临床试验对糖尿病治疗的影响

W. Rose
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引用次数: 0

摘要

作为推进人类疾病治疗的基础,从经验主义和观察研究到实验方法的转变只是最近才发生的。1948年,英国医学研究委员会(British Medical Research Council)对链霉素治疗结核病的研究开创了现代临床试验时代,为循证医学奠定了基础。临床试验被认为是“在这段时间里,预期寿命增加了七年中的三年,平均额外五年部分或完全缓解了与慢性疾病相关的生活质量低下”。临床试验的巨大扩展与最新疗法的发展是同步的。由于大量药物正在开发中,因此需要进行对照临床试验以获得批准,因此临床试验的数量不会增加。尽管将科学方法引入治疗评估有明显的好处,但临床试验的必要性最近受到了挑战。流行病学研究替代临床试验的支持者认为,观察性研究(包括荟萃分析)得出的结论往往与临床试验给出的答案相似。虽然经验数据可能会提供关于已建立的治疗方法的有用信息,但很明显,它们与临床试验起着非常不同的作用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Influence of Clinical Trials on the Treatment of Diabetes Mellitus
The shift from empiricism and observational studies to experimental methods as the basis for advancing the treatment of human disease has occurred only recently. The modern age of clinical trials, born with the British Medical Research Council’s study of streptomycin treatment of tuberculosis in 1948, has provided the substrate for evidence-based medicine. Clinical trials have been credited with “three of the seven years of increased life expectancy over that time and an average of five additional years of partial or complete relief from the poor quality of life associated with chronic disease”. The enormous expansion of clinical trials has paralleled the event of latest therapies. With the massive number of medicine in development and therefore the requirement for controlled clinical trials for approval, the expanding number of clinical trials isn't expected. Despite the obvious benefits of bringing scientific methods to the evaluation of therapies, the need for clinical trials has recently been challenged. Proponents of epidemiological studies as substitutes for clinical trials have suggested that conclusions from observational studies, including meta-analyses, often give similar answers as clinical trials. Although empirical data may provide useful information regarding established therapies, it should be obvious that they play a very different role from clinical trials.
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