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Courage临床研究对中西医结合治疗冠心病的启示
一项由美国Buffalo总医院William E.Boden 医生领衔的取名为Courage (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation,血运重建和优化药物治疗的临床转归)的临床试验研究,历时7年,入选美国和加拿大50家医院的2 287例稳定性冠心病患者进行治疗,其中95%患者具有心肌缺血的客观证据,2/3患者经冠脉造影属多支血管病变,这些患者被随机分为单纯优化药物治疗(optimal medical treatment,OMT)和OMT联合冠脉介入干预(percutaneous coronary intervention,PCI)治疗两组,平均随访4.6年;结果显示,主要终点(所有原因死亡或非致死性心肌梗死)的发生率分别为18.5%和19.0%(P=0.62);死亡、心肌梗死及卒中的复合终点两组亦无显著性差异;在多支病变、既往有心肌梗死病史和合并糖尿病等高危患者的主要终点发生率的亚组分析,也发现两组是相似的.
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COURAGE 研究带来的思考
2007年3月在美国心脏病学会年会上,公布了一项引起极大震动的临床试验研究-COURAGE (The clinical outcomes utilizing revascularization and aggressive drug evaluation:血管再通和强化药物治疗临床结果评价).该项研究的主要结论是,对于稳定性心绞痛患者,PCI联合理想药物治疗与单纯理想药物治疗两组间的总死亡率、心肌梗死及主要心血管事件发生率无明显差异,即PCI治疗并不比强化药物治疗更有效地改善稳定性心绞痛患者的远期临床预后. 这无疑对当今盛行的冠心病PCI治疗观念提出了根本的质疑和挑战,正如心脏病学会执行主席Dr Steven Nissen所称,这项研究结果的公布的确是心血管领域的一枚"重磅炸弹".
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美国处方药广告的管理
美国对处方药广告的管理主要由新药审评中心(Center for Drug Evaluation and Review,CDER)下属的药品市场、广告及通联处(Drug Marketing,Advertising and Communications,DDMAC)负责.
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沙蒿散缓解阻生牙拔除术后日常生活活动能力影响因素的效果评价
AIM:To investigate the effect of locally used Shahaosan on preventing the complication of extraction of impacted tooth.METHODS: 274 cases patients with extraction of impacted teeth were randomly devided into 3 groups named A,B and C.Shahaosan and Yunnan white drug were processed into drug A and B by department of pharmacy with the same color, shape and quality which are blind to doctors and patients.When the impacted teeth were extracted, administed group A(92 cases) with drug A,group B(86 cases) with drug B and group C(96 cases ) was a blank control. After the operation,incidence and severe intensity of dry socket in each group were observed and evaluated by scores.RESULTS: The incidence of dry socket in group A,B and C were 0.09% (1/92),2.32% (2/86),8.33% (8/96).There was no significant difference between group A and B, group B and C, while a significant difference showed between group A and C.The PoSSe score in group A, B and C was 19.36, 27.80 and 22.83 respectively.Afer the experiment the department of pharmacy informed that drug A is Shahaosan and drug B is Yunnan white drug.CONCLUSTON:Compiments of dry socket induced by extracting of lower jaw impacted teeth can be prevented by locally administered with Shahaosan, but no significant effect of alleviating the symptom of dental extraction.
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COURAGE研究提示稳定型心绞痛患者行PCI术未显示长期获益
大量研究证实,急性冠状动脉综合征早期行经皮冠状动脉介入治疗(PCI)术能够改善患者的预后.尽管稳定型心绞痛患者行PCI术可缓解心绞痛发作,减少心脏缺血事件,然而各种临床研究显示其并不能真正改善该类患者的生存率.因此,对于稳定型冠心病患者究竟该选择强化药物治疗还是选择血运重建,一直是学术界争论的焦点.《新英格兰医学杂志》2015 年11 月12 日全文刊登了 COURAGE (Clinical Outcomes Utilizing Revascularization and Ag-gressive Drug Evaluation:血运重建和强化药物治疗临床结果评价)研究的长期随访结果,为这一话题又投下了一枚重磅"炸弹".
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严谨快速地为公众提供安全有效的药品——美国FDA临床审评中的几个话题
如果说美国FDA的中心任务之一是监管食品和药品的安全,使美国公众能得到安全的食品,使用安全的药品,那么CDER(Center for Drug Evaluation and Research,药物评价与研究中心)就是这一中心任务的执行者或执行机构.