微生物农药的安全性研究

为了解微生物农药的安全性,通过对苏云金杆菌,增产菌,白僵菌,棉铃虫核型多角体病毒,茶小卷叶娥颗粒体病毒,苜蓿银纹夜蛾颗粒体病毒５种微生物农药的安全性评价,认为单纯微生物农药没有化学农药意义上的急,慢性毒性,所试微生物对哺乳动物不致病,无生殖毒性和致突变作用,是安全的。     

The use of a safety factor in setting health based permissible levels for occupational exposure

Summary When adequate human observations are not or scarcely available, permissible levels for occupational exposure have to be extrapolated from animal experiments. Taking into account experimental conditions, e. g., duration of exposure ( 3 months), animal species, knowledge of no- (adverse-) effect level or minim al-(adverse-) level, presence of data on human observations, the authors worked out a procedure for extrapolation. This procedure should only be applied for systemic non-carcinogenic effects. The proposed procedure is to be regarded as tentative and as suggestion for international discussion.The evaluation starts with a safety factor = 10 for extrapolation from dose/kg b. w. in long-term animal experiments to exposure of adult workers (40 h/wk); this factor corresponds to a safety factor = 3–10 for extrapolation from doses presented as concentrations in air. If long-term experimental exposure is 24 h daily, the safety factor can be lowered to the minimum value of 1. If only short-term exposure studies are available, the safety factor may have to be increased to a maximum of 400.     

脂质体肺部给药的研究

由于脂质体肺部给药具有刺激性小、吸收迅速、生物利用度高、安全性好、可实现持续缓慢释药等独特优势而成为近年来制剂领域的研究热点之一。本文论述脂质体肺部给药的特点、稳定性以及在药代动力学、药效学和安全性等方面的最新研究进展。     

帕司烟肼介入凝胶体外抗结核活性及安全性研究

目的 观察帕司烟肼凝胶体外抗结核作用和支气管介入的安全性。方法 手工法、仪器法分别测定帕司烟肼及其凝胶的最小抑菌浓度和最小杀菌浓度及家兔经支气管介入的安全性试验。结果 帕司烟肼凝胶对H37Rv标准株、牛型结核分枝杆菌、草分枝杆菌MIC值分别为0．1、0，1、0．4mg／L，MBC值分别为0，2、0．2和1．6mg／L；帕司烟肼凝胶与帕司烟肼单体MIC、MBC值无显著差异；动物实验表明该药应用安全。结论 帕司烟肼凝胶具有与帕司烟肼单体相同的抗结核菌药效，卡波姆基质不影响帕司烟肼的抗菌活性；以卡波姆为基质的帕司烟肼凝胶应用安全。     

Risk assessment in clinical pharmacy

Medication error forms a major proportion of the errors in the medical system. Despite many studies of adverse drug events, there are no systematic ways of ensuring safety, or of assessing how safe a pharmaceutical system is. Risk assessment is required in hazardous industries such as nuclear power or oil and gas. Risk assessments involve identifying the defences and assessing their effectiveness and are relatively uncommon in clinical pharmacy , as opposed to reactive approaches involving incident analyses. Risk factors, that degrade barriers, can be identified and their effect measured. A risk assessment structure for pharmacy processes is proposed that can also be used to support incident investigation and analysis processes and provide a standard for audit.     

放疗增敏剂甘氨双唑钠的Ⅱ期临床研究

目的 :按二期临床研究要求观察注射用甘氨双唑钠 (简称CMNa)的有效性和安全性。方法 :采用平行对照、随机分组的设计方法 ,将 2 8例经病理组织学确诊的需接受放射治疗的头颈部、食管和肺部肿瘤患者 ,按 2∶1的比例分设实验组(CMNa +常规放疗 )和对照组 (单纯常规放疗 ) ,观察其有效性和安全性的相关指标。结果 :治疗前后血常规、肝肾功能的实验室检查 ,治疗中和治疗后不良反应、严重程度的观察比较及不良反应率的结果比较。两组均无显著性差异。肿瘤原发灶和转移灶的CR率和CR +PR率两组未见显著性差异。但转移灶达PR时所需的照射剂量明显低于对照组 (P <0 0 5 )。结论 :安全性与前期研究结果相符 ,在临床推荐剂量内未观察到明显消化道和神经系统等的不良反应 ,有效率未见显著性差异可能与样本数较少有关。据后期汇总的大样本统计显示两组的显著性差异表现在CMNa可提高CR率和总有效率 ,并降低达到CR和PR时的照射剂量     

流行性感冒裂解疫苗安尔来福TM的安全性和免疫原性研究

目的为了评价3价流行性感冒(流感)裂解疫苗安尔来福TM的安全性和免疫原性.方法于2003年6～11月在广西壮族自治区南宁市和柳城县进行以进口同类疫苗为对照的临床研究.受试者为＞6个月～＞60岁健康人群1 332人,接种疫苗后对受试者进行不良反应观察,应用微量血凝抑制(HI)试验对受试者血清进行抗体分型检测.结果试验疫苗组与对照疫苗组各有1例出现接种部位红肿,均在72h内消失;试验组与对照组发热反应率分别为3.21%(35/1 092)、6.25%(15/240),差异有显著的统计学意义.未见其它不良反应发生.试验组和对照组各有734人和163人检测了HI抗体,结果各型HI抗体总阳转率分别为50.0%～84.2%和57.7%～84.0%,抗体几何平均滴度分别增长4.2～11.4倍和5.7～11.6倍,差异均无显著的统计学意义.结论试验疫苗的免疫效果达到欧盟标准,表明流感裂解疫苗安尔来福TM的安全性、免疫原性良好,适于推广使用.     

国产流行性感冒裂解疫苗的安全性和免疫效果研究

目的观察国产流行性感冒(流感)裂解疫苗的安全性和免疫效果。方法以上海生物制品研究所生产的流感裂解疫苗作为试验组,葛兰素史克公司的流感裂解疫苗作为对照组,在上海市虹口区分别接种100名成人进行观察。结果试验组接种后局部反应和全身反应发生率与对照组相似,但局部反应中的红肿和硬结发生人次和反应强度明显低于对照组,但二者的疼痛发生率均>40%。试验组的免疫应答水平基本达到欧盟的标准,流行病学效果与对照组差异无显著的统计学意义。结论试验组的免疫效果与对照组相似,局部反应更温和。     

鲜蛋的品质安全与控制

本文作者根据我国鲜蛋生产的实际,提出鲜蛋品质安全控制措施防止食源性疾病发生,以确保鲜蛋的食品卫生与安全。     

Reserve nitrous oxide cylinders on anaesthetic machines. A survey of attitudes and equipment at a large DGH

The presence of reserve nitrous oxide cylinders on anaesthetic machines is not necessary and potentially hazardous, wasteful and polluting. Although reserve nitrous oxide cylinders are routinely present on the anaesthetic machines in many hospitals in the UK, it is our concern that they are not checked or maintained properly. We examined a sample of cylinders and surveyed the practice amongst the anaesthetic staff in our Department with an anonymous questionnaire. This confirmed that: (1) the equipment is not properly maintained, 68% of cylinders sampled having passed a 3-year expiry date; (2) checks are of little practical use, are not routinely performed by anaesthetists, and only 46% of respondents routinely check the nitrous oxide cylinders. In conclusion, the nitrous oxide cylinders are not properly checked or maintained and may represent a safety hazard.