国产腺苷注射液治疗阵发性室上性心动过速的临床疗效和安全性

Clinical efficacy and safety of homemade adenosine in treatment of paroxysmal supraventricular tachycardia

目的:采用随机、双盲、平行对照多中心试验方法评价国产腺苷注射液治疗阵发性室上性心动过速(PSVT)的临床疗效和安全性。方法:选择126例18-70岁PSVT患者,在心电监测下,先2s内快速静脉冲击注射生理盐水5ml,观察30s不能转变为窦性心律者,随机分入试验(腺苷注射液)组和对照(进口腺苷注射液)组,分别给予国产或进口腺苷注射液3mg,30s不能转变为窦性心律者,可每次增加剂量3mg,最大剂量至12mg/次。记录所用的剂量和转变为窦性心律的时间及不良反应。结果:①试验组3mg、6mg和9mg以下剂量腺苷可分别使49.18%、93.44%和96.72%的PSVT患者恢复窦性心律,达12mg腺苷转复PSVT患者率为100%,与对照组相比无显著性差异(P>0.05)。②试验组和对照组平均起效时间分别是18.95±3.74s和21.67±3.95s。③两组在转为窦性心律前后收缩压、舒张压和心率均无显著性差异(P>0.05)。④两组的不良反应有面红、头晕、胸闷,面色苍白,组间比较无显著性差异(P>0.05)。结论:国产腺苷注射液转复PSVT的疗效与进口制剂相同,临床建议剂量为3-12mg,快速静脉注射。

Objective：To observe conversion rates for paroxysmal supraventricular tachycardia （PSVT）with adenosine.Methods：With the cardiogram monitoring,126 cases of PSVT were randomly divided into domestic adenosine and imported adenosine groups.The patients were given by intravenous injection quickly from first dose of 3mg.The increased dose was 3mg per time until the maximal dose of 12mg if PSVT could not conversed into sinus rhythm.Results：The conversion rates of different dosages of domestic adenosine were 49.1% for 3mg, 93.4% under 6mg and 96.7% under 9mg.All PSVT could be conversed into sinus rhythm under 12mg.The conversion rate and time of homemade adenosine had no significant difference from imported adenosine.There were no differences in blood pressure and heart rate between pre-treatment and post- treatment.The major adverse effects included face blush,dizziness,chest stifling and face pale et al.Conclusion： The domestic adenosine 3-12mg can be given effectively and safely by intravenous injection quickly in treatment of PSVT.