Klein Allan L, Griffin Brian P, Grimm Richard A, Rodriguez L Leonardo, Sallach John A, Morehead Annitta J
Department of Cardiovascular Medicine, The Cleveland Clinic Foundation, Cleveland, Ohio, USA.
Am J Cardiol. 2005 Dec 15;96(12):1711-7. doi: 10.1016/j.amjcard.2005.07.095. Epub 2005 Nov 2.
In 1997, the US Food and Drug Administration (FDA) reported valvular regurgitation (aortic regurgitation [AR] mild or greater and/or mitral regurgitation [MR] moderate or greater) in 32.8% of patients treated with anorexigens. This study sought to determine the natural history of valvular regurgitation in patients who were included in the FDA's original report. This was a nonrandomized, natural history study of these subjects. Cohort I consisted of 155 of 186 patients (83%) who were reported to the FDA. Cohort II consisted of a similar group of 311 patients who were not included. Initial echocardiograms were obtained for medical indications before the study initiation, and study echocardiograms were standardized and obtained at 3-month intervals. Level III echocardiographers performed blinded, side-by-side comparison of the first and last study echocardiograms at a core laboratory. Cohorts I and II consisted of predominantly female, middle-aged, obese subjects. At enrollment, patients in cohorts I and II had mild or greater AR (17.9%, 13.5%) and moderate or greater MR (3.3%, 4.0%), respectively, which was less than in the FDA's report. At follow-up, there were no statistically significant changes in the degree of valvular regurgitation in either cohort when the first and last study echocardiograms were read side by side. In conclusion, this natural history follow-up study demonstrates that MR and AR in long-term anorexigen-treated patients was less than reported to the FDA, did not progress, and remained echocardiographically stable during the 10-month duration of the study.
1997年，美国食品药品监督管理局（FDA）报告称，使用食欲抑制剂治疗的患者中有32.8%出现瓣膜反流（主动脉反流[AR]轻度及以上和/或二尖瓣反流[MR]中度及以上）。本研究旨在确定FDA原始报告中所纳入患者瓣膜反流的自然病史。这是一项针对这些受试者的非随机自然病史研究。队列I由向FDA报告的186例患者中的155例（83%）组成。队列II由未纳入的311例类似患者组成。在研究开始前，因医疗指征获取初始超声心动图，研究超声心动图标准化并每3个月获取一次。III级超声心动图医生在核心实验室对首次和末次研究超声心动图进行盲法、并排比较。队列I和队列II主要由中年肥胖女性受试者组成。入组时，队列I和队列II的患者分别有轻度及以上AR（17.9%，13.5%）和中度及以上MR（3.3%，4.0%），低于FDA报告中的比例。随访时，当并排读取首次和末次研究超声心动图时，两个队列中瓣膜反流程度均无统计学显著变化。总之，这项自然病史随访研究表明，长期接受食欲抑制剂治疗患者的MR和AR低于向FDA报告的情况，未进展，且在为期10个月的研究期间超声心动图表现保持稳定。
