Furst D E, Caldwell J R, Klugman M P, Enthoven D, Rittweger K, Scheer R, Sarkissian E, Dromgoole S
University of Iowa Hospitals, Iowa City.
Clin Pharmacol Ther. 1988 Aug;44(2):186-94. doi: 10.1038/clpt.1988.135.
Thirty-eight patients with active, definite, or classical rheumatoid arthritis were tested in a double-blind, 3-week-per-arm, multiple-crossover, randomized, block-design comparison of 100, 300, 600, and 800 mg/day carprofen given b.i.d. A linear dose-response relationship was demonstrated for six of nine efficacy measures (p less than 0.052). A plasma concentration to therapeutic response relationship was shown just before or 1 to 2 hours after a dose (p less than 0.05) for seven efficacy parameters for the patients with at least three serum carprofen concentrations. By nonparametric analysis, with the patients divided into three equal groups, the percent of responders rose from 38.1% to 50% to 59.1%. Sixty-nine percent of patients responded when carprofen concentrations were greater than 10 micrograms/ml, whereas only 9% responded when they were below 1.9 micrograms/ml. Although only seven patients had limiting side effects, there was a tendency toward a dose-toxicity relationship through 600 mg daily carprofen.
对38例活动性、明确或典型类风湿性关节炎患者进行了一项双盲、每臂为期3周、多次交叉、随机区组设计的比较试验，比较每日两次服用100、300、600和800毫克卡洛芬的效果。在9项疗效指标中的6项上显示出线性剂量反应关系（p<0.052）。对于至少有3次血清卡洛芬浓度测定值的患者，在给药前或给药后1至2小时，7项疗效参数显示出血浆浓度与治疗反应的关系（p<0.05）。通过非参数分析，将患者分为三组，反应者的百分比从38.1%升至50%，再升至59.1%。当卡洛芬浓度大于10微克/毫升时，69%的患者有反应，而当浓度低于1.9微克/毫升时，只有9%的患者有反应。虽然只有7例患者出现了限制性副作用，但在每日卡洛芬剂量达600毫克时，有出现剂量-毒性关系的趋势。
