Strauss W E, McIntyre K M, Parisi A F, Shapiro W
Am J Cardiol. 1982 Feb 18;49(3):560-6. doi: 10.1016/s0002-9149(82)80012-x.
Sixty-three patients completed a multicenter 10 week, double-blind, parallel group protocol evaluating the efficacy of diltiazem versus placebo with respect to rate of attacks of angina, nitroglycerin consumption and duration of treadmill exercise. An additional 36 patients were evaluated for drug safety. A 4 week placebo lead-in phase was followed by a 2 week dose titration period and two treatment evaluation periods of 2 weeks each. Both diltiazem and placebo were associated with a significant reduction in weekly frequency of angina from the baseline rate. Intergroup comparison disclosed a significantly greater reduction for the patients receiving diltiazem than for those receiving placebo. A similar reduction was noted for nitroglycerin consumption. Total exercise duration at week 10 was statistically greater in patients treated with diltiazem. Diltiazem was well tolerated. No abnormalities in hematologic profiles or in routine serum chemistry values were observed; electrocardiographic P-R and QRS intervals were unaffected. Adverse effects that could have been related to drug administration were reported in 11 patients who received diltiazem and in 12 patients who received placebo. Of the 17 episodes in the diltiazem group only 3 were considered significant and drug-related, and only one of these resulted in discontinuation of the drug.
63名患者完成了一项多中心、为期10周的双盲平行组试验方案，评估地尔硫䓬与安慰剂在心绞痛发作率、硝酸甘油消耗量及平板运动持续时间方面的疗效。另外36名患者接受了药物安全性评估。先有4周的安慰剂导入期，接着是2周的剂量滴定期以及两个各为期2周的治疗评估期。地尔硫䓬组和安慰剂组的心绞痛每周发作频率均较基线水平显著降低。组间比较显示，接受地尔硫䓬治疗的患者较接受安慰剂治疗的患者降低幅度更大。硝酸甘油消耗量也有类似降低。在第10周时，接受地尔硫䓬治疗的患者的总运动持续时间在统计学上更长。地尔硫䓬耐受性良好。未观察到血液学指标或常规血清化学值有异常；心电图P-R间期和QRS间期未受影响。接受地尔硫䓬治疗的11名患者和接受安慰剂治疗的12名患者报告了可能与用药相关的不良反应。在地尔硫䓬组的17例不良反应中，只有3例被认为严重且与药物相关，其中只有1例导致停药。
