Cryer Byron, Berlin Roger G, Cooper Stephen A, Hsu Ching, Wason Suman
Dallas Veterans Affairs Medical Center, Dallas, Texas, USA.
Clin Ther. 2005 Feb;27(2):185-91. doi: 10.1016/j.clinthera.2005.01.011.
Patients taking aspirin for cardioprotection may occasionally take over-the-counter (OTC) ibuprofen for pain relief, which might interfere with the antiplatelet effects of aspirin.
The present study was undertaken to determine whether ibuprofen, taken according to OTC label directions, would affect inhibition of thromboxane B2 (TXB2), a surrogate for platelet inhibition.
This was a prospective, multiple-dose,single-center, double-blind, randomized, parallel, placebo-controlled study. Eligible subjects received chewable, immediate-release aspirin 81 mg QD for 8 days, and were then randomized to receive either ibuprofen 400 mg TID or placebo TID, in addition to aspirin, for 10 days.
Fifty-one subjects were randomized; 47(24 placebo, 23 ibuprofen) completed the study. No subjects withdrew prematurely. Subjects were predominantly white (49%) or black (38%), and 53% were male. The mean (SD) age was 38.4 (9.8) years and mean (SD) body weight was 173.2 (26.7) pounds. On days 1, 3, 7, and 10 of the study period, mean TXB2 inhibitions were 99.24%, 98.88%, 97.75%, and 98.17% for ibuprofen and 98.82%, 98.93%, 98.75%, and 98.83% for placebo. Although a statistically significant reduction of TXBZ inhibition was seen in the ibuprofen group at days 7 and 10 (P = 0.003 and P = 0.023, respectively), TXBZ inhibition was >90% on all days tested in all subjects. Aspirin, ibuprofen, and placebo were all well tolerated. There were 3 adverse events (1 mild and 2 moderate) during the aspirin run-in period and 8 (2 mild and 6 moderate) during the randomized study period.
No clinically meaningful loss of cardioprotection was found, as reflected by TXB2 inhibition in healthy volunteers who received OTC doses of ibuprofen. When using this regimen of OTC ibuprofen with immediate-release, low-dose aspirin, concerns about the loss of cardioprotective antiplatelet effects of aspirin are not supported by this study.
服用阿司匹林进行心脏保护的患者偶尔会服用非处方（OTC）布洛芬来缓解疼痛，这可能会干扰阿司匹林的抗血小板作用。
本研究旨在确定按照OTC标签说明服用的布洛芬是否会影响对血栓素B2（TXB2）的抑制作用，TXB2是血小板抑制的替代指标。
这是一项前瞻性、多剂量、单中心、双盲、随机、平行、安慰剂对照研究。符合条件的受试者每天服用81毫克咀嚼型速释阿司匹林，持续8天，然后随机分为两组，除阿司匹林外，一组每天服用三次400毫克布洛芬，另一组每天服用三次安慰剂，持续10天。
51名受试者被随机分组；47名（24名服用安慰剂，23名服用布洛芬）完成了研究。没有受试者提前退出。受试者主要为白人（49%）或黑人（38%），53%为男性。平均（标准差）年龄为38.4（9.8）岁，平均（标准差）体重为173.2（26.7）磅。在研究期的第1、3、7和10天，布洛芬组TXB2的平均抑制率分别为99.24%、98.88%、97.75%和98.17%，安慰剂组分别为98.82%、98.93%、98.75%和98.83%。虽然布洛芬组在第7天和第10天TXB2抑制率有统计学意义的降低（分别为P = 0.003和P = 0.023），但在所有测试日所有受试者的TXB2抑制率均>90%。阿司匹林、布洛芬和安慰剂的耐受性均良好。在阿司匹林导入期有3例不良事件（1例轻度，2例中度），在随机研究期有8例（2例轻度，6例中度）。
在接受OTC剂量布洛芬的健康志愿者中，通过TXB2抑制反映出未发现有临床意义的心脏保护作用丧失。当使用这种OTC布洛芬与速释低剂量阿司匹林联合使用的方案时，本研究不支持对阿司匹林心脏保护抗血小板作用丧失的担忧。
