Division of Cardiology, Kaiser Permanente, San Jose, California, USA.
Pharmacoepidemiol Drug Saf. 2012 Mar;21(3):276-80. doi: 10.1002/pds.2274. Epub 2012 Jan 9.
The aim of this study was to determine whether the presence of symptoms would aid in the detection of valvular heart disease (VHD) in those exposed to pergolide.
Utilizing a prospective, cross-sectional study design, patients with an exposure to pergolide were asked regarding the presence or absence of chest pain, shortness of breath or lower extremity edema through a questionnaire. Echocardiograms were obtained on the same day as the questionnaire and were blinded to all staff involved in the study. The sensitivity, specificity, positive and negative predictive value of the reported symptoms towards the outcome moderate or severe valvular regurgitation were obtained. Using the area under the receiver-operating characteristic curve, we also ascertained whether a relationship existed between symptoms, pergolide dose and presence of VHD. To understand the associations between symptoms and echocardiographic covariates, a logistic regression analysis was performed adjusted for age and gender.
The sensitivity, specificity, positive and negative predictive value of symptom presentation and total dose was sufficiently low that it did not aid in the determination whether significant valvular regurgitation was present. Multivariable analysis noted a significant association with indexed left atrial volume (p = 0.011), estimated pulmonary artery pressure (p = 0.047) and shortness of breath.
The presence or absence of symptoms does not help guide whether valvular regurgitation is present or absent in individuals exposed to pergolide. Therefore, echocardiography is needed to confirm or refute pergolide-associated VHD.
本研究旨在确定症状的出现是否有助于发现曾接触培高利特的患者是否患有瓣膜性心脏病(VHD)。
采用前瞻性、横断面研究设计,通过问卷询问暴露于培高利特的患者是否存在胸痛、呼吸急促或下肢水肿。同日获取超声心动图,并对参与研究的所有工作人员进行盲法处理。获得报告症状对中度或重度瓣膜反流这一结局的敏感性、特异性、阳性和阴性预测值。我们还通过接受者操作特征曲线下面积来确定症状、培高利特剂量与 VHD 之间是否存在关系。为了了解症状与超声心动图协变量之间的关联,我们进行了调整年龄和性别后的逻辑回归分析。
症状表现和总剂量的敏感性、特异性、阳性和阴性预测值均较低,无法帮助确定是否存在明显的瓣膜反流。多变量分析显示与左心房容积指数(p=0.011)、估计肺动脉压(p=0.047)和呼吸急促显著相关。
症状的出现或不存在并不能帮助指导曾接触培高利特的个体是否存在或不存在瓣膜反流。因此,需要进行超声心动图检查来确认或排除培高利特相关的 VHD。