摘要
目的 以硝酸甘油(NTG)为对照，评价观察静脉注射地尔硫Zhuo(DIL)治疗不稳定心绞痛患者的临床疗效和安全性。方法采用多中心、开放、随机、平行对照试验。共入选患者213例。随机分为静脉注射DIL组和NTG组，DIL组从100μg/min起始，最大用量200～300μg/min；NTG组从20μg/min起始，最大用量80～100μg/min。持续静滴48h。以难治性心绞痛、急性心肌梗死、死亡、急诊经皮冠状动脉腔内成形术、冠状动脉旁路移植术为观察的终点。结果(1)静脉注射DIL与NTG对不稳定性心绞痛患者的症状和心电图的改善同样有效。(2)DIL比NTG更明显地降低了心率和心肌耗氧指数(收缩压×心率)。(3)用药后DIL组较NTG组难治性心绞痛发生明显减少[4例(3．8％)比13例(11．9％)，相对危险度0．32(95％可信限0．11～0．96)，P<0．05]。(4)DIL组较NTG组心率明显减缓(≤50次／min)[8例(7．7％)比0例，P<0．01]，但绝大多数患者均可耐受。(5)DIL组较NTG组减少了患者对β受体阻滞剂或钙拮抗剂的需求量[2例(1．9％)比13例(11．9％)，P<0．01]。结论静脉注射DIL治疗不稳定性心绞痛安全、有效，可降低难治性心绞痛发生的风险。
Objective To investigate the clinical efficacy and safety of intravenous diltiazem compared with nitroglycerin in the patients with unstable angina pectoris.Methods A multicenter,randomized,open lable,parallel group trial was conducted.A total of 213 eligible patients were enrolIed.They were randomized either to diltiazem or nitroglycerin treatment.The diltiazem was administered from 100 μg/min at the initiation of treatment, the largest dosage was 200 300 μg/min; the nitroglycerin was administered from 20 μg/min at the initiation of treatment.The largest dosage was 80 100 μg/min Intravenous infusion was kept over 48 hours.The endpoints included refractory angina pectoris, acute myocardial infarction,death, emergency PTCA and CABG.Results (1) Intravenous diltiazem was effective on the improvement of symptom and electrocardiogram , and its effects were similar to intravenous nitroglycerin.(2)Compared with nitroglycerin,intravenous diltiazem lowered heart rate and myocardial oxygen consumption index (systolic pressure ×heart rate) to more extent significantly.(3)After treatment,the onsets of refractory angina pectoris were reduced more significantly in the diltiazem group than in nitroglycerin group[4(3 8%)vs13(11 9%), RR 0 32(95% CI 0 11 0 96), P <0 05].(4)The patients whose heart rate were reduced significantly (≤50 beats per minute)in the diltiazem group were more than in the nitroglycerin group[8(7 7%)vs 0(0%), P <0 01].But these patients could tolerate the lower heart rate very well in the diltiazem group.(5)The needs of β receptor blocker or calcium antagonists were reduced more significantly in the diltiazem group compared with those in the nitroglycerin group[2(1 9%)vs 13(11 9%), P <0 01].Conclusion Intravenous diltiazem therapy is effective and safe for patients with unstable angina pectoris.It may significantly lower the risk of refractory angina pectoris compared with intravenous nitroglycerin.
出处
《中华心血管病杂志》
CAS
CSCD
北大核心
2005年第3期238-242,共5页
Chinese Journal of Cardiology
