临床试验clinical trail-2014.pdfVIP

2014/4/22 1 Today：2014/4/22 临床试验 Clinical trail 赵 琦 Today: 22 April 2014 学习目的 掌握实验流行病学的基本概念 掌握实验流行病学的研究设计 了解常见实验流行病学研究方法 Today: 22 April 2014 Citrus Fruit Scurvy James Lind – The first planned, controlled clinical trial Today: 22 April 2014 18th Century Navy Life “the number of seaman in time of war who died of shipwreck, capture, famine, fire or sword, are but of inconsiderable in respect of such as are destroyed by the ship diseases, and by the usual maladies of intemperate climates.” - James Lind, 1753 Today: 22 April 2014 Typical Diet:HMS Salisbury Daily 1 lb., 4 oz. of cheese biscuits 1 gallon of beer 2 days / week 2 lb. salted beef 3 days / week 2 oz. dried fish and butter 4 days / week 8 oz. peas Today: 22 April 2014 Study Design: usual diet + dietary supplement (6 options) 2014/4/22 2 Today: 22 April 2014 Quart of apple juice daily Today: 22 April 2014 25 drops of elixir vitriol (sulfuric acid and aromatics) Today: 22 April 2014 2 spoonfuls of vinegar 3 times a day Today: 22 April 2014 Concoction of herbs and spices Today: 22 April 2014 2 oranges and 1 lemon daily Today: 22 April 2014 half-pint of sea water daily (comparison group) 2014/4/22 3 Today: 22 April 2014 Results of the Experiment “…the most sudden and visible good effects were perceived from the use of the oranges and lemons; one of those who had taken them being at the end of six days fit for duty….The other was the best recovered of any in his condition, and being now deemed pretty well was appointed nurse to the rest of the sick...” - James Lind, 1753 Today: 22 April 2014 1919年， Topley提出了实验流行病学 流行病学实验（epidemiological experiment） 研 究 ， 也 即 实 验 流 行 病 学 (experimental epidemiology)，是将满足实验目的的人群随 机地分为实验组和对照组（或不同水平试验 组），由研究者有控制地给予实验组人群实验 措施或称干预措施，随访并比较两组（或多组） 人群的疾病或健康结局，从而判断该措施是否 有效及效果大小。 Today: 22 April 2014 特征 1.流行病学实验研究是前瞻性研究，必须观察 随访研究对象一段时间，这些研究对象可以在 不同时间进入研究，但是必须有明确的观察起 止点； 2.流行病学实验研究必须有明确的由研究者所 控制的干预措施，措施可以是疫苗、药物或临 床诊断、治疗方法等，可以是一种或多种措施， 这些措施必须施加给至少一组研究对象； Today: 22 April 2014 3.