盐酸去甲乌药碱负荷超声心动图诊断冠心病的有效性和安全性

Efficacy and safety of higenamine hydrochloride stress echocardiography for diagnosis of coronary artery disease

目的评价正性肌力药物盐酸去甲乌药碱负荷超声心动图诊断冠心病的有效性和安全性。方法本研究为前瞻性、随机、开放、对照、交叉设计的多中心临床研究，共纳入90例怀疑冠心病的患者。盐酸去甲乌药碱按0.5、1、2、4 μg·kg－1·min－1剂量递增，每一剂量级负荷时间为3 min。腺苷注射液输注剂量为140 μg·kg－1·min－1，用药时间为6 min，总剂量0.8 mg/kg。超声心动图评价室壁运动采用左室17节段分段法。以冠脉造影为＂金标准＂，冠脉造影诊断冠心病标准为左右冠状动脉主支或其一级分支狭窄〉50%狭窄。记录不良反应。结果盐酸去甲乌药碱组负荷超声心动图的敏感性、特异性、准确性、阳性预测值和阴性预测值分别为28.9%、89.7 %、57.1 %、76.5%和47.8 %，腺苷组分别为26.7 %、94.9 %、58.3 %、85.7%和47.1 %，两组间比较，上述各指标差异均无统计学意义（P〉0.05）。盐酸去甲乌药碱和腺苷超声心动图负荷试验诊断单支敏感性分别为11.1%和5.6%（P〉0.05），双支病变的敏感性均为37.5 %，三支病变的敏感性均为44.4 %。盐酸去甲乌药碱组不良反应的发生率为84.4 %，腺苷组为92.2 %（P〉0.05）。结论盐酸去甲乌药碱超声心动图负荷试验诊断冠心病有较好的特异性，安全性良好，敏感性低，与腺苷负荷超声心动图比较无差别。

ObjectiveTo evaluate the efficacy and safety of higenamine hydrochloride（HG） stress echocardiography for diagnosis of coronary artery disease （CAD）.MethodsThe study was designed as prospective, randomized, open-labled, positively controlled and crossover phase II multi-center clinical research. Ninety subjects who were suspected to have CAD were enrolled.HG dosage was titrated at 0.5, 1, 2, 4 μg·kg-1·min-1 every 3 min. Adenosine was injected 140 μg·kg-1·min-1 for 6 min with total dosage 0.8 mg/kg. Visual assessment of the left ventricle wall motionand 17-segment model were used for analysis of stress echocardiography. CAD was defined as identifying 〉50% diameter stenosis in at least one major coronary artery by coronary angiogram. All adverse reaction were recorded.ResultsFor HG group, the sensitivity, specificity, accuracy, positive predictive value and negative predictive value were 28.9%, 89.7%, 57.1%, 76.5% and 47.8%, respectively; for adenosine group, they were 26.7%, 94.9%, 58.3%, 85.7% and 47.1%, respectively. There was no significant difference between the two groups（P〉0.05）. The diagnostic sensitivities of HG and adenosine echocardiography for single vessel stenosis were 11.1% and 5.6%, respectively（P〉0.05）. Both HG and adenosine echocardiography have the same sensitivity with 37.5% for double vessel stenosis and 44.4% for triple vessel stenosis. Advers reaction rate was 84.4% in HG group and 92.2% in adenosine group（P〉0.05）.ConclusionsHG stress echocardiography for CAD diagnosis has high specificity, good safety and low sensitivity, which are similar to adenosine echo.