Effect of low-dose aspirin on urinary 11-dehydro-thromboxane B2 in the ASCEND (A Study of Cardiovascular Events iN Diabetes) randomized controlled trial.
Effect of low-dose aspirin on urinary 11-dehydro-thromboxane B2 in the ASCEND (A Study of Cardiovascular Events iN Diabetes) randomized controlled trial.
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阿司匹林因其阻断血栓素A2的产生而具有抗血小板作用，被广泛用于心脏保护。然而，有研究表明，糖尿病患者的血小板异常阻止了每日一次阿司匹林的充分抑制。在ASCEND随机双盲试验中，对无心血管病史的糖尿病患者每日服用阿司匹林100 mg与安慰剂对照，通过测量尿液中11-脱氢血栓素B2的排泄（U-TXM）来评估抑制作用，随机选择152名参与者（阿司匹林组76人，安慰剂组74人），加上198名（阿司匹林组93人，安慰剂组105人）坚持服用研究药物，并选择在尿液取样前12-24小时最大限度地摄入最后药片。在随机分组后平均2年邮寄的样本中，使用竞争性ELISA法检测U-TXM，并记录在提供样本时服用最后一片阿司匹林/安慰剂片的时间。比较阿司匹林有效抑制（U-TXM < 1500 pg/mg肌酐）和降低U-TXM的百分比。在随机样本中，阿司匹林组的U-TXM比安慰剂组低71% （95% CI 64-76%）。在阿司匹林组的依从性受试者中，U-TXM比安慰剂组低72% (95% CI 69-75%)， 77%的受试者总体上达到了有效抑制。在尿样前12小时以上服用最后一片药的患者中，抑制作用相似，阿司匹林组的水平比安慰剂组低72% (95% CI 67-77%)， 70%的患者达到了有效抑制。每天服用阿司匹林可显著降低糖尿病患者的U-TXM，包括在服用后12-24小时。ISRCTN ISRCTN60635500。于2005年9月1日注册；ClinicalTrials.gov NCT00135226。于2005年8月24日注册在线版本包含补充资料，可在10.1186/s13063-023-07198-z获得。
Aspirin is widely used for cardioprotection with its antiplatelet effects due to the blocking of thromboxane A2 production. However, it has been suggested that platelet abnormalities in those with diabetes prevent adequate suppression with once daily aspirin. In the ASCEND randomized double-blind trial of aspirin 100 mg once daily versus placebo in participants with diabetes but no history of cardiovascular disease, suppression was assessed by measuring 11-dehydro-thromboxane B2 excretion in urine (U-TXM) in a randomly selected sample of 152 participants (76 aspirin arm, 74 placebo arm), plus 198 (93 aspirin arm, 105 placebo arm) adherent to study drugs and selected to maximize the numbers ingesting their last tablet 12–24 h before urine sampling. U-TXM was assayed using a competitive ELISA assay in samples mailed a mean of 2 years after randomization, with time since taking last aspirin/placebo tablet recorded at the time of sample provision. Effective suppression (U-TXM < 1500 pg/mg creatinine) and percentage reductions in U-TXM by aspirin allocation were compared. In the random sample, U-TXM was 71% (95% CI 64–76%) lower among aspirin vs placebo-allocated participants. Among adherent participants in the aspirin arm, U-TXM was 72% (95% CI 69–75%) lower than in the placebo arm and 77% achieved effective suppression overall. Suppression was similar among those who ingested their last tablet more than 12 h before urine sampling with levels in the aspirin arm 72% (95% CI 67–77%) lower than in the placebo arm and 70% achieving effective suppression. Daily aspirin significantly reduces U-TXM in participants with diabetes, including at 12–24 h after ingestion. ISRCTN ISRCTN60635500. Registered on 1 Sept 2005; ClinicalTrials.gov NCT00135226. Registered on 24 Aug 2005. The online version contains supplementary material available at 10.1186/s13063-023-07198-z.
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