甲双胍年.ppt

谢谢！ * 二甲双胍相关乳酸酸中毒问题的解决 处方二甲双胍时，避开禁忌症和相对禁忌症，乳酸酸中毒的发生率非常低（估计约3例/100，000病人年）。然而，文献中仍常将二甲双胍与这种严重副反应联系在一起。COSMIC研究，连同一个系统综述，最终解决了这个问题。COSMIC研究的设计是和FDA商议制定的，推动了二甲双胍在美国的正式应用。COSMIC是一个大样本单一试验，通过与其他常用抗糖尿病治疗比较，揭示二甲双胍的安全性。相应地，终点事件集中在严重副反应事件的发生率。这个研究设计良好（随机平行设计），样本规模足以检测二甲双胍相关性酸中毒（如果它发生的话）。 Laying to rest the issue of metformin-related lactic acidosis The incidence of lactic acidosis is very low (estimated at 3 cases/100,000 patient-years of treatment1) when metformin is prescribed according to its contraindications and precautions. However, associations are still often made between metformin and this serious adverse event in the literature. The results of the COSMIC Approach Study2 should finally, along with a systematic review of the subject (described later) should finally lay this issue to rest. The design of the COSMIC Approach Study was negotiated with the FDA to facilitate the introduction metformin into clinical use in the USA. This was a ‘large simple trial’ designed to reveal the safety profile of metformin compared to other usual-care antidiabetic treatments. Accordingly, endpoints focused on the incidence of serious adverse events. The study was well designed (randomised, parallel-group design), and large enough to detect metformin-associated lactic acidosis, should it occur. 1. Howlett HC, Bailey CJ. A risk-benefit assessment of metformin in type 2 diabetes mellitus. Drug Saf 1999;20:489-503 2. Cryer DR et al. Comparative Outcomes Study of Metformin Intervention versus Conventional Approach: The COSMIC Approach Study. Diabetes Care Diabetes Care 2005;28:539-43 * COSMIC研究中二甲双胍治疗没有乳酸酸中毒 二甲双胍的安全性与其他常用抗糖尿病治疗没有差异。尤其是，二甲双胍治疗没有出现乳酸酸中毒。 No lactic acidosis with metformin in the COSMIC Approach study The safety profile of metformin did not differ from that of other usual care antidiabetic treatments. In particular, there was no lactic acidosis. Cryer DR et al. Comparative Outcomes Study of Metformin Intervention versus Conventional Approach: The COSMIC Approach