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使用芬氟拉明对患有瓣膜病的芬-芬(fen-phen)患者瓣膜性心脏病严重程度的剂量效应。

Dose-effect of fenfluramine use on the severity of valvular heart disease among fen-phen patients with valvulopathy.

作者信息

Li R, Serdula M K, Williamson D F, Bowman B A, Graham D J, Green L

机构信息

Epidemic Intelligence Service, Epidemiology Program Office and Division of Nutrition and Physical Activity, Centers for Disease Control and Prevention, Atlanta, GA 30341-3717, USA.

出版信息

Int J Obes Relat Metab Disord. 1999 Sep;23(9):926-8. doi: 10.1038/sj.ijo.0801020.

DOI:10.1038/sj.ijo.0801020
PMID:10490797
Abstract

OBJECTIVE

To determine whether the severity of valvulopathy was associated with the dosage of fenfluramine taken by fenfluramine-phentermine users with valvulopathy.

DESIGN

Out of 105 suspected valvulopathy case reports received by the US Food and Drug Administration (FDA) among fenfluramine-phentermine users, 74 patients meeting FDA case definition for valvulopathy were included in this study. Patients with severe valvulopathy were classified as those either undergoing valve replacement surgery or having severe aortic or mitral regurgitation; all other patients were considered to have less severe valvulopathy.

RESULTS

The proportion with severe valvulopathy increased from 20-66% with increasing fenfluramine dosage from </=40 mg/d to >/=60 mg/d. Compared with patients taking<40 mg/d fenfluramine, patients taking >/=60 mg/d had an adjusted odds ratio of 9.2 (95% confidence interval=2.1-40.8) for severe valvulopathy.

CONCLUSION

Compared to patients with less severe valvulopathy, those with severe valvulopathy were substantially more likely to have taken >/=60 mg/d fenfluramine.

摘要

目的

确定瓣膜病的严重程度是否与服用芬氟拉明-苯丙胺的瓣膜病患者所服用的芬氟拉明剂量相关。

设计

在美国食品药品监督管理局(FDA)收到的105份关于芬氟拉明-苯丙胺使用者疑似瓣膜病的病例报告中,74例符合FDA瓣膜病病例定义的患者纳入本研究。患有严重瓣膜病的患者被分类为接受瓣膜置换手术或患有严重主动脉瓣或二尖瓣反流的患者;所有其他患者被认为患有不太严重的瓣膜病。

结果

随着芬氟拉明剂量从≤40mg/天增加到≥60mg/天,严重瓣膜病的比例从20%增加到66%。与服用芬氟拉明<40mg/天的患者相比,服用≥60mg/天的患者发生严重瓣膜病的校正比值比为9.2(95%置信区间=2.1-40.8)。

结论

与瓣膜病不太严重的患者相比,严重瓣膜病患者服用≥60mg/天芬氟拉明的可能性要大得多。

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