葛根素注射剂不良反应流行病学特点研究

目的 探讨葛根素注射剂不良反应的流行病学特点.方法 通过检索1978～2008年医药学期刊,收集葛根素注射剂不良反应详细病案120例;在构建数据库的基础上,应用统计学方法对其相关信息进行分析.结果 葛根素注射剂不良反应类型多样,其中以溶血反应数量最多,共32例,构成比为21.33%;其余依次为皮肤损害31例(20.67%),循环系统损害24例(16%),呼吸系统损害19例(12.67%),消化系统损害17例(11.33%),药物热11例(7.33%)和过敏性休克9例(6.00%)等.结论 溶血反应是葛根素注射剂最常见的不良反应;超剂量、不合理配伍、过敏性体质等可能是葛根素注射剂不良反应发生的主要原因.     

Flavocoxid is as effective as naproxen for managing the signs and symptoms of osteoarthritis of the knee in humans: a short-term randomized,double-blind pilot study

Flavocoxid (Limbrel), a proprietary mixture of flavonoid molecules (baicalin and catechin), was tested against a traditional nonsteroidal anti-inflammatory drug, naproxen, for the management of the signs and symptoms of moderate osteoarthritis (OA) in humans. Discomfort and global disease activity were used as the primary end points, and safety assessments were also taken for both treatments as a secondary endpoint. In this double-blind study, 103 subjects were randomly assigned to receive either flavocoxid [500 mg twice daily (BID)] or naproxen (500 mg BID) in a 1-month onset of action trial. Outcome measures included the short Western Ontario and McMaster University Osteoarthritis Index, subject Visual Analogue Scale for discomfort and global response, and investigator Visual Analogue Scale for global response and fecal occult blood. Both flavocoxid and naproxen showed significant reduction in the signs and symptoms of knee OA (P ≤ .001). There were no statistically detectable differences between the flavocoxid and naproxen groups with respect to any of the outcome variables. Similarly, there were no statistically detectable differences between the groups with respect to any adverse event, although there was a trend toward a higher incidence of edema and nonspecific musculoskeletal discomfort in the naproxen group. In this short-term pilot study, flavocoxid was as effective as naproxen in controlling the signs and symptoms of OA of the knee and would present a safe and effective option for those individuals on traditional nonsteroidal anti-inflammatory drugs or cyclooxygenase-2 inhibitors. A low incidence of adverse events was reported for both groups.     

注射用丹参分子排阻色谱及指纹图谱差减分析

目的 探讨注射用丹参质量差异的分析方法.方法 取临床不良反应有差异的不同批号的样品进行平行比对试验,分别应用凝胶分子排阻色谱、碳十八反相液相色谱进行指纹图谱分析,通过综合差减分析揭示非小分子酚酸类成分信息.结果 注射用丹参的凝胶分子排阻色谱有显著的批间差异,非小分子酚酸类成分批间差异显著,与豚鼠急性毒性反应程度相对应.结论 非小分子酚酸类成分应作为丹参系列注射剂质量控制的重点.提出谱毒学研究是中药注射剂安全性研究的重要方向之一.     

Clinical Efficacy of New Antiepileptic Drugs in Refractory Partial Epilepsy: Experience in the United States With Three Novel Drugs

Summary: A number of new antiepileptic drugs (AEDs), including topiramate (TPM), felbamate (FBM), and gabapentin (GBP), are approved or believed to be close to approval for marketing in the United States. Key efficacy findings for these AEDs in refractory partial epilepsy were reviewed. Large and significant drug-placebo differences were observed with TPM in two large dose-finding trials conducted in the United States. The minimal effective dose of TPM in the population studied was determined to be approximately 200 mg/day, and doses above 600 mg/day produced good efficacy but little incremental benefit versus the lower dosages for the overall study population. FBM is active in partial epilepsy, although seizure reduction is less marked and drug interactions complicate the findings. GBP is also active in this population, but only the 1,800 mg/day dosage was significantly better than placebo with respect to percent re-sponders. It may be useful to explore higher dosage ranges for both FBM and GBP if they can be well tolerated.     

Adverse drug reactions: physicians' opinions versus a causality assessment method

Since spontaneous reporting of adverse drug reactions depends on the physician's opinion of the relationship between the drug and the adverse event, we compared physicians' opinions with the scores obtained by the causality assessment method used in France. During a 2 month period, all physicians who reported adverse drug reactions (ADRs) to our pharmacovigilance centre expressed their opinions on the causal link by means of visual analogue scales. ADR reports were then assessed with the French causality assessment method by a clinical pharmacologist who was blind to physicians' opinions.The assessment by both physicians and the standardized method was performed for 75 ADR cases involving 120 drugs. Physicians used a wide range of assessments, with a preponderance of extreme scores, resulting in a U-shaped distribution, while the standardized method gave generally low scores. Scores given by physicians were very high (causality considered very likely or likely) in 60% of cases and very low (causality considered unlikely or dubious/possible) in 32% of cases. Scores obtained using the causality assessment method were low (causality dubious/possible) in 89% of cases and causality considered likely in only 11 cases, essentially in cases with positive rechallenge. Complete agreement occurred in only 6% of cases. Adding complete agreement and minor discrepancies raised the percentage to 49%.     

Adverse reactions to non-ionic contrast media with special regard to high-risk patients

Non-ionic contrast media (CM) are proven to be significantly safer than the high osmolar ionic contrast media (HOCM). Nevertheless deaths are reported after administration of non-ionic agents. The aim of the study was to investigate the rate of adverse reactions to non-ionic CM with special regard to high-risk patients and the effects of premedication with H1-and H2-receptor antagonists.In a prospective study conducted over about 2 years 12 995 examinations with intravenous or intra-arterial non-ionic CM were evaluated. Premedication with H1-and H2-antagonists was used in 1276 high-risk patients with known adverse reaction to CM, history of allergy or severe cardiac or pulmonary disease. 229 patients received no premedication inspite of known risk factors. In total, there were 143 (1.10%) adverse reactions (mild in 0.58%, moderate in 0.41% and severe in 0.05%). In high-risk patients there were adverse reactions in 4.37% without and in 1.57% with premedication. There were no severe adverse reactions in the high-risk patients after premedication. The age of the patient, CM dosage and CM concentration were not shown to be risk factors in the present study. In conclusion, the additional premedication with H1- and H2-antagonists could be an effective agent to reduce the risk of mild and moderate adverse reactions and to avoid severe adverse reactions in high-risk patients. Correspondence to: U. Fink     

脑梗死后抑郁与负性生活事件相关性研究

目的　探讨脑梗死后抑郁与负性生活事件的关系。方法　将脑梗死患者按是否受负性生活事件影响分为 A(n=75 )、B(n=73)两组。采用抑郁自评量表 (SDS)及 Hamilton抑郁量表筛查 ,对两组进行比较分析 ,并观察其治疗效果。结果　A、B两组脑梗死后抑郁的发生率分别为 5 6 %、38.4 % ,两者比较差异显著 (P<0 .0 5 ) ;百忧解可显著改善或治愈脑梗死后抑郁 ,总有效率 6 1.7%。结论　脑梗死后抑郁发生与负性生活事件相关。百忧解治疗有效     

军事飞行员生活事件量表的编制

目的 根据军事飞行员的职业特点，编制适用于该群体的生活事件量表，建立军事飞行员群体心理负荷的来源及其强度的标准化测量工具。方法 为确定量表结构分别采用三个同质样本(n=152、n2=157和n3=437)进行了项目施测。其中前两个样本作为项目甄选的预测样本，进行二次项目增减，同时采用20人分组讨论的形式对项目进行了反复修订。在项目选择上，采用职业应激事件与一般性生活事件相结合的构念，尽可能涵盖与军事飞行员工作及生活密切相关的特殊生活事件。在质的研究基础上，对正式施测的437名被试的数据进行统计分析。结果 军事飞行员生活事件量表共有六个分量表，包含36个项目。经检验，其信度和效度的各项指标均达到了心理测量学的要求。结论 该量表尚有待进一步扩大样本进行更严格的检验。     

磁共振增强扫描中欧乃影不良反应的临床观察及预防措施

目的探讨欧乃影在临床应用中不良反应的发生和预防措施。方法观察2003年10月至2006年7月所作1000例增强扫描者静脉注射欧乃影0.2mL/kg(其量浓度(c)为0.5mol/L)后,不良反应发生的情况。结果1000例患者中,出现不良反应6例,其中,非过敏反应3例,轻度过敏反应3例,无中度及重度过敏反应。结论欧乃影在磁共振增强扫描中不良反应发生率低,临床应用安全。