Maintenance treatment with esomeprazole following initial relief of non-steroidal anti-inflammatory drug-associated upper gastrointestinal symptoms: the NASA2 and SPACE2 studies

Non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclo-oxygenase-2 (COX-2) inhibitors, cause upper gastrointestinal (GI) symptoms that are relieved by treatment with esomeprazole. We assessed esomeprazole for maintaining long-term relief of such symptoms. Six hundred and ten patients with a chronic condition requiring anti-inflammatory therapy who achieved relief of NSAID-associated symptoms of pain, discomfort, or burning in the upper abdomen during two previous studies were enrolled and randomly assigned into two identical, multicentre, parallel-group, placebo-controlled studies of esomeprazole 20 mg or 40 mg treatment (NASA2 [Nexium Anti-inflammatory Symptom Amelioration] and SPACE2 [Symptom Prevention by Acid Control with Esomeprazole] studies; ClinicalTrials.gov identifiers NCT00241514 and NCT00241553, respectively) performed at various rheumatology, gastroenterology, and primary care clinics. Four hundred and twenty-six patients completed the 6-month treatment period. The primary measure was the proportion of patients with relapse of upper GI symptoms, recorded in daily diary cards, after 6 months. Relapse was defined as moderate-to-severe upper GI symptoms (a score of more than or equal to 3 on a 7-grade scale) for 3 days or more in any 7-day period. Esomeprazole was significantly more effective than placebo in maintaining relief of upper GI symptoms throughout 6 months of treatment. Life-table estimates (95% confidence intervals) of the proportion of patients with relapse at 6 months (pooled population) were placebo, 39.1% (32.2% to 46.0%); esomeprazole 20 mg, 29.3% (22.3% to 36.2%) (p = 0.006 versus placebo); and esomeprazole 40 mg, 26.1% (19.4% to 32.9%) (p = 0.001 versus placebo). Patients on either non-selective NSAIDs or selective COX-2 inhibitors appeared to benefit. The frequency of adverse events was similar in the three groups. Esomeprazole maintains relief of NSAID-associated upper GI symptoms in patients taking continuous NSAIDs, including selective COX-2 inhibitors.     

药物临床试验伦理审查存在的问题及对策研究

依据GCP药物临床试验管理规范,分析我国药物临床试验伦理审查工作中存在的问题,从如何保障受试者知情同意、加强伦理委员伦理知识培训、全程伦理监督及引入伦理验收、加强监管力度和完善监督体制等4个方面对药物临床试验伦理审查工作提出针对性建议,以逐步完善我国药物临床试验伦理审查工作。     

上海市某区社区卫生服务中心门诊用药合理性评价

利用6个合理用药国际指标以及TOPSIS法,综合分析和评价了2009年上海市某区12所社区卫生服务中心门诊用药状况。12种社区卫生服务中心门诊处方分析显示：平均药费为77.11元/张,平均药物数为2.30种,抗菌药物费用比例为12.02%,针剂费用比例为12.95%,抗菌药物处方比例为26.27%,国家基本药物使用比例为56.45%。根据C _i值分析,社区卫生服务中心的门诊用药基本合理,部分医疗机构门诊用药合理性有待提高。     

切尔诺贝利核事故以来隔离区动物生态的研究概况

综述了切尔诺贝利核事故以来乌克兰Schmalhausen动物研究所(SIZ)对核工厂周围隔离区(exclusionzone ,EZ)的野生动物所进行的长达20年的放射生态学调查研究。基于乌克兰以往鸟类迁移的观察资料,评估了137Cs和 90Sr在隔离区候鸟体内的含量。而且还选择一些动物物种作为环境状况的标准指示生物,目的是为了阐明1 37Cs在隔离区脊椎动物体内的污染情况;整个第聂伯河流域、基辅行政区和隔离区软体动物贝壳内 90Sr的β活性。结果表明不同物种相对放射性核累积、迁移和累积因素呈有规律的季节性和长期性变化趋势,这些参数的运用可以大大地减少数据的波动和复杂性。直接辐射毁坏森林后,营养链的崩溃和病死树昆虫害虫的爆发导致了其次级生态变化。99 %的隔离区并不直接受辐射的影响,人员撤离、农业和森林管理停止以及大规模排除污染是这些区域生态变化的主要因素。在初始变化之后,由于自然资源、捕食者和偷猎者等的限制,隔离区的动物密度和分布达到一个稳定的极限值。数年前成功地在隔离区引入了一群蒙古野马,该群体保持了稳定增长。重新评估了以前划定的若干自然保护位点目前的保护状况,并提出了建议扩大这些自然保护区的范围等保护措施。     

实施医师手术权限管理效果评价与分析

???? 目的 评价实施手术医师权限管理对手术质量和医疗安全的影响,为手术医师能力评价提供依据。方法 收集新疆某三甲医院实施手术医师权限管理前后同期所有住院由本院医师主刀进行三级及以上非介入手术病例,分析手术级别、主刀医师职称、学历、专业年限与手术并发症发生率的关系。结果 实施手术医师权限管理后,三级及以上手术患者例数同期增长32.66%,手术并发症发生率下降了1.74%,研究生学历组及高年资组的手术并发症发生率明显低于对照组。结论 通过开展手术医师权限管理,有效降低了手术并发症发生率,保障了医疗安全。手术难度、手术医师学历、年资是影响手术并发症发生率的关键因素,单一采用职称与手术操作相对应的技术准入标准存在不合理性。