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AMI病人及早给予溶栓治疗,使闭塞的冠脉再通,缺血心肌重新获得灌注而免于坏死,降低病死率,保存心功能,已视为80年代心血管治疗学中的一大进展。但就目前已有的溶栓剂,何者较佳?何种投药方法或药物组合,辅助治疗较佳?成为80年代米西方的一个研究热点。经过TIMI-1,-2,-3,ISIS-1,-2,-3,GISSI-1,-2等以大规模(观察达数万人),终点简单明确为特点的一系列临床试验,虽已初步得出结论,认为现有的溶栓剂链激酶t-PA、APSAC三者中,未有一种优于其他两种。但许多问题还未得到解答。目前新溶栓剂的研制、新溶栓方案和假设的提出,方兴未艾。无一不需要经过临床的检证。临床心脏病学在这方面将难免这长期的重负。寻找更有效、实用的评价方法,无疑将有助于研究的更顺利进展。美国哈佛医学院心脏病学教授Eugerie Braunwald是TIMI-1,-2,-3的组织和参与者,在AMI溶栓疗法的临床试验方面积累了大量的经验。他在1992年8月的美国“循环”杂志上撰文建议AMI溶栓疗法临床试验采用“不满意结局”终点代替时下习用的病死率终点,以期减少观察人数,减小临床试验的规模。这种终点能够以较少的观察病例就某个问题得出解答,这样就可以精选研究协作单位。这一点在各临床单位的科研素质参差不齐的我国,尤其有利。观察的项目虽然略多于简单的“死”、“生”,但采用这样的终点既可以使临床试验分析得细些而又不增加临床医生过多的负担,是值得考虑的。鉴于我国亦正在开展溶栓临床试验,故译出供参考。
Thrombolytic therapy in patients with AMI, the recanalization of the occluded coronary arteries, the reperfusion of ischemic myocardium from necrosis, the reduction of mortality, and the preservation of cardiac function have been identified as a major advance in cardiovascular therapy in the 1980s. However, the current thrombolytic agents, which is better? What kind of administration method or combination of drugs, adjuvant therapy is better? Become a hot spot in the 1980s. After a series of clinical trials characterized by large scale (up to tens of thousands of observations) and simple and definite endpoints of TIMI-1, -2, -3, ISIS-1, -2, -3, GISSI- Although it has been initially concluded that none of the existing thrombolytic agent streptokinase t-PA, APSAC three, better than the other two. But many questions have not yet been answered. The current development of new thrombolytic agents, new thrombolysis programs and assumptions put forward in the ascendant. Needless to go through clinical examination. Clinical cardiology will inevitably have this long-term burden in this area. Finding a more effective and practical evaluation method will undoubtedly help to make the research progress more smoothly. Eugerie Braunwald, a professor of cardiology at Harvard Medical School in the United States, is a TIMI-1, -2, -3 organization and participant with a wealth of experience in the clinical trials of thrombolytic therapy for AMI. In an article in the August 1992 issue of Circulation, he suggested that AMI thrombolytic therapy clinical trials use the “unsatisfactory outcome” endpoint instead of the current endpoint of mortality in order to reduce the number of observers and reduce the size of clinical trials. This end point gives answers to a few questions with fewer observed cases, so that you can focus on researching collaborative units. This is particularly beneficial in our country, where the quality of research in various clinical units is uneven. Although the observed items are slightly more than the simple “dead” and “raw”, it is worth considering the use of such an end point to make clinical trials more detailed without increasing the burden on the clinicians. In view of our country is also carrying out thrombolytic clinical trials, it is translated for reference.