哌齐进行治疗,研究组在对照组基础上联合美金刚进行治疗。回顾性分析两组患者的临床资料,对比分析两组患者临床疗效、认知功能以及日常生活能力的具体情况,并记录治疗期间不良反应发生情况。结果 对照组总有效率为7750%,研究组总有效率为9592%,研究组总有效率高于对照组（P＜005）;治疗12周后,两组患者UPDRS总评分、MMSE评分、MoCA评分、ADL评分均较前明显改善。研究组UPDRS总评分低于对照组,MMSE评分、MoCA评分、ADL评分高于对照组,两组对比存在明显差异（P＜005）;治疗12周后,两组患者血清CRP、PARK7、NT 3水平均较前明显改善。研究组血清CRP、PARK7水平低于对照组,NT 3水平高于对照组,两组对比存在明显差异（P＜005）;对照组患者治疗后的不良反应发生率（1250%）高于研究组患者（1224%）,但两组比较无明显差异（P＞005）。结论 美金刚与多奈哌齐合用对帕金森痴呆患者具有良好的临床疗效,可以有效改善帕金森痴呆患者行为功能以及认知功能,并明显降低患者血清CRP、PARK7水平,提高了NT 3水平,且安全性较高,可作为帕金森痴呆患者首选的治疗方案。     

Direct renin inhibition: an evaluation of the safety and tolerability of aliskiren

ABSTRACT

Background: Aliskiren, an antihypertensive drug approved in the United States and Europe, is the first in a new class known as direct renin inhibitors. Aliskiren has been evaluated for safety and tolerability in more than 6400 patients. It has demonstrated a favorable safety and tolerability profile alone or in combination with other drugs.

Objective: This article reviews the currently available safety and tolerability data for aliskiren.

Methodology: Using the search term aliskiren, MEDLINE (no timeframe set) and major cardiovascular congresses (2005–2008) were searched. Articles and abstracts with safety and drug interaction data were included.

Findings: Aliskiren may share common adverse effects observed with angiotensin-converting enzyme (ACE)-inhibitor and angiotensin receptor blocker (ARB) therapy. In placebo-controlled trials, those commonly reported for aliskiren at the approved dosage were headache, diarrhea, and fatigue, with incidences similar to those of placebo. Aliskiren has been well tolerated in black, geriatric, diabetic, or obese patients and patients with renal or hepatic impairment. Aliskiren neither inhibits nor induces the cytochrome P450 system; it does not inhibit P-glycoprotein, but is a substrate for this drug transporter. Adding a direct renin inhibitor to another renin–angiotensin–aldosterone system (RAAS) inhibitor may further improve cardiovascular outcomes, renal outcomes, or both, without increasing the incidence of adverse effects.

Conclusions: Aliskiren is well tolerated, has an adverse effect profile comparable to that of placebo, and has a low potential for drug interactions. Data from ongoing trials evaluating the effects of aliskiren on surrogate markers, morbidity, and mortality will further define the role of direct renin inhibition in the antihypertensive armamentarium.     

The Safe and Effective Use of Pharmacological Agents Used for Sedation During Radiological Procedures

The use of pharmacological agents to decrease the pain and anxiety associated with the performance of invasive and noninvasive radiological procedures is well documented. The use of such agents is also increasing. This article is intended both as a review for the nonanesthesia professional administering these agents and a primer for those who wish to administer these agents. The physiological mechanisms by which anxiety occurs, and is modulated, are discussed, as are those surrounding pain. A discussion of the continuum of consciousness and sedation is discussed. Individual agents are reviewed, along with their strengths, weakness, warning, and contraindications. Finally, the safety and monitoring of the sedated patient is reviewed.     

Potential health risks to adults and children in the UK from exposure to dietary lead in gamebirds shot with lead ammunition

We estimate potential risks to human health in the UK from dietary exposure to lead from wild gamebirds killed by shooting. The main source of exposure to lead in Europe is now dietary. We used data on lead concentrations in UK gamebirds, from which gunshot had been removed following cooking to simulate human exposure to lead. We used UK food consumption and lead concentration data to evaluate the number of gamebird meals consumed weekly that would be expected, based upon published studies, to result in changes, over and above those resulting from exposure to lead in the base diet, in intelligence quotient (IQ), Systolic Blood Pressure and chronic kidney disease (CKD) considered in a recent opinion of the European Food Safety Authority (EFSA) to be significant at a population level and also in SAT test scores and in rates of spontaneous abortion. We found the consumption of <1 meal of game a week may be associated with a one point reduction in IQ in children and 1.2–6.5 gamebird meals per week may be associated with the other effects. These results should help to inform the development of appropriate responses to the risks from ingesting lead from ammunition in game in the UK and European Union (EU).