地尔硫治疗扩张型心肌病多中心临床试验221例总结报告  

Summary report of multiple centric clinical trial on diltiazem therapy in 221 patients with dilated cardiomyopathy

作　　者：中国扩张型心肌病地尔硫干预试验协作组 

出　　处：《临床心血管病杂志》1997年第4期205-208,共4页Journal of Clinical Cardiology

摘　　要：将全国16家医院的221例扩张型心肌病患者在心衰治疗基础上随机分组，分别加用地尔硫（地尔硫组，n＝114）、安慰剂（安慰剂组，n＝107）进行干预试验，平均随访7．4月。结果表明，与治疗前比较，地尔硫组平均心功能改善1级以上，心胸比（0．59±0．07vs0．56±0．07）和左室内径（65．40±8．60vs61．12±9．86）明显缩小、射血分数（35．75％±10．78％vs42．52％±11．41％）显著增加（P＜0．01），死亡率（3．5％vs11．2％）明显降低（P＜0．05）；而安慰剂组心功能参数无改善。试验还表明地尔硫治疗对心功能参数的影响主要见于左室内径＜70mm组患者。提示地尔硫明显改善扩张型心肌病患者心功能及预后，其主要作用可能是干预抗体介导心肌损伤，保护心肌。The 221 patients with dilated cardiomyopathy (DCM) from 16 hospitals of China were carried out intervention trial using the diltiazem (n=114, 30mg two times daily) or placebo( n= 107) on the basis of the conventional therapy of heart failure by random dividing groups at a mean follow-up period of 7.4 months. Compared with the pretreatment, the heart function was improved over 1 grade, heart-thorax ratio (0. 59±0. 07 vs 0. 56± 0. 07, P<0. 05), the left ven tricular end diastolic diameter (65. 40± 8. 60 vs, 61. 12± 9. 86 ), the left ventricular ejection fraction (LVEF, 35. 75% ± 10. 78 % vs 42. 52 %± 11. 41 %, P<0. 01 ) were markedly increased, mortality (3. 5 % vs 11. 2 %, P<0. 05 ) was reduced in diltiazem group; but the above heart function param eter were not changed in placebo group. Further analysis in subgroups, effect of diltiazem on heart function mainly was observed in patients with DCM group of LVEDd<70 mm. The trials showed that diltiazem obviously improved heart function and prognosis in patients with DCM; the main ef fect might be intervening in antibody-mediated myocardial damage, protecting myocardium.

关 键 词：扩张型心肌病 地尔硫Zuo 药物疗法 

分 类 号：R542.205[医药卫生—心血管疾病]