Stengaard-Pedersen K, Ekesbo R, Karvonen A-L, Lyster M
Department of Rheumatology, Aarhus University Hospital, Denmark.
Rheumatology (Oxford). 2004 May;43(5):592-5. doi: 10.1093/rheumatology/keh121. Epub 2004 Feb 3.
The primary objective was to demonstrate equivalence between a.m. and p.m. dosing of celecoxib 200 mg q.d. An equivalence assessment of q.d. vs b.i.d. dosing was a secondary objective.
In this randomized, double-blind study, patients with symptomatic osteoarthritis of the knee or hip were randomized to receive celecoxib 200 mg q.d. a.m., celecoxib 200 mg q.d. p.m. or celecoxib 100 mg b.i.d. The primary outcome variable, measured at week 12 on a 0- to 10-point integrated scale, was patient satisfaction assessment (pain relief, walking/bending, and willingness to continue medication). Equivalence was declared if the 95% confidence interval (CI) of the difference (a.m. q.d. vs p.m. q.d., b.i.d. vs q.d.) fell within the interval of -2 to +2.
A total of 697 patients were enrolled in this trial. For the a.m. vs p.m. comparison, the 95% CIs were within the prespecified equivalence criteria for all three measures of patient satisfaction: pain relief, mean -0.2, 95% CI -0.53 to 0.68; ability to walk and bend, mean -0.2, 95% CI -0.54 to 0.64; willingness to continue medication, mean -0.7, 95% CI -0.98 to 0.49. The 95% CIs for the q.d. vs b.i.d. comparison were also within the -2 to +2 interval.
Regardless of the time of day at which celecoxib 200 mg q.d. is administered, patients are equally satisfied with the pain relief, ability to walk and bend, and willingness to continue medication.
主要目的是证明塞来昔布200毫克每日一次上午给药与下午给药之间的等效性。每日一次给药与每日两次给药的等效性评估为次要目的。
在这项随机、双盲研究中，有症状的膝或髋骨关节炎患者被随机分配接受塞来昔布200毫克每日一次上午给药、塞来昔布200毫克每日一次下午给药或塞来昔布100毫克每日两次给药。在第12周以0至10分综合量表测量的主要结局变量为患者满意度评估（疼痛缓解、行走/弯曲以及继续用药的意愿）。如果差异（每日一次上午给药与每日一次下午给药、每日两次给药与每日一次给药）的95%置信区间（CI）落在-2至+2区间内，则宣布等效。
本试验共纳入697例患者。对于上午给药与下午给药的比较，所有三项患者满意度测量指标的95%CI均在预先设定的等效标准范围内：疼痛缓解，均值-0.2，95%CI -0.53至0.68；行走和弯曲能力，均值-0.2，95%CI -0.54至0.64；继续用药的意愿，均值-0.7，95%CI -0.98至0.49。每日一次给药与每日两次给药比较的95%CI也在-2至+2区间内。
无论塞来昔布200毫克每日一次在一天中的什么时间给药，患者在疼痛缓解、行走和弯曲能力以及继续用药的意愿方面的满意度均相同。
