Department of Psychological Medicine, University of Auckland, Auckland 1142, New Zealand.
Psychosom Med. 2013 Jan;75(1):90-6. doi: 10.1097/PSY.0b013e3182738826. Epub 2012 Oct 31.
Generic medications are associated with reduced perceived effectiveness, increased perceived adverse effects, and increased rates of nonadherence compared with brand-name medications. This study examined the effect of an apparent medication formulation change on subjective and objective measures of medication effectiveness and medication side effects.
Sixty-two university students participated in a study purportedly testing the effectiveness of fast-acting β-blocker medications in reducing preexamination anxiety. All tablets were placebos. In session 1, all participants received a yellow tablet ("Betaprol"). In session 2, participants were randomly allocated to receive Betaprol (no change condition) or a white tablet labeled either as "Novaprol" (branded change condition) or "Generic" (generic change condition). Blood pressure and state anxiety were measured before and after tablet ingestion. Side effects attributed to medication were assessed.
The no change group showed significantly greater decreases in systolic blood pressure (mean [M] [standard deviation] = -7.72 mm Hg, standard error [SE] = 1.45) than the branded change (M = -2.75 mm Hg, SE = 1.44, p = .02) and generic change (M = -3.26 mm Hg, SE = 1.45, p = .03) groups. The no-change group showed significantly greater decreases in state anxiety (M = -1.53, SE = 0.33) than the branded change (M = -0.50, SE = 0.33, p = .03) and generic change (M = -0.52, SE = 0.33, p = .04) groups. Significantly more side effects were attributed to the medication in the generic change (M = 1.83, SE = 0.23) (but not the branded change) condition when compared with the no change condition (M = 0.87, SE = 0.31, p = .03).
Medication formulation change, particularly to generic medication, seems to be associated with reduced subjective and objective measures of medication effectiveness and increased side effects.
与品牌药物相比，仿制药被认为疗效降低、不良反应增加、不遵医嘱的比例更高。本研究旨在考察药物制剂外观改变对药物疗效和药物副作用的主观和客观测量的影响。
62 名大学生参与了一项研究，该研究旨在测试快速起效的β受体阻滞剂药物在降低考前焦虑方面的效果。所有片剂均为安慰剂。在第 1 次就诊时，所有参与者均服用黄色片剂（“Betaprol”）。在第 2 次就诊时，参与者被随机分配到接受 Betaprol（无变化条件）或白色片剂，标签为“Novaprol”（品牌变化条件）或“Generic”（仿制药变化条件）。服药前后测量血压和状态焦虑。评估归因于药物的副作用。
无变化组收缩压降低幅度显著大于品牌变化组（M [标准误] = -7.72 mm Hg，SE = 1.45）和仿制药变化组（M = -3.26 mm Hg，SE = 1.45，p =.03）。无变化组状态焦虑降低幅度显著大于品牌变化组（M = -1.53，SE = 0.33）和仿制药变化组（M = -0.52，SE = 0.33，p =.04）。与无变化条件相比，仿制药变化组（M = 1.83，SE = 0.23）（但品牌变化组则不然）归因于药物的副作用显著更多（M = 0.87，SE = 0.31，p =.03）。
药物制剂改变，特别是仿制药的改变，似乎与药物疗效的主观和客观测量降低以及副作用增加有关。
