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[维拉帕米在冠心病患者中的多中心长期研究]

[Multicenter long-term study of gallopamil in patients with coronary heart disease].

作者信息

Sućić M, Schiemann J

出版信息

Arzneimittelforschung. 1984;34(11):1587-94.

PMID:6543136
Abstract

Efficacy and tolerance of gallopamil (Procorum) were investigated over a period of 1 year under practice conditions in a total of 455 patients (254 male, 201 female), aged 62 years (male) and 66 (female) on an average, with electrocardiographically confirmed coronary heart disease. The most frequently applied dosage was 1 film-coated tablet of gallopamil 50 mg 2-3 times daily. Frequency of attacks and nitro consumption as criteria of efficacy decreased by an average of approx. 80% in comparison to the placebo period. Full effectiveness was usually reached 4 weeks after start of therapy. ST-depression under exercise diminished by approx. 50%. An improved exercise tolerance was likewise observed, especially in patients who only tolerated up to 100 Watt prior to therapy. Therapeutic success was defined as good in 73% of the cases, satisfactory in 17.3% and insufficient in 6.7% by the trial physicians - the patient's opinion also being taken into consideration. A decrease of effectiveness was not observed during the one-year therapy. No uniform influence on the laboratory parameters could be revealed. The most frequent side-effects were: gastric discomfort (13 patients), bradycardia (7 patients) and AV-prolongation (3 patients). A total of 77 patients (16.9%) had to discontinue therapy. 29 out of these discontinuations were not therapy-related (drop-outs); 12 were based on an insufficient therapeutic success, 13 on hospitalization, 11 on extracardiac, 4 on cardiac adverse reactions and 8 patients (1.8%) died during the study. In a global assessment the trial physicians described the tolerability as good in 92% of the patients, fair in 2.9% and poor in 2.4%.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

在实际临床环境中,对455例经心电图确诊为冠心病的患者(男性254例,女性201例,平均年龄男性62岁,女性66岁)进行了为期1年的加洛帕米(Procorum)疗效和耐受性研究。最常用剂量为每日2 - 3次,每次1片50mg薄膜包衣加洛帕米片。与安慰剂期相比,以发作频率和硝酸酯类药物消耗量作为疗效标准,平均降低约80%。治疗开始4周后通常达到完全疗效。运动时ST段压低减少约50%。同样观察到运动耐量有所改善,尤其是治疗前仅能耐受100瓦的患者。试验医生将73%的病例治疗成功定义为良好,17.3%为满意,6.7%为不足,同时也考虑了患者的意见。在一年的治疗期间未观察到疗效下降。未发现对实验室参数有一致影响。最常见的副作用为:胃部不适(13例患者)、心动过缓(7例患者)和房室传导延长(3例患者)。共有77例患者(16.9%)不得不停药。其中29例停药与治疗无关(退出研究);12例基于治疗效果不佳,13例基于住院,11例基于心脏外不良反应,4例基于心脏不良反应,8例患者(1.8%)在研究期间死亡。在总体评估中,试验医生称92%的患者耐受性良好,2.9%为尚可,2.4%为较差。(摘要截断于250字)

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