ABSTRACT
Objective To evaluate the efficacy and safety of higenamine hydrochloride(HG) stress echocardiography for diagnosis of coronary artery disease (CAD). Methods The 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-1every 3 min.Adenosine was injected 140 μg.kg -1.min-1for 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. Results For 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).Conclusions HG stress echocardiography for CAD diagnosis has high specificity,good safety and low sensitivity,which are similar to adenosine echo.
ABSTRACT
Objective To evaluate the effectiveness and safety of higenamine (HG),a pharmaco logical stress agent,for the detection of myocardial ischemia using SPECT.Methods This study was an open,multi-center,randomized and positively controlled trial with crossover references.It consisted of 120patients clinically confirmed or suspected of myocardial ischemia.Each patient underwent a resting MPI and two separate stress MPI in a randomized crossover manner with intravenous administration of HG or adenosine (Ad) on different days.The severity and extent of myocardial ischemia were diagnosed on stress MPI.The degree of vascular stenosis in terms of percentage narrowing was measured by CAG (＞50％ was defined as coronary disease),thus defined as gold standard.The diagnostic efficacy of HG and Ad was compared.Vital signs,routine blood and urine tests,blood biochemical items and side effects were documented for evaluation of procedure safety.Two-sample t test,x2 or Fisher's exact test,and Kappa test were used.Results A total of 109 patients completed the trim and CAG.The diagnostic sensitivity,specificity,accuracy,positive predictive value,negative predictive value of HG MPI were 56.1％ (32/57),78.8％ (41/52),67.0％(73/109),74.4％ (32/43) and 62.1％ (41/66),respectively,which were not significantly different from those ofAd MPI (52.6％ (30/57),82.7％ (43/52),67.0％ (73/109),76.9％ (30/39) and 61.4％(43/70) ;x2 =0-0.2476,all P＞0.05).The sensitivity of HG vs Ad MPI in the diagnosis of single-,double-and triple-vessel ischemia was 29.6％ (8/27) vs 22.2％ (6/27),64.7％ (11/17) vs 64.7％ (11/17)and 100％ (13/13) vs 100％ (13/13),respectively.The concordance between HG and Ad for the detection of LAD,LCX and RCA ischemia was 95.41％ (104/109),97.25％ (106/109) and 97.25％ (106/109) (Kappa=0.8905,0.8420 and 0.8874).HG did not induce significant systolic blood pressure change during or after administration.Both HG and Ad could induce temporary decrease of diastolic blood pressure.Either HG or Ad induced significantly increased HR during administration and 5 min after administration.The clinical laboratory profile (hematology,serum chemistry,and urinalysis) was either normal or with no significant change.A total of 176 side effects (e.g,dyspnea,short breath,palpitation,dizziness,headache) were found related to HG (69.2％,83/120) and Ad (77.5％,93/120) administration (x2=2.1307,P＞0.05),which were mostly mild and transient.Conclusion HG is a safe and effective pharmacological stress test agent as compared to adenosine for the detection of CAD with SPECT perfusion imaging.