Genotoxicity studies on fucoidan from Sporophyll of Undaria pinnatifida

The sulfated seaweed extract, fucoidan, has anticoagulant, antithrombotic, and antiviral activities. Despite extensive work on the biological activities of fucoidan, detailed studies on the genotoxicity of fucoidan from Sporophyll of Undaria pinnatifida sources have not been tested before. The objective of this study was to investigate the genotoxicity effects of fucoidan extracted from Sporophyll of U. pinnatifida using a test battery of three different methods. In a reverse mutation assay using four Salmonella typhimurium strains and Escherichia coli, fucoidan did not increase the number of revertant colonies in any tester strain regardless of metabolic activation by S9 mix, and did not cause chromosomal aberration in short tests with S9 mix or in the continuous (24 h) test. A bone marrow micronucleus test in ICR mice dosed by oral gavage at doses up to 2000 mg/kg bw/day showed no significant or dose-dependent increases in the frequency of micronucleated polychromatic erythrocytes (MNPCE), and the high dose suppressed the ratio of polychromatic erythrocytes (PCE) to total erythrocytes. We conclude that fucoidan presents no significant genotoxic concern under the anticipated conditions of use.     

Scientific evaluation of the chronic toxicity of the herbal medicine CGX in beagle dogs

CGX is a potential hepatoprotective herbal medicine used to treat various chronic liver disorders. The purpose of the study was to evaluate the pharmaceutical safety of CGX via a systemic 13-week repeated dose toxicity test in beagle dogs. Male and female beagle dogs were divided into four groups and two animals each from the control and high-dose group (400 mg/kg) were allocated into recovery groups. The dogs were administered with CGX (0, 100, 200, 400 mg/kg) for 13 weeks. During the experimental period, the dogs were observed for signs of gross toxicity and for behavioral changes; body weight and food consumption were measured. An ophthalmologic examination and urinalysis were performed at 0 and 13th week and blood biochemistry and hematological parameters analyses were performed at 0, 6th, and 13th week. A histopathological examination was also performed at the end of the experiment. There were no CGX-induced abnormalities in clinical signs, organ weights, food consumption, hematological, urine, and blood biochemical parameters, or histopathological findings in any of the groups during or after the 13 weeks. We demonstrated the safety of CGX for 13-week repeated dose and considered that it is safe for chronic clinical use.     

Acute and repeated dose (4 weeks) oral toxicity studies of two antihypertensive peptides,RYLGY and AYFYPEL,that correspond to fragments (90–94) and (143–149) from αs1-casein

The Lowpept® is a powdered casein hydrolysate containing the antihypertensive peptides RYLGY and AYFYPEL, two sequences that correspond to α_s1-casein f (90–94) (RYLGY) ¹ and α_s1-casein f (143–149) (AYFYPEL) ¹. To support the safety, Lowpept® has been examined in an acute and in a 4-week repeated dose oral toxicity studies in rats. Powdered casein hydrolysate administered in a single oral gavage dose of 2000 mg/kg resulted in no adverse events or mortality. Also, casein hydrolysate administered as a daily dose of 1000 mg/kg for 4 weeks by gavage resulted in no adverse events or mortality. No evidence or treatment-related toxicity was detected during both studies. Data analysis of body weight gain, food consumption, clinical observations, blood biochemical, haematology, organ weight ratios and histopathological findings did not show significant differences between control and treated groups. It is concluded that the casein hydrolysate containing the peptides RYLGY and AYFYPEL orally administered to rats was safe and that not treatment-related toxicity was detected even at the highest doses investigated in both acute (2000 mg/kg of body weight) and repeated dose (4 weeks) oral (1000 mg/kg of body weight) toxicity studies.     

雷公藤多甙片联合地氯雷他定治疗慢性特发性荨麻疹疗效观察

目的观察雷公藤多甙片联合地氯雷他定治疗慢性特发性荨麻疹的临床疗效和安全性。方法共入选180例患者,将其随机分成两组,每组各90例,治疗组予雷公藤多甙片10mg口服,3次/d,地氯雷他定5mg口服,1次/d,均连用28天;对照组仅予地氯雷他定5mg口服,1次/d,连用28天。结果治疗第7天时治疗组有效率为69.77%,对照组为54.02%;第14天时治疗组有效率82.56%,对照组59.77%;第28天时治疗组有效率93.02%,对照组67.82%。两组患者在治疗第7,14和28天时有效率比较,差异均有统计学意义(P均<0.05)。患者主观生活质量评估在治疗14天后DLQI和睡眠情况改善明显好于对照组,28天后DLQI、睡眠情况和日常活动评分也明显好于对照组(P均<0.05)。不良反应:治疗组发生率为8.14%,对照组为6.90%,两组差异无统计学意义。停药6周后进行随访和复诊,试验组复发率低于对照组,差异有统计学意义(P<0.05)。结论雷公藤多甙片联合地氯雷他定治疗慢性特发性荨麻疹的临床疗效比单纯应用地氯雷他定治疗的疗效好,停药后复发率低。     

如何制定临床试验的数据和安全监察计划

在临床试验中实施数据和安全监察是为了确保参加临床试验的受试者安全和采集的数据有效、完整、准确,每一个临床试验都有必要制定数据和安全监察计划,并经伦理委员会批准。数据和安全监察计划的内容包括方案概要、试验管理、数据管理和分析、质量保证、法规、试验安全、试验的有效性、数据和安全监察计划的实施、必要时制定数据和安全监察委员会计划。制定数据和安全监察计划时需要考虑试验的风险、研究期、试验设计、干预研究的疾病/症状、研究人群、干预措施、终点/结果指标等,监察的程度需与试验的风险、规模和复杂程度一致。     

Excluding pulmonary embolism at the bedside with low pre-test probability and D-dimer: safety and clinical utility of 4 methods to assign pre-test probability

INTRODUCTION: Less than 35% of patients suspected of having pulmonary embolism (PE) actually have PE. Safe bedside methods to exclude PE could save scarce health care resources if they exclude large proportions of patients with suspected PE and are widely applicable. Non-Elisa D-dimer in combination with pre-test probability of suspected PE can safely exclude PE at the bedside. Pre-test probability can be assigned by gestalt or by using clinical models (Wells, Wicki, Rodger). MATERIALS AND METHODS: We combined two databases from studies of patients with suspected PE and retrospectively compared the diagnostic test characteristics of the different methods of assigning pre-test probability. RESULTS: 535 patients were studied. PE was confirmed in 20.8% of study patients. Two clinical predictive models (Rodger and Wells) and overall diagnostic impression have similar sensitivities ranging from 96% (95% confidence interval (CI) 89-99%) to 99% (93-100%). Wicki's model has a sensitivity of 89% (77-96%). The Wells' model with a cutoff of less than 2 points in association with semi-quantitative D-dimer has a specificity of 11% (CI 7-15%). The specificities for the other clinical predictive model are ranging from 21% (17-25%) to 49% (CI 42-55%). CONCLUSION: Semi-quantitative D-dimer must be combined with safe clinical probability assessment to safely exclude PE in a significant proportion of patients. Wicki's model in association with semi-quantitative D-dimer has the lowest sensitivity and should be used carefully to exclude PE at the bedside. The Wells' model with a cutoff of less than 2 points when combined with semi-quantitative D-dimer excluded very few patients and therefore limits its clinical utility.     

院前急救中隐私保护难度分析及伦理学探讨

目的 通过对院前急救过程中,针对患者隐私控制的现状进行分析,从而提出合理化应对策略.方法 通过对院前急救医疗事件的回顾性分析,探讨院前院内隐私控制异同,结合本中心处置经验及资深急救医师的临床经验,进行总结分析.结果 院前急救中对患者的隐私控制,相比较院内医疗,有其独特的性质,目前院前急救从业人员对隐私控制缺乏重视,造成极大安全隐患,且对提高院前急救质量不利,应引起救护人员重视.结论 院前急救中对患者隐私控制有其独特的价值地位,是安全医疗中容易被忽视的环节,采取减少暴露时间、加强现场隐私控制设备等应对策略有助于保护患者隐私.     

中药注射剂在儿科临床应用的安全性评价研究

目的了解中药注射剂在儿科应用引发不良反应/不良事件(ADR/ADE)的特点和规律,评价其安全性,为临床合理应用提供参考。方法通过对我院近五年发生的166例儿科中药注射剂ADR/ADE进行回顾性统计分析。结果 166例ADR/ADE中男性122例次,女性64例次,涉及中药注射剂12种,清热解毒类中药注射剂是致儿童ADR/ADE的主要药物;变态反应发生率最高,其中痰热清注射液引起ADR/ADE的例数最多,为80例次,占43.01%。所致ADR/ADE最常见的是皮肤及附件损害,占58.72%。结论中药注射剂说明书应进一步规范儿童用量,医院应高度重视儿科应用中药注射剂引起的ADR/ADE并加强ADR/ADE报告和监测工作,严格遵循中药注射剂临床使用基本原则,加强监护并及时处理,保障患儿用药安全,促进临床合理用药。