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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 evaluate the clinical efficacy and safety of domestic adenosine injection in the treatment of paroxysmal supraventricular tachycardia (PSVT) using a randomized, double-blind, parallel-controlled multicenter trial. Methods: A total of 126 PSVT patients aged 18-70 years were enrolled in this study. Rapid intravenous injection of 5 ml normal saline within 2 seconds after electrocardiographic monitoring was used to observe the changes of sinus rhythm in 30 seconds. The patients were randomly assigned to test (adenosine injection) Control (imported adenosine injection) group, were given domestic or imported adenosine injection 3mg, 30s can not be converted to sinus rhythm, can increase the dose of 3mg, the maximum dose to 12mg / time. Record the dose used and the timing of conversion to sinus rhythm and adverse effects. Results: (1) In the experimental group, adenosine at doses of 3mg, 6mg and 9mg could restore sinus rhythm in 49.18%, 93.44% and 96.72% of PSVT patients, respectively, and the rate of adenosine up to 12mg was 100% No significant difference (P> 0.05). ② The average onset time of the experimental group and the control group were 18.95 ± 3.74s and 21.67 ± 3.95s, respectively. ③ Before and after conversion to sinus rhythm, systolic blood pressure, diastolic blood pressure and heart rate had no significant difference (P> 0.05). The two groups of adverse reactions are red, dizzy, chest tightness, pale, no significant difference between groups (P> 0.05). Conclusion: The efficacy of domestic adenosine injection in the recovery of PSVT is the same as that of imported preparations. The recommended dosage is 3-12mg, which is given by rapid intravenous injection.