Rayment C M, Kaul A F, Garfield J M
Am J Hosp Pharm. 1985 Jun;42(6):1362-5.
Factors that might affect patient acceptance of transdermal drug-delivery system patches were evaluated in healthy volunteers using placebo patches. Placebo transdermal nitroglycerin patches (Transderm-Nitro 5 placebo, Ciba Pharmaceutical Company; Nitro-Dur 10 cm2 placebo, Key Pharmaceuticals; and Nitrodisc 5 placebo, Searle Laboratories) were supplied by the manufacturers. Eighty-two healthy subjects were randomly assigned to begin using one of the three brands of patches. Using a Latin-square crossover design, subjects applied each brand of patch daily for five days and crossed over to the other brands on study days 6 and 11. At the end of each study phase, subjects completed a written questionnaire designed to evaluate their overall acceptance of each brand of patch. A total of 80 subjects completed all three phases of the study. According to forced rank preference, 84% of subjects preferred the Ciba patch to one of the other two brands. Subjects judged the Ciba patch to be the easiest of the three brands to use and reported significantly fewer side effects and skin irritation while using the Ciba patch; they also preferred the size of the Ciba patch and experienced significantly fewer problems with adherence of the Ciba patch. A significant percentage of subjects indicated that they would prefer a transdermal patch over tablets or ointment. Most subjects preferred the Ciba patch over the Key patch or Searle patch.
在健康志愿者中使用安慰剂贴片评估了可能影响患者对透皮给药系统贴片接受度的因素。安慰剂透皮硝酸甘油贴片(西巴制药公司的Transderm-Nitro 5安慰剂;基制药公司的Nitro-Dur 10平方厘米安慰剂;以及先灵葆雅实验室的Nitrodisc 5安慰剂)由制造商提供。82名健康受试者被随机分配开始使用这三种品牌贴片中的一种。采用拉丁方交叉设计,受试者每天使用每个品牌的贴片,持续五天,并在研究的第6天和第11天换用其他品牌。在每个研究阶段结束时,受试者完成一份书面问卷,旨在评估他们对每个品牌贴片的总体接受度。共有80名受试者完成了研究的所有三个阶段。根据强制排序偏好,84%的受试者更喜欢西巴品牌的贴片,而不是其他两个品牌中的任何一个。受试者认为西巴品牌的贴片是三个品牌中最容易使用的,并且在使用西巴品牌贴片时报告的副作用和皮肤刺激明显更少;他们还更喜欢西巴品牌贴片的尺寸,并且在西巴品牌贴片的粘贴方面遇到的问题明显更少。相当比例的受试者表示,他们更喜欢透皮贴片而不是片剂或软膏。大多数受试者更喜欢西巴品牌的贴片,而不是基品牌或先灵葆雅品牌的贴片。