Hougham A J, Hawkinson R W, Crowley J K, Wilson R R, Brown S G, Dougherty P J, Fogel M A, Hash V W, Rietbrock M J
3M Riker, St. Paul, Minnesota.
Clin Ther. 1989;11(1):15-22.
Sixty-three angina patients were recruited to participate in a two-week, randomized, open-label, crossover, multicenter trial to compare patient acceptance of two transdermal nitroglycerin delivery systems, Minitran and Transderm-Nitro (TDN). Patients were enrolled if they had stable angina and had been on a stabilized dose (5, 10, or 15 mg/24 hr) of Nitro-Dur II (ND II) for at least one month before entering the study. Patients with a bias against TDN or with any of the contraindications for transdermal nitroglycerin therapy were excluded. During the two consecutive one-week treatment periods, the patients received their prestudy dose regimen of Minitran and TDN in random order. Patients completed daily diaries, weekly questionnaires, and poststudy patient preference evaluation forms. Of the 63 patients who completed the study, 70% preferred Minitran overall (P less than or equal to 0.001), 24% preferred TDN, and 6% had no overall preference.
63名心绞痛患者被招募参加一项为期两周的随机、开放标签、交叉、多中心试验,以比较患者对两种经皮硝酸甘油给药系统Minitran和硝酸甘油透皮贴剂(TDN)的接受程度。如果患者患有稳定型心绞痛,且在进入研究前至少一个月一直使用稳定剂量(5、10或15mg/24小时)的长效硝酸甘油(ND II),则将其纳入研究。对TDN有偏见或有任何经皮硝酸甘油治疗禁忌症的患者被排除在外。在连续两个为期一周的治疗期内,患者以随机顺序接受其研究前的Minitran和TDN剂量方案。患者填写每日日记、每周问卷以及研究后患者偏好评估表。在完成研究的63名患者中,70%总体上更喜欢Minitran(P小于或等于0.001),24%更喜欢TDN,6%没有总体偏好。