Caldwell J R, Furst D E, Smith A L, Clark J A, Bonebrake R A, Gruhn W B, McIlwain H H, Logue C M
Halifax Clinical Research Center, Daytona Beach, Florida, USA.
J Rheumatol. 1998 Jan;25(1):30-5.
To evaluate the use of a randomized, double blind, drug withdrawal design as a means to test the efficacy of longterm therapy with antirheumatic drugs.
We evaluated 286 patients with rheumatoid arthritis (RA) treated with amiprilose hydrochloride for 1-3 years, with response, with or without other antirheumatic therapy, in a double blind, 12 week withdrawal study that compared patients randomized to continue amiprilose therapy vs patients randomized to placebo. The primary efficacy variable was preventing a predefined degree of clinical reactivation, or flare; the statistical tests of success were a difference in the proportion of flares and in the mean time to flare.
Thirty percent of patients taking amiprilose and 43% of placebo patients experienced flare (p = 0.026). Patients taking amiprilose had a longer flare-free interval compared to placebo patients (p = 0.027), with the time to reactivation or flare becoming statistically different 73 days after withdrawal.
Placebo controlled withdrawal designs are useful as evidence to support the longterm effectiveness of therapy in a proportion of patients with RA.
评估采用随机、双盲、撤药设计作为测试抗风湿药物长期治疗疗效的一种方法。
我们评估了286例接受盐酸氨甲普明治疗1至3年的类风湿关节炎（RA）患者，这些患者无论是否接受其他抗风湿治疗均有反应，在一项双盲、为期12周的撤药研究中，将患者随机分为继续接受氨甲普明治疗组和随机接受安慰剂组进行比较。主要疗效变量是预防预定义程度的临床复发或病情加重；成功的统计检验是病情加重比例和平均病情加重时间的差异。
服用氨甲普明的患者中有30%出现病情加重，服用安慰剂的患者中有43%出现病情加重（p = 0.026）。与服用安慰剂的患者相比，服用氨甲普明的患者无病情加重间隔时间更长（p = 0.027），撤药73天后，复发或病情加重时间在统计学上出现差异。
安慰剂对照撤药设计可作为支持一部分RA患者长期治疗有效性的证据。
