瑞加诺生负荷心肌灌注显像诊断冠心病的初步临床研究

Regadenoson stress myocardial perfusion imaging for detecting coronary artery disease

  • 摘要:
    目的 探讨瑞加诺生注射液作为负荷药物行核素心肌灌注显像(MPI)诊断冠心病的有效性及安全性。
    方法 选取2017年9月至2018年10月于山西医科大学第一医院住院的疑似冠心病的42名受试者进行回顾性研究。采用完全随机法将受试者分为2组:瑞加诺生组男性8名、女性9名,年龄(59.83±7.88)岁和腺苷组男性12名、女性13名,年龄(56.32±7.34)岁,分别行瑞加诺生和腺苷注射液的静息MPI后再行负荷MPI,之后2周内所有受试者均行冠状动脉血管造影(CAG)检查。以CAG结果为标准,分析2组MPI诊断冠心病的效能并观察不良反应。计量资料的组间比较采用两独立样本t检验、配对t检验或方差分析、Wilcoxon Z秩和检验;计数资料的组间比较采用McNemar检验或Fisher's确切概率法;瑞加诺生和腺苷的MPI检查方法的一致性比较采用Kappa检验。
    结果 2组一般资料、CAG阳性率及狭窄程度的比较,差异均无统计学意义(t=−1.503~1.201,Z=−1.346~−0.228,Fisher's确切概率法,均P>0.05)。瑞加诺生负荷MPI诊断冠心病的灵敏度为70.00%(7/10)、特异度为87.80%(36/41)、阳性预测值为58.33%(7/12)、阴性预测值为92.31%(36/39)、准确率为84.31%(43/51);腺苷负荷MPI诊断冠心病的灵敏度为71.43%(10/14)、特异度为86.89%(53/61)、阳性预测值为55.56%(10/18)、阴性预测值为92.98%(53/57)、准确率为84.00%(63/75),2种MPI方法诊断效能的各项指标的比较差异均无统计学意义(Fisher's确切概率法,均P=1.00),其分别与CAG结果比较,均存在中度一致性(κ=0.537、0.525,均P<0.001)。药物不良反应为轻微和暂时的,2组间在脸红、胸痛和胸闷、呼吸困难、头晕和头痛、恶心、心悸等不良反应的比较,差异均无统计学意义(Fisher's确切概率法,均P>0.05),只有腹部不适的差异有统计学意义(Fisher's确切概率法,P=0.044)。
    结论 瑞加诺生作为心脏负荷试验药物用于MPI诊断冠心病,与腺苷注射液比较具有相似的有效性及安全性。

     

    Abstract:
    Objective To investigate the efficacy and safety of regadenoson injection as cardiac stress medicine. It was compared with adenosine injection by using radionuclide myocardial perfusion imaging (MPI) to diagnose coronary disease. Coronary angiography (CAG) was the standard used for this study.
    Methods Forty-two subjects with suspected coronary heart disease who were admitted in the First Hospital of Shanxi Medical University from September 2017 to October 2018 were retrospectively analyzed. All subjects were randomly divided into two groups, namely, regadenoson group (8 males; 9 females; age: 59.83±7.88 years old) and adenosine group (12 males; 13 females; age: 56.32±7.34 years old). All subjects underwent rest MPI and stress MPI. Regadenoson and adenosine were injected as medicines. All subjects underwent CAG within 2 weeks. The diagnostic efficacy of regadenoson and adenosine were compared with the results of CAG, which was defined as the gold standard. Adverse reactions were also observed for the two drugs. Two sample t-test, paired t-test or analysis of variance, and Wilcoxon Z rank sum test were used to compare measurement data. Two sample McNemar test or Fisher's exact test were used to measure data. Kappa test was used to test the consistency of the two groups.
    Results There were no statistically significant difference between the two groups of general data, the positive rate and the degree of stenosis (t=−1.503−1.201, Z=−1.346−−0.228, Fisher's exact test, all P>0.05). With the results of CAG as the gold standard, the diagnosis sensitivity of regadenoson MPI was 70.00% (7/10), specificity was 87.80% (36/41), positive predictive value was 58.33% (7/12), negative predictive value was 92.31% (36/39), and accuracy was 84.31% (41/51). The sensitivity of adenosine MPI was 71.43% (10/14), specificity was 86.89% (53/61), positive predictive value was 55.56% (10/18), negative predictive value was 92.98% (53/57), and accuracy was 84.00% (63/75). No obvious statistically significant difference for each value was found between the two drugs (Fisher's exact test, all P=1.00). The consistency was moderate between the two groups of drugs and CAG (κ=0.537, 0.525, respectively, both P<0.001). The side effects were mild and transient. No obvious statistically significant difference (Fisher's exact test, all P>0.05) was found between the two groups in terms of adverse reactions, such as blushing, chest pain, chest tightness, dyspnea, dizziness, headache, nausea, and palpitation. Statistically significant difference was only found for abdominal discomfort (Fisher's exact test, P=0.044).
    Conclusion Regadenoson injection is similar in terms of efficacy and safety when compared with the injection drug load of adenosine according to the results of myocardial perfusion imaging.

     

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