环磷酸腺苷葡甲胺注射液治疗充血性心力衰竭的多中心临床研究报告

目的：评估环磷酸腺苷葡甲胺（心先安）注射液（ＭＣＡ）治疗充血性心力衰竭（ＣＨＦ）的疗效及安全性。方法：采用多中心随机分组安慰剂对照临床试验方法，选择ＣＨＦ心功能Ⅲ～Ⅳ级住院患者。心先安注射液治疗组（ｎ＝６４２例）与安慰剂对照组（ｎ＝６０９例）患者两组基础临床特征有可比性。治疗前后分别进行临床症状、体征计分和心功能分级、心功能指标及心电图测定，观察疗效和记录有无副作用。结果：治疗１周后，治疗组临床总有效率９１．１％，对照组总有效率７０．８％（Ｐ＜０．００１）；按心功能指标评定的总有效率，治疗组为８２．１％，对照组为１４．０％（Ｐ＜０．００１）；按心电图改善程度评定的总有效率，治疗组为５１．１％，对照组为９．０％（Ｐ＜０．００１）。治疗组在用药过程中未见毒副作用。结论：心先安注射液是治疗充血性心力衰竭患者安全有效的新型药物，明显优于对照组，建议推广应用。

Meglumine cyclic adenylate (MCA) injection in treating patients with congestive heart failure

Objective: To investigate the efficacy and safety of MCA in treating congestive heart failure (CHF). Method: The patients with CHF (NYHA class ) were treated for one week.The baseline clinical characteristics of patients were similar between the MCA group (n=642) and placebo group (n=609).Before and after the treatment,clinical symptoms,singns,cardiac functional classes,inotropic indices,and ECG of both groups were investigated,the siedeffects were also observed and recorded. Result: Total effective rate of the MCA group was 91.1% and the placebo group was 70.8% (P<0.001).MCA was associated with a higher rate of improvement in NYHA functional class 82.1% vs 14.0% (P<0.001).and ECG change (51.1% vs 9.0%,P<0.001).There were no significant sideeffects observed in the MCA group. Conclusion: MCA was a safe,effective and new type drug for the patients with CHF.